With the government's new initiative of enabling ease of doing business in the country, the Indian pharma cos are expected to reap good benefits from the biosimilar sector in the next 15 years.
According to a study report released by Assocham, it is stated that the biosimilars would offer more than $240 billion global opportunity for Indian pharmaceutical industry. The report pointed out that the Indian biosimilars industry had crossed $300 million in the year 2015 of which the domestic sales reported at $250 million while $50 million are contributed from the export component. “India had witnessed a combined annual growth rate of 14 per cent both in domestic and export markets,” revealed the Assocham report.
Biosimilars are drugs designed to have properties similar to a biological drug that has previously been licensed. It is also sometimes referred to as follow-on biologic or subsequent entry biologic used as a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. In fact, the biosimilars are officially approved versions of original "innovator" products, and can be manufactured when the original product's patent expires.
Unlike the generic drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes.
According to Prof D. Swaminadhan, president and director general of Jawahar Nehru Institute of Advance Studies (JNIAS), the Indian pharma companies can reap in the global opportunities offered by the Biosimilars and by 2030 India can reach $40 billion market size.
Major drivers of biosimilars markets can be regulatory policy and increased affordability that biosimilars offer. The domestic market is expected to grow at an accelerated pace and reach the set target by 2030. Experts are of the view that Indian pharma cos are having huge potential and can command more than 20 per cent share in the global markets.
“Based on our analysis of the currently approved biologic drugs, clinical pipeline and expectations around price erosion and market penetration, Assocham and Sathguru estimate that global market for biosimilars will be $240 billion by 2030,” said Prof D. Swaminadhan.
Swaminadhan feels that the current market landscape called for stakeholders including the government and industry to join forces and push the boundaries of biosimilars to realise the potential for the benefit of both industry and the patient.