Biotechnology in India

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Biotechnology in India is a sunrise sector within the Indian economy. [1] Agencies of the Government of India concerned with the biotechnology industry include the Department of Biotechnology and the proposed Biotechnology Regulatory Authority of India. As of 2022, the sector is valued at $80 billion. [2] Biotechnology in India is in a growth phase and the sector is expected to be valued at $150 billion by 2025 and surpass $300 billion in value by 2030. [2]

Contents

History

The first Indian biotechnology company to be established was Biocon, which was founded by Kiran Mazumdar-Shaw in 1978. [3] The Indian biotechnology industry formally began in 1986 with the establishment of the Department of Biotechnology (DBT) by the Ministry of Science and Technology. [4] From 1999, St. Joseph’s College, Irinjalakuda, Kerala is offering a government-aided B.Sc. Biotechnology program. It is the only institution in Kerala offering an aided graduation program in biotechnology. [5]

Regulation

Department of Biotechnology

The Department of Biotechnology is an Indian government department under the Ministry of Science and Technology, responsible for administering development and commercialization in the field of modern biology and biotechnology in India. The DBT was also one of the world's first government departments that was established to focus solely on the biotechnology sector. [4]

Biotechnology Regulatory Authority of India

The Biotechnology Regulatory Authority of India (BRAI) is a proposed regulatory body in India for uses of biotechnology products including genetically modified organisms (GMOs). [6] The institute was first suggested under the Biotechnology Regulatory Authority of India (BRAI) draft bill prepared by the Department of Biotechnology in 2008. Since then, it has undergone several revisions. [7]

Companies

Biologics and biosimilars manufactures

Several of the large Indian pharmaceutical companies also manufacture biologics and biosimilars. One of Biocon's subsidiaries, Biocon Biologics, manufactures biosimilars. [8] [9] Intas Pharmaceuticals also manufactures biosimilars. [10] Dr. Reddy's Laboratories entered the biosimilars market in 2008. [11] Cipla entered the biosimilars market in 2010. [12] Aurobindo Pharma is focusing on developing biosimilars in various segments. [13] Enzene Biosciences is the biologics subsidiary of Alkem Laboratories. [14] [15]

Reliance Life Sciences, owned by Mukesh Ambani, Asia's wealthiest man, manufactures biosimilars and other biopharmaceutical and pharmaceutical products. [16] [17]

Vaccine manufactures

India is the world's largest vaccine maker as of 2020. [18] Indian vaccine manufactures include the Serum Institute of India (SII). [19] SII is the world's largest vaccine manufacturer. [20] [21] Reliance Life Sciences, among other products, also manufactures vaccines. [22] [23] Another established vaccine manufacturer is Bharat Biotech. [24] Hester Biosciences is Asia’s largest company that manufactures animal and poultry vaccines. [25]

Contract manufacturers, researchers and developers

Syngene International, is a subsidiary of Biocon and is a contact development and manufacturing organisation (CDMO) that, among other areas, offers CDMO services for biologics. [26] [27] Laurus Bio is a subsidiary of Laurus Labs and was originally an independent company named Richcore, before Laurus Labs acquired Richcore and renamed it. [28] [29] Laurus Bio, among other products and services, also offers CDMO services for microbial precision fermentation. [30] In 2021, Cipla entered into a joint venture with biopharmaceutical CDMO company Kemwell Biopharma, to develop, manufacture and commercialize biosimilars for global markets. [31] Concord Biotech, among other areas, offers contract research and manufacturing services for fermentation products. [32]

Active pharmaceutical ingredients

Concord Biotech manufactures, among other products, fermentation based complex active pharmaceutical ingredients. [33] [34]

Bioinformatics

Tata Consultancy Services (TCS), one of the largest information technology companies in India, offers bioinformatics and biostatistics services. [35] [36]

