USD 3.9 billion
Digital Biomarkers Market Size, Share, and Growth Analysis
Digital Biomarkers Market By Type (Wearable, Mobile based Applications), By Clinical Practice (Diagnostic digital biomarkers, Monitoring digital biomarkers), By Therapeutic Area, By End Users, By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35G2218 |
Region:
Global |
Published Date: April, 2025
Pages:
219
|Tables:
128
|Figures:
77
Format -
Digital Biomarkers Market Insights
Global Digital Biomarkers Market size was valued at USD 3.9 billion in 2023 and is poised to grow from USD 5.02 billion in 2024 to USD 38.05 billion by 2032, growing at a CAGR of 28.8% during the forecast period (2025-2032).
The digital biomarkers market growth is attributed to the increasing demand for telecare services remote patient monitoring, rapid development of healthcare technology, high adoption of current innovations, and higher healthcare expenditure. The market is also fueled by increased investment in decentralized clinical trials, widening therapeutic area applications, and increased new wearables in line with the increased utilization of smartphones. New innovative technology that detects indicators such as breathing, voice, heat, and eye movements makes it possible to monitor complex diseases in real time with increasing availability of smartphones and wearables. Among these, DBMs, vocal digital biomarkers, are even more new and hold a lot of scope for expansion. In June 2021, the Luxembourg Institute of Health released CoLive Voice-a digital health company with a focus on improving risk prediction, diagnosis, and monitoring of a range of chronic diseases from afar. Given that patients already carry cellphones and other devices, the above biomarkers should allow sampling with little to no burden on users, and this should be done through audio recordings. Furthermore, the past few years have also witnessed a large percentage of people using smartwatches, cellphones, and even other wearable digital technology like fitness trackers and medical wristbands. This is because the demand for wristwatches has continually increased, year in year out.
US Digital Biomarkers Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Wearable
Fastest Growth
Mobile-Based Applications
Growth Rate
28.8% CAGR
Global Digital Biomarkers Market ($ Bn)
Country Share for North America Region (%)
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Digital Biomarkers Market Segments Analysis
Global Digital Biomarkers Market is segmented by Type, Clinical Practice, Therapeutic Area, End Users and region. Based on Type, the market is segmented into Wearable, Mobile based Applications, Sensors and Others. Based on Clinical Practice, the market is segmented into Diagnostic digital biomarkers, Monitoring digital biomarkers, Predictive and Prognostic digital biomarkers and Others. Based on Therapeutic Area, the market is segmented into Cardiovascular and metabolic disorders (CVMD), Respiratory disorders, Psychiatric disorders, Sleep & Movement Disease, Neurological disorders, Musculoskeletal disorders and Others. Based on End Users, the market is segmented into Healthcare companies, Healthcare Providers, Payers and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Digital Biomarkers Market Analysis by Type
The wearable segment dominated the digital biomarkers industry with the highest revenue share of 39.6% in 2023. The growth in this segment is due to increased new wearable medical applications. In a scenario whereby the manufacturer will always introduce new wearables and smart devices, the market demand for products is going to increase. For instance, Zepp Health announced in November 2022 that its Amazfit Band 7 fitness band was now available in India. The gadget features sophisticated sensors for the determination of heart rate, blood oxygen levels, and stress levels. The Digital Biomarkers Market will expand through newer product launches and increased use of wearable technology.
The mobile-based applications segment is expected to lead the digital biomarkers industry with the highest CAGR of 24.7% over the projection period. Increases in internet usage in some countries, such as China, Brazil, and India, have fueled the segment's growth and thus led to a surging demand for mobile-based apps globally. Increasing mobile applications has made it even more urgent to improve customer experience. For instance, it collaborated agreement with AliveCor, Inc. in January 2022. Under this partnership deal, Theraxium would probably be integrated with AliveCor's KardiaMobile technology. Through the integration, the company aims at increasing self-monitoring in fibrillation conditions as well as controlling cardiotoxicity from cancer treatment.
Digital Biomarkers Market Analysis by Clinical Practice
The diagnostic digital biomarkers segment generated the highest revenue share and dominated the digital biomarkers industry in 2023. The main reason behind this is that connected digital devices and health-related mobile applications are increasingly being adopted for diagnosing and recording measurement tracking for various categories of diseases, such as diabetes, mental health, neurological disorders, and cardiovascular ailments. Due to this, industry players are investing in biomarker research, which will further improve growth. For example, an Israel-based digital biomarker firm, Imagene AI, raised USD 21.5 million in May 2022, focusing on precision medicine in cancer care. That's a combination of USD 3 million seed round led by Blumberg Capital and USD 18.5 million Series A round led by investors in technology-driven cancer treatments.
However, as per the digital biomarkers market forecast, continuous investments in wearables and smartwatches manufacturing lead the monitoring digital biomarkers segment, the next most strongly growing segment of healthcare technology. These devices improve the care and follow-up monitoring of patients by providing access to health information faster and more effectively. Biopharmaceutical companies are actively working on the advancement of advanced wearable technology, which improves the assessment of internal systems through analysis of patient biometrics, such as heart rate and sleep patterns or even some disease-specific metrics. Innovations such as electrostimulation, continuous monitoring, and sweat analysis transform concepts about health and the path of disease. This is also a way to make the trend more helpful for physicians to give every client more personalized treatment while making it possible for patients to oversee their health.
Global Digital Biomarkers Market By Type
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Digital Biomarkers Market Regional Insights
North America secured the highest digital biomarkers Digital Biomarkers Market share in 2023 at 58.4% compared to other markets, leading to increased R&D spending, the presence of major market players, growing acceptance of smart devices, major product launches, and the growing knowledge of the efficacy of digital biomarkers in that region. The market is also expanding due to the growing number of programs encouraging healthcare infrastructure construction. The Digital Biomarker Summit USA, organized in Tarrytown, New York, by the Digital Biomarkers Summit USA event in May 2024, featured and presented key notes and a discussion on the topic: digital biomarkers in clinical trials, bringing instances with wearable technology that provide aspects of AI integration. In addition, digital phenotyping and how this affects observational research was investigated. It has also focused on new innovations and improvements in regulatory preparedness to embrace these cutting-edge endpoint measurement techniques. These are expected to sustain a high requirement of uptake and breadth of digital biomarker in the region.
However, Europe is the second-largest region to grow significantly during the forecast period. Growing numbers of patients with chronic illnesses, for which real-time monitoring and diagnosis of many diseases are necessary, are driving the European digital biomarkers market. Furthermore, the governments and markets of Europe attribute the greatest importance to the e-Enablement of chronic disease monitoring services and offer solutions that would enable access to medical records, reduce the strain on healthcare resources and facilities, and decrease the number of unnecessary prescriptions and tests. To date, the European Medicines Agency (EMA) currently regulates the European Union's clearance process for medications and medical devices. Although the CDRH clearance for medical devices uses its same old precursor, a new law, the Medical Device Regulation, governs all contemporary medical equipment and subjects it to tougher regulations.
Global Digital Biomarkers Market By Geography
- Largest
- Fastest
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Digital Biomarkers Market Dynamics
Digital Biomarkers Market Drivers
Increasing Prevalence of Chronic Illnesses
- The incidence of diabetes, hypertension, and cardiovascular conditions continues to escalate and underlines the growing demand for digital biomarkers. Digital biomarkers offer crucial information that ensures immediate reaction and uninterrupted monitoring by healthcare systems towards chronic illnesses. It encourages best management practices that allow patients to stay healthy for longer periods and to be hospitalized fewer times, thus contributing toward improved quality of life while reducing healthcare expenditure.
Increase in Patient Involvement in Healthcare
- The consumer involvement in managing health has dramatically evidenced change with the coming of the health-conscious lifestyle. With wearable technology and smartphone applications, a digital biomarker can be made more frequently by people for better knowledge of their general wellbeing by observing their health measurements. In that respect, being proactive empowers people about their health; therefore, the approach towards taking on health management fosters a more cooperative connection between patients and healthcare professionals alike and accelerates the uptake of digital health technology.
Restraints
Lack of Clinical Validity
- A lot of promise is displayed by digital biomarkers, but most of them lack clinical validation, a strong prerequisite for implementing and mainstream adoption by medical practitioners. There will be questions on accuracy and dependability because of the missing intensive research that verifies its efficacy in practical and real contexts. Without validated digital biomarkers, their general acceptance and incorporating them into routine treatment protocols may be limited when physicians need to only apply evidence-based tools within their realm of practice.
Accessibility Concerns and Health Inequalities
- Socioeconomic limitations in accessing digital biomarkers market could be the reasons for health inequalities. Conversely, the adoption of digital health solutions may require huge drawbacks, such as unequal access to technologies and even internet and healthcare resources by different populations. Consequently, public health may lack the needed total impact of these advancements due to this inequality, which creates a gulf between those who can benefit and cannot from these digital biomarkers.
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Digital Biomarkers Market Competitive Landscape
The global digital biomarkers market outlook is characterized by rapid technical breakthroughs, intense rivalry, and new investment. Companies in this sector are directing their attention to partnerships, collaborations, innovative products, and mergers and acquisitions to obtain a competitive advantage. Companies are investing in R&D to produce new, advanced products with the most modern features and capabilities.
Top Players in Digital Biomarkers Market
- BioSensics (United States)
- AliveCor (United States)
- BACtrack (United States)
- Eyenuk (United States)
- Quibim (Spain)
- Biofourmis (United States)
- Fitbit (United States)
- Evidation Health (United States)
- Empatica (United States)
- Philips Healthcare (Netherlands)
- Medtronic (Ireland)
- Akili Interactive (United States)
- Apple Inc. (United States)
- Biotricity (United States)
- Tempus (United States)
- Pear Therapeutics (United States)
- BioBeats (United Kingdom)
- Oura Health (Finland)
- ActiGraph (United States)
- Koneksa (United States)
Digital Biomarkers Market Recent Developments
- February 2024: Biofourmis, a world leader in decentralized clinical trial solutions and research in digital biomarkers, announced four new alliances with the world's top pharmaceutical firms. The partnership supports clinical trial initiatives in the US, Europe, Asia-Pacific, and the MEA. The strategy is driven by tapping the proven competency of the company in digital biomarker innovation.
- March 2023: Koneksa announced that it has expanded its agreement with SSI to help grow the number of in-house digital biomarker solutions it uses in clinical trials. The SSI is likely operating to service this demand.
- February 2023: uMotif and ActiGraph, LLC announced that they have partnered to provide patient-centric clinical research solutions by integrating uMotif's patient interaction platform with ActiGraph's wearable technology.
Digital Biomarkers Key Market Trends
- Integration of AI: One of the major digital biomarkers market trends is the integration of AI. It may be that all wearables and health application-generated data could end up processed by AI algorithms and result in patterns and insights that doctors might not immediately identify. That said, however, this trend enables more proactive and individualized approaches to healthcare, better management of an illness, and better results by improving the predictive power of the digital biomarkers.
- Collaborative Data Sharing: Increasingly, healthcare stakeholders-for instance, providers, researchers, and technology developers-are embracing cooperative data sharing. The programs aggregate the data from digital biomarkers to further improve research and clinical practice. Stakeholders can contribute through collaborative efforts and ideas for spurring innovation and leveraging knowledge of health trends and creating more powerful treatments. From the cooperative approach, patients and providers alike benefit, working toward an integrated health care environment.
Digital Biomarkers Market SkyQuest Analysis
SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the digital biomarkers market share is expected to grow significantly due to an increase in the incidence of chronic diseases, increasing consumer engagement in the management of their own health, and technological advancements. While there are still challenges that remain, such as the need for clinical validation and data privacy considerations, the combination of AI and cooperative data sharing programs is very encouraging. For the foreseeable future, digital biomarkers would be a significant factor in improving patients' recovery outcomes and the speed at which healthcare delivery is provided unless the healthcare systems adhere to preventative and individualized treatments. The digital biomarkers industry seems to hold a bright future with revolutionary possibilities for both patients and providers due to continuous improvements and a trend toward more connected health solutions.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 3.9 billion |
| Market size value in 2032 | USD 38.05 billion |
| Growth Rate | 28.8% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Digital Biomarkers Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Digital Biomarkers Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Digital Biomarkers Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Digital Biomarkers Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Digital Biomarkers Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Digital Biomarkers Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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