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Authors

Dikshu C. Kukreja
Dikshu C. Kukreja
Mr. V. Raman Kumar
Mr. V. Raman Kumar
Ms. Chandra Ganjoo
Ms. Chandra Ganjoo
Sanjay Bhatia
Sanjay Bhatia
Aprameya Radhakrishna
Aprameya Radhakrishna
Colin Shah
Colin Shah
Shri P.R. Aqeel Ahmed
Shri P.R. Aqeel Ahmed
Dr. Vidya Yeravdekar
Dr. Vidya Yeravdekar
Alok Kirloskar
Alok Kirloskar
Pragati Khare
Pragati Khare
Devang Mody
Devang Mody
Vinay Kalantri
Vinay Kalantri

India on the path to becoming a Bio-manufacturing Hub

India on the path to becoming a Bio-manufacturing Hub

India is regarded as one of the leading destinations for bio innovation and biomanufacturing and is thus recognized as a sunrise sector and a critical component of India's mission of becoming a US$ 5 trillion economy by 2024. Biotechnology is the application of biological knowledge and techniques related to molecular, cellular, and genetic processes in order to create considerably enhanced products and services. The use of biotechnology in products and processes has ensured ease of living, enhanced healthcare, increased agricultural productivity, and created employment opportunities, among other benefits. India is ranked third in Asia and is one of the top 12 biotech destinations in the world. In the last eight years, India's bioeconomy industry has expanded eightfold, from US$ 10 billion in 2014 to more than US$ 80 billion in 2022 and is expected to surpass US$ 150 billion dollars by 2025 and over US$ 300 billion dollars by 2030. India is well-positioned to take part in a new global wave of industrial revolution arising from recent advancements in biotechnology to build more sustainable manufacturing practises due to its fast-expanding bioeconomy and growing scientific and innovation temper. In the Union Budget 2023-2024, India announced its Green Growth vision. Taking this into account, the Department of Biotechnology proposes to launch a national project entitled "Fostering High Performance Biomanufacturing: An Integrated Approach towards promoting Circular Economy for Green, Clean and Prosperous India," which will establish world-class expertise, facilities, and skilled workforce in synthetic biology-based sustainable manufacturing methods to facilitate Circular-Bioeconomy in India.

Biotechnology Industry in India
India's bioeconomy industry accounts for approximately 3% share of the global Biotechnology industry. Furthermore, India has the second-highest number of USFDA-approved manufacturing plants outside of the United States. India is the world's top supplier of DPT, BCG, and measles vaccines. In 2021-22, the Indian Bioeconomy sector contributed nearly 2.6% share in India’s Gross Domestic Product (GDP). Due to the expanding enabling ecosystem, the number of biotech start-ups in the nation has surged from 50 to over 5,300 in the last ten years. Biotech start-ups emerging from a robust talent pool are predicted to further double, exceeding more than 10,000 by 2025. In 2021, BT Cotton, Biopesticides, Biostimulants, and Biofertilizers contributed around US$ 10.48 billion to the country's bioeconomy. India was one of the first countries to establish a Biotechnology Department. The Indian biotech industry is expected to grow significantly because of rising economic prosperity, increased health consciousness, and a billion-plus population base. In the Union Budget 2023-24, the Department of Biotechnology (DBT) was allotted US$ 162.7 million (Rs. 1,345 crore).

Market Size
According to current projections, the industry is estimated at US$ 80.12 billion in 2021-22 and is projected to grow to US$ 150 billion by FY25. India's bioeconomy surpassed US$ 80.12 billion in FY22, registering a rise of 14.1% over US$ 70.2 billion in FY21. The Indian biotechnology industry has the potential to reach US$ 300 billion by the year 2030.



Source: Department of Biotechnology (DBT)
Note: E stands for Estimated Value

Segments

In the Indian bio-economy market, biopharmaceuticals and the medical devices industry are the two largest segments, accounting for nearly 62% of the total contribution. India’s Biotechnology sector is categorized into 5 segments:

  • Biopharmaceuticals

India is one of the world's largest suppliers of affordable medications and vaccinations. India is a global leader in biosimilars, with the most biosimilars approved in the domestic market. It accounts for the largest share, contributing 49%, amounting US$ 39.4 billion of the total Indian Bioeconomy industry in CY21. The BioPharma segment's primary components are therapeutics accounting for 26%, Vaccines accounting for 22%, and Diagnostics accounting for 52%. The vaccination market was estimated at US$ 8.7 billion, excluding Covid-19 Vaccines. While therapeutics had a market value of US$ 10.3 billion and diagnostics had a value of US$ 20.4 billion in FY22.

