KEY POINTSYano Research estimates 35 digital therapeutics products are under development in Japan as of June 2026Japan expands insurance coverage to five approved DTx products after adding two in June 2026Yano Research projects 24 reimbursed DTx products will reach the market by fiscal 2032
A Yano Research Institute chart projects the number of digital therapeutics products by 2032. Note: Japanese text in the original image from press release has been translated into English by our editorial team.
Yano Research Institute
Yano Research Institute said on August 6 that 35 digital therapeutics, or DTx, products were under research and development in Japan as of June 2026, highlighting a still-nascent market where insurance coverage has begun to widen.
The Tokyo-based research firm estimated that about 20 companies were continuing DTx research and development in Japan as of June, with startups accounting for the core of domestic product development. Its estimate of 35 products includes cases in which Japanese companies introduced products developed by overseas firms.
DTx refers to application-based medical devices used to support treatment, including products integrated with measurement devices. Smartphone-based applications account for the main format, while applications for XR technologies such as virtual reality and augmented reality are also included in the definition.
In Japan, two products that had already obtained marketing approval as medical devices became newly eligible for public health insurance coverage in June 2026, bringing the total number of reimbursed DTx products to five, the company said. Under Japan’s universal health insurance system, reimbursement is generally seen as a key factor in whether approved medical products are broadly used in routine clinical practice.
The main disease areas under development are lifestyle-related diseases, psychiatric and neurological disorders, and cancer. Developers are also working on products based on cognitive behavioral therapy as well as digital versions of conventional therapies such as dietary and exercise treatment, alongside products incorporating game elements.
Yano Research projected that launches of new products would continue through fiscal 2032, with 24 products expected to be on the market with insurance coverage by that year.
The research firm also pointed to changes in the competitive landscape as Japan refines rules for software-based medical devices. Progress in institutional frameworks, including reimbursement under the category for designated medical materials and a two-stage approval system for program medical devices, has helped multiple products reach the market.
At the same time, some companies that had entered the field are reassessing whether to continue DTx operations. In particular, the firm noted cases in which companies focused on general healthcare applications that do not seek medical-device approval had suspended or terminated DTx businesses.
The survey was conducted from April to June 2026 and covered companies participating in the DTx market, using direct interviews including online meetings and desk research. Japan has been developing a regulatory framework for software as a medical device as digital health products move from wellness applications toward approved treatments.
Yano Research said broader recognition of DTx itself as a treatment tool would be essential for market expansion.