Regulatory approved apps, which are classified as medical devices that are part of the digital health segment, are expected to rapidly grow in market value, with GlobalData’s forecasts showing strong double-digit growth up to 2034.
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, irritable bowel syndrome, obesity and type 1 and type 2 diabetes. The adoption of these apps is rising across regions and therapeutic areas, showcasing a strong push towards digitally monitored healthcare for the near future. GlobalData’s Regulatory Approved Apps Market Size by Segments, Share, Regulatory, Reimbursement, and Forecast to 2036 report reveals that both categories are experiencing strong double-digit growth, contributing to an overall projected compound annual growth rate of 17% between 2024 and 2034.
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The market is still in the early stages of growth, and its landscape remains competitive. Otsuka Pharmaceutical currently leads in regulatory approved apps market share with 16% of global revenue, and other significant companies, including Stryker, Medtronic and Dexcom, are well-positioned as the market expands. The market’s progress is closely tied to regulatory paths, regional healthcare infrastructure and digitalisation.
North America and Europe are currently the largest markets for regulatory approved apps. North America, driven largely by the US, is expected to maintain its lead through increasing adoption, increasing federal initiatives, and a 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 digitalisation accelerates and digital health usage increases.
GlobalData forecasts that the use of regulatory approved apps in the Asia-Pacific region will grow rapidly up to 2034. 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.
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By GlobalData
