The demand for digital biomarkers is rapidly increasing, largely due to the worldwide rise in chronic illnesses such as cardiovascular, neurological, and metabolic disorders. This trend is further fueled by the growing elderly population, which is more susceptible to these conditions because of age-related health decline. Moreover, the widespread use of wearable technologies-combined with continuous innovation and regular new product launches by major industry players-is helping to drive the market forward even faster.
LAS VEGAS, Aug. 26, 2025 /PRNewswire/ -- 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.
To read more about the latest highlights related to the digital biomarkers market, get a snapshot of the key highlights entailed in 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 through laboratory tests or imaging, digital biomarkers are gathered continuously and remotely, allowing real-time monitoring of health status, disease progression, and treatment response. These can include metrics like heart rate variability, sleep patterns, gait speed, voice tone, and even typing speed. The rise of connected devices and AI-driven analytics has enabled large-scale data collection, offering 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 integrating digital endpoints into trials to improve patient stratification, enhance adherence tracking, and generate more meaningful, real-world evidence. In chronic conditions such as Parkinson's, diabetes, or mental health disorders, digital biomarkers offer early detection of symptom changes and enable timely interventions.
Digital Biomarkers Market Insights
North America is expected to command the largest share of the digital biomarkers market in 2024 due to a combination of critical factors. This leadership is largely driven by the high incidence of chronic conditions such as cardiovascular diseases, neurological disorders, and diabetes, which is further amplified by the growing elderly population and the increasing use of wearable technologies. In addition, continuous product innovation and regulatory approvals by major industry players are accelerating market growth in the region. Together, these elements are solidifying North America's position as the dominant region in the global digital biomarkers market.
To know more about why North America is leading the market growth in the digital biomarkers market, get a snapshot of the Digital Biomarkers Market Outlook
Digital Biomarkers Market Dynamics
The digital biomarkers market is experiencing rapid growth, driven by the increasing adoption of wearable technologies and connected health devices that continuously collect physiological and behavioral data. These tools enable real-time monitoring of health parameters such as heart rate, glucose levels, sleep patterns, and activity levels, offering valuable insights for disease prevention, diagnosis, and management. With the rise in chronic diseases globally and greater focus on preventive healthcare, digital biomarkers are emerging as a critical component in personalized medicine and remote patient monitoring.
Pharmaceutical and biotechnology companies are actively integrating digital biomarkers into clinical trials to enhance patient stratification, monitor treatment adherence, and generate real-world evidence. This technological convergence is improving trial efficiency, reducing time to market, and supporting data-driven decision-making. Moreover, favorable regulatory initiatives and progressive FDA guidelines for digital health tools are fostering a more structured framework for validation and commercialization of digital biomarkers.
Interoperability and data integration remain key challenges, as the industry deals with disparate data sources, varying device standards, and concerns around data privacy and security. Companies are investing heavily in secure data platforms and AI-driven analytics to interpret complex datasets and derive actionable insights. Strategic collaborations between technology firms, healthcare providers, and pharmaceutical companies are helping overcome these challenges and accelerating market expansion.
Looking ahead, continued innovation in sensors, mobile health apps, and machine learning algorithms will further expand the scope of digital biomarkers beyond chronic disease management into areas such as mental health, neurology, and oncology. As the ecosystem evolves, market players that can offer secure, scalable, and interoperable solutions are likely to gain significant competitive advantage, shaping the next phase of growth in this dynamic and transformative market.
Get a sneak peek at the digital biomarkers market dynamics @ Digital Biomarkers Market Dynamics Analysis
Report Metrics | Details |
Coverage | Global |
Study Period | 2022-2032 |
Digital Biomarkers Market CAGR | ~17% |
Digital Biomarkers Market Size by 2032 | ~USD 14 Billion |
Key Digital Biomarkers Companies | 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 others |
Digital Biomarkers Market Assessment
- Digital Biomarkers Market Segmentation
- Digital Biomarkers Market Segmentation By Product Type: Wearable Devices, Implantable Devices, and Application/Software
- Digital Biomarkers Market Segmentation By Biomarker Type: Physiological Biomarkers, Behavioral Biomarkers, and Biochemical Biomarkers
- Digital Biomarkers Market Segmentation By Indication: Neurological Disease, Cardiovascular Disease, Metabolic Disease, and Others
- Digital Biomarkers Market Segmentation By Application: Diagnostic Biomarker, Monitoring Biomarker, and Predictive Biomarker
- Digital Biomarkers Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
- Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View
Which MedTech key players in the digital biomarkers market are set to emerge as the trendsetter explore @ Digital Biomarkers Companies
Table of Contents
1 | Digital Biomarkers Market Report Introduction |
2 | Digital Biomarkers Market Executive Summary |
3 | Competitive Landscape |
4 | Regulatory Analysis |
5 | Digital Biomarkers Market Key Factors Analysis |
6 | Digital Biomarkers Market Porter's Five Forces Analysis |
7 | Digital Biomarkers Market Layout |
8 | Digital Biomarkers Market Company and Product Profiles |
9 | KOL Views |
10 | Project Approach |
11 | About DelveInsight |
12 | Disclaimer & Contact Us |
Interested in knowing the digital biomarkers market by 2032? Click to get a snapshot of the Digital Biomarkers Market Trends
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