• Capgenus Staff


Conducting meta-analysisfor drug therapies in new markets. 

Japan Market Access – New Drug Entry


CSL Behring

Project Scope

This project elucidated the access process and evidence requirements for the Japanese pharmaceutical market, with a focus on cardiovascular medications and multi-infusion products with in-patient and out-patient administration.

Overarching questions guiding this work were: What is the structure, and what are the components, of the Japanese health care and market access system? What do successful market access and poor market access mean in Japan?


CSL Behring, a global biotechnology leader, is developing a novel apolipoprotein A-I infusion therapy intended to reduce the high incidence of early recurrent cardiovascular events which occur in the weeks to months following a heart attack. Japan is an attractive market and growth opportunity for global pharmaceutical companies. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and the Japan Association for the Advancement of Medical Equipment together function as an equivalent to the Food and Drug Administration (FDA) in the U.S.

Capgenus developed a deep knowledge of the Japanese healthcare and drug approval system.

We delivered a meta-analysis report on the Japanese health care system, the market access environment in Japan, and market access successes and failures among analogous or similar therapies recently launched in Japan supporting CSL Global Health team.

Valued Insight. Customized Solutions.