Digital Biomarkers Market Size, Share & Trends Analysis Report By Type (Data Collection Tools, Data Integration Tools), By Clinical Practice (Diagnostic, Monitoring, Prognostic, Predictive, Others), By Therapeutic Area (Cardiovascular and Metabolic Disorders, Respiratory Disorders, Neurological Disorders, Musculoskeletal Disorders, Psychiatric Disorders, Other Applications), By End-User (Pharmaceutical Companies, Healthcare Providers, Payers, Other End-Users) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Digital Biomarkers Market Size

The global digital biomarkers market size was valued at USD 3.43 billion in 2023 and is projected to reach USD 49.17 billion by 2032, growing at a CAGR of 34.43% during the forecast period (2024–2032).

In recent years, the global market growth has been driven by several factors, including the increasing usage of wearables, growing awareness about fitness, and the introduction of innovative and easy-to-use wearables. The market is also expected to witness strong growth during the forecast period due to a rise in the number of clinical trials and the increasing prevalence of chronic diseases across the globe.

Digital biomarkers are a class of medical measurements obtained by digital health technologies. They are employed as biomarkers for pathogenic processes, normal biological processes, or reactions to treatments, including therapeutic ones or exposures. Digital biomarkers are also used to differentiate between healthy and pathogenic biological processes. The use of sensors and computational tools to collect and apply objective data in a digital format distinguishes them from traditional biomarkers. This allows for a more comprehensive understanding of a patient's health status than is possible with traditional biomarkers.

In digital biomarkers, two subcategories can be distinguished: passive and active. It is possible to collect passive digital biomarkers without the patient having to actively participate in the process. This can be accomplished through the utilization of wearable sensors that monitor the patient's sleep patterns or physical activity levels. On the other hand, active digital biomarkers necessitate the patient's active participation, which can be accomplished through the utilization of mobile applications that monitor the patient's adherence to medication or the severity of symptoms.

Top 4 Key Highlights

• Data Collection tools dominate the type segment.
• Diagnostic dominates the clinical practice segment.
• Cardiovascular and metabolic disorders dominate the therapeutic area segment.
• North America is the highest shareholder in the global market

Digital Biomarkers Market Growth Factors

Rising Number of Clinical Trials and the Increasing Prevalence of Chronic Diseases

The need for faster and more effective drug development to address the rising prevalence of chronic and neurodegenerative diseases, which is particularly driven by an aging population, is causing the market to experience significant growth. This is the primary reason for the market's expansion. In order to provide real-time insights into the efficacy of drugs, digital biomarkers play a crucial role. This enables interventions to be more effective and targeted. Researchers are able to remotely monitor the health of patients, collect continuous data, and gain valuable insights into the efficacy of treatments.

In the context of chronic diseases, where early detection and intervention are essential to improving patient outcomes and reducing the burden on healthcare systems, this trend is particularly important because it presents an opportunity to improve patient outcomes. Digital biomarkers are poised to play a pivotal role in revolutionizing disease management and drug development processes, ultimately contributing to improved patient care and outcomes. This is becoming increasingly important as the demand for innovative healthcare solutions continues to rise.

Market Restraining Factors

High capital investments and data security concerns

The development and implementation of digital biomarkers require significant financial resources, which can be a barrier for small and medium-sized enterprises (SMEs) and startups. The high cost of research and development, as well as the need for advanced technologies and infrastructure, can make it challenging for companies to enter the market or expand their offerings. Also, digital biomarkers involve the collection and analysis of sensitive health data that leads to concerns about data privacy and security. The risk of data breaches and cyber-attacks can make patients and healthcare providers hesitant to adopt digital biomarkers. Strict regulations around data protection and privacy, as well as the need for robust security measures, can add to the cost and complexity of developing and implementing digital biomarkers.

Market Opportunities

Increasing adoption of health-related mobile applications and rising smartphone usage

There is a wealth of data that is being generated that can be utilized for the purpose of gaining health insights as a result of the increasing number of people who are incorporating health and wellness monitoring into their daily lives through the use of mobile applications and wearable devices. An increase in user engagement has occurred as a result of the convenience and accessibility of health-related mobile applications. These applications have made it possible for individuals to monitor a variety of health metrics, including their heart rate, sleep patterns, and physical activity levels, among other things. This data, when combined with advanced analytics and digital biomarkers, provides valuable insights into the health status of an individual. These insights allow for the early detection of health issues, personalized interventions, and an overall improvement in well-being.

A further factor that has contributed to the widespread adoption of digital biomarkers is the widespread use of smartphones, which act as a central hub for health-related applications and wearable devices. In order to monitor health metrics, smartphones are equipped with sensors that are capable of collecting a wide variety of health data. This makes smartphones a convenient and versatile tool for monitoring health metrics. Continuous monitoring of health parameters is made possible by the seamless integration of digital biomarkers with smartphones. This makes it possible for individuals to take charge of their own well-being and facilitates proactive health management.

