Schizophrenia Market Insights Highlight Expanding Outlook Till 2034, DelveInsight Evaluates

DelveInsight's "Schizophrenia Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Schizophrenia, historical and forecasted epidemiology as well as the Schizophrenia market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Schizophrenia Market Report:
• The Schizophrenia market size was valued ~USD 7,972 million in 2022 and is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In May 2025, Vanda Pharmaceuticals reported that the FDA has accepted the New Drug Application (NDA) for BysantiTM (milsaperidone) without raising any review concerns. The agency has scheduled February 21, 2026, as the decision date. Milsaperidone, a novel chemical entity and active metabolite of iloperidone, has demonstrated dose-dependent bioequivalence in clinical studies.
• In April 2025, CMG Pharmaceutical, a subsidiary of CHA Biotech, secured FDA approval for Mezofy (formerly Depipzo), an oral film therapy for schizophrenia. Formulated with aripiprazole, it dissolves in the mouth, improving adherence without requiring water.
• In March 2025, Vanda Pharmaceuticals Inc. has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for BysantiTM (milsaperidone) as a treatment for acute bipolar I disorder and schizophrenia, backed by several clinical studies demonstrating its safety and efficacy.
• In March 2025, LB Pharmaceuticals Inc., a clinical-stage biopharma company focused on developing innovative treatments for neuropsychiatric disorders such as schizophrenia, has shared new positive findings from its NOVA1 Phase 2 clinical trial of LB-102 in patients experiencing acute schizophrenia exacerbations. The data was presented at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS), currently taking place in Chicago.
• In February 2025, The September 2024 approval of xanomeline-trospium chloride (Cobenfy; Bristol Myers Squibb) marks the first novel schizophrenia treatment in 70 years. While some experts have welcomed the milestone, others remain cautious. Unlike traditional antipsychotics that target dopamine D2 receptors, this therapy works through muscarinic acetylcholine receptors, offering a distinct mechanism of action.
• In January 2025, German pharmaceutical leader Boehringer Ingelheim revealed that its investigational drug iclepertin, intended to treat cognitive impairment in schizophrenia patients, did not meet any primary or secondary endpoints across three Phase III trials. The CONNEX program results showed no significant cognitive or functional improvements over placebo after six months. However, the company noted that iclepertin maintained a favorable safety profile.
• In January 2025, Segal Trials, a private clinical research organization focused on acute schizophrenia and other psychiatric conditions, has shared its enrollment performance data from its involvement in NOVA-a Phase 2 dose-finding study in adults with acute schizophrenia assessing LB-102, a once-daily oral small molecule and potential first-in-class benzamide antipsychotic.
• In December 2024, Adams Clinical, LLC ("Adams" or the "Company"), a prominent neuroscience-focused clinical trial site network, announced that it has reached an agreement to partner with InSite Clinical Research ("InSite"). InSite, based in the Dallas-Fort Worth metroplex, specializes in conducting inpatient and outpatient clinical trials for psychiatric and neurological conditions, including schizophrenia.
• In November 2024, AbbVie announced that its two Phase 2 EMPOWER trials of emraclidine, a once-daily oral monotherapy for adults with schizophrenia experiencing acute psychotic symptoms, failed to meet the primary endpoint. The trials revealed no statistically significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score when compared to placebo at week 6.
• In September 2024, Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted approval for COBENFYTM (xanomeline and trospium chloride), an oral treatment for adult schizophrenia. COBENFY marks the first new class of medication in decades, offering a novel approach by specifically targeting M1 and M4 receptors in the brain, without blocking D2 receptors.
• In May 2024, Teva and Medincell reported positive results from the Phase III SOLARIS trial, which evaluated the efficacy of TEV-'749 (olanzapine), a once-monthly subcutaneous long-acting injectable for adults with schizophrenia. SOLARIS is a multinational, multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of olanzapine extended-release injectable suspension for subcutaneous use in patients aged 18-65 with schizophrenia.
• In April 2024, Bristol Myers Squibb (BMS) has released new interim data from the Phase III EMERGENT-4 open-label extension trial, showing that KarXT (xanomeline-trospium) led to a reduction in symptoms in adults with schizophrenia.
• In March 2024, US-based biopharmaceutical company Acadia Pharmaceuticals announced that its Phase III ADVANCE-2 clinical trial evaluating pimavanserin for treating negative symptoms of schizophrenia failed to meet its primary endpoint. The 26-week, placebo-controlled trial enrolled 454 adult participants with negative symptoms of schizophrenia who had stable control of positive symptoms through ongoing antipsychotic therapy.
• The US holds the largest market share for schizophrenia, valued at approximately USD 5,749 million, compared to the EU4 (Germany, Italy, France, and Spain), the UK, and Japan.
• In 2022, Germany had the largest schizophrenia market size among the EU4 and the UK, at approximately USD 432 million. This market is expected to grow further, with Germany projected to maintain the largest share, followed by the UK, by 2034.
• In 2022, Japan's schizophrenia market was valued at approximately USD 676 million, making it the second largest market. This is expected to grow further by 2034.
• According to DelveInsight's analysis, the total diagnosed prevalent cases of schizophrenia in the 7MM were approximately 3,796,850 in 2022, and this number is expected to rise throughout the study period (2020-2034).
• DelveInsight's analysis estimates that in 2022, the EU4 and the UK accounted for the largest share, approximately 42%, of the total diagnosed prevalent schizophrenia cases in the 7MM. These cases are expected to increase further by 2034.
• DelveInsight analysts reported that in 2022, the gender-specific diagnosed prevalent cases of schizophrenia in the US were approximately 757,469 for males and 655,002 for females. These numbers are expected to fluctuate throughout the forecast period (2024-2034).
• Key Schizophrenia Companies: Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others
• Key Schizophrenia Therapies: RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others
• The Schizophrenia market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Schizophrenia pipeline products will significantly revolutionize the Schizophrenia market dynamics.

Schizophrenia Overview
Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. Individuals with schizophrenia may experience symptoms such as delusions (false beliefs), hallucinations (hearing or seeing things that aren't there), disorganized thinking, and impaired cognitive abilities. It can also lead to social withdrawal and difficulty functioning in daily life. The exact cause is unknown, but it is believed to involve a combination of genetic, biological, and environmental factors. Treatment typically includes antipsychotic medications and therapy to manage symptoms and improve quality of life.

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Schizophrenia Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Schizophrenia Epidemiology Segmentation:
The Schizophrenia market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Schizophrenia
• Prevalent Cases of Schizophrenia by severity
• Gender-specific Prevalence of Schizophrenia
• Diagnosed Cases of Episodic and Chronic Schizophrenia

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Schizophrenia Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Schizophrenia market or expected to get launched during the study period. The analysis covers Schizophrenia market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Schizophrenia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Schizophrenia Therapies and Key Companies
• RP5063 (brilaroxazine): Reviva Pharmaceuticals
• MIN-101 (roluperidone): Minerva Neurosciences
• KarXT (xanomeline-trospium): Karuna Therapeutics
• NUPLAZID (pimavanserin): Acadia Pharmaceuticals
• ICELPERTIN (BI-425809): Boehringer Ingelheim
• SEP-363856 (ulotaront): Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical
• OKEDI (risperidone ISM): Laboratorios Farmacéuticos Rovi
• LYN-005: Lyndra Therapeutics
• NW-3509/NW-3509A (evenamide): Newron Pharmaceuticals
• CVL-231 (emraclidine): Cerevel Therapeutics
• Seroquel Sustained Release: AstraZeneca
• Intramuscular Olanzapine Depot: Eli Lilly and Company
• Xanomeline and Trospium Chloride Capsules: Karuna Therapeutics
• NBI-1117568: Neurocrine Biosciences

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Schizophrenia Market Drivers
• Increasing popularity among individuals for long-acting injectable (LAI) antipsychotics are key factors driving growth of the global schizophrenia drugs market.

Schizophrenia Market Barriers
• WHO's Comprehensive Mental Health Action Plan 2013- 2030 will further enhance the awareness about mental health by ensuring 100 million more people have access to quality and affordable care for mental health conditions.

Scope of the Schizophrenia Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Schizophrenia Companies: Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others
• Key Schizophrenia Therapies: RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others
• Schizophrenia Therapeutic Assessment: Schizophrenia current marketed and Schizophrenia emerging therapies
• Schizophrenia Market Dynamics: Schizophrenia market drivers and Schizophrenia market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Schizophrenia Unmet Needs, KOL's views, Analyst's views, Schizophrenia Market Access and Reimbursement

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