Digital Biomarkers Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2032)

Digital Biomarkers Market Size

Digital Biomarkers Market Trends and Growth Drivers

Integration of AI Is Major Trend

The healthcare system is evolving into a value-based delivery model, which spurs the development of AI-integrated digital biomarkers, enabling a better analysis of patients’ health information. With the advancements in the AI and ML techniques, key insights can be derived of the data collected via wearables and mobile applications, as well as from the real-time, non-invasive monitoring of physiological and behavioral patterns.

For instance, continuous glucose monitoring systems enable personalized diabetes management, while mHealth applications, such as SmokeBeat, analyze smoking behavior using the sensors of a smartphone. Further, major HIT companies, including ActiGraph, Huma, and Biogen, are investing in research and development for the improvement of the healthcare infrastructure. Similarly, software as medical device (SaMD) firms are working to seamlessly integrate digital biomarkers into clinical practice, for enhanced data evaluation.

AI and ML enhance the discovery of biomarkers by assessing compounded multi-omics data on patients’ protein, genetic, and metabolite makeup. Moreover, convolutional neural networks (CNNs) and Google DeepVariant improve genomic variant detection, while AI enhances the analysis of protein structure with MaxQuant and AlphaFold. AI is utilized in drug discovery, notably cancer chemotherapy, new compounds, and personalized therapies.

Further, AI augments the interoperability of digital biomarkers, enabling the real-time monitoring and early detection of health conditions. This improves the efficiency of clinical trials by greatly diminishing the sample sizes used in research, as evidenced by the recent studies of Roche and AstraZeneca.

Rising Smartwatch Usage and Government Initiatives Drive Market Growth

Government initiatives and partnerships with international manufacturers are the primary growth drivers for the digital biomarkers market, as the rising public healthcare expenditure worldwide increases the usage of digital biomarkers.

For instance, the European Union has allocated EUR 5.3 billion under its EU4Health program from 2021 to 2027 for public health, mental health, and the development of medical products. For digital health alone, the European Commission has earmarked EUR 25,750,000 for 2024 to integrate digital innovations into the healthcare infrastructure.

Similarly, the inter-government Global Initiative on Digital Health, conceptualized and overseen by the World Health Organization, aims to assess what countries need for digital healthcare, align resources and fund cash-starved nations, and encourage local development.

Moreover, India’s digital health initiatives include the Aarogya Setu mobile app, eSanjeevani telemedicine service, hospital information management system, e-BloodBank mobile app, online registration system, and e-RaktKosh blood bank management system.

Inadequate Knowledge and Data Privacy Concerns Hinder Market Growth

The growth of the digital biomarkers market faces numerous challenges, primarily in developing regions, such as Latin America (LATAM) and the Middle East and Africa (MEA). Most healthcare professionals and patients here are unaware of the benefits and applications of digital biomarkers. In addition, the lack of qualified practitioners to use these technologies worsens the problem, widening the gap in service delivery compared to the developed regions of Europe and North America.

The other significant obstacles are data security issues and strict guidelines in this regard. The varying regulatory policies across countries create further complexity in compliance and operations for companies that offer digital biomarker solutions. Moreover, in some emerging economies, access to reliable and secure internet and developed technology infrastructure is still limited, thus hampering digital health tools from being utilized to their full potential.

Digital Biomarkers Market Analysis

Component Analysis

• The data collection tools category accounts for more than 70% share in 2024.
• These tools aid in data gathering and the extraction of novel digital biomarkers that are more precise, patient-centric, clinically useful, and more objective than those extracted via conventional research approaches, such as subjective rating scales and patient diaries.
• Wearables, which include fitness bands and smartwatches by ActiGraph, Fitbit, Garmin, and a variety of other brands have been used successfully in clinical studies spanning several fields of medicine, such as oncology, cardiovascular diseases, diabetes, rehabilitation, and mental health, to assess step count, activity intensity, heart rate, sleep-related outcomes, blood oxygen level, and sweating intensity.
• Wearable devices are increasingly being employed as a key data source to develop highly personalized and adaptable patient treatment plans, thus allowing for the implementation of prompt therapeutic interventions based on minor changes in health patterns.
• Data integration software is the faster-growing category owing to the soaring demand for comprehensive health data management solutions.
• As digital health technologies are increasingly adopted, it becomes imperative to integrate the data coming from wearables, mobile health applications, and electronic health records.
• This enables healthcare providers to obtain an encompassing view of patients' health for regular monitoring and offering personalized care.
• The complexity in the maintenance of multimodal information necessitates integration tools that guarantee the accuracy and interoperability of the data.
• Advanced integration software improves clinical workflows, simplifies data analysis, and enables decision-making on a real-time basis.
• Additionally, the need to protect data and patient privacy raises the requirement for more-advanced integration software compliant with the regulations.

