Digital Biomarkers Market – By Type, By Clinical Practice, By Therapeutic Area, By End Use, Global Forecast, 2025 to 2034

Digital Biomarker Market Size

The global digital biomarkers market size was valued at USD 3.8 billion in 2024 and is estimated to grow at 28.8% CAGR from 2025 to 2034. Digital biomarkers are objective, quantifiable physiological, behavioral, or environmental data collected and measured using digital devices such as wearables, smartphones, or other sensor-equipped tools. These biomarkers provide insights into an individual’s health status, disease progression, and treatment responses by leveraging data captured in real-world settings.
 

The global digital biomarkers market is experiencing significant growth, driven by the rising prevalence of chronic diseases. For instance, according to the World Health Organization (WHO), noncommunicable diseases (NCDs) are responsible for 41 million deaths annually, accounting for 74% of global mortality. Of these, 17 million premature deaths occur each year, with 86% affecting low- and middle-income countries. This growing burden of disease underscores the importance of reliable diagnostics, particularly in resource-constrained settings. These trends highlight the urgent need for innovative and scalable solutions, such as digital biomarkers, to enhance early detection, monitoring, and management of chronic diseases, especially in regions where traditional healthcare infrastructure may be limited.
 

Furthermore, advancements in artificial intelligence (AI) and machine learning, the adoption of wearable devices, and an increasing focus on remote monitoring are propelling market growth.
 

Digital Biomarker Market Trends

• The integration of artificial intelligence in healthcare (AI) and machine learning (ML) has significantly advanced the capabilities of digital biomarkers, enabling more accurate, scalable, and personalized healthcare solutions.
   
• AI and ML algorithms analyze vast amounts of data from wearables, smartphones, and other digital devices to identify patterns and subtle changes in physiological or behavioral metrics. For instance, these technologies can detect atrial fibrillation from smartwatch ECG data or predict disease flare-ups in conditions such as multiple sclerosis through gait or speech analysis.
   
• In parallel, AI models can process multi-dimensional datasets to identify early signs of diseases such as Alzheimer’s, diabetes, or mental health disorders, even before symptoms become apparent. An example of this is the use of speech-based biomarkers analyzed by ML algorithms to detect early cognitive decline.
   
• Moreover, ML-powered algorithms enable tailored health recommendations by correlating individual biomarker trends with broader datasets. This can optimize treatment plans for chronic diseases by predicting medication responses, thereby enhancing the personalization of patient care.
   

Digital Biomarker Market Analysis

Based on type, the market is segmented into wearable, mobile based applications, sensors, and other types. The wearable segment dominated the market accounting for 42.5% of revenue share in 2024.
 

• Wearables enable real-time, 24/7 tracking of physiological and behavioral data, such as heart rate, sleep patterns, physical activity, and glucose levels. This continuous stream of data provides deeper insights compared to periodic clinical assessments.
   
• Additionally, by capturing subtle changes in biomarkers, wearables facilitate the early detection of diseases, enabling timely interventions. For instance, wearable ECG monitors can detect atrial fibrillation before significant symptoms develop.
   
• Furthermore, wearables offer a non-invasive method for collecting health data, making them more comfortable and user-friendly than traditional diagnostic methods, such as blood tests or invasive sensors, thereby driving market growth.
   

Based on clinical practice, the digital biomarker market is bifurcated into diagnostic digital biomarkers, monitoring digital biomarkers, predictive and prognostic digital biomarkers, and other clinical practices. The monitoring digital biomarkers segment accounted for a 45.8% market share in 2024 and is projected for significant growth to reach USD 21.4 billion by 2034.
 

• Monitoring digital biomarkers aids in the early detection of diseases by identifying subtle physiological or behavioral changes. This enables timely interventions, improving patient outcomes, particularly in chronic and progressive conditions such as diabetes and Alzheimer’s.
   
• Unlike traditional diagnostics, digital biomarker monitoring delivers continuous data streams, providing real-time insights into an individual's health. This dynamic approach ensures quicker responses to health changes, thereby reducing the risk of complications.
   
• Additionally, digital biomarker monitoring often employs non-invasive devices like wearables or smartphones, offering greater comfort to users and enhancing adherence compared to invasive diagnostic methods. These advantages are driving market growth.
   

Based on therapeutic area, the digital biomarker market is bifurcated into cardiovascular and metabolic disorders (CVMD), diabetes, respiratory disorders, psychiatric disorders, sleep and movement diseases, neurological disorders, musculoskeletal disorders, and other therapeutic areas. The cardiovascular and metabolic disorders (CVMD) segment accounted for a 22.5% market share in 2024.
 

• Digital biomarkers play a critical role in identifying early signs of cardiovascular and metabolic disorders. For instance, wearable devices can track irregular heart rhythms, such as atrial fibrillation, which may indicate an increased risk of stroke or heart failure. Similarly, continuous glucose monitors (CGMs) can detect abnormal blood sugar trends, signaling the early stages of diabetes or metabolic syndrome.
   
• Patients with CVMD benefit from real-time tracking of physiological parameters, enabling healthcare providers to monitor disease progression effectively. Blood pressure monitors integrated with digital platforms can detect hypertension trends, while wearables tracking physical activity and heart rate variability provide insights into cardiovascular fitness and recovery rates post-surgery or heart attack.
   
• Furthermore, by analyzing trends in digital biomarkers, such as heart rate, oxygen saturation, and glucose levels, AI algorithms can predict acute events such as myocardial infarctions, strokes, or hypoglycemia episodes. This predictive capability allows for timely medical interventions, potentially saving lives, thus propelling market growth.
   

