New Delhi: Biologics and biosimilars could be the next rising stars in biotechnology with a new review by the Department of Biotechnology finding that the market size of the segment could grow at a compounded annual rate (CAGR) of 22% in the coming years to reach $12 billion by 2025.
The pharmaceutical industry is currently facing many changes both within India and globally. Small molecule therapeutics had till recently dominated research and accounted for a major share of the pharma market as they had several inherent advantages such as a tendency to be chemically and thermally stable, ability to access targets in intracellular regions and a simpler drug discovery and development process, besides being suitable for oral delivery.
However, biologics and biosimilars, which are larger molecule therapeutics have recently taken a lead over them as they were better in terms of targeted delivery and had substantially lower side effects in areas such as cancer treatments. They are increasingly becoming the treatment of choice.
Biologics are basically products that are produced from living organisms or contain components of living organisms. They include a wide variety of products derived from human, animal or microorganisms using the tools of biotechnology. Follow-on biologics and biosimilars as a class of drugs has emerged as an effective alternative to reduce the cost of biologic therapies.
A biosimilar is a biotherapeutic product that are almost similar to an already licenced biotherapeutic in terms of quality, safety and efficacy, except for some minor differences and modifications. Follow-on biologics, in turn, are nothing but biotherapeutics, whose patent has expired.
A report on the new review released as part of the ongoing international meet on biotechnology, Global Bio-India 2019, noted that the Indian pharmaceutical industry in the country was well geared to take advantage of the emerging situation.
It has pointed out that while globally 1,015 biosimilars and follow-up biologics are under development for various therapy areas such as rheumatoid arthritis, neutropenia and cancer by 475 companies, in India 201 active biosimilars were in the pipeline of 52 domestic pharmaceutical companies.
It also noted that product patents of more than 10 blockbuster biologics with total revenue of $60 billion are set to expire within the next 3 years, thus offering further potential boost to the biosimilars market.
The report was prepared in collaboration with the Department of Biotechnology’s BIRAC (Biotechnology Industry Research Assistance Council), Association of Biotechnology Led Enterprises (ABLE), a not-for-profit pan-India forum that represents the Indian Biotechnology Sector, and Cortellis, a global firm that specialises in providing insights into various aspects of life science research.
The report was released by Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Harsh Vardhan, who also inaugurated the Summit along with the Minister for Petroleum & Natural Gas and Steel, Dharmendra Pradhan.
At the Summit yesterday, Vardhan also released a report on private investment in biotechnology. The report, among other things, has highlighted the need for the Government to find out why there was inadequate private investment in biotech research.
Speaking at the inauguration, Vardhan had remarked that India has the potential to emerge as a world leader in Biotechnology, while Dharmendra Pradhan noted that India has the highest scope globally for growth of biofuels.