Biotechnology plays a pivotal role in the innovation ecosystem of the country. The sector is divided into five major segments- Bio-pharma, Bio-services, Bio-agri, Bio-industrial, and Bio-informatics. Bio-pharma accounts for the largest share of 64 percent in the total revenue of the industry. In 2019, India’s Biotech industry was valued at US$ 64 billion. India accounts for approximately 3 percent in the global biotechnology industry. India is the 3rd largest biotech destination in the Asia Pacific Region and among top 12 biotech destinations in the world.
Capacity and Production
India’s Biotech industry is the largest producer of recombinant Hepatitis B vaccine and second largest producer of BT Cotton in the world. The Indian biotech innovation ecosystem witnessed 122 patent applications since 2016. A total of 294 technologies and products are developed and commercialized till 8th September 2020. With the support of more than 2500 institutions and 1400 scientists, the Department of Biotechnology (DBT), under the Ministry of Science and Technology, Government of India, published more than 5200 publications since 2016.
According to CRISIL Research, India's biopharmaceutical exports recorded a CAGR of 14-15 percent during the period FY15-20, aided by demand for vaccines by the UNESCO and Pan American Health Organization, and export growth in the therapeutic segments.Further, revenue of the biopharmaceuticals industry also registeredyear-on-year growth of 17 percent in 2019-20.
Trends in Export of SelectCommodities under Biotech Industry
(In US$ Million)
|300220||Vaccines for human medicine||576.65||702.70||626.30||644.63||651.45||806.89||6.95|
|300230||Vaccines for veterinary medicine||5.38||4.61||9.78||8.77||10.48||11.07||15.51|
|310100||Animal/vegetable fertilizers, w/n mixed together or chemically treated||7.65||10.73||8.95||12.54||11.15||12.46||10.24|
|3507||Enzymes; prepared enzymes||42.43||43.93||47.07||49.91||41.03||42.73||0.14|
|382200||Composite diagnostic/laboratory reagents||34.65||32.62||52.99||46.00||54.91||67.03||14.11|
|392390||Other articles for the conveyance/packing of goods||78.18||87.45||92.39||110.15||137.51||154.04||14.53|
|Source: DGCIS, Exim Bank Research|
Foreign Direct Investment (FDI) of upto 100 percent is allowed under the automatic route for greenfield pharma. Out of 100 percent FDI allowed for brownfield pharma, up to 74 percent is under the automatic route while for beyond 74 percent, government approval route is required. Additionally, FDI up to 100 percent is allowed under the automatic route for the manufacturing of medical devices.
Growth in Bio-Pharma sector is aided by demand for recombinant vaccines and therapeutics, especially in semi-regulated markets. Indian companies are amongst the largest suppliers of vaccines to the World Health Organisation (WHO) and programmes such as USESCO and PAHO, supported by demand from Asia, Latin America, East Europe and Africa.
On the other hand, the launch of bio-similars in the regulated markets over the next five years is expected to help drive incremental growth in the exports segment and offset impact of pricing pressure in the vaccines segment. The low-cost advantage for Indian vaccines (30-40 percent lower than in the US and Europe) is estimated to be another growth driver. Additionally, availability of low-cost skilled labour and lower material and equipment costs give India an edge.
According to CRISIL Research, during fiscals 2020 to 2025, growth is expected to be higher on account of new product launches in the domestic market, coupled with approvals and launches in the regulated market. Biopharma companies across the world are racing to deliver the required supplies and vaccines in wake of the global Covid-19 pandemic. Several Indian players have teamed up with US universities and firms for development of vaccine. Hence, the industry is likely to benefit in the medium term as a vaccine is developed.The outlook for the industry looks positive in the medium term.
Select Government Incentives
Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal system for evaluating products developed using modern biotechnology. The U.S. Government agencies responsible for the safe use of genetically engineered organisms are the USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies. For more Information, click Regulation of Biotech Plants
The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of Genetically Modified Organisms (GMOs), takes place in safe conditions. For more information, click GMO Legislation