Psychiatric Digital Biomarkers Market Size, Share & Trends Analysis Report By Type (Wearables, Mobile-based Applications, Sensors), By Clinical Practice (Diagnostic, Monitoring, Predictive & Prognostic), By End-use, By Region, And Segment Forecasts, 2025 - 2030

Psychiatric Digital Biomarkers Market Trends

The global psychiatric digital biomarkers market size was estimated at USD 631.3 million in 2024 and is projected to grow at a CAGR of 24.4% from 2025 to 2030. The rising prevalence of mental health disorders, advancements in digital health technologies, and growing demand for personalized medicine drive the market. For instance, according to the World Health Organization, approximately 280 million individuals across the globe have depression. Depression is about 50% more common among women than men.

The rising adoption of wearable devices and mobile health apps in mental healthcare contributes to market growth. Moreover, according to the International Data Corporation (IDC), shipments of wearable devices increased by 2.6% across the globe in the third quarter of 2023 compared to the previous year, setting a new third-quarter record with a total of 148.4 million units.

Moreover, the global burden of mental health disorders is on the rise, with conditions such as depression, anxiety, bipolar disorder, and schizophrenia affecting millions of individuals worldwide. In 2023, Mental Health America, Inc. found that 20.17% of youths aged 12-17 had encountered a major depressive episode, with 15% suffering severe impairment affecting daily activities. This increasing prevalence is driving the need for more effective tools to monitor and manage mental health conditions, leading to a growing demand for psychiatric digital biomarkers.

Technological advancements in digital health technologies have revolutionized the field of mental healthcare. Innovations such as artificial intelligence (AI), machine learning, and data analytics enable the development of sophisticated digital biomarkers that provide valuable insights into an individual’s mental health status. AI-powered algorithms analyze data from smartphone sensors to detect changes in behavior patterns that indicate early signs of a mental health crisis. For instance, in September 2022, Feel Therapeutics Inc., a digital biomarkers and therapeutics developer to bring objective data in mental health, introduced the Digital Precision Medicine Platform. With this platform, the company is able to collect clinically valuable data points passively and on a 24/7 basis to generate real-world evidence (RWE) and discover novel digital biomarkers and endpoints.

Market Concentration & Characteristics

The global psychiatric digital biomarkers industry is characterized by a high degree of innovation, owing to ongoing advancements in the field of real-time monitoring of complicated diseases by detecting biomarkers. For instance, in March 2023, Koneksa, a digital biomarkers company, extended its partnership with SSI Strategy, a life sciences consulting firm. This partnership enables SSI to enhance Koneksa’s medical strategy division, particularly in translational and clinical drug development. SSI clients gain access from Koneksa’s expertise in designing and employing evidence-based digital biomarkers.

The market is characterized by medium merger and acquisition activity, owing to several factors, such as growing awareness regarding mental health, the need to cater to the growing demand for digital biomarker devices, and the need to maintain a competitive edge in the market.

Regulatory guidelines established by various authorities significantly influence market growth. In the U.S., the Food and Drug Administration (FDA) governs digital biomarkers, including psychiatric digital biomarkers, by overseeing medical devices and digital health technologies. The FDA has a Biomarker Qualification Program (BQP) for new biomarkers and a Digital Health Center of Excellence (DHCoE).

Several market players are expanding their business by launching new products to strengthen their market position and portfolio. For instance, in October 2022, Koneksa, a digital biomarkers company, introduced its clinical pipeline, featuring biomarkers across respiratory, neuroscience, oncology, and other therapeutic areas. In addition, with 15 digital biomarker programs in development, the company is expected to introduce several upcoming clinical studies.

Type Insights

By type, the wearable segment held the largest market share of 39.9% in 2024. Wearable devices are becoming popular within psychiatric care, offering real-time mental health tracking through physiological and behavioral data. The demand for such innovative diagnostic and management tools is growing. This adoption of wearables for personalized care and monitoring is set to improve outcomes for patients with mental health conditions. For instance, in February 2024, Empatica, an AI company developing digital biomarkers, was chosen by the U.S. Department of Defense (DoD) as a technology partner for the Defense Health Agency’s Posttraumatic Stress Disorder Drug Treatment (PTSD) Program. This collaboration is part of a clinical study aimed at developing innovative therapies for treating PTSD.

