Biotech

MARKET & OPPORTUNITIES

 Biotech
MARKET & OPPORTUNITIES

CONTENTS
Market Overview 2

Key Opportunities 6

Bio-Agri 12

Bioinformatics 14

Bio-Industrial 16

Key Growth Drivers & Trends 17

Policy & Regulations 23

Key Players 26

Advantage India 33

A report by Ernst & Young for IBEF

 MARKET & OPPORTUNITIES

Market Overview

Indian biotech industry crosses Bio-Pharma continues to lead; Bio-Agri and

the US$ 2 billion mark Bio-Services show impressive growth

The Indian biotech market has doubled in size in the
past two years, reaching a value of US$ 2.08 billion in
2006-07, compared to US$ 1.45 billion in 2005-06. The
industry grew by a remarkable 31 per cent, fuelled by the
rise in domestic business, exports, mergers and acquisitions
and new product innovations. Over the past five years, the
industry has sustained a 30 per cent growth rate, indicating
The Biotech sector in India listed over 325 companies in
2006-07, across the industry value chain. Larger number
of biotech companies are involved in Bio-Pharmaceuticals,
followed by Bio-Services and Bio-Agri. Bio-industrial companies
are still a minority in the Indian market at 5 per cent.
Companies (in percentage) involved in
each Biotech Segment 2006-07

a rapidly maturing market. The sector at present, employs Bio-Pharma 40%

approximately 20,000 scientists, who continue to drive it Bio-Services 21%
towards further growth. Bio-Agri 19%

Biotech Industry Revenues Bio-informatics 14%

Bio-industrial 6%
Segment 2006-07 2005-06 Change
(US$ million) (US$ million) Sourc: Biospectrum-ABLE Annual Survey 2007

Bio-Pharma 1453 1145 26.87% The Bio-Pharma segment, continues to contribute more
Bio-Services 268 175 53.06% than two-thirds of the biotech sector revenues. It recorded
Bio-Agri 225 145 54.85% sales of around US$ 1.46 billion in 2006-07 and a growth of
Bio-Industrial 96 91 5.33% about 27 per cent and accounts for 71 per cent of the total
Bio-informatics 35 29 20.83% industry revenues
Total 2078 1587 30.98% Contribution of Various Segments to
the Total Biotech Revenues 2006-07
Number may appear inconsistent because of rounding off
Bio-Pharmaceuticals 71.00%
Source: Biospectrum, June ‘07
Bio-Services 13.10%
The Indian market currently accounts for a little over Bio-Agri 10.84%
1.1 per cent of the global biotech market. However, its rapid Bio-industrial 4.70%
growth is likely to position it as a leading player in the years Bio-informatics 1.72%
to come. India already ranks third in Asia-Pacific, after Japan
Source: Biospectrum -ABLE Annual Survery 2007
and Korea and among the top 12 globally.
Bio-Agri and Bio-Services, showed the most robust
growth among the Biotech segment and recorded
55 per cent and 53 per cent growth respectively. The Bio-
Industrial sector grew by a relatively modest 5 per cent.
 B IOTECH 

Biotech exports account for US$ 1.2 billion Biotech Industry Exports vs Domestic Sales 2006-07
in revenues
Bioinform 83
atics 17
The Indian biotech industry generated US$ 1.2 billion
from exports alone. Almost, 58 per cent of the industry Bio- 11
Industrial 89
revenues in 2006-07 came from exports, as compared to the
51.5 per cent in 2005-06. This indicates that, India-based
Bio-Agri 5
companies have been focusing on expanding their global 95
horizon.
Bio- 95
Biotechnology Sector Exports from India
services 5
Segment Exports Segment Sales 2006-07
(US$ Million) (US$ million) Bio-pharm 61
aceuticals 39
Bio-Pharma 894 1,453
Bio-Services 256 268 0 10 20 30 40 50 60 70 80 90 100
Bio-Agri 11.4 225 per cent

Bio-Industrial 10.9 96 n Exports n Domestic

Bio-Informatics 29
Total Industry Size 1,201 2,078
Number may appear inconsistent because of rounding
Source: BioSpectrum, June ‘07
Bio-Pharma exports accounted for over 74 per cent of
the overall export market share in 2006-07 and 61 per cent
of the Bio-Pharma segment sales. Following Bio-Pharma,
Bio-Services contributed about 21 per cent of the total
export share. Bio-Agri and Bio-Industrial were the segments
that contributed the least to export revenues in 2006-07.
Sourcs: Biospedrum June ‘07
35
However, for the Bio-Agri and Bio-Industrial segments,
domestic sales contributed a major share of revenues. In
Bio-Pharma, almost 40 per cent of revenues came from
domestic sales
Biotech activity concentrated in key clusters
The research intensive and knowledge driven Indian
biotech industry is predominantly distributed over six major

Segments Contribution to total exports 2006-07 • Department of Biotechnology

• Center for Biotechnology
• Food biotech park (proposed) • The National Institute of Immunology
• Institute of Genomics & Interative
Bio-Pharmaceuticals 74% Biology
• National Brain Research Centre
Bio-Services 21% Panjab
Haryana • National Centre for Plant Genome
Bio-informatics 2% • Food biotech park Research
(proposed)
Bio-industrial 1%
New Delhi
Bio-Agri 1%
Lucknow

Source: Biospectrum -ABLE Annual Survery 2007

Vadodhara • Food biotech park (proposed)
• Savli biotech Park
• Central Drug Research Institute
(proposed)
Kolkata
• Tata Institute of • India Institute of
Mumbai Chemical Biology
Fundamental Research
Bioinformatics and Bio-Services revenues primarily
ride on exports • National Chemical
Laboratory Hyderabad
Pune
• N
 ational Center • C enter for Cellular & Molecular
for Cell Sciences Biology
Out of the total Bioinformatics sales, 83 per cent of the • Hinjewadi Biotech Park • Center for DNA Fingerprinting
& Diagnostics
revenue came from exports, while 17 per cent were • N ational Center for
Bengaluru • Indian Institute of Chemical
Biological Seiences
Technology
accounted by domestic sales. In the Bio-Services segment, • Jawaharlal Nehru Center for
• National Institute of Nutrition
Advanced Scientific Research
a similar trend was observed with sales from exports • India Institute of Science • Shapoorji Pallonji Biotech Park
• Institute of Bioinformatics and • ICIC Knowledge Parke
accounting for 95 per cent of the total segment sales. Applied Biotechnology • Ticel Biotech Park
 MARKET & OPPORTUNITIES
regions in India - Bangalore, Hyderabad, Chennai, Pune-
Mumbai, Delhi and Ahmedabad-Vadodara. Out of these,
Bangalore, Hyderabad, Pune-Mumbai, and Ahmedabad-
Vadodara have been natural biotechnology strongholds.
Recognising the large concentration of biotech companies
and institutions in these regions, the respective State
Governments have provided an impetus for accelerated
growth to the local biotech industry, by establishing biotech
parks and offering incentives to biotech enterprises. On the
other hand, several states in India have induced cluster
formation, by establishing biotech parks, as a first step.
Western region accounted for highest share of
revenues in 2006-07
The western part of India accounted for 48 per cent of the
country’s biotech business in 2006-07, with revenues at
US$ 998 million. This was followed by the southern region
with revenues at US$ 831 million and the northern region
with US$ 249 million. The western part of the country
is home to most of the top diagnostics companies.
Bio-Pharma companies accounted for 44 per cent of
the total companies in the western part, and Bio-Agri
companies followed next with a 31 per cent share. most of
the 50 per cent of Bio-Industrial companies and over half
the country’s Bio-Services companies are concentrated in
the Western region. The Pune-Mumbai and Ahmedabad-
Vadodara clusters are the predominant centres of biotech
activity in the west.
Biotechnology Revenues by Regions
Region 2006-07 Share
(US$million)
North 249 12%
South 831 40%
West 998 48%
Total 2,078 100%
Number may appear inconsistent because of rounding off
Source: Biospectrum ,July ‘07
Karnataka - India’s single largest bio-cluster
The Biotech clusters in southern India comprise mainly
of the Bangalore (Karnataka) and Hyderabad (Andhra
Pradesh) clusters. During 2006-07, Karnataka brought in
revenues worth approximately US$ 488 million, recording
a growth of over 35 per cent over the previous year. Out of
the Total Revenue Generated, US$245 million came solely
from exports. Over 183 biotech companies in India are
based in Karnataka, out of which around 137 are located in
Bangalore, alone.
Hyderabad’s ‘Genome Valley’ is in fact, a natural
bio-cluster, that was later officially demarcated as a bio-
cluster, by the Government of Andhra Pradesh. Genome
Valley, comprises the Shapoorji Pallonji Biotechnology Park
and the ICICI Knowledge Park, among several other leading
biotech R&D institutions and dynamic biotech companies.
R&D and infrastructure investments
in 2006-07 more than US$ 552 million
During 2006-07, the Indian biotech sector saw investments
of around US$ 552 million in both R&D and infrastructure,
a remarkable growth of 38 per cent over the previous
year and the second largest percentage increase in the
past 5 years.
Investments into the Indian biotech industry are
expected to increase at a robust pace. Many international
biotech firms are laying out plans for direct investments in
India. In addition, international organisations such as the
World Bank, have been funding the Indian biotech sector
and Indian companies have been able to attract investors,
such as hedge funds. Despite these positive indications,
there however appears to be a lack of adequate funding
Investments in the Biotech Sector
Year US$ million Growth
2002 - 03 155 N/A
2003 - 04 207 33.86%
2004 - 05 296 42.94%
2005 - 06 401 35.80%
2006 - 07 552 37.58%
Number may appear inconsistent because of rounding off
Source : Biospectrum, June ‘07
for early-stage biotech ventures. According to industry
experts, seed capital to fund start-ups, will be a critical
factor influencing the growth of India’s biotech sector and
Government incentives/initiatives to spur seed capital, hold
the key to the much needed investments.
 B IOTECH 

Biotech Industry Growth (2002-06)

Year Bio-informatics Bio-Industrial Bio-Agri Bio-Services Bio-Pharma

2006 1453 268 225 96 35

2005 1146 175 146 91 29
2004 869 103 80 78 24
2003 670 67 58 32 19
2002 436 57 33 27 18

Source: Biospectrum-ABLE Annual Survey 2007

Industry revenues pegged at US$ 5 billion by 2010

India is estimated to be home to more than 400 biotech

companies by 2010, with nearly 10 of them going public
and another 50 on a high growth curve. The overall size of
the Indian market is expected to touch US$ 5 billion by the
end of this decade, and US$ 25 billion by 2015.
There are almost 17 recombinant products, which have
been approved for marketing in India as of today, compared
to the 12 products present in 2005-06. It is expected that
this number will move up to approximately 100 biotech
products. (both domestic and imported) The industry has
tremendous employment potential and about 50,000
scientists would be working in Indian biotechnology labs
in 2010.
 MARKET & OPPORTUNITIES

Key Opportunities

Bio-Pharmaceuticals Of the top ten bio-pharma companies in India, seven

Bio-pharma generates revenues of US$ 1.45 billion;
Vaccines driving growth
The Bio-pharma sector, comprising vaccines, therapeutics
and diagnostics, generated revenues of around
US$ 1.45 billion in 2006-07, with a growth of almost
27 per cent over the previous year.
were vaccine manufacturers The top five companies
accounted for approximately 45 per cent of the entire
bio-pharma segment and contributed a total of about
US$ 626 million in terms of revenues. Indian bio-pharma is
export-driven, with 61 per cent of revenues coming from
exports.
Vaccines

Bio-Pharma Sector-wise Revenues

At US$ 743 million in revenues, vaccines accounted for
Sector 2006 2005 Change Share in 51 per cent of the bio-pharma market in 2006 (accounting
(US$ m) (US$ m) 2006
for both human and animal healthcare). Serum Institute
Vaccines 743 570 30.41% 51%
was the leader among vaccine players with a turnover of
Diagnostics 231 220 4.97% 16%
US$ 231 million.
Therapeutics 176 156 13.28% 12%
Top 5 Vaccine Companies 2006
Others 303 200 51.46% 21%
Total 1,453 1,146 26.87% 100% Company Revenue
Bio-pharma (US$ million 2006)
Revenues
Serum Institute of India 231
Number may appear inconsistent because of rounding off Panacea Biotec 146
Source : Biospectrum, June ‘07 Venkateshwara Hatcheries 46
Indian Immunologicals 38

