R&D IN BIOTECHNOLOGY

BIOTECHNOLOGY

The application of
Science & Technology
to living organisms
as well as parts,
products and models
thereof, to alter living
or non-living materials
for the production of
knowledge, goods
and services
India and Biotechnology Base

 India is one of the emerging economies in the World.

 Biotechnology - One of the most promising industry of the future
 Bio-diversity of India will be an advantage for Biotech companies.
 Vast reservoir of scientific human resource with reasonable cost, wealth of
R&D institutions, centers of academic excellence in Biosciences
 Vibrant Pharmaceutical Industry and fast developing clinical capabilities
collectively point to promising biotech sector
 Over 300 companies and 241 institutions use some form of biotechnology
in agricultural, medical or environmental application.
Biotechnology Industry in India

• Nascent stage
• Vast growth and opportunity
• Over 300 registered biotechnology companies,
out of which ~100 in are modern biotech sector
• Twelfth most successful biotechnology sector in
the world as measured by number of companies
(Ernst & Young)
• 96 enterprises exclusively as Biotech
companies, making India the third largest in
Asia [after Australia (228) and China (136)]
Biotechnology market

• Total Biotech sector: $2200 million in 2007-

2008
• Bio-pharma sector (70%)
• Bio-service sector including clinical research,
contract research and contract
manufacturing: (7%)
• Agricultural Biotech sector: (6%)
• Projections: Total Biotech sector to increase to
• $ 5000 million by 2010
Break up of Biotech market
Pharmaceutical Biotechnology
in India
• Market

2005: $1100 million

2009 : $3000 million (expected)
• Vaccines (new generation and combinations)
Bharat Biotech, Bharat Serum, Biological E, Haffkine
Bio-Pharmaceutical, Panacea, Pfizer, Serum Institute
of India, Shanta Bio-techniques, Smithkline Beecham
and Wockhardt
• Therapeutics
Biocon, Eli Lilly and Wockhardt
• Diagnostics
Bharat Biotech, Qualigens Diagnostics, Span
Diagnostics, J. Mitra
• VACCINE MARKET AROUND US $ 100 Million.
VALUED

GROWTH 20%
RATE

• DIAGNOSTICS MARKET DEMAND US $ 50 Million.

• ANIMAL HEALTH BIOTECHNOLOGY MARKET

• ENZYMES 70% REQUIREMENT IMPORTED

MARKET GROWING WITH
INCREASING AWARENESS
• PHARMA : Today 40-45% of all drugs originate
in bio-technology but in the next decades
biotechnology will have a much greater
role on the production of drugs and
pharmaceuticals.
• FERMENTATION : Modest fermentation industry
mainly breweries, Antibiotics and
chemicals. But great potential in the areas
of food processing,
Pharma and chemicals
• FOOD India Is The Largest Producer
Processing Of Milk And Second Largest
Industry Producer Of Fruits, Vegetables
And Food grains. But processing
is limited to only 2% of fruits and
vegetables and 15% milk. Thus,
Tremendous scope for the development of processing of
milk
Fruits &vegetables, meat, fish and
Foodgrains
Key Methods of Doing Business
in India
• Set up joint venture companies to locally
manufacture the product
• Collaborative research
• Contract research
• Contract manufacturing
• Technology transfer
• Marketing arrangement for bio-supplies
(appoint distributor/agent)
• Clinical research
Why outsourcing in India ?
• Proven scientific talent pool
• No language barrier English is an official language
• Cost effective – Makes innovation affordable

