BIOTECHNOLOGY - IBEF · State wise share for Approved Biotech Project Cost FY15 STATE WISE SHARE...

11NOVEMBER 2016

BIOTECHNOLOGY

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

22NOVEMBER 2016 For updated information, please visit www.ibef.org

Executive Summary………….…………..…..3

Advantage India……………….………..…….4

Market Overview and Trends….....................6

Strategies Adopted……………….………….16

Growth Drivers…......................................…20

Opportunities………………………………...33

Success Stories: Major Players…….……..38

Useful Information.......................................42

BIOTECHNOLOGY

NOVEMBER 2016

33NOVEMBER 2016For updated information, please visit www.ibef.org

Source: Department of Biotechnology, Ministry of Science & Technology , Ministry of External Affairs, Government of India, Make In India, TechSci Research

Note: F - Forecast

EXECUTIVE SUMMARY

BIOTECHNOLOGY

By FY25, India’s biotech

industry is estimated to

increase to USD100 billion from

USD7 billion in FY15 and is

currently valued at USD11

billion.

The biotech industry is

expected to experience

significant growth amid

favourable business conditions

In 12th Five-Year Plan, the

government aims to spend

USD3.7 billion on

biotechnology compared to

USD1.1 billion in the 11th Five-

Year Plan

Increasing government

expenditure is likely to augment

growth in biotechnology

industry.

India’s pharmaceuticals market

size is USD30 billion in 2015

and estimated to reach at

USD55 billion in 2020F

Growing pharmaceuticals

market is estimated to aid

growth of the biotech industry

Percentage rise in

investments 236.36%

CAGR: 12.8%

CAGR: 30.46%

30

55

FY15 FY20FUSD 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

ADVANTAGE INDIA

BIOTECHNOLOGY

55NOVEMBER 2016

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

Robust demand

• India’s billion-plus population base offers a huge market for biotech products and services

• Increasing economic prosperity and health consciousness would continue to fuel demand for healthcare services

• Better accessibility to healthcare services further accelerates the demand

Innovation opportunities

• Public funding is being offered for product innovation and research in the biotech sector

• The private sector has been aggressively pursuing focused R&D

• Public-Private partnerships will improve the market with innovative research and development

Increasing investments

• FDI investment up to 100 per cent is permitted via the automatic route

• A low cost and skilled labour force is attracting outsourced research activity

• Launch of Biotechnology Industry Partnership Programme (BIPP) is boosting industry participation

FY16

Market

Value:

USD11

billion

FY25E

Market

Value:

USD100

billion

Advantage

India

BIOTECHNOLOGY

Policy support

• In FY15, Ministry of Biotechnology adopted the open access policy

• In FY16, National Intellectual Property Rights Policy 2016 has been released

• Research Assistance Council has been set up

• National Rural Healthcare Mission launched to boost healthcare spending

• Also, in FY16, DBT launched National Biotechnology Development Strategy

MARKET OVERVIEW & TRENDS

BIOTECHNOLOGY


MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY

Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research

Note: R&D - Research and Development

DBT – Department of Biotechnology

BIOTECHNOLOGY

• 1978: India’s first biotech firm,

Biocon, was setup

• 1981: Centre for Cellular and

Molecular Biology setup in

Hyderabad

• 1984: Institute for Microbial

Technology, Chandigarh was setup

• 1986: Department of Biotechnology

(DBT) was formed

• 1987: National Institute of

Immunology was setup by DBT

• 1989: Bangalore Genei commenced

operations

• 1991: National Centre for Biological

Sciences pursued R&D in molecular

biology

• 1994: Syngene, India’s first Contract

Research Organisation (CRO),

started R&D services

• 1997: Centre for Biological

Technology (CBT) was established

to focus on bioinformatics and

genomics

• 1998: Monsanto Research

established an R&D centre for plant

genomics

• 1998: DBT approved Mahyco-

Monsanto to grow Bt cotton

• 2007: National Biotechnology

Development Strategy launched

• 2007: With the joint efforts of

Government of Uttar Pradesh,

Department of Biotechnology and

Government of India & Department

of Science and Technology, a fully

functional biotechnology park was

setup in Lucknow.

• 2009: National Biotechnology

Regulatory Authority Bill 2008

introduced in the parliament and

Biotechnology Industry Partnership

Programme was launched

• 2010: Cadila Healthcare, Serum

Institute of India and Bharat Biotech

launched first H1N1 swine flu

vaccine

1978–90 1990–99 2000-10


MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY

Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research

Note: R&D - Research and Development

DBT – Department of Biotechnology

BIOTECHNOLOGY

• 2011: Government approved setting

up the Biotechnology Industry

Research Assistance Council

(BIRAC)

• 2012: India ranked 12th in the world

in biotech and 3rd largest in Asia-

Pacific, after Japan and Korea

• 2013: India became the biggest

producer of Hepatitis B vaccine

recombinant

• 2015: DBT allocated USD0.735

million to University of Agricultural

Sciences to support a national multi-

institutional project.

• 2015: DBT launched “The National

Biotechnology Development

Strategy 2015-2020 programme” to

turn India into

biotechnology hub.

