Global Psychiatric Digital Biomarkers Market 2025–2034

Reports Description

Global Psychiatric Digital Biomarkers Market is estimated to be USD 7.65 Billion in 2025 and is projected to reach USD 36.8 Billion in 2034. The market is anticipated to grow at a CAGR of 19.5% during the forecast period 2025 – 2034.

Psychiatric Digital Biomarkers Market: Overview

The conventional method of manually tracking individuals’ health data is associated with a number of challenges, such as the risk of loss or damage to health records, the susceptibility to errors, the time and cost-intensive process, and the delay in the timely assessment of critical health information.

Consequently, the timely treatment of patients, particularly the aging population, is impeded. It is estimated that 65% of hospital patients and over 90% of post-acute care patients are manually monitored for vital signs and patient-specific parameters every four to eight hours. Consequently, telemedicine has become increasingly prevalent, as it employs digital tools to offer remote consultations and services.

Further, the World Health Organization predicts that by 2030, one-sixth of the global population will be over the age of 60. Therefore, it is intuitively superior to preemptively identifying their symptoms at an early stage rather than treating patients who are critically ill (due to the extended waiting period).

Studies have demonstrated that patients’ quality of life has been significantly enhanced, and healthcare costs have been reduced due to continuous symptom monitoring and early intervention. The healthcare industry’s increasing digitalization has resulted in the creation of numerous digital solutions that are capable of generating, accumulating, and monitoring medical information (through biomarkers in the body).

Digital solutions for biomarkers are defined as digital devices (such as smartphones, sensors, and wearable devices) that quantify or measure physiological and behavioral or biometric data, including blood pressure, emotional health, heart rate, glucose level, physical activity, respiratory function, and sleep pattern.

Digital Biomarkers are the data that is utilized to monitor anatomical, psychological, and behavioral changes in the human body. This is achieved using various sensors, Machine Learning (ML), and Artificial Intelligence (AI) techniques, allowing the wearer and other interested parties to access the data.

Digital biomarkers are the primary source of big data insights in the healthcare sector. They aid in the examination of the current and anticipated health conditions and/or adverse circumstances. Wearables, portables, and digestible and implantable devices comprise the devices.

The demand for the same has increased in the market due to the direct consumer usage of devices such as smartphones, wearables, and medical bracelets, as well as the advancement of technologies. The heart rate monitor and oxygen saturation (SpO2) monitor are two of the most frequently encountered features of consumer wearables.

These devices are indispensable for monitoring heart and lung biostatistics to detect and notify users of adverse reactions. Cardiovascular disease is the cause of mortality for over 960,000 individuals annually, as per the Centers for Disease Control and Prevention (CDC).

Consumer device sales have experienced an increase as a result of the COVID-19 pandemic. Fitbit’s product has experienced an annual increase in user base since 2014, with an average growth rate of 37%.

Psychiatric Digital Biomarkers Market: Opportunities

Market Opportunities: Enhanced Healthcare Expenditure, Government Investments, and Increasing Use of Smartphones and Smartwatches

Globally, healthcare expenditures have increased. The National Health Expenditure Accounts (NHEA) indicate that the expenditure in the United States increased by 9.7% in 2020, equivalent to USD 4.1 trillion or USD 12,530 per person. Health expenditure represented 19.7% of the gross domestic product as a percentage of GDP.

According to Eurostat, the European Union allocated Euro 1.38 trillion, or 9.94% of its GDP, to healthcare. Consequently, the demand for digital biomarkers will increase in response to an increase in healthcare expenditures, which will subsequently facilitate the development of the industry.

Additionally, there has been a significant rise in the use of wearable digital technological devices, such as fitness monitors and medical bracelets, as well as smartphones and smartwatches.

According to recent research, the smartwatch segment is dominated by Apple, which holds a 30.1% market share, and Samsung, which holds a 10.1% market share. The market for digital biomarkers is being further bolstered by the year-over-year increase in smartwatch sales.

Similarly, smartphones have experienced a significant increase in sales in recent years. These devices are equipped with various sensors, including accelerometers and motion sensors, which aid in monitoring an individual’s health. Furthermore, the process of drug development is becoming increasingly time-consuming and capital-intensive. Consequently, the augmentation of investments in digital biomarkers would be resource- and time-efficient.

Psychiatric Digital Biomarkers Market: Constraints

The substantial expense associated with establishing a manufacturing facility and marketing for digital biomarkers can be regarded as an industry constraint. Companies are increasingly creating digital biomarkers due to the rapid advancement of technologies.

Consequently, it is highly probable that this sector will develop into an appealing investment opportunity in the future. Vasudevanet al (2022) conducted a study that revealed that the FDA employs the BEST (Biomarkers, Endpoints and Other Tools) glossary to define digital biomarkers, even though their definitions are diverse.

The acceptance of various categories of data and devices has increased companies investment in producing digital biomarkers. In May 2022, Imagine AI, an Israeli corporation, received USD 21 million in funding to continue the development of its patented algorithms for cancer pathology. Therefore, it may be perceived as an appealing investment.

Consumers and institutions have experienced a substantial increase in the utilization of digital biomarkers. According to a study published in the Journal for Frailty and Aging by Piguet et al. (2020), the WHO action plan mandates the implementation of “Integrated Care for Older People” (ICOPE).

This initiative necessitates the integration of contemporary technology to enable the addition of continuous data flow for analysis and real-time interpretations to monitor the fragile health conditions of senior citizens.

Furthermore, the Centers for Disease Control and Prevention (CDC) has determined that notifications for atrial fibrillation on a particular smartwatch were 84% accurate in predicting an actual ECG for patients, thereby reducing the mortality risk among individuals. Consequently, we are witnessing a rise in the utilization of smartwatches and other consumer wearables that monitor various physiological factors in the human body.

Psychiatric Digital Biomarkers Market: Significant Product

The Empatica health monitoring platform was cleared by the U.S. Food and Drug Administration (FDA) in November 2022, according to Empatica, a biotechnology research company.

The clearance offers healthcare professionals and researchers a clinically validated digital biomarker and a modern, intuitive, and reliable instrument for remotely collecting data. This data can be used to monitor electrodermal activity (EDA), SpO2, skin temperature, and movement during sleep.

Psychiatric Digital Biomarkers Market: Segmentation Analysis

By Type:

The market is divided into wearables, mobile-based applications, sensors, and other categories based on their nature. The wearable segment accounted for 38% of the market’s revenue in 2023. The wearable segment is driven by its ability to continuously monitor physiological and behavioural parameters, such as pulse rate, sleep patterns, and physical activity, which are essential for assessing mental health conditions.

The popularity of wearable devices among patients and healthcare providers is due to their convenience and their integration with sophisticated analytics platforms, such as fitness monitors and smartwatches.

By Clinical Practice:

The market is segmented into diagnostic psychiatric digital biomarkers, monitoring psychiatric digital biomarkers, predictive & prognostic psychiatric digital biomarkers, and others based on clinical practice. In 2023, the monitoring psychiatric digital biomarkers segment held a 27% revenue share in the market.

The increasing emphasis on personalized care and continuous mental health management drives this segment. These biomarkers facilitate the real-time monitoring of a patient’s mental state, thereby supplying valuable information for evaluating treatment efficacy and disease progression.

The integration of mobile applications and the increasing utilization of telehealth services have increased the accessibility of monitoring solutions.

By End Use:

The market is segmented into healthcare companies, healthcare providers, payers, and others based on end use. In 2023, the healthcare companies segment held a 48% market revenue share. These companies invest significantly in research and development, utilizing advanced technologies such as AI, machine learning, and big data analytics to create cutting-edge mental health diagnostics and management solutions.

Strategic partnerships with healthcare providers, academic institutions, and technology firms further enhance their capacity to create clinically validated, scalable, and robust products.

