United States Digital Biomarkers Market 2033 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Global Digital Biomarkers Market reached US$ 4.16 Billion in 2024 and is expected to reach US$ 26.69 Billion by 2033, growing at a CAGR of 22.7% during the forecast period 2025-2033, according to DataM intelligence report.

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Key Development:

United States / North America: Recent Digital Biomarker Developments

✅ In November 2025, There is a rapid growth in the adoption of AI-powered wearables and mobile health apps across North America, reinforcing the region's leadership in remote monitoring and digital-biomarker integration.

✅ In November 2025, researchers introduced a new digital biomarker called "AI-PPG age," which uses wearable PPG signals to estimate vascular and biological aging. Individuals with higher AI-PPG age showed significantly elevated cardiovascular-risk indicators.

✅ In October-November 2025, a study demonstrated that one night of sleep data captured through wearables or contactless sensors can be used by transformer-based AI models to detect antidepressant usage, creating a new digital biomarker for medication-adherence monitoring.

✅ In late 2025, clinical-trial ecosystems in the U.S. reported growing integration of wearable-derived digital biomarkers as remote endpoints, supported by regulatory interest in decentralized and data-driven monitoring frameworks.

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Europe: Recent Digital Biomarker Developments

✅ In November 2025, European researchers contributed to the "AI-PPG age" breakthrough, validating the wearable-derived vascular-aging biomarker using large population datasets across multiple European cohorts.

✅ In 2025, major research programs expanded efforts to develop digital biomarkers for both physical and mental-health outcomes by combining sensor data, sleep patterns, activity metrics and digital-phenotyping datasets.

✅ In mid-to-late 2025, European health-tech analyses reaffirmed rising adoption of wearable-based digital-health solutions, driven by preventive-care initiatives and increasing reliance on remote monitoring for chronic-disease management.

✅ In 2025, regulatory progress under initiatives like the European Health Data Space strengthened secure data-sharing frameworks, enabling more robust integration of digital biomarkers in clinical practice, research and public health.

Key Players:

=> Koneksa Health, Altoida Inc, Empatica Inc, Evidation Health, Inc., ActiGraph LLC, Quartet Health, IXICO plc, Vivo Sense, Aural Analytic, Neurotrack Technologies, Inc and among others.

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Key Segments:

By System Component

Wearable Devices dominate the market with around 40% share, driven by increasing adoption of smartwatches, biosensors, fitness trackers, and clinical-grade wearables used for continuous physiological and behavioral monitoring. Mobile Applications hold nearly 25%, supported by the growing integration of smartphone-based health tracking, symptom logging, and remote monitoring systems. Sensors account for approximately 20%, with rising use of motion, biochemical, optical, and environmental sensors in clinical trials and patient monitoring. Digital Platforms, Data Integration & Analytics Platforms represent 10% share, driven by advancements in cloud analytics, AI-driven biomarker interpretation, and data interoperability solutions. Others, including implantables and telehealth tools, contribute about 5%.

By Application

Cardiovascular Diseases lead with nearly 30% share due to high global prevalence and increasing deployment of digital biomarkers for arrhythmia detection, blood pressure monitoring, and heart failure management. Neurological Disorders hold 25%, propelled by demand for digital measures in Parkinson's, Alzheimer's, epilepsy, and mental health monitoring. Respiratory Disorders represent around 15%, with strong adoption in asthma, COPD, sleep apnea, and pulmonary monitoring applications. Metabolic Disorders account for 15%, driven by rising diabetes cases, lifestyle disease management, and continuous glucose monitoring technologies. Gastrointestinal Disorders hold nearly 10%, supported by digital assessments of motility, gut health, and IBS symptoms. Others, including oncology, rare diseases, and immune disorders, make up the remaining 5%.

By End User

Pharmaceutical Companies dominate with ~35% market share, driven by the rising use of digital biomarkers in decentralized clinical trials, drug development, patient stratification, and real-time outcome measurement. Healthcare Providers hold 30%, supported by adoption of digital biomarker platforms in hospitals, remote patient monitoring programs, and chronic disease management. Payers represent 15%, integrating digital biomarkers for risk assessment, personalized plans, and cost optimization. Academic & Research Institutions hold 10%, utilizing digital biomarker tools for clinical research, validation studies, and scientific advancements. Others, including government bodies and digital health startups, contribute about 10%.

By Region

North America - 40% Share
North America leads due to strong digital health adoption, FDA approvals for digital endpoints, major wearable manufacturers, and high investment in remote monitoring and AI-driven healthcare.

Europe - 25% Share
Europe follows with 25%, supported by digital therapeutics growth, EU initiatives for digital health data sharing, and robust clinical research infrastructure.

Asia Pacific - 23% Share
Asia Pacific is rapidly expanding with 23% share, driven by rising chronic diseases, mobile-health penetration, wearable usage, and government support for digital healthcare.

Latin America - 6% Share
Latin America shows steady growth with 6%, driven by increasing telehealth adoption and interest in remote monitoring tools.

Middle East & Africa - 6% Share
MEA accounts for 6%, supported by smart healthcare projects, rising investments in digital health infrastructure, and growing wearable adoption.

FAQ

What is the current size of the Digital Biomarkers Market?

A: In 2024, the Digital Biomarkers Market was valued at US$ 4.16 Billion, reflecting its strong industry presence.

Q2: How large is the Digital Biomarkers Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Digital Biomarkers Market will grow to around US$ 26.69 Billion , demonstrating significant expansion.

Q3: What is the growth rate of the Digital Biomarkers Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 22.7% during the forecast period from 2025 to 2033.

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