Summary of Research Findings

Digital therapeutics (DTx) in this research refer to “the applications as medical device used for medical treatment (including those that are unified with measuring device)”. They have been launched in many in the US and Germany. In Japan, two products have been released in the market, of those three products that have been approved for medical equipment production and sales.

Domestic DTx products are chiefly developed by small business ventures. The number of such companies that have initiated research and development for DTx is over 40, as of December 2023, while there are multiple companies trying to introduce overseas DTx products to Japan. The estimated number of domestic DTx products with research and development being commenced is 76 as of November 2023. Top 5 target diseases for these products are diabetes, depression/anxiety disorder, cancer, chronic pain, and heart disease. Other than these, many diseases are being catered to development of DTx products.
Meanwhile, DTx therapies (treatment) with development underway are extensive. In addition to the therapy that bases on cognitive behaviors, there are digitized versions of conventional therapies such as diet and exercise therapies, and those that utilize neurofeedback (provides audio or video feedback after measuring and confirming brain waves real time), those that use unique video games, etc.

Noteworthy Topics

Dozens of DTx Product Launches Expected by Latter Half of 2020s

As of December 2023, there are only two DTx products launched in Japan, but many have their research and development underway. In addition, the systematic enhancement (SaMD [Software as a Medical Device]) has been in place.
Because of the above factors, the number of DTx product launches is projected to count dozens by the latter half of 2020s. Furthermore, as many of those companies developing DTx products also develop non-SaMD services (healthcare service using nonmedical equipment) that have been derived from DTx, such a trend can enter full-scale development.
In 2030s, DTx product launches seem to continue, with many DTx projected to cater to the above-mentioned top 5 diseases starting from diabetes. In association with the increase of product launches, full penetration of DTx to medical institutions and patients is expected.

Research Outline