Other established companies

Startups

There have been an increasing number of startups being founded in the Indian biotechnology industry. In 2021, the total number of biotechnology startups stood at 5365, whereas in 2010, there were only 50 startups in the sector. [2] As of 2021, more than half of the biotechnology startups are being founded in the medical sector, however, other large sectors where biotechnology startups are being founded include 18% in the biotechnology services sector and 14% of startups are in agricultural biotechnology. [4]

Biotechnology parks

The DBT has set up biotechnology parks in India, and as of 2022, there are 9 biotechnology parks across the country. [39] The parks have been set up by the DBT to give infrastructure support that will assist in making biotechnology research into products and services. [39] The biotechnology parks give scientists and small and medium-sized enterprises facilities that can help them in developing and demonstrating technologies, and assist in their pilot plant studies as well.

Related Research Articles

FUJIFILM Diosynth Biotechnologies, abbreviated FDB and also referred to simply as Diosynth, is a biopharmaceutical contract manufacturing organization that develops manufacturing processes and manufactures active ingredients and provides fill and finish services for pharmaceutical companies. FUJIFILM Diosynth Biotechnologies is the world's second largest contract manufacturer of biopharmaceuticals, with manufacturing facilities in Morrisville, North Carolina and College Station, Texas in the United States, Teesside, United Kingdom and Hillerød, Denmark in Europe, and recently added sites in Thousand Oaks, California and Watertown, Massachusetts. FUJIFILM Diosynth Biotechnologies operates a highly automated multipurpose manufacturing facility in College Station, Texas under the federal government's Center for Innovation in Advanced Development and Manufacturing (CIADM) program, which is the largest scale-out cell culture manufacturing facility in the United States.

<span class="mw-page-title-main">Cipla</span> Indian multinational pharmaceutical company

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai. Cipla primarily develops medication to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression, and other medical conditions.

Pharming, a portmanteau of "farming" and "pharmaceutical", refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes, thus creating a genetically modified organism (GMO). Pharming is also known as molecular farming, molecular pharming or biopharming.

<span class="mw-page-title-main">Biocon</span> Indian multinational biopharmaceutical company

Biocon Limited is an Indian biopharmaceutical company based in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries, including the United States and Europe. It also manufactures novel biologics as well as biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets.

A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.

<span class="mw-page-title-main">Kiran Mazumdar-Shaw</span> Indian entrepreneur (Biocon), billionaire

Kiran Mazumdar-Shaw is an Indian billionaire entrepreneur. She is the executive chairperson and founder of Biocon Limited and Biocon Biologics Limited, a biotechnology company based in Bangalore, India and the former chairperson of Indian Institute of Management, Bangalore. In 2014, she was awarded the Othmer Gold Medal for outstanding contributions to the progress of science and chemistry. She was on the Financial Times 2011 top 50 women in business list. In 2019, she was listed as the 68th most powerful woman in the world by Forbes. She was named EY World Entrepreneur Of The Year 2020. She is married to John Shaw.

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.

<span class="mw-page-title-main">Genome Valley</span> Life Sciences in Telangana, India

Genome Valley is an Indian high-technology business district spread across 2,000-acre (8.1 km2)/(3.1 sq mi) in Hyderabad, India. It is located across the suburbs, Turakapally, Shamirpet, Medchal, Uppal, Patancheru, Jeedimetla, Gachibowli and Keesara. The Genome Valley has developed as a cluster for Biomedical research, training and manufacturing. Genome Valley is now into its Phase III, which is about 11 kms from the Phase I and II with the total area approximately 2,000-acre (8.1 km2).

<span class="mw-page-title-main">Economy of Bangalore</span>

The economy of Bengaluru contributes over 43.65% to the economy of the State of Karnataka, accounting for 98% of the Software Exports of the State.

