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 physiological, behavioral, or environmental data that are collected and recorded by means of digital devices such as smartphones, wearables, or other sensor-equipped tools. By means of extrapolated data, these biomarkers assess one’s health, disease stage, as well as treatment effects.
 

The high prevalence of chronic diseases is the key area benefitting from the rise in the global market, reaching new heights. For example, the World Health Organization (WHO) states that 41 million people die each year because of noncommunicable diseases (NCDs), which represent 74% of the overall global mortality. Of this total, 17 million are the result of premature death, with 86% of these fatalities occurring in middle and low-income economies.

This increasing disease burden indicates the need for effective diagnostics to combat the diseases, especially in areas that lack resource availability. These trends justify the development and global integration of new tools such as digital biomarkers that will further facilitate the monitoring and control of chronic disease management, even in areas with little or no access to healthcare services.
 

Furthermore, improvement in artificial intelligence (AI) and machine learning, increased popularity of wearable technology, and remote monitoring, are propelling the market growth.
 

Digital Biomarker Market Trends

• The incorporation of artificial intelligence in healthcare and machine learning has propelled the evolution to digital biomarkers, resulting in better forecasting, reaching a wider population, and a tailored approach to the healthcare sector.
   
• AI and ML algorithms are multidisciplinary approaches that leverage huge amounts of data gathered from wearables, smartphones, and other digital devices by identifying subtle changes in mantled behaviors as well as physiological metrics. For example, Li et al (2020) have suggested that these technologies can identify atrial fibrillation from ECG recordings obtained from smartwatches and can even anticipate variations in multiple sclerosis patients by carrying out gait and speech analyses.
   
• In parallel, AI algorithms are able to analyze multimodal datasets and offer improvement indicators of mitigating diseases, such as Alzheimer’s or Diabetes and even mental disorders, where symptoms are minimal or absent. ML algorithms that utilize speech-based biomarkers are one such example of assessing cognitive decline in patients at a much earlier stage.
   
• In addition, ML algorithms can make specialized health suggestions by merging specific biomarker trends with larger datasets. This is useful in chronic diseases to tailor the treatment by forecasting the response to medication, thus optimizing the patient’s care.
   

Digital Biomarker Market Analysis

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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.
 

• Wearable devices provide the capability to track physiological and behavioral indicators such as heartbeats, total hours of sleep, degree of physical activity, and even glucose concentration on a daily basis, non-stop. Such unending data greatly surpasses the information offered by sporadic clinical visits.
   
• Also, the change that is slightly captured in the biomarkers is done so by wearables, and this helps in ruling out the disease at an early stage so that treatment can be performed on time. For example, wearable ECG monitors can detect atrial fibrillation, which is one of the signs of the disease before other main symptoms are detected.
   
• Moreover, wearables reduce health diagnostic tests to a more comfortable level than a blood test or even invasive sensors, so consumers can be more willing to use them, which in turn facilitates market growth.

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Based on clinical practice, the digital biomarkers 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.
 

• Disease prevention can be accomplished with the help of biomarkers and wearable technology. Predictive medicine suits them perfectly. If the alterations are fairly vague in terms of behavior or physiology, digital monitoring assists in diagnosing the condition earlier on, which allows for timely actions to be made that will consequently have a significantly better outcome for the patient when compared to more progressive and chronic illnesses such as diabetes or Alzheimer’s.
   
• The use of digital biomarker monitoring reveals a substantial amount of data as well as in-depth insight into the patient’s health. This approach allows for interventions and changes to be made significantly faster, which reduces the chances of health-related complications.
   
• Another significant advantage is the possibility of wearing devices instead of having them implanted, as most digital biomarker monitoring systems use wearable devices or mobile phones. Compared to other diagnostic approaches, these devices are considerably more comfortable and encourage users to be more compliant. With these factors in mind, it is clear to see how they can aid in the advancement of the market.
   

Based on therapeutic area, the digital biomarkers 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.
 

• This concept aims to extend the use of digital biomarkers in diagnosing and monitoring diseases such as diabetes and cardiovascular and metabolic disorders. Wearable technology such as monitoring devices may identify atypical heart patterns such as fibrillation, which increases stroke and heart failure risk. Early indications of diabetes or metabolic syndrome may be identified with the help of continuous glucose monitors (CGM), which detect unusual blood sugar patterns.
   
• CVMD patients can leverage continuous monitoring of physiological parameters that allow true monitoring of the evolution of the disease by healthcare professionals. Online platforms combined with blood pressure monitors can determine the movement towards hypertension, and the wearable weighing commercially available physical activity and heart rate variability show cardiovascular fitness and recovery rate after surgery or heart attack.
   
