Precedence Research predicts the global digital biomarkers
market size will grow from USD 5.04 billion in 2025 to approximately USD 31.82
billion by 2034, expanding at a strong CAGR of 22.71% from 2025 to 2034.
What is the Digital Biomarkers Market Size?
The global digital biomarkers market size accounted for USD 5.04 billion in 2025 and is predicted to rise from USD 6.26 billion in 2026 to nearly USD 31.82 billion by 2034. The market is expected to grow at a double-digit CAGR of 22.71% from 2025 to 2034.
Digital biomarkers refer to physiological, behavioral, or environmental information that is gathered and stored through digital devices such as wearables, smartphones, or other sensor-equipped instruments. These data points are utilized to assess a patient's health, stage of illness, and therapeutic response through extrapolated information. This field emphasizes developing digital biomarkers for the manufacturing of different pharmaceuticals.
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Digital Biomarkers Market Key Takeaways
🔹North America led the digital biomarkers market with the major market share of 58.45% in 2024.
🔹The Asia Pacific region is expected to grow at a solid CAGR of 23.52% from 2025 to 2034.
🔹By end-use, the healthcare companies segment held the biggest market share of 50.18% in 2024.
🔹By end-use, the payers segment is projected to expand at a strong CAGR of 24.5% during the forecast period.
🔹By clinical practice, the diagnostic digital biomarkers segment contributed the largest market share in 2024
🔹By system component, the data collection tools segment led the market in 2024.
🔹By system component, the data integration systems segment is likely to experience the fastest growth during the forecast period.
🔹By application, the cardiovascular diseases segment held the largest market share in 2024.
Digital Biomarkers Market Size, Growth and Forecast 2025 to 2034
→ Market Size in 2024: USD 4,110 Million
→ Market Size in 2025: USD 5,040 Million
→ Forecasted Market Size by 2034: USD 31,820 Million
→ CAGR (2025-2034): 22.71%
→ U.S. Market Size in 2025: USD
2,000 Million
→ U.S. Market Size by 2034: USD 12,750 Million
→ U.S. CAGR (2025-2034): 22.83%
→ Largest Market in 2024: North America
→ Fastest Growing Market: Asia Pacific
Market Overview and Industry Potential: Remote Technology & Innovation Driving the Market
The growth is due to the rising popularity of new innovations and remote technologies, the swift progress in healthcare technology alongside increasing healthcare spending and a higher demand for remote patient monitoring services. Furthermore, the growing adoption of smartphones combined with the introduction of new wearables, broadening therapeutic area applications, and heightened investment in decentralized clinical trials are also fueling the market.
How is AI Helping the Digital Biomarkers Market to Grow?
Artificial Intelligence (AI) is playing a transformative role in accelerating the growth of the digital biomarkers market. By enabling advanced data analysis, AI allows researchers and clinicians to process vast amounts of health data from wearables, mobile apps, electronic health records, and biosensors with speed and precision.
This analytical power helps uncover patterns and correlations that traditional methods often miss, facilitating the development of more accurate and timely biomarkers. AI also supports personalized healthcare by tailoring diagnostics and treatments to individual patient profiles, improving outcomes and reducing adverse events. Through remote monitoring and real-time feedback, AI enables continuous health tracking, which is especially valuable for managing chronic conditions and detecting early signs of disease.
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What is Major Opportunity in Digital Biomarkers Market for the Coming Years?
Drug Development and Clinical Trials Offer Growth Opportunity
A major chance for growth exists in incorporating digital biomarkers into drug development processes and clinical studies. Conventional clinical trials frequently experience elevated dropout rates, irregular data gathering, and obstacles in recruiting participants. Digital biomarkers provide a means to gather ongoing, real-world data that enhances participant involvement, adherence, and trial precision. Pharmaceutical companies are collaborating with digital health firms to implement digital endpoints that measure treatment responses, side effects, and outcomes reported by patients.
