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February 2025
The global digital biomarkers market size was estimated at USD 5.09 billion in 2025 and is anticipated to reach around USD 32.37 billion by 2034, expanding at a CAGR of 22.74% from 2025 to 2034. The rise has been attributed to the growing need for remote patient monitoring services, the fast improvement of healthcare technology, the increased popularity of current advances, and rising healthcare costs have boosted the growth of the digital biomarkers market.
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Digital biomarkers are physiological, behavioral, or environmental data that is collected and preserved using digital devices like wearables, smartphones, or other instruments with sensors, which are used to evaluate a patient’s health, disease illness stage, and response to therapy using extrapolated data. The market for digital biomarkers is an important area of the life sciences sector. This sector focuses on creating digital biomarkers for the production of various medications. This industry uses a variety of components, including wearable technology, digital platforms, biosensors, desktop software, mobile apps, and others. There are many different types of biomarkers on the market, including digital biomarkers for diagnosis, monitoring, prognostication, and prediction, among others. Many treatment domains, such as neurological diseases, musculoskeletal disorders, respiratory disorders, sleep and movement disorders, cardiovascular and metabolic disorders (CVMD), and others, employ these biomarkers. This sector includes a number of end customers, including payers, healthcare providers, and healthcare companies, among others. Additionally, the government is encouraging expansion by increasing financing and requesting grant proposals for telehealth services.
AI has the potential to greatly impact the market for digital biomarkers by enhancing healthcare precision and customization. AI can analyze massive amounts of information from wearables and sensors using machine learning algorithms, finding patterns that enable real-time monitoring of ailments, including neurological problems, mental health concerns, and cardiovascular diseases. Assessing patient data to develop a personalized treatment plan also makes more individualized medication and care possible. By automating mistake detection and clinical validation, AI improves the dependability of digital biomarkers. It also speeds up drug development by discovering prospective biomarkers for clinical trials, lowering research costs, and offering real-time efficacy information. In order to uncover hidden patterns and connections, AI can effectively combine and analyze enormous volumes of data from many sources, such as wearable technology, sensor data, and electronic health records. Finally, artificial intelligence (AI) is improving disease management and preventative healthcare practices by making healthcare more accurate and accessible, particularly in underprivileged or rural places.
Regulatory Advancements in Digital Health
The FDA has used more than one strategy for digital biomarkers in an effort to expand the number of goods available on the market. For example, the government has changed its software to medical device (SaMD) rules. Additionally, this agency has introduced PreCert, a pre-certification program. The FDA would authorize the business, not the product it produces, according to the scheme. Through this program, the agency hopes to enhance a company's market launch and include the company's product modification process.
Government Initiatives
Government programs and partnerships with international producers are major factors propelling the digital biomarkers market's expansion. Growth is also being aided by increased government funding and grant applications for telehealth services.
Data security and sample collection concerns
The market for digital biomarkers deals with a number of challenges on a daily basis. One of the main challenges facing the market is security and privacy hazards because of the nature of data and its susceptibility to data theft and cybersecurity attacks. Moreover, several issues come up during the collection and processing of samples. The market for digital biomarkers is thus anticipated to be constrained by these issues.
Wearables and Sensor Advancements
Wearable technology has become more and more popular in recent years. These devices generate health data in real-time, which may then be converted into digital biomarkers. It is also employed to assess any medical intervention's safety and/or effectiveness. Digital biomarker fingerprints, data gathering, and data analysis are only a few of the uses for the many technical developments in medical sensors. As a result, increasing wearables usage and sensor technology developments are anticipated to provide businesses with a wealth of future growth prospects.
By system component, the data collection tools segment registered its dominance over the global digital biomarkers market in 2024. This category covers a range of gadgets and technologies, including wearables, implanted parts, desktop software, mobile and tablet apps, and platforms that are used to gather health-related data from people. The rising popularity of health-related mobile applications and the expanding number of smartphone users are two of the key factors propelling the growth of the data collection tools market.
By system component, the data integration systems segment is predicted to witness the fastest growth in the digital biomarkers market over the forecast period. As the use of digital health technology grows, it is essential to combine data from electronic health records, wearables, and mobile health apps. This makes it possible for medical professionals to have a comprehensive picture of individuals' health for routine checkups and individualized treatment. Because maintaining multimodal information is complicated, integration technologies that ensure data accuracy and interoperability are required. Cutting-edge integration software facilitates real-time decision-making, streamlines data processing, and enhances healthcare operations.
