The document discusses the Indian biotechnology landscape from an international perspective. It finds that India has become a prominent global player in biotechnology, and its contribution to the global market is expected to grow significantly by 2025. However, it also identifies several issues that could hamper growth, such as low R&D spending, a lack of coordination between regulatory bodies, and insufficient industry-academia linkages. The document provides recommendations to address these issues, including increasing private sector investment in R&D, improving research quality and infrastructure, developing biotechnology clusters, and streamlining the regulatory environment.

1. Assessment of
The Indian
Biotechnology
Landscape
An International perspective
DEPARTMENT OF BIOTECHNOLOGY

2. The world is confronted with
potentially irreparable changes to its
climate; unprecedented exploitation
of natural resources through
unsustainable development paths;
and social upheaval caused by high
unemployment rates and record high
inequality.
These issues would be exacerbated by the
increase in population that is expected to
reach 9.7 billion in 2050, up from the current
figure of 7.7 billion. The wellbeing of our
current and future generations depends on
how these complex and inter-connected
socio-economic challenges are tackled by the
countries.
7.7bn
9.7bn
2019 2050
Population figures
The biotechnology sector, mainly
due to its holistic nature, holds the
potential to provide a solution
these societal challenges.
Introduction

3. Source: IFC Analysis
Scenario-1
Growth Projection
under different Scenarios
Scenario-2
Scenario-3
Sizeoftheindustry(USDBn)
$84 Bn
$128 Bn
$162 Bn

4. The Indian biotech industry has already become a
prominent player in the global biotech industry
The evolution of the global share of the Indian
biotechnology industry is more clearly reflected in
the Figure.
If India follows the growth at the same rate as that
of the global biotech industry, then by 2025,
Global biotech would be a $670.09 bn industry and
Indian biotech would be a $128 bn industry.
Thus, the contribution of the Indian biotechnology
industry in the global biotechnology market is
expected to grow from 3 percent in 2017 to just
over 19 percent by the year 2025.
Source: IFC Analysis
Contribution
to the Global Economy
Indian Industry Value Global Industry Value

5. Source: IFC Analysis
• The National Biotechnology Development Strategy highlights underlying
problems faced by the industry and provide recommendations.
• States have introduced their own biotechnology policy documents to
attract investments.
• Lack of coordination between departments and ministries which makes the
system confusing
• India is home to young minds and could
act as affordable high-quality skilled
workforce.
• Industry-academia collaborative mission
of department of biotechnology (DBT)
in collaboration with World bank is an
initiative for improving the linkages
between industry and academia, the
absence of which hinder research and
developmental activities.
• The educational curriculum does not
prepare the students for the industry’s
demands
• Need for state-of-the-art research
facilities across the country to boost
R&D.
• Lack of venture capital funding due to
information asymmetry regarding the
biotech industry
• Global biotechnology industry is
growing at the rate of 7.4 percent and
there is huge demand within each
segment of the industry that Indians can
cater to.
• With an established IT system and
infrastructure, growth in Bio-IT, an
untapped segment, could propel the
growth.
• India’s production of insulin could turn
out to be the key, as the forecasted
burden of diabetes seems to be big.
• Biofuels could be of strategic
importance given the increasing global
energy needs.
• Low percentage of clinical trials
conducted in India when compared to
the rest of the world is a concern.
• Separate departments for Biotechnology, Scientific and Industrial Research,
Science and Technology promote research, formulate policy and provide
financial assistance.
• Presence of bio-incubators, bio-clusters and biotech parks will help in
multiplying the output, revenue and employment generation in the industry
Strengths Weakness
Diamond Model
Analysing the Competitiveness

6. Issues &
Challenges

7. Source:UNESCO
India’s research & development
expenditure is low i.e., just
0.8% of its GDP while China is
contributing nearly 2%.
The private sector spending
on R&D is very low.
Also, the country falls short of
the number of researchers
(216 full time researchers)
R&D as % of GDP
Low Investment in R&D

8. Regulatory Practices
Source:UNESCO
The Indian biotechnology industry
is regulated by four main bodies
There is a need to increase
coordination between each
department

9. Human Capital
India should focus on
increasing the
employability of its work-
force.
There is a need to align the
demands of the industry
with university curriculum
for the students to thrive in
a competitive market.