• Signatory to WTO, Acceptance of Indian Patent

• Strong judicial systems
• Strong financial systems
• Strong Government support
Indian opportunity in
outsoursing of R&D
• Drug Discovery/Optimization/ informatics/ Novel delivery systems
Target identification and validation, Proof of concept development,
drug discovery , lead optimization. New Formulation development.
• Process development /drug manufacturing
Chemistry& biology based process development – for Biologics & Small
molecules. Biomanufacturing as well as conventional manufacturing
for clinical trials . Final dosage form and fill/ finish .
• Pre-clinical & Clinical Development –
Pre-clinical animal studies, Phase 1 to 4 Clinical Trials, BA/BE studies,
Clinical lab. Services, Data management, Pharmaco-vigilance
• Ag Biotech
Increasing crop yields/ disease resistance/ new traits.
MAIN ACTITIVITES AND
POTENTIAL
• Rich biodiversity-India has 7.76% of total
mammal species 12.6% of bird species,
11.7% of fish and roughly 6.0% of total
flowering plants present in the world with
excellent agro-climatic conditions. This is
a great resource for research and
developmental activities in biotechnology.
• Focus– Genomics, recombinant DNA,
Transgenics. Stem cell research and new
drugs development
 Institutions & Manpower
 Number of hospitals : 16,000
 Number of doctors : 5,00,000
 Number of research institutions : 200
 Number of Scientists : 25,000
 Medical graduates produced : 17,500 per yr
 Science graduates produced : 5,00,000 per yr
 Number of Agriculture Univs. : 40
Main R&D players
• Universities
• Public research institutes
• Private research institutes
• Large industry (mainly Pharma industry)
India - R&D Hotspot
• In a recent survey conducted by EIU, India
was featured as the 3rd most preferred
overseas R&D destination – after China &
the US
• Indian R&D salaries are about one fourth
that in US
• Scope to lower capex through
indigenization of equipment
• Overheads can be managed through smart
operation
The ‘Hot’ Jobs in
Biotech
1. R&D 28%

2. QA/QC 17%

3. Clinical Research 11%

4. Process Development/Mfg
10%

5. Sales and Marketing 9%

6. Admin/Operations 7%

7. Information systems 5%

8. Regulatory Affairs 5%

9. Finance 4%

10. Business Development 4%

11. HR .5%
IMPLICATIONS FOR
OUTSOURCING –
Bio-manufacturing
 Market Growth - Outsourcing
 A recent survey by NIH found:

only 21% of respondents currently outsourced

mammalian cell culture for biomanufacturing, but
44% of the respondents estimated that by 2008
they would outsource mammalian cell culture
Contract Research

• Compound Discovery & Development

• Process Development & Synthesis

expertise in chemical synthesis can be utilized for
development of cost-effective processes for
new drugs and intermediates .

• Clinical trials
one of potential attraction for foreign big player
Advantage India : Clinical
Trials
• Large and heterogeneous population and
prevalence of wide spectrum of disease
conditions offer wide patient-resource.
• Low clinical trials cost in India .
• India has the 2nd highest number of
qualified doctors in the world.
• Patient enrollment rate for Phase III
studies could be up to 6 times faster in
India than in the Western countries.
Indian Biotechnology Industry
Number of biotech companies : 300
Global ranking in terms biotech companies : 11
Investment growth in last 5 years : 50 % per annum
Annual Turnover (Apr 06 – Mar 07) : US $ 1.27
Billion
Annual increase : 57 %
Percentage of global business (2006-07)
: 2.8% (2005-06) : 2.3%
(2004-05) : 1.6 %
(2003-04) : 1.5 %
(2002-03) : 1.2 %
Exports : 63 %
Major areas : Biopharma, Bioservices, Bioindustries,
Bioagriculture, Bioinformatics, Biosupplies
Biotechnology in India
Initiative in early 1980’s
Agencies - DST, CSIR, ICAR, ICMR, UGC
National Biotechnology Development Board – 1982
Department of Biotechnology – 1986
Strategy :
• Creation of Infrastructure
• Human Resources Development
• Promotion of R & D
• Technology Transfer
• Promotion of Industry
• Public Private Partnership
• Regulation
• International Co-operation
Indian Biotech Industry
Number of health-biotechnology patents
(Major developing countries) issued by US in 2006

India

South Korea

China

Brazil

Cuba

South Africa

Egypt

0 5 10 15 20 25 30 35
Manpower in
Biotechnology
TOTAL INVESTMENT IN
BIOTECH INDUSTRY
Core Areas of competence in
India
Core Areas of competence in India
•Capacity in bioprocess engineering
•Skills in gene manipulation of microbes and animal cells
•Capacity in downstream processing and isolation methods
•Skills in extraction and isolation of plants and animals products
•Competence in recombinant DNA technology of plants and
animals
•Excellence in traditional and molecular marker assisted breeding
of plants and animals
•Infrastructure in fabricating bio-reactors and processing
equipment
 Indian Biotechnology: Strengths

• Human Resource: Trained manpower and knowledge base.