Top 5 Bio-Pharma Companies 2006 GlaxoSmithKline 29

Total Vaccines Market 743

Company Revenue Per cent change
(US$ million 2006) from 2005 Number may appear inconsistent because of rounding off
Serum Institute of 231 35.27 Source : Biospectrum, June ‘07
India
Biocon 177 20.73
India recognised as the “Vaccine Capital”
Panacea Biotec 146 37.04
of the world
NovoNordisk 54 26.86
Venkateshwara 46 N/A
The Indian vaccines market is experiencing strong growth
Hatcheries
The country posseces the ability to produce large volumes
Number may appear inconsistent because of rounding off of traditional vaccines at low costs. Several vaccines are
Source : Biospectrum, June ‘07 being procured from India in large volumes by multinational
 B IOTECH 

organisations such as GAVI, UNICEF, PAHO etc. According to
UNICEF, India supplies more than 60 per cent of the world’s
requirement of basic vaccines.
Presently, India is one of the largest producers of
traditional vaccines in the world comprising mainly of
pediatric vaccines such as Anti Rabies Vaccine, Oral Polio
Vaccine, Hepatitis B Vaccine and Hib. Furthermore, a
large number of companies have received approval from
UN, enabling them to supply larger vaccine quantities.
Enhanced capacities in vaccines have also made India an
active global exporter of vaccines.
Pediatric vaccines such as DTP, MCV, polio, MMR etc.
form a major part of the Indian vaccine market. There are
several domestic companies and international players
manufacturing and marketing vaccines at affordable
prices. Early domestic movers in the vaccines business are
Serum Institute of India, Biological E, Panacea Biotec, Bharat
Foundation and the Program for Appropriate Technology
in Health (PATH) for accessing testing technology for a
pneumococcal vaccine. The company also has agreements
with ICMR and WHO for an improved delivery system
for an aerosol measles vaccine. Serum Institute is also
collaborating with ICMR and John Hopkins University for
the development of the Hib vaccine
Indian Immunologicals has been working closely with
the Indian Institute of Science (IISc) to develop a DNA
vaccine for rabies. In a similar manner, Shantha Biotech
is currently developing a cholera and typhoid vaccine in
collaboration with the International Vaccine Institute of
Korea. Shantha Biotech is also working with the National
Institute of Health (NIH) for a rotavirus vaccine.
Select Indian Collaborations
Indian Company Alliance Partner Description

Biotech and Shantha Biotec. Multinational companies such Bharat Biotech Acambis plc (UK) Manufacturing &
International Limited marketing agreement
as GSK and Sanofi Aventis have been manufacturing and for Acambis
supplying vaccines from India for a considerable time. investigational vaccine
against Japanese
Since 1975, the country has seen an impressive decline Encephalities
in the incidence of diseases such as diphtheria, whooping
Panacea Biotec Chiron Vaccine To provide
cough, and measles due to a strong domestic vaccine (USA) breakthrough
industry. Polio is another area where major breakthroughs combination vaccines
to the Indian market
have been made by researchers in India. Despite the immense
Panacea Biotec Combridge In-licensing of CBL’s
progress in these areas, there are many under-served Biostability (UK) stable, liquid vaccine
markets in India. Among these are Japanese Encephalitis technology
and HIV/AIDS. India has one of the highest rates of HIV/AIDS Ranbaxy Sanofi Pasteur Marketing of Vaxigrip,
incidence in the world. As a result, many biotech companies a global preventive
vaccine against
are focusing on developing an HIV vaccine not just for the Influenza
global market, but also for the large domestic market.
Rabies vaccine market in India is valued at about
India recognised as an ideal partner for US$ 93 million
global companies
In India, three million people undergo anti-rabies treatment
Global companies have recognised the Indian expertise and and 30,000 deaths are reported every year- accounting for
engage the services of Indian companies as pre-qualified 50 per cent of mortality from rabies worldwide.
vaccine manufacturers. Global companies than Purchase The domestic market for rabies vaccine is approximately
vaccines from them at highly competitive prices. US$ 93 million, and the export market is valued at about
Cutting-edge research is being carried out by Indian US$ 349 million. Imported vaccines dominate the market
companies in close collaboration with leading research currently, with prices ranging from US$ 8-9 per dose. A full
institutions and companies around the world. For example, course of rabies vaccine costs about US$ 32 in India.
Bharath Biotech has partnered with US-based Novavax to Indian companies are increasingly focusing on
develop an Avian Influenza Vaccine, and also tied up with producing affordable rabies vaccines locally. Bharat Biotech
Acambis to develop a vaccine for Japanese Encephalitis. is one such company that plans to supply Rabirix, a rabies
Chiron is partnering with Serum Institute for a Meningitis vaccine developed by the company, at a price that is
Vaccine. Serum Institute is also collaborating with the Gates 30 per cent lower than the existing vaccines in India.
 MARKET & OPPORTUNITIES
Hepatitis B vaccine market continues to grow
The Indian Hepatitis B vaccine market comprises of both
Indian and multinational players. One of the leading players,
Bharat Biotech, has developed the world’s first recombinant
Hepatitis B vaccine (Revac B) without the use of Cesium
Chloride.
Industry experts predict that there will be a boost in
demand for the Hepatitis B vaccine, due to the Union Health
Ministry’s decision to include the vaccine in the National
Immunisation Program.
Combination vaccines attract industry’s attention
A recent trend in the Indian vaccine industry is towards
high-value combination vaccines. Combination vaccines
are meant to provide protection against multiple diseases,
with lesser number of doses. Companies such as Shantha
Biotechnics and Serum Institute have already produced
combination vaccines and other players are increasingly
showing interest in this area.
Diagnostics
The diagnostics segment at US$ 231 million, constituted
16 per cent of the Indian bio-pharma market during
2006-07. The diagnostics market showed a relatively low
growth rate of about 5 per cent, mainly due to the stiff
competition existing in the Indian market. There are over
50 companies including MNCs involved in the diagnostics
market in India. The top companies have consolidated their
market presence and are growing between 15 to 20 per
cent.
Top 5 Diagnostics Companies 2006-07
Company Revenue
(US$ million 2006-07)
Tulip 40
TransAsia Biomedical 37
Bayer 18
Span Diagnostics 13
Becon Diagnostics 5 million people suffer from diabetes in India. Based on dietary
Others 118
Total Revenues 231
Number may appear inconsistent because of rounding off
Source : Biospectrum, June ‘07
The leading Indian diagnostics company is Tulip with a
turnover of about US$ 40 million in 2006-07.
With the spread of health consciousness and increasing
awareness amomg Indians about diseases such as AIDS,
Hepatitis, etc on one hand and active steps taken by the
Government on the other in promoting community health,
such as compulsory testing by blood banks for AIDS and
Hepatitis, the potential of the diagnostic industry is very
promising.
Large players from across the world have found the Indian
market very attractive and set up their operations in India.
Many of the diagnostic products are being imported, however,
an increasing number of local players and an expanding
customer base have made the market competitive in the
recent past.
Therapeutics
Therapeutics revenues stood at US$ 176 million in 2006,
with a growth rate of around 13 per cent. Human insulin
is the largest contributor to the therapeutics market with
revenues of approximately US$ 88 million. Novo Nordisk
was the leading human insulin company generating
revenues of about US$ 54 million. Novo Nordisk also ranked
fourth among the top bio-pharma companies.
Therapeutics have remained the thrust area in India’s
R&D efforts, with human insulin being the most common
area of research. Plasma proteins have also carved their
own niche in the Indian bio-pharma industry.
Human insulin continues to be
an attractive prospect
There are many brands available in the Indian insulin market
by both local and multinational companies. However, the
market is dominated by multinational companies such as
Novo Nordisk, Eli Lilly and Aventis Pasteur. This is mainly due
to the fact that diabetes patients have been using brands of
multinationals for many years.
There is a large opportunity for insulin manufacturers
due to high incidence of diabetics in the country. Over 37.5
habits and the sedentary lifestyle that many Indians follow,
the country is expected to experience an increased incidence
of about 48 million by 2016. Having recognised the growth
potential for anti-diabetic products, Indian companies have
invested considerably in developing indigenous human

insulin. Indian companies have also entered into various tie-
ups with multinationals to market human insulin products
in the country. In the last few years, Indian companies have
launched rDNA Insulin products under different brands at
lower prices. This intense competition has further pushed
down the price of insulin products, thus making it affordable
for a larger segment of the Indian population.
Major potential for plasma proteins in India
Hemophiliacs are the target population for players
interested in plasma protein R&D. India has over 100,000
people who are affected with hemophilia, contributing
25 per cent to the world hemophiliac population. As a
result of this high incidence, India needs about 900,000
liters of plasma proteins per year. India has been meeting
this requirement so far by sourcing these proteins from
MNCs such as Baxter. However, India has the potential to
manufacture plasma proteins locally. Reliance Life Sciences
has been the first company to tap into this potential. RLS
uses a combination of raw materials from the US, Europe,
and India to develop the plasma products indigenously.
In 2005, the company was able to successfully launch its
first set of five plasma proteins, namely Albumin (AlbuRel)
Immunoglobulin (ImmunoRel), Anti Hemophilic Factor VIII
(HemoRel), Fibrin Sealant (ReliSeal) and Virus inactivated
plasma (ReliPlasma) at prices 30 to 40 per cent lower than
the imported products.
Anti-hemophilic factor is the lifeline of hemophiliacs,
however, only one protein type is manufactured by RLS.
None of the other Plasma protiens is being manufactured in
India as yet (most are imported from Baxter). Manufacturing
these proteins locally would mean that patients can get the
products at short notices and at a much cheaper price.
Monoclonal antibodies are becoming a fast growing
segment in India
A large number of Monoclonal Antibodies (mAbs) have
already been introduced in India by innovator companies,
either through distribution agreements with local
companies, or through their own subsidiaries. The mAbs
market is becoming a fast-growing segment in India,
especially in oncology and auto-immune diseases such as
Rheumatoid Arthritis. At present there are approximately
3 million cancer patients in the country and about 700,000
new cases are added to this every year. Linked to urban
B IOTECH 
lifestyles, Arthritis and Inflammatory Immune Disorders
(AIID) are becoming increasingly prevalent. At present only
a few therapies for oncology are available and the existing
therapies have a high side-effect profile. AIIDS drugs
primarily treat symptoms, representing a large unmet
medical need in the country.
Due to the technological complexity, Monoclonal
Antibodies Development is at a nascent stage in India.
However, having recognised the commercial and the
rapeutic potential, biopharma companies have begun
to take steps for development, either in-house or via
collaborations.
India’s Biocon has partnered with the innovator for
an anti-EGFR (Epidermal Growth Factor Receptor) mAb.
It is indicated for the treatment of head and neck cancer,
non-small cell lung cancer, brain tumors, colorectal cancer
and pancreatic cancer. The drug was approved in India in
2006 for head and neck cancer.
In April 2007, Dr. Reddy’s Laboratories launched
Reditux, in India the generic version of Rituximab, at a price
50 per cent lower than the innovator’s price. Reditux has the
distinction of being the first generic mAb to be launched in
the world.
Zenotech, a Hyderabad-based biopharma company,
has started to build capabilities in the development of
monoclonal antibodies.
Serum Institute of India is another Indian company
witch has taken steps towards development of mAbs. The
company has entered into an agreement with Akorn of USA
for definitive development and exclusive distribution rights
for a rabies monoclonal antibody.
Biosimilars
As the patents for several successful biologicals expire
globally, the manufacturing of biosimilars offers an
increasingly attractive opportunity to Indian biotech
companies. Recombinant proteins and Monoclonal
Antibodies (mABs) are the major targets for biosimilars
being developed globally. More than 95 per cent of total
biotech sales between 2004-10 are expected to come from
these two classes of products alone. More specifically,
Epoetin, Human Insulin, Human Growth Hormone (HGH),
Colony Stimulating Factors (CSFs), Interferon Alpha and
Beta are the key biopharma products coming off-patent .
These products offer a large market size to justify the cost
of biosimilar development. These classes of molecules are
10 MARKET & OPPORTUNITIES
expected to touch annual sales of US$ 12 billion in USA and
US$ 25 billion in Europe by 2015.
The regulatory pathway for approval of biosimilars has
been slow to evolve globally. Risks related to clinical efficacy
and safety of biosimilars have resulted in a cautious approach
adopted by developed countries towards approving
biosimilars. The European Medicine Evaluation Agency
(EMEA) has had a legal framework in place for approval of
biosimilars since 2004. It has introduced guidelines for select
biosimilars in order to ensure a cost-effective and speedy
regulatory process.
While the US still does not have a defined abbreviated
regulatory pathway for biosimilars, the FDA in May 2006 took
a significant step in by allowing the first follow on version of
a Recombinant Human Growth Hormone, Omnitrope. FDA
however stressed that this precedent does not establish a
pathway for approval. Biosimilars gained momentum in the
US in September 2006, with the introduction of the Access
to Life-Saving Medicine Act, this will give FDA the express
legal authority to approve safe biosimilars. The bill has
attracted the wide support of a diverse group of lobbyists,
health plans and pharmacy benefit managers. This indicates
a strong likelihood of the regulatory pathway being in place
soon.
The establishment of regulatory processes for
biosimilars in both Europe and USA open doors to a huge
export opportunity for the Indian biotech industry. Many
Indian companies have already focused their efforts on
developing biosimilars.
Biocon has recently divested its enzyme business by
selling it to Denmark-based Novozymes for US$115 million.
The company aims to focus increasingly on bio-pharma,
more specifically, on biosimilars, alliances, and discovery.
Dr. Reddy’s Laboratories (DRL), India’s largest drug
maker has eight biosimilars in its pipeline currently and
plans to release one every year into the market. The drugs
include Monoclonal Antibodies for cancer and medicine
for arthritis. DRL expects that biosimilars will contribute as
much as 30 per cent to the company’s revenues within the
coming decade.
Wockhardt in India has recently been seeking US
sales of insulin and a genetically engineered version
of Erythropoietin (EPO). Other major companies such
as Nicholas Piramal, Glenmark, US vitamins, and Intas
Biopharma have also been venturing into opportunities in
biosimilars.
Bio-Services
Bio-services, at US$ 268 million, second fastest
growing sector
Bio-services in India includes Clinical Research and
Contract Research Organisations (CROs) and Custom
Manufacturing.
Top 5 Bio-services Companies 2006-07
Company Revenue
(US$ million 2006-07)
Syngene 38.0
Quintiles 36.0
Lambda 15.0
Vimta Labs 13.9
Veeda 13.8
Others 152.0
Total Revenues 268.0
Number may appear inconsistent because of rounding off
Source : Biospectrum, June ‘07
At present there are more than 70 companies involved
in activities such as data management, clinical trials, site
management, bioequivalence, bioavailability studies and
toxicology studies and also knowledge process outsourcing
for the bio-pharma industry. The bio-services sector has
growm by approximately 53 per cent in 2006-07. The
sector contributed revenues of US$ 268 million to Indian
biotechnology, second only to the bio-pharma sector.
Bio-services is also the second fastest growing sector in
Indian biotechnology after Bio-agri.
Biocon’s subsidiary, Syngene, has collected the highest
revenues at US$ 38 million in the bio-services sector
during 2006-07. Syngene also recorded an exceptionally
high growth rate of around 71 per cent over the previous
year. Syngene is followed closely by Quintiles, it registered
revenues of about US$ 36 million and a growth rate close to
65 per cent during 2006-07.
Outsourcing of R&D to India is on the rise and is evident in
the number of deals that have been concluded recently.vii
 B IOTECH 11

