PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2029868
PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2029868
The global digital biomarkers market is projected to reach USD 17.73 billion by 2031, growing from USD 7.41 billion in 2026 at a CAGR of 19.1%. The digital biomarkers market is being driven by the rapid evolution of data-driven clinical trials and the growing trend of integrating digital health technology into clinical trials.
| Scope of the Report | |
|---|---|
| Years Considered for the Study | 2026-2031 |
| Base Year | 2025 |
| Forecast Period | 2026-2031 |
| Units Considered | Value (USD billion) |
| Segments | Type, Therapeutic Area, Application, and End User |
| Regions covered | North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
Pharmaceutical and biotech companies are increasingly using digital biomarkers in various stages of clinical trials to enable continuous and objective patient monitoring, thus improving data quality and endpoint accuracy. This is a part of a larger trend towards more efficient and patient-centric clinical trials, in which data from real-world sources plays a crucial role in determining the effectiveness of a drug. At the same time, there is a growing trend toward more decentralized clinical trials, in which data is collected more frequently by using remote data collection technology such as wearable devices and sensor technology. This is a part of a larger trend towards more digital biomarker software technology in clinical trials.

"By type, the physiological biomarkers segment is expected to account for the largest market share of the digital biomarkers market during the forecast period."
By type, the physiological biomarkers segment is expected to hold the largest share of the digital biomarkers market during the forecast period. This is mainly due to the widespread use of continuous physiological measures like heart rate, ECG, respiratory rate, and activity levels in various clinical research and patient care settings. Physiological biomarkers are scalable and are well validated, making them more suitable for remote patient monitoring and chronic disease management. In addition, the growing trend of using software platforms and AI-based tools associated with wearable devices is further propelling their adoption, particularly in cardiovascular and metabolic conditions where continuous monitoring is critical in making clinical decisions. This is also evident from published research that states that physiological data streams like heart rate and activity levels are some of the most commonly used digital endpoints in clinical trials, mainly due to their objectivity and ability to provide high-frequency and real-world data. In addition, the move towards decentralized trials and RWE generation is also further solidifying their position in the field of digital biomarkers, as they allow for patient monitoring outside traditional clinical environments.
In June 2025, AliveCor, Inc. (US) partnered with the British Heart Foundation (UK), donating proceeds from its KardiaMobile 6L device to support cardiovascular research and promote the adoption of digital heart rhythm monitoring technologies. These examples further hint at the growing role of physiological digital biomarkers in advancing cardiac care and research.
"By end user, the hospitals & specialty clinics segment is expected to achieve the fastest growth during the forecast period."
By end user, the hospitals & specialty clinics segment is expected to witness the highest growth in the digital biomarkers market over the forecast period. The growth in this segment can be attributed to the rising adoption of digital biomarkers in hospitals and specialty clinics for real-time patient monitoring. Digital biomarkers are being increasingly integrated into the workflows of hospitals and specialty clinics for data-driven decision-making. Hospitals and specialty clinics are adopting wearable-enabled platforms and artificial intelligence-based analytics solutions for continuously monitoring physiological, cognitive, and behavioral changes in patients. Digital biomarkers help hospitals and specialty clinics in continuously monitoring patient data in real-time, thus helping in the early detection of changes in patient health. Moreover, the rising trend of value-based care is fueling the adoption of remote monitoring solutions in hospitals and specialty clinics. The rising prevalence of chronic diseases such as cardiovascular diseases, neurological disorders, and diabetes is also contributing to the growth of the digital biomarkers market in hospitals and specialty clinics. The rising trend of health information technology, which allows for seamless integration of digital biomarker solutions into electronic health records, is also fueling the growth of the digital biomarkers market in hospitals and specialty clinics.
"Asia Pacific to witness the highest growth rate during the forecast period."
The digital biomarkers market in Asia Pacific is growing rapidly, with the region witnessing high growth in the expansion of clinical research activities. The region is witnessing the incorporation of digital technologies into the healthcare infrastructure. Countries such as India, South Korea, Japan, and Australia are gaining importance as hubs for clinical research activities. Due to the improvement in the regulatory environment and the cost advantage, the pharmaceutical and biotech industries are increasingly using the Asia Pacific as a hub for conducting clinical research activities. As the pharmaceutical and biotech industries increasingly rely on digital technologies to conduct clinical research activities, the digital biomarkers market is growing rapidly.
Asia Pacific is witnessing the incorporation of digital technologies into the healthcare infrastructure. The region is witnessing the expansion of clinical research activities. In November 2025, Lunit Inc., a South Korean-based company, announced its collaboration with Labcorp to conduct research using digital pathology technology powered by artificial intelligence and expand access to imaging-based biomarkers for clinical and translational oncology research globally. Such developments indicate the potential of the region as a lucrative market for digital biomarkers.
IXICO PLC (UK), Ametris, LLC (US), and Empatica, Inc. (US) are some of the key players in the digital biomarkers market. The study includes an in-depth competitive analysis of these key players, their company profiles, recent developments, and key market strategies.
This research report categorizes the digital biomarkers market by type (physiological biomarkers, idiosyncratic biomarkers, cognitive biomarkers, vocal biomarkers, and other biomarkers), therapeutic area {cardiovascular [atherosclerotic cardiovascular disease (ASCVD)/secondary prevention, heart failure (HFrEF and HFpEF), hypertension, atrial fibrillation (AF)/stroke prevention, pulmonary hypertension, and structural heart disease/interventional cardiology], oncology (solid tumors, hematologic malignancies), diabetes, mental health & behavioral health, respiratory disorders, lifestyle & wellness improvement, neurology, musculoskeletal disorders/pain management, women's health & reproductive health, and other diseases}, application, [clinical research applications (phase II, phase III, phase IV) and clinical care applications], end user [pharmaceutical and biotechnology companies, contract research organizations (CROs), hospitals and specialty clinics, and others (including research institutes, etc.)] and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa).
The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the digital biomarkers market. A detailed analysis of the key industry players has been done to provide insights into their business overview; solutions and services; contracts, partnerships, agreements, product & service launches, mergers & acquisitions; and recent developments associated with the digital biomarkers market. Competitive analysis of upcoming startups in the digital biomarkers market ecosystem is covered in this report.
The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the digital biomarkers market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and to plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, challenges, and opportunities.