• Moreover, employing artificial intelligence can further smooth the process of medicine through algorithms that integrate analytics from digital biomarkers such as heart rate, blood oxygen saturation percentage, and glucose levels. Such capabilities have proven useful in emergencies by allowing doctors to predict myocardial infarctions, strokes, and hypoglycemic episodes. Predicting capability means appropriate medical care can be provided at the right time, which in some instances helps in reducing loss of lives and therefore leads to growth in the market.
   

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.
 

• The use of digital tools, apps, and devices, wearable devices for instance, has allowed healthcare professionals to be able to predict sickness onset alongside changes in vital signs and behaviors that are more in-depth. Tracking heart conditions such as atrial fibrillation or even early onset of diabetes or mental disorders before they manifest into the full-blown disease makes the process of treatment easier and faster.
   
• Digital biomarkers also assist healthcare practitioners in treating chronic illnesses such as hypertension, diabetes, and cardiovascular issues. When crucial indicators such as blood pressure, heart variability, or glucose levels are monitored, treatment can be adjusted, which aids in further growing the market for digital biomarkers with time.

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• The U.S. digital biomarkers market is projected to grow significantly, reaching USD 16.5 billion by 2034.
   
• The emergent technological ecosystem within the US provides a fertile ground for the development and application of various sophisticated digital biomarker solutions. Established technology corporations and new ventures in artificial intelligence, ML, and cloud computing offer the requisite infrastructure of novel ideas.
   
• Furthermore, wearable technologies, including smartwatches, fitness trackers, and continuous glucose monitors (CGMs), have been widely adopted in the U.S. Wearable technology is crucial for digital markers of the information age and promotes the market's growth owing to the high level of demand for consumers' attention, which fosters creativity.
   

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

• The UK is graced with a healthcare system that is among the best in the world, the NHS, and the agency is increasingly adopting more digital health approaches. There is frequent integration of digital biomarkers into its processes with the focus on care enhancement and process efficiency, especially in chronic disease management, and wearables, which has increased the market growth.
   

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

• Japan is a nation that is at the forefront of new technological developments and innovations with strength in countries such as robotics, AI, and electronics. This inbuilt strength aids in the performance and inclusion of digital biomarkers into the markets with improvements in sensor technology and smart wearables alongside artificial intelligence diagnostics engineers enhancing the output efficacy.
   
• Japan also experiences a high prevalence of chronic diseases due to their chronic aging population, which includes cardiovascular disease, diabetes, and Alzheimer’s disease. Digital biomarkers provide an ideal solution that facilitates active care through remote monitoring, making them effective to facilitate improved management of chronic diseases related to aging.
   

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

• Saudi Arabia is focusing on medical, and so the government is investing in multiple policies in order to push the economy in the right direction and enhance competitiveness on a global scale. Digital biomarkers will be pivotal in the development of the economy as it helps set a global standard, not only within Saudi Arabia but also in Saudi Arabia as a part of the Vision 2030 goals.
   
• Saudi Arabia aims for the healthcare sector to focus on the digital sphere and has invoked programs such as SHIE or the Saudi Health Information Exchange to ease the integration of digital technologies such as digital biomarkers with the end goal of improving patient outcomes, encouraging the growth of the digital biomarkers industry.
   

Digital Biomarker Market Share

The market is competitive, featuring both major global companies and a variety of developing specialized regional companies characterize the market. A major effort for the participants focuses on developing sophisticated data analytics platforms, wearable health monitoring applications, and AI solutions that improve the reliability and efficacy of disease diagnosis, chronic management, and healthcare delivery.
 

Along with them, however, in order to successfully implement these solutions and expand the coverage of the emerging market, it is necessary to establish strategic alliances with healthcare providers, research institutes, and regulatory bodies. Unquestionably, democratization through favorable government regulations and encouragement for the enhancement of healthcare supportive technologies further motivate entrepreneurs and thus allow for the competitive positioning of firms in the flourishing strategy of the 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
   

• ActiGraph, focuses on real-world data collection through the use of validated wearables. The also offers strong and scalable analytics for sleep, activity, and other physiological markers.
   
• AliveCor's AI technology leads the industry in the development of personal ECG devices specifically for the purpose of detecting arrhythmias such as atrial fibrillation.
   
• There is an emphasis on continuous and seamless health monitoring to improve the quality of life. The company has partnered with major healthcare companies for clinical research.
   
• Amgen Inc. implements AI and machine learning to analyze digital health data, accelerating clinical trial efficiency and outcome prediction. It ensures compliance with stringent clinical and regulatory requirements, enhancing the credibility of its digital health initiatives.
   

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