Digital Biomarkers Market

The report "Digital Biomarkers Market by Type (Physiological, Vocal, Idiosyncratic), Therapy [Cardio, Onco (Lung, Breast Cancer), Mental Health, Neuro], Application [Clinical Research (Phase IV)], End User (Pharma & Biotech Companies, CROs) – Global Forecast to 2031", is projected to grow from USD 7.41 billion in 2026 and to reach USD 17.73 billion by 2031, at a Compound Annual Growth Rate (CAGR) of 19.1% during the forecast period.

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The digital biomarkers market is being driven by the increasing burden of chronic and multi-system diseases, which is directly reflected in the scale and distribution of clinical trial activity across key therapeutic areas. As of May 2025, there were 22,985 clinical trials actively recruiting patients in the US, with an additional 10,296 trials ongoing but no longer recruiting, highlighting the vast and continuous clinical research landscape. Therapeutically, oncology leads clinical trial activity with 46,144 studies, accounting for 25.0% of total trials, followed by mental health and behavioral disorders (27,947; 15.1%) and nervous system diseases (22,885; 12.4%). Metabolic and endocrine disorders (20,206; 10.9%) and cardiovascular diseases (18,482; 10.0%) also represent significant shares, alongside infectious diseases (8.3%) and respiratory conditions (7.1%). This concentration of trials in chronic and complex disease areas underscores the growing need for continuous, multi-domain patient monitoring, as these conditions often coexist and require high-frequency, real-world data capture. As a result, pharmaceutical and biotechnology companies are increasingly adopting digital biomarkers to support clinical trials, enabling more precise endpoint measurement, improved patient stratification, and enhanced trial efficiency, particularly in studies involving long-term and multi-system disease management.

By application, the clinical research applications segment is expected to achieve significant growth in the digital biomarkers market during the forecast period.

The clinical research applications segment is expected to witness significant growth during the forecast period. This is due to the increasing adoption of software platforms and digital endpoint analytics in the field of clinical trials, which allows for the monitoring of trials in a continuous manner. In fact, it has also been found that about 59% of the total participants had already implemented remote data capture, including the use of digital biomarkers, in their studies, thereby indicating the increasing adoption of the technology in the field of clinical trials. For example, conditions such as cardiology, neurology, endocrinology, and psychiatry are increasingly adopting the technology for the purpose of continuous and real-time data capture in the field of trials, as mentioned in the Digital Medicine Society Library of Digital Endpoints. Furthermore, clinical trial trends show that early-phase trials (Phase I and II) are increasingly incorporating digital biomarkers, reflecting a strong move toward objective, high-frequency endpoint measurement.

By therapeutic area, the cardiovascular segment accounted for the largest share of the digital biomarkers market in 2025.

The dominance of the cardiovascular segment in the market for digital biomarkers is being fueled by the combined effect of the high burden of cardiovascular diseases and the high acceptance of digital monitoring solutions in cardiovascular medicine and research. Cardiovascular diseases cause approximately 17.9 million deaths every year. This accounts for approximately 32% of all deaths globally. This has necessitated the need for constant monitoring solutions. This has contributed to the increased acceptance of digital biomarker software solutions that monitor various physiological activities, such as heart rate, rhythm, and activity, using wearable devices and mobile-based solutions. In addition, cardiovascular diseases are among the top therapeutic areas that have been extensively researched globally. This is because there are thousands of active clinical trials conducted on cardiovascular diseases. The EU Clinical Trials Register currently displays 44393 clinical trials with an EudraCT protocol, of which 7405 are clinical trials conducted with subjects less than 18 years old. In this regard, research published in Nature Communications Medicine in 2026, conducted in 2026, supports this trend, stating “Cardiovascular conditions are one of the leading therapeutic areas for digital endpoints and biomarker-driven evaluation, given the presence of physiological signals such as ECG and heart rate variability. Wearable-based technologies for ECG have demonstrated sensitivity and specificity rates of over 90% for the detection of atrial fibrillation in clinical validation studies, thus emphasizing the accuracy of these technologies in research and real-world settings. Consequently, it is expected that this trend will continue, with cardiovascular conditions being the largest segment in the digital biomarkers market.”

North America accounted for the largest share of the global digital biomarkers market in 2025.

Growth of North America is driven by strong adoption of digital health technologies and a highly advanced clinical research ecosystem. The US plays a central role in this growth due to the increasing use of digital endpoints in clinical trials and rising demand for remote patient monitoring, supported by regulatory encouragement for decentralized and data-driven studies. The region’s leadership is further reinforced by the presence of top healthcare and research institutions with extensive clinical trial activity, including Mayo Clinic (6,438 trials), MD Anderson Cancer Center (6,399), and Massachusetts General Hospital (5,656), along with other major centers such as Memorial Sloan Kettering, Duke University Hospital, and Dana-Farber Cancer Institute, each conducting thousands of trials. This high concentration of clinical research, combined with advancements in sensor technologies, AI, and real-world data analytics, continues to drive the adoption and expansion of digital biomarkers across North America.

Major players operating in the digital biomarkers market are IXICO PLC (UK), Ametris, LLC (US), Empatica, Inc. (US), AliveCor, Inc. (US), CONNEQT Health (US),  VivoSense (US), BioSensics (US),  Lunit, Inc. (South Korea), Akili, Inc. (US), Quibim (Spain), Clario (US), Proscia, Inc. (US), Koneksa Health (US), and Linus Health (US).

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