Regulatory-approved medical apps surge globally

• GlobalData’s report forecasts a 17% compound annual growth rate for the overall market between 2024 and 2034.
• Otsuka Pharmaceutical leads the market with a 16% share of global revenue, while Stryker, Medtronic, and Dexcom are also well positioned as competition intensifies.

Regulatory-approved health apps classified as medical devices are posting strong double-digit growth globally, signaling a shift toward digitally monitored care models, according to GlobalData.

GlobalData’s report forecasts a 17 per cent compound annual growth rate (CAGR) for the overall market between 2024 and 2034. The apps fall into two broad categories: clinical-focused tools for physicians and nurses, and indication-specific apps for conditions such as cancer, depression, IBS, obesity, and Type 1 and Type 2 diabetes. Both segments are growing at double-digit rates.

Otsuka Pharmaceutical leads the market with a 16 per cent share of global revenue, while Stryker, Medtronic, and Dexcom are also well positioned as competition intensifies. “The market’s progress is closely tied to regulatory paths, regional healthcare infrastructure, and digitalisation,” said Thomas Fleming, medical analyst at GlobalData.

North America and Europe currently account for the largest share of demand. The US is expected to sustain North America’s lead on the back of rising adoption, federal initiatives, and strong consumer appetite for digital health tools.

Europe’s growth trajectory remains solid despite a patchwork of national regulations. The Asia-Pacific region is projected to expand rapidly as countries broaden healthcare access and introduce incentives to support regulated app usage.

The market displayed resilience during the COVID-19 pandemic, helping maintain care delivery and support data management. Looking ahead, GlobalData expects continued expansion driven by consumer preference for mobile health solutions and advances in smart device capabilities. As the sector scales, consolidation via mergers and acquisitions is likely alongside efforts to cement long-term market leadership.