• 2016: USD238.09 million was

allocated by the DBT under Budget

2016-17.

• 2016: 8th Biotechnology Industry

Research Assistance Council

(BIRAC) announced 8th call for

proposals related to inventions and

ideas under Biotechnology Ignition

Grant (BIG) Scheme.

• 2016: The Regional Centre for

Biotechnology Bill, 2016 was passed

by Lok Sabha to impart training and

education under guidance of United

Nations Educational, Scientific and

Cultural Organization (UNESCO).

• 2016: India's National Intellectual

Property Rights policy was

launched.

2010-15 Post 2015


KEY SEGMENTS IN THE INDIAN BIOTECHNOLOGY INDUSTRY

Source: ABLE - Biospectrum Industry Survey, June 2013; TechSci Research

BIOTECHNOLOGY

• Bio-pharmaceutical

products are

therapeutic or

preventative

medicines that are

derived from

materials naturally

present in living

organisms, using

recombinant DNA

(rDNA) technology

• Bio-services

mainly include

clinical research

and CRO along

with custom

manufacturing

• Bio-agriculture is

segmented into

hybrid seeds,

transgenic

crops, bio-

pesticides and

bio-fertilisers

• Bio-industrial

predominantly

comprises enzyme

manufacturing and

marketing

companies

• Bio-informatics deals

with the creation and

maintenance of

extensive electronic

databases on various

biological systems;

industry

Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics

Biotechnology


MAJOR PRODUCTS/SERVICES OF THE INDIAN BIOTECHNOLOGY INDUSTRY

Source: ABLE - Biospectrum Industry Survey, Ministry of External Affairs, TechSci Research

BIOTECHNOLOGY

Biotechnology

Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics

Vaccines

Diagnostic

Therapeutic

Custom

Manufacturing

Contract

Research

Organisation

Hybrid seeds

Bio-fertilisers

Bio-pesticides

Industrial

enzymes

Database

services

Integrated

research app

software

Biotech software

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 and 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.

Serum Institute of India is the largest BioPharma company

in the country and accounts for approximately 22 per cent of

BioPharma market in FY15

India is becoming a leading destination for clinical trials,

contract research and manufacturing activities which is

leading to the growth of bio services sector

In FY16, the bio-services and bio-agri segments accounted

for 18.0 per cent and 14.0 per cent of the biotech industry,

respectively

BIO-PHARMA ACCOUNTS FOR MAJORITY MARKET SHARE AND WITNESSES FASTEST GROWTH IN FY16

BIOTECHNOLOGY

64%

18%

14%

3%1%

Bio-pharma

Bio-services

Bio-agri

Bio-industry

Bio-informatics


Source: Department of Biotechnology, TechSci Research

In FY15, provision of USD89.47 million has been made by

Department of Biotechnology for the approved

biotechnology projects in India.

Karnataka is the hub for biotechnology sector. Investments

of USD25.95 million was allocated towards biotechnology

projects in Karnataka. Delhi has the second largest share

with 13.26%.

In FY16, Government of Karnataka planned to raise

USD7.34 million funds for research activities in

biotechnology.

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

million

BIOTECHNOLOGY

State wise share for Approved Biotech Project

Cost FY15

STATE WISE SHARE FOR APPROVED BIOTECH PROJECT COST FY15

29.04%

13.26%

11.68%9.69%

7.76%

6.01%

4.56%

3.30%

14.69%

Karnataka

Delhi

Haryana

Tamil Nadu

Maharashtra

Telangana

West Bengal

Uttar Pradesh

Others


Source: Department of Biotechnology, Government Of

India, TechSci Research

In FY16, 2,621 projects have been received by Department

of Biotechnology which are categorized as ongoing number

of biotechnology projects in India.

Delhi accounted for the largest share of 13.93 per cent of

the total number of projects received in biotechnology

sector, followed by Tamil Nadu, which accounted for a

share of 10.95 per cent.

In FY16, a total of 365 biotechnology projects were

allocated to Delhi at an approved project cost of USD11.87

million.

As of November 2016, Odisha released the draft of its first

Biotechnology policy. The state aims to become one of the

top five bio-tech hubs in the country. The state government

has proposed to set up a fund with investment of USD 3.73

million and provide land on priority for setting up of

biotechnology projects.

BIOTECHNOLOGY

State wise share for Ongoing Number Of Biotech

Projects FY16

STATE WISE SHARE FOR ONGOING NUMBER OF BIOTECH PROJECTS FY16

13.93%

10.95%

9.92%

8.32%

6.64%6.64%

5.80%

3.43%

34.38%

Delhi

Tamil Nadu

Karnataka

Maharashtra

Telangana

Uttar Pradesh

West Bengal

Haryana

Others


Remarkable global

positioning

• India is among the top 12 biotech destinations in the world

• India ranks second in Asia, after China

• India is the world’s largest producer of recombinant Hepatitis B vaccine

• Bharat Biotech commercially launched first novel ROTAVAC® vaccine, to eradicate

rotavirus diarrhea, in India.

