Regulatory approved apps, classified as medical devices, are a rapidly emerging segment of digital health, having strong double-digit growth. The adoption of these apps is rising across many regions and therapeutic areas, signalling a strong push towards digitally monitored healthcare models, says GlobalData, a leading data and analytics company.

Regulatory approved apps are broadly classified into two categories: clinical-focused apps designed for physicians and nurses; and indication-specific apps aimed at managing conditions such as cancer, depression, IBS, obesity, and Type 1 and Type 2 diabetes.

GlobalData’s report, “Regulatory Approved Apps Market Size by Segments, Share, Regulatory, Reimbursement, and Forecast to 2036,” reveals that both categories are experiencing strong double-digit growth, contributing to an overall projected compound annual growth rate (CAGR) of 17% between 2024 and 2034.

The market is still in the early stages of growth, and the market landscape remains competitive. Otsuka Pharmaceutical Co., Ltd. currently leads in market share with 16% of global revenue, though other significant companies, including Stryker Corp, Medtronic, Inc, and Dexcom Inc, are well positioned as the market expands. 

Thomas Fleming, Medical Analyst at GlobalData, comments: “The market’s progress is closely tied to regulatory paths, regional healthcare infrastructure, and digitalization.”

North America and Europe currently are the largest markets for regulatory approved apps. North America, driven largely by the US, is expected to maintain its lead through rising adoption, rising federal initiatives, and strong consumer preference for digital health tools. Europe’s market is more complex due to varying national regulations, yet growth is expected to remain strong as digitalization accelerates and usage rises.

Fleming continues: “The Asia-Pacific (APAC) region is projected to grow rapidly. Many countries in the region are expanding healthcare access and introducing incentives that support regulatory approved app usage, creating conditions for substantial growth throughout the forecast period.”

The regulatory approved apps market demonstrated resilience during the COVID-19 pandemic, as they remained essential for maintaining healthcare services and facilitating data management.

Fleming concludes: “Looking ahead, the combination of consumer preference for mobile health solutions and continued improvements in smart device capabilities is expected to support sustained market expansion. As competition intensifies, the sector will likely experience consolidation through mergers and acquisitions, alongside continued efforts to establish long-term market leadership.”