The mobile-based application segment is expected to grow at the fastest rate over the forecast period. Mobile-based applications transform the psychiatric digital biomarker market using smartphones to monitor mental health indicators. In October 2023, the GSMA's State of Mobile Internet Connectivity Report 2023 revealed that 54% of the global population, or 4.3 billion people, have smartphones. These apps utilize advanced technology to track mood, sleep, and social interactions, offering a convenient way to improve early detection and monitoring of mental health issues. Favorable government initiatives, increasing funding for network infrastructure development, and rising consumer awareness about mHealth apps are other key factors driving market growth. According to Mercom Capital Group, mHealth apps raised USD 1.6 billion in venture funding in 1H 2021, a 100% YoY increase.

Clinical Practice Insights

By clinical practice, the diagnostic psychiatric digital biomarkers segment held the largest market share of 31.2% in 2024. The rising burden of mental health conditions emphasizes the urgency for advanced diagnostic solutions, such as psychiatric digital biomarkers, to enhance early detection and intervention. Advancements in technology, such as wearable devices and mobile applications, enable the collection of real-time data on various behavioral and physiological parameters, facilitating the identification of digital biomarkers associated with different psychiatric disorders. For instance, in April 2024, Tris Pharma Inc., a biopharmaceutical company, partnered with Braingaze Ltd., a digital health company, and launched Tris Digital Health, a new business focusing on developing digital therapies and diagnostics for attention deficit hyperactivity disorder (ADHD) and neurological disorders.

The monitoring psychiatric digital biomarkers segment is expected to grow at the fastest CAGR over the forecast period. The growing focus on personalized medicine and precision psychiatry drives the market towards treatments tailored to individuals, considering their profiles. Monitoring digital biomarkers, such as sleep and activity patterns, helps understand patient responses to treatment and disease progression. There is growing potential for these biomarkers to predict relapses in mood disorders. This shift towards data-driven, outcomes-focused healthcare promotes using digital monitoring solutions to enhance patient care in psychiatry. For instance, in March 2024, Merck & Co., Inc., a pharmaceutical company, joined the LEARNS observational study to investigate digital biomarkers for Parkinson’s disease, aiming to enable early diagnosis and treatment through data from smartphones and wearables.

End-use Insights

By end use, the healthcare companies segment held the largest market share of 50.7% in 2024. Healthcare companies are increasingly investing in psychiatric digital biomarkers due to the rising demand for personalized mental health solutions. Integrating digital biomarkers into psychiatric care allows for continuous monitoring and early intervention, improving patient outcomes. For instance, in March 2024, NeuraMetrix identified typing cadence as a novel digital biomarker for neurological disorders, utilizing it for diagnostic precision through an algorithm that measures typing consistency and correlates it with brain diseases. This innovation aims to enhance diagnostic accuracy in neurology and psychiatry significantly.

The payers segment is expected to witness the fastest CAGR over the forecast period. Payers are recognizing the value of psychiatric digital biomarkers in reducing healthcare costs associated with mental health disorders. By leveraging these innovative technologies, payers enhance care coordination, optimize treatment plans, and improve patient adherence to therapy. Insurers such as Cigna Healthcare and UnitedHealth Group are actively exploring partnerships with digital health companies to incorporate these tools into their coverage offerings, which leads to a growing acceptance of psychiatric digital biomarkers in the payer segment.

Regional Insights

North America dominated the psychiatric digital biomarkers industry with a 58.4% market share in 2024. The market is experiencing significant growth in North America, driven by the increasing prevalence of mental health disorders and the rising adoption of digital health technologies. Moreover, North America is one of the first regions to adopt innovative healthcare solutions that include various technologies, such as smart wearables, mobile apps, and digital biomarkers, for remote access to information on neurological conditions.

U.S. Psychiatric Digital Biomarkers Market Trends

The psychiatric digital biomarkers market in the U.S. is expected to grow significantly over the forecast period. The presence of key players, advanced healthcare infrastructure, and high investment in research and development activities fuels the market. For instance, in October 2023, Michael Schöll, a Professor of Molecular Medicine at the University of Gothenburg, secured funding from the U.S. National Institutes of Health (NIH) and joined an international study conducted by The Cognitive Technology Research Lab at Washington University in St. Louis. This research aims to design and evaluate digital biomarkers for Alzheimer's disease in individuals with Down syndrome.

Europe Psychiatric Digital Biomarkers Market Trends

Europe psychiatric digital biomarkers industry is anticipated to witness the fastest CAGR growth over the forecast period, owing to strong government regulations and initiatives promoting digital health solutions and a growing acceptance of telemedicine services. European countries invest significantly in mental health programs incorporating digital biomarkers to enhance diagnostic accuracy and treatment efficacy. Partnerships between pharmaceutical companies and technology firms are driving innovation in psychiatric care across Europe, leading to the development of novel digital tools for mental health assessment and management.

