Market Overview

Digital therapeutics (DTx) refers to “applications used as medical devices to assist in treatment, etc. (including those integrated with measurement devices).” In Japan, two products that had already received approval for the manufacture and sale of medical devices became eligible for health insurance coverage in June 2026. This brought the total number of covered DTx products to five.  

The development of DTx products is primarily conducted by small business ventures in Japan. As of June 2026, approximately 20 companies were still conducting their research and development of DTx products. It was estimated that there were 35 DTx products under research and development. This figure included products developed overseas and introduced by domestic companies. 

The target diseases of the products in development include lifestyle-related diseases, mental and neurological disorders, and cancer.

These products include those grounded on cognitive behavioral therapy, digitized versions of existing therapies, such as diet and exercise therapies, and those that incorporate gaming elements.

Noteworthy Topics

Institutional Development Led Market Participants to Review or Withdraw From DTx Business

As the institutional development of software as a medical device (SaMD) has progressed, such as treating these products as special treatment materials (STMs), covering them by insurance, and approving them in two stages (before and after use in clinical settings), multiple SaMD products have been released. However, as the market structure has become clearer in recent years, market participants have begun to question the viability of their DTx business.

Companies that develop general healthcare apps, which are not intended for medical device approval, have started to suspend or discontinue their DTx businesses.

Raising awareness of DTx itself, which uses apps and other instruments to deliver evidence-based medical treatment to patients, is essential to increasing the market size.  

Future Outlook

Going forward, twenty-four products are expected to be launched by FY2032, (meaning they will be sold with insurance coverage). The development of DTx centered on lifestyle diseases, mental and neurological disorders, and cancers will increase its use in treatment sites.

Research Outline