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

Regulatory fast-track supports global approvals, McKinsey says

Japan recorded 24 US Food and Drug Administration novel-drug approvals between 2015 and 2023, the highest total among Asian markets, according to McKinsey & Company.

Japan’s biopharma sector operates across the full value chain, from discovery through commercialisation, enabling the development of launch-ready assets for global markets, according to McKinsey.

The consultancy noted that Japanese pharmaceutical companies have built international franchises in areas such as antibody-drug conjugates and neurodegenerative disease, reinforcing Japan’s role beyond early-stage pipeline contribution.

Regulatory frameworks underpin this positioning, with the Ministry of Health, Labour, and Welfare’s Sakigake designation streamlining priority drug reviews and accelerating time to market, McKinsey said.

Japan has also introduced a conditional, time-limited approval pathway for regenerative medicine, supporting earlier clinical application of cell and gene therapies whilst remaining aligned with global regulatory standards.

Public funding and internationally oriented talent continue to support Japan’s biopharma ecosystem, with the Japan Agency for Medical Research and Development operating on an annual budget of about US$1b across six research pillars, including advanced drug discovery and regenerative medicine, according to McKinsey.

The consultancy added that one in four leaders at Japan’s leading pharmaceutical companies has international work experience, strengthening the country’s position as Asia’s most globally integrated biopharma partner.