Digital Biomarkers Market
Digital Biomarkers Market by Product (Wearables, Sensors, Mobile-based Applications), Type (Physiological, Idiosyncratic), Disease Indication (Autoimmune, Cardiovascular), End User (Pharma & Biotech Companies, Medtech Companies) – Global Forecast to 2030
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The digital biomarkers market is projected to reach USD 15.60 billion by 2030 from USD 6.30 billion in 2025, at a CAGR of 19.9% from 2025 to 2030. Digital biomarkers are objective measures of health and disease derived from digital devices and technologies to support diagnosis, disease monitoring, and treatment decision-making.
KEY TAKEAWAYS
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BY REGIONNorth America accounted for the largest share of 58% of the digital biomarkers market in 2024.
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BY ProductBy product, the wearables segment is expected to dominate the market with a 40% share.
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BY TypeBy type, the physiological biomarkers segment dominates the digital biomarkers market.
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COMPETITIVE LANDSCAPEAmetris, AliveCor, and BioSensics were identified as star players in the digital biomarkers market, given their strong market share and product portfolios.
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COMPETITIVE LANDSCAPEKoneksa, Altoida Inc., and Empatica Inc., among others, have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas, underscoring their potential as emerging market leaders.
The digital biomarkers market is expanding rapidly, propelled by the mainstreaming of precision medicine, broader reimbursement for digital health solutions, and accelerating adoption of wearable sensors, mobile health technologies, and advanced analytics across oncology and chronic disease management.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The digital biomarkers market is growing rapidly due to the development of AI-enabled wearables and the remote monitoring of patients. The incorporation of features such as motion, physiological, and behavioral data into clinical trials, chronic disease care, and precision medicine is driving demand for digital endpoints. With an increase in the usage of big data platforms by labs and organizations related to the pharmaceutical industry, there is a growing requirement for quality digital biomarker solutions that can support consistent results, thereby enhancing faster drug development, improving patient selection, and enabling optimized treatment outcomes.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
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Growth of Wearables & Remote Monitoring Devices
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Advanced Analytics & AI Integration
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Regulatory Uncertainty Around Validation
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Partnerships Between Tech and Life Sciences
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Clinical Validation and Standardization
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Growth of Wearables & Remote Monitoring Devices
Increasing application of wearable sensors, smart devices, and remote patient monitoring platforms are driving the rapid adoption of digital biomarkers. Real-time capture of data has been facilitating long-term health evaluation, management of chronic diseases, thereby improving the efficiency of clinical studies in cardiovascular, neurological, and metabolic diseases.
Restraint: Regulatory Uncertainty Around Validation
Lack of harmonized regulatory frameworks for the clinical validation, qualification, and approval of digital biomarkers limits market adoption. Variability in evidence requirements across regions creates uncertainty for developers, increases time-to-market, and constrains reimbursement approvals.
Opportunity: Partnerships Between Tech and Life Sciences
New opportunities for digital biomarker development arise from collaborations between technology firms and pharma, biotech, and medtech companies. These partnerships combine the strengths of analytics, AI, and sensing technologies with clinical expertise to deliver scalable solutions in drug development, real-world evidence, and precision medicine.
Challenge: Clinical Validation and Standardization
Ensuring clinical relevance, reproducibility, and consistency with variable populations is an ever-green challenge. The inability to compare studies because of the absence of standardized approaches, common datasets, and benchmarking systems hampers the possibility of adopting such research by the regulatory and clinical world.
DIGITAL BIOMARKERS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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AI-enabled ECG-based digital biomarkers captured via mobile and wearable devices for continuous cardiac monitoring, early arrhythmia detection (including atrial fibrillation), and remote cardiovascular disease management across clinical and home settings | Enables real-time, non-invasive cardiac biomarker monitoring, supports early diagnosis and intervention, reduces hospital visits, and improves long-term cardiovascular outcomes through scalable remote patient monitoring |
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Digital biomarker platforms leveraging multimodal data (physiological, behavioral, and sensor-derived signals) to support disease monitoring, clinical trial optimization, and real-world evidence generation across chronic and neurological conditions | Improves data-driven decision-making, enhances patient stratification and endpoint sensitivity in clinical trials, accelerates drug development timelines, and supports personalized disease management through continuous digital insights |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The digital biomarkers market brings together device manufacturers, AI solution providers, app developers, healthcare organizations, pharma companies, CROs, service partners, and other end clients. Vendors offer FDA-approved wearables, mobile apps, and algorithms for extracting real-world data on mobility, heart rate rhythm, sleep, and cognitive functioning, all within a highly regulatory framework. Healthcare organizations and telemedicine organizations employ them in monitoring and diagnostic applications, while pharma/CRO organizations use them in trials for efficacy assessment.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Digital Biomarkers Market, by Product
In 2024, wearable devices accounted for the largest share of the digital biomarkers market by product, driven by widespread adoption of smartwatches, fitness trackers, and medical-grade wearables for continuous physiological monitoring.
Digital Biomarkers Market, by Type
In 2024, physiological biomarkers held the largest share of the digital biomarkers market by type, reflecting their extensive use in monitoring vital signs, activity levels, sleep patterns, and cardiovascular parameters across chronic disease management and clinical trials.
Digital Biomarkers Market, by Disease Indication
In 2024, cardiovascular disorders represented the largest disease indication segment, owing to high disease prevalence and strong adoption of digital monitoring solutions such as ECG, heart rate, and blood pressure tracking.
Digital Biomarkers Market, by End User
In 2024, hospitals, specialty clinics, and diagnostic laboratories accounted for the largest share of the digital biomarkers market, supported by integration of digital monitoring solutions into routine clinical workflows and remote patient management programs.
REGION
Asia Pacific to be fastest-growing region in market during forecast period
During the forecast period, the Asia Pacific region is expected to grow at the fastest rate in the digital biomarkers market. This growth is driven by several factors: Japan's aging population is increasingly adopting wearables for elderly care; China's focus on artificial intelligence is enhancing remote monitoring; and India's telehealth services are expanding through smartphone use. Additionally, government initiatives such as Australia's Digital Health Strategy are promoting the use of digital biomarkers in clinical trials and chronic disease management, enabling the region to outpace others.
DIGITAL BIOMARKERS MARKET: COMPANY EVALUATION MATRIX
The digital biomarkers market matrix positions AliveCor as a star player, supported by its FDA-cleared, AI-driven ECG-based digital biomarkers, strong penetration in remote cardiac monitoring, and expanding collaborations with healthcare providers and pharmaceutical companies for clinical trials and population health programs. iCOMETRIX is emerging as a key emerging leader, leveraging its advanced AI-powered imaging biomarkers in neurology, a growing footprint across academic hospitals, and increasing partnerships with pharma companies seeking objective digital endpoints for CNS drug development and real-world evidence generation.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
- Ametris (US)
- AliveCor (US)
- BioSensics (US)
- Mindstrong Health (US)
- iCOMETRIX (Belgium)
- BACtrack (US)
- AccuLabs (US)
- AtCor Medical (Australia)
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2024 (Value) | USD 4.10 Billion |
| Market Forecast in 2030 (Value) | USD 15.60 Billion |
| Growth Rate | CAGR of 19.9% from 2025-2030 |
| Years Considered | 2023-2030 |
| Base Year | 2024 |
| Forecast Period | 2025-2030 |
| Units Considered | Value (USD Million) |
| Report Coverage | Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, and Trends |
| Segments Covered |
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| Regions Covered | North America, Europe, Asia Pacific, Latin America, Middle East, Africa |
WHAT IS IN IT FOR YOU: DIGITAL BIOMARKERS MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Digital Biomarker Adoption Roadmap for Clinical Trials |
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Helps sponsors and CROs prioritize digital biomarker selection and integration with trial design, reducing risk of delays and increasing confidence in endpoint validity |
| Evidence Generation Strategy for Digital Biomarker Validation |
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Enables device manufacturers and sponsors to build credible evidence packages for regulatory submission and payer acceptance, accelerating commercialization and reimbursement |
RECENT DEVELOPMENTS
- February 2023 : Ametris and uMotif partnered to provide patient-centered solutions for clinical research, combining ActiGraph's wearable technology with uMotif’s patient engagement platform.
- November 2022 : Empatica, Inc. announced that its health monitoring platform has been approved by the US FDA. The health monitoring platform of the company is an advanced data collection solution for healthcare professionals.
