Schizophrenia Market to Witness Significant Growth by 2034 Across 7MM as New Therapies Enter Late-Stage Trials | DelveInsight

The schizophrenia market size is expected to grow during the forecast period (2025–2034). DelveInsight’s analysis projects growth in the schizophrenia market, driven by rising disease prevalence, the expanding market for approved therapies, and the anticipated launch of new treatments such as Olanzapine LAI (TEV-‘749), Iclepertin (BI-425809), Ulotaront (SEP-363856), Brilaroxazine (RP5063), and others during the forecast period.

/EIN News/ -- New York, USA, May 01, 2025 (GLOBE NEWSWIRE) -- Schizophrenia Market to Witness Significant Growth by 2034 Across 7MM as New Therapies Enter Late-Stage Trials | DelveInsight

The schizophrenia market size is expected to grow during the forecast period (2025–2034). DelveInsight’s analysis projects growth in the schizophrenia market, driven by rising disease prevalence, the expanding market for approved therapies, and the anticipated launch of new treatments such as Olanzapine LAI (TEV-‘749), Iclepertin (BI-425809), Ulotaront (SEP-363856), Brilaroxazine (RP5063), and others during the forecast period.

Schizophrenia is a serious mental health disorder that affects a person’s thoughts, emotions, decision-making abilities, and social behavior. It typically begins in late adolescence or early adulthood—usually in the late teens to early 20s for men, and in the late 20s to early 30s for women.

This complex brain condition impacts roughly 1 in 100 people, translating to around 150,000 to 200,000 individuals in Australia. Approximately 20–30% of those diagnosed experience only a few short-lived episodes.

Schizophrenia symptoms generally appear earlier in men, often during adolescence or early adulthood, whereas in women, onset is more likely in their late 20s or early 30s. It is relatively rare for schizophrenia to develop after the age of 45. Studies also indicate a slightly higher occurrence in males, who make up about 55% of all cases.

According to a 2023 analysis by DelveInsight, there were an estimated 3.8 million diagnosed cases of schizophrenia across the 7MM, with the United States contributing nearly 1.4 million of these. This number is expected to grow by 2034, driven by advancements in psychiatric research and diagnostic tools, leading to better identification of the condition.

Effective management of schizophrenia typically involves a combination of medications, therapy, and social support. However, nearly one-third of patients do not respond well to standard treatments, and many experience relapses characterized by psychotic episodes and decreased daily functioning.

In a significant development, the FDA approved Bristol Myers Squibb’s COBENFY (xanomeline and trospium chloride) in September 2024 for adult schizophrenia treatment. Previously known as KarXT, COBENFY is the first novel schizophrenia treatment drug approved in decades. It works by targeting the M1 and M4 receptors in the brain, avoiding the traditional D2 receptor blockade.

Learn more about the schizophrenia medication @ Schizophrenia Drug Market 

Many patients require more than just medication and counseling; current antipsychotic drugs often cause side effects, and stigma and misunderstandings add further challenges. Addressing these issues is key to improving functional recovery and enhancing the quality of life for those with schizophrenia. Ongoing research is focused on developing safer and more effective treatments. 

DelveInsight estimates that the schizophrenia market size is expected to grow from USD 7.9 billion in 2023 with a significant CAGR by 2034. This growth is mainly due to increasing awareness about schizophrenia may increase market size in the coming years, assisted by an increase in the prevalence of schizophrenia.  

Various potential schizophrenia treatment medication that are projected to enter the market during the forecast period include Teva Pharmaceutical/MedinCell/Royalty Pharma’s Olanzapine LAI (TEV-‘749), Boehringer Ingelheim’s Iclepertin (BI-425809), Sunovion Pharmaceutical (Sumitomo Pharma)/Otsuka’s Ulotaront (SEP-363856), Reviva Pharmaceuticals’ Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma’s Roluperidone (MIN-101/MT-210), Neurocrine Biosciences/Mitsubishi Tanabe Pharma’s Valbenazine (NBI-98854), Lyndra Therapeutics’ LYN-005 (long-acting oral risperidone), and Newron Pharmaceuticals’ Evenamide (NW-3509), among others.

Keen to know how the schizophrenia treatment drugs market will evolve by 2034? Find out @ Medicine for Schizophrenia Patients

The potential for effective schizophrenia treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, various new schizophrenia drugs are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall schizophrenia market. Now, let’s examine the schizophrenia pipeline therapies under investigation.

Teva Pharmaceutical/MedinCell/Royalty Pharma’s Olanzapine LAI

Phase III

TEV-749 is an experimental, long-acting subcutaneous injection of the second-generation antipsychotic olanzapine, designed for once-monthly administration. It has not yet received regulatory approval for any indication, and its safety and effectiveness are still under investigation. In November 2023, Teva Pharmaceuticals partnered with Royalty Pharma in a funding agreement worth up to USD 125 million to advance the clinical development of TEV-749. By May 2024, Teva reported favorable results from the Phase III SOLARIS trial, which assessed the drug in adults with schizophrenia. The trial met its primary endpoint, showing a significant reduction in PANSS total scores after 8 weeks compared to placebo. Later, in November 2024, Teva released additional positive findings from the same study, highlighting improvements in social functioning and quality of life among the treated patients.

Boehringer Ingelheim’s Iclepertin

Phase III

Iclepertin (BI 425809) is an experimental drug that inhibits glycine transporter 1 (GlyT1), aiming to address the cognitive symptoms of schizophrenia (CIAS) by targeting brain mechanisms involved in cognition. Disruptions in glutamatergic signaling, particularly through NMDA receptors, are known to play a role in cognitive impairment. Enhancing NMDA receptor activity may support synaptic plasticity and cognitive function. Glycine, an essential co-agonist of the NMDA receptor, is regulated by GlyT-1 and GlyT-2 transporters, which are found in presynaptic neurons and astrocytes and help maintain synaptic glycine levels. By inhibiting GlyT1, BI 425809 is thought to raise synaptic glycine concentrations, thereby enhancing NMDA receptor activity. The US FDA has granted Iclepertin Breakthrough Therapy Designation.

This potent and selective GlyT1 inhibitor, taken orally, was also explored as a potential treatment for Alzheimer’s disease. However, top-line data from its Phase II trial in early 2020 did not support continued development for that indication. As a result, research efforts have shifted toward evaluating the drug’s potential in treating schizophrenia. Currently, multiple Phase III clinical trials of Iclepertin (BI 425809) are underway, with some in the recruitment phase and others marked as active but not recruiting, all focused on schizophrenia. Boehringer Ingelheim has also partnered with Sosei Group Corporation in a global collaboration and exclusive option-to-license deal to advance and commercialize Sosei Heptares’ first-in-class GPR52 agonists. These compounds aim to improve outcomes in schizophrenia by targeting its positive, negative, and cognitive symptoms. In January 2025, Boehringer Ingelheim released top-line results from the Phase III CONNEX program assessing cognitive impairment in adults with schizophrenia, which showed that the trial did not achieve its primary or key secondary endpoints.

Sunovion Pharmaceutical (Sumitomo Pharma)/Otsuka’s Ulotaront

Phase III

Ulotaront (SEP-363856) is an oral small-molecule drug that acts as an agonist of the trace amine-associated receptor 1 (TAAR1) and also targets the serotonin 5-HT1A receptor. Unlike traditional antipsychotics, it does not bind to dopamine D2 or serotonin 5-HT2A receptors. It was co-developed by Sunovion Pharmaceuticals and PsychoGenics, discovered through the use of PsychoGenics’ SmartCube in vivo phenotypic platform and AI algorithms.

Currently, Ulotaront is in late-stage clinical development for treating schizophrenia and generalized anxiety disorder (GAD) in Japan, and is also being studied for adjunctive treatment in major depressive disorder, schizophrenia, and GAD in the U.S. Sunovion has shared top-line results from the Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia. However, the company has opted to discontinue the Phase III DIAMOND 3 trial in the U.S. Likewise, Sumitomo Pharma has ended both a Phase III trial in Japan and a Phase II/III trial spanning Japan and other regions, citing strategic business reasons. Despite this, one Phase III study remains ongoing.

In a recent update, Otsuka and Sumitomo revised their licensing deal—removing SEP-4199 and SEP-378614 from the original terms. Under the new agreement, Otsuka has obtained exclusive global rights to develop, manufacture, and commercialize ulotaront. No upfront payment is required, but Otsuka could pay up to $30 million in milestone payments, along with royalties on future sales. From January 2024 onwards, Otsuka will bear the full cost of most studies and plans to continue development, aiming for a launch during the fourth MTMP period.

