Why Many Global Drugs Never Reach Japan

This BioWorld article examines Japan’s problem of “drug lag” wherein a significant proportion of drugs approved in the U.S. and Europe are never developed, submitted, or launched in Japan. While historical barriers such as local data requirements and PMDA’s review capacity have eased, uncertainty around evidence expectations, pricing dynamics, and reimbursement timing continues to deter sponsors. The article also underscores that Japan’s access gap is most acute in rare diseases, pediatrics, and novel therapeutic modalities.

For biopharma leaders, the key takeaway is that Japan drug lag should be treated as a system-level market access issue. Addressing it requires integrating Japan earlier into global programs, aligning quantitative evidence strategies with local expectations, and coordinating regulatory and commercial planning to avoid late-stage drug loss.