Global companies find India an imperative for Examples of Outsourching Deals in Bio-services

outsourcing services
GlaxoSmithKline - Tata Consultancy Services

As clinical trials get larger and more complicated and the
R&D expenditures escalate, global R&D outsourcing creates
a huge opportunity for Indian players. According to industry
sources, India offers a US$ 1 billion opportunity, in clinical
research alone. Global firms, are using different models to
GSK signed a multi-million dollar contract with TCS to establish an
R&D Support center in Mumbai
Bristol -Myers Squibb - Syngene
A research collaboration agreement has been signed to enhance
capabilities and service offerings.

leverage India’s advantage, either through acquiring stakes Acunova Life Sciences - Kiecana Clinical Research
or notching a direct presence to hold a slice of the market KCR (Poland -based) formed a strategic regional alliance with
pie. Abundant manpower, speedy trials, and high quality Acunova Life Sciences for leveraging operations in South Asia, Europe
and Latin America.
of service, make India a preferred destination for global
GVK BIosciences - Drug Development Solutions
clinical services outsourcing.
Leading global CROs in India include Quintiles, ICON, Drug Development Solutions (UK -based) has signed a major long-
term agreement with GVK Bio for providing clinical data management
PRA, Parexel, Chiltern, and ClinPharm, among others. Indian services for clinical trails.
CROs include, Lambda Therapeutics, ClinInvent, and iGATE
Clinical Research International. Many Indian players are
expanding their operations by increasing their manpower
and infrastructure, to develop capabilities and scale to
serve their global sponsors reliably.
India has also been involved in various outsourcing
deals involving bio-manufacturing. Nicholas Piramal is one
of the players which has tied up with numerous leading
global biotech companies for bio-manufacturing.
12 MARKET & OPPORTUNITIES

Bio-Agri

Bio-agri a US$ 225 million opportunity, Maharashtra, Andhra Pradesh, Gujarat, and Madhya
driven by Bt cotton seeds Pradesh are the major states cultivating Bt cotton. Karnataka
and Tamil Nadu also grow Bt cotton. The year 2006 brought
Bio-agri is the third largest contributor to Indian biotech about another drastic change in Indian bio-agri from
industry during 2006-07 with a turnover of US$ 225 million, being an importer of cotton, the country became a net
accounting for almost 11 per cent of the biotech pie. exporter of cotton. Cotton export revenues soared from
However, its growth rate of almost 55 per cent is the highest 0.9 million bales in 2005 to 4.7 million bales in 2006.
among all the biotech segments. Biotech companies are working towards offering
The top three companies in the sector, Rasi Seeds, farmers a broader choice of Bt cotton products to choose
Nuziveedu Seeds, and Mahyco generated over 72 per cent of from Bt cotton will continue to be in great demand in India
the segment’s total revenues. in view of the substantial benefits realised by farmers.
These developments offer many opportunities to the
Top 5 Bio-agri Companies 2006-07
Indian bio-agri industry to introduce newer technologies.
Company Revenue The thrust today is on moving towards cutting-edge R&D
(US$ million 2006-07)
efforts in order to meet the increasing demand for food
Rasi Seeds 81 production in India.
Nuziveedu Seeds 55
Mahyco 27 Rising interest in other GM crops
Ankur Seeds 17
Biotech International 6 About 15 biotech products are under development by both
Others 39
the public and private sector in the country.These crops
offer pest and disease resistance and delayed ripening.
Total Revenues 225
R&D work is also being carried out in the areas of mustard
Number may appear inconsistent because of rounding off hybrids, nutritionally enhanced potatoes, and vitamin A-rich
Source : Biospectrum, June ‘07 golden rice. Long term programmes focused on salinity and
drought resistance in rice also hold immense promise for
Bt cotton continues to be in high demand rice is one of India’s main staple food. Fruits and vegetables
of interest in India with regard to GM crop biotechnology
The Bt cotton seeds market is estimated to be worth US$ 203 are eggplants, tomatoes, and lady fingers, among others.
million. In 2006, India overtook China in the total area under
Bt cotton cultivation - India had 3.8 million hectares as Bio-diesel prospects are picking up
opposed to the 3.5 million hectares in China.
Also, 62 Bt cotton hybrids were approved for planting in India’s bio-fuels market is still in its infancy with only about
India in 2006 as opposed to the 20 in 2005 and four in 2004. 66 million gallons of ethanol being utilised in ten states in
By May 2007, 111 Bt cotton hybrids had were approved for the country. India has just taken the initial step towards
commercial cultivation in India. commercial production of bio-diesel. India’s current

production of bio-diesel is not commercially significant,
however the Indian Government has been actively
promoting the use of ethanol. In November 2006, the
Government declared it mandatory to blend five per cent
of Ethanol with petrol in India.
India has So far managed to develop high-yielding
varieties of jatropha seeds, initiating jatropha nurseries,
setting up pilot plants for bio-diesel manufacture, and testing
bio-diesel in public transport locomotives and buses.
There are a number of corporations in India that are
venturing into bio-diesel production by initiating MoUs
with state Governments to establish plantations on
Government waste land or contract farming with small and
medium scale farmers.
Players such as Southern Online Biotechnologies and
Naturol Bioenergy Ltd. have set up commercial production
units for bio-diesel and established collaborations with
companies in USA and Europe. Naturol Bioenergy is also
negotiating with various tissue culture laboratories in India
to provide participating farmers with the right materials in
order to meet the increasing demands for jatropha seedlings.
Domestic and foreign collaborations are expected to boost
India’s bio-diesel production to 1 million tons per year in
the next two to three years.
B IOTECH 13
Biopesticides and biofertilizers are worth
US$ 19.5 million
Biopesticides and biofertilizers are estimated to have a
market value of almost US$ 19.5 million. Leading players
in this segment include Biotech International, Excel, and
Multiplex.
Phosphate-solubilising micro-organisms witnessed the
highest growth among biofertilizers in India. Biofertilizer
production is predominantly concentrated in the states of
Maharashtra, Tamil Nadu, Madhya Pradesh, and Gujarat.
The Indian Government has been promoting the
concept of Integrated Nutrient Supply System (INSS) - the
use of a mixture of mineral fertilizers, organic manures and
biofertilizers. The INSS method improves soil health and
crop productivity.
Many research universities and institutes have been
pursuing studies in biofertilizers. Among these are the
University of Hyderabad, National Research Center for Plant
Biotechnology, IARI, BARC Mumbai, and TERI.
14 MARKET & OPPORTUNITIES
Bio-informatics
Bioinformatics grows to an estimated
US$ 35 million opportunity
India’s Bioinformatics sector is at a relatively early stage;
however dynamic activity in the segment indicates
exponential growth in the near future. India’s long-existing IT
expertise has contributed immensely to the bioinformatics
segment in the country, giving it a strong base for growth.
Though Bioinformatics has at persent a small share of the
total biotech pie at US$ 35 million, it has sen considerable
activity in 2006-07, and has witnessed launching of new
tools, overseas expansion, acquisitions and funding.
Financial institutions are giving closer attention to the
potential of the bioinformatics sector. For example, Kotak
Mahindra Bank, one of India’s premier banks has invested in
Pune-based V Life Sciences.
Besides, the International Finance Corporation (IFC), an
arm of the World Bank, announced its intention of investing
US$ 6.5 million of equity for a minority stake and debt in
Ocimum Biosolutions. Ocimum Biosolutions also acquired
Netherlands- based Isogen Life Science, and set up its
German subsidiary with the intention of expanding its
presence in the European market.
DBT taking initiatives to promote bioinformatics
The BTISnet program of DBT has taken various initiatives for
promoting networking of information resources, researchers
and major infrastructure facilities all over India in an effort
to promote R&D activities in bioinformatics. The network
system comprises of an apex Center at the DBT headquarters
in New Delhi. This Center is linked to 63 bioinformatics
centers in India, including five Centers of Excellence (CoEs).
The CoEs are in Bose Institute, Kolkata, Indian Institute of
Science, Bangalore, Jawaharlal Nehru University, New Delhi,
Madurai Kamaraj University, Madurai, and University of
Pune, Pune. The CoEs are currently participating in top notch
research projects and are part of various collaborations on
the domestic as well as international turf.
Indian Bioinformatics companies go global
The international client base for Indian bioinformatics
companies has expanded rapidly. These entities include
the National Institute of Health (NIH), University of Mexico,
National Institute for Cellular Biology, Dublin, National
Research Council, Sequencing Center at Halifax, and David
Eisenberg’s research lab at DOE Institute for Genomics and
Proteomics, UCLA, among others.
Pure-play bioinformatics companies in India such as
Strand Life Sciences, Ocimum Biosolutions, Molecular
Connections, Mascon Life Sciences, and Helix have created
indigenous tools for various components across the drug
discovery value chain that are being used in various parts
of the world. Indian biotech companies have not only been
careful in creating a set of products that are accurate, user-
friendly, and inter-operable, but have also been meticulous
about understanding the global industry needs and
dynamics to devise aggressive market entry strategies.
Strand Life Sciences, has created a program called
Avadis, and has managed to sell over 300 licenses for the
product across the world. This software has also received
technology awards from both Red Herring and Frost &
Sullivan, the World Economic Forum selected the company
as a “technology pioneer” in 2007. Avadis is an integrated
decision analytics program that deals with the data mining
and analytics needs of various areas in the life sciences
sector. Strands Life Sciences has also tied up with London-
based Pharmidex to create yet another software that
predicts the ability of molecules to cross physical barriers
in the central nervous system. This software could have
potential applications in the research and discovery aspects

