Biotechnology Sector Reports November-2016

11NOVEMBER 2016
BIOTECHNOLOGY
NOVEMBER 2016 For updated information, please visit www.ibef.org

22NOVEMBER 2016 For updated information, please visit www.ibef.org
 Executive Summary………….…………..…..3
 Advantage India……………….………..…….4
 Market Overview and Trends….....................6
 Strategies Adopted……………….………….16
 Growth Drivers…......................................…20
 Opportunities………………………………...33
 Success Stories: Major Players…….……..38
 Useful Information.......................................42
BIOTECHNOLOGY
NOVEMBER 2016

33NOVEMBER 2016
For updated information, please visit www.ibef.org
Source: Department of Biotechnology, Ministry of Science & Technology , Ministry of External Affairs, Government of India, Make In India, TechSci Research
Note: F - Forecast
EXECUTIVE SUMMARY
BIOTECHNOLOGY
By FY25, India’s biotech
industry is estimated to
increase to USD100 billion from
USD7 billion in FY15 and is
currently valued at USD11
billion.
The biotech industry is
expected to experience
significant growth amid
favourable business conditions
In 12th Five-Year Plan, the
government aims to spend
USD3.7 billion on
biotechnology compared to
USD1.1 billion in the 11th Five-
Year Plan
Increasing government
expenditure is likely to augment
growth in biotechnology
industry.
India’s pharmaceuticals market
size is USD30 billion in 2015
and estimated to reach at
USD55 billion in 2020F
Growing pharmaceuticals
market is estimated to aid
growth of the biotech industry
Percentage rise in
investments 236.36%
CAGR: 12.8%
CAGR: 30.46%
30
55
FY15 FY20F
USD Billion
1.1
3.7
Eleventh Five Year Plan Twelfth Five Year Plan
USD Billion
USD Billion
7 11
100
FY 15 FY 16 FY 25F

55NOVEMBER 2016
Growing demand
ADVANTAGE INDIA
Source: CIS India, Ministry OF External Affairs, Government of India, Ministry of Health,, ABLE,
TechSci Research; Note: E - Estimate
Robust demand
• India’s billion-plus population base
offers a huge market for biotech
products and services
• Increasing economic prosperity
and health consciousness would
continue to fuel demand for
healthcare services
• Better accessibility to healthcare
services further accelerates
the demand
Innovation opportunities
• Public funding is being offered for
product innovation and research in
the biotech sector
• The private sector has been
aggressively pursuing focused R&D
• Public-Private partnerships will
improve the market with innovative
research and development
Increasing investments
• FDI investment up to 100 per
cent is permitted via the
automatic route
• A low cost and skilled labour
force is attracting outsourced
research activity
• Launch of Biotechnology Industry
Partnership Programme (BIPP) is
boosting industry participation
FY16
Market
Value:
USD11
billion
FY25E
Market
Value:
USD100
billion
Advantage
India
BIOTECHNOLOGY
Policy support
• In FY15, Ministry of Biotechnology
adopted the open access policy
• In FY16, National Intellectual Property
Rights Policy 2016 has been released
• Research Assistance Council has
been set up
• National Rural Healthcare Mission
launched to boost healthcare spending
• Also, in FY16, DBT launched National
Biotechnology Development Strategy

MARKET OVERVIEW & TRENDS
BIOTECHNOLOGY

77NOVEMBER 2016
MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY
Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research
Note: R&D - Research and Development
DBT – Department of Biotechnology
BIOTECHNOLOGY
• 1978: India’s first biotech firm,
Biocon, was setup
• 1981: Centre for Cellular and
Molecular Biology setup in
Hyderabad
• 1984: Institute for Microbial
Technology, Chandigarh was setup
• 1986: Department of Biotechnology
(DBT) was formed
• 1987: National Institute of
Immunology was setup by DBT
• 1989: Bangalore Genei commenced
operations
• 1991: National Centre for Biological
Sciences pursued R&D in molecular
biology
• 1994: Syngene, India’s first Contract
Research Organisation (CRO),
started R&D services
• 1997: Centre for Biological
Technology (CBT) was established
to focus on bioinformatics and
genomics
• 1998: Monsanto Research
established an R&D centre for plant
genomics
• 1998: DBT approved Mahyco-
Monsanto to grow Bt cotton
• 2007: National Biotechnology
Development Strategy launched
• 2007: With the joint efforts of
Government of Uttar Pradesh,
Department of Biotechnology and
Government of India & Department
of Science and Technology, a fully
functional biotechnology park was
setup in Lucknow.
• 2009: National Biotechnology
Regulatory Authority Bill 2008
introduced in the parliament and
Biotechnology Industry Partnership
Programme was launched
• 2010: Cadila Healthcare, Serum
Institute of India and Bharat Biotech
launched first H1N1 swine flu
vaccine
1978–90 1990–99 2000-10

88NOVEMBER 2016
MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY
Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research
Note: R&D - Research and Development
DBT – Department of Biotechnology
BIOTECHNOLOGY
• 2011: Government approved setting
up the Biotechnology Industry
Research Assistance Council
(BIRAC)
• 2012: India ranked 12th in the world
in biotech and 3rd largest in Asia-
Pacific, after Japan and Korea
• 2013: India became the biggest
producer of Hepatitis B vaccine
recombinant
• 2015: DBT allocated USD0.735
million to University of Agricultural
Sciences to support a national multi-
institutional project.
• 2015: DBT launched “The National
Biotechnology Development
Strategy 2015-2020 programme” to
turn India into
biotechnology hub.
• 2016: USD238.09 million was
allocated by the DBT under Budget
2016-17.
• 2016: 8th Biotechnology Industry
Research Assistance Council
(BIRAC) announced 8th call for
proposals related to inventions and
ideas under Biotechnology Ignition
Grant (BIG) Scheme.
• 2016: The Regional Centre for
Biotechnology Bill, 2016 was passed
by Lok Sabha to impart training and
education under guidance of United
Nations Educational, Scientific and
Cultural Organization (UNESCO).
• 2016: India's National Intellectual
Property Rights policy was
launched.
2010-15 Post 2015

