Japan’s market for Software as a Medical Device (SaMD) is on track for remarkable growth, expanding from approximately 20 million USD in 2024 to more than 95 million USD in 2033. From 2025 through 2033, the SaMD market is forecasted to grow at a 16.9% CAGR, spurred by the accelerated uptake of digital health services, AI-supported diagnostics, and remote patient monitoring applications.
This momentum within the industry was facilitated by recent innovations by leading Japanese companies. In November 2025, Cyberdyne Inc. launched its AI-driven rehabilitation SaMD platform, which generated personalized exercise programs and monitored patients in real time for musculoskeletal recovery. In October 2025, Hitachi introduced a machine-learning diagnostic solution to support earlier detection of heart abnormalities, which was designed to integrate with existing hospital IT environments. Fujifilm Healthcare commenced pilot testing for a cloud-based radiology service to enable remote imaging analysis and AI-assisted reporting.
The impressive growth of the market is driven by the stronger need for digital health and personalized care as chronic diseases rise and Japan’s elderly population drives interest in technology to facilitate continuous at-home monitoring. Primary regulatory support through the PMDA, including a clearly defined pathway for digital health approval, continues to stimulate product use and commercialization.
By indication, diabetes is still the largest segment, mostly because self-monitoring software for glucose and insulin tracking is already widely used. Mental health and cardiovascular SaMD solutions are developing quickly as well.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.