Digital Biomarkers Market Size, Share, Growth, Trends, and Global Industry Analysis: By Product Type (Wearable Devices, Mobile Health Applications, Remote Patient Monitoring, and Telehealth Solution), By Biomarkers Type (Cognitive Biomarkers, Idiosyncratic Biomarkers, Physiological Biomarkers, Vocal Biomarkers, and Other Biomarkers), By Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Diseases, Mental Health Disorders, Neurological Disorders, Respiratory Disorders, Substance Abuse Disorders, and Others), By Purpose of Solution (Diagnosis, Early Detection, Monitoring, and Predictive Insights), By End User (Healthcare Providers, Pharmaceutical Companies, Research Organizations, and Insurance Companies), and Region Forecast 2020-2031

Digital Biomarkers Market size was valued at US$ 5,730.5 million in 2024 and is expected to reach US$ 16,590.6 million by 2031, growing at a significant CAGR of 16.4% from 2025-2031. Moreover, the U.S. Digital Biomarkers Market is projected to grow significantly, reaching an estimated value of US$ 5,176.3 Million by 2031.

The market focuses on the development, validation, and commercialization of digitally collected biological data that provides measurable indicators of health, disease progression, or treatment response. The market is driven by the growing prevalence of cancer and chronic diseases, which demand more precise diagnostic and monitoring tools. Digital biomarkers offer real-time insights into a patient’s molecular and physiological profile, aiding in early diagnosis, personalized treatment, and clinical trial monitoring.

Their utility in tracking disease progression and tailoring therapy has positioned them as essential tools in modern healthcare. A strong push also comes from the surge in clinical trials and the need for continuous data tracking to ensure the efficacy and safety of new treatments. A key trend is the integration of AI and machine learning with wearables and mobile sensors, enabling real-time data interpretation for conditions like cardiovascular, neurological, and mental health disorders. The market is also seeing increased adoption in virtual clinical trials, remote monitoring, and predictive analytics.

Opportunities are rising with decentralized clinical trials and growing demand for remote patient monitoring. The shift towards personalized, home-based care models and the acceptance of digital endpoints by regulatory bodies are accelerating this growth. However, data privacy concerns remain a significant restraint. Lack of standardized data protocols and risks of unauthorized data usage challenge widespread adoption. High development costs and regulatory complexities also pose barriers to seamless implementation.

Facts & Figures

• Rising Chronic & Cancer Disease Burden: Wearables and implants are increasingly used to track disease progression in chronic conditions and cancer. At CES 2025, identifyHer unveiled Peri, a wearable focused on perimenopause symptom tracking, signaling growing consumer demand for continuous health insights beyond traditional fertility apps.
• AI-Powered Health Monitoring: Breakthroughs in AI-integrated devices are accelerating biomarker adoption. Withings’ Omnia smart mirror debuted at CES 2025, uses AI to monitor heart metrics, directly in the home, reflecting the industry shift to non-invasive, real-time health diagnostics.
• Regulatory & Clinical Acceptance: The Academic research is validating new digital biomarkers. In February 2025, an arXiv study showed AI-derived vascular age from wearable PPG strongly predicts cardiovascular events, enhancing credibility for clinical use and prompting regulatory attention.
• Remote Patient Monitoring & Decentralized Trials: The FDA is increasingly supporting remote digital health endpoints. Empatica in 2025 received FDA clearances for pulse and respiratory digital biomarkers, expanding the use of such tools in clinical trials and telehealth settings.