KEY SEGMENTS IN THE INDIAN BIOTECHNOLOGY INDUSTRY
Source: ABLE - Biospectrum Industry Survey, June 2013; TechSci Research
BIOTECHNOLOGY
• Bio-pharmaceutical
products are
therapeutic or
preventative
medicines that are
derived from
materials naturally
present in living
organisms, using
recombinant DNA
(rDNA) technology
• Bio-services
mainly include
clinical research
and CRO along
with custom
manufacturing
• Bio-agriculture is
segmented into
hybrid seeds,
transgenic
crops, bio-
pesticides and
bio-fertilisers
• Bio-industrial
predominantly
comprises enzyme
manufacturing and
marketing
companies
• Bio-informatics deals
with the creation and
maintenance of
extensive electronic
databases on various
biological systems;
industry
Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics
Biotechnology

MAJOR PRODUCTS/SERVICES OF THE INDIAN BIOTECHNOLOGY INDUSTRY
Source: ABLE - Biospectrum Industry Survey, Ministry of External Affairs, TechSci Research
BIOTECHNOLOGY
Biotechnology
Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics
Vaccines
Diagnostic
Therapeutic
Custom
Manufacturing
Contract
Research
Organisation
Hybrid seeds
Bio-fertilisers
Bio-pesticides
Industrial
enzymes
Database
services
Integrated
research app
software
Biotech software
services
Clinical Trials

Market size (USD billion)
Source: ABLE - Biospectrum Industry Survey,
Makeinindia, Ministry of External Affairs, TechSci Research
Global Industry Analysts Report (GIA)
Notes: CAGR - Compound Annual Growth Rate
FY16: As of April 2016.
Note: F-Forecast
Growing at a faster pace, in comparison with the previous
years, the Indian biotech industry witnessed YoY growth of
57.14 per cent in FY16; the total industry size stood at
USD11 billion by FY16 and is estimated to reach USD11.6
billion by FY17
Fast-paced growth is likely to continue; the industry is
expected to increase in size to USD11.6 billion by 2017,
driven by a range of factors such as growing demand,
intensive R&D activities and strong government initiatives
The Indian biotech industry comprising about 800
companies is currently valued at USD11 billion. In order to
achieve market size of USD100 billion by 2025, the
Government of India needs to initiate research activities and
develop infrastructure and human capital, with an
investment of US$ 5 billion.
Fast-developing clinical capabilities with the country
becoming a popular destination for clinical trials, contract
research and manufacturing activities
BIOTECHNOLOGY
ROBUST GROWTH IN BIOTECH INDUSTRY
CAGR: 20.33%
1.1
1.5
1.9
2.6 2.6
3
3.8
4.3 4.3
5
7
11
11.6

Market break-up by revenues (FY16)
Source: ASSOCHAM, Makeinindia, TechSci Research
The bio-pharmaceutical segment accounted for largest
revenue share of 64 per cent in India biotech industry,
during FY16.
Serum Institute of India is the largest BioPharma company
in the country and accounts for approximately 22 per cent of
BioPharma market in FY15
India is becoming a leading destination for clinical trials,
contract research and manufacturing activities which is
leading to the growth of bio services sector
In FY16, the bio-services and bio-agri segments accounted
for 18.0 per cent and 14.0 per cent of the biotech industry,
respectively
BIO-PHARMA ACCOUNTS FOR MAJORITY MARKET SHARE AND WITNESSES FASTEST GROWTH IN FY16
BIOTECHNOLOGY
64%
18%
14%
3%
1%
Bio-pharma
Bio-services
Bio-agri
Bio-industry
Bio-
informatics

Source: Department of Biotechnology, TechSci Research
In FY15, provision of USD89.47 million has been made by
Department of Biotechnology for the approved
biotechnology projects in India.
Karnataka is the hub for biotechnology sector. Investments
of USD25.95 million was allocated towards biotechnology
projects in Karnataka. Delhi has the second largest share
with 13.26%.
In FY16, Government of Karnataka planned to raise
USD7.34 million funds for research activities in
biotechnology.
In FY15, total project cost approved to Delhi is USD11.87
million
BIOTECHNOLOGY
State wise share for Approved Biotech Project
Cost FY15
STATE WISE SHARE FOR APPROVED BIOTECH PROJECT COST FY15
29.04%
13.26%
11.68%
9.69%
7.76%
6.01%
4.56%
3.30%
14.69%
Karnataka
Delhi
Haryana
Tamil Nadu
Maharashtra
Telangana
West Bengal
Uttar Pradesh
Others

Source: Department of Biotechnology, Government Of
India, TechSci Research
In FY16, 2,621 projects have been received by Department
of Biotechnology which are categorized as ongoing number
of biotechnology projects in India.
Delhi accounted for the largest share of 13.93 per cent of
the total number of projects received in biotechnology
sector, followed by Tamil Nadu, which accounted for a
share of 10.95 per cent.
In FY16, a total of 365 biotechnology projects were
allocated to Delhi at an approved project cost of USD11.87
million.
As of November 2016, Odisha released the draft of its first
Biotechnology policy. The state aims to become one of the
top five bio-tech hubs in the country. The state government
has proposed to set up a fund with investment of USD 3.73
million and provide land on priority for setting up of
biotechnology projects.
BIOTECHNOLOGY
State wise share for Ongoing Number Of Biotech
Projects FY16
STATE WISE SHARE FOR ONGOING NUMBER OF BIOTECH PROJECTS FY16
13.93%
10.95%
9.92%
8.32%
6.64%6.64%
5.80%
3.43%
34.38%
Delhi
Tamil Nadu
Karnataka
Maharashtra
Telangana
Uttar Pradesh
West Bengal
Haryana
Others