<span class="mw-page-title-main">Lonza Group</span> Swiss pharmaceutical and biotech company

Lonza Group is a Swiss multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, headquartered in Basel, with major facilities in Europe, North America and South Asia. Lonza was established under that name in the late 19th-century in Switzerland. The company provides product development services to the pharmaceutical and biologic industries, including custom manufacturing of biopharmaceuticals and detection systems and services for the bioscience sector.

The Department of Biotechnology (DBT) is an Indian government department, under the Ministry of Science and Technology responsible for administrating development and commercialisation in the field of modern biology and biotechnology in India. It was set up in 1986.

<span class="mw-page-title-main">Lupin Limited</span> Indian multinational pharmaceutical company

Lupin Limited is an Indian multinational pharmaceutical company based in Mumbai. It is one of the largest generic pharmaceutical companies by revenue globally. The company's key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis.

<span class="mw-page-title-main">Sarfaraz K. Niazi</span>

Sarfaraz Khan Niazi he migrated to Karachi, Pakistan in 1962, and to the United States in 1970. He is an expert in biopharmaceutical manufacturing and has worked in academia, industry, and as an entrepreneur. He has written books in pharmaceutical sciences, biotechnology, consumer healthcare, and poetry. He has translated ghazals of the Urdu poet Ghalib.

<span class="mw-page-title-main">Biological E. Limited</span> Indian biopharmaceutical company

Biological E Limited is an Indian biotechnology and biopharmaceutical company based in Hyderabad, Telangana. It specialises in the areas of low-cost vaccine production.

<span class="mw-page-title-main">Samsung Biologics</span> South Korean biotechnology company

Samsung Biologics is a South Korean biotechnology company headquartered in Songdo, Incheon, South Korea. The biotech division of Samsung Group, it provides contract development and manufacturing (CDMO) services to the biopharmaceutical industry.

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians. In fiscal year 2020, it generated over $3 billion in annual revenue.

Concord Biotech Limited (CBL) is an Indian biotechnology company headquartered in Ahmedabad. The company manufactures fermentation based biopharmaceutical active pharmaceutical ingredients (APIs) sold worldwide.

<span class="mw-page-title-main">Laurus Labs</span> Indian pharmaceutical company

Laurus Labs is an Indian multinational pharmaceutical and biotechnology company headquartered in Hyderabad. Its focus areas include active pharmaceutical ingredients (APIs), generic formulations, custom synthesis (CDMO), biotechnology. veterinary APIs and agro chemicals. The company was founded in 2005 by Dr. Satyanarayana Chava.

BIOTECanada, or the Industrial Biotechnology Association of Canada, is a Canadian biotechnology industry association based in Ottawa, Ontario. It is an industry-funded membership organization composed of over 250 national and international pharmaceutical and gene therapy companies, medical device manufacturers, agricultural science businesses, law firms, academic institutions, research and development networks, advertising agencies, insurance companies and financial services firms.

