India is among the top 12 biotechnology destinations in the world and third largest in Asia-Pacific. The industry was valued at US$ 63 billion in 2019 and is expected to reach US$ 150 billion by 2025 with a CAGR of 16.4%. By 2025, the contribution of the Indian biotechnology industry in the global biotechnology market is expected to grow to 19% from 3% in 2017. The biotechnology sector is divided into five segments, which include biopharmaceuticals, bio-services, bio-agri, bio-industrial and bio-IT.
Biopharmaceutical is the largest segment that contributed ~58% to the Indian biotechnology market in 2019.
The biotechnology industry in India comprises >600 core biotech companies, >100 biotech incubators and >2700 biotech start-ups, which are estimated to reach 10,000 by 2024. Under the Union Budget 2021-22, the government announced plans to set up nine biosafety level-3 (BSL-3) laboratories through Pradhan Mantri Aatmanirbhar Swasth Bharat Yojana.
India has 665, the highest number, of FDA-approved plants outside of the US; 44% global abbreviated new drug applications (ANDA) and >1400 manufacturing plants, which comply with WHO requirements.
The Department of Biotechnology (DBT) has established ‘Biotechnology Parks/Incubators’ across the country. These biotechnology parks offer facilities to scientists and small & medium sized enterprises (SMEs) for technology incubation, technology demonstration and pilot plant studies to accelerate commercial development of biotechnology. The government, at present, supports nine biotechnology parks in various states & Union Territories (UT), with the bulk being in the southern region, which includes Uttar Pradesh, Telangana, Tamil Nadu (2 parks), Assam, Kerala, Jammu & Kashmir (UT) and Chhattisgarh.
DBT has also initiated the ‘National Biotechnology Parks Scheme’ proposed to create an ecosystem to absorb start-ups and give them a platform to scale their R&D activities in collaboration with the state government and industry.
BIRAC (Biotechnology Industrial Research Assistance Council), a public sector undertaking of DBT, partnered with innovative foundations and universities to focus on the ‘Make in India’ and ‘Start-up India’ programmes.
BIRAC established several industry-focussed schemes such as SBIRI, BIPP Biotechnology Ignition Grant, BioNEST, SITARE, PACE, SIIP, SEED, LEAP and Fund of Funds–AcE; supports 50 bio-incubators for potential entrepreneurs.
In March 2021, Gland Pharma Ltd. announced that it will produce 252 million doses of the Sputnik V COVID-19 vaccine in the third quarter of 2021.
In January 2021, Bharat Biotech plans to produce 700 million doses of its COVID-19 vaccine in 2021. The company announced that it will be establishing four facilities and is planning to manufacture 200 million doses in Hyderabad and 500 million does in other cities.
In January 2021, Bharat Biotech signed an agreement with Precisa Medicamentos to supply 20 million doses of Covaxin, a coronavirus vaccine, to Brazil.
In December 2020, the government has launched the Indian SARS-CoV-2 Genomic Consortia (INSACOG), comprising 10 labs across the country.
In November 2020, the Department of Biotechnology (DBT) initiated the ‘Partnership For Advancing Clinical Trials (PACT)’ initiative. Under the PACT programme, DBT in association with Ministry of External Affairs is aiming to strengthen capacities for facilitating Phase III clinical trials of COVID-19 vaccines in neighbouring countries.
The global life sciences industry is shifting from chemical-based drug to biologics and biosimilars. India approved its first biosimilar as early as 2000 and is an emerging hub for biologics and biosimilars.
Biologics economy in India was valued at US$ 7 billion in 2019 and is forecast to reach US$ 12 billion by 2025. In India, the biologics segment is led by Biocon Ltd., which has commercialised the biosimilars Trastuzumab and Pegfilgrastim in partnership with Mylan. Other players in this space include Dr Reddy’s Laboratories, Intas Pharmaceuticals, Zydus Cadila and Lupin.
India is among the preferred destinations for clinical trials owing to a large patient pool, transformation of the healthcare market, well-educated physicians and cost competitiveness
The Indian Council of Medical Research (ICMR) has selected 12 institutes for clinical trial of the country’s first indigenous COVID-19 vaccine. In 2020, the ICMR to develop indigenous COVID-19 vaccine (BBV152 COVID) in partnership with Bharat Biotech International Limited.