Regional Insights

North America Dominates the Global Market

North America is the most significant global market shareholder and is expected to expand substantially during the forecast period. The North American digital biomarkers market is poised for significant growth, driven by the region's advanced healthcare infrastructure, widespread adoption of digital health technologies, and robust investment in research and development. The U.S. dominates the market, accounting for the largest share due to its leading pharmaceutical and biotechnology companies, extensive clinical trials, and supportive regulatory environment. For example, the integration of digital biomarkers in managing chronic diseases like diabetes has seen widespread implementation. Continuous glucose monitors (CGMs) and mobile apps that track blood sugar levels exemplify this trend, enabling personalized treatment plans and improved patient outcomes.

Canada, although smaller in market size compared to the U.S., is rapidly catching up. The Canadian healthcare system's focus on preventive care and chronic disease management is fostering the adoption of digital biomarkers. Initiatives like the Canadian Digital Health Initiative are pushing forward the integration of digital biomarkers in routine care. For instance, wearable devices that monitor heart rate variability are being used to detect early signs of cardiac issues, providing critical data for timely medical intervention.

Furthermore, the increasing prevalence of chronic diseases, the aging population, and the rising awareness of the benefits of digital health solutions are major drivers in this market. Moreover, collaborations between technology companies and healthcare providers are propelling innovation. For instance, partnerships like that between Apple and Stanford Medicine, which launched the Apple Heart Study to identify irregular heart rhythms using the Apple Watch, highlight the region's dynamic market landscape.

Digital Biomarkers Market Segmentation Analysis

By Type

The market is segmented into Data Collection Tools and Data Integration Tools. The Data Collection Tools segment is dominating the market, with a significant share of the revenue. This segment includes various devices and technologies used to collect health-related data from individuals, such as wearables, implantable components, mobile/tablet apps, platforms, and desktop-based software. One of the most important factors that is driving the expansion of the Data Collection Tools market is the growing popularity of health-related mobile applications and the increasing number of people who actually use smartphones.

As the use of smartphones becomes more widespread, there is a growing trend of using applications that are based on mobile devices for the purpose of monitoring and tracking one's health. An assortment of health-related data, including heart rate, blood pressure, sleep patterns, and levels of physical activity, can be gathered by these applications. This information can then be utilized to monitor and manage health conditions.

By Clinical Practice

The market is segmented into Diagnostic, Monitoring, Prognostic, Predictive, and Others. Diagnostic dominates the clinical practice segment. The dominance of the Diagnostic segment in the market is a result of the growing utilization of digital biomarkers for diagnostic purposes in a variety of therapeutic areas. These therapeutic areas include cardiovascular and metabolic disorders, respiratory disorders, psychiatric disorders, sleep and movement disorders, neurological disorders, musculoskeletal disorders, and other disorders. The growing prevalence of chronic diseases, the requirement for more rapid medication development, and the growing awareness of the effectiveness of digital biomarkers in the region have all contributed to the utilization of digital biomarkers in diagnostics.

By Therapeutic Area

The market is bifurcated into Cardiovascular and Metabolic Disorders, Respiratory Disorders, Neurological Disorders, Musculoskeletal Disorders, Psychiatric Disorders, and Other Applications. Cardiovascular and Metabolic Disorders dominate the therapeutic area segment. This dominance is established by the increasing popularity of smart wearables that monitor heart rate and the rising incidence of cardiovascular disorders. Because cardiovascular diseases are so prevalent, digital biomarkers that are specifically designed for these conditions have been developed. These biomarkers make use of real-time health data in order to detect and monitor cardiovascular conditions at an earlier stage. Additionally, the growth of the segment is being driven by the increasing prevalence of metabolic disorders such as diabetes, which necessitate ongoing monitoring and personalized interventions that are made possible by digital biomarkers.

By End-Users

The market is segmented into Pharmaceutical Companies, Healthcare Providers, Payers, and Other End-users. Pharmaceutical Companies dominate the end-user segment. Using digital biomarkers, pharmaceutical companies are able to more effectively monitor the efficacy and safety of their drugs because these biomarkers provide data that is objective, accurate, and in real-time regarding the existing health status of patients. Furthermore, digital biomarkers make it possible for pharmaceutical companies to develop personalized medicines that are tailored to the specific requirements of individual patients. This results in improved patient outcomes and lower overall healthcare costs. The growth of the digital biomarkers market in this particular segment is also being driven by the growing partnerships between pharmaceutical companies and digital health start-ups, as well as the increasing investments that pharmaceutical companies are making in digital health technologies.

Recent Developments

• March 2024 - The company heading LEARNS, Koneksa, stated that Merck's participation in the data syndication partnership for the study will provide its researchers with immediate and real-time access to data and results as the trial progresses. Seventy patients with Parkinson's disease are anticipated to be followed for a duration of twelve months as part of this study; enrollment is currently taking place at clinical facilities located in Florida and Michigan.
• February 2024 - By securing four new agreements with leading pharmaceutical companies, Biofourmis expanded its therapeutic portfolio to include cardiovascular, pain, women's health, and immunology in addition to oncology therapies. These agreements underscore Biofourmis' proficiency in the development of digital biomarkers and its all-encompassing clinical trial solutions, which are independent of devices and locations.