Report Scope

Psychiatric Digital Biomarkers Market: Regional Analysis

North America is anticipated to experience growth during the forecast period due to the high number of digital biomarker product approvals and the high presence of market participants who manufacture them.

For example, Verily Life Sciences, ActiGraph LLC., Alivecor, Koneksa, Amgen, Feel Therapeutics, and Sonde Health, Inc. are significant market participants that produce technologically advanced digital biomarkers.

Additionally, in November 2022, Empatica, a biotechnology research company, announced that the U.S. Food and Drug Administration (FDA) had cleared the Empatica health monitoring platform.

The clearance offers healthcare professionals and researchers a clinically validated digital biomarker and a modern, intuitive, and reliable instrument for remotely collecting data. This data can be used to monitor electrodermal activity (EDA), SpO2, skin temperature, and movement during sleep.

Additionally, the demand for digital biomarkers is rising due to the rising prevalence of cardiovascular disease in North America, driving the market’s growth. For instance, the American Heart Association (AHA) reported in 2020 that approximately 40% of the U.S. population between the ages of 40 and 59 suffers from cardiovascular disease.

Additionally, the American Heart Association (AHA) reported that between 60 and 79 years of age, approximately 75% of the U.S. population and 86% of the U.S. population over the age of 80 were diagnosed with cardiovascular disease (CVD) in 2020.

Thus, it is anticipated that the market will experience a growth spurt due to the population’s increased adoption of digital biomarkers, particularly those affected by chronic diseases like cardiovascular disease.

For instance, in June 2023, 18% of individuals with established CVD and 26% of those at risk for CVD in the United States reported using wearable devices to monitor heart rates, physical activity, and sleep, as well as to obtain electrocardiograms and other parameters, according to JAMA Network.

Nevertheless, the Asia-Pacific digital biomarkers market is anticipated to expand during the forecast period due to the increasing prevalence of chronic diseases, including cardiovascular, neurological, and respiratory diseases.

Different neurological disorders, including Parkinson’s disease and dementia, are assessed, monitored, and diagnosed using digital biomarkers. Therefore, the market is expected to experience development due to the increasing prevalence of dementia and the rise in public awareness of the availability of digital biomarkers.

For example, the National Library of Medicine estimated that the prevalence of dementia among adults aged 60 in India was 7.4% in January 2023. According to the same source, an anticipated 8.8 million Indians over the age of 60 will be diagnosed with dementia in 2023.

Psychiatric Digital Biomarkers Market: Recent Developments

• The FDA authorized the Apple Watch’s atrial fibrillation (AFib) detection instrument for clinical trial use in May 2024 as part of its Medical Device Development Tools (MDDT) program. This is the first digital health instrument to be certified for medical research purposes, enabling it to be utilized to detect arrhythmias.

• Biogen disclosed interim findings from the RESPOND study in March 2024, which assessed SPINRAZA in neonates and toddlers with specific requirements following gene therapy. In the early data, most participants exhibited enhanced motor function and reduced neurodegeneration indicators.

List of the prominent players in the Psychiatric Digital Biomarkers Market:

• Canary Speech Inc
• Sonde Health Inc. (Puretech Health Plc)
• Koneksa Health Inc.
• Empatica Inc.
• VivoSense Inc.
• IXICO Plc
• Neurotrack Technologies Inc.
• Winterlight Labs
• Aural Analytics Inc. (Linus Health)
• Others

The Psychiatric Digital Biomarkers Market is segmented as follows:

By Type

• Wearable
• Mobile based Applications
• Sensors
• Other Type

By Clinical Practice

• Diagnostic Psychiatric Digital Biomarkers
• Monitoring Psychiatric Digital Biomarkers
• Predictive and Prognostic Psychiatric Digital Biomarkers
• Other Clinical Practice

By End Use

• Healthcare Companies
• Healthcare Providers
• Payers
• Other End Use

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America