France psychiatric digital biomarkers market is anticipated to register a considerable growth rate during the forecast period, owing to a strong focus on technological advancements and innovation in healthcare. In addition, collaborations between technology companies and healthcare providers and an increasing number of digital biomarker programs drive market growth. For instance, in February 2023, Ad Scientiam, a provider of digital biomarkers, introduced two ambitious programs to design and evaluate novel digital biomarkers for the self-assessment of patients suffering from neuromyelitis optica spectrum disorders (NMOSD) and generalized myasthenia gravis (gMG).

Asia Pacific Psychiatric Digital Biomarkers Market Trends

The Asia Pacific psychiatric digital biomarkers industry is anticipated to grow significantly over the forecast period. The market is driven by rapid urbanization, increasing healthcare expenditures, and a rising burden of mental health disorders. Countries in Asia Pacific are increasingly adopting telepsychiatry services and mobile health applications to address gaps in mental healthcare accessibility. With a growing emphasis on preventive mental healthcare and early intervention strategies, the Asia Pacific market for psychiatric digital biomarkers is poised for significant expansion over the forecast period.

Japan psychiatric digital biomarkers market is anticipated to register a considerable growth rate during the forecast period, owing to the increasing penetration of smartphones and smart wearable devices, rising research collaborations, and the growing adoption of mHealth applications. For instance, in January 2023, Aculys Pharma, Inc., a developer of drugs for neurology and psychiatry, and Four H, Inc., a Japan-based HealthTech company, announced a research collaboration using wearable devices to assist patients with narcolepsy and excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS).

Latin America Psychiatric Digital Biomarkers Market Trends

Latin America psychiatric digital biomarkers industry is anticipated to register a considerable growth rate during the forecast period. The growing adoption of smartphones is driving the growth of various digital healthcare services, as most smartphones enable access to a patient's digital healthcare information irrespective of location and time. Thus, such factors are anticipated to fuel market growth.

Brazil psychiatric digital biomarkers market is anticipated to register a considerable growth rate during the forecast period. The increasing adoption of digital technology and the growing healthcare sector are key factors facilitating market growth. According to World Population Review, in 2024, Brazil had 165.3 million internet users. This indicates a large pool of users turning to digital health.

Middle East & Africa (MEA) Psychiatric Digital Biomarkers Market Trends

MEA psychiatric digital biomarkers industry is anticipated to register a considerable growth rate during the forecast period. Advancements in healthcare systems are expected to bring digital health into action in these countries. Wearable devices, mHealth apps, and AI are key trends transforming healthcare costs, access, and outcomes in this region. Such factors boost the adoption of psychiatric digital biomarkers in this region.

The UAE psychiatric digital biomarkers market is anticipated to register a considerable growth rate during the forecast period. The UAE is one of the most favorable markets for healthcare and digital platforms. Factors such as government aid to innovative startups and high government funding are propelling market growth in the country.

Key Psychiatric Digital Biomarkers Company Insights

Key players operating in the psychiatric digital biomarkers industry are undertaking various initiatives to strengthen their market presence and increase the reach of their types and services. Strategies such as expansion activities and partnerships play a key role in propelling the market growth.

Recent Developments

• In March 2024, Indivi, a MedTech leader based in Switzerland, entered into a partnership with Biogen to propel digital health innovations, specifically focusing on developing digital biomarkers for Parkinson's disease. As a significant part of this agreement, Biogen licensed its smartphone-based digital biomarker platform, KonectomTM, to Indivi.

• In February 2022, digital biomarker startup Koneksa raised USD 45 million in a Series C funding round. The funds are earmarked for expanding its platform and enhancing its science team, focusing on the development of its digital biomarker platform and improving its clinical data integration tools.

Psychiatric Digital Biomarkers Market Report Scope

Global Psychiatric Digital Biomarkers Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global psychiatric digital biomarkers market report based on type, clinical practice, end-use, and region.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Wearable

  • Mobile based Applications

  • Sensors

  • Others

• Clinical Practice Outlook (Revenue, USD Million, 2018 - 2030)

  • Diagnostic Psychiatric Digital Biomarkers

  • Monitoring Psychiatric Digital Biomarkers

  • Predictive and Prognostic Psychiatric Digital Biomarkers

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Healthcare companies

  • Healthcare Providers

  • Payers

  • Others (Patient, caregivers)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait