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Psychiatric Digital Biomarkers Market Report Scope & Overview:

The psychiatric digital biomarkers market size was valued at USD 626.34 million in 2024 and is expected to reach USD 3591.54 million by 2032, growing at a CAGR of 24.44% over the forecast period of 2025-2032.

The global psychiatric digital biomarkers market is growing at a robust rate, primarily driven by the increasing prevalence of mental disorders and the demand for objective and real-time monitoring devices. AI, wearables, and smartphone platforms are improving the early diagnosis and personalized treatment. The growth of the market is significantly driven by the rising investments in digital health, increased adoption of telepsychiatry, and a conducive regulatory landscape. As clinicians and patients become more aware and acceptance increases, the market will further develop in developed and emerging regions.

The U.S. psychiatric digital biomarkers market size was valued at USD 265.08 million in 2024 and is expected to reach USD 1502.48 million by 2032, growing at a CAGR of 24.26% over the forecast period of 2025-2032.

On account of the advanced digital health infrastructure and superior regulatory support in the country, the U.S. leads the North American psychiatric digital biomarkers market growth, driven by a persistent awareness of the leading mental health conditions. Its leading position in the region is furthered by the enormous adoption of AI-powered mental health tools and an increase in investments in digital therapeutics.

Based on a recent study by JMIR Mental Health, remote monitoring platforms such as RADAR‑base are being used to obtain passive and active data from smartphones and wearables in populations assessing several clinical cohorts (depression, schizophrenia, ADHD, MS, and autism). Incidence level provides for digital biomarker development and high-throughput remote data capture.

In June 2025, an article by Technology Networks noted that digital biomarkers derived from wearables and mobile devices now enable patient-centric, adaptive clinical trials. The use of these sensors allows for real-time sensor-based monitoring of mental health symptoms—an approach that may alleviate trial burden while increasing sensitivity compared to traditional self-report outcomes.

Market Dynamics:

Drivers

  • Growing Mental Health Burden Driving Demand for Digital Solutions, Resulting in Market Growth

The increasing prevalence of global mental disorders such as depression, anxiety, bipolar disorder, and schizophrenia has become a major public health issue. Approximately one in eight people globally suffers from some form of mental illness, and the need for diagnosis and continuous monitoring is growing. The nature of traditional psychiatric assessments — subjective, episodic — leaves little room for early intervention. These digital biomarkers—indicators of health that can be measured within behavioral and physiologic data, including speech patterns, activity levels, and sleep—provide an objective, data-driven approach for identifying early warning signals and optimizing personalized treatment for patients. The move to a more preventive approach to mental health is driving growth in digital biomarker technology in a material way.

A Perspective in nature digital medicine based on an international workshop on digital sensing highlights the scientific need, based on the increasing prevalence of psychiatric conditions, for scalable and longitudinal data collection through wearables and smartphones for studying psychiatric conditions in large, heterogeneous populations (2024).

  • Increasing Accessibility of Wearables and Mobile Platforms Driving the Market Growth

With the swift growth of wearable technology and mobile health apps, it has transformed the collection and analysis of mental health data. Wearables (smart watches, fitness trackers, smartphone-based tools, etc.) have become capable of passively monitoring important metrics such as heart-rate variability, sleep, and physical activity levels, providing digital proxies for aspects of mental health. They enable out-of-clinic continuous, real-time monitoring, which makes it more accessible for patients and providers. Considering the increasing number of people using smartphones globally, which is more than 6 billion, and the rising penetration of upsurge tech is growing rapidly and allow scalable psychiatric care near the house and in remote and underserved areas, owing to these factors, the growth of the psychiatric digital biomarkers market is expected to highly boost during the forecast period.      

A ScienceDirect paper discussed predictors of the severity of neuropsychiatric symptoms in older adults based on wearable-derived biomarkers, using wearable sleep data to predict the severity of depression, showing that signals collected from wearables can be used to build accurate predictive models.

Similarly, a systematic review on research from 2019–2024 on ScienceDirect found that digital biomarkers for depression yielded a performance range from 0.52 to 0.98. This suggests high variability of potential performance based on sensor types and algorithms.

Restraint

  • The Growth of the Market is Inhibited by Factors Such as Data Privacy and Security Concerns

Using phones, wearables, and other digital tools, psychiatric digital biomarkers frequently gather highly sensitive information—mood changes, sleep behaviors, voice tone, the amount and distance of movement, and even social interactions. This constant and passive listening poses a significant risk for data breaches, unauthorized access, and misuse of that data, particularly if it were to be stored in a centralized, unencrypted, or unsecured cloud-based system.

People are particularly sensitive to data handling due to the social stigma around mental health. Patients may shy away from these technologies due to concerns about surveillance, profiling, or leaks of private information. In addition, organizations and healthcare providers are bound by stringent privacy legislation such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. This means that secure data handling, informed consent, and minimization of data sharing are required under these frameworks all of which create cost and operational complexity for developers.

Privacy concerns will be one of the main reasons preventing mental health digital biomarkers solutions from being adopted until trust is established via transparent data governance, solid cyber-securities, and clear control of people over their data.

Segmentation Analysis:

By Type

In 2024, the psychiatric digital biomarkers market share was dominated by the wearable segment with 36.5% owing to the offered real-time, continuous assessment of metrics, including changes in physiological signals and behaviors associated with mental illnesses. Wearable devices (smartwatch, fitness band, and biosensor) are widely used for sleep and activity tracking, which are important parameters for psychiatric disorders such as depression and anxiety, and heart rate (HR) variability (HRV) during everyday activities, which are possible biomarkers for depression. Wearables emerged as a promising tool to monitor mental health due to their associated convenience, non-invasive capability, and progressive accuracy, in addition to growing integration with health care systems and research studies.

The desktop & mobile applications segment is projected to grow the fastest over the forecast period, due to the expanding digital therapeutics and soaring usage of smartphones globally. Such applications use artificial intelligence and machine learning algorithms to explore the speech patterns, facial expressions, and cognitive behaviors of individuals for early detection and customized approach strategies. Apps would be the most high-potential segment, due to their excellent scalability and cost-effectiveness, supported recently by the rise in user engagement through telepsychiatry and digital self-assessment platforms. Also, continuous improvements in cloud computing and data security are speeding adoption even more by providers and mental health tech innovators.

By System Component

The software segment accounted for the largest share of the psychiatric digital biomarkers market in 2024, with around 56.1%, as it plays an important role in centralizing data collection, analysis, and interpretation of behavioral and physiological signals. These software platforms allow digital biomarkers to come together from disparate sources, such as wearables, mobile apps, and sensors, utilizing sophisticated algorithms and AI to identify patterns associated with psychiatric conditions. Software comprises the heart of virtually all psychiatric digital biomarker solutions, a trend primarily driven by increasing needs for scalable, cloud-based solutions and real-time analytics that is now widespread at healthcare systems, research institutions, and digital health startups.

The services segment is expected to witness the fastest growth during the forecast period due to rising demand for implementation support, data management, training & technical assistance. With the adoption of digital biomarker solutions by healthcare providers and mental health organizations, there is demand for tailored services for system integration and compliance, patient onboarding, and customization. This expansion of telehealth, combined with ongoing outsourcing trends and demand for personalized, end-to-end support, will drive growth in product availability, especially in emerging markets and in community-based mental health programs.

By Clinical Practice

The diagnostic psychiatric digital biomarkers segment accounted for the largest market share with around 33.2%, owing to their importance in the early detection of psychiatric diseases and objective measurement of mental health issues. Conventional psychiatric diagnoses are often subjective, lacking the reliable evidence presented in the form of digital biomarkers detected from the speech features, facial expressions, sleep patterns, and physiological activities. As the demand for early intervention increases and machine learning and AI-driven analysis mature, digital diagnostics can also assist clinicians, particularly primary care and remote clinicians, in making their decisions.

The segment of monitoring psychiatric digital biomarkers is anticipated to grow at the fastest CAGR during the forecast period due to the growing focus on continuous mental health tracking and personalized care. Through monitoring tools that provide real-time monitoring of symptoms and behaviors, such as treatment response and progression of symptoms, remote care will allow for more effective long-term management of chronic conditions such as depression, bipolar disorder, and PTSD.

By Application

The depression segment dominated the psychiatric digital biomarkers market share in 2024 with 48.3%, owing to the high global prevalence of depressive disorders and an unmet need for accurate, objective diagnostic and monitoring tools. Depressive symptoms can be identified and tracked with high accuracy using digital biomarkers such as vocal prosody, facial expressions, movement patterns, and sleeping behaviour. The combination of data-driven validated digital tools, a well-established clinical research base, and the increased adoption of wearable and mobile technologies has led to the rapid uptake of digital biomarkers for depression in clinical and home-based care settings.

The anxiety disorders segment is expected to see the fastest growth over the forecast years due to higher awareness rates, diagnosis rates, and increased impact of chronic stress and lifestyle triggers. Obvious signs of anxiety may be intense fear, but there are slight indicators, such as heart rate variability, speech hesitations, and changes in behaviour patterns. The rapid increase in the mobile mental health application market and the increasing acceptance of continuous and immediate measurement of anxiety symptoms are driving the demand for solutions based on digital markers that are particularly suitable for self-administration of anxiety, especially in younger and more technology-friendly populations.

Regional Analysis:

The U.S. and Canada together contribute to the highest share of the psychiatric digital biomarkers market trend in North America, with around a 55.6% market share in 2024, due to the well-established healthcare infrastructure, early adoption of modern digital health technologies, and strong presence of leading biotech and health tech companies in this region. The region is assisted by well-established regulatory frameworks that help accelerate the deployment of the product in the market, for instance, FDA approvals for digital therapeutics and biomarker-based tools. In addition, the growing awareness of mental health, widespread smartphone penetration, and the use of wearable technologies have contributed to the rapid integration of psychiatric digital biomarkers into clinical care and home settings.