Pharma companies

focusing on biotech• Ranbaxy, Cadila Healthcare, Lupin, Wockhardt and Dr Reddy’s are among the major

Indian pharmaceutical companies operating in the bio-pharma segment

NOTABLE TRENDS IN THE INDIAN BIOTECH SECTOR

BIOTECHNOLOGY

Global companies

setting up base

• US based DiabetOmics Inc., medical diagnostic company has raised USD4 million from

Ventureast and USD1 million from KI Varaprasad Reddy for driving manufacturing and

commercialization activities in India.

Biosimilars and

molecular diagnostic

remain strongholds

• Growth in the sector is anticipated to come from the country's strong position in biosimilars

and molecular diagnostics as well as personalised medicine (where export and domestic

trends look promising). In 2016, development of biosimilars has been speeding up via

Glycosylation Control Technology.

Source: Ministry of External Affairs, TechSci Research, Indian Law Offices

Bt:

Growth in Genetically

Modified crops

• According to International Service for the Acquisition of Agri-Biotech Applications, India

has the fourth largest area covered under genetically modified crops

• In India, 11.57 million hectares of area is covered under genetically modified crops which

is majorly dominated by Bt cotton.

• After Bt cotton, Bt brinjal, covering an area of 7.6 million hectares, is potentially benefitting

farmers as well as consumers.

STRATEGIES ADOPTED

BIOTECHNOLOGY


STRATEGIES ADOPTED

BIOTECHNOLOGY

• Indian biotech firms are partnering with niche players to broaden their product portfolio and

strengthen global reach

• Strand Life Sciences recently collaborated with US-based El Camino Hospital to establish a

genomics and pharmacogenomics centre in San Francisco, while Hyderabad-based GVK

Biosciences entered into an agreement with the US FDA for drug repositioning

• BIRAC recently collaborated with Department of Electronics and Information Technology (DeitY) and

announced call for proposal under Industry Innovation Programme on Medical Electronics (IIPME) to

promote innovative technologies in Medical Electronics sector.

• India’s first public-private-partnership agreement was announced between Sun Pharma and Indian

Council of Medical Research (ICMR), Govt. of India, Ministry of Health & Family Welfare (MOHFW),

Govt. of Madhya Pradesh.

• Department of Biotechnology, Ministry of Science & Technology, Government of India, recently

collaborated with Australian government and announced four new research projects in biotechnology

under the Indo Australia Biotechnology Fund.

• Companies in the industry are exploring new avenues in life sciences to strengthen and upgrade the

products and services portfolio through strategic mergers and acquisitions. In 2015, Dr. Reddy’s

Laboratories acquired UCB ( India) for USD131.02 million. The acquisition has been done for

established brands of UCB in India, Nepal, Sri Lanka and Maldives

• To strengthen its business in US pharma market, Cipla acquired two US-based companies namely,

Exelan Pharmaceuticals Inc. and InvaGen Pharmaceuticals Inc. for USD230 million in February 2016.

• As of October 2016, Advanced Enzyme Technologies, a biotech based firm in Mumbai signed an

agreement with JC Biotech - Active Pharmaceutical Ingredient (API) maker in Hyderabad, to acquire

70 per cent stake in the company.

Strategic collaborations

with niche players and

government bodies

Mergers & Acquisitions

Source: Ministry of External Affairs, RBI; Note: Govt. - Government


STRATEGIES ADOPTED

BIOTECHNOLOGY

• Pharma companies, including Avesthagen, TCG Life Sciences, Advinus Therapeutics and

Jubilant Biosys have stepped up investments in personalised medicine. The idea is to eliminate

the unpredictable nature of drug development through personalised medicine.

• For instance, Xcode Life Sciences uses InDNA technology to provide personalised solutions for

lifestyle-related diseases, such as coronary, diabetes and obesity, using saliva samples.

• Action Biotech provides genetic tests to predict response from chemotherapy drugs. Geneombio

Technologies offer gene-based prediction to assess genetic susceptibility towards major lifestyle

diseases. Acton Biotech, OncQuest Laboratories, etc. are few of the other notable players

operating in the field of personalized medicine in India.

• Companies are evolving their product mix to reflect growing repertoire in Biologics, Branded

Formulations and Research Services

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

Stepped up investment

in personalised

medicine

Ramping up service

offerings

Source: Ministry of External Affairs, RBI

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 and

services

Higher healthcare

expenditure and an

increase in Bio-agri

products

Strong growth in

export demand and

a rise in medical

tourism

Adoption of Open

Access Policy in

FY15

R&D focus; Indian

government has

been funding

institutes for biotech

research

Increase in

budgetary

allocations to the

Biotech and

Healthcare sectors in

five-year plans

Rising investments

from domestic and

foreign players

100 per cent FDI

permitted through

automatic route for

manufacturers of

drugs and

pharmaceuticals

Low cost and skilled

labour force

attracting outsourced

research activity


Source: MHRD,

National Biotechnology Development Strategy, DBT, TechSci Research

HIGHER HEALTHCARE EXPENDITURE DRIVING DOMESTIC DEMAND

BIOTECHNOLOGY

Exponential growth in government funding

• Government spending on healthcare, as a percentage

of GDP, for the 12th Five-Year Plan is around 2.5 per

cent , and to at least 3 per cent of GDP by 2022.

