The Indian pharmaceutical companies always had strong chemistry skills to work on small molecules to make generic drugs, but they lacked skills, people and ecosystem to work on large molecules to come up with reverse engineered versions of biotech drugs, many experts complain. However, it is beginning to change.
According to the report 'India: the emerging hub for biologics and biosimilars', the Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. Further, India has 95 approved biosimilars in the domestic market, more than any other country in the world.
The report by global analytics firm Clarivate Analytics was released at the Global Bio-India 2019 event in New Delhi by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel and Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT).
The Association of Biotechnology Led Enterprises (ABLE) estimates the biologics market in India will grow at a compound annual growth rate (CAGR) of 22 per cent to reach $12 billion by 2025. The Indian regulatory authorities approved the first biosimilar in 2000. So far it has approved 98 biosimilars up to September 2019. The revised 'Guidelines of Similar Biologics' was released by DBT and Central Drugs Standard Control Organisation (CDSCO) on August 15, 2016, to simplify the regulatory pathway to enable faster approvals and cGMP manufacturing processes assuring safety, efficacy and quality. Today there are more than 2,700 biotech start-ups in the country, 600 biotech companies and 100 biotech incubators. These numbers are expected to multiply four to five times in the next five years, says the report.
It notes that of the top 10 blockbuster molecules globally in 2018, only two were small molecule therapeutics and eight were biological therapeutics, and considering the growth of the biotech skills of Indian pharmaceutical and biotech industry, India is well placed to capitalise on the substantial opportunity offered by biotherapeutics as companies are developing an extensive pipeline of biosimilars.
Mandakini Goel, senior solution consultant with Clarivate Analytics, says biologics have gained major market share in terms of both revenue and total market, which was $200 billion in 2013 and is expected to grow to $386 billion by the end of 2019 at a CAGR of 10 per cent. The firm estimates the global biosimilars market opportunity will grow to more than $70 billion by 2027. Recent regulatory approvals in developed markets, combined with the upcoming patent expirations of more than 10 blockbuster biologics (total revenue of $60 billion) within the next two to three years, will provide a further boost to the biosimilars market.