of brain disorders such as Alzheimer’s, Parkinson’s, stroke
and brain cancer. This application could be particularly
important because big pharma companies primarily
develop small molecule drug, which have been found to be
ineffective in treating brain disorders.
NetPro, a program developed by Bangalore-based
Molecular Connections, is one of the world’s most
comprehensive and highly granular curated databases of
protein-protein interaction and protein-small molecule
interactions. The program consists of contextual data on the
nature of interactions, pathways, diseases, and location.
Tata Consultancy Services (TCS) signed a multi-million
dollar contract with US-based Sequenom to develop
software solutions. TCS is expected to provide the basic
framework of validated components to Sequenom to
support the company in developing and deploying the
software products to its clients in a minimum time frame.
Industry experts claim that there are three main areas
of opportunities in Indian bioinformatics these include
integrated research application service providers, providers
of database services and discovery software, and the
providers for software requirements of the biotech industry
including micro-array analysis, sequence analysis, database
software, visualisation software, array management and
testing in silico.
B IOTECH 15
DNA chips market shows rapid growth in India
The emerging DNA chips market is valued at about
US$ 1 million and has witnessed a growth of 50 per cent.
DNA chips can tell researchers about the activity and
sequence of many genes in a test sample with a single,
short procedure. These chips are becoming increasingly
important in academic and industry-based research as they
increase the understanding of the influences of a multitude
of factors on disease processes. More than 2000 chips are
currently being consumed in India and the current market
size for DNA chips is 4000-5000. The standard chips are
priced anywhere around US$ 100 - 500, but the disease-
specific chips can be priced much higher.
Because of the expansive range of research that is being
done in India, the demand for DNA chips has also increased.
With the increasing support of the Government for biotech
R&D, it is expected that the demand for DNA chips will
further rise, thereby providing a window of opportunity for
entrepreneurs looking for a niche biotech area to focus on.
The Leading companies in India involved in DNA
chips are Agilent Technologies, Affymetrix, and Ocimum
Biosolutions. These companies sell anywhere around
500 to 1000 chips a year and their clients are often key
institutes that purchase DNA chips in bulk quantities.
16 MARKET & OPPORTUNITIES

Bio-industrial

Bio-industrial sector contributes as food processing, agriculture, animal nutrition, dairy,

US$ 96 million to Indian biotech
The bio-industrial sector in terms of venue touched almost
US$ 96 million with a growth rate of 5.33
per cent in 2006-07. Despite its modest growth, the volume
of the sector has been on a healthy rise and the application
spectrum of industrial enzymes has been increasing.vii
The top five companies in the bio-industrial sector
contributed 87 per cent to the sector’s total market value.
Novozymes and Biocon, with revenues US$ 24 million and
at US$ 23 million respectively, are the largest players in the
sector followed by Advanced Enzymes, Rossari Biotech
and Zytex. Novozymes and Biocon account for almost
50 per cent of the sector’s value.
aquaculture, and marine products. Textile processing has
shown a growing demand for enzymes, so in order to meet
this demand, Rossari Biotech imports enzymes from the US
and supplies formulations to the Indian companies
Potential in exports of enzymes
Many opportunities exist in the manufacturing of industrial
enzymes for export purposes. The Government of India has
also supported this sector by funding many projects related
to industrial enzymes, thus helping the industry to grow
and compete with global players. Some companies such
as Biocon and Rossari are already involved in exporting
enzymes.

Top 5 Bio-services Companies 2006-07

Company Revenue
(US$ million 2006-07)
Novozymes 24
Biocon 23
Advanced Enzymes 17
Rossari Biotech 16
Zytex 4

Others 12

Total Revenues 96

Number may appear inconsistent because of rounding off

Source : Biospectrum, June ‘07

About 15 companies in India are involved in the enzymes

business with some into manufacturing and others into
marketing. Traditionally industrial biotech companies have
focused on chemicals, textiles, breweries and tanneries for
applications of their products. However, existing companies
are now looking closely into new areas of application such

Key Growth Drivers and Trends
A combination of several trends are steering the growth of the
Indian biotech sector, the main trends are highlighted below:
Pharmaceutical companies focus on biotechnology
The success stories of leading biotech players like Biocon
and Serum Institute of India have caught the attention of
several pharma industry players. Major pharmaceutical
companies are now exploring opportunities for diversifying
into biotechnology as a natural choice. This integration
of biotechnology into mainstream research can be seen
in the activities of large pharma companies such as
Ranbaxy, Cadila Healthcare, Lupin, Wockhardt, Dr. Reddy’s
Laboratories (DRL)and Intas.
DRL set up its biotechnology division in 1998 to establish
the recombinant proteins technology platform in India. The
company marketed its first biotechnology product, Grastim
(used in chemotherapy-induced neutropenia and in bone
marrow transplantations) in 2001. Today DRL has several other
recombinant products for the treatment of cancer, diabetes,
and cardiovascular diseases in its R&D pipeline.
More recently in 2006, Ahmedabad-based Cadila
Healthcare announced its entry into the biotech market
by building a strong pipeline of biopharmaceuticals in
oncology and blood disorders. The company expects to
market its biotech products by 2007-08. Cadila Healthcare
has developed its business plan in a away that 30 per cent
of the revenues come from biotechnology.
Cipla, one of India’s largest pharma companies, has also
ventured into biotechnology. The company, focused on
chemistry-based medicine manufacturing and marketing
segment for almost 70 years, it has how decided to enter
the biotech market for the first time.
Other traditional pharma companies in India are
following a similar path.
B IOTECH 17
Indian biotech players expand their capacities
to global standards
The major biotech players in India have been putting
concerted efforts into expanding their facilities and
capabilities in order to create global scale and meet
international standards. This creates favourable situation
for partnerships with international companies.
Biocon has announced its intention to set up a new
plant worth US$ 116 million in Visakhapatnam, Andhra
Pradesh. The new facility is intended to be larger than
the company’s other two plants at Bangalore and will be
manufacturing insulin and biosimilars or generic biotech
drugs for exports. The investment has been planned over
the next five years. In addition, a high-end R&D facility has
also been planned near Hyderabad, with another US$ 122
million of investment. The R&D facility covers 10 acres of
land as opposed to 50 acres for the manufacturing facility.
Approximately 500 new employees are expected to be
recruited in the first phase of expansion.
On a similar note, Reliance Life Sciences (RLS) announced
at the end of 2006 its intention to invest US$ 219 million
into the establishment of four new facilities for producing
home-grown clinical and generic products. The units are
intended to be spread between North India (Haryana,
Punjab, or Himachal Pradesh), Maharashtra, and Gujarat.
The products developed at these facilities are intended
to be 40 per cent cheaper than the imported life-saving
medicines that are currently use in.
Reliance Life Sciences also announced its plans to set
up a world class Clinical Data Management Center (CDM)
in Bangalore, Karnataka. This will enable RLS to become a
fully integrated entity in the global clinical research arena.
The project is estimated to cost around US$ 120-150 million
and a team of 100 scientific and software professionals are
expected to be involved in the project at the initial stage.
18 MARKET & OPPORTUNITIES
The center will handle both in-house projects and client-
based global outsourcing projects.
Direct investments from international biotech firms
Foreign companies are increasingly showing interest and
confidence in the Indian biotech market by making direct
investments into the industry.
At the beginning of 2007, Avesthagen managed to
raise around US$ 36 million from Europe’s Groupe Danone,
Groupe Limagrain and two other strategic investors. Group
Danone, a food major, invested nearly US$ 7 million through
its subsidiary Daninvest for R&D in bio-nutritional products.
Daninvest managed to acquire a four per cent stake in
Avesthagen in the process. Fidelity International acquired a
ten per cent stake by putting in nearly US$ 15 million and
Groupe Limagraine, a European seed major, invested over
US$ 7 million. The new funds will be used for infrastructure
expansion, manufacturing and R&D units, acquisition of
domestic and overseas technology companies, and small
seed units. The company also plans to ramp up its manpower
from the current 250 to around 600 people in covring
months
In mid-2007, the Indian Government approved 17 FDI
proposals amounting to a total of almost US$ 30 million.
Of this total, Shantha Bioetchnics Ltd., a Hyderabad-based
biopharmaceutical firm, will receive close to US$ 10 million
from its majority French partner Merieux Alliance.
Perhaps, the largest vote of confidence in India’s
biotechnology market comes from Amgen-the world’s
largest biotech company. Amgen has opened a wholly
owned subsidiary, Amgen Technology, in Mumbai in early
2007. The Indian branch of the US biotech player will
initially be focusing on clinical development and trials
for Amgen’s drugs, It will work with Contract Research
Organisations (CROs) in India and East Asia. Amgen, valued
at an impressive US$ 14.3 billion, spends over US$ 2 billion
on R&D per year. Amgen is currently working on building
alliances with domestic companies to support its R&D
operations (preclinical development, data management
support and statistical programming).
Other foreign biotech companies like Moscow based
Shreya Life Sciences and Syngenta have invested in India
in the past either by funding or setting up research facilities
in India.
Collaborations, alliances and acquisitions becoming
the norm
In recent years there has been an unprecedented surge
in partnering activity in the life science sector in general
and biotechnology in particular. Mergers, acquisitions,
joint ventures, and other collaborations are becoming the
preferred route to global competitiveness.
The Indian Government and biotech companies have
recognised that partnerships not only allow a means of
entrance into new global markets, but also provide a way
for the domestic industry to expand its competencies and
capacities across the R&D value chain.
RLS announced in 2007 its plans to acquire a company
either in Europe or USA in order to ramp up its clinical
research services business. This move will allow RLS to
widen its customer reach in developed markets and
conduct multi-location phase III tests for its clients. RLS
has also planned to acquire a 74 per cent stake in a
UK-based biotech company called GeneMedix for about
US$ 31 million RLS plans to invest a total of US$ 68 million
in GeneMedix over the next five years as a means to launch
its biosimilars in both Europe and USA.
Biocon announced in early 2007 its plans to enter into
a research partnership with international pharma player
Bristol-Myers Squibb through Biocon’s subsidiary Syngene.
Syngene will be provide R&D services the pharma company
for discovery and early drug development. The partnership
will occur through a dedicated research facility at the Biocon
Park in Bangalore housing over 400 scientists.
Biocon has also signed a Memorandum of
Understanding (MoU) with Deakin University in
Australia, a multi-disciplinary research center focusing
on biotechnology and biosciences research. The MoU
includes the establishment of the Deakin Research Institute
in Bangalore and joint development of a Mammalian Cell
Bioprocessing facility in Australia. In addition, the University
will conduct research on metabolic diseases on behalf of
Biocon.
Panacea Biotec Ltd., one of the largest vaccine producers
in India, acquired a 10 per cent stake in UK-based Cambridge
Biostability Limited (CBL) for a little over US$ 380,000 at the
end of 2006. CBL has also signed a long term licensing
agreement with Panacea Biotec where Panacea will
in-license CBL’s technology to develop, produce and market
combination vaccines for diphtheria, whooping cough,

hepatitis B, haemophilus influenza B and tetanus. CBL has
been working on making vaccines that do not require
storage under refrigeration or reconstitution before use. The
joint venture will allow Pancea Biotec a greater insight into
the development and application of thermostabilisation
technology- an area that CBL specialises in.
Furthermore, Ocimum Biosolutions, a leading integrated
life-sciences solution provider, joined Microsoft’s Bio IT
Alliance in mid-2007. BioIT was created in 2006 it is a
cross-industry group which focuses on integrating Science
and Technology in order to speed up the pace of drug
discovery and recognise the opportunities in personalised
medicine. The alliance includes various pharmaceutical,
biotech, software, and hardware companies. Ocimum
Biosolutions will be playing a key role in addressing the
growing need for intelligent informatics solutions in the
Global Life Sciences Scenario.
Other recent partnerships in India include Nicholas
Pirmal’s acquisition of Avecia, a UK-based biotech company,
in an effort to improve its innovation and contract research
base.
Advinus announced a US$ 150 million drug discovery
deal with Merck in November, 2006 and Merieux Alliance
(a French biotech major) bought a 60 per cent stake in
Shantha Biotechnics, thereby boosting Shantha’s vaccine
capacities to the global level.
The Indian Government has also been actively pursuing
collaborations with other countries as can be seen by the
Indo-Norwegian initiative. DBT in India and the Research
Council of Norway (RCN) intend to set up joint research
initiatives in biotechnology. The initial focus will be on
vaccines research for fish and animals, after which the
products will be marketed and new areas of research will
be taken up. DBT and RCN will jointly fund all projects
as per the guidelines of a roadmap that is to be created
by stakeholders from both countries. One of the main
objectives of the venture is to promote the development of
aquaculture and animal health in India and Norway.
DBT also signed another MoU with the National Research
Council (NRC) in Canada in 2006. The main objective
of the tie up is to promote research collaboration in
biotechnology by encouraging close interactions between
DBT and NRC. The initial focus will be on harnessing plants
for improving human and animal health, and establishing
an understanding of the genomics of plants that are of
common interest to both countries. Besides, other areas
such as vaccine design, production and delivery systems
B IOTECH 19
and bio-devices will also be studied as part of the project. To
jump start the venture, India and Canada agreed to launch a
workshop on ‘Plants For Health’ that was organised by NRC
Plant Biotechnology Institute, Saskatoon in March 2007.
Various other international collaborations are being
pursued by the Government. Some of these have already
been in progress and others are new ventures.
On-Going Bilateral Programs
- Indo-Denmark
- Indo-Finland
- Indo-France
- Indo-Mongolia
- Indo-Singapore
- Indo-UK
New Bilateral Programs
- Indo-Cyprus
- Indo-EU
- Indo-Norway
- Indo-Ukraine
- Indo-Venezuela
- Indo-Canada
A number of conferences and seminars have also been
arranged by the industry and the Government in an effort to
encourage partnerships in the biotech industry. In November
2006, the Global BioPharma Conference Group, comprising
of companies from various countries, organised a conference
to bring to focus synergies in global biotechnology and to
promote partnerships between Indian and US companies.
This conference was held in collaboration with various US
research universities, the major challenges being faced by
the industry were discussed in detail.
Increased Governmental support for biotechnology
The market growth and foreseen potential of the Indian
biotech industry together has provided a stroing stimulus
for Government Initiative in not only supporting, but
also enhancing the opportunities available for players
in this sector. Biotechnology, has carved its own niche
in the economic growth agenda of national and state
policymakers. The Central and State Governments are
increasingly putting efforts into simplifying the regulatory
system for biotechnology. In addition, the Governments
have Initiated a number of proactive reforms for the
industry.
At the Central Government level, Union Finance
Minister P Chidambaram claimed, that over the next couple
20 MARKET & OPPORTUNITIES
of years the biotech industry will receive similar benefits
and advantages as currently provided to the IT industry.
These prerequisites will accelerate scientific research in the
country and eventually result in more innovation and lower
heath care costs.
In addition, there is a National Biotechnology
Development Strategy in the works by the Indian
Government. With the goal of building India’s capabilities
to globally competitive standards, the strategy is intended
to offer a package of incentives and policy measures that
will encourage further industry expansion. There is also an
independent National Biotechnology Regulatory Authority
(NBRA) being set up by the Department of Biotechnology
(DBT) in order to simplify the current multi-clearance system
for products. DBT has also announced its intention to invest
about US$ 52.5 million in 2007-08 on R&D (including new
programmes in medical biotechnology other than those
already in place).
The fast pace at which the biotechnology industry in
India has been growing has convinced states like Gujarat,
Andhra Pradesh, Maharashtra, Karnataka, and Tamil Nadu
that biotechnology has the potential to contribute greatly
to the socio-economic growth. As a result, many Indian
states have introduced supportive policies to promote
industry expansion at the state level. In addition, many
of the state Governments have entered public-private-
partnerships with developers to build biotechnology parks
like the Shapoorji Pallonji Biotech Park (Andhra Pradesh),
Lucknow Biotech Park (Uttar Pradesh), Savli Biotech Park
(Gujarat), etc.
The Maharashtra State Government in collaboration
with the Confederation of Indian Industry (CII), organised
a seminar in 2006 titled ‘Bio Business Opportunities in
Maharashtra, India This aimed at creating awareness among
leading industry players (both domestic and international)
about the potential biotechnology opportunities in the
state. The Maharashtra State Government has also been
actively promoting the development of various biotech
parks, R&D centers and pilot plant facilities for contract
research by placing equity stakes in these projects.
Strengthening Confidentiality and IP protection
In 2005, as a consequence of the TRIPS agreement, India
entered the product patent regime. This move drastically
repositioned the Indian biotechnology industry and its
standing from a global perspective. Roche India Pvt. Ltd.
was the first life sciences company in India to be granted a
product patent. The patent was approved in February 2006
for Roche’s biotech drug Pegasys.
Immense efforts are being placed on making the patent
filing system, examination, search and grant procedures
simpler. As a result, many other product patents have been
successfully approved by Indian authorities since Roche’s
breakthrough. Efforts are also being made to increase the
presence of judicial courts which deal with IP issues in order
to accommodate the growing strength of IP standards.
Currently, patent applications can be submitted in one of the
four locations in India: Delhi, Chennai, Mumbai, and Kolkata.
The strengthening IP scenario in India has contributed
greatly in attracting international biotech players to invest
in the Indian biotechnology sector.
Increased biotech funding for the Indian market
The Indian biotech industry today has a large scope for
investment in order to push R&D to the next level and enable
the industry to grow. It has now become apparent that
investors, who had earlier been wary of the risks associated
with investing in a nascent industry like biotech in India are
now showing an increased confidence in the growth of the
Indian biotech market. The same confidence is now shared
by the state Governments in the country. Various global and
domestic financial institutions are also showing interest in
investing in the biotech market. Among these investors are
entities such as Andhra Pradesh Industrial Development
Corporation (APIDC), Axis Holdings, Chrys Capital, 3i, ICICI
Venture, Kotak Mahindra, Nadathru Holdings, UTI Venture
Funds, and Yes Bank.
Besides, the industry is also taking initiatives to
promote awareness about the various investment
opportunities in Indian biotech indistry. The Association
of Biotechnology Led Enterprise (ABLE) planned a major
workshop titled “Bioinvest”, in collaboration with leading
investment companies in November, 2006 in an effort to
spur the growth of biotech investments. Industry experts
predict that the biotech sector will receive investments of
US$ 730 million to US$ 850 million over the next two years
this includes funding from VC companies, private equity
funds, investment bankers and Indian Central and State
Governments.
Reliance Industries Ltd. is partaking in the US$ 27
billion venture financing space in India through Reliance
Life Sciences (RLS). RLS recently invested between
 B IOTECH 21

US$ 40 to 50 million in a US$ 650 million biotech venture
fund, titled MPM BioVentures IV, floated by US investment
management firm MPM Capital. RLS will invest in start-up
Indian biotech companies that are into R&D. RLS expects
to gain business from at least two-thirds of the clients who
will be associated with the US$ 650 million fund by MPM.
RLS expects that its involvement in this fund will enable it
to gain access to intellectual capital and the capabilities for
the management of life sciences venture funds.
The Gujarat Biotech Venture Fund (GBVF) a 12 year
close-ended fund managed by Gujarat Venture Finance
Limited (GVFL), has a target corpus of about US$ 122 million.
The GBVF has committed itself to invest in start-ups as well
as in early-stage companies involved in areas of biopharma,
bio-agri, contract research, and industrial biotechnology.
GVFL announced its intention of providing almost
US$ 487,000 for early stage biotech funding to Ahmedabad-
based Celestial Biologicals in September, 2006.
Among international investors, the International Finance
Corporation (IFC-the private sector arm of the World Bank
Group) committed equity of up to US$ 4 million to the
APIDC Biotechnology Fund. The fund was established by
APIDC Venture Capital Ltd., the organisation that launched
India’s first biotech focused VC fund. The final closing of the
fund was in April 2005, resulting in total fund amounting to
US$ 37 million. Important investors who contributed to the
fund include IFC, Washington, APIDC (a State Government
institution), Life Insurance Corporation, Andhra Bank, and
the Technology Development Board (TDB), a Government
technology funding institution.
In August 2006, Avestha Gengraine managed to raise
around US$ 24 million from European banks to expand its
facilities and product pipeline. Other global entities that are
interested in investing into Indian biotech include Bank of
America and Citibank.
ICICI, India’s largest private sector bank, announced
in late 2006 that it has allotted over US$ 243 million for
the funding of small pharma and biotech companies and
projects in the country. Of the corpus, ICICI had already
approved loan applications worth US$ 155 to 170 million.
The bank has inducted people from the biotech industry
in order to ensure better understanding of the way the
industry works, and thereby, service the industry in the
most optimal manner. ICICI has signed a MoU with the
Government of Maharashtra to provide banking services in
the biotech sector within the state.
The Government of Maharashtra has also signed three
other MoUs with leading banks in an effort to provide
funding for biotech projects in Maharashtra. These MoUs
have been signed with the Punjab National Bank, State
Bank of India (SBI), and the new private sector entity, Yes
Bank. The agreement asks that the banks to provide timely
and necessary credits and cater to other financial needs
of biotech entrepreneurs. SBI will be handling about
US$ 170 million of the total US$ 1.09 billion, an amount
that has been set aside for small and medium enterprises
and mid-corporates in Maharashtra and Goa. Yes Bank
has an exposure of about US$ 36 million for various
biotech companies and the bank has also decided on a
US$ 125 million life sciences fund out of which some part
will be allocated to biotech companies. The Government
of Maharashtra is also planning a biotech fund named
Maharashtra Biotech Fund this fund will be created out of
budgetary allocations.
Emerging areas in biotechnology are stem cell
research and nanotechnology
Stem cell research continues to pick up momentum in India
and significant investments have been made in this field.
DBT has jointly formulated draft guidelines for stem cell
research activities permissible (such as adult and umbilical

Indian Biotech Players involved in Stem Cell Research

Reliance Life Sciences (RLS)
Asia Cryo-Cell
- S etting up an animal house for conducting regulatory toxicology and preclinical efficiency studies
for cell -based therapies
- Stem cell banking firm
- Plans to set up an extensive clinical trial programne at its stem cell transplant center in Chennai
using technologies licensed from companies in Japan and USA

Life Cell - Based in Chennai

- Operates 26 stem cell transplant centers all over India
- Plans to open five more centres in 2007 and have up to 50 centers operating
in India by the end of 2008
- Has collaborations with CRYO-CELL International (CCI) USA - the world’s largest cord blood bank.
22 MARKET & OPPORTUNITIES

cord blood stem cell research), restricted (embryonic stem

cell research), and prohibited (reproductive cloning and
the introduction of animal embryos in humans). Due to the
marginally less controversial debate about embryonic stem
cells and cloning in India as compared to Western countries,
there has been much room for progress in the field and
Indian players are moving in to tap into this potential.
The Center for Cellular and Molecular Biology (CCMB)
has collaborations with Deccan Medical College (DMC) for
liver stem cell research and the Japan-based Nichi-in Center
for Regenerative Medicine for human trials using stem cells
in end-stage liver failure patients.
The Central Government has also taken active interest in
stem cell research this can be seen by DBT’s move to set up
a Center for Stem Cell- a research facility which will would
undertake studies on stem cell applications for diseases.
DBT has provided Christian Medical College, Vellore about
US$ 6 million and appointed the college to set up the
center. DBT has also been approved by the Indian Council
to conduct India’s first ever multi-centric clinical trials with
stem cells at five hospitals in the country.
The All India Institute for Medical Sciences (AIIMS) has
also been doing therapeutic stem cell research work using
bone marrow mononuclear cells in clinical trials involving
about 40 patients.
The convergence of nanotechnology and biotechnology
has created an opportunity for the innovative development
of medical advances spanning the continuum of drug
discovery and development. Research in Nanotechnology
is being carried out in about 20 top academic and scientific
institutions in India.
Indian biotech is already making use of nanotech
applications as can be seen in the case of Dabur Pharma.
The company recently developed a nanotech-based
chemotherapy agent called Nanoxel. The nanoscale drug
delivery system is the country’s first indigenously developed
chemotherapy agent, and is also the first developed outside
of USA.
 B IOTECH 23