• Government has announced to allocate USD5.43

billion to its healthcare department. Medical tourism in

India has reached USD3.6 billion in FY2015 and is

estimated to reach USD6 billion by 2018.

• During the 11th Five-Year Plan, the Department of

Biotechnology utilised 94.49 per cent of the allocated

resources

• In 2016, government plans to establish 17 new All India

Institute of Medical Sciences (AIIMS) and 20 cancer

institutes, across the country.

Specialised treatment

• The disease profile that inflicts the Indian population

has experienced a gradual shift. The number of

lifestyle-related diseases being reported is rising; this

has led to demand for various kinds of specialised

treatments

• Ailments such as cancer and diabetes have led to a

higher demand for biological products

Preventive healthcare

• Around 1.2 billion ailments are reported annually, and

this number is expected to rise at a CAGR of 30 per

cent to 15 billion cases by 2015. Better access to

healthcare facilities and rising lifestyle diseases are

driving this trend

• Population growth has elevated the vaccine demand

for the geriatric and paediatric population

Funds availability (USD million)

129.4302.1

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 and rural income are increasing

• The number of middle class households (earning

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

estimated to increase more than fourfold to 148 million

by 2030 from 32 million in 2010

• Rising per capita income leads to increased spending

on medical and healthcare services

Higher incidence of chronic lifestyle diseases

• Lifestyle diseases are set to account for a greater part

of the healthcare market

• Lifestyle diseases such as cardiac diseases, cancer

and diabetes are treated with the help of biotechnology

products, thereby boosting revenues of biotech

companies

• The growing GNI per capita, PPP of USD6,020 in FY15

led to improved lifestyle due to increased purchasing

power of customers for healthcare.

Notes: Greater distributional efficiencies and increasing demand (especially

from rural areas) due to rising disposable incomes have created new

markets for products within the country, F - Forecast

Million household, 100%

Income

segment

244 273 322

1% 3% 7%2% 6%17%23%

25%

29%43%

40%

32%

30% 26%15%

2015 2020 2030

Globals(>22065.3) Strivers(11032.7-22065.3)

Seekers(4413.1-11032.7) Aspirers(1985.9-4413.1)

Deprived(<1985.9)


STRONG POLICY SUPPORT CRUCIAL TO THE SECTOR’S DEVELOPMENT

BIOTECHNOLOGY

Source: “Biotechnology facilities,” Department of

Biotechnology, TechSci Research, Note: BIRAC -

Biotechnology Industry Research Assistance Council

Programme for SC/ST

and Rural Population

• Training and demonstration programme in various biotechnology based activities were

undertaken to empower the population resulting in socioeconomic upliftment

National Biotechnology

Development Strategy

• DBT designed the National Biotechnology Development Strategy (NBDS) to strengthen the

industry’s human resources and infrastructure while promoting growth and trade

• As part of the NBDS, government decided to spend 30 per cent of DBT’s Budget in public

private partnerships to promote R&D at various stages and has launched “The National

Biotechnology Development Strategy -2015-2020”.

Single-window

clearance

• As per NBDS, a proposal has been made to set up the National Biotechnology Regulatory

Authority (NBRA) to provide a single-window clearance mechanism for all bio-safety products

to create efficiencies and streamline the drug approval process

Biotechnology Industry

Research Assistance

Council

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

biotech industry

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

product development.

• BIRAC under Small Business Innovation Research Initiative (SBIRI) scheme supports

innovations in biotechnology.

Tamil Nadu Bio

technology Policy 2014• The Policy aims to encourage new companies to operate in Tamil Nadu, thereby increasing

the Research & Development and manufacturing activities in the sector

Biotechnology Based

Programme for Women

• Programme on application of biotechnology for women was done to provide employment, skill

development, awareness generation, health improvement, and socio-economic upliftment of

the women population

“Biotechnology Policy

2015-2020 “

(Andhra Pradesh)

• The Policy has been formulated to promote biotechnology sector in Andhra Pradesh. The new

policy covers the benefits for the following categories: Incubation Centres, Biotech

manufacturing industries, Life Science Park, Life Science Knowledge Centre, Research &

Development Centres.


12th Five-Year Plan expenditure (USD billion)

Source: Deptt. of Science and Technology, TechSci Research

The overall strategy of 12th Five-Year Plan is to accelerate

the pace of research, innovation and development. The

main objective is to advance biotechnology as strategic

area by taking India’s strengths in foundational sciences to

globally competitive levels. In addition, emphasis is on

expanding the application of biotechnologies for overall

growth of bio- economy within the framework of inclusive

development

The 12th Five-Year Plan aims to accelerate the pace of

research, innovation and development to improve

biotechnology in India.