Discover which schizophrenia therapies are expected to grab major schizophrenia drug market share @ Schizophrenia Best Treatment

Reviva Pharmaceuticals’ Brilaroxazine

Phase III

Brilaroxazine (RP-5063) is a novel chemical compound with strong affinity and selectivity for several key serotonin and dopamine receptors involved in schizophrenia and various psychiatric conditions. It acts as a multimodal modulator, targeting serotonin receptors 5-HT1A, 5-HT2A, 5-HT2B, and 5-HT7, as well as dopamine receptors D2, D3, and D4. The drug is currently in clinical development for several neuropsychiatric disorders, with schizophrenia as the lead indication. Most preclinical work has been completed, and preparations are ongoing to support a New Drug Application (NDA) submission, planned for the fourth quarter of 2025.

In addition to schizophrenia, brilaroxazine is also being evaluated for other conditions such as bipolar disorder, major depressive disorder (MDD), attention-deficit/hyperactivity disorder (ADHD), and inflammatory diseases like pulmonary arterial hypertension, idiopathic pulmonary fibrosis, and psoriasis.

Reviva Pharmaceuticals shared findings from the Phase III RECOVER trial of brilaroxazine for schizophrenia at the 2024 annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in Colorado. The results showed that brilaroxazine met all primary and secondary endpoints, significantly improving key schizophrenia symptoms.

In September 2024, the company revealed new vocal biomarker results from the same Phase III trial during a virtual key opinion leader event. This was followed by a presentation of favorable speech latency data in November 2024 at the CNS Summit, highlighting additional benefits of the drug. Also in November, Reviva provided an update on the ongoing one-year open-label extension (OLE) study, which is evaluating long-term safety and tolerability in schizophrenia patients. Preliminary topline findings from this OLE phase were announced in December 2024, indicating positive outcomes. The complete dataset from this extension phase—including extended safety, tolerability, and efficacy results, as well as vocal and blood biomarker analyses—is expected to be released in Q1 2025.

Minerva Neurosciences/Mitsubishi Tanabe Pharma’s Roluperidone

Phase III

Minerva Neurosciences is advancing the development of roluperidone (MIN-101), a potential treatment for the persistent negative symptoms of schizophrenia, which often last a lifetime and significantly impact patients' quality of life and functioning. Roluperidone works by blocking serotonin and sigma receptors—key brain receptors involved in mood, cognition, sleep, and anxiety regulation. The company has global rights to develop, commercialize, and import roluperidone (MT-210) through a licensing agreement with Mitsubishi Tanabe Pharma Corporation. The candidate has completed a Phase III trial in the U.S. targeting negative symptoms of schizophrenia.

Minerva engaged with the U.S. FDA during the review of its New Drug Application (NDA) for roluperidone. However, the FDA issued a Complete Response Letter (CRL), requiring Minerva to conduct at least one more positive, adequate, and well-controlled study to demonstrate the drug's safety and efficacy for treating negative symptoms.

In Q1 2024, the company completed a clinical trial—initiated in October 2023—assessing the safety, tolerability, pharmacodynamics, and pharmacokinetics of combining roluperidone with olanzapine in adults with moderate to severe negative symptoms of schizophrenia. In February 2024, Minerva officially received the CRL from the FDA regarding its NDA for roluperidone.

Discover more about drugs for schizophrenia drugs in development @ Schizophrenia Clinical Trials

DelveInsight’s latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalent Cases of Schizophrenia
• Total Diagnosed Prevalent Cases of Schizophrenia
• Gender-specific Diagnosed Prevalent Cases of Schizophrenia
• Severity-specific Diagnosed Prevalent Cases of Schizophrenia

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include:

• 10-year Forecast
• 7MM Analysis
• Epidemiology-based Market Forecasting
• Historical and Forecasted Market Analysis upto 2034
• Emerging Drug Market Uptake
• Peak Sales Analysis
• Key Cross Competition Analysis 
• Industry Expert’s Opinion
• Access and Reimbursement

Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space.

Related Reports

Schizophrenia Pipeline

Schizophrenia Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others.

Schizophrenia Epidemiology Forecast

Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends.

Dementia Market

Dementia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others.

Bipolar Depression Market

Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including  Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Contact Us
                    
                    Shruti Thakur 
                    
                    info@delveinsight.com 
                    
                    +14699457679