Digital Biomarkers - Market Insights, Competitive Landscape, and Market Forecast - 2032

Digital Biomarkers Market by Product Type (Wearable Devices, Implantable Devices, and Application/Software), Biomarker Type (Physiological Biomarkers, Behavioral Biomarkers, and Biochemical Biomarkers), Indication (Neurological Disease, Cardiovascular Disease, Metabolic Disease, and Others), Application (Diagnostic Biomarker, Monitoring Biomarker, and Predictive Biomarker), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence of chronic diseases globally and increasing product development and launch activities among the key players.

The digital biomarkers market was valued at USD 4.10 billion in 2024, growing at a CAGR of 17.11% during the forecast period from 2025 to 2032 to reach USD 14.47 billion by 2032. The growing demand for digital biomarkers is primarily driven by the rising global prevalence of chronic diseases, including cardiovascular, neurological, and metabolic disorders. A significant contributing factor is the expanding geriatric population, which is more vulnerable to these conditions due to age-related physiological decline. In addition, the increasing adoption of wearable devices, along with continuous product innovation and frequent new product launches by leading market players, is further accelerating market growth. These combined trends are fostering a favorable environment for sustained development, positioning the digital biomarkers market for robust and steady growth during the forecast period from 2025 to 2032.

Digital Biomarkers Market Dynamics:

According to the British Heart Foundation (2024), approximately 640 million people globally were affected by heart and circulatory diseases, a number projected to rise in the coming years. Around 67 million new cases were diagnosed annually. In the UK alone, 1 in every 45 people (about 2 million) lived with heart rhythm-related conditions, with over 270,000 individuals undiagnosed. Similarly, the Australian Bureau of Statistics (2023) reported that 5% of Australians aged 55 and over suffered from atrial fibrillation. These figures highlighted the growing need for effective rhythm management therapies. Digital biomarkers, collected through wearable devices, offer continuous heart rhythm monitoring, enabling real-time detection of heart rhythm irregularities, thereby supporting market growth.

The global diabetes burden is also accelerating. The International Diabetes Federation (2023) estimated that 537 million adults aged 20-79 were living with diabetes in 2021, a figure projected to rise to 643 million by 2030 and 783 million by 2045. Digital biomarkers tracking glucose levels, physical activity, and sleep quality provide real-time insights, supporting early intervention and personalized treatment decisions, driving the market forward.

Neurological disorders further emphasized the need for digital biomarker solutions. The American Brain Foundation (2024) reported that over 3.4 billion people, or 43.1% of the global population, were affected by neurological conditions such as Parkinson’s disease and Alzheimer’s. Additionally, WHO (2023) estimated 280 million individuals living with depression worldwide. Early signs, such as memory issues or slowed responses that can be identified through cognitive apps and speech biomarkers. In Parkinson’s disease, wearables track tremors, gait changes, and bradykinesia to monitor disease progression and treatment response.

Market growth is also being propelled by product innovations. For instance, in November 2023, Empatica received FDA 510(k) clearance for two new digital biomarkers (pulse and respiratory rate) integrated into its Empatica Health Monitoring Platform. These advancements in digital biomarker technology continue to support early diagnosis, treatment monitoring, and personalized healthcare solutions.

However, the data privacy and security concerns and high development and implementation costs, among others, are some of the key constraints that may limit the growth of the digital biomarkers market.

Digital Biomarkers Market Segment Analysis:

Digital Biomarkers Market by Product Type (Wearable Devices, Implantable Devices, and Application/Software), Biomarker Type (Physiological Biomarkers, Behavioral Biomarkers, and Biochemical Biomarkers), Indication (Neurological Disease, Cardiovascular Disease, Metabolic Disease, and Others), Application (Diagnostic Biomarker, Monitoring Biomarker, and Predictive Biomarker), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the biomarker type segment of the digital biomarkers market, the physiological biomarkers category is estimated to account for the largest market share in 2024. This growth is primarily driven by the rising prevalence of chronic diseases, particularly cardiovascular and metabolic disorders, as well as the significant advantages that physiological biomarkers offer in disease detection and management.

Unlike traditional biomarkers that provide only occasional data points, physiological digital biomarkers enable real-time, continuous health monitoring, even outside of clinical settings. This allows for a more comprehensive understanding of a patient’s condition and treatment response over time. The ability to track health parameters continuously helps in early disease detection, more accurate diagnoses, and timely interventions.

Additionally, the personalized data collected through these biomarkers empowers healthcare providers to tailor treatment plans to individual patient needs, potentially improving therapeutic outcomes and optimizing care. These benefits also contribute to enhanced efficiency in clinical trials by enabling more precise and dynamic monitoring of patient responses.

The category’s growth is further propelled by ongoing technological innovation, particularly in wearable devices that serve as platforms for real-world data collection. For example, in 2025, Google received FDA clearance for its Loss of Pulse Detection feature, launched with the Pixel Watch 3. This first-of-its-kind functionality can detect when a user experiences a loss of pulse and automatically trigger a call to emergency services if the user is unresponsive. By transforming passive sensor inputs into clinically meaningful digital biomarkers, such wearables illustrate the expanding role of physiological monitoring in healthcare. Therefore, the development of advanced, FDA-cleared wearable technologies and the increasing demand for personalized, continuous monitoring are driving the dominance and rapid growth of the physiological biomarkers segment in the digital biomarkers market.

Therefore, the rising prevalence of chronic disease and various advantages of digital physiological biomarkers are expected to significantly contribute to the growth of the category, thereby increasing global market revenues and playing a pivotal role in driving the overall growth of the digital biomarkers market throughout the forecast period from 2025 to 2032.

