Biotechnology Sector Report June 2017

11JUNE 2017
BIOTECHNOLOGY
JUNE 2017 (As of 9 June 2017) For updated information, please visit www.ibef.org

22JUNE 2017 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
JUNE 2017

33JUNE 2017
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 & is currently
valued at USD11 billion in FY16.
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 USD36.7 billion in 2016 &
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: 10.6%
CAGR: 30.46%
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
36.7
55
FY 16 FY 20F

55JUNE 2017
Growing demand
ADVANTAGE INDIA
Source: CIS India, Ministry OF External Affairs, Government of India, Ministry of Health,, ABLE,
TechSci Research; Note: E - Estimate
FY16
Market
Value:
USD11
billion
FY25E
Market
Value:
USD100
billion
Advantage
India
BIOTECHNOLOGY
Robust demand
• India’s billion-plus population base offers a
huge market for biotech products &
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
• Government of Gujarat aims to create 1 lakh
jobs in the state’s biotechnology industry
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
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
• In January 2017, 54 MoUs worth USD
767.18 million were signed for projects in
biotechnology sector in Gujarat Global
Summit-2017

MARKET OVERVIEW & TRENDS
BIOTECHNOLOGY

77JUNE 2017
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 1st biotech firm,
Biocon, was setup
• 1981: Centre for Cellular &
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 1st Contract
Research Organisation (CRO),
started R&D services
• 1997: Centre for Biological
Technology (CBT) was established
to focus on bioinformatics &
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 UP, Department of
Biotechnology & Government of India &
Department of Science & Technology, a
fully functional biotechnology park was
setup in Lucknow
• 2009: National Biotechnology
Regulatory Authority Bill 2008
introduced in the parliament &
Biotechnology Industry Partnership
Programme was launched
• 2010: Cadila Healthcare, Serum Institute
of India & Bharat Biotech launched 1st
H1N1 swine flu vaccine.
1978–90 1990–99 2000-2010