Key Developments:

• In February 2025, The ValueCare Group unveiled MICA, a wrist-worn AI platform enabling voice-based health logging and reminders. Approved for NHS trials, it supports real-time remote monitoring and proactive elderly care.
• In January 2025, ElectronRx introduced purpleDx, a regulated cardiac evaluation app enabling home-based tracking of lung function and cardiac biomarkers. Physicians can now remotely customize care plans using real-time insights collected directly from patient smartphones.
• In January 2025, Quibim secured $50 million to scale its advanced imaging biomarker technology (like QP-Brain/Prostate) and accelerate its global expansion. The investment aims to enhance AI-driven diagnostics in oncology and other therapeutic areas.
• In September 2024, the FDA endorsed the use of the αSyn?SAA digital biomarker for early detection of Parkinson’s and related neurodegenerative disorders, paving the way for trial incorporation and future commercial leverage.

Digital Biomarkers Market Segmentation:

Based on the type of product:

• Wearable Devices
• Mobile Health Applications
• Remote Patient Monitoring
• Telehealth Solution

Wearable Devices dominate the global digital biomarker market in terms of market share, primarily due to their widespread adoption for continuous health monitoring. These devices, such as smartwatches and fitness bands, offer real-time tracking of physiological metrics like heart rate, sleep patterns, and activity levels, making them highly valuable in both preventive healthcare and chronic disease management. Their integration with AI and mobile apps further enhances their utility. Remote Patient Monitoring and Mobile Health Applications also contribute significantly, but lag behind Wearables. Telehealth Solutions hold the lowest market share, as they primarily facilitate consultations rather than actively capturing biometric data.

Based on the type of biomarker:

• Cognitive Biomarkers
• Idiosyncratic Biomarkers 
• Physiological Biomarkers
• Vocal Biomarkers
• Other Biomarkers

Physiological Biomarkers hold the highest market share in the digital biomarker market due to their ability to provide continuous, objective, and quantifiable health data such as heart rate, respiration, and glucose levels. These biomarkers are easily captured through wearable devices and integrated into health monitoring platforms, making them widely used in chronic disease management, fitness tracking, and remote patient monitoring. Their clinical relevance and widespread applicability across therapeutic areas contribute to their dominance. In contrast, Vocal and Idiosyncratic Biomarkers currently hold lower market shares due to limited validation, niche use cases, and less integration into mainstream digital health technologies.

Based on the therapeutic area:

• Autoimmune Disorders
• Cardiovascular Disorders
• Infectious Diseases
• Mental Health Disorders
• Neurological Disorders
• Respiratory Disorders
• Substance Abuse Disorders
• Others

Neurological Disorders account for the highest market share in the digital biomarker market, primarily due to the growing prevalence of conditions like Alzheimer's, Parkinson's, and Multiple Sclerosis. Digital biomarkers are increasingly used for early detection, symptom monitoring, and treatment assessment in these disorders, using tools like gait analysis, cognitive performance tracking, and wearable sensors. The demand for non-invasive, real-time monitoring in neurology has accelerated their adoption.   On the other hand, Substance Abuse Disorders currently represent a lower market share due to limited digital biomarker development and challenges in continuous behavioral tracking and validation in clinical settings.

Based on the purpose of solution:

• Diagnosis
• Early Detection
• Monitoring
• Predictive Insights

Monitoring holds the largest market share in the digital biomarker market, which is driven by the rising adoption of wearable devices and remote patient monitoring systems that enable continuous, real-time tracking of health parameters, especially for chronic conditions like cardiovascular and neurological disorders. Monitoring helps manage disease progression and treatment effectiveness efficiently. In contrast, Predictive Insights represents a smaller share due to the complexity of algorithms required and regulatory challenges in validating predictive accuracy across diverse populations.

Based on the end user:

• Healthcare Providers
• Pharmaceutical Companies
• Research Organizations
• Insurance Companies

Based on the end user, Healthcare Providers hold the largest market share in the digital biomarker market. Their role in diagnosis, treatment, and continuous patient monitoring drives high adoption of digital biomarker technologies such as wearables and remote monitoring tools. These solutions enhance clinical decision-making and improve patient outcomes.

In contrast, Insurance Companies hold the lowest market share due to limited integration of digital biomarkers into underwriting and claims processes, though interest is gradually increasing with the rise of personalized healthcare.