Development and Trends of Digital Therapeutics Industry in China: a Multidimensional Analysis Based on Approved Products by China's National Medical Products Administration
摘要
Background Digital Therapeutics (DTx), as an innovative digital interventional method, is internationally regarded as a prescription "digital drug" with significant potential in chronic disease management and mental health. China's "Healthy China 2030" strategy supports healthcare digital transformation. However, there's a lack of systematic analysis on DTx products approved by China's National Medical Products Administration (NMPA). Also, there are challenges such as an imperfect regulatory framework and insufficient clinical evidence. Objective Conduct a systematic analysis of the characteristics of DTx products approved by the NMPA, systematically review approval trends, indication distribution, and industrial landscape, to provide evidence for regulatory policy optimization and industrial development. Methods Research data were primarily sourced from eight medical device databases of the NMPA. Using independent keyword searches, a total of 20 107 candidate devices were generated. After screening, 235 devices meeting the definition of DTx were identified. Seventeen product features were extracted, and statistical analysis was performed using SPSS 25.0 software. Results As of December 2024, NMPA had approved 235 devices that meet the definition of DTx. The number of approvals had increased yearly since 2018, with a significant increasing in 2022. Most were domestically produced (n=227, 96.60%) and approved (n=219, 93.19%) by local medical products administrations. The majority were Class Ⅱ medical devices (n=224, 95.32%), with core functions mostly focused on disease treatment (n=207, 88.09%), widely used for nervous system diseases (n=108, 45.96%). Nearly all require prescriptions (n=227, 96.60%) and often used guided behavioral intervention techniques (n=135, 57.45%). Digital technologies mainly involved online medical services (n=145, 61.70%) and primarily targeted the adult population (n=163, 69.36%). Manufacturers were mostl