Remarkable global
positioning
• India is among the top 12 biotech destinations in the world
• India ranks second in Asia, after China
• India is the world’s largest producer of recombinant Hepatitis B vaccine
• Bharat Biotech commercially launched first novel ROTAVAC® vaccine, to eradicate
rotavirus diarrhea, in India.
Pharma companies
focusing on biotech
• Ranbaxy, Cadila Healthcare, Lupin, Wockhardt and Dr Reddy’s are among the major
Indian pharmaceutical companies operating in the bio-pharma segment
NOTABLE TRENDS IN THE INDIAN BIOTECH SECTOR
BIOTECHNOLOGY
Global companies
setting up base
• US based DiabetOmics Inc., medical diagnostic company has raised USD4 million from
Ventureast and USD1 million from KI Varaprasad Reddy for driving manufacturing and
commercialization activities in India.
Biosimilars and
molecular diagnostic
remain strongholds
• Growth in the sector is anticipated to come from the country's strong position in biosimilars
and molecular diagnostics as well as personalised medicine (where export and domestic
trends look promising). In 2016, development of biosimilars has been speeding up via
Glycosylation Control Technology.
Source: Ministry of External Affairs, TechSci Research, Indian Law Offices
Bt:
Growth in Genetically
Modified crops
• According to International Service for the Acquisition of Agri-Biotech Applications, India
has the fourth largest area covered under genetically modified crops
• In India, 11.57 million hectares of area is covered under genetically modified crops which
is majorly dominated by Bt cotton.
• After Bt cotton, Bt brinjal, covering an area of 7.6 million hectares, is potentially benefitting
farmers as well as consumers.

STRATEGIES ADOPTED
BIOTECHNOLOGY

STRATEGIES ADOPTED
BIOTECHNOLOGY
• Indian biotech firms are partnering with niche players to broaden their product portfolio and
strengthen global reach
• Strand Life Sciences recently collaborated with US-based El Camino Hospital to establish a
genomics and pharmacogenomics centre in San Francisco, while Hyderabad-based GVK
Biosciences entered into an agreement with the US FDA for drug repositioning
• BIRAC recently collaborated with Department of Electronics and Information Technology (DeitY) and
announced call for proposal under Industry Innovation Programme on Medical Electronics (IIPME) to
promote innovative technologies in Medical Electronics sector.
• India’s first public-private-partnership agreement was announced between Sun Pharma and Indian
Council of Medical Research (ICMR), Govt. of India, Ministry of Health & Family Welfare (MOHFW),
Govt. of Madhya Pradesh.
• Department of Biotechnology, Ministry of Science & Technology, Government of India, recently
collaborated with Australian government and announced four new research projects in biotechnology
under the Indo Australia Biotechnology Fund.
• Companies in the industry are exploring new avenues in life sciences to strengthen and upgrade the
products and services portfolio through strategic mergers and acquisitions. In 2015, Dr. Reddy’s
Laboratories acquired UCB ( India) for USD131.02 million. The acquisition has been done for
established brands of UCB in India, Nepal, Sri Lanka and Maldives
• To strengthen its business in US pharma market, Cipla acquired two US-based companies namely,
Exelan Pharmaceuticals Inc. and InvaGen Pharmaceuticals Inc. for USD230 million in February 2016.
• As of October 2016, Advanced Enzyme Technologies, a biotech based firm in Mumbai signed an
agreement with JC Biotech - Active Pharmaceutical Ingredient (API) maker in Hyderabad, to acquire
70 per cent stake in the company.
Strategic collaborations
with niche players and
government bodies
Mergers & Acquisitions
Source: Ministry of External Affairs, RBI; Note: Govt. - Government

STRATEGIES ADOPTED
BIOTECHNOLOGY
• Pharma companies, including Avesthagen, TCG Life Sciences, Advinus Therapeutics and
Jubilant Biosys have stepped up investments in personalised medicine. The idea is to eliminate
the unpredictable nature of drug development through personalised medicine.
• For instance, Xcode Life Sciences uses InDNA technology to provide personalised solutions for
lifestyle-related diseases, such as coronary, diabetes and obesity, using saliva samples.
• Action Biotech provides genetic tests to predict response from chemotherapy drugs. Geneombio
Technologies offer gene-based prediction to assess genetic susceptibility towards major lifestyle
diseases. Acton Biotech, OncQuest Laboratories, etc. are few of the other notable players
operating in the field of personalized medicine in India.
• Companies are evolving their product mix to reflect growing repertoire in Biologics, Branded
Formulations and Research Services
• In FY15, Biocon launched Bionesp, antibody for managing anemia in its early-stage.
Stepped up investment
in personalised
medicine
Ramping up service
offerings
Source: Ministry of External Affairs, RBI

Source: Makeinindia, TechSci Research
SECTOR BENEFITS FROM RISING INCOME AND POPULATION
BIOTECHNOLOGY
Growing demand
Inviting Resulting in
Growing demand Increasing investmentsPolicy support
India’s large
population, a huge
market for biotech
products and
services
Higher healthcare
expenditure and an
increase in Bio-agri
products
Strong growth in
export demand and
a rise in medical
tourism
Adoption of Open
Access Policy in
FY15
R&D focus; Indian
government has
been funding
institutes for biotech
research
Increase in
budgetary
allocations to the
Biotech and
Healthcare sectors in
five-year plans
Rising investments
from domestic and
foreign players
100 per cent FDI
permitted through
automatic route for
manufacturers of
drugs and
pharmaceuticals
Low cost and skilled
labour force
attracting outsourced
research activity

