London, 20th March 2012. The expiration of patents and other intellectual property rights of biological innovators over the next decade opens the opportunity for biosimilars to enter the market and increase industry competition. However, biosimilars manufacturers require heavy investments, which are a major barrier for market entrants.
Biosimilars are legally approved subsequent versions of innovator biopharmaceutical products following patent and exclusivity expiry. However, the definition of biosimilars differs among the various regulatory agencies across the world.
The biosimilars market is in the nascent stage of the industry life cycle, and market experience is limited. “Improvements concerning the manufacturing and the clinical development processes of biosimilars have to take place,” explains Srinivas Sashidhar, Research Analyst at Frost & Sullivan. “Additionally, $100 billion worth biologics are expected to go off patent by 2020, as a result of which the market is likely to hold significant potential.”
Europe is one of the largest biosimilars market in the world. The data exclusivity for biosimilar manufacturers is around 11 years, comprising 10 years for new biologics and a one-year extension for a new indication. The European biosimilars market will continue to grow from roughly $172.0 million in 2010 to $3,987.0 in 2017 at a CAGR of 56.7%.
While the emergence of new market participants in Europe, the reduction in medical expenditure and upcoming patent expiry will drive the biosimilars market, there are also challenges to be faced, such as the interchangeability and biosimilar substitution and high manufacturing costs.
The biosimilars market is in its nascent stage of the industry life cycle with limited market and product development experience. “Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected,” concludes Srinivas Sashidhar. “The strong integration of marketing and research and development skills is the key to success in the biosimilars market.”
Frost & Sullivan has recently organised an on-demand web-conference entitled “Biosimilars in Europe: The Road Ahead”. The web-conference summarises Mr. Sashidhar’s findings, giving a brief analysis of the opportunities and dynamics of the biosimilars market in Europe.
Biosimilars is an interdisciplinary market. The growth of biosimilars market will help the growth of other pharmaceutical markets such as oncology, diabetes, etc. This web-conference will benefit pharmaceutical and biotech companies, pharmacists, doctors and regulatory authorities.
To receive a presentation of the web-conference and a link to the recording, please send an email to Janique Morvan, Corporate Communications, at email@example.com, with your full contact details.
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