Psychiatric Digital Biomarkers Market

Psychiatric Digital Biomarkers Market Size and Share:

The global psychiatric digital biomarkers market size was valued at USD 662.55 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 4659.22 Million by 2033, exhibiting a CAGR of 22.60% from 2025-2033. North America currently dominates the market, driven by the increasing prevalence of mental health disorders, advancements in artificial intelligence (AI) and wearable technology, widespread adoption of telehealth, and strong government support for mental health research and innovation.

The global psychiatric digital biomarkers market is primarily driven by the increasing prevalence of mental health disorders. For instance, approximately 9.5 percent of American adults aged 18 and over have a depressive illness (major depression, bipolar disorder, or dysthymia) annually. In addition, ongoing advancements in technology, such as AI and machine learning (ML), enable more precise and personalized treatment plans, aiding the market growth. Moreover, the rising adoption of telemedicine facilitates remote monitoring and care, driving the market demand. Besides this, the increased awareness about mental health is promoting continuous innovation in psychiatric diagnostics, providing an impetus to the market. Furthermore, government support and funding for mental health initiatives are boosting development, thus catalyzing the market growth.

The United States holds a share of 85.60% in the psychiatric digital biomarkers market. The demand in the region is fueled by the growing integration of digital biomarkers into clinical trial protocols. This enhances efficiency and accuracy in evaluating psychiatric treatments, driving adoption and aiding the market growth. Concurrently, the increasing investment by private companies and venture capitalists in mental health technologies fosters innovation, thus contributing to the market expansion. Moreover, the expansion of employer-sponsored mental health programs highlights the rising corporate focus on employee well-being, which is impelling the market growth. Apart from this, the proliferation of wearable devices equipped with advanced sensors enables real-time data collection, supporting personalized mental health interventions, thereby propelling the market forward.

Psychiatric Digital Biomarkers Market Trends:

Integration of technologies

The integration of AI and ML in psychiatric digital biomarkers is revolutionizing the diagnosis of mental health disorders. These technologies help to approximate a large amount of data produced by wearable gadgets, applications, and various sorts of monitors that describe the mental health status of patients in real-time. In addition, the AI algorithms can detect patterns that predict psychiatric episodes or relapse and develop individualized treatments. In May 2024, Human Health Services (HHS) provided the Leading Edge Acceleration Projects (LEAP) in Health Information Technology (IT) Special Emphasis Notice, including AI and Behavioral Health Projects. This endeavor aims to promote significant solutions to enhance behavioral health via AI. Moreover, the increasing development of AI models improves the feasibility and accessibility of early intervention. Also, the improvements in the accuracy, efficiency, and speed of psychiatric assessment tools offer enhanced personalized care to patients, contributing to the market growth.

Rise in adoption of wearable devices for mental health monitoring

The rising adoption of wearable devices is increasing the psychiatric digital biomarkers market demand. For instance, approximately 60% of survey respondents owned a wearable device, showcasing a significant user base for health monitoring technologies. These smart devices including smartwatches, biosensors, and fitness trackers gather data on sleep cycles, physical activity, and physiological data that are important to track mental health. Also, real-time monitoring with wearables is a mobile and non-intrusive approach to the existing clinical methods of psychiatric evaluation. The growth of this trend is due to the development of sensor technology that has provided better performance and comfort in wearing such devices. Furthermore, the consumer demand for health care and increased attention to their well-being and individuality results in the development of psychiatric digital biomarkers as wearables enable efficient tracking of mental health, thereby impelling the market growth.

Growing focus on personalized and remote mental health care

The growing need for individualized and telemedicine mental health services is driving the expansion of the psychiatric digital biomarkers market. Self-guided Digital Cognitive Behavioral Therapy (CBT) programs translate into a significant reduction of symptoms of depression, thereby providing evidence for the use of personal digital CBT for idiopathic depression. In line with this, the adoption of various technologies in health care allows improved treatments for the patients, based on constant checking of mental health status, making it more personalized. Additionally, tele-technology enables healthcare providers to monitor patients’ status in real-time and change interventions without physically seeing the patient. Apart from this, the surging awareness of mental health problems and the popular approach to a preventative course in treating such conditions are increasing the utilization of digital health solutions in mental health management, thus fostering the market expansion.

Psychiatric Digital Biomarkers Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global psychiatric digital biomarkers market, along with forecasts at the global, regional, and country levels from 2025-2033. The market has been categorized based on type, clinical practice, and end use.

Analysis by Type:

• Wearable
• Mobile-based Applications
• Sensors
• Others

The wearables segment holds the largest market share in the global psychiatric digital biomarkers market, accounting for 38.2%. This growth is primarily due to the demands for constant observation of mental health conditions. Smartwatches and other biosensors give important information regarding one or more mental health parameters. These include activities like sleep, physical, and physiological, which are crucial for the evaluation and treatment of psychiatric illnesses. These convenient, non-invasive, easy-to-use devices make it possible for patients to monitor mental health on their own at a relatively low cost. Moreover, the growth in sensing technology and utilization of AI and ML algorithms in wearables has highly improved their performance and reliability. Furthermore, the increasing incidence of mental health problems and general tendencies toward individualized medicine promote the surging adoption of wearables. Also, with the shift towards remote and preventative healthcare, wearables are significantly driving the market forward.

