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India as an OutsourcingFrontier in Biotechnology
3rd Annual Biotech Supply Chain Academy Conference
K.V. Subramaniam
President & CEO
San Francisco – Oct 26, 2010
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Biotechnology Industry Issues
The biotechnology industry today faces several issues in its
growth and development.
Long gestation period
High costs of development
High costs of manufacturing
Regulatory hurdles
Diverse competency needs
Competition
Funding constraints
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Biotechnology Outsourcing Advantages (1)
Outsourcing can address several of the issues faced by the
biotechnology industry.
Long gestation period
Shorter time to market
High costs of development
Favorable fixed to variable cost ratio
High costs of manufacturing
Access to:
high-productive process technologies
larger scale
Regulatory hurdles
Access to:
genetically diverse patients
therapeutically naïve patients
inaccessible domains ( stem cell research, large animal studies)
4
Biotechnology Outsourcing Advantages (2)
Outsourcing can address several of the issues faced by the
biotechnology industry.
Diverse competency needs
Access to competencies
Competition challenge
Lower costs (biosimilars)
Funding constraints
Lower burn rates
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Biotechnology Outsourcing Opportunities
There are several outsourcing opportunities across many
business domains in biotechnology.
BUSINESS DOMAINS
Biosimilars
Novel Proteins
Vaccines
Plant
Tissue Culture
Molecular
Diagnostics
Molecular
Genetics
Biotherapeutics
Biofuels
Plant
Biotechnology
Industrial
Biotechnology
Predictive
Diagnostics
Plant
Metabolic
Engineering
Diagnostics
Stem cell
therapies
Tissue
Engineered
Products
Companion
Diagnostics
Biomaterials
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Biotechnology Outsourcing Opportunities
Cloning
Expression
Cell line development
Product characterisa-tion
Molecular
Biology
Process
Development
Quality
Management
Clinical
Research
Regulatory
Affairs Manufacture Marketing
Bioprocess development
Process scale-up
Pre-clinical
Animal model development
Toxicity studies
Efficacy
studies
Animal models
Bioassays
Clinical
Phase 1 to 4
PK-PD studies
QTc studies
Mass balance studies
Biometrics
Quality control
Quality
assurance
Validation
Dossiers
preparation
Regulatory
Interface
Intellectual
property
Clinical lots
Commercial batches
Cell line characterisa-tion
Product mgmt.
Sales
Medical affairs
Pharmaco-
Vigilance
Market research
FUNCTIONAL DOMAINS
There are several outsourcing opportunities in functional
domains across the value chain in biotechnology.
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Outsourcing - India Advantages
India has several advantages as an outsourcing frontier in
biotechnology.
Large home market
Enables scale
Less obscure regulatory pathway
Faster time to market
Large and diverse patient pool
Faster accrual and time to market
Lower development costs
Genetic diversity for stratified studies
Therapeutically naïve patients
Growing biotechnology industry
Access to competencies
Innovation
Manufacturing
Frontier areas
Regenerative Medicine
Biofuels
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India Home Market Advantage
India has a reasonably large and growing healthcare
market, which can offer scale advantages.
Source: McKinsey, E&Y
Healthcare Spend India
($ bn)
32
66
80
93
107
125
146
38
54
43
0
20
40
60
80
100
120
140
160
2004 2005 2006 2007 2008 2009E 2010E 2011E 2012E 2013E
% of GDP 4.6 4.7 4.7 4.7 5.6 6.4 6.5 6.4 6.4 6.4
$ 66 billion market growing
16% p.a. to $ 146 billion by
2013
Public spending 0.9% of GDP,
expected to increase to 2% of
GDP by 2010
Life-threatening + Lifestyle
diseases
Cardiac disease capital of the
world
Diabetic capital of the world
Diverse oncology patient pool
Growing medical tourism – $ 2
billion by 2012
Strong in healthcare IT
Healthcare Statistics India US
Population 1.1bn 0.31bn
Hospitals 15,097 7,569
Medical Colleges 162 130
Statistics per 1,000 population
Hospital beds 0.7 6.1
Nurses 1.4 8.3
Physicians 0.7 3.6
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India Regulatory Advantage
India has a well-defined regulatory pathway for
biotechnology products, which can enable speed to market .
Gene Synthesis
Gene Validation
Electrophoresis
Stable Clone
Clone Expression
Process Dev.
Analytical Dev.
Stability Studies
Process Scale-up
Toxicity Studies
Approval by
IBSC and RCGM
Toxicity Studies
Clinical Studies
Approval by
IBSC and RCGM
Clinical Studies
Commercial
Manufacturing
Approval
DCGI
6 to 12 6 to 12 3 4 to 8 4 6 to 15 3
32 to 57 months
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India Clinical Development Advantage
India has several advantages in clinical development, which
can enable better patient quality and faster time to market.
Sites India UK USA Germany
ICH / GCP Sites 500 3,500 25,000 600
Investigators 2002 2005 2008 2010
ICH / GCP trained investigators 450 1,500 3,500 6,000
# of Personnel required 2300 4000 10,000 50,000
Trials 2007 2008 2009E 2010E
Global Trials 16,700 17,700 18,900 20,000
Trials in India 340 700 1,350 2,000
India Mkt. Share 2% 4% 7% 10%
Faster patient accrual
Therapeutically naïve patients
Genetically diverse patient pool
Lower costs (~30% less than USA)
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India Innovation Advantage
Indian companies have been investing in innovation, which
can enable access to competencies.