Source: MHRD,
National Biotechnology Development Strategy, DBT, TechSci Research
HIGHER HEALTHCARE EXPENDITURE DRIVING DOMESTIC DEMAND
BIOTECHNOLOGY
Exponential growth in government funding
• Government spending on healthcare, as a percentage
of GDP, for the 12th Five-Year Plan is around 2.5 per
cent , and to at least 3 per cent of GDP by 2022.
• Government has announced to allocate USD5.43
billion to its healthcare department. Medical tourism in
India has reached USD3.6 billion in FY2015 and is
estimated to reach USD6 billion by 2018.
• During the 11th Five-Year Plan, the Department of
Biotechnology utilised 94.49 per cent of the allocated
resources
• In 2016, government plans to establish 17 new All India
Institute of Medical Sciences (AIIMS) and 20 cancer
institutes, across the country.
Specialised treatment
• The disease profile that inflicts the Indian population
has experienced a gradual shift. The number of
lifestyle-related diseases being reported is rising; this
has led to demand for various kinds of specialised
treatments
• Ailments such as cancer and diabetes have led to a
higher demand for biological products
Preventive healthcare
• Around 1.2 billion ailments are reported annually, and
this number is expected to rise at a CAGR of 30 per
cent to 15 billion cases by 2015. Better access to
healthcare facilities and rising lifestyle diseases are
driving this trend
• Population growth has elevated the vaccine demand
for the geriatric and paediatric population
Funds availability (USD million)
129.4
302.1
1,354.2
3,726.4
Ninth FYP Tenth FYP Eleventh FYP Twelfth FYP
Source: WHO Statistics 2012
Note: FYP – Five Year Plan

Source: Fortis Healthcare Limited 2008–09, McKinsey Quarterly, NCAER, TechSci Research
RISING INCOME AND INCIDENCE OF CHRONIC LIFESTYLE DISEASES
BIOTECHNOLOGY
Rising income; growing middle class
• Per capita income and rural income are increasing
• The number of middle class households (earning
between USD4,413.1 and USD22,065.3 per annum) is
estimated to increase more than fourfold to 148 million
by 2030 from 32 million in 2010
• Rising per capita income leads to increased spending
on medical and healthcare services
Higher incidence of chronic lifestyle diseases
• Lifestyle diseases are set to account for a greater part
of the healthcare market
• Lifestyle diseases such as cardiac diseases, cancer
and diabetes are treated with the help of biotechnology
products, thereby boosting revenues of biotech
companies
• The growing GNI per capita, PPP of USD6,020 in FY15
led to improved lifestyle due to increased purchasing
power of customers for healthcare.
Notes: Greater distributional efficiencies and increasing demand (especially
from rural areas) due to rising disposable incomes have created new
markets for products within the country, F - Forecast
Million household, 100%
Income
segment
244 273 322
1% 3% 7%2% 6%
17%23%
25%
29%
43%
40%
32%
30% 26%
15%
2015 2020 2030
Globals(>22065.3) Strivers(11032.7-22065.3)
Seekers(4413.1-11032.7) Aspirers(1985.9-4413.1)
Deprived(<1985.9)

STRONG POLICY SUPPORT CRUCIAL TO THE SECTOR’S DEVELOPMENT
BIOTECHNOLOGY
Source: “Biotechnology facilities,” Department of
Biotechnology, TechSci Research, Note: BIRAC -
Biotechnology Industry Research Assistance Council
Programme for SC/ST
and Rural Population
• Training and demonstration programme in various biotechnology based activities were
undertaken to empower the population resulting in socioeconomic upliftment
National Biotechnology
Development Strategy
• DBT designed the National Biotechnology Development Strategy (NBDS) to strengthen the
industry’s human resources and infrastructure while promoting growth and trade
• As part of the NBDS, government decided to spend 30 per cent of DBT’s Budget in public
private partnerships to promote R&D at various stages and has launched “The National
Biotechnology Development Strategy -2015-2020”.
Single-window
clearance
• As per NBDS, a proposal has been made to set up the National Biotechnology Regulatory
Authority (NBRA) to provide a single-window clearance mechanism for all bio-safety products
to create efficiencies and streamline the drug approval process
Biotechnology Industry
Research Assistance
Council
• BIRAC has been established to promote research and innovation capabilities in India’s
biotech industry
• Under BIRAC, the government will provide funding to biotech companies for technology and
product development.
• BIRAC under Small Business Innovation Research Initiative (SBIRI) scheme supports
innovations in biotechnology.
Tamil Nadu Bio
technology Policy 2014 • The Policy aims to encourage new companies to operate in Tamil Nadu, thereby increasing
the Research & Development and manufacturing activities in the sector
Biotechnology Based
Programme for Women
• Programme on application of biotechnology for women was done to provide employment, skill
development, awareness generation, health improvement, and socio-economic upliftment of
the women population
“Biotechnology Policy
2015-2020 “
(Andhra Pradesh)
• The Policy has been formulated to promote biotechnology sector in Andhra Pradesh. The new
policy covers the benefits for the following categories: Incubation Centres, Biotech
manufacturing industries, Life Science Park, Life Science Knowledge Centre, Research &
Development Centres.

12th Five-Year Plan expenditure (USD billion)
Source: Deptt. of Science and Technology, TechSci Research
The overall strategy of 12th Five-Year Plan is to accelerate
the pace of research, innovation and development. The
main objective is to advance biotechnology as strategic
area by taking India’s strengths in foundational sciences to
globally competitive levels. In addition, emphasis is on
expanding the application of biotechnologies for overall
growth of bio- economy within the framework of inclusive
development
The 12th Five-Year Plan aims to accelerate the pace of
research, innovation and development to improve
biotechnology in India.
The government plans to strengthen regulatory science and
infrastructure, which involves setting up the Biotechnology
Regulatory Authority of India (BRAI) and a central agency
for regulatory testing and certification of laboratories
The plan also entails expanding and commissioning new
bioclusters at Faridabad, Mohali Kalyani and Hyderabad
It aims to encourage and increase the pool of research
scholars and scientists by three-fivefold in biological and
interdisciplinary space across levels (PhD, PDFs, young
faculty)
BIOTECH IN FOCUS IN 12TH FIVE-YEAR PLAN
BIOTECHNOLOGY
1.1
3.7
Eleventh Five Year Plan Twelfth Five Year Plan
12th Five-Year Plan fund allocation (USD billion)
26%
22%
17%
14%
21%
Medical biotech
Agri biotech
Basic bio & emerging areas
Biodiversity, bioresources &
Environment
Capacity building

Joint Venture fund
• In February 2015, Aurobindo Pharma announced a Joint Venture with Tergene Biotech company for
cost effective development of the Pneumococcal Conjugate Vaccine (PCV).
• Government funding is crucial for biotech industry due to limited access to other sources of funding.
Infrastructure
development
• India’s central government and state governments, in collaboration with private players, continue to
develop new infrastructure facilities, especially at biotechnology parks
• The government is developing three major biotech clusters at Mohali in Punjab, Faridabad in
Haryana, and Bengaluru in Karnataka. It plans to set up an agri-biotech cluster in Pune (Maharashtra)
and Kolkata (West Bengal)
GOVERNMENT FUNDING CRUCIAL FOR THE BIOTECH INDUSTRY
BIOTECHNOLOGY
International
collaborations
• India has partnered with countries such as the UK, Russia, Italy, the US and France to enable
knowledge transition.
• In 2015, the UK Medical Research Council (MRC) and the Government of India Department for
Biotechnology (DBT) formed an alliance to fund three major global research centers
• In 2016, a cooperation agreement with European Molecular Biology Organization (EMBO) was signed
by the Government of India to enhance collaborative research activities between India and Europe.
Clinical Establishments
Bill
• In a move to standardise procedures, the Indian Parliament passed the Clinical Establishments Bill
2010, which would make registration of clinical trials as well as clinical research organisations
mandatory in the country
• The Bill also includes standard operating procedures for various trial related tasks
• Government plans to fast track the approval process for clinical trials while ensuring that CROs
involved comply with stricter quality and compliance checks.
Source: Ernst & Young, TechSci Research; Note: DST-Department
of science and Technology, DBT-Department of Biotechnology
Research Funding
Agency
• The DST has consistently enabled transformational changes through appropriate responses and non-
participative roles. DST accordingly played the role of an extra mural research funding agency
wherein competitive grants for research was provided to investigators based on technical merit. In
2015, DBT and Tekes (Finland) joined to form an alliance to fund international standard joint projects
to address Indian and global needs

CENTRE AND STATE GOVERNMENT INITIATIVES PROVIDE BIG BOOST TO BIOTECH INDUSTRY
BIOTECHNOLOGY
Increasing government support
International collaboration of Department of Biotechnology with other countries
100 per cent foreign equity investment is possible in manufacturing of all drugs
except recombinant DNA products and cell targeted therapies
Single window processing mechanism for all biotech projects involving FDI
Depreciation allowance on plant and machinery raised to 40% from 25%
Customs duty exemption on goods imported in certain cases for R&D
Customs & excise duty exemption to recognised Scientific & Industrial Research
Organisations (SIRO)
150% weighted tax deduction on R&D expenditure
Three years excise duty waiver on patented products
100% rebate on own R&D expenditure
125% rebate if research is contracted in public funded R&D institutions
Joint R&D projects provided special fiscal benefits
The National Biotechnology Development Strategy 2015-20 to make India bio-
manufacturing hub.
Promote innovations through BIPP, SBIRI, BIRAC and Biotech parks
Adoption of new Open Access Policy in FY15
Favorable IP climate
Indian Copyright Act, 1957
The Patent Act, 1970
Indian Patents and Design Act, 1972
The Trademarks Act, 1999
Biotechnology Patent Facilitating Cell (BPFC)
Foundation of Biotechnology Awareness and
Education (FBAE)
National Research Development Corporation (NRDC)
National Guidelines for Stem Cell Research (2013)
Tamil Nadu Biotechnology Policy 2014
Biotechnology Policy 2015-2020, Andhra Pradesh
National Intellectual Property Right Policy 2016
Source: Ernst & Young, TechSci Research
Notes: BIPP - Biotechnology Industry Partnership Programmes,
SBIRI - Small Business Innovation Research Industry,
BIRAC - Biotechnology Industry Research Assistance Council,
IP – Intellectual Property

REGULATORY FRAMEWORK OF THE INDIAN BIOTECH SECTOR
BIOTECHNOLOGY
Source: Policy and rules, Department of Biotechnology website,
TechSci Research
Government of India
Ministry of Science
& Technology
Ministry of
Environment &
Forests
Department of
Biotechnology
Department of
Environment, Forests
& Wildlife
Recombinant DNA
Advisory Committee
(RDAC)
Regulatory Committee
on Genetic
Manipulation
(RCGM)
Institutional Biosafety
Committee
(IBSC)
Genetic Engineering
Approval Committee
(GEAC)

Source: Press Information Bureau, TechSci Research
The 12th Five Year Plan aims to set up 3–5 bio-clusters
with technology incubators, technology parks, innovation
centres and entrepreneurship development units
Biotechnology infrastructure is witnessing a shift from
traditional clusters to specialised industrial infrastructure
such as biotech or science parks
States such as Karnataka, Andhra Pradesh, Maharashtra,
Tamil Nadu and Kerala have been early movers in
establishing world-class biotech parks and clusters.
In 2016, Monsanto, a leading player in global
biotechnology industry planned to establish a seed plant in
Buldhana district of Maharashtra.
Investors such as TCG Bio-pharma and Alexandria have
significantly contributed to the establishment of
biotechnology-related infrastructure in India.
Science and Technology Department has acquired 10
acres of land in Jammu & Kashmir to set up first
biotechnology park in the state.
SOLID INDUSTRY INFRASTRUCTURE WOULD DRIVE GROWTH
BIOTECHNOLOGY
Jogindernagar
Shimla
Chandigarh
AlwarSohna
Jodhpur Jaipur
Gandhinagar
Anand
Jamnagar
Baroda
Aurangabad
Pune
Hyderabad
Bhubaneshwar
Konark
Midnapore
Pantnagar
Bengaluru
Chennai
Puducherry
Visakhapatnam
Kochi
Karwar
Madurai
Operational biotech parks

2929NOVEMBER 2016
Research parks
Communities generating innovation, technology and knowledge
Knowledge of existing firms commercialisation of intellectual
property
Creation of new companies
Research partners
Flow of talent
Exchange of ideas
Access to laboratories and
specialised equipment
Universities
Govt. research
laboratories
Other R&D
institutions
Private firms
Job and income generation
Source: Research and Information System
for Developing Countries (RIS), TechSci Research
CONCEPT OF BIOTECH PARK
BIOTECHNOLOGY
The flow of job and income generation in biotechnology, through involvement of public and private initiatives with proper
utilisation of available resources, is explained in the following diagram:

