The Digital Biomarkers Market is led by North America; growth is anchored by increasing adoption of AI-powered wearable devices, regulatory acceptance of remote endpoints, and pharmaceutical integration of continuous monitoring into trial design.
Hyderabad, Nov. 26, 2025 (GLOBE NEWSWIRE) — Hyderabad, India – November 2025 – According to Mordor Intelligence, the latest reports show that the digital biomarkers market is valued at USD 4.36 billion in 2025 and is projected to surpass USD 10.81 billion by 2030, advancing at a 19.91% CAGR. This growth is supported by rising investment in wearable health technologies, increasing demand for real-time patient monitoring, and the maturation of digital therapeutics. Healthcare providers and biopharma companies are increasingly embracing digital biomarkers to enable better patient stratification, generate richer trial datasets, and support preventative healthcare models. Continuous data streams ranging from heart rate variability to gait dynamics are being used to anticipate disease progression, detect exacerbations, and optimize individualized treatments.
Regional Market Dynamics
North America dominates the digital biomarkers market, powered by its strong technology ecosystem, favorable regulatory landscape, and widespread use of consumer wearables. High adoption of connected health platforms, robust R&D funding, and direct integration with clinical trial operations solidify the region’s leadership.
Asia-Pacific is forecast to be the fastest-growing region over the next several years, driven by growing smartphone penetration, increasing remote care adoption, and supportive digital health regulation in key markets such as China and India. Governments and private players are investing heavily in digital health as a component of health system modernization.
Emerging Key Trends
AI & Machine Learning for Continuous Digital Endpoints:
Complex data from wearable sensors is now being processed via AI to extract digital biomarkers that correlate with clinical outcomes, such as neurological decline, metabolic risk, and cardiovascular stress. These advances reshape both clinical trials and real-world patient management.
Decentralized Clinical Trials (DCT) Adoption:
The shift toward decentralized and hybrid trial models is pushing sponsors to rely more on remote data capture. Digital biomarkers collected from patients in their own environments reduce reliance on site measurements, cut patient burden, and support more continuous, real-world monitoring.
Segmentation Insights
By Component
- Data Collection Tools
- Data Integration & Analytics Platforms
By Data Source:
- Wearables
- Mobile Applications
- Sensors
- Implantables
- Others
By Therapeutic Area
- Cardiovascular & Metabolic Disorders
- Neurological Disorders
- Respiratory Disorders
- Musculoskeletal Disorders
- Others
By Clinical Practice
- Monitoring Digital Biomarkers
- Diagnostic Digital Biomarkers
- Predictive & Prognostic Digital Biomarkers
- Others
By End User:
- Pharmaceutical & Biotech Companies
- Healthcare Providers
- Payers & Employers
- Others
By Geography:
- North America
- Europe
- Asia-Pacific
- Middle East & Africa
- South America
For a full breakdown of market size, segmentation data, and competitive intelligence, access the details of the Mordor Intelligence report:
https://www.mordorintelligence.com/industry-reports/digital-biomarkers-market?utm_source=globenewswire
Competition Outlook
The digital biomarkers market is moderately consolidated and dynamic. Key players include wearable device manufacturers, AI-driven analytics firms, and digital health platforms:
Major Companies in the Digital Biomarkers Include:
- ActiGraph
- Fitbit Health Solutions
- Biogen
- F. Hoffmann-La Roche Ltd.
- Huma
Check out related reports published by Mordor Intelligence:
Neurological Biomarkers Market: The neurological biomarkers market segments the industry into by type (genomic, proteomic, metabolomic, imaging, by application (alzheimers disease, parkinsons disease, multiple sclerosis, autism spectrum disorder), by end-users (hospital & hospital laboratories, independent clinical diagnostic centers, research organizations), and geography (North America, Europe, Asia-Pacific).
Central Lab Market: The central lab market report segments the industry into by services (biomarker services, genetic services, microbiology services, special chemistry services, anatomic pathology/histology, specimen management & storage, other services), end-user (pharmaceutical and biotechnology companies, academic & research institutes, others), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America).
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