Novel product research
Reliance Life Sciences, Biocon, Dr. Reddy’s, Nicholas
Funding
DBT-SIBRI / DBT-BIPP schemes
Global Biotech in India
> $ 250 million invested to date
> 100 Trans-national company funded R&D centers
Amgen, Genzyme, BMS…
State-of-the-art Facilities
Reliance Life Sciences, Biocon, Piramal
Talent
Indian R&D institutions
Returning overseas Indians
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India Manufacturing Advantage
India is gaining ground in biopharmaceutical manufacturing,
which can enable competitive contract manufacturing.
Sr Company Microbial Capacity
(Litres)
Mammalian Capacity
(Litres)
Planned Capacity
(Litres)
1 Avesthagen - √
2 Biocon √ √
3 Cadilla Pharma √ -
4 Dr. Reddy’s √ √ √ (Mammalian)
5 Intas √ √
6 Ranbaxy/ Zenotech √ √
7 Reliance Life Sciences √ √
8 Serum Institute √ (Vaccines) √
9 Shantha √ (Vaccine) √
10 Wockhardt √ (Insulin), √ (Hep B/
Other proteins)
√
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India Competency Advantage
India has an endowment in competencies, many of them a
legacy from its pharmaceutical industry.
Target
identification
Gene synthesis
Gene validation
Electroporation
Stable clone
Clone
expression
Molecular
Biology
Process
Development
Quality
Management
Clinical
Research
Regulatory
Affairs Manufacture Marketing
Biorocess dev.
Bioanalytical
dev.
Stability
studies
Process scale-
up
Pre-clinical
Toxicity studies
Efficacy
studies
Animal models
Bioassays dev.
Clinical
Clinical opns.
Project mgmt.
Biometrics
Medical writing
Quality control
Quality
assurance
Validation
Dossiers
preparation
Regulatory
Interface
Intellectual
property
Upstream
Downstream
Purification
Fill-finish
Packaging
Bioprocess
control
Product mgmt.
Sales
Medical affairs
Pharmaco-
Vigilance
Market research
GXP Compliance
Value Chain
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India Talent Advantage
India has a strong talent base in biotechnology and allied
areas, which can enable access to competencies.
15,000 Biotech scientists
75 universities with biotech-
related programs
India produces each year
25,000 pharmacy graduates
10,000 chemistry post-
graduates
4,500 Ph.Ds
1,000 Engineering Ph.Ds
1,000 Biochemistry and
Chemistry Ph.Ds
2,500 chemical engineers
1,000 biotech post-
graduates
Source: E&Y, IBEF
Medical Institutions
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India Diaspora Advantage
India has a 25 million strong diaspora, many of them in the
pharmaceutical, biotechnology and health care sectors.
25 million strong
Primarily in education,
information technology,
communications,
semiconductors,
pharmaceuticals,
biotechnology and health care
35,000 physicians of Indian
origin in USA with 15% in
academic medicine
Indian Diaspora
UK , 6%USA, 11%
Asia, 72%
Africa, 11%
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India Cost Advantage
India has a cost advantage, which can enable lower
development and operational costs.
Source: KPMG CII Report
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India Limitations
India does have some limitations in certain functional
domains of the value chain.
Research
Extensive biological product
characterisation
Clinical Research
Large animal studies
Manufacture
Large-scale manufacture
(especially MAb production)
Regulatory
Developed market
biotherapeutic dossiers
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India Outsourcing Market
The Indian CRO industry is estimated to grow at a CAGR of
31% to reach USD 3 billion by the year 2015.
Indian CRO Industry
USD Billion
0.6
3
1.4
0
0.5
1
1.5
2
2.5
3
3.5
2008-09 2011-12 2014-15
Source: India Life Sciences Vision - Yes Bank CII Study
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Reliance Life Sciences Initiatives
Bio-
pharmaceuticals
Clinical
Research
Services
BiofuelsMolecular
Medicine
Biopolymers
Industrial
Biotechnology
Biochemicals
Plant Tissue
Culture
Plant
Biotechnology
Plant Metabolic
Engineering
Plant
Products
Embryonic
Stem Cells
Regenerative
Medicine
Hematopoietic
Stem Cells
Cord Blood
Repository
Skin and
Tissue Engg.
Molecular
Diagnostics
Genetics
Agronomy
Plant Tissue
Culture
Plant Metabolic
Engineering
Trans-
Esterification
Farm
Advocacy
Pre-clinical
Studies
BA/BE
Studies
Phase 1
Studies
Phase 2/3/4
Studies
Data Mgmt.
& Biostatistics
Biosimilars
Fusion
Proteins
Monoclonal
Antibodies
siRNA
Molecules
Plasma
Proteins
Pharmaceuticals
API
Formulations
Predictive
Diagnostics
Novel
Therapeutics
Ocular
Stem Cells
QTc Studies Largest pipeline of biosimilars under development globally
Conducting the largest clinical research study in India
(prophylactic for DVT, MNC client, 4050 patients)
Largest biopharmaceutical manufacturing capacity in India . Also
received European regulatory approval for drug substance
Only plasma proteins manufacturer in South Asia
Only company with commercial stem cell therapies in India
Reliance Life Sciences represents one of the most diversified and
integrated life sciences initiatives in the world.
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Summary
India is emerging as an important outsourcing frontier in
biotechnology.
Advantages Growing domestic market to enable
scale
Defined regulatory pathway for speed to market
Large patient pool for faster clinical development
Emerging biotech innovation hub
Strong talent pool and Diaspora for value chain competencies
Cost competitive in clinical development and manufacturing
Limitations Extensive product characterisation
Large animal studies
Large-scale manufacture
Developed market biotherapeutic dossiers