According to Precedence Research, the global mental health clinical trials market size will grow from USD 3.44 billion in 2025 to USD 5.55 billion by 2031 and is expected to hit nearly USD 7 billion by 2034. Fueled by rising disorder prevalence, innovative therapies, and increasing research investments.
The mental health clinical trials market was valued at USD 3,170 million in 2024 and is predicted to exceed more than USD 7,000 million by 2034, accelerating at a healthy CAGR of 8.24% from 2025 to 2034.
Clinical trials for mental health are research studies aimed at assessing the safety, effectiveness, and overall effects of new treatments or interventions for mental health disorders like depression, anxiety, schizophrenia, and bipolar disorder. These trials are an essential part of the drug development process, as they assist in assessing whether a suggested treatment can successfully relieve symptoms and enhance quality of life. Clinical trials for mental health frequently include various interventions, including medications, behavioral treatments, medical devices, or digital health options.
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Mental Health Clinical Trials Market Key Insights:
🔹In terms of revenue, the worldwide mental health clinical trials market has been calculated at USD 3,170 million in 2024.
🔹It is projected to cross over USD 7,000 million by 2034.
🔹In terms of CAGR, the industry is projected to grow at a strong compound annual growth rate (CAGR) of 8.24% between 2025 and 2034.
🔹North America accounted for the highest market share of 51% in 2024.
🔹Asia Pacific is growing at the notable CAGR of 8.82% from 2025 to 2034.
🔹By phase, the phase III segment held more than 33% of market share in 2024.
🔹By phase, the phase I segment is projected to expand at the solid CAGR of 8.71% from 2025 to 2034.
🔹By study design, the interventional segment has captured more than 66% of revenue share in 2024.
🔹By study design, the observational segment is expanding at the highest CAGR between 2025 and 2034.
🔹By sponsor, the pharmaceutical & biopharmaceutical companies segment contributed the major market share of 40% in 2024.
🔹By sponsor, the government agencies segment is registering a solid CAGR of 8.53% during the forecast period.
🔹By disorder, the anxiety disorders segment dominated the market in 2024.
🔹By disorder, the depression segment is expected to grow at the highest CAGR in the market from 2025 to 2034.
Mental Health Clinical Trials Market Overview and Industry Potential
Rising Prevalence of the Mental Disorder Expanding the Mental Health Clinical Trial Market
In recent years, the sector for mental health clinical trials has grown significantly, and this momentum is expected to persist in the upcoming years. The increasing occurrence of mental health disorders globally is a significant reason for this rise. Current statistics show that one in five adults in the United States experiences mental illness annually. The increase in funding for mental health research is a vital factor driving the market for clinical trials in this field.
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What is Major Opportunity for Mental Health Clinical Trials Market?
AI Integration Offer Lucrative Opportunity for the Market to Grow
AI is revolutionizing mental health clinical studies by enhancing diagnostics and customizing treatment methods. With machine learning (ML), AI can analyze extensive datasets like genetic profiles and health records, detecting patterns associated with mental health conditions such as anxiety, depression, and schizophrenia. artificial intelligence (AI) tools provide timely and precise forecasts, resulting in more focused actions. For instance, Fortis Healthcare introduced an AI-driven app in 2024 to assist individuals with tailored mental health care options.
Also Read 👉 AI in Clinical Trials Market Driving a New Era of Data-Driven Drug Development
Major Challenge for Mental Health Clinical Trials Market:
The increasing cost of mental health disorder medicines and treatments
The increasing expenses for medications and therapies related to mental health disorders may hinder the mental health clinical trials market. Access to these innovations may be limited due to the high costs of new medications and treatments, particularly for individuals with insufficient insurance or limited financial resources.
Mental Health Clinical Trials Market Report Coverage
|
Report Attributes |
Key Statistics |
|
Market Size in 2024 |
USD 3.17 Billion |
|
Market Size in 2025 |
USD 3.44 Billion |
|
Market Size in 2031 |
USD 5.55 Billion |
|
Market Size by 2034 |
USD 7.00 Billion |
|
Growth Rate (2025 to 2034) |
CAGR of 8.24% |
|
U.S. Market Size in 2025 |
USD 1,320 Million |
|
U.S. Market Size by 2034 |
USD 2,740 Million |
|
Leading Region in 2024 |
North America |
|
Fastest-Growing Region |
Asia Pacific |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Key Opportunities |
AI-driven diagnostics, personalized treatments, and digital therapeutics innovations |
|
Major Challenges |
Rising treatment and drug development costs limiting accessibility |
|
Key Trends |
Rising prevalence of mental disorders, government funding initiatives (e.g., NIH HEAL), growth of Real-World Evidence (RWE) studies |
|
Recent Developments |
Jan 2025: Cybin & Segal Trials launch Phase 3 trial for MDD; Mar 2025: Mass General Brigham tests stem cell therapy for Parkinson’s |
|
Segments Covered |
Phase, Study Design, Sponsor, Disorder, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America and Middle East & Africa |
|
Top Companies Covered |
ICON Plc, Eli Lilly Company, Caidya, Syneous Health, Novo Nordisk, Pharmaceutical Product Development, LLC, Parexel International Corporation, Corcept, Labcorp Drug Development, IQVIA, and Others. |
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How Broader
Clinical Trials Fuel Mental Health Research
The global Clinical
Trials Market, which spans across oncology,
CNS, autoimmune, and other therapeutic areas, was valued at USD 83.75
billion in 2024 and is projected to reach nearly USD 149.58 billion by
2034, expanding at a healthy CAGR of 6.10% from 2025 to 2034.
The global Clinical Trials Market provides the infrastructure, innovation, and regulatory pathways that support mental health studies. Advances such as virtual trials, AI-driven recruitment, and real-world evidence collection are now being applied in psychiatry and neurology, enabling faster, more effective Mental Health Clinical Trials. This synergy ensures that mental health remains one of the fastest-growing segments within the wider clinical trials landscape.
Clinical Trials Market Highlights:
🔸 In terms of revenue, the global clinical trials market was valued at USD 83.75 billion in 2024.
🔸 It is projected to reach USD 149.58 billion by 2034.
🔸 The market is expected to grow at a CAGR of 6.10% from 2025 to 2034.
🔸 North America has held 59.31% of the total market share in 2024.
🔸 Asia Pacific region is growing at a CAGR of 7.16% during the forecast period.
🔸 By study design, the interventional study segment has captured 70.50% market share in 2024.
🔸 By study design, the expanded access segment is expected to grow at a solid CAGR of 8.20% during the forecast period.
🔸 By indication, the oncology segment captured the biggest market share of 31.70% in 2024.
🔸 By indication, the CNS conditions segment is projected to grow at a solid CAGR of 7.60% during the forecast period.
🔸 By service type, the laboratory services segment generated the major market share of 24.60% in 2024.
🔸 By service type, the decentralized clinical trial services segment is expected to expand at a solid CAGR of 9.40% during the forecast period.
Crucial factors accountable for market growth are
→ Growing prevalence of chronic disorders
→ Increasing number of clinical trials in developing regions
→ Growing number of biologics
→ Increasing demand for advanced treatments such as personalized medicines
Clinical Trials Market Leading Companies
➢ Parexel
➢ IQVIA
➢ Omnicare
➢ Kendle
➢ Chiltern
➢ Pharmaceutical Product Development, LLC
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Mental Health Clinical Trials Market Key Regional Analysis:
What Makes North America the Leader in Clinical Trials?
North America dominated the mental health clinical trials market in 2024, due to its strong healthcare infrastructure, supportive regulatory framework, and significant occurrence of mental health disorders. The existence of leading pharmaceutical and biopharmaceutical firms in the area, including Pfizer, Johnson & Johnson, and Eli Lilly, additionally propels the market's expansion.
How Big is the U.S. Mental Health Clinical Trials Market?
The U.S. mental health clinical trials market size is expected to be worth USD 2.74 billion by 2034 increasing from USD 1.32 billion in 2025, growing at a solid CAGR of 8.52% from 2025 to 2034.
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U.S. Mental Health Clinical Trials Market Trends:
The U.S. mental health clinical trials market is experiencing strong and steady growth, with projections indicating that the market will more than double in value by 2030. Key factors driving this expansion include increasing mental health awareness, rising prevalence of psychiatric disorders, and a growing demand for more effective and personalized treatment options. Clinical research focused on conditions like depression, anxiety, schizophrenia, and neurodegenerative diseases such as Alzheimer’s and Parkinson’s is expanding significantly.
Asia Pacific is expected to grow at the highest CAGR in the mental health clinical trials market during the forecast period. This expansion is fueled by the increasing prevalence of mental health disorders, heightened awareness, changing cultural perceptions, technological progress, and affordable options for clinical research in the area. Numerous major CROs worldwide are establishing operations in Asia to meet this demand. In the past ten years, clinical trials in the region have significantly increased, outpacing those in the United States and Europe.
Japan Mental Health Clinical Trials Market:
Japan’s mental health clinical trials market is growing steadily, driven by an aging population, increasing awareness of psychiatric conditions, and the integration of advanced technologies into clinical research. The overall clinical trials market in Japan is projected to grow significantly over the coming years, with mental health emerging as a key focus area, particularly in areas like depression, anxiety, neurodegenerative diseases, and digital therapeutics.
Also Read 👉 Clinical Trial Investigative Site Network Market Growth and Opportunities in Global R&D Expansion
Mental Health Clinical Trials Market Segmentation Analysis:
By Phase Analysis
The phase III segment led the mental health clinical trials market in 2024, as it represents the last and most comprehensive stage prior to regulatory approval, involves substantial patient groups to validate efficacy and safety, and necessitates considerable investment, making it the largest and most lucrative phase in the drug development process.
The phase I segment is anticipated to experience the highest CAGR in the mental health clinical trials market throughout the forecast period. The impact of mental health disorders globally is increasingly recognized, leading to greater investment from both public and private sectors. This funding boost supports early-stage clinical trials, like Phase I trials, aimed at exploring new medications.
Also Read 👉 Clinical Laboratory Services Market Set to Reach $317 Billion by 2034 Amid Rising Demand for Diagnostics
By Study Design Analysis
The interventional segment dominated the mental health clinical trials market in 2024, as it represents the most effective method to demonstrate the efficacy and safety of new medications, therapies, and treatments, which is essential for regulatory approval. In contrast to observational studies, interventional trials enable researchers to manage variables, implement random assignment, and directly evaluate the causal relationship between an intervention and a patient's result.
The observational segment is expected to grow at the highest CAGR in the mental health clinical trials market during the forecast period, driven by the need for Real-World Evidence (RWE) that offers post-market insights regarding treatment efficacy and safety in real-world environments. This expansion is also propelled by the natural cost-efficiency, reduced ethical dilemmas, and less intrusive characteristics of observational research in contrast to conventional interventional studies.
Also Read 👉 Virtual Clinical Trials Market to Reach $18.3B by 2034, Led by North America’s Digital Health Surge
By Sponsor Analysis
The pharmaceutical & biopharmaceutical companies segment dominated the mental health clinical trials market in 2024, owing to their substantial investments in developing new treatments for mental health disorders. These companies are prepared to conduct extensive clinical trials and introduce innovative drugs. notable R&D expenditures, the development of new therapies such as Esketamine, and a dedicated emphasis on delivering new treatments to the market.
The government agencies segment is expected to grow at the highest CAGR in the mental health clinical trials market during the forecast period. Because of heightened funding, policy execution, and direct research efforts, prompted by a growing worldwide prevalence of mental health issues and increased public consciousness. The HEAL initiative by the National Institutes of Health (NIH) shows a clear government dedication to financing research that tackles significant public health emergencies.
Also Read 👉 Biopharma Clinical Trials Market Driven by Personalized Medicine and AI Adoption
By Disorder Analysis
The anxiety disorders segment dominated the mental health clinical trials market in 2024, influenced by the rising global prevalence of anxiety-related issues, along with heightened public awareness and a stronger readiness to pursue treatment. Elements such as social pressure, heightened awareness of symptoms, and the need for more effective treatments and innovative therapies also play a role in this prevalence.
The bipolar disorder segment is expected to expand the most rapidly during the forecast period. This growth is attributed to a rising prevalence influenced by lifestyle choices and enhanced awareness, resulting in a sustained demand for innovative treatments like mood stabilizers and antipsychotics, bolstered by substantial government efforts, increased investment in R&D, and improvements in diagnostics and treatment access, including telepsychiatry.
Mental Health Clinical Trials Market Top Companies
The mental
health clinical trials market is dominated by key industry leaders whose strong
market share and strategic initiatives shape the future direction of the
industry.
➢ ICON Plc
➢ Eli Lilly Company
➢ Caidya
➢ Syneous Health
➢ Pharmaceutical Product Development, LLC
➢ Parexel International Corporation
➢ Corcept
➢ Labcorp Drug Development
➢ IQVIA
Case Study: ICON plc — Leading the Way in Phase I Clinical Trials
ICON plc, a global leader in clinical research, has recently been recognized for its exceptional performance in Phase I clinical trials. A benchmarking report from Industry Standard Research (ISR) highlights ICON's dominance in the early-phase clinical trial space.
→ Operational Excellence: ICON emerged as one of the top-performing CROs in Phase I trials, surpassing its peers in metrics such as trial efficiency, safety, and adherence to study timelines.
→ Independent Verification: The ISR assessment employed a stringent evaluation methodology—participant screening ensured relevant role-based input and recent CRO engagement—to validate ICON’s strong performance.
→ Market Impact: Following the report, ICON’s stock climbed significantly (up ~13.8%), signaling investor confidence in its operational leadership and strong positioning in early-phase studies.
Relevance to Mental Health Clinical Trials
ICON’s Phase I expertise—particularly in trial execution, rapid start-up, operational precision, and data quality—can directly benefit mental health drug development, where early-stage insights are foundational. Their capabilities lay the groundwork for successful progression into later phases for psychiatric and neurodegenerative disorder therapeutics.
What is Going Around the Globe?
🔹In January 2025, Cybin Inc., a clinical-stage innovative
neuropsychiatry platform firm dedicated to transforming mental healthcare
through new and advanced treatment solutions, revealed the initiation of its
inaugural strategic partnership agreement (SPA) with Segal Trials to advance
Cybin’s multinational pivotal Phase 3 trial assessing CYB003 for the adjunctive
treatment of Major Depressive Disorder (MDD).
🔹In March 2025, a unique phase 1 open-label clinical trial at Mass General Brigham has assessed a groundbreaking therapy for Parkinson's disease that involves using a patient's own reprogrammed stem cells to restore dopamine neurons that have been harmed by the condition. The therapy focuses on tackling the fundamental neuronal loss and revitalizing dopamine activity. The recent research has already enrolled and treated three individuals at Brigham and Women’s Hospital.
Mental Health Clinical Trials Market Segment Covered in the Report
By Phase
• Phase I
• Phase II
• Phase III
• Phase IV
By Study Design
• Interventional
• Observational
• Others
By Sponsor
• Pharmaceutical & Biopharmaceutical Companies
• Government Agencies
• Others
By Disorder
• Anxiety Disorders
• Depression
• Bipolar Affective Disorder
• Dissociation & Dissociative Disorders
• Schizophrenia
• Others
By Geography
• North America
• Asia Pacific
• Europe
• Latin America
• Middle East & Africa
Thanks for reading you can also get individual chapter-wise sections or region-wise report versions such as North America, Europe, or Asia Pacific.
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Frequently Asked Questions
💡How large is the mental health clinical trials market?
➡️The global mental health clinical trials market is projected to grow
from USD 3.17 billion in 2024 to approximately USD 7.00 billion by 2034,
highlighting significant expansion over the forecast period.
💡What is the expected growth rate of the market?
➡️The market for mental health clinical trials is anticipated to
register a compound annual growth rate (CAGR) of 8.24% from 2025 to 2034,
driven by increasing research initiatives and rising demand for advanced
therapies.
💡Who are the key players in the mental health clinical trials
industry?
➡️Leading companies participating in this market include ICON Plc,
Eli Lilly and Company, Caidya, Syneos Health, Novo Nordisk, Pharmaceutical
Product Development, LLC, Parexel International Corporation, Corcept, Labcorp
Drug Development, IQVIA, and several other global players.
💡What factors are driving the growth of the mental health clinical
trials market?
➡️Key growth drivers include increasing awareness of mental health
conditions, rising government support and funding, and strong investments from
pharmaceutical and biotechnology companies to develop innovative treatment
options.
💡Which region dominates the mental health clinical trials market?
➡️North America is expected to maintain
its leadership position in the global mental health clinical trials market
throughout 2025–2034, supported by advanced healthcare infrastructure, robust
research funding, and the presence of leading pharmaceutical companies.
