The schizophrenia therapy market is very crowded. Many of the antipsychotic therapies are generic, although newer oral atypical antipsychotics (e.g., Intra-Cellular Therapies’ Caplyta) are also available. Competition is also intensifying among antipsychotic long-acting injectables (LAIs) as new therapies launch, offering largely incremental advantages over treatment mainstays. Indeed, late-phase emerging therapies—including new oral atypical antipsychotics (Alkermes’s ALKS 3831, Acadia Pharmaceuticals’ pimavanserin), new LAIs (e.g., Janssen’s paliperidone six-month depot, Teva’s TV-46000), and others (Sunovion / Sumitomo Dainippon Pharma’s SEP-363856, BioXcel’s BXCL501)—must be clearly differentiated from established therapies to gain a foothold in this market. The potential of early- to mid-phase therapies to treat the negative symptoms and cognitive impairment associated with schizophrenia (CIAS)—symptom domains on which drug developers are increasingly focusing—remains to be seen; few agents have promising results in mid-phase clinical studies (e.g., Boehringer Ingelheim’s BI 425809 in CIAS).

Questions Answered

  • What is the current size of the schizophrenia market in the G7 countries? What key events will influence the market over the next decade?
  • What factors drive and constrain the use of LAIs of atypical antipsychotics? How is competition heating up in this segment?
  • What are the biggest areas of unmet need? Which late-phase therapies have potential to fulfill these needs?
  • What would key late-phase therapies need to demonstrate in order to compete effectively in this crowded market? How will these agents be placed in the schizophrenia treatment algorithm?

Product Description: Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Geographies: United States, EU5, Japan.

Primary research: 29 country-specific interviews with thought-leading psychiatrists, supported by survey data collected for this and other DRG research.

Epidemiology: Diagnosed prevalence of schizophrenia by country, segmented by positive symptoms and negative symptoms; drug-treated prevalence of schizophrenia by country.

Forecast: Ten-year, annualized, drug-level sales and patient share of key schizophrenia therapies through 2029, segmented by brands / generics.

Emerging therapies: Phase III / PR: 10 drugs. Coverage of select Phase II and Phase I products.

