Strengthening the Competitiveness of Japan's Pharmaceutical Industry: Analysis of Country Differences in the Origin of New Drugs and Japan's Highly Productive Firm.

Abstract

Improving the new drug discovery and development capability of the Japanese pharmaceutical industry, which shows a huge trade deficit, is an urgent issue. To tackle this issue and propose remedies, this study analyzed the originators and characteristics of new drugs approved by the Food and Drug Administration (FDA) from 2017 to 2022 and examined the contributions of Japanese companies. Analysis of the establishment year of the companies that created the approved drugs showed that bio-ventures established in the 1990s and 2000s highly contributed to the creation of the approved drugs in regions other than Japan (particularly in the US), whereas, in Japan, all approved drugs were created by old incumbent pharmaceutical companies. This suggests the presence of an urgent need in Japan to foster start-ups that link scientific discoveries and technologies in academia to drug discovery. The novelty of approved drugs measured by the ratio of first-in-class, orphan drug, and recent drug modalities did not differ between Japan and other countries, suggesting that Japanese pharmaceutical companies follow the technological trends of new drugs. A case analysis of Kyowa Kirin, the Japanese company that created the largest number of the drugs approved by the FDA from 2017 to 2022 among Japanese companies, suggests that focused investment in modality technology development, strengthening collaboration with academia in biology, and the reutilization of small-molecule drug discovery capabilities are important for improving drug discovery productivity.