The government plans to strengthen regulatory science and

infrastructure, which involves setting up the Biotechnology

Regulatory Authority of India (BRAI) and a central agency

for regulatory testing and certification of laboratories

The plan also entails expanding and commissioning new

bioclusters at Faridabad, Mohali Kalyani and Hyderabad

It aims to encourage and increase the pool of research

scholars and scientists by three-fivefold in biological and

interdisciplinary space across levels (PhD, PDFs, young

faculty)

BIOTECH IN FOCUS IN 12TH FIVE-YEAR PLAN

BIOTECHNOLOGY

1.1

3.7

Eleventh Five Year Plan Twelfth Five Year Plan

12th Five-Year Plan fund allocation (USD billion)

26%

22%

17%

14%

21%

Medical biotech

Agri biotech

Basic bio & emerging areas

Biodiversity, bioresources &Environment

Capacity building


Joint Venture fund

• In February 2015, Aurobindo Pharma announced a Joint Venture with Tergene Biotech company for

cost effective development of the Pneumococcal Conjugate Vaccine (PCV).

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

Infrastructure

development

• India’s central government and state governments, in collaboration with private players, continue to

develop new infrastructure facilities, especially at biotechnology parks

• The government is developing three major biotech clusters at Mohali in Punjab, Faridabad in

Haryana, and Bengaluru in Karnataka. It plans to set up an agri-biotech cluster in Pune (Maharashtra)

and Kolkata (West Bengal)

GOVERNMENT FUNDING CRUCIAL FOR THE BIOTECH INDUSTRY

BIOTECHNOLOGY

International

collaborations

• India has partnered with countries such as the UK, Russia, Italy, the US and France to enable

knowledge transition.

• In 2015, the UK Medical Research Council (MRC) and the Government of India Department for

Biotechnology (DBT) formed an alliance to fund three major global research centers

• In 2016, a cooperation agreement with European Molecular Biology Organization (EMBO) was signed

by the Government of India to enhance collaborative research activities between India and Europe.

Clinical Establishments

Bill

• In a move to standardise procedures, the Indian Parliament passed the Clinical Establishments Bill

2010, which would make registration of clinical trials as well as clinical research organisations

mandatory in the country

• The Bill also includes standard operating procedures for various trial related tasks

• Government plans to fast track the approval process for clinical trials while ensuring that CROs

involved comply with stricter quality and compliance checks.

Source: Ernst & Young, TechSci Research; Note: DST-Department

of science and Technology, DBT-Department of Biotechnology

Research Funding

Agency

• The DST has consistently enabled transformational changes through appropriate responses and non-

participative roles. DST accordingly played the role of an extra mural research funding agency

wherein competitive grants for research was provided to investigators based on technical merit. In

2015, DBT and Tekes (Finland) joined to form an alliance to fund international standard joint projects

to address Indian and global needs


CENTRE AND STATE GOVERNMENT INITIATIVES PROVIDE BIG BOOST TO BIOTECH INDUSTRY

BIOTECHNOLOGY

Increasing government support

International collaboration of Department of Biotechnology with other countries

100 per cent foreign equity investment is possible in manufacturing of all drugs

except recombinant DNA products and cell targeted therapies

Single window processing mechanism for all biotech projects involving FDI

Depreciation allowance on plant and machinery raised to 40% from 25%

Customs duty exemption on goods imported in certain cases for R&D

Customs & excise duty exemption to recognised Scientific & Industrial Research

Organisations (SIRO)

150% weighted tax deduction on R&D expenditure

Three years excise duty waiver on patented products

100% rebate on own R&D expenditure

125% rebate if research is contracted in public funded R&D institutions

Joint R&D projects provided special fiscal benefits

The National Biotechnology Development Strategy 2015-20 to make India bio-

manufacturing hub.

Promote innovations through BIPP, SBIRI, BIRAC and Biotech parks

Adoption of new Open Access Policy in FY15

Favorable IP climate

Indian Copyright Act, 1957

The Patent Act, 1970

Indian Patents and Design Act, 1972

The Trademarks Act, 1999

Biotechnology Patent Facilitating Cell (BPFC)

Foundation of Biotechnology Awareness and

Education (FBAE)

National Research Development Corporation (NRDC)

National Guidelines for Stem Cell Research (2013)

Tamil Nadu Biotechnology Policy 2014

Biotechnology Policy 2015-2020, Andhra Pradesh

National Intellectual Property Right Policy 2016

Source: Ernst & Young, TechSci Research

Notes: BIPP - Biotechnology Industry Partnership Programmes,

SBIRI - Small Business Innovation Research Industry,

BIRAC - Biotechnology Industry Research Assistance Council,

IP – Intellectual Property


REGULATORY FRAMEWORK OF THE INDIAN BIOTECH SECTOR

BIOTECHNOLOGY

Source: Policy and rules, Department of Biotechnology website,

TechSci Research

Government of India

Ministry of Science

& Technology

Ministry of

Environment &

Forests

Department of

Biotechnology

Department of

Environment, Forests

& Wildlife

Recombinant DNA

Advisory Committee

(RDAC)

Regulatory Committee

on Genetic

Manipulation

(RCGM)

Institutional Biosafety

Committee

(IBSC)

Genetic Engineering

Approval Committee

(GEAC)


Source: Press Information Bureau, TechSci Research

The 12th Five Year Plan aims to set up 3–5 bio-clusters

with technology incubators, technology parks, innovation

centres and entrepreneurship development units

Biotechnology infrastructure is witnessing a shift from

traditional clusters to specialised industrial infrastructure

such as biotech or science parks

States such as Karnataka, Andhra Pradesh, Maharashtra,

Tamil Nadu and Kerala have been early movers in

establishing world-class biotech parks and clusters.

