Japan leads Asia with 24 FDA novel-drug approvals: McKinsey

McKinsey says regulatory fast-track supports global approvals

Data from McKinsey & Company show that between 2015 and 2023, Japan approved a total of 24 new drugs, the largest number of new drugs approved in the Asian market.

McKinsey said Japan’s biopharmaceutical industry spans the entire value chain from discovery to commercialization, enabling the development of market-ready assets for global markets.

The consultancy noted that Japanese pharmaceutical companies have established international franchises in areas such as antibody-drug conjugates and neurodegenerative diseases, strengthening Japan’s role beyond early-stage pipeline contributions.

McKinsey said the regulatory framework supports this positioning, with Sakigake designation from the Ministry of Health, Labor and Welfare streamlining priority drug review and accelerating time to market.

Japan has also introduced a conditional, time-limited approval pathway for regenerative medicine, supporting early clinical applications of cell and gene therapies while maintaining consistency with global regulatory standards.

McKinsey said public funding and internationally oriented talent continue to support Japan’s biopharmaceutical ecosystem, with the Japan Medical Research and Development Agency’s annual budget of approximately US$1 billion covering six research pillars including advanced drug discovery and regenerative medicine.

A quarter of leaders at Japan’s leading pharmaceutical companies have international work experience, cementing the country’s position as Asia’s most globally integrated biopharmaceutical partner, the consultancy added.