Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies.

Abstract

Emerging biopharma companies are key players in drug development, handling more than half of all clinical trials. Drug loss, a situation in which a drug approved in other countries has not been approved nor has its development been initiated at home, has become an issue in Japan following an increase in new drugs developed by emerging biopharma companies outside Japan. As 80% of these companies are not based in Europe, drug loss may also exist in Europe. In this study, we focused on drugs developed by emerging biopharma companies and examined the state of drug loss in Japan compared to Europe to explore the causes and solutions. Of the 98 new drugs approved in the United States between 2019 and 2023 and filed by emerging biopharma companies, drug-loss products in Japan accounted for 52.0%, which is much higher than that in Europe (19.4%). Regarding involvement in the pivotal study of new drug applications/biologics license applications in the United States, the number of drugs that included Japan in the pivotal study was quite low (16.3%), whereas those that included Europe were 73.4%. Emerging biopharma companies have been more aggressive in drug development in Europe than in Japan because of market attractiveness, language, geographical location, and country-specific regulatory requirements. Since emerging biopharma companies have a different business model from large pharmaceutical companies, taking specific measures to improve the state of drug loss in Japan is necessary.