In 2016, Monsanto, a leading player in global

biotechnology industry planned to establish a seed plant in

Buldhana district of Maharashtra.

Investors such as TCG Bio-pharma and Alexandria have

significantly contributed to the establishment of

biotechnology-related infrastructure in India.

Science and Technology Department has acquired 10

acres of land in Jammu & Kashmir to set up first

biotechnology park in the state.

SOLID INDUSTRY INFRASTRUCTURE WOULD DRIVE GROWTH

BIOTECHNOLOGY

Jogindernagar

Shimla

Chandigarh

AlwarSohna

Jodhpur Jaipur

GandhinagarAnand

Jamnagar

Baroda

Aurangabad

Pune

Hyderabad

Bhubaneshwar

Konark

Midnapore

Pantnagar

BengaluruChennai

Puducherry

Visakhapatnam

Kochi

Karwar

Madurai

Operational biotech parks

2929NOVEMBER 2016

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 and 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 and 50 biotechnology overseas

associateships

Government provided grant-in-aid to the industry for R&D in certain

diseases such as malaria and leishmaniasis or kala-azar

HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION

BIOTECHNOLOGY

Details of key biotechnology parks in India

Parks City Area (in acres)

Shapoorji Pallonji Biotech Park Hyderabad 300

ICICI Knowledge Park Hyderabad 200

International Biotech Park Pune 103

Lucknow Biotech Park Lucknow 20

Golden Jubilee Biotech Park Chennai 8

Ticel Bio Park Chennai 5

Key research institutes in India

Central Drug Research Institute (CDRI), Lucknow

National Institute of Pharmaceutical Education and

Research (NIPER), Mohali

Indian Institute of Chemical Technology (IICT), Hyderabad

Centre for Cellular & Molecular Biology (CCMB),

Hyderabad

Indian Institute of Chemical Biology (IICB), Kolkata

Indian Toxicology Research Institute (ITRI), Lucknow

Institute of Genomics and Integrative Biology (IGIB), New

Delhi

Institute of Microbial Technology (IMTECH), Chandigarh

National Chemical Laboratory (NCL), Pune

National Centre for Biological Sciences (NCBS), Bengaluru

Jawaharlal Nehru Centre for Advanced Scientific Research

(JNCASR), Bengaluru

Indian Institute of Science (IISc), Bengaluru

National Institute of Immunology (NII), New Delhi

National Center for Cell Sciences, Pune

National Center for Plant Genome Research (NCPGR),

New Delhi

List of Biotech Parks at Developing Stage

Parks City Area (in acres)

Guwahati Biotech Park Assam 700

KINFRA Biotech Park Kerala 75

Bio Pharma-IT Park, Odisha 64.61

Bangalore Biotech Park Karnataka 53



for Developing Countries (RIS), TechSci Research, "Mid-term appraisal“

Department of Biotechnology supports various biotech facilities in the nation, which is driving the biotechnology industry by

providing advanced research infrastructure.

Various biotech facilities have been established by Department of Biotechnology under “Task Force on Research

Resources, Service Facilities and Platforms”.

HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION

BIOTECHNOLOGY

List of Key Biotechnology Facilities in India Supported by DBT

Facility Established Name of the Institution Sanction Year

Animal House facility

National Institute of Immunology (NII), New Delhi 2013

Translational Health Science and Technology Institute (THSTI), Faridabad 2014

Indian Institute of Scientific Education and Research (IISER) – Knock Out and

Transgenic Mice, 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 and 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)

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 and recombinant therapeutics are the sectors driving the biotechnology industry’s growth

in India

• Newer therapies are anticipated to be launched in the next few years; prominent among these are

monoclonal antibodies products, stem cell therapies and growth factors

• The country’s huge population makes it among the world’s largest markets for vaccines. In 2015,

Bharat Biotech launched ‘Rotavac’ vaccine in India, three doses of the vaccine can prevent the

Rotavirus diarrhea in infants.

• Indian pharmaceutical firms supply 80 per cent of the anti retroviral drugs to fight AIDS globally

• As on October 2016, Sun Pharmaceutical Industries Ltd and International Centre for Genetic

Engineering and Biotechnology (ICGEB) signed a pact to develop vaccine for all four serotypes of

dengue virus.

HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE

BIOTECHNOLOGY

Bioactive therapeutic

proteins

• Protein and antibody production and fabrication of diagnostic protein chips are promising areas for

investment

• Stem cell research, cell engineering and cell-based therapeutics are other areas, where India can

cash its expertise

Agriculture sector

• India has the potential to become a major producer of transgenic rice and several Genetically

Modified (GM) or engineered vegetables

• Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield

improvement

• Growing at an annual growth rate of 10-15 per cent, the Indian hybrid seed industry is estimated at

USD1.93 billion in FY16, wherein Bt cotton is leading the market accounting for 45 per cent share

India hybrid seed industry.

Source: India Law Offices, TechSci Research

Intellectual Property• Using the patent system as a mechanism to control drug pricing forestalls making the difficult

decisions about necessary investment in the healthcare system, but does not deal with the

underlying issues.


Bio services Sector

• Beyond biothereapeutics, the bioservices sector represents an area of significant promise

for India because of its skilled labour force, attractive costs, and access to major markets

in Asia.

• In FY15, Bio services was the second largest sector in India’s pharmaceutical and

biotechnology industry with 33 per cent market share and accounted for market size of

USD5-6 billion.

• India’s bioservices sector includes global contract research organisations, such as

Quintiles, as well as Indian companies including GVK Bio, Jubilant Biosys, and Advinus.

HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE

BIOTECHNOLOGY

Bio Pharmaceutical

Industry

• As the cost of bringing new molecules from discovery to market continues to rise, the

global biopharmaceutical industry is seeking ways to improve efficiency.

• The Department of Pharmaceuticals, Government of India planned to introduce venture

capital fund of USD146.72 million to fasten growth in biotech and pharmaceutical industry.

Manufacturing

• Manufacturing is also an area where India is leveraging its cost-competitiveness.

• India has the opportunity to replicate in biologics the same type of success it has had with

small molecule drugs.

• Indian Immunologicals Ltd ( IIL) plans to set up a new vaccine manufacturing facility in

Pondicherry with an investment of USD47.99 million

Source: India Law Offices, TechSci Research, Ministry of External Affairs

Bioinformatics

• The convergence of the life sciences with information technology is creating a particular

opportunity for India.

• The country has well-established strengths in the information technology area, and with

the advent of low-cost, whole genome sequencing and the growing role of molecular

diagnostics in both precision and preventive medicine, there is a proliferation of data

creating demand for bioinformatic analysis.


Contract research

• The R&D sector has huge potential; many opportunities have been created with a number

of foreign companies investing in this sector

• Indian pharmaceutical companies possess competitive skills in chemical synthesis and

process engineering; the companies can leverage these skills to develop new chemical

entities

OUTSOURCING OPENS UP FURTHER AVENUES FOR GROWTH OF BIOTECH

BIOTECHNOLOGY

Clinical trials

• India offers a suitable population for clinical trials because of its diverse gene pools, which

cover a large number of diseases

• Cost effectiveness, competition, and increased confidence on capabilities and skill sets

have propelled many global pharmaceutical companies to increase their clinical research

investment in the nation

International

collaboration

• Memorandum of Understanding (MOU) have been signed with Denmark and Finland and

joint call for proposals have been issued

• Joint projects have also been funded with the Biotechnology and Biological Sciences

Research Council (BBSRC), UK

• New agreements on vision research with National Institutes of Health (NIH), USA and an

amendment to the agreement with Contraceptive Research and Development Programme

(CONRAD)

• In 2015, DBT announced Indo-Australian Gold Fellowships to support researches to

undertake collaborative research project in Australia for 24 months.

Source: India Law Offices, Deptt. of Biotechnology, TechSci Research

Others• Other potential areas of development include medicinal and aromatic plants, animal

biotechnology, aquaculture and marine biotechnology, seri biotechnology, stem cell biology,

environmental biotechnology, biofuels, biopesticides, human genetics, and genome

analysis


Market size (USD million)

Source: Deptt. of Biotechnology,

Marketresearch, ABLE, TechSci Research

Note: E - Estimates

India was the first country in the world to establish a

Biotechnology Information System (BTIS) network in 1987.

This facilitated development of bioinformatics that has

provided support to the biotechnology sector

Bioinformatics research is poised to become one of the

fastest emerging markets in India

Bioinformatics is estimated to rise at a CAGR of 34.92 per

cent to USD2.7 billion during FY12–25

India currently has close to 10 per cent of the global

professional and skilled bioinformaticians

With 10 per cent of the global professional and skilled

bioinformaticians, Indian bioinformatics companies can play

a significant role in critical areas such as data mining,

mapping and DNA sequencing

There is also opportunity in functional genomics, proteonics

and molecule design simulation

In July 2016, government allowed setting up of

bioinformatics units in residential areas

BIOINFORMATICS TO GROW CONSIDERABLY

BIOTECHNOLOGY

CAGR: 34.92%

55 140

2,700

FY12 FY15 FY25E

SUCCESS STORIES

BIOTECHNOLOGY


BIOCON: AN EARLY MOVER IN THE GLOBAL BIOTECH MARKET

Biocon’s position in the Indian market during FY13–15

• Biocon received an award: ‘WHO- India Public Health

Champion Award 2015

• Ranked 1st among Indian Insulin companies

• Ranked 1st in the Glargine vial market

• Ranked 3rd in the 40 IU Insulin market

• Ranked 4th in overall Insulin market

• Ranked 6th among the Top 10 global biotech employers

Revenue and net profit (USD million)

Source: Biocon Annual Report 2015

BIOTECHNOLOGY

• Incorporated

in 1978 at

Bengaluru,

India

• IPO

offering in

2004 (BSE,

NSE India)

• Among the

world’s largest

producers of

statins and

immunosuppr

essants

• 2011:

Launched

INSUPen®, a

convenient

and affordable

reusable

insulin

delivery

device

• Market cap of

USD1.5 billion in

FY15

• Revenue in FY15

stood at

USD514.7million

while net profit

totaled USD81.5

million

• Initiated trials for

IN-105 (oral insulin

program) in the US

• Tied-up with Quark

Pharmaceuticals to

develop novel

siRNA-based

therapeutics

• Partnered with

Advaxis to develop

a novel cancer

immunotherapy

• 2016: Biocon’s

biosimilar Insulin

Glargine was

granted

regulatory

approval in Japan

and is estimated

to be launched in

Q1 FY17.

• 2016: First

generic

formulation,

Rosuvastatin

Tablets was

granted

European

approval and is

estimated to be

launched in FY17

with company

benefitting from

an expected

revenue of

USD1.2 billion.

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 and DTP

Strong

presence in Bio

Pharma

space

Company sells

products in 140

countries worldwide

Serum Institute sold

around 1.3 billion

vaccines doses in

2015

Generated revenue of

USD600 million

in FY16

Started operations with manufacturing of Tetanus

Antitoxin, followed by Tetanus Toxoid

Commenced export of vaccines to UN agencies; export crosses over a 100

countries

Focused on gaining R&D edge, global market reach and wide product portfolio

Focus on

R&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 two

consecutive

years

1967 1994–2000 2005–15

Launched the

world's only

adsorbed liquid

HDC Rabies

vaccine

Serum Institute

has bought selling

rights from Biotech

Visterra VIS513

antibody for

dengue

Serum Institute to

distribute BCG-based TB

vaccine in India, originally

developed in Germany

2016


PANACEA BIOTECH: FOCUS ON INNOVATION AND R&D

Source: Company website, TechSci Research

BIOTECHNOLOGY

India’s 3rd largest

Biotech company with

presence in more than

35 countries

worldwide

More than 1,510

patent applications filed

globally; of this, 415

have been granted

In FY10–11, revenues

grew 32% to USD203.7

million

Generated revenue of

USD99.77 million

in FY16

Established plant for vaccine production at New Delhi

under the name Radicura Pharma

Merged Panacea Drugs & Radicura Pharma to form Panacea Biotec Ltd and launched IPO in 1995

Forayed into Healthcare Delivery; entered into a

collaboration to set up 220-bed multi-super specialty

hospital and a R&D centre in Delhi

Strategic alliance

with Kremers Urban

for entry into

generics

Approval for

development &

commercialisation of

Anthrax vaccine

1988 1994–2000 2005–15

Selected by WHO for

developing the sabin

based injectable polio

vaccine

Started drug

delivery R&D

centre at Lalru

Licensing agreement

with National Institute

of Health, US, for hair

growth hormone

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

4343NOVEMBER 2016

INDUSTRY ASSOCIATIONS


BIOTECHNOLOGY

Association of Biotechnology Led Enterprises (ABLE)# 123/C, 16th Main Road, 5th Cross, 4th Block

Near Sony World Showroom/Headstart School

Koramangala, Bengaluru – 560034

Phone: 91 80 41636853 25633853

E-mail: [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

4444NOVEMBER 2016

GLOSSARY


Bt: Bacillus thuringiensis

CAGR: Compound Annual Growth Rate

CRO: Contract Research Organisation

DNA: Deoxyribonucleic acid

FYP: Five Year Plan

GCP: Good Clinical Practice

INR: Indian Rupee

NBTB: National Biotechnology Board

OAD: Oral Anti-diabetic Drugs

R&D: Research And Development

FY: Indian Financial Year (April to AUGUST)

So FY10 implies April 2009 to AUGUST 2010

USD: US Dollar

Wherever applicable, numbers have been rounded off to the nearest whole number

BIOTECHNOLOGY

4545NOVEMBER 2016

Exchange rates (Fiscal Year)


EXCHANGE RATES

Exchange rates (Calendar Year)

BIOTECHNOLOGY

Year INR equivalent of one USD

2004–05 44.81

2005–06 44.14

2006–07 45.14

2007–08 40.27

2008–09 46.14

2009–10 47.42

2010–11 45.62

2011–12 46.88

2012–13 54.31

2013–14 60.28

2014-15 61.06

2015-16 65.46

2016-2017E 66.95

Source: Reserve bank of India,

Average for the year

Year INR equivalent of one USD

2005 43.98

2006 45.18

2007 41.34

2008 43.62

2009 48.42

2010 45.72

2011 46.85

2012 53.46

2013 58.44

2014 61.03

2015 64.15

2016 (Expected) 67.22

4646NOVEMBER 2016

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