Policy & Regulations

Regulatory framework biotech has accomplished to date and the framework for
the future within which strategies and specific actions
The biotech regulatory structure in India comprises to achieve further growth can be taken. The DBT expects
several administrative bodies in order to accommodate that the NBDS will increase India’s biotech revenues to
the cross-sectoral reach of the industry. In order to ensure US$ 5 billion and increase the workforce by adding one
human and environmental safety, the Government has million jobs by 2010. The NBDS assimilates the opinions
established a multi-regulatory structure for the approval of of various stakeholders of the industry-scientists,
GM crops and biotech products for human health. The key educationalists, regulators, representatives of society and
body under the Ministry of Science and Technology is the others. The ten-year strategy addresses various issues such as
Department of Biotechnology (DBT). DBT is responsible for human resource development, academic-industry interface,
approvals for investments and technology-related activities infrastructure development, laboratory and manufacturing,
in biotechnology. Drug Controller General of India (DCGI) promotion of industry and trade, biotechnology parks and
is responsible for the approval of pharmaceutical products incubators, regulatory mechanisms, public education and
including those that are recombinant in nature. awareness building. The most prominent features of the
NBDS have been outlined below:
Government of India
• T he Government will focus on increasing the number of
Department of Ministry of PhD programs in the biosciences and biotechnology in
Biotechnology Environment India since academic leaders are critical for innovation.
A National Task Force will be created to establish model
Regulatory Genetic
Recombinant undergraduate and postgraduate curricula, attract talent
Committee On Engineering
DNA Appraisal
Genetic Manipulation Approval to the life sciences and enable working conditions for
Committee (RDAC)
(RCGM) Committee (GEAC)
scientists to undertake industry oriented research
• Proven technologies such as diagnostics and vaccines will
Institutional Safety
Committee (ISC) be scaled up and infrastructure for biotechnology R&D
Source: ABLE
(especially for molecular modeling, protein engineering,
drug designing and immunological studies) will be
further expanded. DBT plans to establish a Single Window
National Biotechnology Policy Clearance mechanism in an effort to make approval of
biotech plants simpler and also encourage private players
Having recognised rapid growth that Indian biotech to contribute to the infrastructure development for Indian
industry is undergoing and the vast potential the industry biotech
has in India, the Indian Government has adopted various • In order to increase the value from R&D investment
measures in an attempt to ensure further growth. Among and IPR generation, the Government will provide active
these is the National Biotechnology Development Strategy support through incubator funds and provision of various
(NBDS) by the DBT. The NBDS is a compilation of what Indian incentives. In addition to these the Government will also
24 MARKET & OPPORTUNITIES
focus on innovation capacity and the ability to maintain
a continuous pipeline of products. The Government
will establish policies for promotion of innovation and
commercialisation of knowledge so that the industry can
grow
• G
 overnment support in the form of fiscal incentives and
tax benefits will be provided to the biotech sector since
it is a research-intensive industry and has companies
that invest about 20 to 30 per cent of their operating
costs on R&D or technology outsourcing. In addition,
in order to sustain innovation, the Government will
financially support early phase product development and
small/medium enterprises, as they will eventually play a
major role in sustaining innovation
• D
 BT is creating the Small Business Innovation Research
Initiative (SBIRI) as a means to support small and medium
sized enterprises through grants and loans. The initiative
will enable the support of pre-proof concepts, early stage
innovation research, and provide mentorship.
• Various biotech parks are being set up across India in an
effort to facilitate the transfer of technology by serving
as a platform for entrepreneurship through partnerships
among investors from academia, R&D institutions, and
the industry
• The National Biotechnology Regulatory Authority
will be established to meet the need for a scientific,
rigorous, transparent, efficient, and consistent regulatory
mechanism for bio-safety evaluation
National Biotechnology Regulatory Authority
The National Biotechnology Regulatory Authority (NBRA),
being established by DBT, is expected to be fully operational
in about two years. Although it will be administered by the
DBT, the NBRA will remain an independent science-based
body that is completely separate from the bureaucracy
and will be headed by a renowned scientist. The Indian
Government is working closely with US regulatory bodies
such as the FDA, US Environmental Protection Agency
(EPA), and United States Department of Agriculture (USDA)
to create a robust science-based regulatory structure that
would allow for faster application of biotech methods
in agriculture, veterinary and medical sectors within a
framework that meets global standards. In order to keep
regulators and scientists up to date with the changes the
biotech industry faces on a regular basis, an advanced
school of learning will be a part of the regulatory body
Other Recent Policy Initiatives/Developments
The DBT, in collaboration with the Department of Science
and Technology is currently planning to set up a mission
mode program in biomaterial and medical devices to
promote R&D and industrial activity. The Departments are
also setting up various institutions for research to help the
biotech sector pick up momentum in India. DBT also invited
project proposals from Indian scientists (as individuals or
interdisciplinary groups) in mid-2006 for initiating R&D
projects in the area of vaccine development, formulation and
evaluation. DBT proposed to provide competitive financial
support to applicants having proven track records.
The Government has been actively spreading awareness
of the growing potential of biotechnology in India. It has also
made many provisions, both fiscal and non-fiscal, in order
to encourage the growth of the industry. By collaborating
within the public system and with the private sector as well,
the Indian Government has been working towards a strong,
integrated, and sustainable base for the rapidly growing
biotech industry.
State-led initiatives
After having studied other countries, the Indian Government
has recognised that cluster formation leads to dynamic
growth of the life sciences industry globally. Therefore
the State Governments in India have been aggressively
promoting biotechnology through the formation of biotech
clusters, i.e., biotech parks. By offering fiscal incentives in
addition to basic infrastructure, many states in India have
adopted a public-private-partnership model to develop
biotech parks in India. These parks not only attract tenant
companies and institutions because of the fiscal benefits,
but also because of the ease of both industry and industry-
academia collaborations which promotes faster growth
and progress. In addition to facilitating biotech parks, State
Governments in India have also been establishing biotech
policies at the state level. For example, the Government
of Goa announced that it will be establishing a State Level
Implementation Committee (SLIC) to ensure the smooth
implementation of its Biotechnology Policy 2006. The policy
has been formed in an attempt to increase biotech research and
industry in the state of Goa. Under the policy, the Government
promotes R&D through financial and infrastructural support
and also encourages public-private partnerships.
 B IOTECH 25

Select Biotech Parks in India

Park Operating Model Area Occupied (Approx) Facilities

S.P. Biotech Park, Hyderabad - P

 ublic-Private (Private
player-Shapoorji Pallonji
Group)
ICICI Knowledge Park, - P
 ublic-Private
Hyderabad (Private Player - ICICI Bank)
- P
 hase I - 145 acres (100%
Occupied
- Phase II - 162 acres (75%
Booked)
- Phase III - Proposed
- 200 acres
- (Innovation corridor I (Phase
1 & phase 2, 100% Booked
and Occupied, Phase III
- Under Construction,
(Innovation Corridor III 100%
Booked)
- L and plots of varying sizes.
- Basic infrastructure like quality roads,
continuous water supply and uninterrupted
power.
- Ready to use modular laboratory
- Developed plots
- Virtual information System
- Shared facilities like NMR, etc.
- Dedicated electric substation, Sound telecom
connectivity, Water & sewage treatment plants,
etc.

TICEL Bio Park, - Govt. of Tamil Nadu - 5 acres (Expected complete - Wet Laboratories
Chennai occupancy by 2006) - T ransgenic Greenhouse
- Training Center
- Bioinformatics infrastructure

International Biotech - P
 ublic-Private (Private - 1 10 acres (Under - Independent plots
Park, Pune player- The Chatterjee Construction) - 10 Laboratory modules
Group (TCG)
- Developments India Pvt.
Ltd.)
KINFRA Biotech Park, - P
 ublic-Private (Private - 50 acres (Proposed) - N.A
Kochi Player- TCG)

Source : Ernst & Young Analysis

In a similar move, the Government of Gujarat
announced a five-year biotechnology policy to accelerate
biotech growth in the state. The Biotechnology Policy
(BT) Policy 2007- 2012 has been created as an attempt to
increase biotech business by five times. Under the policy, the
State Government will provide incentives and concessions
as well as support in the form of infrastructure, training,
accreditation etc. The Government has also decided to fund
new biotech research projects to some extent in order to
jump start the industry’s progress. Karnataka has decided to
address the shortage of trained manpower by establishing
a Finishing School in Biotechnology in July, 2007. Various
industry experts are working in collaboration to design
the course content and duration. The Finishing School is
intended to prepare graduates for the skill sets that are
required in the industry. It is expected that the training
offered by the Finishing School will cover many skill aspects
that biotech companies spend much time and money to
cover in thier in-house trainings. The Syndicate Bank has
agreed to start an education loan for the program.
Budget 2007-08
provide the much needed support to sustain the biotech
industry’s growth. The Association of Biotechnology Led
Enterprises (ABLE) had presented a set of recommendations
to the Finance Minister as part of the pre-budget exercise. Of
these, one of the key demands of these recommendantions
that was met by the Government was the removal of clinical
services and drug development research from the realm
of service tax levy, thereby making clinical services more
competitive in the global market.
Additionally, the incentive on R&D expenditure spend
has been given a five-year extension on 150 per cent
weighted average tax deduction.
Also, excise duty has been removed for life saving
vaccines and recieved focus HIV detection and control has
by the Government.
Biotechnology has received a boost through excise duty
and sales tax exemption. Bio-pharma also benefited from the
2007-08 Budget as manufacturing and specific equipment
(including medical equipment) was awarded duty reduction.
The Budget also provides tax benefits to VCs investing
in biotechnology, thereby creating a positive business
environment for the Indian market.

The Union Budget proposals for 2007-08 are expected to

26 MARKET & OPPORTUNITIES

Key Players

Top 5 biotech companies in India are companies have crossed US$ 122 million in revenues Serum
home grown is well on its way to crossing the US$ 243 million mark.
Among the top companies there is a balanced mix of
The top 30 home grown Indian biotech companies companies involved in bio-agriculture, bio-services and
contributed US$ 1.05 billion in revenues, accounting for bio-pharma activities. Bio-industrials and bioinformatics
a little over 50 per cent of the total revenue, indicating are segments that are still in the process of picking up
rapid pace of development of the domestic industry. momentum in India. Venkateshwara Hatcheries and
Serum, Biocon, and Panacea, all of which are home grown Indian Immunologicals are among the leading players
for poultry and animal health care respectively. In the
Top 20 Companies 2006-07 bio-industrial segment, companies such as Advanced
Enzyme Technologies and Rosari Biotech made it to the top
Company Revenue change from
(US$million) 2005-06 30 biotech players.
2006-2007 Serum Institute of India grew by about 35 per cent
in 2006-07, making it the top biotech company in India.
Serum Institute of India Ltd. 231.4 35.27%
Leading bio-agri companies Rasi Seeds and Nuziveedu Seeds
Biocon 200.2 19.62%
moved ahead to make it to the top 5 biotech companies in
Panacea Biotec 145.9 37.04%
India. The top 5 companies in India contributed 35 per cent
Rasi Seeds 81.1 7.70%
of the total industry revenues with the top 3 involved in the
Nuziveedu Seeds 55.1 262.16%
bio-pharma segment and the fourth and fifth in bio-agri.
Novo Nordisk 54.0 26.86%
Furthermore, 16 out of the top 20 companies had revenues
Venkateshwara Hatcheries 46.4 N/A
over US$ 24 million in 2006-07.
Indian Immunologicals 38.4 54.50%
Mahyco Monsanto Biotech 36.6 - 61.58%
GlaxoSmithKline 29.2 27.66%
Leading Indian biotech companies
Aventis Pharma 29.1 4.50%
Shantha Biotechnics 28.0 39.90%
Serum Institute of India Ltd.
Eli Lilly and company 27.3 31.76%
Mahyco 26.9 - 6.00% Serum Institute of India Ltd Fact File
Bharat serums 26.4 39.00%
- S egment: Bio-pharma
Novozymes South Asia 24.3 20.48% - Start-up year: 1966
Intervet India 19.6 22.99% - Biotech Revenue 2006-2007: US$ 231 million
- Leader in Vaccines market
Bharat Biotech International 17.0 45.53%
- Launched HIB vaccine
Ankur Seeds 16.9 N/A - Involved with global organisations in conducting clinical trials for
Advanced Enzymes 16.9 23.75% Meningitis vaccine
Technologies - Bought stakes in UK-based Lipoxen
- Entered into agreement US-based Akom