Table of contents

  • Schizophrenia - Landscape & Forecast - Disease Landscape And Forecast G7
    • Key Updates
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • November 2020
      • Q3 2020
        • September 2020
      • Q2 2020
        • May 2020
    • Key Findings
      • Schizophrenia - Key Findings - January 2021
        • May 2020
    • Market Outlook
      • Key Findings
        • Market Share of Drug Classes for Schizophrenia: 2019
        • Market Share of Drug Classes for Schizophrenia: 2029
        • Schizophrenia SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Schizophrenia?
          • What Factors Are Constraining the Market for Schizophrenia?
          • Market Share and Share of Treated Patients for Schizophrenia by Region: 2019 and 2029
          • Major-Market Sales in Schizophrenia by Drug Class: 2019-2029
          • Major-Market Patient Share by Drug Class and Drug-Treated Patients in Schizophrenia: 2019-2029
          • Major-Market Brand and Generic Sales in Schizophrenia: 2019-2029
          • Major-Market Brand and Generic Patient Share in Schizophrenia: 2019-2029
        • Drug-Class-Specific Trends
          • Major-Market Sales of Key Oral Atypical Antipsychotics in Schizophrenia: 2019-2029
          • Patient Share of Key Oral Atypical Antipsychotics for Schizophrenia in the United States: 2019-2029
          • Patient Share of Key Oral Atypical Antipsychotics for Schizophrenia in the EU5: 2019-2029
          • Patient Share of Key Oral Atypical Antipsychotics for Schizophrenia in Japan: 2019-2029
          • Major-Market Sales of LAIs of Key Atypical Antipsychotics in Schizophrenia: 2019-2029
          • Patient Share of LAIs of Atypical Antipsychotics for Schizophrenia in the United States: 2019-2029
          • Patient Share of LAIs of Atypical Antipsychotics for Schizophrenia in the EU5: 2019-2029
          • Patient Share of LAIs of Atypical Antipsychotics for Schizophrenia in Japan: 2019-2029
          • Sales and Patient Share of BXCL501 in Schizophrenia in the United States: 2019-2029
          • Sales of SEP-363856 in Schizophrenia by Region: 2019-2029
          • Patient Share of SEP-363856 in Schizophrenia by Region: 2019-2029
      • Forecast
        • Market Forecast Assumptions - Schizophrenia (2019-2029) - January 2021
        • Market Forecast Dashboard - Schizophrenia (2019-2029) - January 2021
      • Etiology and Pathophysiology
        • Disease Overview
          • Genetic Factors
            • Environmental Factors
              • Environmental Risk Factors
            • Key Pathways and Drug Targets
              • Abnormalities in Brain Structure and Function
              • Epidemiology
                • Key Findings
                  • Epidemiology Populations
                    • Disease Definition
                    • Methods
                    • Sources Used for Lifetime Prevalence Estimates of Schizophrenia
                    • Diagnosed Lifetime Prevalent Cases of Schizophrenia: 2019-2029 (in Thousands)
                    • Disease Definition
                    • Methods
                    • Sources Used for Symptom Status of Schizophrenia
                    • Positive Symptom Cases of Schizophrenia: 2019-2029 (in Thousands)
                    • Negative Symptom Cases of Schizophrenia: 2019-2029 (in Thousands)
                    • Number of Lifetime Diagnosed and Drug-Treated Prevalent Cases of Schizophrenia in the Major Pharmaceutical Markets: 2019-2029 (Thousands)
                • Current Treatment
                  • Key Findings
                    • Treatment Goals
                      • Key Endpoints Used in Clinical Trials for Schizophrenia
                    • Key Current Therapies
                      • Overview
                      • Mechanism of Action of Key Current Drug Classes Used for Schizophrenia
                      • Current Treatments Used for Schizophrenia
                      • Market Events Impacting the Use of Key Current Therapies for Schizophrenia
                      • Historical Timeline of Launch of Key Branded Atypical Antipsychotics for Schizophrenia in the United States
                      • Atypical Antipsychotics
                      • Impact of Receptor-Binding Profile on Efficacy / Safety Profile of Select Atypical Antipsychotics
                      • Advantages and Disadvantages of Oral Aripiprazole
                      • Advantages and Disadvantages of Aripiprazole Depot
                      • Expert Insight: Aripiprazole
                      • Advantages and Disadvantages of Aripiprazole Lauroxil
                      • Expert Insight: Aripiprazole Lauroxil
                      • Advantages and Disadvantages of Oral Asenapine
                      • Advantages and Disadvantages of Asenapine Transdermal Patch
                      • Expert Insight: Asenapine
                      • Advantages and Disadvantages of Oral Blonanserin
                      • Advantages and Disadvantages of Blonanserin Transdermal Patch
                      • Advantages and Disadvantages of Brexpiprazole
                      • Ongoing Clinical Development of Brexpiprazole
                      • Key Ongoing Clinical Trials of Brexpiprazole in the Treatment of Schizophrenia
                      • Expert Insight: Brexpiprazole
                      • Advantages and Disadvantages of Cariprazine
                      • Ongoing Clinical Development of Cariprazine
                      • Key Ongoing Clinical Trials of Cariprazine in the Treatment of Schizophrenia
                      • Expert Insight: Cariprazine
                      • Advantages and Disadvantages of Clozapine
                      • Expert Insight: Clozapine
                      • Advantages and Disadvantages of Iloperidone
                      • Advantages and Disadvantages of Lumateperone
                      • Expert Insight: Lumateperone
                      • Advantages and Disadvantages of Lurasidone
                      • Expert Insight: Lurasidone
                      • Advantages and Disadvantages of Oral Olanzapine
                      • Advantages and Disadvantages of Olanzapine Pamoate
                      • Expert Insight: Olanzapine
                      • Advantages and Disadvantages of Oral Paliperidone
                      • Advantages and Disadvantages of Paliperidone Palmitate One-Month Depot
                      • Advantages and Disadvantages of Paliperidone Palmitate Three-Month Depot
                      • Expert Insight: Paliperidone
                      • Advantages and Disadvantages of Quetiapine