10. Infrastructural Facilities
India has made
considerable progress on
the physical facilities
(roads, rail, transport
etc.) and should now
focus on research
facilities.
The focus should be on
world-class Clinical Trial
Infrastructure as today
India has just 1.3 beds
per 1000 of population.
Though bio-incubators are
present, but they lack in
productivity as a US bio-
incubator can employ about
20 times more than an Indian
one.
Electronic records are
valuable for research
purposes and a
roadmap should be
created for its
adoption.

11. Source: DBT
Contribution of States to the biotech industry:
How Innovation and Clusters play a role?
Job Creation In Biopharmaceutical Cluster,
India (Relative to 2009) Many states have their own specialized departments for
biotechnology and also have released specific biotech policies.
States such as Karnataka, Tamil Nadu have taken the lead and
Delhi, Maharashtra have also become strong in this sector.
The reason that these regions are the front-runners in the growth
and development of India’s biotechnology sector lies in their
innovative potential.
As per the recent India Innovation Index, released by NITI Aayog,
the states such as Maharashtra, Karnataka, Delhi and Tamil Nadu
have a strong innovation landscape and are also the states that are
contributing the most to the Biotech economy.
Evidence suggests that clusters provide an environment conducive
to innovation and knowledge creation. They do so by offering
advantages to firms in as compared to isolated firms.

12. Segments of
Indian
Biotechnology
Industry

13. Biotechnology
Competitiveness Assessment
• This dimension is reflective of the
country’s capability in providing a
conducive environment for starting
and operating a business.
• These include human capital,
investment in research and
development, and strength of legal
institutions.
• The second dimension comprises of
advanced factors that govern that ensure the
overall development and long-term
sustainability of the biotechnology industry.
• It includes elements such as technology
transfers, which talk about the industry-
academia linkages, regulatory environment,
and market incentives.
• This dimension evaluates the benefits that
have been derived from the enablers and
facilitators.
• It is divided into three sub-dimensions –
Clinical Trials, Research output, and
Biotechnology output that together provide a
comprehensive view of the performance of
biotechnology industry in deriving benefits
from the inputs.
The assessment is conducted by comparing 20
emerging as well as mature biotech markets of the
world. The comparison is performed on the basis of 3
broad dimensions with 29 indicators.
Enablers
Facilitators
Performance

14. • Industry-Academia Linkages on R&D
• Barriers to technology transfers of publicly funded
and supported research
• State of Cluster development
• Patents filed in 2 or more offices
• Regulatory framework for Biopharmaceuticals
• Regulatory framework for bio-agri
• Regulatory Quality
The Framework
Enablers Facilitators Performance
1. Human Capital 1. Technology Transfers 1. Clinical Trials
2. Investment in R&D
2. Regulatory Environment
2. Research Output
3. Safety and legal Environment 3. Market Incentives 3. Biotechnology Output
• Number of Researchers per million of population
(Full time equivalent)
• Knowledge workers
• Quality of Research Institutions
• Clinical Trials
• Clinical trials per million population to date
• Clinical trials for biologics per million population to
date
• Expenditure on R&D as a percentage of GDP
• Government spending on R&D
• Business and private (BERD) sector spending on R&D
• Universities spending on R&D
• Biotechnology triadic patenting, share of global
total average 1999-2013
• Scientific publications standardized for population
• Quality of academic publications
• Intellectual Property Protection
• Efficiency of legal framework in challenging regulations
• Efficiency of legal framework in challenging regulations
• Rule of Law
• Biopharmaceutical pricing and reimbursement
policies
• R&D tax incentives
• Ease of Doing Business
• Biopharmaceutical product launches, percentage
available in country within 5 years of global
product launch
• Biofuels production, percentage of global total
• Biotechnology crops, hectares under cultivation,
percentage of total

15. • Switzerland is the top scorer, with
an overall score of 74.27 and
Vietnam being the weakest of all
(20.62).
• India performs better than
Vietnam, Egypt, and Indonesia, yet
there is substantial ground to
cover.
• India needs to perform better in
R&D spending. Though country
has relatively efficient legal system
challenging regulations and
settling disputes.
Source: IFC Analysis
Results
01 Enablers

