Analysis of digital therapeutics patterns by economic level: evidence from the United States Patents and Trademark Offices and ClinicalTrials.gov

The rapid growth of digital therapeutics (DTx) development is expected to enhance global health access and expand treatment options for broader patient populations. Nevertheless, because high-income countries remain the primary drivers of digital healthcare innovation, global analyses on DTx often overlook patterns in middle- and low-income countries. Without careful consideration to foster balanced growth, innovation gaps and disparities in accessibility may deepen. Accordingly, this study explores DTx development trends across therapeutic areas and technologies in countries with varying economic levels. Specifically, we examined 1672 patents filed with the United States Patent and Trademark Office and 7439 clinical trials registered in ClinicalTrials.gov from 2011 to 2025, analyzing patterns using large language models, network analysis, and the Bass diffusion model. Within these records, developed economies demonstrate broad coverage across therapeutic areas and technologies, positioning themselves as key innovators, whereas less developed economies tend to concentrate on underserved conditions with engagement limited to established technologies. We outline practical strategies tailored to different economic contexts and highlight the importance of international collaboration for the sustainable advancement of DTx to enhance balanced digital health access.