                      • Expert Insight: Quetiapine
                      • Advantages and Disadvantages of Oral Risperidone
                      • Advantages and Disadvantages of Risperidone Microspheres: Risperdal Consta
                      • Advantages and Disadvantages of Risperidone One-Month Depot: Perseris
                      • Expert Insight: Risperidone
                      • Advantages and Disadvantages of Ziprasidone
                      • Expert Insight: Ziprasidone
                      • Advantages and Disadvantages of Typical Antipsychotics
                      • Expert Insight: Typical Antipsychotics
                    • Medical Practice
                      • Overview
                      • Country-Specific Schizophrenia Treatment Guidelines
                      • Factors Influencing Drug Selection in Schizophrenia
                      • Treatment Decision Tree for Schizophrenia: United States
                      • Treatment Decision Tree for Schizophrenia: Europe
                      • Treatment Decision Tree for Schizophrenia: Japan
                      • Major-Market Treatment Decision Tree for CIAS
                      • Major-Market Treatment Decision Tree for the Side Effects of Antipsychotics in Schizophrenia
                      • Major-Market Treatment Decision Tree for the Comorbid Symptoms of Schizophrenia
                  • Unmet Need Overview
                    • Current and Future Attainment of Unmet Needs in Schizophrenia
                    • Top Unmet Needs in Schizophrenia: Current and Future Attainment
                    • Expert Insight: Unmet Need in Schizophrenia
                  • Emerging Therapies
                    • Key Findings
                      • Pipeline Trends for Schizophrenia
                    • Key Emerging Therapies
                      • Key Therapies in Development for Schizophrenia
                      • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Schizophrenia
                      • ALKS 3831 Profile
                      • Analysis of the Clinical Development Program for ALKS 3831
                      • Expert Insight: ALKS 3831
                      • Expectations for Launch and Sales Opportunity of ALKS 3831 in Schizophrenia
                      • Key Development Milestones for ALKS 3831 in the Treatment of Schizophrenia
                      • Likely Uses of ALKS 3831 for the Treatment of Schizophrenia
                      • Pimavanserin Profile
                      • Expert Insight: Pimavanserin
                      • Expectations for Launch and Sales Opportunity of Pimavanserin in Schizophrenia
                      • Key Development Milestones for Pimavanserin in the Treatment of Schizophrenia
                      • Likely Uses of Pimavanserin for the Treatment of Schizophrenia
                      • Paliperidone Palmitate Six-Month Depot Profile
                      • Analysis of the Clinical Development Program for Paliperidone Palmitate Six-Month Depot
                      • Expert Insight: Paliperidone Palmitate Six-Month Depot
                      • Expectations for Launch and Sales Opportunity of Paliperidone Palmitate Six-Month Depot in Schizophrenia
                      • Key Development Milestones for Paliperidone Palmitate Six-Month Depot in the Treatment of Schizophrenia
                      • Likely Uses of Paliperidone Palmitate Six-Month Depot for the Treatment of Schizophrenia
                      • Doria Profile
                      • TV-46000 Profile
                      • Rykindo Profile
                      • Analysis of the Clinical Development Program for Extended-Release Forms of Risperidone
                      • Expert Insight: Extended-Release Forms of Risperidone
                      • Expectations for Launch and Sales Opportunity of Extended-Release Forms of Risperidone in Schizophrenia
                      • Key Development Milestones for Doria in the Treatment of Schizophrenia
                      • Key Development Milestones for TV-46000 in the Treatment of Schizophrenia
                      • Likely Uses of Extended-Release Forms of Risperidone for the Treatment of Schizophrenia
                      • BXCL501 Profile
                      • Analysis of the Clinical Development Program for BXCL501
                      • Expert Insight: BXCL501
                      • Expectations for Launch and Sales Opportunity of BXCL501 in Schizophrenia
                      • Key Development Milestones for BXCL501 in the Treatment of Schizophrenia
                      • Likely Uses of BXCL501 for the Treatment of Schizophrenia
                      • SEP-363856 Profile
                      • Analysis of the Clinical Development Program for SEP-363856
                      • Expert Insight: SEP-363856
                      • Expectations for Launch and Sales Opportunity of SEP-363856 in Schizophrenia
                      • Key Development Milestones for SEP-363856 in the Treatment of Schizophrenia
                      • Likely Uses of SEP-363856 for the Treatment of Schizophrenia
                      • Roluperidone Profile
                      • Analysis of the Clinical Development Program for Roluperidone
                      • Expert Insight: Roluperidone
                      • Expectations for Launch and Sales Opportunity of Roluperidone in Schizophrenia
                      • KarXT Profile
                      • Analysis of the Clinical Development Program for KarXT
                      • Expectations for Launch and Sales Opportunity of KarXT in Schizophrenia
                    • Early-Phase Pipeline Analysis
                      • Select Compounds in Early-Phase Development for Schizophrenia
                  • Access & Reimbursement Overview
                    • Region-Specific Reimbursement Practices
                      • Key Market Access Considerations in Schizophrenia: United States
                      • General Reimbursement Environment: United States
                      • Key Market Access Considerations in Schizophrenia: EU5
                      • General Reimbursement Environment: EU5
                      • Key Market Access Considerations in Schizophrenia: Japan
                      • General Reimbursement Environment: Japan
                  • Appendix
                    • Key Abbreviations Related to Schizophrenia
                    • Brands, Marketers, and Generic Availability of Key Therapies for Schizophrenia by Market
                    • Schizophrenia Bibliography