88JUNE 2017
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 & 3rd largest in Asia-Pacific, after
Japan & 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.
2010-15
• 2016: 8th Biotechnology Industry Research
Assistance Council (BIRAC) announced 8th call
for proposals related to inventions & ideas under
Biotechnology Ignition Grant (BIG) Scheme.
• 2016: The Regional Centre for Biotechnology
Bill, 2016 was passed by Lok Sabha to impart
training & education under guidance of United
Nations Educational, Scientific & Cultural
Organization (UNESCO).
• 2016: India's National Intellectual Property
Rights policy was launched.
• 2017: Ministry of Health, Malaysia, awarded,
Biocon, a contract worth US$68.43 million to
supply recombinant human insulin formulations
for a duration of 3 years
• 2017: Syngene, the contract research arm of
Biocon, has decided to invest USD200 million in
capital expenditure till fiscal 2019.
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 &
CRO along with
custom
manufacturing
• Bio-agriculture is
segmented into
hybrid seeds,
transgenic
crops, bio-
pesticides & bio-
fertilisers
• Bio-industrial
predominantly
comprises enzyme
manufacturing &
marketing
companies
• Bio-informatics deals
with the creation &
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 & 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 & 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 & develop infrastructure & 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 & manufacturing activities
India biotech start-ups attracted investments worth
US$ 2.8 billion between 2012 & February 2017.
Recent studies have revealed that India has about 7.6
per cent of total mammal species, 12.6 per cent of bird
species, 11 per cent of fish & approximately 6 per cent
of the total flowering plants of the world. The country’s
large population base is a huge contributor to the
continuing growth of the industry.
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.
India is becoming a leading destination for clinical trials,
contract research & manufacturing activities which is
leading to the growth of bio services sector
In FY16, the bio-services & bio-agri segments accounted
for 18 per cent & 14 per cent of the biotech industry,
respectively
Serum Institute of India is the largest BioPharma
company in the country & accounts for approximately 22
per cent of BioPharma market
In May 2017, the Department of Biotechnology held a
strategy meet in Delhi to discuss the future scenario of
the Biotechnology industry in the country. The meet
highlighted the aim of reaching US$100 billion mark by
2025, research and development of cutting edge
technologies and other important aspects.
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, Government Of
India, TechSci Research
In FY16, 2,621 projects have been received by Department of
Biotechnology which are categorised 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 1st
Biotechnology policy. The state aims to become one of the
top 5 bio-tech hubs in the country. The state government has
proposed to set up a fund with investment of USD3.73 million
& provide land on priority for setting up of biotechnology
projects
In September 2016, Department of Biotechnology,
Government Of India, decided to set up marine biotech
institute and laboratory in Goa.
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 2nd in Asia, after China
• India is the world’s largest producer of recombinant Hepatitis B vaccine
Pharma companies
focusing on biotech
• Ranbaxy, Cadila Healthcare, Lupin, Wockhardt & 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 & USD1 million from KI Varaprasad Reddy for driving manufacturing &
commercialisation 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 &
molecular diagnostics as well as personalised medicine (where export & 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 4th
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
• Strand Life Sciences recently collaborated with US-based El Camino Hospital to establish a
genomics & pharmacogenomics centre in San Francisco,
• BIRAC in 2016 collaborated with Department of Electronics & Information Technology (DeitY) &
announced a proposal under Industry Innovation Programme on Medical Electronics (IIPME) to
promote innovative technologies in Medical Electronics sector.
• India’s 1st public-private-partnership agreement was announced between Sun Pharma & Indian
Council of Medical Research (ICMR), Govt. of India, Ministry of Health & Family Welfare (MOHFW),
Govt. of Madhya Pradesh.
• Department of Biotechnology, Department of Science & Technology, Government of India, recently
collaborated with Australian government & announced 4 new research projects in biotechnology
under the Indo Australia Biotechnology Fund.
• 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 & Maldives
• 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.
• Tata Trusts along with Lockheed, an aerospace major brand has collaborated with Department of
science & technology under the 2nd edition of the India innovation growth programme (IIGP 2.0), to
improve and utilise the science & technology infrastructure in the country.
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 & Jubilant
Biosys have stepped up investments in personalised medicine. The idea is to eliminate the
unpredictable nature of drug development through personalized medicine.
• For instance, Xcode Life Sciences uses InDNA technology to provide personalised solutions for
lifestyle-related diseases, such as coronary, diabetes & 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 & Research Services
• In June 2017, vaccine manufacturer Bharat Biotech announced the commencement of phase-1
first-in-human clinical trials of the in-house developed chikungunya vaccine.
Stepped up investment
in personalised
medicine
For 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
Growing demand Increasing investmentsPolicy support
India’s large
population, a huge
market for biotech
products & services
Higher healthcare
expenditure & an
increase in Bio-agri
products
Strong growth in
export demand & a
rise in medical
tourism
Adoption of Open
Access Policy in
FY15
R&D focus; Indian
government has
been funding
institutes for biotech
research
Rising investments
from domestic &
foreign players
100 per cent FDI
permitted through
automatic route for
manufacturers of
drugs &
pharmaceuticals
Low cost and skilled
labour force
attracting outsourced
research activity
Increase in
budgetary
allocations to the
Biotech & Healthcare
sectors in 5 year
plans
Resulting in

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 & 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 & 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 & 20 cancer institutes, across the country.
Specialised treatment
• 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 & diabetes have led to a higher demand
for biological products
• Bugworks Research India has made the world’s largest Google
traffic map for oncology pathways which is being used by global
medical professionals across the globe for customize treatment for
cancer patients.
Preventive healthcare
• Around 1.2 billion ailments are reported annually & this
number is expected to rise at a CAGR of 30 per cent to
15 billion cases by 2015 on account of better access to
healthcare facilities & rising lifestyle diseases
• Population growth has elevated the vaccine demand
for the geriatric & paediatric population
• In April 2017, scientists from IIT Chennai discovered
that Aspirin can cure cancer
Healthcare 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 USD2,300 and USD30,800 per annum) is
estimated to increase more than fourfold to 234 million
by 2025 from 113 million in 2005
• 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.
• The growing GNI per capita, PPP of USD6,020 in FY15
resulted in 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
209.10 266.50 304.80
Notes: Income distribution is calculated in constant 2015 dollars; $1=65.
Because of rounding, not all percentages add up to 100. F - Forecast
1.5% 2.0% 5.0%3.0% 6.0%
11.0%8.0%
15.0%
20.0%
42.0%
45.0%
46.0%
44.0%
31.0%
18.0%
2005 2016 2025F
Elite(>30800) Affluent(15400-30800)
Aspirers(7700-15400) Next billion(2300-7700)
Strugglers(<2300)

