New analysis from Frost & Sullivan, Opportunity Analysis for Biosimilars – South Korea says that, with South Korea introducing a regulatory pathway for manufacturing biologics in 2009, the Government has raised its stakes in the biosimilars market.
It is providing both financial and institutional support to help the market emerge as a global leader by 2020. The market is expected to come into its own in 2013-2016, when new products and segments will be launched.
The new market analysis finds that the market earned revenues of $62.3 million in 2011 and estimates this to reach $89.8 million in 2017, with erythropoietin expected to be the biggest revenue generator.
The South Korean Government considers biosimilars drug development significantly cheaper than new drug development,” saidFrost & Sullivan Research Analyst Poornima Srinivasan . “Moreover, biosimilars’ time-to-market is half of new drugs’, making them attractive investment options.”
However, biosimilars’ requirements of huge upfront investments and infrastructure dissuade potential investors. More importantly, biosimilars need to prove that their clinical efficacy is as robust as biologic innovator drugs’. Currently, physicians and doctors are reluctant to prescribe biosimilars because they may not be as familiar with the biosimilar developer’s capabilities and expertise, as they are with the credentials of innovator drug manufacturing companies.
Further, by 2020, the market will be facing a familiar challenge of dwindling pipeline, as newer and more complex originator molecules need to be identified as target markets. With many domestic companies attempting to establish a foothold, the biosimilars market will also witness changing business models.
High costs associated with biosimilar development will necessitate partnerships with full-service contract research organization (CRO) providers. Aggressive merger and acquisitions encourage more pharmaceuticals to work together to expand their therapeutic products line and bolster their market prospects.
Growth will be largely fueled fuelled by numerous patent expiries of original biologics between 2011 and 2019,” noted Srinivasan. “The market will also get a boost from the increasing adaptability and ability of large pharmaceutical companies to make the most of opportunities, primarily by focusing on an unique combination of R&D and manufacturing capabilities.”
Source: Frost&Sullivan press release