Key facts
- Over half of drugs approved in the U.S. between 2021 and 2025 have not yet been approved in Japan.
- Japanese patients with cancer and rare diseases are missing treatments available overseas.
- Regulatory and language barriers, along with resource constraints for smaller companies, hinder drug availability in Japan.
- The U.S. approves drugs earlier on average than Japan.
- The IQVIA Institute report analyzed 545 novel active substances approved between 2014 and 2022.
Japanese patients are facing significant delays in accessing new treatments for cancer and rare diseases, with over half of the drugs approved in the U.S. between 2021 and 2025 not yet having received approval in Japan. This gap in availability is a growing concern, impacting patient outcomes and highlighting systemic challenges within the drug approval and accessibility landscape.
The IQVIA Institute's report, "Assessing Availability of New Drugs in Europe, Japan, and the U.S.," analyzed 545 novel active substances (NASs) approved between 2014 and 2022. The findings indicate that while the U.S. leads in the number of approvals and approves drugs earlier on average, Japan faces unique hurdles. Approximately 22% of NASs were approved by the U.S. and EU but not Japan, and 13% were approved only in the U.S.
Smaller pharmaceutical companies, particularly startups that are increasingly driving drug discovery in Europe and the U.S., often lack the necessary resources to navigate the complex regulatory and language requirements for clinical trials in Japan. This resource constraint is a primary driver behind the disparity in drug availability.