• Academic Resource: Good network of research laboratories.
• Industry Base: Well developed base industries (e.g.
pharmaceuticals, seeds).
• International Experts: Access to intellectual resources of
NRI’s in this area.
• Clinical Capability: Extensive clinical trials and research
access to vast and diverse disease in the huge population.
• Bio-diversity: India’s human gene pools and unique plant,
animal & microbial diversity offer an exciting opportunity
for genomic research.
• Stem Cells Research: Several labs have commenced
research in stem cells and have valuable stem cell lines.
Indian Biotechnology:
Weakness
•Missing link between research and
commercialization
•Lack of venture capital
•Relatively low R&D expenditure by
industry
•Image of Indian industry –doubts about
ability of Indian products to meet
International standards of quality
Indian Biotechnology:
Opportunities
•Large domestic market
•Large export potential
•Low cost research base for international companies in comparison
with other countries
•Vast and diverse disease based patient populations provide unique
opportunities for clinical research and clinical trials
•Supportive Government policy on embryonic stem cells research
provides a useful opportunity for International companies to pursue
such research in India
•Human bio-diversity provides unique research opportunity in
genomics
•Plant & microbial bio-diversity provides vast prospecting opportunities
for new drugs
•Conducive Government policy on GM crops provides useful
opportunities for Agri-biotech companies
Indian Biotechnology: Threats
•Danger of anti-biotech propaganda
gaining ground
•Inadequate protection of Intellectual
Property Rights (IPR), significant
improvement remains in the areas of
implementation and enforcemen
Indian Policy on Biotechnology

•DBT (started in 1985) is developing policy for India

•Indian Council of Medical Research (ICMR)
•Indian Council of Agricultural Research (ICAR)
•Council of Scientific and Industrial Research (CSIR)
•Department of Science and Technology (DST)
–Current focus on genomics, proteomics, transgenics, stem
cell research and product development.
–Technology Development Fund (TDF) and additional VC
funds to promote small and medium biotech enterprises
•Regulatory framework is in place to approve GM crops and r-
DNA products for human health
•State government initiatives: AP, KA, MH
IPR Issues & R&D management

•IP is a central issue in any industry

•Robust intellectual property rights framework is
the need of the hour
•India is already member of
Paris Convention
Berne Convention
Convention on biological diversity
WTO
•Should make legislation clear on the criteria for
the patentability of biotechnological inventions
 Patents provide owner with “market
exclusivity" that creates increased
profits profits motivate innovation
 Patents require disclosure of new
innovations that fosters dissemination of
knowledge and further innovation
 Patents discourage the keeping of trade
secrets
Trend in biotechnology patent
in India
Year no. of
patents
 1995 172
 1998 287
 2002 395
 2006 305
Patents in Biotechnology

• 1980 -Diamond v. Chakrabarty

• 1980 -First Cohen-Boyer recombinant DNA patent
• 1984 -Cell line derived from human leukemia patient
patented
• 1986 -Genetically engineered corn patented
• 1988 -Harvard Onco-mouse patent - extends
Chakrabarty concept to transgenic animals
• 1991 -Isolated human bone marrow stem cells patent
What can be Claimed?
 Diagnostic tests
 Research tools
 Gene therapy
 Therapeutic proteins Sensors
 Bioinformatics
 Sequences
 Pharmaceuticals
R&D management

 Build culture
 Build data base
 Sharing of knowledge
 Documentation
 Promote for paper publication
 Regular meeting
Biotech Products in Indian market
• r DNA Hep ‘B’ vaccine
• Recombinant streptokinase
• Erythropoietin
• α, β, γ – interferon
• Haemophilus influenzae B vaccine
• Human insulin
• Human Growth Hormone
• Human Interleukin
• Streptokinase
• Granulocyte Colony Stimulating Factor
• Follicle Stimulating Hormone
• Tissue Plasminogen Activator
My Experience in R&D
 Microcarreier
 3-D culture
 S- adenocylmethionine
 Selenium enriched yeast
Conclusion
• Growing market
• Strong base , proven quality
• Cheapest health facility
• Vaccines, diagnostics and therapeutics
• Biomedical devices, instruments and
sensors
• Bioartificial organs using tissue
engineering and stem cells
• Clinical trial and contract research
THANK YOU