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BIOTECHNOLOGY

SEPTEMBER 2016

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BIOTECHNOLOGY

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

SEPTEMBER 2016

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BIOTECHNOLOGY
EXECUTIVE SUMMARY
100

CAGR: 30.46%

The biotech industry is


expected to experience
significant growth amid
favourable business conditions

11

7
FY 15

Increasing government
expenditure is likely to augment
growth in biotechnology
industry.

FY 16
USD Billion

Percentage rise in
investments 236.36%

FY 25F

3.7

1.1

By FY25, Indias biotech


industry is estimated to
increase to USD100 billion from
USD7 billion in FY15 and is
currently valued at USD11
billion.

In 12th Five-Year Plan, the


government aims to spend
USD3.7 billion on
biotechnology compared to
USD1.1 billion in the 11th FiveYear Plan

Eleventh Five Year Plan


Twelfth Five Year Plan
USD Billion

CAGR: 12.8%

Growing pharmaceuticals
market is estimated to aid
growth of the biotech industry

55

30

FY15

USD Billion

Indias pharmaceuticals market


size is USD30 billion in 2015
and estimated to reach at
USD55 billion in 2020F

FY20F

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

SEPTEMBER 2016

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BIOTECHNOLOGY

ADVANTAGE INDIA
SEPTEMBER 2016

BIOTECHNOLOGY
ADVANTAGE INDIA
Robust demand
demand
Growing

FY16
Market
Value:
USD11
billion

Innovation opportunities

Indias 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

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

Advantage
India

Increasing investments

SEPTEMBER 2016

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

FY25E
Market
Value:
USD100
billion

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

Source: CIS India, Ministry OF External Affairs, Government of India, Ministry of Health,, ABLE,
TechSci Research; Note: E - Estimate

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BIOTECHNOLOGY

MARKET OVERVIEW & TRENDS


SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY
197890

1978: Indias first biotech firm,


Biocon, was setup

1981: Centre for Cellular and


Molecular Biology setup in
Hyderabad

1984: Institute for Microbial


Technology, Chandigarh was setup

199099

1987: National Institute of


Immunology was setup by DBT

1989: Bangalore Genei commenced


operations

SEPTEMBER
JUNE 2016 2016

1991: National Centre for Biological


Sciences pursued R&D in molecular
biology

1994: Syngene, Indias first Contract


Research Organisation (CRO),
started R&D services

1997: Centre for Biological


Technology (CBT) was established
to focus on bioinformatics and
genomics

1986: Department of Biotechnology


(DBT) was formed

2000-10

1998: Monsanto Research


established an R&D centre for plant
genomics

1998: DBT approved MahycoMonsanto 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

Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research
Note: R&D - Research and Development
DBT Department of Biotechnology 7

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BIOTECHNOLOGY
MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY
2010-15

Post 2015

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 AsiaPacific, 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 multiinstitutional project.

2015: DBT launched The National


Biotechnology Development
Strategy 2015-2020 programme to
turn India into
biotechnology hub.

SEPTEMBER
JUNE 2016 2016

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.

Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research
Note: R&D - Research and Development
DBT Department of Biotechnology 8

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BIOTECHNOLOGY
KEY SEGMENTS IN THE INDIAN BIOTECHNOLOGY INDUSTRY
Biotechnology

Bio-pharma

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

Bio-services
mainly include
clinical research
and CRO along
with custom
manufacturing

Bio-agri

Bio-industrial

Bio-agriculture is
segmented into
hybrid seeds,
transgenic
crops, biopesticides and
bio-fertilisers

Bio-industrial
predominantly
comprises enzyme
manufacturing and
marketing
companies

Bio-informatics

Bio-informatics deals
with the creation and
maintenance of
extensive electronic
databases on various
biological systems;
industry

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

SEPTEMBER
JUNE 2016 2016

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BIOTECHNOLOGY
MAJOR PRODUCTS/SERVICES OF THE INDIAN BIOTECHNOLOGY INDUSTRY
Biotechnology

Bio-pharma

Bio-services

Bio-agri

Bio-industrial

Bio-informatics

Vaccines

Contract
Research
Organisation

Hybrid seeds

Industrial
enzymes

Database
services

Diagnostic

Custom
Manufacturing

Bio-fertilisers

Integrated
research app
software

Therapeutic

Clinical Trials

Bio-pesticides

Biotech software
services

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

SEPTEMBER
JUNE 2016 2016

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10

BIOTECHNOLOGY
ROBUST GROWTH IN BIOTECH INDUSTRY
Market size (USD billion)

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

11.6

11

CAGR: 20.33%

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

SEPTEMBER
JUNE 2016 2016

3.8

1.1

1.5

1.9

2.6

2.6

4.3

4.3

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

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11

BIOTECHNOLOGY
BIO-PHARMA ACCOUNTS FOR MAJORITY MARKET SHARE AND WITNESSES FASTEST GROWTH IN FY16
Market break-up by revenues (FY16)

The bio-pharmaceutical segment accounted for largest


revenue share of 64 per cent in India biotech industry,
during FY16.

1%
3%
Bio-pharma

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

14%
Bio-services
Bio-agri
18%

Bio-industry

64%

Bioinformatics

Source: ASSOCHAM, Makeinindia, TechSci Research

SEPTEMBER
JUNE 2016 2016

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12

BIOTECHNOLOGY
STATE WISE SHARE FOR APPROVED BIOTECH PROJECT COST FY15
State wise share for Approved Biotech Project
Cost FY15

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%.

Karnataka
Delhi

14.69%
29.04%

3.30%

Tamil Nadu

4.56%

In FY16, Government of Karnataka planned to raise


USD7.34 million funds for research activities in
biotechnology.

Maharashtra

6.01%

Telangana
West Bengal

7.76%

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


million

Haryana

13.26%

Uttar Pradesh
Others

9.69%
11.68%

Source: Department of Biotechnology, TechSci Research

SEPTEMBER
JUNE 2016 2016

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13

BIOTECHNOLOGY
STATE WISE SHARE FOR ONGOING NUMBER OF BIOTECH PROJECTS FY16

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


of Biotechnology which are categorized as ongoing number
of biotechnology projects in India.

State wise share for Ongoing Number Of Biotech


Projects FY16
13.93%

34.38%

Delhi

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.

Tamil Nadu
10.95%

Karnataka
Maharashtra
Telangana

In FY16, a total of 365 biotechnology projects were


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

Uttar Pradesh
9.92%

West Bengal

Haryana
Others
3.43%
8.32%

5.80%
6.64%

6.64%

Source: Department of Biotechnology, Government Of


India, TechSci Research

SEPTEMBER
JUNE 2016 2016

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14

BIOTECHNOLOGY
NOTABLE TRENDS IN THE INDIAN BIOTECH SECTOR
Remarkable global
positioning

Pharma companies
focusing on biotech

Global companies
setting up base

Biosimilars and
molecular diagnostic
remain strongholds

India is among the top 12 biotech destinations in the world


India ranks second in Asia, after China
India is the worlds largest producer of recombinant Hepatitis B vaccine
Bharat Biotech commercially launched first novel ROTAVAC vaccine, to eradicate
rotavirus diarrhea, in India.

Ranbaxy, Cadila Healthcare, Lupin, Wockhardt and Dr Reddys are among the major
Indian pharmaceutical companies operating in the bio-pharma segment

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.

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.

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

SEPTEMBER
JUNE 2016 2016

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15

BIOTECHNOLOGY

STRATEGIES ADOPTED
SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
STRATEGIES ADOPTED
Strategic collaborations
with niche players and
government bodies

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.

Indias 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. Reddys 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.

Mergers & Acquisitions

SEPTEMBER
JUNE 2016 2016

Source: Ministry of External Affairs, RBI


Note: Govt. - Government

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17

BIOTECHNOLOGY
STRATEGIES ADOPTED

Stepped up investment
in personalised
medicine

Ramping up service
offerings

SEPTEMBER
JUNE 2016 2016

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.

Source: Ministry of External Affairs, RBI

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18

BIOTECHNOLOGY

GROWTH DRIVERS
SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
SECTOR BENEFITS FROM RISING INCOME AND POPULATION

Growing demand
Growing
demand

Indias large
population, a huge
market for biotech
products and
services

Strong growth in
export demand and
a rise in medical
tourism

Rising investments
from domestic and
foreign players

Adoption of Open
Access Policy in
FY15

Inviting
Higher healthcare
expenditure and an
increase in Bio-agri
products

Increasing investments

Policy support

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

Resulting in

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: Makeinindia, TechSci Research

SEPTEMBER
JUNE 2016 2016

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20

BIOTECHNOLOGY
HIGHER HEALTHCARE EXPENDITURE DRIVING DOMESTIC DEMAND
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.

Funds availability (USD million)


3,726.4

1,354.2

129.4
Ninth FYP

302.1
Tenth FYP

Eleventh FYP

Twelfth FYP

Specialised treatment

Preventive healthcare

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

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

Source: WHO Statistics 2012


Note: FYP Five Year Plan

SEPTEMBER
JUNE 2016 2016

Source: MHRD,
National Biotechnology Development Strategy, DBT, TechSci Research

For updated information, please visit www.ibef.org

21

BIOTECHNOLOGY
RISING INCOME AND INCIDENCE OF CHRONIC LIFESTYLE DISEASES
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

Million household, 100%

244

273

30%

26%

322
15%
32%

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.

40%

43%

29%
25%

23%
2%
2015

Income
segment

1%

6%

3%

2020

17%
7%
2030

Globals(>22065.3)

Strivers(11032.7-22065.3)

Seekers(4413.1-11032.7)

Aspirers(1985.9-4413.1)

Deprived(<1985.9)

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
Source: Fortis Healthcare Limited 200809, McKinsey Quarterly, NCAER, TechSci Research

SEPTEMBER
JUNE 2016 2016

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22

BIOTECHNOLOGY
STRONG POLICY SUPPORT CRUCIAL TO THE SECTORS DEVELOPMENT
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

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 Based
Programme for Women

National Biotechnology
Development Strategy
Single-window
clearance

DBT designed the National Biotechnology Development Strategy (NBDS) to strengthen the
industrys human resources and infrastructure while promoting growth and trade
As part of the NBDS, government decided to spend 30 per cent of DBTs Budget in public
private partnerships to promote R&D at various stages and has launched The National
Biotechnology Development Strategy -2015-2020.

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 Indias
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

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.

Biotechnology Policy
2015-2020
(Andhra Pradesh)

SEPTEMBER 2016

Source: Biotechnology facilities, Department of


Biotechnology, TechSci Research, Note: BIRAC Biotechnology Industry Research Assistance Council

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23

BIOTECHNOLOGY
BIOTECH IN FOCUS IN 12TH FIVE-YEAR PLAN
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 Indias 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

12th Five-Year Plan expenditure (USD billion)


3.7

1.1

Eleventh Five Year Plan

Twelfth Five Year Plan

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


Medical biotech
21%

26%

The plan also entails expanding and commissioning new


bioclusters at Faridabad, Mohali Kalyani and Hyderabad

Agri biotech
Basic bio & emerging areas

14%

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)

22%
17%

Biodiversity, bioresources &


Environment
Capacity building

Source: Deptt. of Science and Technology, TechSci Research

SEPTEMBER
JUNE 2016 2016

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24

BIOTECHNOLOGY
GOVERNMENT FUNDING CRUCIAL FOR THE BIOTECH INDUSTRY

Research Funding
Agency

Joint Venture fund

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
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.
Indias 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)

Infrastructure
development

International
collaborations

Clinical Establishments
Bill

SEPTEMBER 2016

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.

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
Source: Ernst & Young, Times of India, TechSci
Research; Note: DST-Department of science and
Technology, DBT-Department of Biotechnology

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25

BIOTECHNOLOGY
CENTRE AND STATE GOVERNMENT INITIATIVES PROVIDE BIG BOOST TO BIOTECH INDUSTRY
Increasing government support

Favorable IP climate

International collaboration of Department of Biotechnology with other countries


Indian Copyright Act, 1957
100 per cent foreign equity investment is possible in manufacturing of all drugs
except recombinant DNA products and cell targeted therapies

The Patent Act, 1970

Single window processing mechanism for all biotech projects involving FDI
Indian Patents and Design Act, 1972

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

The Trademarks Act, 1999

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

Biotechnology Patent Facilitating Cell (BPFC)

Customs & excise duty exemption to recognised Scientific & Industrial Research
Organisations (SIRO)

Foundation of Biotechnology
Education (FBAE)

150% weighted tax deduction on R&D expenditure

National Research Development Corporation (NRDC)

Three years excise duty waiver on patented products

Awareness

and

National Guidelines for Stem Cell Research (2013)

100% rebate on own R&D expenditure


Tamil Nadu Biotechnology Policy 2014
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 biomanufacturing hub.
Promote innovations through BIPP, SBIRI, BIRAC and Biotech parks
Adoption of new Open Access Policy in FY15

SEPTEMBER 2016

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

For updated information, please visit www.ibef.org

26

BIOTECHNOLOGY
REGULATORY FRAMEWORK OF THE INDIAN BIOTECH SECTOR
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: Policy and rules, Department of Biotechnology website,


TechSci Research

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

27

BIOTECHNOLOGY
SOLID INDUSTRY INFRASTRUCTURE WOULD DRIVE GROWTH
The 12th Five Year Plan aims to set up 35 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

Jogindernagar
Shimla
Chandigarh

Pantnagar
Alwar

Sohna
Jodhpur

Jaipur

States such as Karnataka, Andhra Pradesh, Maharashtra, Gandhinagar


Anand
Tamil Nadu and Kerala have been early movers in Jamnagar
establishing world-class biotech parks and clusters.
Baroda

Midnapore

Bhubaneshwar

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.

Konark
Aurangabad
Pune
Hyderabad

Visakhapatnam
Karwar
Bengaluru
Chennai
Madurai
Puducherry
Kochi

Operational biotech parks

Source: Press Information Bureau, TechSci Research

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

28

BIOTECHNOLOGY
CONCEPT OF BIOTECH PARK
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:

Universities

Research partners

Govt. research
laboratories

Flow of talent

Other R&D
institutions

Private firms

Exchange of ideas
Access to laboratories and
specialised equipment

Research parks
Communities generating innovation, technology and knowledge

Knowledge of existing firms

commercialisation of intellectual
property
Creation of new companies

Job and income generation

SEPTEMBER
JUNE 2016 2016

Source: Research and Information System


for Developing Countries (RIS), TechSci Research

For updated information, please visit www.ibef.org

29

BIOTECHNOLOGY
HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION
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

Details of key biotechnology parks in India


Parks
City
Area (in acres)

Key research institutes in India


Central Drug Research Institute (CDRI), Lucknow

National Institute of Pharmaceutical


Research (NIPER), Mohali

Education

and

Indian Institute of Chemical Technology (IICT), Hyderabad


Centre for
Hyderabad

Cellular

&

Molecular

Biology

(CCMB),

Indian Institute of Chemical Biology (IICB), Kolkata

Shapoorji Pallonji Biotech Park

Hyderabad

300

ICICI Knowledge Park

Hyderabad

200

Pune

103

Institute of Genomics and Integrative Biology (IGIB), New


Delhi

Lucknow Biotech Park

Lucknow

20

Institute of Microbial Technology (IMTECH), Chandigarh

Golden Jubilee Biotech Park

Chennai

National Chemical Laboratory (NCL), Pune

Ticel Bio Park

Chennai

National Centre for Biological Sciences (NCBS), Bengaluru

International Biotech Park

Jawaharlal Nehru Centre for Advanced Scientific Research


(JNCASR), Bengaluru

List of Biotech Parks at Developing Stage


Parks

Indian Toxicology Research Institute (ITRI), Lucknow

City

Area (in acres)

Guwahati Biotech Park

Assam

700

National Institute of Immunology (NII), New Delhi

KINFRA Biotech Park

Kerala

75

National Center for Cell Sciences, Pune

Bio Pharma-IT Park,

Odisha

64.61

Karnataka

53

Bangalore Biotech Park

SEPTEMBER
JUNE 2016 2016

Indian Institute of Science (IISc), Bengaluru

National Center for Plant Genome Research (NCPGR),


New Delhi
Source: Research and Information System
for Developing Countries (RIS), TechSci Research, "Mid-term appraisal

For updated information, please visit www.ibef.org

30

BIOTECHNOLOGY
HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION
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.

List of Key Biotechnology Facilities in India Supported by DBT


Facility Established

Name of the Institution

Sanction Year

National Institute of Immunology (NII), New Delhi

2013

Translational Health Science and Technology Institute (THSTI), Faridabad

2014

Indian Institute of Scientific Education and Research (IISER) Knock Out and
Transgenic Mice, Pune

2016

Indian Institute of Science (IISc), Bengaluru

2016

High Resolution Mass


Spectrometry Facility

Indian Institute of Bombay, Mumbai

2016

Containment Facilities

Tuberculosis Aerosol Challenge Facility, International Centre for Genetic


Engineering and Biotechnology (ICGEB), New Delhi

2016

Electron Microscopy Referral Facility, Govind Ballabh Pant Institute of


Postgraduate Medical Education & Research, Delhi

2015

Animal House facility

Flowcytometry, Imaging and


Microarray Facilities

SEPTEMBER
JUNE 2016 2016

Source: Research and Information System


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

For updated information, please visit www.ibef.org

31

BIOTECHNOLOGY
STRONG INFLOW OF FOREIGN INVESTMENT
Date
announced

Acquirer name

Target name

Value of deal
(USD million)

Jan 2016

Venaxis

Strand Life Sciences

Oct 2015

Recipharm

CMO Nitin Lifesciences

109.92

July 2015

Lupin Limited

Gravis Pharmaceuticals LLC

800

Dec 2014

Leaders Group Asia Ltd

Dr Datsons Labs Ltd

Oct 2014

B Braun Singapore Pte Ltd

Ahlcon Parenterals (India) Ltd

7.89

May 2014

Cancer Genetics Inc

Bioserve Biotechnologies

1.9

May 2014

Anglo Gulf Ltd

SciGen BioPharma Pvt Ltd

7.00

Jan 2014

Lotus Pharmaceutical Co Ltd

Alvogen Pharma India Pvt Ltd

10.00

Oct 2013

Innovation Software Exports

Agrata Biotech Ltd

May 2013

Bio Harvest Pte Ltd

Camson Bio Technologies Ltd

51.06

Dec 2012

Malabar Trading Co Ltd

SPL Biotech Pvt Ltd

Oct 2012

GE Equity International

Syngene International Ltd

302.13

Jun 2012

Nandan Cleantec PLC

Xtraa Cleancities Infra

Mar 2012

Origio A/S

Trivector Scientific Pvt Ltd

8.61

Aug 2011

DMV-Fonterra Excipients GmbH

Brahmar Cellulose Products

Aug 2011

Arvind Remedies Ltd

Undisclosed Pharmaceutical Co

Source: Thomson One Banker, TechSci Research

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

32

BIOTECHNOLOGY

OPPORTUNITIES
SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE

Vaccines

Vaccines and recombinant therapeutics are the sectors driving the biotechnology
industrys 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 countrys huge population makes it among the worlds 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

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

Intellectual Property

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.

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.
Source: India Law Offices, TechSci Research

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

34

BIOTECHNOLOGY
HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE

Bio services Sector

Bio Pharmaceutical
Industry

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 Indias pharmaceutical and
biotechnology industry with 33 per cent market share and accounted for market size of
USD5-6 billion.
Indias bioservices sector includes global contract research organisations, such as
Quintiles, as well as Indian companies including GVK Bio, Jubilant Biosys, and Advinus.

