Data shows while the overall biosimilars category has clocked a 10.3 per cent value compound annual growth rate (CAGR) over the past few years, the market size for the top molecule has more than doubled.
A biologic drug is produced from living organisms or contains components of living organisms, unlike chemical drugs. A biosimilar is a copy-cat of a biologic drug, once the patent period ends. The moving annual turover (MAT) for biosimilar molecules sold in the domestic market as on August 2019 stood at Rs 1,498 crore as per data from market research firm AIOCD AWACS, up 34 per cent from Rs 1,117 crore in August 2016.
The value CAGR for the period is 10.3 per cent, while the volume CAGR is 3 per cent.
During the same period, the domestic pharma market clocked 7.7 per cent value CAGR and 1.9 per cent volume CAGR. Leading molecules — Adalimumab, Bevacizumab, Rituximab and Trastuzumab — have seen their market sizes more than double during the period from Rs 243 crore MAT in August 2016 to Rs 551.3 crore in August.
Adalimumab is a rheumatoid arthritis drug, Bevacizumab is used for several types of cancer, Rituximab is used for certain auto-immune diseases as well as some forms of cancer while Trastuzumab is used for breast cancer.
Pankaj Patel, chairman of Cadila Healthcare, which is one of the leading biosimilars players in the country, said, “Patient compliance in biologics drugs has improved in recently with the prices coming within the reach of many. Indian companies have started investing in creating a meaningful pipeline. The Indian market has always seen price elasticity in such segments.” Patient compliance basically means that patients put on these medicines are not dropping off the therapy after sometime, and more compliant towards finishing it. “If one sees the new drug pipeline of major drug firms, it would have a growing list of biologic drugs,” Patel added.
Cadila Healthcare’s biologics pipeline comprises 21 biosimilars and six novel biologic entities (both in development stage as well as launched) and covers therapeutic areas such as oncology, autoimmune disease, nephrology, ophthalmology, inflammation, rheumatology, hepatology and infectious disease, among others. So far, Cadila Healthcare has invested Rs 350 crore in its biologics facility, noted Edelweiss. The company aims to launch two molecules each year, it said. These drugs are expensive and earlier used to see low patient compliance. For example, in 2014, when Cadila Healthcare launched the generic version of innovator AbbVie’s Humira, it priced it at one-fifth of the price of the innovator drug.
Humira cost $1,000 per vial. Cadila Healthcare’s Exemptia is the market leader in the segment in India now followed by Torrent's Adfrar.
A Vaidheesh, vice-president, South Asia and India managing director (MD) of GlaxoSmithKline Pharmaceuticals said India is still a nascent market for biologics, but is growing rapidly. “For the market to mature, there is a need to enhance insurance coverage for patients as these are expensive drugs and even the cheapest generic versions would not cost less than Rs 4,000-5,000 a dose,” he said.
As a part of a global deal, GSK’s cancer molecules had gone to Novartis. Some of GSK’s biologic drugs like Xgeva (used for bone metastasised solid tumours) have clocked 50 per cent value CAGR in India, according to AIOCD.
The biosmilars division head of another Gujarat-based pharma company said the segment had entry barriers as it required significant technical expertise and adequate manufacturing infrastructure.
“However, recently many new players have entered the space through in-licensing partnerships. This has significantly expanded the market,” he added.
Drugmaker Lupin, for example, had licensing agreements with Reliance Life Sciences, Intas and Hetero for biosimilars Bevacizumab, Trastuzumab and Rituximab (cancer drugs).