The Indian biologics market has the potential to reach US$ 12 billion by 2025 while registering a CAGR of 22% from 2019 to 2025. In terms of the Indian biotechnology sector, the industry accounted for US$ 63 billion in 2019 and is expected to reach US$ 150 billion by 2025.
The global biologics market is expected to grow at the CAGR of 6 percent from US$ 253.41 billion in 2020 to US$ 268.51 billion in 2021. By 2025, the market can account for US$ 420.55 billion, growing at the CAGR of 12 percent.
Looking at these numbers, the Indian biopharmaceutical industry and the bio-services can become a leading destination for contract research, clinical trials and manufacturing of biologics says Dr R B Smarta, CMD, Interlink, Vice President, Health Foods and Dietary Supplements Association (HADSA) in an exclusive interview with the Financial Express online. Excerpts
Interlink is a Business Performance and Strategy Consultancy firm with expertise in Pharmaceuticals, Nutraceuticals, Wellness and Healthcare segment for the past 35 years.
What are biologics and how different are they from conventional drugs?
Vaccines, allergenics, somatic cells, blood and blood components, recombinant therapeutic proteins and a wide variety of products which are isolated from natural sources including human, animals or microorganisms are categorised under Biologics.
The major difference between the biologics and conventional drugs is lies in the method of production. Conventional medicines are the product of chemical synthesis while biologics production involves biotechnological methods hence they require aseptic principles from the very beginning phase of manufacturing. Hence, the investment involved in terms of time and money is huge. That’s not the case for most of the conventional drugs.
In terms of structure, most biologics are complex mixtures as compared to conventional drugs and as biologics represent the cutting-edge of biomedical research, biologics have the potential to offer the most effective treatment for a wide range of diseases and conditions which were incurable with conventional medicines.
Are we seeing some kind of a focus globally on developing biologics?
In terms of the global market, USFDA has already revised its regulations to eliminate the outdated biologics requirement which is allowing innovators and manufacturers to explore new technologies to boost the production of biologics. The continuous updating of regulatory requirements by USFDA for biologics approval is expected to increase regulatory flexibility in the global pharma industry.
Moreover, patent expiration of blockbuster biologics and governments’ thought to reduce the healthcare cost by introducing biosimilars (highly similar copies of biologics) in the market is further fuelling the Go-to-global-market excellence amongst the pharma and biotech industry.
Being the ‘Global Generic Hub’, India is exploring the opportunities in biologics and biosimilars to expand beyond generics. How well are we prepared for this?
At this point, the Indian biologics market is dominated by simple biologics including insulin, erythropoietin, drugs for cardiovascular and autoimmune disease, monoclonal antibodies among others.
The Indian government is promoting biotech-based drug development with various approaches in terms of fundings and investments. Initiatives under ‘Making in India’ campaigns are favourable enough for the Indian pharma industry. Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), union health ministry and Indian Council of Medical Research (ICMR) are some of the main governing bodies actively encouraging India’s biotech sector with various initiatives. Such bodies also motivate Public Private Partnerships (PPP) to attract investments for biotech business.
Leading Indian companies like Biocon, Zydus Cadila, Bharat Biotech and even the Serum Institute of India (SII) are making good efforts in the space of biologics and vaccines production. Opportunities presented by manufacturing capabilities, labour availability and low development cost can make a huge difference for Indian biologics business in coming years.
From a regulatory perspective, what can be done to make India a R&D and manufacturing hub for biologics?
Development of biologics products require considerable amount of time and investments. As the regulatory process involved in approval of biologics in India are slow and also involve multiple clearance stages, the market entry of the biologics is delayed which can be prohibitive for innovations in the industry. Following are some suggestions which can be considered to maximize Go-to-market opportunities for Indian biologics.
Autonomy in policy making and implementation is needed which can be achieved by establishing a single and empowered regulatory body. To avoid delay in market entry due to lack of guidance on subject matter, agreements, SOPs, a fast-track cell is required to streamline these legal processes.
Building capabilities and up-skilling of regulatory body reviewers can make a real difference in the procedures involved in the approval of Biologics in India. Periodic policy reviews are also essential to hasten the regulatory processes.