The demand for digital biomarkers is rising rapidly, driven primarily by the global increase in chronic diseases, including cardiovascular, neurological, and metabolic disorders. This growth is further supported by the expanding elderly population, which is more vulnerable to age-related health conditions. Additionally, the widespread adoption of wearable technologies, along with ongoing innovation and frequent new product launches by key industry players, is accelerating the market’s expansion.
DelveInsight’s Digital Biomarkers Market Insights report provides the current and forecast market analysis, individual leading digital biomarkers companies’ market shares, challenges, digital biomarkers market drivers, barriers, trends, and key market digital biomarkers companies in the market.
Key Takeaways from the Digital Biomarkers Market Report
- As per DelveInsight estimates, North America is anticipated to dominate the global digital biomarkers market during the forecast period.
- In the biomarker type segment of the digital biomarkers market, the physiological biomarkers category accounted for the largest market share in 2024.
- Notable digital biomarkers companies such as BioSensics, AliveCor, Inc., Eyenuk, Inc., Quibim, Huma, Evidation Health, Inc., Oura Health Oy, Biobeat, Omada Health Inc., F. Hoffmann-La Roche Ltd., Koneksa Health, Altoida, Empatica Inc., VivoSense, IXICO plc, Proscia Inc., Agenus Inc., Lunit, BostonGene Corporation, PathAI, Inc., and several others, are currently operating in the digital biomarkers market.
- In June 2025, Agenus and Noetik announced a collaboration to develop AI-enabled predictive biomarkers for BOT/BAL using foundation models of virtual cell biology. This partnership aims to advance precision immunotherapy by using AI-driven virtual cell models to identify patients most likely to benefit from BOT/BAL treatment.
- In March 2025, Lunit announced a collaboration with the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), to explore innovative AI applications in cancer research. The partnership focuses on developing AI-driven digital biomarkers for tumor microenvironment analysis and immune phenotyping, aiming to uncover insights from NCI data that could advance personalized cancer care.
- In March 2025, BostonGene announced a collaboration to evaluate biomarkers for colorectal cancer and multiple myeloma using AI-driven molecular profiling in clinical trials. This initiative aims to enhance cancer treatment strategies by leveraging advanced AI technologies to identify clinically relevant biomarkers.
Read more about the latest insights in the digital biomarkers market with a snapshot of key highlights from the @ Global Digital Biomarkers Market Report
Digital Biomarkers Overview
Digital biomarkers are quantifiable physiological and behavioral data collected through digital devices such as wearables, smartphones, and biosensors. Unlike traditional biomarkers, which are typically measured via laboratory tests or imaging, digital biomarkers are gathered continuously and remotely, enabling real-time monitoring of health status, disease progression, and treatment response. Examples include metrics such as heart rate variability, sleep patterns, gait speed, voice tone, and even typing speed. The proliferation of connected devices and AI-driven analytics has facilitated large-scale data collection, providing deeper insights into patients’ daily lives outside clinical settings.
The growing adoption of digital biomarkers is transforming clinical trials, personalized medicine, and chronic disease management. Pharmaceutical and medtech companies are increasingly incorporating digital endpoints into trials to improve patient stratification, monitor adherence, and generate meaningful real-world evidence. In chronic conditions like Parkinson’s disease, diabetes, and mental health disorders, digital biomarkers enable early detection of symptom changes and support timely interventions.
Digital Biomarkers Market Insights
North America is projected to hold the largest share of the digital biomarkers market in 2024, driven by several key factors. High prevalence of chronic conditions, including cardiovascular diseases, neurological disorders, and diabetes, coupled with an aging population, is a primary driver. The widespread adoption of wearable technologies, continuous product innovation, and regulatory approvals by major industry players further accelerate market growth. Collectively, these factors reinforce North America’s leading position in the global digital biomarkers market.
Learn why North America is driving growth in the digital biomarkers market with a snapshot of the @ Digital Biomarkers Market Outlook
Digital Biomarkers Market Dynamics
The digital biomarkers market is witnessing rapid expansion, driven by the widespread adoption of wearable technologies and connected health devices that continuously capture physiological and behavioral data. These devices enable real-time monitoring of health metrics such as heart rate, glucose levels, sleep patterns, and activity levels, providing critical insights for disease prevention, diagnosis, and management. With the global rise in chronic diseases and increased emphasis on preventive healthcare, digital biomarkers are becoming an essential component of personalized medicine and remote patient monitoring.
Pharmaceutical and biotechnology companies are increasingly integrating digital biomarkers into clinical trials to improve patient stratification, track treatment adherence, and generate real-world evidence. This convergence of technology and healthcare is enhancing trial efficiency, reducing time to market, and supporting data-driven decision-making. Favorable regulatory initiatives and evolving FDA guidelines for digital health tools are also providing a structured framework for the validation and commercialization of digital biomarkers.
However, challenges remain, particularly in interoperability and data integration. The industry must navigate disparate data sources, inconsistent device standards, and concerns surrounding data privacy and security. To address these issues, companies are investing in secure data platforms and AI-driven analytics capable of interpreting complex datasets and deriving actionable insights. Strategic collaborations among technology firms, healthcare providers, and pharmaceutical companies are helping to overcome these hurdles and accelerate market growth.
Looking forward, ongoing innovations in sensors, mobile health applications, and machine learning algorithms are expected to broaden the applications of digital biomarkers beyond chronic disease management into areas such as mental health, neurology, and oncology. As the ecosystem evolves, market players offering secure, scalable, and interoperable solutions are poised to gain a competitive edge, driving the next phase of growth in this dynamic and transformative market.
Take a sneak peek at the digital biomarkers market dynamics @ Digital Biomarkers Market Dynamics Analysis
Digital Biomarkers Market Assessment
Digital Biomarkers Market Segmentation
- By Product Type: Wearable Devices, Implantable Devices, and Application/Software
- By Biomarker Type: Physiological Biomarkers, Behavioral Biomarkers, and Biochemical Biomarkers
- By Indication: Neurological Disease, Cardiovascular Disease, Metabolic Disease, and Others
- By Application: Diagnostic Biomarker, Monitoring Biomarker, and Predictive Biomarker
- By Geography: North America, Europe, Asia-Pacific, and Rest of World
Additional Insights: Porter’s Five Forces Analysis, Product Profiles, Case Studies, Key Opinion Leaders (KOLs) Views, Analyst’s View
Discover which MedTech key players in the digital biomarkers market are poised to become trendsetters @ Digital Biomarkers Companies
About DelveInsight
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions.