The components evaluated here are:

• Data Collection Tools (Larger Category)
  • Wearables
  • Implantables
  • Mobile apps
  • Others
• Data Integration Software (Faster-Growing Category)

Type Analysis

• Clinical trials are the larger category in the market for digital biomarkers because of the high importance of biomarkers in the drug development process.
• The integration of digital biomarkers in clinical trials enables more-accurate monitoring of a patient’s treatment and response, allowing for adaptive trial designs.
• This approach is cost-effective, improves the quality of the data captured, and diminishes the costs of trials.
• It also improves patients’ engagement through the real-time tracking of their health information.
• This increases the confidence of entities conducting clinical trials on the ability of digital biomarkers to give actionable insights through their advanced analytics capabilities.
• Clinical settings are the faster-growing category, at a CAGR of 30.0%, during the forecast period, driven by the rising need for personalized and proactive healthcare.
• Furthermore, as digital technologies are increasingly adopted by care providers, digital biomarkers are enhancing routine practice.
• Continuous health monitoring enables doctors to optimize disease management and treatment.
• Other strong drivers for this category include the emerging telehealth and remote monitoring technologies and the shift toward value-based and patient-centric care.

The types analyzed here are:

• Clinical Trials (Larger Category)
• Clinical Settings (Faster-Growing Category)

Clinical Practice Analysis

• The diagnostics category is expected to have the highest value, of USD 1.25 billion, in 2032.
• It is propelled by the rising use of connected digital devices and mobile health applications to diagnose various diseases, such as cardiovascular diseases, neurological illnesses, diabetes, and mental disorders.
• Voice patterns, texting behavior, and sleep data are analyzed to identify mood and predict incidents of depression and anxiety.
• For instance, Kardiacare Plus and KardiaMobile 6L are physiological biomarkers used for data collection and analysis for disease diagnosis and risk assessment.
• Monitoring is the fastest-growing category, because the advances in telehealth propel the demand for digital biomarkers that help in the continuous monitoring of patients with long-term diseases.
• They are essential for managing chronic conditions from home and remote locations.
• Additionally, people are investing more in smartwatches and wearables that help with proper and accurate health monitoring.
• Wearables improve the evaluation of patient conditions through sleep analysis, biometrics, heart rate tracking, and disease-specific data tracking.

The clinical practices evaluated here are:

• Diagnostic (Largest category)
• Monitoring (Fastest-Growing category)
• Predictive & Prognostic
• Others

End User Analysis

• Pharmaceutical & biopharmaceutical companies dominate the market with revenue of USD 1.5 billion in 2024.
• This is attributed to the consistent efforts by biopharmaceutical companies to develop a synergy between digital technologies and clinical procedures.
• Several biopharma companies apply digital health tools and data analytics to improve clinical trials and drug development.
• For instance, Pfizer applies automation, AI, and predictive analytics to digitalize the R&D process by leveraging large volumes of patient data with minimal chances of errors, while accelerating the time-to-market.
• The advancements in remote data collection through wearable devices and mobile apps also help participants become more engaged in clinical trials, further helping increase the efficacy of the drugs under development.
• Providers are the fastest-growing category, credited to their aim to improve health outcomes, understand patient responses, and optimize therapeutic interventions.
• The implementation of digital biomarkers in clinical practice allows for better management of diseases, early diagnoses, and tailored treatments.

The end users analyzed here are:

• Pharmaceutical & Biopharmaceutical Companies (Largest Category)
• Payers
• Providers (Fastest-Growing Category)
• Academic & Research Institutions
• Others

Application Analysis

• The cardiovascular category holds the largest share in 2024.
• This is due to a rise in the prevalence of cardiovascular disorders in the global population, as an upshot of numerous causes, such as high tobacco consumption, bad eating habits, and excessive alcoholism, which is likely to fuel the expansion of this category in the future.
• Digital biomarkers capture patient data and improve patient care and treatment outcomes.
• Psychiatric disorders are the fastest-growing category with 31.0% CAGR.
• This is because of the expanding prevalence of cognitive and behavioral problems, and the growing pace of technological improvements in the digital biomarker environment.
• Mood disorders affect the entirety of the world's population, thus resulting in a massive functional and economic burden.
• As a result, it is critical to diagnose and monitor mood and behavioral symptoms at an early stage, to detect clinical deterioration promptly.
• Current psychiatric assessment approaches are time-consuming and resource-intensive and require a trained clinician to evaluate various parameters.
• Digital biomarkers can greatly facilitate a scalable, time-sensitive, and cost-effective assessment of mood and behavior.
• For this purpose, measurements can be taken with the help of actigraphy (a technique that collects the user's gross activity level), which is useful in detecting mood-related disorders, because these disorders are frequently characterized by a significant increase or decrease in energy levels, in addition to behavioral symptoms.

