Market Share of Biosimilars in Japan and Other Countries

Abstract

Advances in biotechnology led to a variety of commercially available biologics with reported clinical efficacy. Many biosimilars have been developed and some are currently on the market in the EU, Japan and the US after the expiration of market exclusive rights of original innovator biologics. The market share of biosimilars is growing steadily year by year, representing global and Japanese biosimilars market at 1.6 billion dollars and 18.4 billion yen, respectively, in 2016. Moreover, the market share of biosimilars is expected to expand further in the future. As a result of calculating market shares of five biosimilars in Japan based on the unit sales of innovators and biosimilars, they are 4.2%–90.2%. It was revealed that the market shares are greatly different with each product. Various factors derived from each product and its clinical usage, such as the product property, its market environment, physician’s treatment decisions and policies, may influence the biosimilar penetration. So, some efforts including new government policymaking toward the further penetration of biosimilars in Japan should be considered from a variety of perspectives. The Japanese Government issued a basic policy on economic and fiscal management and reform 2017 where necessary governmental support to enhance R&D capability for originating innovative biologics as well as biosimilars in Japan was noted. It is expected that such support leads both the further penetration of biosimilars and accelerating the development of the biopharmaceutical industry in Japan in the future.