Psychiatric digital biomarkers have been revolutionizing mental healthcare in the US through artificial intelligence, machine learning, and pervasive computing to ensure accurate diagnostics, monitoring, and management of mental illnesses. The technology uses phone behavior, voice, facial behaviors, physical activities, and cognitive activities to generate objective and quantifiable measures of the mental disorders.
The trend has redefined the ways through which the American healthcare facilities and pharmaceutical organizations handle psychiatric disorders. Neurophysiological biomarkers still remain the largest validated category of such biomarkers, but the fastest-growing category of such biomarkers are behavioral biomarkers generated by smartphone-based digital phenotyping. The rise in mental disorder incidences and increase in government grants to conduct mental health research have been behind the rapid development. In 2025, Koneksa Health Company continued its expansion of digital biomarker platform, which aimed at developing sensor-based technologies for pharmaceutical clinical trials and mental illness endpoints.
The United States Psychiatric Digital Biomarkers Market was valued at approximately USD 0.377 billion in 2025 and is projected to reach around USD 2.988 billion by 2035, driven by superior digital health infrastructure, effective regulation, and growing awareness of major mental disorders affecting roughly 9.5% of Americans annually. Globally, the Psychiatric Digital Biomarkers Market was valued at USD 0.758 billion in 2025 and is expected to reach USD 5.893 billion by 2035, expanding at a CAGR of 22.76% during the forecast period of 2026–2035.
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U.S. Psychiatric Digital Biomarkers Market Analysis
This leadership in the U.S. is attributed to superior health IT infrastructure in the country, sound regulations, and high public consciousness about mental disorders which are prevalent among the Americans each year. Continuous uptake of AI-powered mental health solutions in the country has ensured the sustained dominance of the market.
There are many instances of increased investments in digital therapies in the U.S. The Boston, MA based Akili Interactive Labs continued development of its digital therapeutics suite in 2025 after securing approvals for its gaming therapies and thereby strengthening its position as an innovative evidence-based technology company in psychiatry.
In addition, pharmaceutical industry is another area driving demand for digital biomarkers market in the United States. Increasing utilization of predictive digital biomarkers by healthcare companies to ensure efficient patient stratification during clinical trials and growing telemedicine adoption to conduct remote monitoring of psychiatric cases in America is driving the market demand.
Top 5 Leading Psychiatric Digital Biomarkers Companies
1. Koneksa Health
Koneksa Health is one of the top innovators in remote, sensor-driven digital biomarkers, concentrating on enabling pharma-sponsored clinical trials and bringing an objective approach to psychiatric endpoints evaluation. Koneksa was actively developing its platform in 2025, working on innovations in measurement technologies that would enable drug discovery programs in the US market.
The objective and remote approach to data gathering makes Koneksa an important player in the pharma industry, which needs more precise infrastructure for conducting psychiatric clinical trials in American settings.
2. Akili Interactive Labs
Boston-headquartered Akili Interactive Labs is known to be one of the pioneers of evidence-based digital therapies for psychiatric disorders. Moreover, Akili Interactive Labs extended its product line of digital therapies in 2025, following its previous FDA approval of its gamified therapies for treatment of attention and cognition.
The ongoing innovations of the company prove its reputation as a prominent American provider of evidence-based digital therapies for mental health.
3. Biogen Inc.
In 2025, Biogen expanded further its research collaborations on digital biomarkers, developing measurement technologies that aim at supporting neuropsychiatric drug development and clinical trial endpoints evaluation. As a significant biopharmaceutical company, Biogen provides significant R&D capabilities for the field of digital biomarker research.
Continuous investment by Biogen in digital biomarker research is characteristic of the pharmaceutical industry, which integrates objective technology assessment tools for neuropsychiatric drug development in the U.S.
4. Empatica
Empatica kept on developing its physiological monitoring platform in 2025, reinforcing its leadership in collecting continuous real-time data on mental health for clinical research purposes and patient care. Empatica’s wearable technology is a key component of the most rapidly growing market segment.
Empatica’s commitment to continuous physiological monitoring fits in well with the overall industry move towards technology-enabled objective mental health evaluation.
5. Sonde Health
Sonde Health kept working to develop its voice-based depression and anxiety screening technology during 2024 in order to satisfy the needs of payers and providers who were looking for objective, non-invasive tests. It can be considered a unique way of testing that is available to American healthcare specialists.
The growing interest in establishing relations with payers and providers is due to the fact that digital biomarkers have become a common part of American mental health care.
What the Future of the Psychiatric Digital Biomarkers Market Holds
Market growth of digital biomarkers in psychiatry will continue on account of constant evolution in AI-fueled personalization which will help create ever more precise treatment approaches in all psychiatric use cases. The adoption of digital psychiatric biomarkers in pharmaceuticals for patient stratification in clinical trials will continue to play an important role.
A major market opportunity in developing scalable and affordable psychiatric monitoring solutions in underdeveloped parts of America should be pursued by developers of technologies; firms demonstrating clinical trials productivity in the form of predicting biomarkers will generate large revenues. Robust government interest in mental health research further solidifies demand in nearly all categories.
In 2025, North America already accounts for approximately 58.40% of the world's revenue in psychiatric digital biomarkers, with the U.S. comprising 84.20% of the regional revenue share. It is expected that the U.S. will continue being the leader in digital psychiatric biomarkers market until at least 2035.