The applications evaluated here are:

• Gastrointestinal Diseases
• Sleep & Movement Disorders
• Cardiovascular Diseases (Largest Category)
• Psychiatric Disorders (Fastest-Growing Category)
• Chronic Pain
• Neurodegenerative Diseases
• Diabetes
• Respiratory Diseases
• Others

Digital Biomarkers Market Geographical Outlook

North America is the largest digital biomarkers market by region, with 40% revenue in 2024. The growing healthcare spending, combined with the rising consumer demand for effective, and advanced solutions, is assisting in the market's development. Moreover, the high adoption of digital technologies in North America has significantly fueled the market growth in recent years.

APAC will have the highest CAGR, of 30%, during this decade. In recent years, the increasing government spending on the development of advanced healthcare infrastructure has significantly boosted the adoption of digital biomarkers in the APAC region. The proliferation of digital technologies and their increasing adoption in the APAC healthcare sector are essentially driving the market growth. Furthermore, the presence of a large population, rising prevalence of chronic diseases, and rampant aging are expected to exponentially increase the demand for digital biomarkers in the near future.

The market in China is rapidly expanding as a result of the increasing acceptance of mobile phones, internet connectivity, and digital health technologies, which have opened up new pathways for improving non-transmissible disease care delivery and population health management. Furthermore, mental health problems are widespread in China, and the country's mental health facilities lack the resources to provide high-quality care to those in need. Thus, aided by the growing Chinese economy and the rapidly rising adoption of digital health technologies, the digital mental health approach provides an effective solution to this shortage.

In addition, with the rapid development of the internet technology, the parental influence in mHealth to consult with medical professionals appears to be widespread in China. More parents with hectic schedules are turning to mHealth, and, as a result, healthcare professionals are increasingly advising their patients to use digital health technologies or mobile health apps to track their children’s vital signs effectively. Chinese patients are also more likely to act on their own health information.

The adoption of this concept in Europe is also growing at a steady pace, on account of the rising healthcare IT expenditure, high awareness of advanced technological solutions and the readiness to adopt them, favorable government initiatives, emergence of startups, growing smartphone penetration, lucrative funding options, and advancements in internet technology. Furthermore, globalization, the growing geriatric population, increasing incidence of chronic disorders, changing lifestyles, and rising demand for value-based care are driving the European digital biomarkers market growth.

Moreover, governments in LATAM and MEA have launched several digital health initiatives, including educational projects and training programs, aimed at increasing the pool of digital healthcare resources and boosting the adoption of this approach among the populace.

The geographical breakdown of the market is as follows:

• North America (Largest Regional Market)
  • U.S. (Larger Country Market)
  • Canada (Faster-Growing Country Market)
• Europe
  • U.K. (Largest Country Market)
  • Germany (Fastest-Growing Country Market)
  • Spain
  • Italy
  • France
  • Rest of Europe
• Asia-Pacific (APAC) (Fastest-Growing Regional Market)
  • China (Largest Country Market)
  • India (Fastest-Growing Country Market)
  • South Korea
  • Japan
  • Australia
  • Rest of the APAC
• Latin America (LATAM)
  • Brazil (Largest Country Market)
  • Mexico (Fastest-Growing Country Market)
  • Rest of LATAM
• Middle East and Africa (MEA)
  • U.A.E. (Fastest-Growing Country Market)
  • South Africa
  • Saudi Arabia (Largest Country Market)
  • Rest of MEA

Digital Biomarkers Market Share

• The digital biomarkers market is consolidated in nature.
• The stringent regulations that govern the healthcare and pharmaceutical sectors make it challenging for corporations to be compliant, particularly for new enterprises.
• Data privacy and security regulations, including the HIPAA and GDPR, not only require technical expertise but also adequate investment in research and development to comply with, which can daunt small companies.
• New entrants may also struggle with interoperability needs, which can only be currently met by big companies that have the necessary resources, funds, and technical capability.
• Trust and credibility are predominant in the healthcare sector, which established brands have been able to hold because of their longer presence.

Digital Biomarkers Market News

• In June 2024, ActiGraph collaborated with PKG Health to integrate the latter’s algorithms into the CentrePoint Cloud Platform of the former. This was done to improve clinical trials for neurodegenerative disorders, such as Huntington’s disease, essential tremors, and Parkinson's disease. The partnership will provide objective digital measures with more-sensitive and real-time data collection for better results.
• In March 2024, Biogen and Indivi signed a strategic agreement for improvements in digital health technology and to create digital biomarkers for Parkinson’s disease. This collaboration intends to utilize the digital biomarker platform Konectom and assess the efficiency and safety of BIIB122 for people with early-stage Parkinson's disease.
• In February 2024, Biofourmis signed four new partnerships with pharmaceutical companies to improve oncologic therapies via its digital clinal trial solutions. These collaborations emphasize developing digital biomarkers for the detection of cytokine release syndrome, to minimize study timelines and improve remote patient monitoring through inclusive and decentralized trials.