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11APRIL 2017

BIOTECHNOLOGY

APRIL 2017 (As of 13 April 2017) For updated information, please visit www.ibef.org

22APRIL 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

APRIL 2017

33APRIL 2017For 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 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

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: 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

36.755

FY 16 FY 20F

ADVANTAGE INDIA

BIOTECHNOLOGY

55APRIL 2017

Growing demand

For updated information, please visit www.ibef.org

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 PropertyRights Policy 2016 has been released

• Research Assistance Council has been setup

• National Rural Healthcare Missionlaunched to boost healthcare spending

• Also, in FY16, DBT launched NationalBiotechnology 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


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


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: 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 & 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 &

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

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

servicesClinical 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 & manufacturing activities

BIOTECHNOLOGY

ROBUST GROWTH IN BIOTECH INDUSTRY

CAGR: 20.33%

1.11.5

1.92.6 2.6

33.8

4.3 4.35

7

1111.6


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

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. Government of Karnataka planned to

raise USD7.34 million funds for research activities in

biotechnology.

Delhi has the 2nd largest share with 13.26 per cent in FY16.

In FY15, total project cost approved to Delhi is USD11.87

million, allocation of USD22.91 million was made for the

development of science & technology sector in the state.

The funds will be made available to the state by the

Department of Biotechnology (DBT), Earth Science (ES),

Polymer Science & technology (PST), Council of Scientific

& Industrial Research (CSIR), for a period of 5 years

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 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

• Bharat Biotech commercially launched 1st novel ROTAVAC® vaccine, to eradicate rotavirus

diarrhea, in India.

• While offering tax holidays & investor-friendly environment, Thailand Board of Investment seeks

investments from India in areas such as biotech, automation, etc.

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 &

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 &

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 agenomics & pharmacogenomics centre in San Francisco, while Hyderabad-based GVK Biosciencesentered into an agreement with the US FDA for drug repositioning

• BIRAC in 2016 collaborated with Department of Electronics & Information Technology (DeitY) &announced call for proposal under Industry Innovation Programme on Medical Electronics (IIPME) topromote innovative technologies in Medical Electronics sector.

• India’s 1st public-private-partnership agreement was announced between Sun Pharma & IndianCouncil 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, recentlycollaborated with Australian government & announced 4 new research projects in biotechnologyunder the Indo Australia Biotechnology Fund.

• Companies in the industry are exploring new avenues in life sciences to strengthen & upgrade theproducts & services portfolio through strategic mergers & acquisitions. In 2015, Dr. Reddy’sLaboratories acquired UCB (India) for USD131.02 million. The acquisition has been done forestablished brands of UCB in India, Nepal, Sri Lanka & Maldives

• As of October 2016, Advanced Enzyme Technologies, a biotech based firm in Mumbai signed anagreement with JC Biotech - Active Pharmaceutical Ingredient (API) maker in Hyderabad, to acquire70 per cent stake in the company.

• Tata Trusts along with Lockheed, an aerospace major brand has collaborated with Department ofscience & technology under the 2nd edition of the India innovation growth programme (IIGP 2.0), toinvest in social & industrial innovations, offer support in incubation, aid in business development &train innovators in world-class commercialisation strategies.

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 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 & Research Services

• In FY15, Biocon launched Bionesp, antibody for managing anemia in its early-stage.

• In FY15, Ministry of Science & Technology adopted National Biotechnology Development

Strategy 2015-2020.

Stepped up investment

in personalised

medicine

For ramping up service

offerings

Source: Ministry of External Affairs, RBI

GROWTH DRIVERS

BIOTECHNOLOGY


Source: Makeinindia, TechSci Research

SECTOR BENEFITS FROM RISING INCOME AND POPULATION

BIOTECHNOLOGY

Growing demand

Inviting Resulting in

Growing demand Increasing investments Policy 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


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 disease profile that inflicts the Indian population hasexperienced a gradual shift. The number of lifestyle-relateddiseases being reported is rising; this has led to demand forvarious kinds of specialised treatments

• Ailments such as cancer & diabetes have led to a higherdemand for biological products

• Started in 2007, Bugworks Research India has made theworld’s largest Google traffic map for oncology pathways whichis being used by global medical professionals across the globefor customise treatment for cancer patients. The research firm isalso working on finding solutions to deal with superbuginfections