16. 02 Facilitators
Source: IFC Analysis
• Disparity among scores remain
quite high with the United States
of America performing
exceptionally well in all the
components and scoring 90.23
and Egypt, the lowest (12.88)
• India’s performance in this
dimension with an overall score
of 47.97, is better than the
‘Enablers’.
Results

17. Source: IFC Analysis
• The average score is lowest
amongst the three (28.30 as
compared to 50.5 in enablers and
61.8 in facilitators).
• Also, maximum disparity is
observed within this dimension
as the scores range between 0.24
(Vietnam) and 78.1 (US).
• India has immense potential to
improve its performance on this
dimension
03 Performance
Results

18. • A strong relationship between
the Enablers, Facilitators and
Performance.
• The United States of America is
the top performer led by its
outstanding performance in two
of the three dimensions i.e.
facilitators and performance.
• The performance between India
and China is close in the third
dimension as both of them have
not fared well.
• Concentrated efforts should be
put in by India specially in the
performance dimension.
Source: IFC Analysis
Overall Scores

19. Improving Ease of
Doing Business
R&D Tax
Incentives
Favourable
FDI Policy
Efficient Legal
Framework
Demographic
Advantage
Indian Biotechnology Industry
As an Investment Prospect

20. Policy
Recommendations

21. Source: UNESCO
The Indian government undertakes
more than 60 percent of the total
research and development
expenditure. This is in stark contrast
with countries like Israel, US, China,
Japan, Republic of Korea and Australia
where more than 70 percent of the
spending is undertaken by the private
sector on an average.
Thus, private sector needs to step up
its level of research spending and the
government should identify reasons
that are impeding private investment.
R&D Expenditure undertaken by various entities
Derive Value from Research and
Development

22. The number of research
publications in India is following
an upward trajectory and has
just surpassed Japan. However,
the number of citations have
still not increased. Thus, not
only quantity but the quality of
research institutions should also
be increased.
The launch of National
Biopharma Mission, is a step in
the same direction.
Source: Science and Engineering
Indicators 2018
Improve Industry-Academia Linkages and
the Quality of Research Output
S&E publication output in the top 1% of cited publications
India
Japan
China
USA

23. Biotechnology has created deeper impacts on the Indian lives
than often acknowledged. The sector contributed extensively in
Green Revolution that used hybrid seeds to enhance farm yields,
which made India self-sufficient
Similar benefits were reaped in during White Revolution that
enhanced India’s dairy production through biotechnology
interventions.
Sustainable growth of agriculture sector will help in ensuring zero
hunger in the future. Biofuels and bio-crops are by-products of
sustainable agriculture.
India is the world’s largest producer of BT cotton and cultivates 6
percent of the global biotech land under cultivation.
India has already taken major steps in introducing these two
products in the market but can do more to expand its use
Bio-crops and Biofuels,
the way ahead

24. Creation of
Market
Database
Emphasis
on
Clusters
Easing the
Regulatory
Environment
The Indian biotechnology sector is
growing exponentially with more start-
ups joining and expanding the share of
output for the industry (according to
the latest ABLE data). Hence it is
necessary that a database must be
maintained to identify such firms and
record their contributions to the
industry.
Maintaining a database will lead to
better understanding of the market
size and the rate of its growth.
Policy Recommendations
Clusters possess the ability to attract
large number of companies, and
generate employment, revenue and
output. there is a strong positive
correlation between presence of
clusters and economic growth &
innovation. Cluster based production
quickens the innovation process and
further creates ancillary industries
which will then establish a consistent
supply chain emphasizing on
specialized goods. Thus, we must focus
on identifying such clusters.
There is a need to establish coordination
between the departments and ministries
to fasten the rate of assessment of
applications.
Japan provides a perfect example where
applications for approvals of new drugs
(bio-pharma products) are put on the
fast track in order to expedite the
approval process as these are goods with
substantial medical needs.
India also needs to establish a similar set
up that would speed up the application
approval process and quality checks
process.