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BIOTECHNOLOGY

FDI In Biotechnology Sectors

The biotechnology sector in the country has played a significant role in enhancing India's global profile. India stands among the top 12 biotech destinations globally and ranks third in the Asia Pacific, with approximately a 3% share in the worldwide biotechnology industry.

The Indian biotech industry comprises over 5,000 companies (760 core companies and 4,240 start-ups). It is aligned around five significant segments: BioPharma, BioAgriculture, BioIndustrial, and a combined element of BioServices comprising BioIT, CROs, and Research Services.

As the world's leading supplier of DPT, BCG, and measles vaccines, the sector plays a critical role in the global vaccine market, contributing 70 percent of WHO's vaccines (essential Immunization Schedule). On the Global Innovation Index, India is ranked 48th.

The industry is critical to India's goal of becoming a $5 trillion economy by 2024.

100% FDI for the biotechnology sector is allowed under the automatic route for greenfield pharma.

100% FDI in biotechnology is allowed under the government route for brownfield pharma in up to 74% FDI is under automatic way and beyond 74% is under the government approval route.

Up to 100%, FDI in biotechnology in India is allowed under the automatic route for manufacturing medical devices.

9

Biotechnology Parks
4

Biotechnology Science Clusters
60 +

Bio-incubators
14 %

Expected CAGR (2022-2025)

1

World's largest producer of recombinant Hepatitis B vaccine
2

World's largest producer of BT Cotton with 35.7 million bales produced in FY19-20
3

World's highest number of USFDA approved plants outside the US.

The sector is divided into five major segments- Bio-pharma, Bio-services, Bio-Agri, Bio-industrial, and Bio-informatics.
The percentage share of the biotechnology segments is:

Bio-Pharmaceuticals: 62%
CRO/BioIT/Research: 15%
Bio-agriculture: 16%
Bio-Industrial: 7%

India is becoming a leading destination for clinical trials, contract research, and manufacturing activities, further fuelling the growth of the bio services sector.
India was also one of the first countries to establish a Biotechnology Department. Furthermore, the Department has established BIRAC (Biotechnology Industry Research Assistance Council), a non-profit organization whose mission is to strengthen and empower emerging biotechnology businesses to engage in strategic research and innovation by guiding them from concept to commercialization.

Growing population
India to become the world’s most populous country by 2030
Rising demand for treatments
Increased insurance penetration and a growing burden of disease
Medical infrastructure facilities
$ 200 Bn expenditure planned on medical infrastructure over the next decade
Strong skilled manpower pool
‘National Biopharma Mission’, an Industry-Academia mission to skill the workforce
Cost competitive manufacturing
Development of life-science clusters builds collaborations between research institutes and the private sector

July 2021- Ivanhoe´ Cambridge and Lighthouse Canton are planning a $ 100 million investment in Hyderabad's life sciences research and development facilities.
November 2020- The world's largest vaccine manufacturer, Serum Institute of India, has produced 40 million doses of AstraZeneca's prospective Covid-19 vaccine.
July 2020- In Bengaluru, Karnataka plans to build a 5000 crore integrated biotech and life sciences park.