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Digital Biomarkers Market to Reach ~USD 26.8 Billion by 2035, Driven by Wearables, AI, and Personalized Medicine
Digital Biomarkers Market to Reach ~USD 26.8 Billion by 2035, Driven by Wearables, AI, and Personalized Medicine
The global Digital Biomarkers Market is projected to grow from USD 3.0 billion in 2025 to ~USD 26.8 billion by 2035, at a CAGR of 24.5%. Growth is fueled by the rapid integration of wearables, sensors, and mobile apps into clinical research and remote patient monitoring, alongside pharma's increasing use of AI-enabled endpoints to personalize therapy and accelerate trials.
MarketGenics identifies North America as the most attractive region, with robust infrastructure, strong regulatory engagement, and high innovation velocity.
Get the Detailed Industry Analysis (including the Table of Contents, List of Figures, and List of Tables) - from the Digital Biomarkers Market Research Report: https://marketgenics.co/press-releases/digital-biomarkers-market-78664
Recent Developments Shaping the Market
Parkinson's Disease Programs Accelerate Digital Endpoints
June 2025: Rune Labs and the Parkinson's Foundation launched a clinical program to correlate genetic and digital biomarkers with daily symptomology in Parkinson's.
November 2024: Neuron23 incorporated Roche's digital biomarker and device into a Parkinson's clinical trial, underscoring big-pharma confidence in digital readouts.
Clinical-Grade Wearables Gain Validation
February 2025: Oura Health and UC San Diego partnered to validate sleep/activity-based biomarkers for early metabolic disorder detection via the Oura Ring-strengthening the case for research-grade wearables.
Pharma Expands Real-World, Tech-Driven Insights
April 2024: Evidation Health and Eli Lilly used wearable-derived biomarkers to detect early cognitive decline in Alzheimer's.
March 2024: Biogen applied smartphone-based gait as a digital biomarker in multiple sclerosis trials.
Market Outlook to 2035
The market is set to create an incremental opportunity of USD 30.5 billion through 2035 as digital biomarkers move from pilots to scaled, regulated endpoints across neurology, cardiometabolic disease, oncology, and immunology.
Expect deeper ties between clinical trials, decentralized patient monitoring, and personalized medicine-with validated endpoints increasingly embedded in pivotal studies and post-market evidence programs.
To know more about the Digital Biomarkers Market - Download our Sample Report: https://marketgenics.co/download-report-sample/digital-biomarkers-market-78664
Key Drivers, Challenges, and Opportunities
Driver - Rising Neurological & Cardiovascular Burden
Continuous, unobtrusive monitoring supports early diagnosis and long-term management.
February 2024: MindMaze released a platform using digital biomarkers to assess cognitive and motor function in stroke and Parkinson's, enabling earlier interventions and cost savings.
Restraint - Regulatory Standardization & Validation Gaps
Fragmented requirements slow approvals and cross-border scaling.
January 2024: Verily's Onduo faced EU MDR scrutiny, requiring additional validation despite strong U.S. performance-illustrating regulatory heterogeneity and extended timelines.
Opportunity - Digital Therapeutics (DTx) Integration
Embedding biomarkers into DTx enables personalized, responsive interventions.
March 2024: Akili Interactive enhanced EndeavorRx for pediatric ADHD with eye-tracking and latency biomarkers to optimize engagement and adherence.
Key Trend - Smartphone-Based Biomarker Platforms
Smartphones deliver at-scale, low-cost data capture.
April 2024: Koneksa Health advanced mobile biomarkers (voice, facial expression, touchscreen signals) for remote mental-health trials, broadening participation and reducing hardware friction.
Segmental Insights
Data Collection Tools Lead (~68% Share)
Wearables, sensors, and mobile apps remain the backbone for real-time physiological/behavioral data, essential for DCTs (decentralized clinical trials) and home-based monitoring.
May 2024: Empatica launched EmbracePlus (FDA-approved) for respiratory and cardiovascular biomarker collection-signaling demand for validated capture devices.
Platforms & Analytics
Data integration and analytics platforms transform raw signals into regulatory-grade endpoints, supporting signal detection, quality control, and AI-assisted interpretation across therapeutic areas.
Buy Now: https://marketgenics.co/buy/digital-biomarkers-market-78664
Regional Highlights
North America:
Dominant today and beyond, with strong regulatory engagement, clinical networks, and tech-pharma collaboration.
March 2024: FDA Breakthrough Device designation to NeuroRPM for an AI-powered wearable tracking Parkinson's symptoms in real time-an example of regulator-supported innovation.
Europe & Asia Pacific:
Europe advances on RWE frameworks and public-health initiatives; Asia Pacific scales rapidly via mobile health adoption and large patient bases in chronic disease programs.
Competitive Landscape
The market is fairly consolidated; top 5 hold >39% share (2025).
Key players: Fitbit (Google), Apple, AliveCor, Evidation Health, Empatica, and other innovators spanning wearables, endpoints, and analytics.
Tier-1 ecosystems (Apple, Alphabet/Verily, Philips) anchor validated devices and data stacks; Tier-2/3 specialists (e.g., Koneksa, Mindstrong) advance neuro/behavioral biomarkers.
Notable Moves (2025):
VivoSense × argenx: presented an end-to-end digital endpoint implementation model improving trial efficiency and data completeness.
ElectronRx: launched purpleDx (Jan 2025), a clinician app for remote cardiac and pulmonary biomarker evaluation via smartphone.
Get a preview of our Digital Biomarkers Market Playbook - your guide to GTM strategy, competitive intelligence, supplier dynamics, and Consumer Behavior Analysis: https://marketgenics.co/playbook/digital-biomarkers-market-78664
Future Outlook
By 2035, digital biomarkers will be standard across R&D and care pathways, enabling:
Adaptive trials with continuous endpoint capture
Always-on pharmacovigilance and symptom management
DTx-linked, closed-loop therapies with real-time feedback
Interoperable evidence pipelines spanning wearables, EHRs, and patient-reported outcomes
Expect tighter AI validation, privacy-by-design, and global standardization to unlock scale while preserving trust.
About Us
MarketGenics is a global market research and management consulting company empowering decision makers across healthcare, technology, and policy domains. Our mission is to deliver granular market intelligence combined with strategic foresight to accelerate sustainable growth.
We support clients across strategy development, product innovation, healthcare infrastructure, and digital transformation.
Contact:
Mr. Debashish Roy
MarketGenics India Pvt. Ltd.
800 N King Street, Suite 304 #4208, Wilmington, DE 19801, United States
USA: +1 (302) 303-2617
Email: sales@marketgenics.co
Website: https://marketgenics.co
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