Mental Health Clinical Trials Market Report 2025

The mental health clinical trials market size has grown strongly in recent years. It will grow from $2.96 billion in 2024 to $3.23 billion in 2025 at a compound annual growth rate (CAGR) of 9.1%. The growth in the historic period can be attributed to increasing interest in neuropsychiatric drug development, rising prevalence of stress, anxiety, and depression, growing support from government and regulatory bodies, an expanding geriatric population, and rising demand for non-pharmacological interventions.

The mental health clinical trials market size is expected to see strong growth in the next few years. It will grow to $4.51 billion in 2029 at a compound annual growth rate (CAGR) of 8.7%. The growth in the forecast period can be attributed to the rising prevalence of mental health disorders, increasing awareness of mental health issues, growing demand for personalized medicine, rising healthcare expenditures, and expanding use of digital health technologies. Key trends expected during the forecast period include advancements in digital health platforms, developments in wearable devices, improvements in neuroimaging technologies, innovations in electronic data capture (EDC) systems, and the adoption of technology-driven decentralized clinical trial models.

The rising prevalence of mental health disorders is expected to propel the growth of the mental health clinical trials market going forward. Mental health disorders are conditions that significantly affect an individual’s emotions, thinking, behavior, and overall psychological functioning. The prevalence of these disorders is increasing due to rising stress from modern lifestyles, including work pressure, social isolation, and constant digital connectivity. Mental health clinical trials support advancements in care by evaluating the safety and effectiveness of new drugs, therapies, and behavioral interventions for mental health conditions. For instance, in May 2024, according to the American Psychiatric Association, approximately 43% of adults in the USA reported feeling more anxious in 2024, up from 37% in 2023 and 32% in 2022. Therefore, the increasing prevalence of mental health disorders is driving the growth of the mental health clinical trials market.

Companies in the mental health clinical trials market are focusing on novel therapies to enhance mood stability, improve treatment efficacy, and minimize side effects. Adjunctive therapies refer to medications used alongside primary treatments to enhance their effectiveness in managing complex mental health conditions. For example, in December 2022, AbbVie Inc., a US-based biopharmaceutical company, received FDA approval for VRAYLAR (cariprazine) as an adjunctive treatment for major depressive disorder in adults. VRAYLAR employs a dopamine-serotonin partial agonist mechanism, complementing traditional antidepressants, reducing depressive symptoms in patients with inadequate response to standard therapy, and improving mood stabilization with fewer side effects.

In March 2025, Wysa, a US-based mental health technology company, partnered with April Health Inc. to integrate its AI coach into primary care. This partnership aims to improve access to mental health services, streamline patient support, and enhance outcomes through continuous, technology-enabled care. April Health Inc. is a US-based digital behavioral health company providing evidence-based mental health care through primary care channels.

Major players in the mental health clinical trials market are Pfizer Inc., Johnson & Johnson, Merck & Co. Inc., AbbVie Inc., Sanofi S.A., Bristol-Myers Squibb Company, AstraZeneca plc, GSK plc, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., IQVIA Holdings Inc., Biogen Inc., ICON plc., Parexel International Corporation, CMIC Holdings Co. Ltd., Medpace Holdings Inc., PSI CRO AG., Supernus Pharmaceuticals Inc., Worldwide Clinical Trials, Inc., Ergomed, Celerion Inc., Biotrial S.A.S., Lindus Health Ltd., Novotech Health Holdings Pte Ltd., Precision for Medicine Inc.

North America was the largest region in the mental health clinical trials market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in mental health clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the mental health clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Mental health clinical trials are research studies designed to evaluate the safety, efficacy, and impact of treatments, interventions, or diagnostic tools for mental health conditions. These trials involve medications, psychotherapy, behavioral therapies, or digital tools, aiming to identify effective strategies for preventing, managing, or treating mental disorders.

The main phases of mental health clinical trials include Phase I, Phase II, Phase III, and Phase IV. Phase I trials represent the first stage of human testing for a new drug, focusing on safety, dosage, and side effects, typically involving 20-100 healthy volunteers. These trials employ various study designs, including interventional and observational approaches, and target disorders such as anxiety, depression, bipolar affective disorder, dissociative disorders, schizophrenia, and others. Key sponsors of these trials include pharmaceutical and biopharmaceutical companies, government agencies, and other organizations.

The mental health clinical trials market research report is one of a series of new reports that provides mental health clinical trials market statistics, including the mental health clinical trials industry's global market size, regional shares, competitors with the mental health clinical trials market share, detailed mental health clinical trials market segments, market trends and opportunities, and any further data you may need to thrive in the mental health clinical trials market. This mental health clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The mental health clinical trials market includes revenues earned by entities through study design, patient recruitment, clinical monitoring, data management, regulatory consulting, site management, and statistical analysis. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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