Asia Pacific is growing significantly in the global psychiatric digital biomarkers market analysis over the forecast period, primarily due to an increase in mental health problems, increasing access to mobile health technologies, and increasing digital literacy.  governments around the globe, ranging from China, India, to Japan, are initiating and turning the tide with investments into mental health infrastructure and in digital health innovation. The vast, untreated patient population combined with the explosion of lower-cost AI-based health solutions makes the region a ripe fit for widespread uptake of psychiatric digital biomarkers in sophisticated cities and less resourced, rural communities alike.

The psychiatric digital biomarkers market trend in Europe is also rising due to the growing awareness of mental health issues and the rising demand for innovative solutions for diagnosis and monitoring. Supportive health policies, investment in digital health research, and collaboration between providers and technology companies in the region are key drivers. Market adoption of digital biomarkers continues to advance in other countries, too, such as Germany, the U.K., and the Netherlands, as national initiatives and pilot programs are integrating them into mental health care.

The psychiatric digital biomarkers market shows moderate growth in Latin America and the MEA regions due to the provision of improved access to healthcare and increasing awareness about mental health problems. Digital health adoption has been slower than in the developed regions, but growing smartphone penetration and gradual policy changes for mental health support are still driving market growth. It is further complemented by regional pilot initiatives along with partnerships with global technology enterprises that are providing an entry for digital biomarker researchers to localize their tools in clinical and community-based mental health contexts.

Key Players:

Psychiatric Digital Biomarkers Market companies are Koneksa Health, Empatica Inc., Sonde Health, Biogen Inc., VivoSense Inc., IXICO plc, Clario, Mindstrong Health, Behavioral Signals, Neurotrack Technologies, Ginger (Ginger.io), Quartet Health, Akili Interactive, Pear Therapeutics, Huma Therapeutics, NeuroFlow, Headspace Health, Brainomix, PureTech Health, and Big Health Ltd., and other players.

Recent Developments:

  • April 2024 – Sonde Health reported the release of a new study in Frontiers in Psychiatry, confirming the validity of its Mental Fitness Vocal Biomarker (MFVB) platform. The study points out that the MFVB is able to accurately identify symptoms of mental illness using brief voice recordings.

  • October 2022 – Koneksa, a digital biomarker-focused healthcare technology company with evidence-based biomarkers, introduced its clinical pipeline of validated biomarkers across several therapeutic categories such as neuroscience, oncology, and respiratory health. It aims to facilitate more accurate and timely clinical decision-making using digital health solutions.

  • April 2024 – A Swiss medical technology firm partnered with Biogen to create a digital biomarker platform to support a future clinical trial for BIIB122, Biogen's experimental treatment for Parkinson's disease. The partnership will promote the use of digital technologies in clinical research and management of neurodegenerative diseases.

    Psychiatric Digital Biomarkers Market Report Scope:
    Report Attributes Details
    Market Size in 2024 USD 626.34 million 
    Market Size by 2032 USD 3591.53 million 
    CAGR CAGR of 60.20% From 2025 to 2032
    Base Year 2024
    Forecast Period 2025-2032
    Historical Data 2021-2023
    Report Scope & Coverage Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
    Key Segments • By Type (Wearable, Smartphones, Desktop and Mobile Applications, Sensor-based Devices, Artificial Intelligence & Machine Learning Platforms)
    • By System Component (Software, Hardware, Services)
    • By Clinical Practice (Diagnostic Psychiatric Digital Biomarkers, Monitoring Psychiatric Digital Biomarkers, Predictive and Prognostic Psychiatric Digital Biomarkers, Others [Safety, Pharmacodynamics/Response, Susceptibility])
    • By Application (Depression, Anxiety Disorders, Schizophrenia, Bipolar Disorder, Post-Traumatic Stress Disorder [PTSD], Attention Deficit Hyperactivity Disorder [ADHD])
    • By Deployment Mode (Cloud-Based, On-Premise)
    • By End Use (Hospitals & Clinics, Research & Academic Institutions, Pharmaceutical & Biotech Companies, Digital Health Startups, Homecare Settings)
    Regional Analysis/Coverage North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)
    Company Profiles Psychiatric Digital Biomarkers Market companies are Koneksa Health, Empatica Inc., Sonde Health, Biogen Inc., VivoSense Inc., IXICO plc, Clario, Mindstrong Health, Behavioral Signals, Neurotrack Technologies, Ginger (Ginger.io), Quartet Health, Akili Interactive, Pear Therapeutics, Huma Therapeutics, NeuroFlow, Headspace Health, Brainomix, PureTech Health, and Big Health Ltd., and other players