Table of Contents
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Methodology
This research study extensively used secondary sources, directories, and databases to identify and collect valuable information to analyze the global digital biomarkers market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
Secondary research was used mainly to identify and collect information for the extensive, technical, market-oriented, and commercial study of the digital biomarkers market. The secondary sources used for this study include American Society of Clinical Oncology (ASCO), Canadian Alliance for Healthy Hearts and Minds (CAHHM), Canadian Institute for Health Information (CIHI), Central Drugs Standard Control Organization (CDSCO), Center for Disease Evaluation and Research (CDER), Centers for Disease Control and Prevention (CDC), Chinese Medical Journal, Clinicaltrials.gov.in, European Medicines Agency (EMA), Food and Drug Administration (FDA), GLOBOCAN, International Agency for Research on Cancer (IARC), National Cancer Institute (NCI), National Center for Biotechnology Information (NCBI), National Institutes of Health (NIH), National Comprehensive Cancer Network (NCCN), Organization for Economic Co-operation and Development (OECD), Population Health Research Institute (PHRI), PubMed, World Bank, World Health Organization (WHO), Corporate and Regulatory Filings, Annual Reports, Sec Filings, Investor Presentations, and Financial Statements; Business Magazines & Research Journals; Press Releases, MarketsandMarkets Analysis. These sources were also used to obtain key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global digital biomarkers market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand side (personnel from pharmaceutical & and biotechnology companies, hospitals & diagnostic laboratories, academic & research institutes, and other end users) and supply side (C-level and D-level executives, product managers, and marketing and sales managers of key manufacturers, distributors, and channel partners, among others, across six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East, and Africa. Approximately 70% of primary interviews were conducted with supply-side representatives, while demand-side participants accounted for the remaining share. This preliminary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
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Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the digital biomarkers market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
Bottom-up Approach
- The key players in the industry and market have been identified through extensive secondary research.
- The revenues generated from the digital biomarkers market business of leading players have been determined through primary and secondary research.
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Top-down Approach
- After arriving at the overall market size from the market size estimation process, the total market was split into several segments and subsegments.
Data Triangulation
After arriving at the market size from the market size estimation process explained above, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable.
Market Definition
A biomarker is a measurable indicator of a biological condition or process, often used to diagnose diseases, predict disease progression, and evaluate treatment response. Digital biomarkers can be molecular, histologic, radiographic, or physiological characteristics that provide valuable insights into normal and pathological processes. The digital biomarkers market encompasses a broad range of products and services that support biomarker discovery, validation, and application in clinical and research settings. This includes offerings such as consumables (assay kits, reagents, and instruments), software tools, and related services that facilitate biomarker analysis. The market report analyzes biomarker usage across multiple applications, including clinical diagnostics, drug discovery and development, personalized medicine, and clinical research. It also studies the adoption of digital biomarkers across key research areas, such as oncology, neurology, cardiology, infectious diseases, and metabolic disorders. Furthermore, the report segments the market by type of digital biomarkers, including safety, efficacy, and validation digital biomarkers. The study also considers regional trends, end-user adoption, and technological advancements shaping the global biomarker landscape.
Stakeholders
- Academic & Research Institutes
- Digital biomarkers Assays and Reagents Manufacturers, Vendors, and Distributors
- Contract Research Organizations (CROs)
- Digital Biomarkers Service & Software Providers
- Diagnostics Companies
- Market Research and Consulting Firms
- Pharmaceutical and Biotechnology Companies
- Regulatory Agencies
- Venture Capitalists
- Forensics Labs
- Government organizations
- Private research firms
- Contract development and manufacturing organizations (CDMOs)
- Hospitals and Diagnostic Laboratories
Report Objectives
- To define, describe, and forecast the global digital biomarkers market based on offering, type, research area, technology, disease indication, application, end user, and region
- To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
- To strategically analyze micro-markets with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments in six regions: North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa
- To profile the key players in the global digital biomarkers market and comprehensively analyze their core competencies and market shares
- To track and analyze competitive developments such as acquisitions, product launches, expansions, agreements, partnerships, and collaborations in the digital biomarkers market
- To benchmark players in the digital biomarkers market using the “Company Evaluation Matrix” framework, which analyzes market players based on various parameters, including product portfolio, geographic reach, and market share
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Growth opportunities and latent adjacency in Digital Biomarkers Market