Summary of Research Findings

Digital therapeutics (DTx) indicate medical apps to be used by the patients to treat a medical disorder or disease. It includes those apps attached to medical measuring instrument as well as some apps for physicians. The DTx market is growing globally, especially in the United States.

In Japan, the development of DTx has started in around 2015. Japan’s first DTx was launched in December 2020, and the second product launched in September 2022. In fact, another product has already applied to obtain marketing approval in December 2022, and there are a total of 30 companies developing DTx domestically as of December 2022. Some companies, mainly pharmaceuticals, show intention of deploying DTx developed by suppliers overseas for Japanese users. Meanwhile, discussion on introduction of regulatory framework for Software as a Medical Device (SaMD) including DTx is underway.

Under the circumstances, the market launch of DTx products is expected to shoot up around 2026, and the penetration of DTx will be in full-scale around 2030.

 

Noteworthy Topics

A Range of Targeting Indication Widens as DTx Companies Expand Their Pipelines

As the number of DTx development multiplied rapidly in the last few years, some DTx companies have begun broadening the scope of their products from lifestyle disease (behavior-modifiable disease) and psychiatric conditions to chronic pain, cardiac disease, dementia/MCI (Mild Cognitive Impairment), and cancer (mainly breast cancer). In addition to the DTx utilizing psychotherapy (cognitive behavioral therapy, etc.), new types of DTx have been developed. Some DTx encourage patients to adhere to a particular diet and/or exercise routine, and others use neurofeedback*.

*Neurofeedback is a therapy that measures a patient’s brainwaves and provides the patient with real-time feedback by audio and/or visual.

Research Outline