Major Challenges for Digital Biomarkers Market:
Data Security Concern Restraining the Market
A factor impeding the expansion of the global digital biomarkers market is the apprehensions regarding data security. Security and privacy threats represent significant obstacles for the market, given the characteristics of data and its susceptibility to cyberattacks and data breaches. Digital therapeutics products or services can also be susceptible to external disturbances, signal inaccuracies, and transmission failures. This could lead to the loss of essential patient information.
Biomarkers as the Foundation of Digital Biomarkers
The biomarkers market represents the overarching industry covering all measurable indicators of biological processes, disease progression, or therapeutic response. Biomarkers can be molecular (DNA, RNA, proteins), imaging-based (MRI, PET, CT), physiological, or biochemical. They are widely used across drug discovery, clinical diagnostics, personalized medicine, risk assessment, and patient monitoring.
According to Precedence Research, the global biomarkers market size reached USD 82.30 billion in 2024 and is forecasted to climb to about USD 318.76 billion by 2034, expanding at a CAGR of nearly 14.5%. This positions biomarkers as one of the central pillars of modern precision medicine and pharmaceutical R&D.
Within this broader space, digital biomarkers have emerged as a distinct, fast-growing sub-segment. Unlike traditional biomarkers that are usually measured in controlled laboratory or imaging settings, digital biomarkers are derived from wearables, smartphones, biosensors, and digital platforms. These tools capture real-time physiological, behavioral, or environmental data, enabling continuous and remote health tracking. While the parent biomarkers market includes biochemical assays and imaging modalities, digital biomarkers extend the category into IoT-enabled, AI-driven, and real-world health data collection.
This structural relationship explains the sharper growth trajectory of the digital biomarkers market — valued at USD 5.04 billion in 2025 and projected to reach USD 31.82 billion by 2034, at a CAGR of 22.71%, outpacing the parent market. Digital biomarkers build upon the foundation of traditional biomarkers but bring added scalability, patient engagement, and decentralized trial capabilities. As the pharmaceutical and healthcare industries shift toward precision medicine and digital health ecosystems, digital biomarkers are becoming one of the fastest-expanding verticals within the wider biomarkers market.
Biomarkers Market Key Takeaways
🔹North America has held a revenue share of more than 46% in 2024.
🔹By type, the safety segment has accounted highest revenue share in 2024.
🔹By application, the drug discovery and development segment will dominate the market in 2024.
🔹By disease, the cancer segment captured a biggest revenue share of in 2024.
Biomarkers Market Key Players
➢ Bio-Rad Laboratories, Inc.
➢ Qiagen
➢ Epigenomics AG
➢ Abbott
➢ Hoffmann-La Roche Ltd.
➢ Agilent Technologies, Inc.
➢ Johnson & Johnson Services, Inc.
➢ Abbott
➢ Siemens
➢ Thermo Fisher Scientific, Inc.
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Digital Biomarkers Market Report Coverage 2025 to 2034
|
Report Attributes |
Key Statistics |
|
Market Size in 2024 |
USD 4.11 Billion |
|
Market Size in 2025 |
USD 5.04 Billion |
|
Market Size by 2034 |
USD 31.82 Billion |
|
CAGR 2025 to 2034 |
22.71% |
|
U.S. Market (2024) |
USD 1.63 Billion |
|
U.S. Market (2034) |
USD 12.75 Billion (22.83% CAGR) |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Largest Market |
North America |
|
Fastest Growing Region |
Asia Pacific |
|
Segments Covered |
System Component, Application, Clinical Practice, End Use and Region |
|
Leading System Component |
Data Collection Tools (2025) |
|
Fastest Growing Component |
Data Integration Systems |
|
Leading Application |
Cardiovascular Diseases (2025) |
|
Leading Clinical Practice |
Diagnostic Biomarkers (2025) |
|
Leading End-use Segment |
Healthcare Companies more than 50% share (2025) |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa |
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Case Study — Empatica’s Embrace Watch for Epilepsy Management
A leading digital health company, Empatica, launched the FDA-cleared Embrace smartwatch to improve seizure detection and patient safety in individuals with epilepsy. The device integrates multiple sensors, including electrodermal activity, skin temperature, and motion tracking, to generate real-time digital biomarkers of seizure activity. When abnormal patterns are detected, the smartwatch automatically sends alerts to caregivers, enabling faster intervention. Pharmaceutical firms also integrated the Embrace system into clinical trials to collect objective biomarker data for drug efficacy and adherence monitoring.
Results after deployment:
🔸Seizure detection accuracy improved significantly compared to patient self-reporting.
🔸Caregiver response times reduced due to instant real-time alerts.
🔸 Patient quality of life enhanced through continuous at-home monitoring, reducing hospital dependency.
🔸 Clinical trials using Embrace data achieved higher participant compliance and better treatment response tracking.
🔸 Objective, scalable biomarker data reduced trial variability and accelerated drug development timelines.
Impact: The case demonstrates how wearable-driven digital biomarkers can transform patient safety, empower caregivers, and deliver measurable value to clinical research. Empatica’s approach shows how merging consumer wearables with medical-grade standards creates both healthcare ROI and broader adoption of digital biomarker solutions.
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Digital Biomarkers Market Key Regional Landscape:
➢ The North America digital biomarkers market was valued at USD 2.40 billion in 2024 and is projected to reach nearly USD 18.25 billion by 2034, growing at a CAGR of around 22.53%. The primary driver is the early adoption of advanced healthcare technologies and strong U.S. investments in digital health infrastructure.
➢ The Europe digital biomarkers market stood at USD 0.92 billion in 2024 and is anticipated to expand to approximately USD 6.70 billion by 2034, registering a CAGR of about 21.52%. Growth is primarily driven by regulatory support for digital therapeutics and increasing emphasis on personalized medicine.
➢ The Asia Pacific digital biomarkers market was estimated at USD 0.53 billion in 2024 and is forecasted to reach nearly USD 4.28 billion by 2034, advancing at the fastest CAGR of 23.52%. The key driver is the rapid expansion of digital health adoption in China, India, and Japan, coupled with rising healthcare digitization initiatives.
➢ The Latin America digital biomarkers market held a value of USD 0.14 billion in 2024 and is expected to rise to USD 1.02 billion by 2034, witnessing a CAGR of around 21.52%. Market growth is primarily fueled by increasing mobile health penetration and gradual improvements in healthcare infrastructure.
➢ The Middle East & Africa digital biomarkers market was valued at USD 0.12 billion in 2024 and is projected to generate nearly USD 0.86 billion by 2034, expanding at a CAGR of 20.51%. The main driver is the growing focus on digital healthcare transformation and rising prevalence of chronic diseases demanding advanced monitoring tools.
How Big is the Digital Biomarkers Market Size?
According to Precedence Research, the U.S. digital biomarkers market size is predicted exceed USD 12.75 billion by 2034 up from USD 2 billion in 2025, growing at a notable CAGR of 22.83% from 2025 to 2034.
North America Digital Biomarkers Market Trends:
North America dominated the digital biomarkers market with the largest market share in 2024, mainly because of sophisticated healthcare infrastructure, extensive technology utilization, and a robust network of startups, educational institutions, and clear regulations. The U.S. particularly gains from a supportive reimbursement environment, early pioneers in digital health, and significant funding from private and government sectors.
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Asia Pacific to Boom Fast: Rising Chronic Burden to Act as a Driver
Asia Pacific is expected to expand at a significant CAGR during the forecast period, driven by the growing elderly population and the rising incidence of chronic illnesses. Chronic diseases adversely affect individuals by raising mortality rates, lowering life quality, and limiting mobility. Moreover, it is expected that the demand for digital biomarkers will significantly rise in the coming years because of the large population, the growing prevalence of chronic diseases, and the aging demographic.
Indian Government Initiatives to Support Digital Biomarkers Discovery:
➡️Ayushman Bharat Digital Mission (ABDM)
ABDM is building a nationwide digital health ecosystem with Health IDs, digital
health records, and interoperability standards, providing a strong foundation
for collecting and utilizing digital biomarkers across the healthcare system.
➡️ National Digital Health Blueprint
(NDHB)
NDHB outlines the digital transformation of India’s healthcare infrastructure,
focusing on standardized health data systems, patient registries, and digital
governance, all of which are essential for effective digital biomarker
research.
➡️Digital Public Infrastructure and Open Data Platforms
The government promotes open data and interoperable digital public goods
through initiatives like the National Data Sharing and Accessibility Policy
(NDSAP) and the Open Government Data (OGD) Platform, enabling researchers to
access health-related datasets for biomarker development.
Digital Biomarkers Market Segmentation Analysis:
By System Components Analysis
The data collection tools segment led the market in 2024, as it provides the crucial basis for obtaining ongoing, real-time physiological and behavioral information from wearables, sensors, and mobile applications. The ongoing data feed from these tools enables customization of treatments and interventions to meet personal needs, shifting away from a uniform approach.
The data integration systems segment is the fastest growing in the digital biomarkers market during the forecast period, indicating a structural transition towards sophisticated pipelines that cleanse, merge, and analyze data for clinical decision support. Due to the complexity of managing multimodal information, integration technologies are necessary to guarantee data accuracy and interoperability.
By Application Analysis
The cardiovascular diseases segment held the largest market share in 2024, because of the rising global occurrence of chronic cardiovascular diseases, heightened healthcare expenditures, the extensive use of smart wearables for real-time tracking of vital signs such as heart rate, and the need for ongoing, tailored patient care and disease management.
The respiratory disease segment is expected to be the fastest-growing segment during the forecast period. The widespread global occurrence of chronic respiratory conditions like asthma, COPD, and infectious lung diseases results in a large patient group needing ongoing monitoring and treatment. The advancement of novel digital respiratory tools, like intelligent inhalers and linked nebulizers, provides ongoing, real-time data gathering for patients through clinical practice.
By Clinical Practice Analysis
The diagnostic digital biomarkers segment contributed the highest market share in 2024. This expansion is due to the rising utilization of connected digital devices and health-focused mobile apps for diagnosing and tracking measurements employed across various disease types, such as cardiovascular conditions, mental health issues, neurological disorders, and diabetes. As a result, industry market participants are putting money into biomarker research, which is expected to fuel expansion.
The monitoring digital biomarkers segment is projected to rise with the highest growth rate during the forecast period. The increase is due to the rising investment in wearable technology and smartwatches, facilitating easier and more precise access to health-related data. Additionally, wearables from biopharmaceutical industries are improving assessment of internal systems by understanding patient biometrics and functionality tracking heart rate, sleep time, and disease-related biometrics.
By End Use Analysis
The healthcare companies segment contributed the biggest market share in 2024. This dominance can be projected to the fact that healthcare industries have been working toward incorporating digital measurements across the line of clinical care & research to ensure connected devices give an extensive view of patient health.
The payers segment is projected to grow at a solid CAGR during the forecast period. An increase in number of insurance companies offering various healthcare policies has boosted the market growth. These insurance companies have started utilizing digital biomarkers for detecting and assessing the efficacy of disorders that are claiming their policies for treatment.
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Digital Biomarker Market Top Companies
🔸Bayer AG – A global pharmaceutical
and life sciences company, Bayer leverages digital health technologies to
enhance disease diagnosis and patient monitoring.
🔸 Biogen Inc. – Biogen focuses on
neurological diseases and utilizes digital biomarkers to track disease
progression in conditions like multiple sclerosis and Alzheimer's.
🔸ActiGraph LLC – A leader in wearable
activity and sleep monitoring devices, ActiGraph provides validated digital
tools for clinical trials and health research.
🔸Amgen Inc. – As a biotechnology
company, Amgen incorporates digital biomarkers into its R&D to better
understand and manage chronic diseases.
🔸F. Hoffmann-La Roche Ltd – Roche integrates digital
health solutions and biomarkers to personalize healthcare, particularly in
oncology and neurology.
🔸Fitbit Inc. – Now part of Google,
Fitbit develops consumer wearable devices that gather health data useful in
digital biomarker research and development.
🔸 GlaxoSmithKline Plc – GSK employs digital
biomarkers in its drug development pipeline to improve patient outcomes and
precision medicine efforts.
🔸Koninklijke Philips N.V. – Philips offers advanced
digital health technologies, including remote monitoring and diagnostics powered
by digital biomarkers.
🔸 Mindstrong Health – A pioneer in using
smartphone-based digital biomarkers to assess mental health conditions such as
depression and anxiety.
🔸 Medical Care Corporation – Specializes in digital
tools that help detect cognitive impairment and Alzheimer’s disease through
digital health assessments.
What is Going Around the Globe?
In May 2025, GrayMatters Health (GMH), the homesteaders in mental health treatment through digital brain biomarkers, launched Prism™ Suite, an inclusive, next-generation portfolio of solutions developed to empower providers and improve patient outcomes. Creating on the success of the FDA cleared Prism™ for PTSD, the newly expanded suite involves a Depression protocol, further broadening GMH's impact on the mental health landscape.
Digital Biomarkers Market Segmentation
By System Component
🔸 Data Collection Tools
→ Mobile Apps
→ Wearable
→ Digital Platforms
→Biosensors
→ Desktop-Based Software
🔸 Data Integration Systems
By Application
🔸 Sleep & Movement Disease
🔸 Cardiovascular Diseases
🔸 Respiratory Disease
🔸 Neurodegenerative Disorders
🔸 Diabetes
🔸 Gastrointestinal Disease
🔸 Psychiatric Disorder
🔸 Others
By Clinical Practice
🔸 Diagnostic Digital Biomarkers
🔸 Monitoring Digital Biomarkers
🔸 Predictive And Prognostic Digital Biomarkers
🔸 Other's (Safety, Pharmaco dynamics/ Response, Susceptibility)
By End-use
🔸 Healthcare Companies
🔸 Healthcare Providers
🔸 Payers
🔸 Others (Patient, caregivers)
By Region
🔸 North America
🔸 Europe
🔸 Asia-Pacific
🔸 Latin America
🔸 The Middle East and Africa
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Frequently Asked Questions:
✚ What is the digital biomarkers market?
➢ A healthcare segment using wearables, smartphones, and sensors to
collect and analyze real-time physiological and behavioral data for disease
monitoring and drug development.
✚ How big is the digital biomarkers market in 2025?
➢ Valued at USD 5.04 billion in 2025.
✚ What is the forecast size of the digital biomarkers market by 2034?
➢ Expected to reach USD 31.82 billion by 2034.
✚ What is the CAGR of the digital biomarkers market?
➢ 22.71% from 2025 to 2034.
✚ Which region dominates the digital biomarkers market?
➢ North America with 58.45% market share in 2024.
✚ Which region is growing fastest in the digital biomarkers market?
➢ Asia Pacific at 23.52% CAGR.
✚ What are the main applications of digital biomarkers?
➢ Cardiovascular diseases, respiratory diseases, neurodegenerative
disorders, diabetes, and psychiatric conditions.
✚ How are digital biomarkers used in clinical trials?
➢ They provide continuous, real-world data to improve accuracy,
patient adherence, and trial outcomes.
✚ What is the biggest opportunity in the digital biomarkers market?
➢ Integration into drug development and decentralized clinical
trials.
✚ What challenges does the digital biomarkers market face?
➢ Data security, privacy risks, and transmission failures.
✚ How does AI support digital biomarkers?
➢ By analyzing large health datasets, identifying hidden patterns,
and enabling personalized healthcare.
✚ Who are the key players in the digital biomarkers market?
➢ Bayer, Biogen, Amgen, Roche, Philips, Fitbit (Google), GSK,
ActiGraph, and Mindstrong Health.
✚ What
is the U.S. digital biomarkers market size by 2034?
➢ Estimated at USD 12.75 billion, growing at 22.83% CAGR.
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