Dublin, May 13, 2026 (GLOBE NEWSWIRE) — The “Digital Biomarkers Market by Type, Therapy, Application, End User – Global Forecast to 2031” has been added to ResearchAndMarkets.com’s offering.

The global digital biomarkers market is set to reach USD 17.73 billion by 2031, expanding from USD 7.41 billion in 2026 at a CAGR of 19.1%. This growth is driven by advancements in data-driven clinical trials and the integration of digital health technologies. Pharmaceutical and biotech firms are leveraging digital biomarkers for continuous, objective patient monitoring, thereby enhancing data quality and endpoint accuracy.

The shift towards patient-centric clinical trials uses real-world data to assess drug efficacy. Increasingly decentralized trials utilize remote technologies, such as wearable devices, for frequent data collection, signaling a trend towards digital biomarker software in clinical settings.

By Type: Predominance of Physiological Biomarkers

Physiological biomarkers are poised to dominate the market during the forecast period due to their extensive application in measuring continuous physiological parameters like heart rate and activity levels, essential in clinical research and patient care. The incorporation of AI-based tools and wearable technology is propelling their use, notably in cardiovascular and metabolic conditions where ongoing monitoring is vital. Published studies highlight physiological data streams as critical digital endpoints due to their ability to deliver high-frequency data.

The trend towards decentralized trials further cements their position, allowing patient monitoring outside traditional healthcare environments. AliveCor, Inc.’s collaboration with the British Heart Foundation exemplifies the integration of physiological digital biomarkers, fostering advancements in cardiac care.

By End User: Growth in Hospitals and Specialty Clinics

Hospitals and specialty clinics are expected to be the fastest-growing segment, driven by the adoption of digital biomarkers for real-time patient monitoring. These institutions are integrating wearables and AI analytics for continuous physiological, cognitive, and behavioral monitoring, aiding in early disease detection.

As chronic diseases become more prevalent, digital biomarkers enable value-based care models through remote monitoring solutions. Seamless integration with electronic health records further bolsters this trend, enhancing data-driven decision-making and patient management in clinical settings.

Regional Insights: Growth in Asia Pacific

The Asia Pacific region is experiencing rapid growth in the digital biomarkers market, driven by expanding clinical research activities and integration of digital technologies. Countries like India, South Korea, Japan, and Australia are emerging as pivotal hubs for clinical research, offering a favorable regulatory environment and cost advantages.

In November 2025, Lunit Inc. commenced a collaboration with Labcorp to enhance imaging-based biomarkers’ access for oncology research. Such partnerships underscore Asia Pacific’s potential as a lucrative digital biomarker market.

Research Coverage

The report categorizes the digital biomarkers market by type, therapeutic area, application, and end user. It examines key growth drivers, such as the expansion of connected health systems and decentralized trials, while also addressing challenges like data privacy concerns and regulatory hurdles.

Key players include IXICO PLC, Ametris, LLC, and Empatica, Inc. This analysis offers insights into their business strategies, recent developments, and competitive dynamics.

Key Attributes

Report Attribute Details
No. of Pages 402
Forecast Period 2026-2031
Estimated Market Value (USD) in 2026 $7.41 Billion
Forecasted Market Value (USD) by 2031 $17.73 Billion
Compound Annual Growth Rate 19.1%
Regions Covered Global

Market Dynamics

  • Drivers
    • Expansion of Smartphones, Wearables, and Connected Health Ecosystems
    • Expansion of Decentralized and Remote Clinical Trials
    • Rising Prevalence of Chronic Diseases That Require Continuous Monitoring
    • Advancements in AI and Digital Health Analytics
  • Restraints
    • Data Privacy and Cybersecurity Concerns
    • Limited Digital Literacy and Technology Access Among Patients
  • Opportunities
    • Increasing Use in Drug Development and Clinical Trial Endpoints
    • Growth of Precision Medicine and Personalized Healthcare
    • Emerging Applications in Neurological and Mental Health Monitoring
  • Challenges
    • Lack of Standardized Validation Frameworks for Digital Biomarkers
    • Regulatory Uncertainty Around Digital Endpoints and Biomarker Validation

Company Profiles

  • Ixico PLC
  • Ametris, LLC
  • Empatica Inc.
  • Alivecor, Inc.
  • Conneqt Health
  • Vivosense
  • Biosensics
  • Lunit Inc.
  • Akili, Inc.
  • Quibim
  • Clario
  • Proscia Inc.
  • Koneksa Health
  • Linus Health
  • Sonde Health, Inc.
  • Altoida
  • Imvaria Inc.
  • Cumulus Neuroscience Limited
  • Delve Health
  • Feel Therapeutics
  • Nanowear Inc.
  • Exosystems
  • Cardiosignal
  • Imagene AI Ltd.
  • Neurotrack Technologies, Inc.

For more information about this report visit https://www.researchandmarkets.com/r/hjro56

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  • Digital Biomarkers Market

            
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