3030NOVEMBER 2016
for Developing Countries (RIS), TechSci Research, "Mid-term appraisal“
Fellowships rose from 100 to 250 per year for PhD students, in
addition to 100 postdoctoral and 50 biotechnology overseas
associateships
Government provided grant-in-aid to the industry for R&D in certain
diseases such as malaria and leishmaniasis or kala-azar
HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION
BIOTECHNOLOGY
Details of key biotechnology parks in India
Parks City Area (in acres)
Shapoorji Pallonji Biotech Park Hyderabad 300
ICICI Knowledge Park Hyderabad 200
International Biotech Park Pune 103
Lucknow Biotech Park Lucknow 20
Golden Jubilee Biotech Park Chennai 8
Ticel Bio Park Chennai 5
Key research institutes in India
Central Drug Research Institute (CDRI), Lucknow
National Institute of Pharmaceutical Education and
Research (NIPER), Mohali
Indian Institute of Chemical Technology (IICT), Hyderabad
Centre for Cellular & Molecular Biology (CCMB),
Hyderabad
Indian Institute of Chemical Biology (IICB), Kolkata
Indian Toxicology Research Institute (ITRI), Lucknow
Institute of Genomics and Integrative Biology (IGIB), New
Delhi
Institute of Microbial Technology (IMTECH), Chandigarh
National Chemical Laboratory (NCL), Pune
National Centre for Biological Sciences (NCBS), Bengaluru
Jawaharlal Nehru Centre for Advanced Scientific Research
(JNCASR), Bengaluru
Indian Institute of Science (IISc), Bengaluru
National Institute of Immunology (NII), New Delhi
National Center for Cell Sciences, Pune
National Center for Plant Genome Research (NCPGR),
New Delhi
List of Biotech Parks at Developing Stage
Parks City Area (in acres)
Guwahati Biotech Park Assam 700
KINFRA Biotech Park Kerala 75
Bio Pharma-IT Park, Odisha 64.61
Bangalore Biotech Park Karnataka 53

3131NOVEMBER 2016
for Developing Countries (RIS), TechSci Research, "Mid-term appraisal“
Department of Biotechnology supports various biotech facilities in the nation, which is driving the biotechnology industry by
providing advanced research infrastructure.
Various biotech facilities have been established by Department of Biotechnology under “Task Force on Research
Resources, Service Facilities and Platforms”.
HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION
BIOTECHNOLOGY
List of Key Biotechnology Facilities in India Supported by DBT
Facility Established Name of the Institution Sanction Year
Animal House facility
National Institute of Immunology (NII), New Delhi 2013
Translational Health Science and Technology Institute (THSTI), Faridabad 2014
Indian Institute of Scientific Education and Research (IISER) – Knock Out and
Transgenic Mice, Pune
2016
Indian Institute of Science (IISc), Bengaluru 2016
High Resolution Mass
Spectrometry Facility
Indian Institute of Bombay, Mumbai 2016
Containment Facilities
Tuberculosis Aerosol Challenge Facility, International Centre for Genetic
Engineering and Biotechnology (ICGEB), New Delhi
2016
Flowcytometry, Imaging and
Microarray Facilities
Electron Microscopy Referral Facility, Govind Ballabh Pant Institute of
Postgraduate Medical Education & Research, Delhi
2015

STRONG INFLOW OF FOREIGN INVESTMENT
BIOTECHNOLOGY
Date
announced
Acquirer name Target name
Value of deal
(USD million)
Jan 2016 Venaxis Strand Life Sciences -
Oct 2015 Recipharm CMO Nitin Lifesciences 109.92
July 2015 Lupin Limited Gravis Pharmaceuticals LLC 800
Dec 2014 Leaders Group Asia Ltd Dr Datsons Labs Ltd -
Oct 2014 B Braun Singapore Pte Ltd Ahlcon Parenterals (India) Ltd 7.89
May 2014 Cancer Genetics Inc Bioserve Biotechnologies 1.9
May 2014 Anglo Gulf Ltd SciGen BioPharma Pvt Ltd 7.00
Jan 2014 Lotus Pharmaceutical Co Ltd Alvogen Pharma India Pvt Ltd 10.00
Oct 2013 Innovation Software Exports Agrata Biotech Ltd -
May 2013 Bio Harvest Pte Ltd Camson Bio Technologies Ltd 51.06
Dec 2012 Malabar Trading Co Ltd SPL Biotech Pvt Ltd -
Oct 2012 GE Equity International Syngene International Ltd 302.13
Jun 2012 Nandan Cleantec PLC Xtraa Cleancities Infra -
Mar 2012 Origio A/S Trivector Scientific Pvt Ltd 8.61
Aug 2011 DMV-Fonterra Excipients GmbH Brahmar Cellulose Products -
Aug 2011 Arvind Remedies Ltd Undisclosed Pharmaceutical Co -
Source: Thomson One Banker, TechSci Research

Vaccines
• Vaccines and recombinant therapeutics are the sectors driving the biotechnology industry’s growth
in India
• Newer therapies are anticipated to be launched in the next few years; prominent among these are
monoclonal antibodies products, stem cell therapies and growth factors
• The country’s huge population makes it among the world’s largest markets for vaccines. In 2015,
Bharat Biotech launched ‘Rotavac’ vaccine in India, three doses of the vaccine can prevent the
Rotavirus diarrhea in infants.
• Indian pharmaceutical firms supply 80 per cent of the anti retroviral drugs to fight AIDS globally
• As on October 2016, Sun Pharmaceutical Industries Ltd and International Centre for Genetic
Engineering and Biotechnology (ICGEB) signed a pact to develop vaccine for all four serotypes of
dengue virus.
HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE
BIOTECHNOLOGY
Bioactive therapeutic
proteins
• Protein and antibody production and fabrication of diagnostic protein chips are promising areas for
investment
• Stem cell research, cell engineering and cell-based therapeutics are other areas, where India can
cash its expertise
Agriculture sector
• India has the potential to become a major producer of transgenic rice and several Genetically
Modified (GM) or engineered vegetables
• Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield
improvement
• Growing at an annual growth rate of 10-15 per cent, the Indian hybrid seed industry is estimated at
USD1.93 billion in FY16, wherein Bt cotton is leading the market accounting for 45 per cent share
India hybrid seed industry.
Source: India Law Offices, TechSci Research
Intellectual Property
• Using the patent system as a mechanism to control drug pricing forestalls making the difficult
decisions about necessary investment in the healthcare system, but does not deal with the
underlying issues.