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

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

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

35

BIOTECHNOLOGY
OUTSOURCING OPENS UP FURTHER AVENUES FOR GROWTH OF BIOTECH

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

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

Others

SEPTEMBER
JUNE 2016 2016

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.

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

For updated information, please visit www.ibef.org

36

BIOTECHNOLOGY
BIOINFORMATICS TO GROW CONSIDERABLY
Market size (USD million)

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

CAGR: 34.92%

2,700

Bioinformatics is estimated to rise at a CAGR of 34.92 per


cent to USD2.7 billion during FY1225
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

55

140

FY12

FY15

FY25E

Source: Deptt. of Biotechnology,


Marketresearch, ABLE, TechSci Research
Note: E - Estimates

There is also opportunity in functional genomics, proteonics


and molecule design simulation
In July 2016, government allowed
bioinformatics units in residential areas

SEPTEMBER
JUNE 2016 2016

setting

up

of

For updated information, please visit www.ibef.org

37

BIOTECHNOLOGY

SUCCESS STORIES
SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
BIOCON: AN EARLY MOVER IN THE GLOBAL BIOTECH MARKET

2016: Biocons
Market cap of
biosimilar Insulin
USD1.5 billion in
Glargine was
FY15
Among the
granted
worlds largest
regulatory
Revenue in FY15
IPO
producers of
approval in Japan
stood at
offering in
statins and
and is estimated
USD514.7million
2004 (BSE, immunosuppr
to be launched in
while net profit
NSE India) essants
Q1 FY17.
totaled USD81.5
Incorporated
in 1978 at
Bengaluru,
India

million
2011:

Launched
Initiated trials for
INSUPen, a
IN-105 (oral insulin
convenient
program) in the US
and affordable
reusable
Tied-up with Quark
insulin
Pharmaceuticals to
delivery
develop novel
device
siRNA-based
therapeutics

SEPTEMBER
JUNE 2016 2016

2016: First
generic
formulation,
Rosuvastatin
Tablets was
granted
European
approval and is
estimated to be
launched in FY17
with company
benefitting from
Partnered with
Advaxis to develop an expected
revenue of
a novel cancer
USD1.2 billion.
immunotherapy

FY 09

FY 10

FY 11

FY 12

Revenue

FY 13

FY 14

545.4

514.7

486.6

467.3

448.0

408.0

315.0

260.0

Revenue and net profit (USD million)

FY 15

FY 16

Net Profit

Biocons position in the Indian market during FY1315


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
Source: Biocon Annual Report 2015

For updated information, please visit www.ibef.org

39

BIOTECHNOLOGY
SERUM INSTITUTE OF INDIA: GAINING GLOBAL GROUND
Serum Institute to
distribute BCG-based TB
vaccine in India, originally
developed in Germany
2016
Serum Institute recognised
as the world's largest
producer of vaccines for
Measles and DTP

Generated revenue of
USD600 million
in FY16

Serum Institute sold


around 1.3 billion
vaccines doses in
2015

One out of every two


children in the world
vaccinated by Serum
Institutes vaccine
Focus on
R&D

Launched India's
first MMR
Vaccine Tresivac

Company sells
products in 140
countries worldwide

Strong
presence in Bio
Pharma
space

Launched the
world's only
adsorbed liquid
HDC Rabies
vaccine

Serum Institute
has bought selling
rights from Biotech
Visterra VIS513
antibody for
Recognised as
dengue
India's number
one bio-tech
company for two
consecutive
years

