디지털 바이오마커 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, digital biomarkers market size in 2026 is estimated at USD 5.22 billion, growing from 2025 value of USD 4.36 billion with 2031 projections showing USD 12.77 billion, growing at 19.62% CAGR over 2026-2031.

This report is Segmented by Component (Data Collection Tools and Data Integration & Analytics Platforms), Data Source (Wearables, Implantables, and More), Therapeutic Area (Neurological Disorders and More), Clinical Practice (Monitoring Digital Biomarkers and More), End User (Healthcare Providers and More) and Geography (North America, and More). The Market and Forecasts are Provided in Terms of Value (USD).

Global Digital Biomarkers Market Trends and Insights

Increasing prevalence of chronic & metabolic diseases

Commercial health systems face rising costs from diabetes, obesity, and hypertension. Continuous monitoring fills clinical gaps by spotting deterioration between visits, lowering avoidable admissions, and enabling lifestyle coaching. Six in ten U.S. adults live with a chronic illness, creating healthcare spend above USD 4.1 trillion annually. Dexcom's USD 75 million investment in Oura aligns glucose trends with sleep, exercise, and stress metrics, demonstrating multi-modal metabolic tracking that supports preventive care .

Rapid proliferation of clinical trials adopting sensor-based endpoints

Pharma sponsors now embed digital endpoints to reduce site visits and capture real-world function. EMA qualification of stride velocity in Duchenne studies trimmed recruitment needs by 70% and validated remote gait metrics for rare diseases. Regeneron's internal digital biomarker laboratory and dedicated summit further prove that large sponsors view sensor data as pivotal for trial acceleration within the digital biomarkers market.

Fragmented regulatory pathways across regions

Although the EU Medical Device Regulation seeks harmonization, divergent evidence demands still force sponsors to run extra studies, raising costs . Germany's Digital Health Care Act grants reimbursement for DiGA apps, yet similar frameworks lag in other member states, slowing multinational launches. Japan's historical device-approval lag illustrates how inconsistent timelines limit cross-border scalability in the digital biomarker market.

Other drivers and restraints analyzed in the detailed report include:

1. Accelerated FDA qualification of Software-as-a-Medical-Device solutions
2. Wearable-centric disease prevention programs by payers & employers
3. Cyber-security & patient-consent hurdles for continuous data capture

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Data Collection Tools commanded 65.12% of digital biomarkers market share in 2025 because sensors and gateways remain essential for capturing physiological and behavioral signals. However, Data Integration & Analytics Platforms are growing at a 20.12% CAGR, reflecting a structural shift toward advanced pipelines that clean, fuse, and interpret data for clinical decision support. Study Watch by Verily converts multi-channel raw inputs into validated gait, tremor, and sleep biomarkers, illustrating how software unlocks predictive power for trial sponsors and care teams.

Platform suppliers raise entry barriers through proprietary algorithms and regulatory dossiers. Consolidation is expected as device-centric vendors acquire analytics assets, mirroring the USD 75 million Dexcom-Oura tie-up that links sensor streams with metabolic insights. In this context, data-fusion engines that deliver real-time phenotyping at point of care are projected to capture the bulk of future revenue upside.

Wearables retained 39.44% of the digital biomarker market revenue in 2025 due to wide consumer uptake and near-continuous data capture. The segment still benefits from iterative hardware upgrades such as cuffless blood pressure and noninvasive glucose sensing. Mobile Applications, forecast to rise at 20.2% CAGR, benefit from the 6.8 billion smartphone installed base and zero incremental hardware cost. Vocal biomarkers, valued highly in 2024, show how built-in microphones classify airway obstruction and neurological decline without specialist equipment.

Implantables remain niche yet offer adherence-free sensing for heart failure and epilepsy. Environmental sensors round out contextual markers, and emerging smart textiles leverage conductive fibers to monitor vitals during sleep. As ecosystem builders such as Samsung prepare the Galaxy Ring with noninvasive metabolic monitoring, multi-device orchestration will turn siloed datapoints into unified risk profiles.

Complete Report Scope:

• By Component
  • Data Collection Tools
  • Data Integration & Analytics Platforms
• By Data Source
  • Wearables
  • Implantables
  • Mobile Applications
  • Sensors
  • 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
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America generated 42.88% of digital biomarkers market size in 2025 thanks to FDA leadership, Medicare CPT codes, and widespread broadband. Large integrated delivery networks deploy remote programs that cut readmissions for chronic heart failure, incentivizing further investment. U.S.-based pharmaceutical sponsors dominate trial activity, meaning endpoints validated locally often propagate worldwide.

Asia-Pacific is projected to grow at a 20.41% CAGR through 2031, fueled by Chinese government mandates to embed AI monitoring into primary care and Japan's super-aged society seeking fall prevention and arrhythmia screening. Local manufacturing of sensors lowers device price points, while public-private partnerships roll out regional telehealth hubs. India and Southeast Asia adopt smartphone-based respiratory and metabolic screening to bridge specialist shortages, enabling leapfrog diffusion.

Europe balances strict privacy law with supportive reimbursement. Germany reimburses prescribed apps up to EUR 700 (USD 735) per year, proving commercial pathways, while the wider European Health Data Space aims to harmonize cross-border data use. EMA qualification of digital stride metrics in neuromuscular trials underlines regulatory openness, yet differing country-level evidence standards still slow uniform coverage, keeping platform vendors focused on targeted pilot contracts.

1. ActiGraph
2. Akili Interactive Labs
3. AliveCor
4. Altoida AG
5. Apple (Health & Sensor Platforms)
6. Biogen
7. Dexcom
8. Empatica
9. Evidation Health
10. Fitbit Health Solutions
11. Roche
12. Garmin
13. Huma Therapeutics
14. IXICO PLC
15. Koneksa Health
16. Medtronic
17. Oura Health
18. Koninklijke Philips
19. Samsung Electronics
20. Verily Life Sciences

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing prevalence of chronic & metabolic diseases
  • 4.2.2 Rapid proliferation of clinical trials adopting sensor-based endpoints
  • 4.2.3 Accelerated FDA qualification of Software-as-a-Medical-Device solutions
  • 4.2.4 Wearable-centric disease prevention programs by payers & employers
  • 4.2.5 Generative-AI-enabled multi-modal data fusion for real-time phenotyping
  • 4.2.6 Pharma shift to outcome-based contracts leveraging longitudinal DBx
• 4.3 Market Restraints
  • 4.3.1 Fragmented regulatory pathways across regions
  • 4.3.2 Cyber-security & patient-consent hurdles for continuous data capture
  • 4.3.3 Lack of reimbursement codes for stand-alone digital endpoints
  • 4.3.4 Signal drift & algorithm bias in diverse populations
• 4.4 Technological Outlook
• 4.5 Porters Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Component
  • 5.1.1 Data Collection Tools
  • 5.1.2 Data Integration & Analytics Platforms
• 5.2 By Data Source
  • 5.2.1 Wearables
  • 5.2.2 Implantables
  • 5.2.3 Mobile Applications
  • 5.2.4 Sensors
  • 5.2.5 Others
• 5.3 By Therapeutic Area
  • 5.3.1 Cardiovascular & Metabolic Disorders
  • 5.3.2 Neurological Disorders
  • 5.3.3 Respiratory Disorders
  • 5.3.4 Musculoskeletal Disorders
  • 5.3.5 Others
• 5.4 By Clinical Practice
  • 5.4.1 Monitoring Digital Biomarkers
  • 5.4.2 Diagnostic Digital Biomarkers
  • 5.4.3 Predictive & Prognostic Digital Biomarkers
  • 5.4.4 Others
• 5.5 By End User
  • 5.5.1 Pharmaceutical & Biotech Companies
  • 5.5.2 Healthcare Providers
  • 5.5.3 Payers & Employers
  • 5.5.4 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 ActiGraph LLC
  • 6.3.2 Akili Interactive Labs
  • 6.3.3 AliveCor Inc.
  • 6.3.4 Altoida AG
  • 6.3.5 Apple (Health & Sensor Platforms)
  • 6.3.6 Biogen
  • 6.3.7 Dexcom Inc.
  • 6.3.8 Empatica Inc.
  • 6.3.9 Evidation Health
  • 6.3.10 Fitbit Health Solutions
  • 6.3.11 F. Hoffmann-La Roche Ltd
  • 6.3.12 Garmin Ltd.
  • 6.3.13 Huma Therapeutics
  • 6.3.14 IXICO PLC
  • 6.3.15 Koneksa Health
  • 6.3.16 Medtronic plc
  • 6.3.17 Oura Health
  • 6.3.18 Philips Healthcare
  • 6.3.19 Samsung Electronics
  • 6.3.20 Verily Life Sciences

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment