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The global digital biomarkers market, valued at USD 5.6 billion in 2024, is estimated to reach USD 7.4 billion in 2025 and USD 35.8 billion by 2035, representing a CAGR of 17.0% during the forecast period.
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The conventional approach of manually tracking the health data of individuals is associated with several challenges, including delay in timely assessment of critical health information, susceptibility to errors, time and cost-intensive process, and risk of loss / damage of health records, thereby hindering timely treatment of patients (specifically the aging population). It is estimated that 65% of hospital patients and more than 90% of post-acute care patients are manually tracked for vitals and patient-specific parameters, every four to eight hours. As a result, there has been a rising prominence of telemedicine that leverages digital tools in order to provide remote consultations and services.
Notably, digital health technologies enable continuous patient monitoring, thereby allowing health practitioners to timely track the baseline changes in individual patients. Additionally, the implementation of continuous monitoring system has proven to significantly reduce adverse events and hospital re-admissions. The growing field of digital biomarkers as well as digital therapeutics are a part of the broader digital health market.
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Further, as per the World Health Organization, by 2030, one-sixth of the global population will be aged over 60 years. Hence, detecting their symptoms proactively at an early stage is intuitively better than treating patients who are seriously ill (due to longer waiting time). Studies have shown that continuous symptom tracking with early intervention has not only led to remarkable improvement in quality of life of patients, but also led to reduced healthcare costs.
The rising digitalization in the healthcare industry has led to the development of several digital solutions, that are capable of generating, collecting and tracking medical information (via biomarkers in the body). Digital solutions for biomarkers are defined as digital devices (such as smartphones, sensors and wearable devices) that measure / quantify the physiological and behavioral or biometric data (including blood pressure, emotional health, heart rate, glucose level, physical activity, respiratory function and sleep pattern).
These advanced solutions enable real-time monitoring of an individual’s health (specifically in chronic disease management), encourage proactive participation of individuals in wellness activities, and allow personalized healthcare by tailoring the treatments based on individual data. With the rising prevalence of chronic diseases, growing emphasis on remote patient monitoring and continuous advancements in the technologies, the digital biomarkers market size is prepared for growth, in the foreseen future.
The digital biomarkers market research report presents an in-depth analysis of various companies that are involved in the global digital biomarkers industry, across different segments, as defined in the table below:
| Key Report Attributes | Details | |
| Historical Trend | Since 2018 | |
| Forecast Period | 10+ Years | |
| Future Trend | Till 2035 | |
| Market Size 2025 | USD 7.4 billion | |
| Market Size 2035 | USD 35.8 billion | |
| CAGR (Till 2035) | 17.0% | |
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| Purpose of Solution |
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| Type of Biomarker |
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| Therapeutic Area |
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| Business Model |
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| Key Geographical Regions |
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| Key Companies Profiled |
(Full list of 130+ companies captured is available in the report) |
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| PowerPoint Presentation (Complimentary) |
Available | |
| Customization Scope | 15% Free Customization | |
| Excel Data Packs (Complimentary) |
Market Overview Product Competitiveness Analysis Partnership and Collaboration Analysis Funding and Investments Analysis Global Events Analysis Patent Analysis Big Pharma Initiatives Market Forecast and Opportunity Analysis |
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One of the key objectives of this market report was to estimate the current market size, opportunity and the future potential of the global digital biomarkers market growth, over the forecast period. We have provided informed estimates on the likely evolution of the market during the forecast period, till 2035.
Our year-wise projections of the current and future opportunity within the digital biomarkers market have been segmented based on relevant parameters, such as type of product (software / applications, wearables, sensors and gaming solutions), purpose of solution (diagnosis, early detection, monitoring, and predictive insights), type of biomarker (cognitive, idiosyncratic, physiological, vocal and others), therapeutic area (autoimmune disorders, cardiovascular disorders, infectious disorders, mental health disorders, neurological disorders, respiratory disorders, substance abuse disorders and others), business model (B2B and B2C) and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World).
In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.
The opinions and insights presented in the market report were influenced by our discussions with stakeholders in the industry. The report features detailed transcripts of interviews held with the following individuals:
Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.
The digital biomarkers market highlights the market segmentation of digital biomarkers, based on the type of product, into software / applications, wearables, sensors and gaming solutions. Currently, the wearables market segment captures maximum share (50%) of the overall market; this can be attributed to the shifting preference of patients towards virtual consultations and telemedicine, leading to an increased demand for technologies that can monitor patients remotely. However, the market for sensors is likely to grow at a relatively faster pace in the next decade.
The digital biomarkers market highlights the market segmentation of digital biomarkers, based on the purpose of solution, into diagnosis, early detection, monitoring, and predictive insights. Currently, the monitoring segment captures the highest share of the market and is expected to dominate during the forecast period. Further, the digital biomarker solutions market for predictive insights is anticipated to capture 30% of the overall market in 2035, owing to the likely advancements in artificial intelligence and machine learning based technologies for predicting patient outcomes based on large amounts of historical data.
The digital biomarkers market is segmented based on the type of biomarker, into cognitive, idiosyncratic, physiological, vocal, and other biomarkers. The digital biomarker solutions that capture physiological biomarkers occupy the highest market share in 2024; this can be attributed to availability of clinically validated data on reliability of physiological biomarkers. Further, vocal digital biomarkers segment is expected to witness substantial market growth in the coming years.
The digital biomarkers market highlights various therapeutic areas such as autoimmune disorders, cardiovascular disorders, infectious diseases, mental health disorders, neurological disorders, respiratory disorders, substance abuse disorders and others. Among these segments, the market for neurological disorders is likely to capture the highest market share, followed by mental health disorders.
This segment highlights the distribution of digital biomarkers market across various geographies, such as North America, Europe, Asia-Pacific, Middle East and North Africa (MENA) and Rest of the World. According to our projections, North America is likely to capture the majority share (44%) of this market, and this trend is unlikely to change in the future as well. It is worth highlighting that the market in Asia-Pacific is expected to grow at a CAGR of 21.8%, during the forecast period 2024-2035.
The “Digital Biomarkers Market: Industry Trends and Global Forecasts, till 2035” market report features an extensive study of the current market landscape, market size and future opportunities for digital biomarker companies, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the global digital biomarkers market report are briefly discussed below.
The digital biomarkers market features over 220 digital biomarkers. Majority (80%) of these solutions are software / applications which digitally identify various types of biomarkers. Further, over 75% of the solutions are data collection tools which capture biomarker data via various types of sensors, including accelerometers, cameras, spirometers and temperature sensors. It is noteworthy that more than 25% of the digital biomarkers detect / monitor physiological biomarkers, while close to 20% of these solutions are used as imaging biomarkers, for analyzing images and scans. In addition, majority (60%) of the digital biomarkers are used for monitoring patients suffering from wide range of diseases.
The current market landscape features the presence of more than 125 developers of digital biomarkers, across the globe. Overall, the market seems to be dominated by the presence of small and very small digital biomarker companies. Notably, 50% of the companies in the digital biomarkers industry are based in North America, followed by companies-based Europe (39%).
During our research, we came across nearly 135 digital biomarker solutions that integrate artificial intelligence -based algorithms to detect / monitor numerous biomarkers. More than 40% of these solutions are currently under research and development while around 25% of these are approved by the regulatory agencies. It is worth highlighting that, in December 2023, Quibim announced the launch of QP-Brain®, FDA 510(k) cleared, and CE marked artificial intelligence (AI)-based software for the detection of early-stage neurodegenerative disorders. In February 2022, AliveCor received FDA clearance for its KardiaMobile Card, which provides medical grade ECG in 30 seconds, thereby allowing for early diagnosis of cardiac arrhythmias.
Currently, the digital biomarker solutions are intended for applications across a plethora of disease indications; over 35% of the solutions are neurological digital biomarkers that are used for monitoring patients with different neurological disorders, including attention deficit hyperactivity disorder (ADHD), Alzheimer’s disease, dementia, epilepsy and Parkinson’s disease. It is worth noting that, Akili Interactive’s EndeavorRx™ is a unique video game-based prescription treatment useful for children with ADHD. Further, several innovative digital solutions are currently available / being developed for cardiovascular and oncological disorders.
Recent emergence of digital technologies in healthcare, increasing number of decentralized clinical trials and the increasing adoption of such technologies among consumers has led to increased research in this domain (to further identify relevant clinical end-points). The ANeED Joint Effort 21 clinical study aims to develop predictive algorithms to detect disease fluctuations in lewy-body dementia patients. In addition, DreaMS clinical study was designed to evaluate the feasibility of DreaMS app, which collected patient health data via smartphone sensors and wearable devices, for monitoring patients with Multiple Sclerosis.
In recent years, several partnerships have been inked by the industry stakeholders, in order to consolidate their presence in this field. It is worth highlighting that nearly 25% of deals have been forged since 2023. Interestingly, most of the agreements (21%) were product / technology integration agreements, followed by product / technology utilization agreements (16%). In November 2023, Oura entered into an agreement with Clue in order to offer integrated services to their customers, wherein the Oura ring could be paired with the Clue app for tracking health parameters.
Several stakeholders in this domain have raised funds in order to fuel their growth operations. It is noteworthy that companies offering digital biomarker solutions have raised a cumulative sum of more than USD 1.6 billion, since 2022. Further, majority of the funding instances are venture capital investments (46%), followed by grants (24%) and seed funding (20%). In September 2023, BioSensics received a grant worth USD 3 million, from the National Institutes of Health (NIH) for development of a wearable device designed for tracking vocal biomarkers.
Since 2021, more than 55 global events have been organized across the globe for discussing the innovations being made in the field of digital biomarkers. Majority (36%) of the events held were conferences, followed by summits (33%). Further, the agenda of many of these events was to discuss the results of digital biomarker focused clinical trials. Notably, artificial intelligence (AI) was an important topic that was conversed about in multiple events.
In the past five years, over 765 patents focused on digital biomarkers have been granted / filed, indicating the substantial efforts made by the researchers in this market. It is worth highlighting that majority of the patents (70%) in this domain were patent applications (not having received approval yet), followed by granted patents (27%). Further, most of the patents have been filed by non-academic players in this industry.
The digital biomarkers market is currently estimated to be worth USD 7.4 billion. Further, driven by the rise in the incidence of chronic diseases, surge in the ageing population and increasing adoption of digital technologies in healthcare, the digital biomarkers market is anticipated to grow at a CAGR of 17.0% during the forecast period. In terms of purpose of solution, the digital biomarker solutions market for monitoring is expected to capture the majority of market share during the forecast period.
Majority of the digital biomarker companies are headquartered in North America, followed by those based in Europe. Consequently, nearly 40% of the digital biomarkers market is anticipated to be captured by the developers based in North America, in 2035. Further, the digital biomarkers market in Asia-Pacific is expected to grow at a relatively higher CAGR during the forecast period (2024-2035).
Examples of key digital biomarkers companies (which have also been profiled in this report) include (in alphabetical order) AliveCor, BACtrack, Biogen, BioSensics, empatica, Eyenuk, Feel Therapeutics, icometrix, and Quibim.
Further, examples of other key players involved in the development of digital solutions for biomarkers include (in alphabetical order) Acculi Labs, ActiGraph, ATCOR, BioSerenity, iMediSync, IXICO, Kinsa, Koneksa Health, Kontigo Care, Progentec Diagnostics, and Vocalis Health.
The digital biomarkers market report presents an in-depth analysis, highlighting the capabilities of various stakeholders in this industry, across different geographies. Further, the market report includes:
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Several recent developments have taken place in the field of digital biomarkers. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.