Source: ABLE Annual Survey 2007 Sourcs: Biospectrumw, June 2007


Serum, with record sales of around US$ 231 million in
2006-07 and a growth of 35 per cent, continued to be the
leading vaccine company and largest biotech company in
India. At 80 per cent, Serum’s overseas sales hold the key
to its growth. The company supplies vacancies to over
130 countries and is an Indian leader for MMR and Hep B
vaccines.
Serum’s subsidiary company, Serum International rapid
revenues of about US$ 10 million in 2006-07with a growth
of 16 per cent, making the entire Serum group’s revenues
touch almost US$ 242 million.
Serum Institute of India Ltd. Business Revenues 2006-07
2006
2005 171
2004
123
0 30 60 90 120 150 180 210
US$
Source: Biospectrum , June 2007
The year 2006-07 was a significant one for Serum with
the launching of its indigenously developed HIB vaccine
(also available in the market as SiiHIB Pro vaccine). The
company is currently the only indigenous manufacturer
of HIB vaccine in India. Serum is able to produce over
100 million doses of the vaccine and plans to supply this
vaccine to the Global Alliance for Vaccines and Immunisation
(GAVI), Pan American Health Organisation (PAHO) and
UNICEF at prices lower than those quoted by MNCs.
Furthermore, Serum bought a 14 per cent stake in
Lipoxen PLC, a bio-pharma company specialising in the
development of oncology drugs, differentiated biologicals,
and vaccines. This has allowed Lipoxen to raise US$ 5 million
in funds from Serum and in return, Serum will have access
to some of Lipoxen’s technology.
Serum has also collaborated with Akorn, an US-based
company giving Akorn the rights for exclusive distribution of
rabies monoclonal antibodies. In return, Akorn is to help fund
Serum’s product development through milestone payments
including the successful completion of Phase I, Phase II, and
Phase III clinical trials, and receipt of CBER approval for a
Biological License Applications (BLA) license (expected to
occur in 2012). Serum has also offered Akorn the first option
to obtain exclusive marketing rights in the entire Americas for
Anti-D human monoclonal antibody. Akorn also has the first
option right to expand marketing into Europe.
B IOTECH 27
Serum Institute is also actively involved in the
development of vaccines for the world’s poorest countries
where vaccines are in critical shortage. Serum’s involvement
in the Meningitis Vaccine Project (MVP), a partnership
between Seattle-based non-profit PATH and the WHO, has
spurred the company to complete Phase I trials of a new
conjugate vaccine against serogroup A meningococcal
disease. The vaccine will now be tested in Africa in order
to make it a part of the public health vaccine collection.
The vaccine can also be used in India during the sporadic
occurrences of the disease.
The Serum Institute has also set up the first biotech SEZ,
known as Serum Bio Pharma Park, in Pune at the beginning of
231 2006. The multi-phase project will require a total investment
of approximately US$ 292 million, with the first phase
requiring a minimum US$ 122 million that will be covered by
the company. The whole project is expected to be completed
240 by 2010. About one billion doses of various vaccines are
expected to be made per year from this SEZ alone.
Biocon Ltd.
Biocon Fact File
- S egment: Bio-pharma/Bio-industrial/Bio-services
- Start-up year: 1978
- Biotech Revenue 2006-07: US$ 200 million
- Strong in stains, immunosuppressants, and recombinant insulin
- W
 ide range of products across key therapeutic segments:
diabetology, cardiology, and oncology
- Syngene entered into research partnership with Bristol-Myers
Squibb
- Developing Nasulin with Bentley
- Signed a MoU with Abu Dbai’s NMC Group
- Launched BIOMAb-EGFR for head/neck tumors
- Established a partnership with Ferozsons Laboratories in Pakistan
- Launched a comprehensive portfolio of renal therapy products
Source : Biospectrum, June 2007
Biocon reported revenues of about US$ 200 million in
2006-07 from the sale of bio-pharma and industrial enzyme
products. This amount accounted for 83 per cent of the
total operating revenues for Biocon,. It showed an almost
20 per cent growth from the previous year’s revenues of
around US$ 167 million. Research services and licensing
accounted for the remaining 17 per cent of the operating
revenues, jumping from US$ 24 million in 2005-06 to almost
US$ 40 million in 2007-08 (growth rate of 63 per cent). As
a group, Biocon ended the financial year with revenues of
about US$ 241 million.
28 MARKET & OPPORTUNITIES
The Biocon Group consists of Biocon Ltd. (focused on
bio-pharma), Syngene International, Clinigene, and Biocon
Biopharmaceuticals. Syngene does custom research work
(bio-services) while Clinigene is involved in clinical research
work. Syngene is the leading company for bio-services in
India. Biocon Biopharmaceuticals focuses on new molecule
developments.
Biocon Ltd. Business Revenues 2006-07
2006
2005 167
2004
157
0 25 50 75 100 125 150 175
US$
Source: Biospectrum , June 2007
Biocon’s bio-pharma capabilities are strongest in the
areas of statins, immunosuppressants, and recombinant
insulin. The company has an extensive product range in the
areas of diabetology, cardiology, and oncology, amongst
others. Having begun with a focus on fermentation-
derived microbial enzymes in 1984, Biocon has extended
its activities into new domain areas such as bioprocess
development, gene expression technologies, proteomics,
bioconversions, and secondary metabolites. Biocon’s strong
R&D and engineering skills can be seen with the invention
of PlaFractor- a tool that is able to present novel production
processes for therapeutic molecules.
Nasulin, an intra-nasal insulin spray being developed
by Biocon, has been approved by the Drug Controller
General of India (DCGI) for Phase II trials on type-2 diabetic
patients. Bentley Pharmaceuticals has conducted the
pharmacokinetic clinical studies with the drug in India
and is planning to complete the majority of the US clinical
Phase II trials soon. IN105 is yet another non-injectable
insulin product that Biocon is working on simultaneously
with Nasulin. Both Nasulin and IN105 are expected to hit
the market in about three to four years.
Biocon plans to manufacture and market an array of
bio-pharma products in a joint venture with Abu Dhabi’s
NMC Group. An MoU has been signed for the venture and
the products will be made available to the Gulf Cooperation
Council (GCC) - the region’s first initiative to develop and
market bio-pharmaceuticals. The set of drugs will cover
Biocon’s specialty therapeutic segments such as cardiology,
diabetology and oncology- and will contribute to GCC’s
US$ 5 billion pharmaceutical market.
BioMAb-EGFR, a therapeutic monoclonal antibody-
based drug for treating tumors of epithelial origin was
launched in India by Biocon and is the first of its kind to be
clinically developed in the country. The product has shown
positive results in trials initiated in various countries and is
being studied overseas for its potential use in treatments
for lung, colorectal, glioma, and pancreatic cancers.
Biocon also launched a complete portfolio of renal
therapy products priced 35 per cent cheaper than current
200 products. The company has major plans of expanding its R&D
activities and has decided to double its R&D expenditure in
2007-08 for this purpose. Biocon also plans to out-license
12 of its molecules over the next one to two years.
200
Panacea Biotec
Panacea Biotec Fact File
- S egment: Bio-pharma
- Start-up year: 1984
- Biotech Revenue 2006-07 : US$ 146 million
- Product pipeline includes Hep B vaccine, and other vaccines for
renal disease, neuropathy, cough and cold, and pain management
among others
- R eceived first supply order from WHO in 2007
- Many new drugs added to product list in the formulations segment
- Entered into collaboration with Netherlands Vaccines Institute for
IPV vaccine in 2006
- Acquired a 10 per cent stake in Cambridge Biostability
- Planned joint venture with Vovartis Vaccines
- Planning launch of Polprotec in India and overseas
Source : Biospectrum, June 2007
2006-07 was a significant year for Panacea Biotech with year-
end revenues of almost US$ 148 million and a growth rate
of a little over 37 per cent from 2005-06. Vaccines accounted
for over US$ 115 million and formulations accounted for
around US$ 32 million.
Panacea Biotec, one of the first companies to have
introduced the Hep B vaccine received its first supply order
from WHO for Hep B vaccine in 2007. The estimated market
demands for Hep B vaccine in 2007 and 2008 are 163 million
Panacea Biotech Business Revenues 2006-07
2006 146
2005 107
2004 53
0 20 40 60 80 100 120 140 160
US$
Source: Biospectrum, June 2007
 B IOTECH 29

and 198 million respectively. Panacea will also be supplying Nove Nordisk India Business Revenues 2006-07
Hep B Combos vaccines to UNICEF, and anti-TB and ARV
2006 54
vaccines to WHO/UNICEF.
2005 43
Panacea has also added various new drugs to its profile
in 2006 for areas including renal disease management, 2004 34
pain management, neuropathy, diabetes, and cough. The
0 10 20 30 40 50 60 70
company entered into a partnership with the Netherlands US$
Vaccine Institute for IPV vaccine and PT Bio Farma, Indonesia Source: Biospectrum , June 2007

for measles vaccine in 2006. In addition to these, Panacea

also bought a 10 per cent stake in Cambridge Biostability
by investing around US$ 6.5 million.
Panacea already has four state-of-the-art research
facilities in progress, and further infrastructural expansion
is being undertaken currently. The company is planning to
increase its visibility in the private market through a joint
venture with Novartis Vaccines and the launch of one of
its products, Polprotec, in India and other countries. It is
expected that in approximately four years, the company
will be ready to launch a set of thermo stable vaccines,
along with JE and dengue vaccines. Panacea plans to
out-license some of its patented products in Europe and
the US in the coming years.
contains diabetes products, human growth hormone and
haemostasis management.
Torrent Pharma manufactures insulin formulations
for Novo Nordisk as part of an exclusive agreement. The
agreement has been in action for over 15 years with a
manufacturing facility that has often been quoted as the
best maintained site of Novo Nordisk globally.
Novo Nordisk also has an agreement with TCS for
offshore clinical operations service. Where TCS provides a
range of data management services for trials that are run by
Novo Nordisk globally.
GlaxoSmithKline (India)

Novo Nordisk India GlaxoSmithKline (India) Fact File

- S egment : Bio-pharma
Novo Nordisk India Fact File - Start-up year : 2001
- Biotech Revenue 2006-07 : US$ 29 million
- S egment : Bio-pharma - Leader for vaccines among MNCs in India
- Start-up year : 1990
- Biotech Revenue 2006-07 : US$ 54 million -  as promoted awareness on the use of vaccines in India
H
- World leader in diabetes care - Has set up vaccines facility in Nasik
- About to launch a cardiovascular drug
- D iabetes care products, human growth hormone and haemostasis - In discussions with Japanese and American companies for laughing
management of other products
- Launched Levemir, a basal insulin analogue, in May 2006 - Has idenfitied 6 oncology centers for conducting clinical trials
- Has an exclusive agreement with Torrent Pharma for manufacturing
of insulin
- Has distributorship alliance with Abbot India Source : Biospectrum, June 2007

- Has an agreement with TCS for offshore clinical operations service

GlaxoSmithKline (GSK) grew by approximately 27 per cent
Source : Biospectrum, June 2007
with its US$ 29 million biotech sales in 2006-07 as opposed
to the US$ 23 million revenues generated in 2005-06.
The company is the leader for vaccines among MNCs in
Novo Nordisk India, the Indian subsidiary of Novo Nordisk,
is a world leader in diabetes care. The company generated GlaxoSmithkline India Business Revenues 2006-07
revenues valued at US$ 54 million in 2006-07 rendering an
2006 29
almost 27 per cent growth from the previous year.
2005 23
Novo Nordisk launched Levemir, an insulin analogue
that is delivered through a pen-like device and works on 2004 19
prolonging action, in India around mid-2006. The pen-like
0 4 8 12 16 20 24 28 32
device is called FlexPen and Levemire is imported from US$
Denmark. The company’s service and product portfolio Source: Biospectrum , June 2007
30 MARKET & OPPORTUNITIES
India and continues to propel its growth by encouraging
awareness regarding vaccine use in India through dynamic
initiatives.
GSK in India, an affiliate of GSK Biologicals, is currently
involved in the marketing of 13 vaccine products. The
company is a leader in the Indian market for vericella,
haemophilus conjugate, hepatitis A, diphtheria, and
typhoid vaccines. GSK has set up a state-of-the-art vaccines
filling facility in Nasik that conforms to cGMP norms.
GSK is about to launch a cardiovascular drug called
Carvedilol from Roche. Among the products launched two
were pediatric vaccines, Boosterix and Infanrix and one was
an anti-asthmatic drug co-developed by Zydus Cadila. The
company is currently considering other such licensing deals
with companies in Japan and USA.
Like in the case of Novo Nordisk, GSK has established
partnership with TCS for clinical data management where
all of GSK’s data worldwide would be managed by TCS.
Having recognised India as a prime center for clinical
research in various areas such as oncology, psychiatry and
infectious diseases, GSK has aggressively pursued the trials
avenue in order to achieve company growth. The company
has selected six oncology centers to conduct early phase
clinical trials in India. These centers are being developed
by the Institute of Cancer Medicine, University of Oxford.
GSK India was involved in more than 15 global clinical trials
investigating six therapy areas and 200 patients in 2006.
Quintiles Spectral India
Quintiles India, a subsidiary of Quintiles Transnational is
the second largest provider of bio-services in India. The
company generated revenues of US$ 34 million in 2006-07
with a growth rate of almost 65 per cent.
Quintiles was the first foreign CRO to establish its
operations in India in 1997. The Company chose the
Joint-Venture route to enter India however soon bought out
its partner’s stake to become a 100 per cent subsidiary of
Quintiles Transnational. Quintiles Spectral (India) Pvt Ltd has
a strong presence in the Indian clinical research industry.
Quintiles India now offers full portfolio of services for
Phase I-IV clinical studies in various therapeutic areas. Many
of the top global companies have worked with Quintiles
in India. The company has so far undertaken numerous
international studies in India involving a large number of
patients and covering a wide range of therapeutic areas
including oncology, psychiatry, neurology, anti-infectives,
gastroenterology, ophthalmology, endocrinology and
cardiology. It has completed many oncology studies as part
of multi-country programs for regulatory submissions.
Quintiles India has also conducted a number of
parasitology trials, bacterial keratitis studies and a large
anti-diarrheal study for its European clients. Significantly, it
has completed a diabetes study for a European sponsor. It
has also conducted pivotal studies on bipolar disorder and
the drug has been approved based on the data generated
in India. Pivotal Phase III study in bacterial conjunctivitis was
completed and the drug was approved by USFDA based
on the Indian data. Quintiles India has also undertaken
a study in chronic spinal cord injury under a US FDA fast
track approval.
Using India’s IT expertise, Quintiles assembled a team
in Bangalore that is trained and skilled in offering data
management services in Clintrial, Oracle Clinical and
various Electronic Data Capture platforms. The unit provides
customised solutions including Case Report Forms (CRFs)
design, database design, query management, double
data entry, coding and quality control as per the global
standards and at highly competitive prices. The company
follows globally accepted Standard Operating Procedures
(SOPs) and ICH guidelines.
Quintiles India is backed by a large team of clinical
researchers, ITES professionals and also regulatory staff
who have built their credibility with investigators and
regulatory authorities.
Quintiles entered into an agreement with the Manipal
Quintiles Fact File
- S egment : Bio-Services
- Start-up year : 1997
- Biotech Revenue 2006-07 : US$ 34 million
- Ranked second in Indian bio-services
- O ne of the leading CROs in India
- Has done studies in various therapeutic areas
- Has clinical research collaborations with Manipal Group Alliance
Source: Biospectrum, July 2007
Group, whereby the Manipal Group will be the preferred
research partner for Quintiles in India, Nepal and South
East Asia for clinical trials. The Manipal Group has the
largest teaching hospital network in India and has built a
reputation for high-quality patient care through its super
specialty hospital in Bangalore and its network of teaching
hospitals across its campuses.

