Digital Biomarkers Market Size, Share, Growth Analysis, By Type(Wearable, Mobile based Applications, Sensors, Others), By Clinical Practice(Diagnostic digital biomarkers, Monitoring digital biomarkers, Predictive and Prognostic digital biomarkers, Others), By Therapeutic Area(Cardiovascular and metabolic disorders (CVMD), Respiratory disorders, Psychiatric disorders, Sleep & Movement Disease), By End-Use(Healthcare companies, Healthcare Providers, Payers, Others (Patient), By Region - Industry Forecast 2025-2032

North America secured the highest digital biomarkers market share in 2023 at 58.4% compared to other markets, leading to increased R&D spending, the presence of major market players, growing acceptance of smart devices, major product launches, and the growing knowledge of the efficacy of digital biomarkers in that region. The market is also expanding due to the growing number of programs encouraging healthcare infrastructure construction. The Digital Biomarker Summit USA, organized in Tarrytown, New York, by the Digital Biomarkers Summit USA event in May 2024, featured and presented key notes and a discussion on the topic: digital biomarkers in clinical trials, bringing instances with wearable technology that provide aspects of AI integration. In addition, digital phenotyping and how this affects observational research was investigated. It has also focused on new innovations and improvements in regulatory preparedness to embrace these cutting-edge endpoint measurement techniques. These are expected to sustain a high requirement of uptake and breadth of digital biomarker in the region. 

However, Europe is the second-largest region to grow significantly during the forecast period. Growing numbers of patients with chronic illnesses, for which real-time monitoring and diagnosis of many diseases are necessary, are driving the European digital biomarkers market. Furthermore, the governments and markets of Europe attribute the greatest importance to the e-Enablement of chronic disease monitoring services and offer solutions that would enable access to medical records, reduce the strain on healthcare resources and facilities, and decrease the number of unnecessary prescriptions and tests. To date, the European Medicines Agency (EMA) currently regulates the European Union's clearance process for medications and medical devices. Although the CDRH clearance for medical devices uses its same old precursor, a new law, the Medical Device Regulation, governs all contemporary medical equipment and subjects it to tougher regulations.