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 & demonstration programme in various biotechnology based activities were undertaken
to empower the population, resulting in socioeconomic upliftment
Single-window
clearance
• NBDS has made a proposal to set up the National Biotechnology Regulatory Authority to provide a
single-window clearance mechanism for all bio-safety products to create efficiencies & streamline
the drug approval process
Biotechnology Industry
Research Assistance
Council
• BIRAC has been established to promote research & innovation capabilities in India’s biotech
industry. The council will provide funding to biotech companies for technology & product
development.
• BIRAC under Small Business Innovation Research Initiative scheme supports innovations in
biotechnology.
Biotechnology Based
Programme for Women
• Programme on application of biotechnology for women being conducted to provide employment,
skill development, awareness generation, health improvement & socio-economic upliftment.
State Policy Support
• The Andhra Pradesh government in 2015 formulated a new policy which covers the benefits for
the following categories: Incubation Centres, Biotech manufacturing industries, Life Science Park,
Life Science Knowledge Centre, Research & Development Centres.
• The Tamil Nadu government announced a biotech policy in 2014 which aims to encourage new
companies to operate in Tamil Nadu & increasing the R&D & manufacturing activities.
• The Biotechnology Policy of Gujarat established in 2015, promises to provide financial incentives
up to USD3.81 million & capital assistance up to USD7.63 million would be given to biotechnology
parks & companies.

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 & 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 & development to improve biotechnology
in India.
The government plans to strengthen regulatory science &
infrastructure, which involves setting up the Biotechnology
Regulatory Authority of India (BRAI) & a central agency for
regulatory testing & certification of laboratories
The plan also entails expanding & commissioning new
bioclusters at Faridabad, Mohali Kalyani & Hyderabad
It aims to encourage & increase the pool of research scholars &
scientists by three-fivefold in biological & interdisciplinary space
across levels (PhD, PDFs, young faculty)
Central Government approved development of 6 new IT & Bio-
Tech SEZs, from 4 developers for across 3 states. As of 31st
March 2016, Special Economic Zones attracted investments
worth USD57439 million.
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).
Infrastructure
development
• India’s central government & state governments, in collaboration with private players, continue to develop
new infrastructure facilities, especially at biotechnology parks
• The government is developing 3 major biotech clusters at Mohali in Punjab, Faridabad in Haryana &
Bengaluru in Karnataka. It plans to set up an agri-biotech cluster in Pune (Maharashtra) & 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, the European Molecular Biology Organization (EMBO) signed an agreement with 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 & non-
participative roles. In 2015, DBT & Tekes (Finland) joined to form an alliance to fund international standard
joint projects to address Indian & 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 & cell targeted therapies
Single window processing mechanism for all biotech projects involving FDI
Depreciation allowance on plant & machinery raised to 40 per cent from 25 per
cent
Customs duty exemption on goods imported in certain cases for R&D
Customs & excise duty exemption to recognised Scientific & Industrial Research
Organisations (SIRO)
150 per cent weighted tax deduction on R&D expenditure
Three years excise duty waiver on patented products
100 per cent rebate on own R&D expenditure
125 per cent 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 & Biotech parks
Adoption of new Open Access Policy in FY15
Favourable 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 & 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 (2012–17) aims to set up 3–5 bio-
clusters with technology incubators, technology parks,
innovation centres & entrepreneurship development units
Biotechnology infrastructure is witnessing a shift from
traditional clusters to specialised industrial infrastructure
such as biotech or science parks Karnataka, Andhra
Pradesh, Maharashtra, Tamil Nadu & 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.
Science & Technology Department has acquired 10 acres
of land in Jammu & Kashmir to set up 1st biotechnology
park in the state.
Life sciences & advanced biotechnology committee,
economic development board & the Government of Andhra
Pradesh, is planning to develop a biotechnology research
park to develop the state as a biotech hub.
According to the Association of Biotechnology Led
Enterprises (ABLE), over 3,000 entrepreneurs have
established 1,022 biotechnology start-ups across the
country between 2012 and 2016.
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

2828JUNE 2017
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 & private initiatives with proper
utilisation of available resources, is explained in the following diagram:

2929JUNE 2017
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 & 50 biotechnology overseas associateships
Government provided grant-in-aid to the industry for R&D in certain
diseases such as malaria & 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 & 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

3030JUNE 2017
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 & Technology Institute (THSTI), Faridabad 2014
Indian Institute of Scientific Education & Research (IISER) – Knock Out &
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 & 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 & recombinant therapeutics are the sectors driving the biotechnology industry’s growth in India
• Newer prominent therapies such as monoclonal antibodies products, stem cell therapies are expected
to pick up pace in the foreseeing future
• 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 & International Centre for Genetic Engineering
& 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 & antibody production & fabrication of diagnostic protein chips are promising areas for
investment
• Stem cell research, cell engineering & cell-based therapeutics are other areas, where India can cash its
expertise
Agriculture sector
• 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 is poised to grow because of its skilled labour force,
attractive costs & access to major markets in Asia.
• In FY16, Bio services was the 2nd largest sector in India’s biotechnology industry with 18 per cent
market share & accounted for market size of US$1.98 billion.
• India’s bioservices sector includes global contract research organisations, such as Quintiles, as well as
Indian companies including GVK Bio, Jubilant Biosys & 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
US$146.72 million to fasten growth in biotech & pharmaceutical industry.
• In May 2017, the government approved a programme for the development of the bio pharmaceuticals
through industry-institution tie-ups. The government has decided to invest US$223.14 million towards
this mission over the next five years.
Manufacturing
• 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 US$47.99 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 advent of low-cost, whole genome sequencing & the growing role of molecular diagnostics in both
precision & preventive medicine, and proliferation of data has created a significant demand for
bioinformatics.

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 & process engineering;
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 & 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 & Finland & joint call for
proposals have been issued
• Joint projects have also been funded with the Biotechnology & Biological Sciences Research Council
(BBSRC), UK
• New agreements on vision research with National Institutes of Health (NIH), USA & 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, aromatic plants, animal biotechnology,
aquaculture, marine biotechnology, seri biotechnology, stem cell biology, environmental biotechnology,
biofuels, biopesticides, human genetics & genome analysis
• Revised India-Cyprus tax treaty includes the plan for developing hi-tech sector in Cyprus, which will lead
to the future cooperation among the two countries in the field of Biotechnology.

Market size (USD million)
Source: Deptt. of Biotechnology,
Marketresearch, ABLE, TechSci Research
Note: E - Estimates
India was the 1st 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 & 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, proteomics
& 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 FY15–16
• Biocon received an award Greentech Environment Gold
Award for Excellence in Environment Management
• Pharmexcil Gold Patent Award
• Golden Peacock Award for CSR
• Biocon Foundation is recognized for Outstanding
• Contribution to Public Health by WHO India
Revenue and net profit (USD million)
Source: Biocon Company Website
BIOTECHNOLOGY
• Incorporated
in 1978 at
Bengaluru,
India
• IPO
offering in
2004 (BSE,
NSE India)
• Among the
world’s largest
producers of
statins &
immunosuppr
essants
• 2011:
Launched
INSUPen®, a
convenient &
affordable
reusable
insulin
delivery
device
• Market cap of
USD3.39 billion in
FY16
• Revenue in FY17
stood at
USD606.72 million
while net profit
totaled USD91.03
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
& is estimated to
be launched in
Q1 FY17.
• 2016: 1st generic
formulation,
Rosuvastatin
Tablets was
granted
European
approval & is
estimated to be
launched in FY17
with company
benefitting from
an expected
revenue of
USD1.2 billion.
260
315
408
448
467.3
486.6
514.7
545.4
606.72
50.9
56.9
74.6
70.6
93.3
68.8
81.5
136.6
91.03
FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17
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 & 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 2
consecutive
years
1967 1994–2000 2005–16
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.
Present in
>35 countries
worldwide
>1,510 patent
applications filed
globally; of this, 415
have been granted
FY10–11
revenues up by 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 &
launched IPO in 1995
Forayed into Healthcare
Delivery; entered into a
collaboration to set up 220-
bed multi-super specialty
hospital & 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 2005–16
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

4242JUNE 2017
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

4343JUNE 2017
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

4444JUNE 2017
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

4545JUNE 2017
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
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 presentation),
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 Report June 2017

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