Rasi Seeds
Rasi Seeds is the leading seed company in India. The
company generated revenues of US$ 77.5 million in
2006-07, and US$ 72 million during 2005-06. Rasi Seeds
sells quality seeds of various crops to farmers all over India.
In 2006, the company accounted for 29 per cent of the total
Bt cotton seeds sold in India. The company has been using
Bollgard technology developed by Monsanto.
Rasi Seeds R&D center has been recognised by the
Department of Scientific and Industrial Research (DSIR) and
the company’s product coverage measures an impressive
ten million acres in the past decade.
Rasi Seeds Fact file
- S egment : Bio-agri
- Start-up year : 1973
- Biotech Revenue 2006-07 : US$ 81million
- Leading seed company
- C ompany provides seeds of various crops
- Has undertaken field trials and large scale trials of Bt cotton
- Top notch marketing network all over India and two procuction
centres
- Entered contract farming with an ELS cotton hybrid
Source : Biospectrum, June 2007
Apart from cotton, Rasi Seeds has also been focusing its
R&D efforts into other crops. Among these, the comapny
has made promising progress in hybrid maize, sunflower,
lady finger, bottle gourd, ribbed gourd, bitter gourd,
tomato and chilli. Current R&D projects have been focusing
on using recombinant DNA technology, in vitro plant tissue
culture, molecular biology, and molecular breeding in crops
in order to address natural weaknesses in the crops.
Rasi Seeds Business Revenues 2006-07
2006
2005
2004
21
0 10 20 30 40 50 60 70
US$
Source: Biospectrum , June 2007
Rasi Seeds has established a highly sophisticated
biotech laboratory with facilities for research on DNA
finger-printing, DNA-based genetic purity test, and tissue
culture and transformation of different crops. Other facilities
include a modern high through-put biotech facility for
breeding of transgenic crop production.
B IOTECH 31
Rasi Seeds has entered into contract farming with
An Extra Long Staple (ELS) cotton hybrid with the idea of
“Breeding to Branding”- the first of its kind in the world.
The company has also been taking initiatives to outsource
technologies-especially those for drought, improving
fertilizer use efficiency for viruses in different crops-from
technology providers around the world.
Nuziveedu Seeds
Nuziveedu Seeds grew to US$ 53 million in 2006-07 from
US$ 14.5 million in the year 2005-06. The company released
two Bt hybrid cotton varieties after approval from the
Genetic Engineering Approval Committee (GEAC). These
new varieties are being sold in various states in India. The
economic benefits from these cotton varieties are almost
US$ 700 per hectare under irrigated conditions. The
company has produced 500,000 packets of the Bt hybrid
seeds for cultivation of which about 130,000 were sold in
the state of Andhra Pradesh alone. Each packet was priced
at about US$ 42, of which around US$ 29 is Monsanto’s
share as it owns the technology used.
Nuziveedu Seeds Fact File
- S egment : Bio-agri
- Start-up year : 1973
- Biotech Revenue 2006-07 : US$ 55 million
- Manufacturer of hybrid cotton seeds
- Commercially released two Bt hybrid varieties
-  orking on indigenous transgene to combat bollworms
W
- Has 15 cotton hybrids in pipeline
- Signed a MoU with Tamil Nadu Industrial Development Corporation
(TIDCO) to establish a biotech/IT SEZ near Chennai
Source : Biospectrum, June 2007
The technology used by Nuziveedu was outsourced
81 from Monsanto-Mahyco and it provides bollworm
75 resistance in the cotton hybrids. Although Nuziveedu is
currently using technology from Monsanto, the company
has been working on developing its own technology along
80 90 similar lines. The company’s current pipeline includes 15
cotton hybrids of which two are in the last stages of trials. In
Nuziveedu Seeds Business Revenues 2006-07
2006 55
2005 16
0 10 20 30 40 50 60 70
US$
Source: Biospectrum , June 2007
32 MARKET & OPPORTUNITIES

addition to cotton, Nuziveedu has also been working on Bt

varieties in rice and brinjal.
Nuziveedu Seeds has a total customer base of about
6.5 million farmers. As a result the company has a large
marketing network spread over 12 states in India.

Novozymes South Asia

Novozymes, a group company of Novo Nordisk, generated

revenues worth US$ 23 million in 2006-07 as compared
to US$ 19 million in the previous year. Novozymes
caters to mostly clients in Europe, North America and
Asia. The company uses tools such as gene technology,
microbiological techniques and fermentation technology.
Industrial enzymes and microorganisms account
for 95 per cent and five per cent of Novozymes’ business
respectively. Novozymes’ products include technical
enzymes, food enzymes, and feed enzymes. In the area
of microorganisms, the company is involved in sales of
microorganisms for aquaculture, wastewater management,
cleaning and biological plant care.
Novozymes has planned to expand its presence in
India by building a new laboratory and office facilities in
Bangalore by mid-2008. This would enable the company
to establish a R&D unit in India for the first time. The initial
focus of research will be on optimising enzyme properties.

Novozymes South Asia Fact File

- S egment : Bio-Industrial
- Start-up year : 2000
- Biotech Revenue 2006-07 : US$ 24 million
- Leaker for industrial enzymes
- S ells more than 600 products in 130 countries
- Building new laboratory/office space in India
- Establishing R&D operations in India soon
- Novozyme’s enzymes play a significant role in food, textile, cleaning,
and wastewater treatment

Source : Biospectrum, June 2007

 B IOTECH 33

Advantage India

Infrastructure and skilled labor, cornerstones of any
venture, ware available in India at significantly lower costs.
In addition to these, favorable patent regulations, have
served to catapult the Indian biotechnology sector onto
the global radar. This comes at an opportune time, with
global companies scouting for strategies to maintain costs,
while simultaneously retaining quality. With the public
and private sector’s growing focus on ramping up the
industry to global standards and beyond more and more
overseas biotech markets are viewing India as an excellent
choice of partner to enhance their operational range and
productivity.
Low Cost Operations in India
R&D costs in India are significantly lower than those in the
developed world. Outsourcing part of a drug discovery chain
to an Indian company can save up to US$ 200 million on
development costs. The low cost of operations is attributed
to availability of skilled manpower and infrastructure at
comparatively lower rates. Salaries for R&D personnel are
significantly lower in India compared to Europe or USA.
The cost of clinical trials is 50 per cent lower in Phase-I, and
60 per cent lower in Phase-II in India when compared to the
country, employing 15,000 scientists; there are more than
346 universities and 16,500 colleges with about 9.5 million
students enrolled. India produces about 350,000 graduates in
biosciences and about 172,000 post-graduates. Furthermore
there are more than 5,000 PhDs and 1,000 post-docs in the
bioscience-related fields in India. Established names in life
science education and research include the Indian Institute
of Science (IISc), Tata Institute of Fundamental Research
(TIFR), National Center for Biological Sciences (NCBS), and
the Centre for Cellular & Molecular Biology (CCMB) to name
a few. The large proportion of English speaking manpower is
also a big advantage for India. The biotech parks across the
country that offer various cost-benefit incentives and allow
for easy industry-industry and industry-academia synergies
also play a big role in making India an attractive biotech
destination.
Some Bioscience-related Indian Institutions
Institution Name Area of focus
National Center for Biological Biochemistry, Bioinformatics &
Sciences Genetics
Jawaharlal Nehru Institute for Molecular and Chemical
advanced Scientific Research Biology & Genetics
National Institute of Immunology Immunology

global clinical trials market. Also, the time taken to conduct a Institute of Genomics & Integrative
Biology
clinical trial is considerably lesser in India due to the availability
International Centre for Genetic
of a large patient pool and faster enrollment rates.
Engineering and Biotechnology
Centre for Cellular & Molecular
Large human resource pool Biology
Centre for DNA Fingerprinting &
With the distinction of being ranked as the number one Diagnostics
reservoir of scientific manpower, ahead of countries like Central Drug Research Institute
Philippines, China, Australia, and Japan, as well as home
Genomics, Genome
Informatics and Proteomics
Molecular Biology &
Biotechnology
Bioinformatic & Genetics
Computational Biology and
Bioinformatics
Drug Discovery & Regulatory
studies

to a legacy in higher education in the sciences, easily

justifies why companies are coming to India to fuel their
growth. There are 40 national research laboratories in the
34 MARKET & OPPORTUNITIES

Favorable IP climate

Adherence to the TRIPS agreement with regard to the

Patent Protection Act implemented in 2005 has been key
to the renewed interest in Indian biotech. This move has
increased the confidence of innovator companies in India,
spurred the steady inflow of investment and collaborations.
Areas related to data exclusivity, patentability rules
and compulsory licensing are in the process of being
strengthened.
 B IOTECH 35

Exchange Rate of US$ 1 = INR 41 has been used throughout

this report.

Disclaimer

This publication has been prepared for the India Brand Equity
Foundation (“IBEF”).

All rights reserved. All copyright in this publication and related

works is owned by IBEF. The same may not be reproduced, wholly
or in part in any material form (including photocopying or storing it
in any medium by electronic means and whether or not transiently
or incidentally to some other use of this publication), modified or
in any manner communicated to any third party except with the
written approval of IBEF.

This publication is for information purposes only. While due care

has been taken during the compilation of this publication to ensure
that the information is accurate to the best of IBEF’s knowledge and
belief, the content is not to be construed in any manner whatsoever
as a substitute for professional advice.

IBEF neither recommends nor endorses any specified products or

services that may have been mentioned in this publication and
nor does it assume any liability or responsibility for the outcome
of decisions taken as a result of any reliance placed on this
publication.

IBEF shall, in no way, be liable for any direct or indirect damages

that may arise due to any act or omission on the part of the user
due to any reliance placed or guidance taken from any portion of
this publication.
India Brand Equity Foundation (IBEF) is a public-private partnership
between the Ministry of Commerce & Industry, Government of India
and the Confederation of Indian Industry. It aims to effectively present
the India business perspective and leverage business partnerships
in a globalising market-place.

India Brand Equity Foundation

c/o Confederation of Indian Industry
249-F Sector 18, Udyog Vihar Phase IV
Gurgaon 122015, Haryana, INDIA

Tel: +91 124 401 4087, 4060 - 67

Fax: +91 124 401 3873, 401 4057
Email: j.bhuyan@ciionline.org
Web: www.ibef.org
Website in the Russian language: www.ibef.org/russia