Preventive healthcare

• Around 1.2 billion ailments are reported annually & thisnumber is expected to rise at a CAGR of 30 per cent to15 billion cases by 2015. Better access to healthcarefacilities & rising lifestyle diseases are driving this trend

• Population growth has elevated the vaccine demandfor the geriatric & paediatric population

• In April 2017, scientists from IIT Chennai discoveredthat Aspirin, the common headache drug, can curecancer

Healthcare Funds availability (USD million)

129.4302.1

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 & rural income are increasing

• The number of middle class households (earning

between USD4,413.1 & USD22,065.3 per annum) is

estimated to increase more than 4-fold to 148 million

by 2030 from 32 million in 2010

• Rising per capita income leads to increased spending

on medical & 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 &

diabetes are treated with the help of biotechnology

products, thereby boosting revenues of biotech

companies

• The growing GNI per capita, PPP of USD6,030 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 & demonstration programme in various biotechnology based activities were undertaken

to empower the population resulting in socioeconomic upliftment

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 & streamline the drug approval process

Biotechnology Industry

Research Assistance

Council

• BIRAC has been established to promote research & innovation capabilities in India’s biotech

industry

• Under BIRAC, the government will provide funding to biotech companies for technology & 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

R&D & 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 & 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.

State Biotechnology

Policy

(2016-2021) (Gujarat)

• Financial incentives of up to USD3.81 million & capital assistance of up to USD7.63 million would

be given to biotechnology parks & biotechnology companies. Moreover, for new biotechnology

finishing schools, the government has decided to allocate USD 0.15 million.


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).

• Government funding is crucial for biotech industry due to limited access to other sources of funding.

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, 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 & non-participative roles. DST accordingly played the role of an extra mural research funding agency whereincompetitive grants for research was provided to investigators based on technical merit. 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

States such as 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.

Investors such as TCG Bio-pharma & Alexandria have

significantly contributed to the establishment of

biotechnology-related infrastructure in India.

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.

SOLID INDUSTRY INFRASTRUCTURE WOULD DRIVE GROWTH

BIOTECHNOLOGY

Jogindernagar

Shimla

Chandigarh

AlwarSohna

Jodhpur Jaipur

GandhinagarAnand

Jamnagar

Baroda

Aurangabad

Pune

Hyderabad

Bhubaneshwar

Konark

Midnapore

Pantnagar

BengaluruChennai

Puducherry

Visakhapatnam

Kochi

Karwar

Madurai

Operational biotech parks

2929APRIL 2017

Research parksCommunities 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:



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



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, Pune2016

Indian Institute of Science (IISc), Bengaluru 2016

High Resolution Mass

Spectrometry FacilityIndian Institute of Bombay, Mumbai 2016

Containment FacilitiesTuberculosis Aerosol Challenge Facility, International Centre for Genetic

Engineering & Biotechnology (ICGEB), New Delhi2016

Flowcytometry, Imaging and

Microarray Facilities

Electron Microscopy Referral Facility, Govind Ballabh Pant Institute of

Postgraduate Medical Education & Research, Delhi2015


STRONG INFLOW OF FOREIGN INVESTMENT

BIOTECHNOLOGY

Date

announcedAcquirer name Target name

Value of deal

(USD million)

Sept 2016 Bayer Mosanto 2,830

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

OPPORTUNITIES

BIOTECHNOLOGY


Vaccines

• Vaccines & 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 & 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

• India has the potential to become a major producer of transgenic rice & 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 & 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 USD1.98 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

USD146.72 million to fasten growth in biotech & 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 & with the advent of

low-cost, whole genome sequencing & the growing role of molecular diagnostics in both precision &

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 & 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 & 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


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

SUCCESS STORIES

BIOTECHNOLOGY


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 Annual Report 2016

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 FY16

stood at

USD545.4million

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

& 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.

26

0.0

31

5.0 4

08

.0

44

8.0

46

7.3

48

6.6

51

4.7

54

5.4

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 & 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&DLaunched 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 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 & 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

2004Started 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

4343APRIL 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: [email protected]

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: [email protected]

Website: www.aibaonline.com

4444APRIL 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

4545APRIL 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

4646APRIL 2017

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