Started operations with


manufacturing of Tetanus
Antitoxin, followed by
Tetanus Toxoid

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

1967

19942000

Focused on gaining R&D


edge, global market reach
and wide product portfolio

200515
Source: Company website, ABLE, TechSci Research

SEPTEMBER
JUNE 2016 2016

For updated information, please visit www.ibef.org

40

BIOTECHNOLOGY
PANACEA BIOTECH: FOCUS ON INNOVATION AND R&D

Selected by WHO for


developing the sabin
based injectable polio
vaccine

Generated revenue of
USD99.77 million
in FY16

In FY1011, revenues
grew 32% to USD203.7
million

Strategic alliance
with Kremers Urban
for entry into
generics

Started new state-ofthe-art Oncology


centre at Baddi
Started drug
delivery R&D
centre at Lalru

Established plant for vaccine


production at New Delhi
under the name Radicura
Pharma
1988

SEPTEMBER
JUNE 2016 2016

Launched antidiabetic drug


Tenepan
2016

Licensing agreement
with National Institute
of Health, US, for hair
growth hormone
2004

Approval for
development &
commercialisation of
Anthrax vaccine

More than 1,510


patent applications filed
globally; of this, 415
have been granted

Indias 3rd largest


Biotech company with
presence in more than
35 countries
worldwide

Launched
CABAPAN for
treatment of mCRPC
2016

Note: mCRPC stands for metastatic Castration


Resistant Prostrate Cancer

Merged Panacea Drugs &


Radicura Pharma to form
Panacea Biotec Ltd and
launched IPO in 1995
19942000

Forayed into Healthcare


Delivery; entered into a
collaboration to set up 220bed multi-super specialty
hospital and a R&D centre in
Delhi
200515
Source: Company website, TechSci Research

For updated information, please visit www.ibef.org

41

BIOTECHNOLOGY

USEFUL INFORMATION
SEPTEMBER
JUNE 2016 2016

BIOTECHNOLOGY
INDUSTRY ASSOCIATIONS
Association of Biotechnology Led Enterprises (ABLE)
# 123/C, 16th Main Road, 5th Cross, 4th Block
Near Sony World Showroom/Headstart School
Koramangala, Bengaluru 560034
Phone: 91 80 41636853 25633853
E-mail: info@ableindia.org
Website: www.ableindia.org

All India Biotech Association (AIBA)


"VIPPS Center" 2. Local Shopping Centre Block EFGH, Masjid Moth,
Greater Kailash-II, New Delhi-110048
Tel: 91 11 29211487 (Direct), 29220546/547
Fax: 91 11 29223089, 29229166
Email: unmalik@aibaonline.com
Website: www.aibaonline.com

SEPTEMBER
JUNE 2016 2016

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43

BIOTECHNOLOGY
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

SEPTEMBER
JUNE 2016 2016

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44

BIOTECHNOLOGY
EXCHANGE RATES
Exchange rates (Fiscal Year)
Year

INR equivalent of one USD

200405

44.81

200506

44.14

200607

45.14

200708

Exchange rates (Calendar Year)


Year

INR equivalent of one USD

2005

43.98

2006

45.18

40.27

2007

41.34

200809

46.14

2008

43.62

200910

47.42

2009

48.42

201011

45.62

2010

45.72

201112

46.88

201213

54.31

2011

46.85

201314

2012
60.28

53.46

2013

58.44

2014-15

61.06

2014

61.03

2015-16

65.46

2015

64.15

2016-2017E

66.95

2016 (Expected)

67.22

SEPTEMBER
JUNE 2016 2016

Source: Reserve bank of India,


Average for the year

For updated information, please visit www.ibef.org

45

BIOTECHNOLOGY
DISCLAIMER
India Brand Equity Foundation (IBEF) engaged TechSci to prepare this presentation and the same has been
prepared by TechSci in consultation with IBEF.
All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. The
same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any
medium by electronic means and whether or not transiently or incidentally to some other use of this presentation),
modified or in any manner communicated to any third party except with the written approval of IBEF.
This presentation is for information purposes only. While due care has been taken during the compilation of this
presentation to ensure that the information is accurate to the best of TechSci and IBEFs knowledge and belief, the
content is not to be construed in any manner whatsoever as a substitute for professional advice.
TechSci and IBEF neither recommend nor endorse any specific products or services that may have been mentioned in
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Neither TechSci nor IBEF shall be liable for any direct or indirect damages that may arise due to any act or omission
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46