According to the article (Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies | Therapeutic Innovation & Regulatory Science (springer.com)) recently published by Dr. Uyama (Associate Executive Director at PMDA), understanding regional drug development strategies is key in the competitive realm of pharmaceuticals, particularly for those looking to navigate the Japanese market. A recent study comparing strategies over a decade (2012–2021) reveals stark differences in how Japanese and foreign companies approach drug development and licensing, shedding light on the “drug lag” issue.
Key Insights:
- Development Approaches: Japanese firms predominantly utilize an “only-Japan” strategy for 51.1% of products, focusing on domestic markets. Foreign firms, conversely, often adopt “Multi-Regional Clinical Trials (MRCT)” strategies for 54.9% of their products, indicating a more global outlook.
- Licensing and Drug Lag: Japanese companies show a preference for original products with minimal drug lag when there’s “no approval in the US and EU” (59.1%). However, the figure for “license-in” products with a drug lag of ≥5 years is 52.5%. This trend is not seen in foreign companies’ products.
- Global Collaboration: The data suggests a pressing need for Japanese firms to engage in global partnerships, especially with emerging foreign companies, to reduce drug lag by considering earlier licensing and adopting global development strategies.
These findings highlight the importance of strategic planning and partnerships in Japan for international business development professionals in the pharmaceutical sector. Embracing a global approach, including engaging in MRCTs and fostering early-stage collaborations, could be key to minimizing drug lag and maximizing market presence.