Based on end use, the digital biomarkers market is bifurcated into healthcare providers, payers, pharmaceutical and biotechnology companies, and academic and research institutions. The healthcare providers segment accounted for a 38.4% market share in 2024.
 

• Digital biomarkers enable healthcare providers to identify diseases at an early stage with greater precision. For instance, wearable devices and apps collect real-time data on vital signs and behaviors, aiding in the detection of conditions such as atrial fibrillation, diabetes, or mental health disorders before symptoms become severe.
   
• Healthcare providers can utilize digital biomarkers to monitor patients remotely and continuously, offering a more comprehensive view of health trends over time. This approach eliminates gaps in patient care and enables timely interventions in response to detected abnormalities.
   
• Additionally, digital biomarkers enhance the management of chronic conditions like hypertension, diabetes, and cardiovascular diseases. By tracking key metrics such as blood pressure, glucose levels, and heart rate variability, healthcare providers can adjust treatments proactively, further driving market growth for digital biomarkers.
   

• The U.S. digital biomarkers market is projected to grow significantly, reaching USD 16.5 billion by 2034.
   
• The U.S. has a well-established technological ecosystem, enabling the development and deployment of advanced digital biomarker solutions. Leading tech companies and startups in artificial intelligence, machine learning, and cloud computing provide the essential backbone for innovation.
   
• Additionally, the U.S. is a global leader in the adoption of wearable devices, such as smartwatches, fitness trackers, and continuous glucose monitors (CGMs). High consumer demand drives innovation in wearable technology, which serves as a key enabler for digital biomarkers, propelling market growth.
   

The digital biomarkers market in UK is expected to experience significant and promising growth from 2025 to 2034.
 

• The UK benefits from a world-class healthcare system, the National Health Service (NHS), which has increasingly adopted digital health solutions. The NHS’s focus on improving patient care and efficiency provides a fertile ground for integrating digital biomarkers into its processes, particularly for chronic disease management and remote monitoring, contributing to market growth.
   

Japan digital biomarkers market is anticipated to witness lucrative growth between 2025 – 2034.
 

• Japan is a global leader in technology and innovation, with significant expertise in fields such as robotics, AI, and electronics. This technological prowess supports the development and integration of digital biomarkers, with advancements in sensors, wearables, and AI-driven diagnostics playing a key role in improving patient outcomes.
   
• Japan also has one of the oldest populations in the world, leading to a high prevalence of age-related chronic conditions such as cardiovascular diseases, diabetes, and dementia. Digital biomarkers offer a unique solution for continuous monitoring and early detection of health issues in elderly populations, making them a critical tool for improving the management of chronic diseases and age-related health conditions.
   

The digital biomarker market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.
 

• Saudi Arabia’s Vision 2030 plan aims to diversify the economy and enhance the healthcare sector. This includes initiatives to advance digital health technologies, such as the use of digital biomarkers. The government’s investment in healthcare infrastructure, digital transformation, and innovation-driven policies provides a strong foundation for the adoption and development of digital biomarkers in the country.
   
• Saudi Arabia is undergoing rapid digital transformation, particularly in the healthcare sector, with the introduction of the Saudi Health Information Exchange (SHIE) and other digital health initiatives. These projects aim to integrate digital technologies, including digital biomarkers, into healthcare delivery, enhancing patient outcomes and streamlining healthcare processes, contributing to the growth of the market.
   

Digital Biomarker Market Share

The market is competitive, featuring both major global players and a range of specialized regional companies. A key strategy for participants is investing in the development of advanced data analytics platforms, wearable health monitoring devices, and AI-driven solutions to enhance the accuracy and efficiency of disease detection, chronic condition management, and personalized healthcare.
 

Strategic partnerships with healthcare providers, research institutions, and regulatory bodies are essential for deploying these solutions effectively, as well as expanding market reach to meet the growing demand for innovative digital health technologies. Favourable government regulations and support for healthcare infrastructure development further drive innovation and ease market entry, reinforcing the position of companies within the expanding market.
 

Digital Biomarker Market Companies

Some of the eminent market participants operating in the digital biomarkers industry include:

• ActiGraph
• AliveCor
• Altoida
• Amgen Inc.
• Adherium Limited
• Aural Analytic
• Brainomix
• Biogen
• Clario
• Empatica Inc.
• Evidation Health Inc.
• IXICO plc
• Koneksa
• Sonde Health, Inc.
• Vivo Sense
   

Digital Biomarker Industry News:

• In June 2024, AliveCor announced FDA clearance and the commercial launch of KAI12L AI technology and the Kardia 12L ECG System, the world’s first AI capable of detecting life-threatening cardiac conditions, including heart attacks, using a reduced leadset. This innovation enhances remote cardiac monitoring, enabling early detection and timely intervention, transforming cardiovascular care with accessible and efficient diagnostic solutions.
   
• In February 2023, ActiGraph, LLC, and uMotif formed a partnership to offer patient-focused solutions for clinical research by integrating ActiGraph's wearable technology with uMotif's patient engagement platform.
   

The digital biomarkers market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Type

• Wearable
• Mobile based applications
• Sensors
• Other types

Market, By Clinical Practice

• Diagnostic digital biomarkers
• Monitoring digital biomarkers
• Predictive and prognostic digital biomarkers
• Other clinical practices

Market, By Therapeutic Area

• Cardiovascular and metabolic disorders (CVMD)
• Diabetes
• Respiratory disorders
• Psychiatric disorders
• Sleep and movement diseases
• Neurological disorders
• Musculoskeletal disorders
• Other therapeutic areas 

Market, By End Use

• Healthcare providers
• Payers
• Pharmaceutical and biotechnology companies
• Academic and research institutions

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE