Japan Digital Therapeutics

U.S. digital health companies have a timely opportunity to enter Japan’s emerging and fast-evolving market for digital therapeutics (DTx). As Japan modernizes its healthcare system, DTx—evidence-based, software-driven treatments focused on behavioral modification—has gained increasing policy and clinical attention. U.S. firms offering proven DTx solutions that improve outcomes, reduce costs, and enhance quality of life are well positioned to help meet Japan’s demand for innovative, scalable care models.

According to leading Japanese market research firm, Yano Research Institute, the number of DTx products is expected to steadily rise, reaching around 40 by 2030. The market size, based on total annual sales to healthcare providers, is projected to expand from several billion yen today to about $230 million (¥35 billion) by 2030. Similarly, IQVIA, a global healthcare data analytics company, forecasts that Japan’s DTx market could grow 8 to 10 times its current size by 2030, assuming improvements in regulations, reimbursement systems, and greater awareness of DTx among doctors and patients.

As of April 2025, five DTx products have been approved in Japan, with two of them covered by national health insurance. While this number remains relatively small compared to the number of approved DTx products globally, many are currently in development by not only pharmaceutical companies and domestic DTx firms, but also healthcare institutions and academia. In addition, pharmaceutical companies are working to bring overseas DTx products to the Japanese market.  On the regulatory front, momentum is building to ease rules for low-risk Software as a Medical Device (SaMD) to help bring products to market faster.

While DTx products are currently used primarily for conditions such as diabetes and smoking cessation, their application is expected to expand to a wider range of conditions, including mental health disorders like depression, anxiety, and ADHD, as well as cardiovascular and respiratory diseases. For U.S. companies delivering innovative DTx solutions that drive cost savings, boost treatment effectiveness, and enhance patients’ quality of life, the Japanese market is a promising gateway with growth opportunities.

Opportunities:

Medical Japan
Dates: October 1-3, 2025 
Venue: Makuhari Messe
https://www.medical-jpn.jp/hub/en-gb.html  

BioJapan
Regenerative Medicine Japan
healthTECH Japan
Dates: October 8-10, 2025 
Venue: Pacifico Yokohama 
https://jcd-expo.jp/en/

WHX Osaka
Dates: June 24-26, 2026
Venue: Intex Osaka
https://japanhealthonline.com/en/

For more information, contact Office.Tokyo@trade.gov or visit our website at https://www.trade.gov/japan.