Korea aiming to become global leader in the biosimilars market by 2020
Government is providing both financial and institutional support
With South Korea introducing a regulatory pathway for manufacturing biologics in 2009, the government is providing both financial and institutional support to help the country emerge as a global leader in the biosimilars market by 2020. The market is expected to come into its own in 2013–2016, when new products and segments will be launched.
New analysis from Frost & Sullivan, Opportunity Analysis for Biosimilars – South Korea, finds that the market earned revenues of US$62.3m in 2011 and estimates this to reach $89.8m 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,’ said Frost & Sullivan Research Analyst Poornima Srinivasan. ‘Moreover, biosimilars’ time-to-market is half that of new drugs, making them attractive investment options.’
However, biosimilars’ requirements of huge upfront investments and infrastructure dissuade potential investors. More important, biosimilars need to prove that their clinical efficacy is as robust as that of 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 pipelines, 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.
Aggressive mergers and acquisitions encourage more pharmaceutical companies to work together to expand their therapeutic products line and bolster their market prospects
High costs associated with biosimilar development will necessitate partnerships with full-service contract research organisation (CRO) providers. Aggressive mergers and acquisitions encourage more pharmaceutical companies to work together to expand their therapeutic products line and bolster their market prospects.
‘Growth will be largely 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 a unique combination of R&D and manufacturing capabilities.’
Meanwhile Canadian generics maker Pharmascience has taken its first tentative steps into the Korean market and plans to launch its Canadian-made medicines there by 2014. Montreal-based Pharmascience has entered into a joint venture with Seoul-based Korea Kolmar Holdings.
David Goodman, CEO, Pharmascience, said that the two firms would put equal amounts of capital into the new Pharmascience Korea joint venture, which will seek Korean regulatory approval to sell bio-equivalent drugs to treat a variety of psychiatric disorders. Financial details of the deal were not disclosed.
The products will come from Pharmascience’s Montreal manufacturing plant, expanded and upgraded at a cost of $40m in 2011. The deal is expected to give the Canadian company significant presence in the Korean market with the local expertise in the partnership termed a key asset. The Korean bioequivalent drug market is ranked the 13th largest in the world while that of Canada is ranked 10th. Management of the new company will be announced shortly.