Analysis by Clinical Practice:

• Diagnostic Psychiatric Digital Biomarkers
• Monitoring Psychiatric Digital Biomarkers
• Predictive and Prognostic Psychiatric Digital Biomarkers
• Others

The diagnostic psychiatric digital biomarkers segment holds a significant market share of 32.5%. This segment is driven by the increasing need for accurate, non-invasive diagnostic tools in mental health care. In line with this, mental health disorders are becoming more common globally, and increased development of more complex techniques in diagnosing clinical conditions such as depression, anxiety, and schizophrenia is being required. These self-care devices use technologies like AI, ML, and big data analysis to analyze data from wearable, applications, and tests that offer instant and individualized readouts on mental health conditions. As a result, patients can be managed early and given individualized treatment plans providing improved results. Besides this, the demand has arisen with the move towards precision medicine and the need for more effective healthcare systems, leading to the advancement of diagnostic biomarkers. These shifts entailing increased costs of healthcare and requiring better psychiatric therapies are making diagnostic digital biomarkers a vital tool for improving the management of mental health, thus propelling the market forward.

Analysis by End Use:

• Healthcare Companies
• Healthcare Providers
• Payers
• Others

The healthcare companies segment holds the largest market share of 48.7%. This segment is driven by the increasing demand for innovative solutions to improve mental health diagnosis and treatment. Healthcare businesses are pioneers in adopting digital biomarkers in psychiatric services, with AI, ML, and wearable technologies. These technologies allow for constant vigilance, the collection of data in real time, and better individual care for patients. Moreover, with the increasing rate of mental health disorders along with the shifting emphasis on the development of preventive medicine, healthcare companies are widely adopting digital health solutions. In addition to this, regulatory support, reimbursement policies, and collaboration between tech firms and healthcare providers continue to drive the market of psychiatric digital biomarkers. Furthermore, the shifting trends toward patient-centric models, reliance on data analysis, and technological advances are significantly contributing to the market expansion.

Regional Analysis:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others

• Middle East
• Africa

North America holds the largest market share in the global psychiatric digital biomarkers market. This segment is expanding due to the region's advanced healthcare infrastructure and growing mental health awareness. The growing incidence of mental illness including major depressive disorder and anxiety disorder has led to a high desire for newer diagnostic and clinical procedures. According to reports, it is estimated that one in four adults in the United States, individuals aged 18 or over, have a mental disorder in a given year. Moreover, the increased utilization of digital health technologies such as wearables and AI solutions has fueled the fast expansion of psychiatric digital biomarkers. Besides this, the growing attention of the authorities, subsidies, grants, and scientific studies of the potential to advance healthcare for mentally ill patients is fostering the development. Furthermore, telemedicine and remote patient monitoring (RPM) are highly prevalent in the region which is a key factor in enhancing digital biomarkers due to ongoing and customized care of patients. Additionally, the increased demand for cheap and non-invasive diagnostic tools in the healthcare market is strengthening the market share.

Key Regional Takeaways:
 

United States Psychiatric Digital Biomarkers Market Analysis

The United States holds a significant position in the global psychiatric digital biomarkers market, driven by the increasing demand for advanced mental health solutions. The rising prevalence of mental health disorders such as depression, anxiety, and Post-Traumatic Stress Disorder (PTSD) in the U.S. has spurred the need for more effective, non-invasive diagnostic tools. For instance, the indigenous Caucasian males over the age of 85 years record the highest suicide rates in the United States of America. However, another preventable cause of death is suicide especially among teens and adults within the ages of 15-24 years. Also, the rising adoption of digital biomarkers, including wearables, mobile apps, and AI-driven platforms, is growing due to their ability to provide continuous real-time monitoring and personalized treatment. Additionally, the widespread availability of telehealth services has further propelled the use of digital health technologies, allowing remote care and early intervention. Concurrently, government support through initiatives like the National Institute of Mental Health (NIMH) and funding for mental health research are enhancing innovation in the region. Moreover, the shift toward precision medicine and personalized healthcare is driving demand for tailored mental health treatments. Apart from this, the healthcare system in the U.S. increasingly focuses on preventative care, bolstering the market demand.

Europe Psychiatric Digital Biomarkers Market Analysis

Europe is experiencing significant growth in the global psychiatric digital biomarkers market, driven by the rising awareness of mental health issues and the increasing prevalence of psychiatric disorders. The region's strong healthcare infrastructure and regulatory support create a conducive environment for the adoption of digital health technologies, including wearables, mobile applications, and AI-driven diagnostic tools. European governments are investing in mental health research and initiatives, further supporting innovation in psychiatric care. According to the World Health Organization (WHO), only 19 countries released the criteria for the assessment of digital health interventions in 2023, which is critical to make the processes safe and efficient. The demand for personalized and remote healthcare solutions is also growing, as patients seek non-invasive, cost-effective ways to monitor and manage mental health. Furthermore, the region's focus on integrating digital health technologies with traditional healthcare systems is boosting the adoption of psychiatric digital biomarkers. With increasing investments from both private and public sectors, along with evolving healthcare policies, the region is poised to continue to encourage the advancement of psychiatric digital biomarkers.

Asia Pacific Psychiatric Digital Biomarkers Market Analysis

The Asia Pacific region is witnessing rapid growth in the psychiatric digital biomarkers market, driven by the rising prevalence of mental health disorders and the growing demand for innovative healthcare solutions. According to reports, a survey revealed that about 56% of the Asia Pacific understanding of the anti-Asian mental health prejudice, thus the demand for more awareness and prevention of such health problems. Rapid urbanization, evolving healthcare infrastructure, and greater access to digital technologies are key factors contributing to the market expansion. Additionally, the region's rising awareness of mental health issues and the adoption of wearable devices and AI-driven tools for continuous monitoring are fueling the market growth. Moreover, government initiatives, along with partnerships between healthcare providers and tech companies, are supporting the development and integration of psychiatric digital biomarkers in the Asia Pacific.

Latin America Psychiatric Digital Biomarkers Market Analysis

The Latin American market for psychiatric digital biomarkers is expanding as mental health awareness increases promoting the demand for advanced diagnostic tools in the region. For example, over 70% of the population in Latin America and the Caribbean with a demand for mental health treatment is unserved. Limited access to traditional psychiatric care drives the adoption of non-invasive, cost-effective solutions like wearables and mobile apps. Furthermore, government initiatives and partnerships with healthcare providers are promoting the integration of digital health technologies. Besides this, the region focuses on improving healthcare access and outcomes. As a result, psychiatric digital biomarkers are gaining traction in mental health management across Latin America.

Middle East and Africa Psychiatric Digital Biomarkers Market Analysis

The Middle East and Africa market for psychiatric digital biomarkers is significantly expanding, driven by increasing awareness of mental health issues and a shift towards digital health solutions. The region's growing adoption of wearable devices and AI-driven tools for psychiatric monitoring is addressing gaps in healthcare access. Additionally, rising government initiatives and investments in healthcare technology are supporting the development of digital biomarkers. For instance, Saudi Arabia in its 2023 budget plan committed more than $50 billion towards investment in a package of measures that included digital health services targeted at increasing productivity, as well as the opportunities and the clarity of health care. As mental health care evolves, the demand for non-invasive and cost-effective diagnostic solutions is boosting market growth in the region.

Competitive Landscape:

The competitive landscape of the psychiatric digital biomarkers market is marked by significant activity from key players, including healthcare companies, technology firms, and startups, all aiming to innovate and capture market share. Major trends include the integration of AI and ML to enhance diagnostic accuracy and the development of wearable devices for continuous mental health monitoring. Companies are focusing on strategic partnerships, acquisitions, and collaborations to advance research and expand their product portfolios. Several companies are working with academic institutions and healthcare providers to enhance the clinical validation of digital biomarkers. Additionally, there is a growing emphasis on data privacy and regulatory compliance as mental health data becomes more integrated into digital health solutions.

The report provides a comprehensive analysis of the competitive landscape in the psychiatric digital biomarkers market with detailed profiles of all major companies, including:

• Empatica Inc
• iMediSync,Inc
• IXICO plc
• Kintsugi Mindful Wellness, Inc
• Koneksa Health
• Sonde Health, Inc.

Latest News and Developments:

• In December 2024, Empatica, a digital health company, tied up with Personal KinetiGraph (PKG) Health to provide digital endpoints for tremor and movement disorders in clinical trials. This synergy combines PKG’s movement disorder algorithms with Empatica’s wearable for improving neurology clinical trials in general and more specifically for Parkinson’s disease.
• In October 2024, Empatica partnered with the U.S. Department of Health, utilizing EmbracePlus wearables to collect data from 4,000 participants post-vaccination, advancing public health emergency preparedness initiatives.
• In July 2024, Sonde Health launched a cognitive fitness tracker that measures voice samples from 30 seconds of voice activity to determine cognitive load. The tool helps people to track their mental status to improve mental health and efficiency.
• In February 2024, Kintsugi partnered with Wellin5, an online counseling provider, to integrate Kintsugi's AI-driven mental health technology into Wellin5's platform. This collaboration aims to enhance mental health care by providing more personalized and effective support to users.

Psychiatric Digital Biomarkers Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the psychiatric digital biomarkers market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global psychiatric digital biomarkers market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's Five Forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the psychiatric digital biomarkers industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.