Market Trends of Mental Health Clinical Trials Industry
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.