References

  1. ↑ Livemint (11 June 2022). "India's biotech sector likely to reach $150 billion in 4 years: Minister". mint. Retrieved 6 December 2022.
  2. 1 2 3 Basu, Mohana (20 July 2022). "R&D investment in Indian biotech tripled in 2021 to cross $1 billion, says govt report". ThePrint. Retrieved 25 December 2022.
  3. ↑ Dey, Soma (2019). "Biocon: Taking a Crack at the Global Biosimilar Market". South Asian Journal of Business and Management Cases. 8 (1): 100–110. doi: 10.1177/2277977918803186 . ISSN   2277-9779.
  4. 1 2 3 Nogrady, Bianca (12 December 2018). "How Indian biotech is driving innovation". Nature. 564 (7735): S53–S55. doi: 10.1038/d41586-018-07671-9 . PMID   30542184.
  5. ↑ "Department of Biotechnology, St. Joseph's College, Irinjalakuda".
  6. ↑ Regulatory Authority to be Set Up on Bio-Technology, PIB, GOI, 22 May 2012
  7. ↑ "BRAI Bill leaves biotech commercialisation in limbo", The Hindu , 9 September 2010
  8. ↑ "Who we are - Biocon - Global Biopharmaceutical company". Biocon. Retrieved 11 September 2022.
  9. ↑ Kumar, Manoj (24 May 2023). "India's Biocon Biologics says biosimilars put revenue on $1 bln trajectory". Reuters. Retrieved 8 August 2023.
  10. ↑ BS Reporter (23 February 2015). "Ahmedabad-based Intas Pharma launches biosimilar in EU". Business Standard. Retrieved 17 August 2023.
  11. ↑ "Dr Reddy's looks to biosimilars for growth". Generics and Biosimilars Initiative. 23 March 2012. Retrieved 21 August 2023.
  12. ↑ "Cipla enters the biosimilars market". Generics and Biosimilars Initiative. 2 July 2010. Retrieved 21 August 2023.
  13. ↑ Sharma, Neetu Chandra (13 September 2022). "Biosimilars has Pushed Aurobindo Pharma to Second Place Among Indian Pharma Companies. Can it Become No. 1?". Business Today. Retrieved 10 August 2023.
  14. ↑ "Alkem launches first cetuximab similar biologic in India". Generics and Biosimilars Initiative. 13 June 2023. Retrieved 22 August 2023.
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  16. ↑ Gopalan, Krishna (31 July 2023). "Reliance Life Sciences: How a new campus in Nashik is helping the firm make the moves". Business Today. Retrieved 22 August 2023.
  17. ↑ "Mukesh Ambani". Forbes. Retrieved 27 January 2023.
  18. ↑ Roy, Abhirup; Rocha, Euan; Das, Krishna N. (10 December 2020). "Not without India: World's pharmacy gears up for vaccine race". Reuters. Retrieved 26 December 2022.
  19. ↑ "About Serum Institute Of India Pvt. Ltd". www.seruminstitute.com. Retrieved 6 September 2022.
  20. ↑ Kalra, Aditya (24 May 2022). "Indian vaccine giant Serum plans African plant in global expansion". Reuters. Retrieved 6 September 2022.
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  24. ↑ "Bharat Biotech International Ltd - Company Profile and News". Bloomberg.com. Retrieved 6 September 2022.
  25. ↑ "About". www.hester.in. Retrieved 6 October 2022.
  26. ↑ "Syngene International Ltd". Contract Pharma. Retrieved 7 August 2023.
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  28. ↑ Ramarathinam, Ashwin (25 November 2020). "Laurus Labs buys 73% stake in Biotech firm Richcore Lifesciences for Rs247 crore". mint. Retrieved 2 May 2022.
  29. ↑ "Laurus Bio | Enabling precision fermentation and synthetic biology". LAURUS Bio. Retrieved 2 May 2022.
  30. ↑ "CDMO Services". Laurus Bio. Retrieved 22 August 2023.
  31. ↑ "Cipla, Kemwell Enter Biosimilars Joint Venture". Contract Pharma. 30 August 2021. Retrieved 22 August 2023.
  32. ↑ "Contract Research & Manufacturing". Concord Biotech. Retrieved 30 August 2023.
  33. ↑ "About us". Concord Biotech. Retrieved 4 August 2023.
  34. ↑ Manohar, Asit (5 August 2023). "Concord Biotech IPO: What GMP, subscription signal as offer ends on Tuesday". Mint. Retrieved 30 August 2023.
  35. ↑ "TCS' cutting-edge Genomics Research Services". TATA Consultancy Services. Retrieved 6 September 2023.
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  37. ↑ "Corporate Profile". Advanced Enzymes. Retrieved 6 October 2022.
  38. ↑ How Bengaluru became the biotech capital of India, The Economic Times, 12 November 2015
  39. 1 2 PTI (28 May 2022). "North India's first biotech park inaugurated in J-K's Kathua". The Economic Times. Retrieved 28 December 2022.
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