By application, the cardiovascular disease segment will be the highest contributor to the digital biomarkers market in 2024. The increase in incidence is driven by the expanding range of therapeutic uses and the rising prevalence of cardiovascular diseases across the world. The World Health Organisation estimates that around 32% of fatalities worldwide are caused by cardiovascular illnesses. It is referred to as the primary cause of death. The increasing rate of cardiovascular disorders brought on by a number of causes, including smoking, bad eating habits, and increased tobacco use, is also anticipated to support this segment's expansion in the years to come.
In application, the respiratory disease segment is expected to grow at the fastest rate in the digital biomarkers market over the forecast period. The increasing incidence of respiratory conditions such as asthma and chronic obstructive lung disease worldwide is the reason behind this. According to the World Health Organization, respiratory disorders caused around 36.2 fatalities per 100,000 people in 2024, compared to 52.1 deaths per 100,000 people in the United States.
By clinical practice, the diagnostic digital biomarkers segment registered its dominance over the digital biomarkers market in 2024. The growing usage of connected digital devices and health-related mobile applications for diagnosis and measurement tracking for a range of disease categories, such as diabetes, mental health, neurological disorders, and cardiovascular ailments, is the cause of this rise. The market's growth has been facilitated by research institutions' increasing usage of diagnostic digital biomarkers.
By clinical practice, the monitoring digital biomarkers segment is anticipated to witness the fastest growth over the forecast period. Many applications, including neurological and motor diseases, health status monitoring, and personalized therapy, are made possible by these biomarkers. The digital biomarkers market has grown as a result of the increased use of digital biomarkers for monitoring the detection of CVDs.
By end-use, the healthcare companies segment held the largest share of the digital biomarkers market in 2024. As healthcare organizations aim to integrate digital measures throughout clinical treatment and research to ensure linked devices deliver an integrated view of patient health, the growing use of sophisticated technologies in these organizations has spurred market expansion. Biomarkers are now being employed by healthcare organizations for various medication development applications. Clinical studies employ these biomarkers to assess various treatments.
The payers segment is projected to grow at a solid CAGR during the forecast period. The increasing use of innovative digital biomarkers by insurance companies and payers' capacity to employ these tools to better meet patient demands and create customized treatment plans with prior authorization schedules are responsible for the segment's rise.
North America dominated the digital biomarkers market share by 59% in 2024. The market for digital biomarkers in North America is expected to increase significantly because of the region's sophisticated healthcare system, extensive use of digital health technology, and substantial R&D spending. Because of its top biotechnology and pharmaceutical businesses, extensive clinical trials, and benevolent regulatory environment, the United States holds the largest portion of the industry. For instance, there has been extensive use of digital biomarkers in the treatment of long-term conditions like diabetes. This trend is best illustrated by continuous glucose monitors (CGMs) and blood sugar-tracking smartphone apps, which allow for more individualized treatment regimens and better patient results.
Despite having a smaller market than the United States, Canada is quickly catching up. The use of digital biomarkers is being encouraged by the Canadian healthcare system's emphasis on chronic illness management and preventive care. The use of digital biomarkers in normal care is being advanced by programs such as the Canadian Digital Health Initiative. For example, wearable technology that tracks heart rate variability is being utilized to identify cardiac problems early on and provide vital information for prompt medical attention.
Asia-Pacific digital biomarkers market is estimated to expand rapidly during the forecast period, owing to the increasing aging population and rising prevalence of chronic diseases. According to data released by The Lancet Regional Health, NCDs were responsible for 55% of all fatalities in 2023 and the majority of NCD deaths (3.9 million) in Southeast Asia in 2023. Chronic illnesses have a negative impact on people's lives by increasing mortality, decreasing quality of life, and reducing mobility. Furthermore, it is anticipated that the need for digital biomarkers will increase dramatically in the near future due to the large population, the rising prevalence of chronic illnesses, and the aging population.
In September 2024, Biofourmis, a global leader in digital health and decentralized clinical trial solutions, announced four new agreements with top pharmaceutical companies. These engagements focused on oncology therapies, will leverage Biofourmis’ expertise in digital biomarker development and its comprehensive, device-agnostic clinical trial solution. The oncology programs will develop digital biomarkers and safety monitoring algorithms, particularly for cytokine release syndrome (CRS) detection, using cutting-edge data science to enhance remote data collection, patient monitoring, and safety.
By System Component
By Application
By Clinical Practice
By End-use
By Region
February 2025
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