  • Bio Agriculture (Agri)

India is one of the world's top producers of BT-Cotton and has the fifth-largest area of land used for organic agriculture, with over 55% of the country's land covered by agriculture and related activities. The Bio Agri segment was estimated to be US$ 10.48 billion. The biopesticides, biostimulants, biofertilizers, and BT cotton constitute the bio-agriculture segment.

  • Bio industrial

The integration of biotechnology into industrial processes is revolutionising manufacturing and waste management across India. The Bio Industrial market was valued at US$ 10.3 billion in 2021, with a robust CAGR of 101.3%. Biofuels / Bioenergy and Industrial Enzymes are the two verticals that make up the Bio Industrial segment. In FY21, the Enzymes industry experienced a strong growth of 65.7%, while the Biofuels sub-segment experienced a phenomenal growth of 138.8%.

  • Bio Services

They are aids and services offered to clinical trials, healthcare sectors, biotech firms, and educational initiatives to increase support and research so that these entities can channel and strengthen their research progress. India has the most US FDA-approved facilities worldwide, outside of the US and has a strong competence in contract manufacturing, research, and clinical trials.

  • Bioinformatics/IT

It is the use of computer technology to comprehend and utilise biological and biomedical data effectively. It gathers Big Data from clinical or life sciences investigations and stores, analyses, and interprets it.


Source: Biotechnology Industry Research Assistance Council (BIRAC)

Biotech parks

Biotechnology parks and incubators are established across the country by the Department of Biotechnology (DBT), under the Ministry of Science and Technology, to translate research into products and services by providing necessary infrastructure support. These biotechnology parks offer facilities to scientists, and small and medium-sized enterprises (SMEs) for technology incubation, technology demonstration and pilot plant studies to accelerate the commercial development of biotechnology. The government, at present, supports nine biotechnology parks in various states, with the bulk being in the southern region.

National and international partnerships

  • In December 2022, Bengaluru-headquartered Centre for Cellular and Molecular Platforms (C-CAMP), an initiative supported by the Department of Biotechnology, announced a next-generation Indo-Dutch bilateral collaboration to address challenges posed by Antimicrobial Resistance (AMR).
  • In November 2022, Yara India, which is part of the Oslo-based, Norwegian multinational Yara International, tied up with a Bengaluru-based start-up and ABLE Member Sea6 Energy, to market and distribute its bio-stimulant AG Boost in India.
  • In June 2022, Serum Institute of India partnered with US company Novavax to manufacture their Covid vaccine (NVX-CoV2373) for the US market.
  • In February 2022, Pune-based Mylab Discovery Solutions entered into a strategic partnership with Shilpa Biologicals, a subsidiary of Shilpa Medicare, to manufacture vaccines and therapeutics, starting with the Covid-19 vaccine.
  • IIL started supplying the vaccines to Bharat Biotech in August 2021, while BIBCOL plans to finish production of the trial batch of Covaxin in February 2022.
  • In November 2021, the World Health Organization (WHO) issued an emergency use listing (EUL) for Bharat Biotech’s Covid-19 vaccine COVAXIN. It was found to have 78% efficacy against Covid-19 virus of any severity.
  • In November 2021, INOVIO announced that it has received authorization from India's Central Drugs Standard Control Organization’s (CDSCO) Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in India. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the trials.
  • In October 2021, the Department of Biotechnology launched a ‘One Health’ consortium that will survey important bacterial, viral and parasitic infections of zoonotic as well as transboundary pathogens in the country. The consortium consists of 27 organizations and is led by the DBT-National Institute of Animal Biotechnology, Hyderabad.
  • In May 2021, Indian Immunologicals Limited (IIL) and Bharat Immunologicals and Biologicals Corporation (BIBCOL) signed technology transfer pacts with Bharat Biotech to develop the vaccine locally to boost India's vaccination drive.

Startup Landscape
The rise of India's biotech start-up base (the total number of companies filed since 2010) is expected to continue in 2021. The overall number of biotech start-ups increased to 5,365 in 2021, up from 4,237 in 2020. In 2021, the total number of startups increased by 26.6%. For the first time ever, in FY22, the biotech sector in India had more than 1,000 new start-up registrations in a single calendar year. In August 2022, Minister of State (Independent Charge) Science & Technology; Minister of State (Independent Charge) Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr. Jitendra Singh, announced 75 "Amrit" Grants worth US$ 1.22-1.83 million (Rs. 10-15 crore) for biotech projects involving startups, industry, academia, and research organisations working together. Department for Promotion of Industry and Internal Trade (DPIIT) recognised 84,102 organisations as startups as of November 30th, 2022, spread across 56 sectors including agriculture, biotechnology, and chemicals.


Source: Biotechnology Industry Research Assistance Council (BIRAC)

Moreover, the start-up ecosystem in India is strongly supported on the back of gradual improvements in the ease of doing business, proof-of-concept funds for start-ups and favorable government policies. BIRAC, a public sector undertaking of DBT, partnered with innovative foundations and universities to focus on ‘Make in India’ and ‘Start-up India’ programmes. There are more than 1,000 startups supported by BIRAC funding. Furthermore, BIRAC established several industry-focused schemes such as Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Partnership Programme (BIPP) Biotechnology Ignition Grant (BIG), Bioincubators Nurturing Entrepreneurship For Scaling Technologies (BioNEST), Students Innovations for Translation & Advancement of Research Explorations (SITARE), Promoting Academic Research Conversion to Enterprise (PACE), SOCIAL INNOVATION IMMERSION PROGRAM (SIIP), Sustainable Entrepreneurship And Enterprise Development (SEED), Launching Entrepreneurial Driven Affordable Products Fund (LEAP) and Fund of Funds- Accelerating Entrepreneurs (AcE). BIRAC has supported 60 bio-incubators for potential entrepreneurs.

BIRAC (Bio-Incubator) (As of November, 2022)

Incubators supported

75

Amount committed for BioNEST

US$ 44.85 million

Incubation area supported

715,000 sq. ft.

Incubatees supported

1,800

Resident incubatees supported

935

Non-resident incubatees supported

264

Total products/technologies supported

800

Total employment generated

32,474

Total IPs generated

1,250

Total trainings/workshops conducted

1,000

Source: Biotechnology Industry Research Assistance Council (BIRAC)

As depicted in the graph below, in 2021, 39.4% of the 1,128 new firms established were in the biotech and life sciences manufacturing area. Over 35.6% of the startups were in the Bio Services area, which included R&D and other services. Another 13.5% of the life sciences enterprises were registered with trading activity. Moreover, 8% of the businesses were engaged in activities related to engineering, machinery, and equipment and 3.5% of all startups created in 2021 were in the bio agriculture and related area.


Source: Biotechnology Industry Research Assistance Council (BIRAC)

Government Initiative on Biomanufacturing
The national initiative “Fostering High Performance Biomanufacturing: An integrated approach towards promoting Circular Economy for Green, Clean and Prosperous India” has been proposed by the Department of Biotechnology. This initiative's foundation is made up of advanced biotechnology tools such as synthetic biology, gene editing, metabolic engineering, and so on. It is believed that building a biomanufacturing program's capacity for synthetic biology requires a robust national infrastructure platform.

This goal can be met by bio foundries' high-throughput capabilities. Bio foundries contribute to the development and strengthening of a Design-Build-Test-Learn (DBTL) approach for developing new high-throughput biological solutions using cutting-edge automation technologies such as robotics, AI algorithms, high-throughput analytical equipment and software, and so on. Bio foundries will rapidly develop tools and datasets to enable and improve rational strain improvement in biomanufacturing.

The pilot-scale biomanufacturing units will use fermentation and enhanced microbial cell factories (together with sugar/biomass/waste-based raw materials) to produce bio-based products as an alternative to chemical products in a variety of industrial sectors. Food additives, biopharmaceuticals, biogenic dyes, bulk chemicals, animal feed products, flavours/fragrances, biomaterials, Agri-bioproducts, etc. are a few of these industries.

The 'Lifestyle for the Environment (LiFE)' initiative launched on October 20, 2022, encourages us to use green and friendly environmental solutions in all aspects of life in order to effectively meet climate and energy goals. As a result, a pan-India biomanufacturing programme based on biomass/waste resources can assist meet rising consumer demand, increase the country's economy, and put the country on pace to achieve net-zero carbon emissions.

The Road Ahead
For the last decade, BIRAC has been nurturing the country's biotech ecosystem in accordance with the National Missions of Startup India and Make-in-India. Moreover, India's bioeconomy is rising by double digits year on year, from US$ 51 billion in 2018 to US$ 81 billion in 2021. Diagnostic and medical device exports as well as imports are anticipated to rise sharply in India. By 2025, the therapeutics industry is projected to generate US$ 15 billion in bioeconomic activity with the aid of recombinant and biosimilar goods. Biomanufacturing has enormous potential because it's flexible to innovation, energy efficient, and produces less pollution. It is vital to develop a national strategy for biomanufacturing advancement in order to improve our country's scientific and economic competitiveness. The expansion of start-ups and the advancement of research would be aided by an increase in the number of biotech incubators, which is essential for the success of the Indian biotech industry. The biotechnology industry has the ability to offer a variety of solutions for problems in several fields like health, agriculture, the environment, energy, and industrial processes, mostly because of its multidisciplinary approach.

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