Mental Health Clinical Trials Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 3.29 Billion |
| Market Size (2029) | USD 4.87 Billion |
| CAGR (2024 - 2029) | 8.11 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | High |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Mental Health Clinical Trials Market Analysis
The Mental Health Clinical Trials Market size is estimated at USD 3.29 billion in 2024, and is expected to reach USD 4.87 billion by 2029, growing at a CAGR of 8.11% during the forecast period (2024-2029).
The key factors driving the growth of the mental health clinical trials market are the increasing prevalence of mental health disorders, increased funding from government agencies, pharmaceuticals, and biotech companies, rising number of clinical trials, and growing awareness of mental health conditions. In addition, the pharmaceutical companies' growing research and development efforts are another factor anticipated to drive global market growth over the coming years.
The increasing prevalence of mental health conditions such as anxiety disorders, depression, and bipolar affective disorder is projected to drive the growth of the mental health clinical trials market. For instance, according to an article published by the Middle East Current Psychiatry in May 2023, an estimated 4.05% of the global population suffers from anxiety disorders, which account for around 301 million people.
In addition, according to the same source, the global burden of anxiety has risen significantly over the last few decades, and the burden is rising amid factors such as socioeconomic development, a highly dependent older population, and urbanization. This exponentially higher disease burden is expected to accelerate the development of potential treatment interventions through clinical trials to support patient well-being.
Moreover, the growing association of mental disorders with all age groups has facilitated the demand for new therapeutic approaches to manage such conditions. For instance, according to February 2024 data from the Australian Institute of Health and Welfare, around 1 in 5 Australians aged 16 to 85 experienced a mental disorder, and over 17% of Australians had anxiety disorder. Such evolving disease burdens have put pressure on pharmaceutical and biopharmaceutical companies to develop improved treatment regimens to manage disease symptoms of mental conditions, and this is further likely to contribute to greater clinical trial volumes.
The significant burden of mental disorders across the globe pushed pharmaceutical and biotechnology companies to develop and commercialize promising therapies for these disorders.
For instance, according to August 2024 data from the Clinical Trials. Gov, there were around 360 studies for anxiety disorders sponsored by pharmaceutical and biotechnology in North America, followed by 121 studies in Europe. Some key companies that sponsored those studies were AstraZeneca, Novartis AG, Pfizer, and Lilly. Thus, such initiatives by key pharmaceutical companies to develop a promising treatment for mental health conditions are likely to accelerate industry uptake during the forecast period.
In addition, several efforts by market players to strengthen their development pipelines through business acquisitions are projected to spur industry uptake. For instance, in September 2023, Otsuka Pharmaceuticals signed an agreement to acquire Mindset Pharma. This acquisition would help Otsuka strengthen its investigational pipeline for anxiety and depression disorders. Such efforts undertaken by pharmaceutical and biopharmaceutical companies to foster research and innovation in the mental health space are further anticipated to offer significant growth avenues for industry uptake.
Thus, the above-mentioned factors, such as the growing burden of mental health conditions worldwide and a surge in pharmaceutical company research and development, are projected to accelerate market expansion over the coming years. However, the stringent regulations related to mental health clinical trials and limited awareness in developing economies about mental health are projected to limit market expansion over the coming years.
Mental Health Clinical Trials Market Trends
The Phase III Clinical Trials Segment is Expected to Hold Significant Share in the Market During the Forecast Period
The phase III clinical trial segment is expected to have a significant impact over the period as it involves investigating a drug's efficacy, safety, and side effects on a large patient population across numerous facilities. The increase in the burden of diseases and rising research activities drive segment growth during the forecast period.
For instance, according to ClinicalTrials.gov., accessed in July 2024, there were approximately a total of 2,124 phase III trials focused on conditions such as anxiety disorders (137 trials), depression (985 trials), schizophrenia (672 trials), bipolar affective disorder (296 trials), and other disorders like OCD and eating disorders (34 trials) globally. Phase III studies are critical for validating therapeutic interventions and establishing their effectiveness in diverse patient populations. Therefore, the significant investment in phase III underscores its vital role in shaping the future of mental health care and driving innovation in the clinical trials market.
In addition, the increasing number of candidates in phase III of the clinical trials and positive results from phase III studies are expected to accelerate segment uptake over the coming years. For instance, in June 2024, Intra-Cellular Therapies Inc. reported the successful topline results in the second phase III from Study 502, which evaluated lumateperone 42 mg as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD). In this double-blind, placebo-controlled study, lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and key secondary endpoints. The company anticipates submitting this sNDA to the United States Food and Drug Administration (FDA) in the second half of 2024.
Similarly, in May 2024, Johnson & Johnson published positive topline results from the pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and safety of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (MDD) with insomnia symptoms. Seltorexant is an investigational first-in-class selective antagonist of the human orexin-2 receptor studied for the adjunctive treatment of MDD with insomnia symptoms. Thus, such positive pipeline results of phase III candidates are expected to bolster the revenue share of the segment over the coming years.
Therefore, the above-mentioned factors, such as a growing volume of phase III trials and positive results from phase III studies, will likely support segment uptake during the forecast period.
North America Holds the Largest Market Share of the Mental Health Clinical Trials Market
North America is expected to dominate the mental health clinical trials market during the forecast period owing to the rising prevalence of mental health disorders such as anxiety, depression, and substance use, advancement in technologies, and favorable regulatory environment.
The region’s high prevalence of mental illness is projected to drive the mental health clinical trials market growth during the forecast period. For instance, according to the 2023 infographics of the National Alliance on Mental Illness (NAMI), 1 in 5 United States adults experience mental illness, and 1 in 20 adults experience serious mental illness. In addition, 17% of youth (6-17 years) experienced mental health disorders in 2023. This shows the high prevalence of mental illness among the people in the country, which is expected to increase the demand for clinical trials for mental health treatment, which is likely to propel the market growth during the forecast period.
Rising investments by companies, universities, and government institutions increase the demand for mental health workers and assess the need for medical treatment disorders in different states of the United States. For instance, in June 2023, the Indiana University School of Medicine collaborated with Lilly Endowment Inc. and received a grant of USD 515,005. This collaborative initiative with partners across Indiana was designed to gain insight into Indiana's post-secondary pipeline of mental and behavioral health care providers.
The project's primary objective was to comprehend the post-secondary pipeline for those training in particular professional fields in behavioral and mental health care. Thus, investment and collaborations with government institutions and companies would increase the demand for healthcare workers, further contributing to the growth of the mental health clinical trials market.
In addition, the strong presence of large biopharmaceutical and pharmaceutical players such as Eli Lilly, Johnson & Johnson, and Pfizer contributes to the market growth. Key market players are undertaking various strategic initiatives, such as partnerships, mergers and acquisitions, collaborations, and geographic expansions, to strengthen their services, thus providing a competitive advantage. For instance, in April 2023, CHEPLAPHARM acquired Zyprexa, an antipsychotic drug of Eli Lily and Company. This product is indicated for the treatment of schizophrenia and bipolar disorders.
In addition, there were numerous trials on drug development for serious mental illness in the United States. For instance, in April 2024, Neurocrine Biosciences Inc. received positive topline data for its Phase 2 SAVITRI study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD). Such positive topline results are further expected to bolster the number of clinical trials for mental disorders, which, in turn, is expected to accelerate market growth over the coming years.
Thus, the factors mentioned above are expected to propel the regional market growth during the forecast period.
Mental Health Clinical Trials Industry Overview
The mental health clinical trials market is highly competitive. The key market players include IQVIA, Parexel International Corporation, Caidya, and Pharmaceutical Product Development LLC. Major players also adopt various strategies, including mergers and acquisitions and partnerships, to maintain market share and expand their product and service offerings.
Mental Health Clinical Trials Market Leaders
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IQVIA Inc.
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Parexel International Corporation
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ICON PLC
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FortreaHoldings INC
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Caidya
*Disclaimer: Major Players sorted in no particular order
Mental Health Clinical Trials Market News
- March 2024: MapLight Therapeutics Inc. initiated a Phase 1 clinical trial for ML-007/PAC, a novel extended-release fixed-dose combination therapy designed for the treatment of schizophrenia and Alzheimer's disease psychosis. This trial marks a critical advancement in developing targeted treatments for these complex central nervous system (CNS) disorders.
- February 2023: The Wellcome Trust granted USD 18.3 million to Oxford's Department of Psychiatry as part of its investment in mental health research for the Stratification & Treatment in Early Psychosis (STEP) program. The program would have 1,000 participants, including those with psychosis who have not responded to conventional treatment, others with first-episode psychosis, and those at clinically high risk for developing psychosis.
Mental Health Clinical Trials Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Prevalence of Mental Health Conditions
4.2.2 Increasing Investment in Research and Development by Pharmaceutical and Biotech Companies
4.3 Market Restraints
4.3.1 Limited Awareness in Developing Economies Pertaining to Mental Health
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Study Design
5.1.1 Interventional
5.1.2 Observational
5.1.3 Other Study Designs
5.2 By Phase
5.2.1 Phase I
5.2.2 Phase II
5.2.3 Phase III
5.2.4 Phase IV
5.3 By Disorder
5.3.1 Anxiety Disorders
5.3.2 Depression
5.3.3 Dissociation and Dissociative Disorders
5.3.4 Schizophrenia
5.3.5 Bipolar Affective Disorder
5.3.6 Other Disorders
5.4 By Sponsor
5.4.1 Pharmaceutical and Biopharmaceutical Companies
5.4.2 Government Agencies
5.4.3 Other Sponsors
5.5 Geography
5.5.1 North America
5.5.1.1 United States
5.5.1.2 Canada
5.5.1.3 Mexico
5.5.2 Europe
5.5.2.1 Germany
5.5.2.2 United Kingdom
5.5.2.3 France
5.5.2.4 Italy
5.5.2.5 Spain
5.5.2.6 Rest of Europe
5.5.3 Asia-Pacific
5.5.3.1 China
5.5.3.2 Japan
5.5.3.3 India
5.5.3.4 Australia
5.5.3.5 South Korea
5.5.3.6 Rest of Asia-Pacific
5.5.4 Middle East and Africa
5.5.4.1 GCC
5.5.4.2 South Africa
5.5.4.3 Rest of Middle East and Africa
5.5.5 South America
5.5.5.1 Brazil
5.5.5.2 Argentina
5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 IQVIA Inc.
6.1.2 Altasciences
6.1.3 Parexel International Corporation
6.1.4 Thermo Fisher Scientific Inc. (PPD Inc.)
6.1.5 LindusHealth Limited
6.1.6 Syneous Health
6.1.7 Medpace Holdings Inc.
6.1.8 ICON PLC
6.1.9 Fortrea Holdings Inc.
6.1.10 Caidya
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Mental Health Clinical Trials Industry Segmentation
Mental health clinical trials investigate methods to prevent, detect, or treat various diseases and conditions, playing a pivotal role in advancing comprehension and treatment of mental health disorders.
The mental health clinical trials market is segmented by study design, phase, disorder, sponsor, and geography. By study design, the market is segmented into interventional, observational, and expanded access. By phase, the market is segmented into phase I, phase II, phase III, and phase IV. By disorder, the market is segmented into anxiety disorders, depression, dissociation and dissociative disorders, schizophrenia, bipolar affective disorder, and other disorders. By sponsor, the market is segmented into pharmaceutical and biopharmaceutical companies, government agencies, and other sponsors. By geography, the market is segmented into North America, Europe, Asia-Pacific, and Middle East and Africa. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers market sizes and forecasts in terms of value (USD) for the above segments.
| By Study Design | |
| Interventional | |
| Observational | |
| Other Study Designs |
| By Phase | |
| Phase I | |
| Phase II | |
| Phase III | |
| Phase IV |
| By Disorder | |
| Anxiety Disorders | |
| Depression | |
| Dissociation and Dissociative Disorders | |
| Schizophrenia | |
| Bipolar Affective Disorder | |
| Other Disorders |
| By Sponsor | |
| Pharmaceutical and Biopharmaceutical Companies | |
| Government Agencies | |
| Other Sponsors |
| Geography | ||||||||
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Mental Health Clinical Trials Market Research FAQs
How big is the Mental Health Clinical Trials Market?
The Mental Health Clinical Trials Market size is expected to reach USD 3.29 billion in 2024 and grow at a CAGR of 8.11% to reach USD 4.87 billion by 2029.
What is the current Mental Health Clinical Trials Market size?
In 2024, the Mental Health Clinical Trials Market size is expected to reach USD 3.29 billion.
Who are the key players in Mental Health Clinical Trials Market?
IQVIA Inc., Parexel International Corporation, ICON PLC, FortreaHoldings INC and Caidya are the major companies operating in the Mental Health Clinical Trials Market.
Which is the fastest growing region in Mental Health Clinical Trials Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Mental Health Clinical Trials Market?
In 2024, the North America accounts for the largest market share in Mental Health Clinical Trials Market.
What years does this Mental Health Clinical Trials Market cover, and what was the market size in 2023?
In 2023, the Mental Health Clinical Trials Market size was estimated at USD 3.02 billion. The report covers the Mental Health Clinical Trials Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Mental Health Clinical Trials Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Mental Health Clinical Trials Industry Report
Statistics for the 2024 Mental Health Clinical Trials market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Mental Health Clinical Trials analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