North America is expected to dominate the overall digital biomarkers market:

North America is projected to hold the largest share of the digital biomarkers market in 2024, driven by several key factors. This regional dominance is primarily attributed to the growing prevalence of chronic diseases such as cardiovascular disease, neurological disorders, and diabetes, mainly attributed to the rising geriatric population, and the growing adoption of wearable devices. Additionally, ongoing product development and regulatory approvals by key market players are further contributing to market expansion. Collectively, these factors are positioning North America as the leading market in the global digital biomarkers market.

According to the Centers for Disease Control and Prevention (2024), in 2022, nearly 6.7 million adults aged 20 years or older were living with heart failure in the United States. Similarly, data from the Heart & Stroke Foundation of Canada (2022) reported that 750,000 Canadians were living with heart failure, with approximately 100,000 new diagnoses each year. Digital biomarkers play a vital role in managing heart failure by enabling continuous, real-time monitoring of patients through wearable devices and sensors. These technologies facilitate early detection of disease progression, track treatment response, and support timely clinical interventions, ultimately improving patient outcomes. The rising prevalence of heart failure across North America is therefore a key driver of digital biomarker market growth in the region.

Neurological conditions such as Parkinson’s disease are also contributing to the growing demand for digital biomarkers. As per the Parkinson’s Foundation (2022), approximately 90,000 people were diagnosed with Parkinson’s disease each year in the U.S., marking a sharp 50% increase from the previously estimated 60,000 annual diagnoses. Digital biomarkers are crucial in Parkinson’s care, as they enable objective and continuous monitoring of motor symptoms, including tremors, gait disturbances, and bradykinesia, through wearable sensors and mobile apps. These tools support early diagnosis, track disease progression, and help evaluate treatment effectiveness, advancing personalized care and clinical decisions.

The diabetes burden further underscores the importance of digital biomarkers. According to the American Heart Association (2024), around 29.3 million adults in the U.S. have been diagnosed with diabetes, while an estimated 9.7 million remain undiagnosed. Additionally, about 115.9 million Americans were living with prediabetes. The increasing prevalence of diabetes is driving demand for digital biomarkers that enable real-time tracking of blood glucose trends, facilitate early detection of complications, and support individualized treatment strategies to improve disease management and patient outcomes.

Beyond the rising disease burden, strategic collaborations among key market players are also accelerating the adoption of digital biomarkers, particularly in diagnostics and drug development. For example, in March 2023, Koneksa announced an expanded partnership with SSI Strategy aimed at enhancing client service offerings to scale the use of evidence-based digital biomarkers in clinical trials. Such initiatives are further propelling market growth across the region.

Collectively, the rising disease burden and the strategic collaboration among key market players are expected to drive strong and sustained growth in the North America digital biomarkers market throughout the forecast period from 2025 to 2032.

Digital Biomarkers Market Key Players:

Some of the key market players operating in the digital biomarkers market include 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.

Recent Developmental Activities 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.

Key takeaways from the digital biomarkers market report study

• Market size analysis for the current digital biomarkers market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the digital biomarkers market.
• Various opportunities available for the other competitors in the digital biomarkers market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current digital biomarkers market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for the digital biomarkers market growth in the coming future?

Target audience who can benefit from this digital biomarkers market report study

• Digital biomarkers product providers
• Research organizations and consulting companies
• Digital biomarkers-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in digital biomarkers
• Various end-users who want to know more about the digital biomarkers market and the latest technological developments in the digital biomarkers market.

Frequently Asked Questions for the Digital Biomarkers Market:

1. What are digital biomarkers?

• Digital biomarkers are objective, quantifiable physiological and behavioral data collected through digital devices such as wearables, smartphones, sensors, or remote monitoring tools. These biomarkers are used to monitor health status, detect disease onset, track disease progression, and evaluate treatment responses in real time. Unlike traditional biomarkers derived from blood or tissue samples, digital biomarkers offer continuous, non-invasive insights into a patient's condition, enabling more personalized and proactive healthcare.

2. What is the market for digital biomarkers?

• The digital biomarkers market was valued at USD 4.10 billion in 2024, growing at a CAGR of 17.11% during the forecast period from 2025 to 2032 to reach USD 14.47 billion by 2032.

3. What are the drivers for the digital biomarkers market?

• The growing demand for digital biomarkers is primarily driven by the rising global prevalence of chronic diseases, including cardiovascular, neurological, and metabolic disorders. A significant contributing factor is the expanding geriatric population, which is more vulnerable to these conditions due to age-related physiological decline. In addition, the increasing adoption of wearable devices, along with continuous product innovation and frequent new product launches among the leading market players, is further accelerating market growth. These combined trends are fostering a favourable environment for sustained development, positioning the digital biomarkers market for robust and steady growth during the forecast period from 2025 to 2032.

4. Who are the key players operating in the digital biomarkers market?

• Some of the key market players operating in the digital biomarkers market include 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.

5. Which region has the highest share in the digital biomarkers market?

• North America is projected to hold the largest share of the digital biomarkers market in 2024, driven by several key factors. This regional dominance is primarily attributed to the growing prevalence of chronic diseases such as cardiovascular disease, neurological disorders, and diabetes, mainly attributed to the rising geriatric population, and the growing adoption of wearable devices. Additionally, ongoing product development and regulatory approvals by key market players are further contributing to market expansion. Collectively, these factors are positioning North America as the leading market in the global digital biomarkers market.

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