Bio services Sector
• Beyond biothereapeutics, the bioservices sector represents an area of significant promise
for India because of its skilled labour force, attractive costs, and access to major markets
in Asia.
• In FY15, Bio services was the second largest sector in India’s pharmaceutical and
biotechnology industry with 33 per cent market share and accounted for market size of
USD5-6 billion.
• India’s bioservices sector includes global contract research organisations, such as
Quintiles, as well as Indian companies including GVK Bio, Jubilant Biosys, and Advinus.
HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE
BIOTECHNOLOGY
Bio Pharmaceutical
Industry
• As the cost of bringing new molecules from discovery to market continues to rise, the
global biopharmaceutical industry is seeking ways to improve efficiency.
• The Department of Pharmaceuticals, Government of India planned to introduce venture
capital fund of USD146.72 million to fasten growth in biotech and pharmaceutical industry.
Manufacturing
• Manufacturing is also an area where India is leveraging its cost-competitiveness.
• India has the opportunity to replicate in biologics the same type of success it has had with
small molecule drugs.
• Indian Immunologicals Ltd ( IIL) plans to set up a new vaccine manufacturing facility in
Pondicherry with an investment of USD47.99 million
Source: India Law Offices, TechSci Research, Ministry of External Affairs
Bioinformatics
• The convergence of the life sciences with information technology is creating a particular
opportunity for India.
• The country has well-established strengths in the information technology area, and with
the advent of low-cost, whole genome sequencing and the growing role of molecular
diagnostics in both precision and preventive medicine, there is a proliferation of data
creating demand for bioinformatic analysis.

Contract research
• The R&D sector has huge potential; many opportunities have been created with a number
of foreign companies investing in this sector
• Indian pharmaceutical companies possess competitive skills in chemical synthesis and
process engineering; the companies can leverage these skills to develop new chemical
entities
OUTSOURCING OPENS UP FURTHER AVENUES FOR GROWTH OF BIOTECH
BIOTECHNOLOGY
Clinical trials
• India offers a suitable population for clinical trials because of its diverse gene pools, which
cover a large number of diseases
• Cost effectiveness, competition, and increased confidence on capabilities and skill sets
have propelled many global pharmaceutical companies to increase their clinical research
investment in the nation
International
collaboration
• Memorandum of Understanding (MOU) have been signed with Denmark and Finland and
joint call for proposals have been issued
• Joint projects have also been funded with the Biotechnology and Biological Sciences
Research Council (BBSRC), UK
• New agreements on vision research with National Institutes of Health (NIH), USA and an
amendment to the agreement with Contraceptive Research and Development Programme
(CONRAD)
• In 2015, DBT announced Indo-Australian Gold Fellowships to support researches to
undertake collaborative research project in Australia for 24 months.
Source: India Law Offices, Deptt. of Biotechnology, TechSci Research
Others
• Other potential areas of development include medicinal and aromatic plants, animal
biotechnology, aquaculture and marine biotechnology, seri biotechnology, stem cell biology,
environmental biotechnology, biofuels, biopesticides, human genetics, and genome
analysis

Market size (USD million)
Source: Deptt. of Biotechnology,
Marketresearch, ABLE, TechSci Research
Note: E - Estimates
India was the first country in the world to establish a
Biotechnology Information System (BTIS) network in 1987.
This facilitated development of bioinformatics that has
provided support to the biotechnology sector
Bioinformatics research is poised to become one of the
fastest emerging markets in India
Bioinformatics is estimated to rise at a CAGR of 34.92 per
cent to USD2.7 billion during FY12–25
India currently has close to 10 per cent of the global
professional and skilled bioinformaticians
With 10 per cent of the global professional and skilled
bioinformaticians, Indian bioinformatics companies can play
a significant role in critical areas such as data mining,
mapping and DNA sequencing
There is also opportunity in functional genomics, proteonics
and molecule design simulation
In July 2016, government allowed setting up of
bioinformatics units in residential areas
BIOINFORMATICS TO GROW CONSIDERABLY
BIOTECHNOLOGY
CAGR: 34.92%
55 140
2,700
FY12 FY15 FY25E

BIOCON: AN EARLY MOVER IN THE GLOBAL BIOTECH MARKET
Biocon’s position in the Indian market during FY13–15
• Biocon received an award: ‘WHO- India Public Health
Champion Award 2015
• Ranked 1st among Indian Insulin companies
• Ranked 1st in the Glargine vial market
• Ranked 3rd in the 40 IU Insulin market
• Ranked 4th in overall Insulin market
• Ranked 6th among the Top 10 global biotech employers
Revenue and net profit (USD million)
Source: Biocon Annual Report 2015
BIOTECHNOLOGY
• Incorporated
in 1978 at
Bengaluru,
India
• IPO
offering in
2004 (BSE,
NSE India)
• Among the
world’s largest
producers of
statins and
immunosuppr
essants
• 2011:
Launched
INSUPen®, a
convenient
and affordable
reusable
insulin
delivery
device
• Market cap of
USD1.5 billion in
FY15
• Revenue in FY15
stood at
USD514.7million
while net profit
totaled USD81.5
million
• Initiated trials for
IN-105 (oral insulin
program) in the US
• Tied-up with Quark
Pharmaceuticals to
develop novel
siRNA-based
therapeutics
• Partnered with
Advaxis to develop
a novel cancer
immunotherapy
• 2016: Biocon’s
biosimilar Insulin
Glargine was
granted
regulatory
approval in Japan
and is estimated
to be launched in
Q1 FY17.
• 2016: First
generic
formulation,
Rosuvastatin
Tablets was
granted
European
approval and is
estimated to be
launched in FY17
with company
benefitting from
an expected
revenue of
USD1.2 billion.
260.0
315.0
408.0
448.0
467.3
486.6
514.7
545.4
FY 09 FY 10 FY 11 FY 12 FY 13 FY 14 FY 15 FY 16
Revenue Net Profit

SERUM INSTITUTE OF INDIA: GAINING GLOBAL GROUND
Source: Company website, ABLE, TechSci Research
BIOTECHNOLOGY
Serum Institute recognised
as the world's largest
producer of vaccines for
Measles and DTP
Strong
presence in Bio
Pharma
space
Company sells
products in 140
countries worldwide
Serum Institute sold
around 1.3 billion
vaccines doses in
2015
Generated revenue of
USD600 million
in FY16
Started operations with
manufacturing of Tetanus
Antitoxin, followed by
Tetanus Toxoid
Commenced export of
vaccines to UN agencies;
export crosses over a 100
countries
Focused on gaining R&D
edge, global market reach
and wide product portfolio
Focus on
R&D
Launched India's
first MMR
Vaccine Tresivac
One out of every two
children in the world
vaccinated by Serum
Institute’s vaccine
Recognised as
India's number
one bio-tech
company for two
consecutive
years
1967 1994–2000 2005–15
Launched the
world's only
adsorbed liquid
HDC Rabies
vaccine
Serum Institute
has bought selling
rights from Biotech
Visterra VIS513
antibody for
dengue
Serum Institute to
distribute BCG-based TB
vaccine in India, originally
developed in Germany
2016

PANACEA BIOTECH: FOCUS ON INNOVATION AND R&D
Source: Company website, TechSci Research
BIOTECHNOLOGY
India’s 3rd largest
Biotech company with
presence in more than
35 countries
worldwide
More than 1,510
patent applications filed
globally; of this, 415
have been granted
In FY10–11, revenues
grew 32% to USD203.7
million
Generated revenue of
USD99.77 million
in FY16
Established plant for vaccine
production at New Delhi
under the name Radicura
Pharma
Merged Panacea Drugs &
Radicura Pharma to form
Panacea Biotec Ltd and
launched IPO in 1995
Forayed into Healthcare
Delivery; entered into a
collaboration to set up 220-
bed multi-super specialty
hospital and a R&D centre in
Delhi
Strategic alliance
with Kremers Urban
for entry into
generics
Approval for
development &
commercialisation of
Anthrax vaccine
1988 1994–2000 2005–15
Selected by WHO for
developing the sabin
based injectable polio
vaccine
Started drug
delivery R&D
centre at Lalru
Licensing agreement
with National Institute
of Health, US, for hair
growth hormone
2004
Started new state-of-
the-art Oncology
centre at Baddi
Launched anti-
diabetic drug
“Tenepan”
2016
Launched
“CABAPAN” for
treatment of mCRPC
2016
Note: mCRPC stands for metastatic Castration
Resistant Prostrate Cancer

USEFUL INFORMATION
BIOTECHNOLOGY

4343NOVEMBER 2016
INDUSTRY ASSOCIATIONS
BIOTECHNOLOGY
Association of Biotechnology Led Enterprises (ABLE)
# 123/C, 16th Main Road, 5th Cross, 4th Block
Near Sony World Showroom/Headstart School
Koramangala, Bengaluru – 560034
Phone: 91 80 41636853 25633853
E-mail: info@ableindia.org
Website: www.ableindia.org
All India Biotech Association (AIBA)
"VIPPS Center" 2. Local Shopping Centre Block EFGH, Masjid Moth,
Greater Kailash-II, New Delhi-110048
Tel: 91 11 29211487 (Direct), 29220546/547
Fax: 91 11 29223089, 29229166
Email: unmalik@aibaonline.com
Website: www.aibaonline.com

4444NOVEMBER 2016
GLOSSARY
Bt: Bacillus thuringiensis
CAGR: Compound Annual Growth Rate
CRO: Contract Research Organisation
DNA: Deoxyribonucleic acid
FYP: Five Year Plan
GCP: Good Clinical Practice
INR: Indian Rupee
NBTB: National Biotechnology Board
OAD: Oral Anti-diabetic Drugs
R&D: Research And Development
FY: Indian Financial Year (April to AUGUST)
So FY10 implies April 2009 to AUGUST 2010
USD: US Dollar
Wherever applicable, numbers have been rounded off to the nearest whole number
BIOTECHNOLOGY

4545NOVEMBER 2016
Exchange rates (Fiscal Year)
EXCHANGE RATES
Exchange rates (Calendar Year)
BIOTECHNOLOGY
Year INR equivalent of one USD
2004–05 44.81
2005–06 44.14
2006–07 45.14
2007–08 40.27
2008–09 46.14
2009–10 47.42
2010–11 45.62
2011–12 46.88
2012–13 54.31
2013–14 60.28
2014-15 61.06
2015-16 65.46
2016-2017E 66.95
Source: Reserve bank of India,
Average for the year
Year INR equivalent of one USD
2005 43.98
2006 45.18
2007 41.34
2008 43.62
2009 48.42
2010 45.72
2011 46.85
2012 53.46
2013 58.44
2014 61.03
2015 64.15
2016 (Expected) 67.22

4646NOVEMBER 2016
India Brand Equity Foundation (“IBEF”) engaged TechSci to prepare this presentation and the same has been
prepared by TechSci in consultation with IBEF.
All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. The
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modified or in any manner communicated to any third party except with the written approval of IBEF.
This presentation is for information purposes only. While due care has been taken during the compilation of this
presentation to ensure that the information is accurate to the best of TechSci and IBEF’s knowledge and belief, the
content is not to be construed in any manner whatsoever as a substitute for professional advice.
TechSci and IBEF neither recommend nor endorse any specific products or services that may have been mentioned in
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DISCLAIMER
BIOTECHNOLOGY

Biotechnology Sector Reports November-2016

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