                Author(s): Himanshu Jain, M.S. Pharm.; Emma McFadden, Ph.D.; Harinder Kumar; Shefali Gulati, M.B.A.

                Himanshu Jain, M.S.(Pharm.), is a manager on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. He has authored content for ophthalmology (retinal / nonretinal) and psychiatry indications, including age-related macular degeneration, diabetic retinopathy / diabetic macular edema, glaucoma, uveitis, and schizophrenia. He has more than ten years of experience working in market research and consulting firms. He earned his master’s degree from the National Institute of Pharmacological Education and Research and holds an Executive Post-Graduate Diploma in international business from the Indian Institute of Foreign Trade.

                Emma McFadden, Ph.D., is a director on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. Her focus is on ophthalmic indications, such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema, although she has authored reports in a number of other indications, including multiple sclerosis and epilepsy. Dr. McFadden earned a B.A. in neuroscience and a Ph.D. in biochemistry from Trinity College in Dublin.

                 

                Harinder Kumar, B.D.S., M.P.H., is an associate epidemiologist at DRG, part of Clarivate. Prior to joining DRG, Dr. Kumar worked with the government of Punjab, National Health Mission, India. He received his M.P.H. from the Tata Institute of Social Sciences in Mumbai. He holds a B.D.S. in dentistry from the National Dental College and Hospital in Punjab.

                Shefali Gulati, M.B.A., is an analyst on the CNS/Ophthalmology Disorders team at DRG, part of Clarivate. She is responsible for performing extensive secondary market research and analysis for major pharmaceutical markets. She has authored several CNS/Ophthalmology reports, including U.S. Treatment Algorithms, Unmet need, Special topics. Prior to joining DRG, Ms. Gulati was a knowledge management associate with ZS Associates, where she worked on multiple client projects pertaining to real-world claims data analysis, opportunity assessment, competitive landscape, pipeline analysis, and key product profiling. She holds an M.B.A. in pharmaceutical management from the National Institute of Pharmaceutical Education and Research and a bachelor’s degree in pharmacy from the Delhi Institute of Pharmaceutical Sciences and Research.

                 


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