Schizophrenia – Landscape & Forecast – Disease Landscape & Forecast
The schizophrenia therapy market is very crowded, with multiple oral long-acting injectable (LAI) antipsychotic agents. Indeed, to gain a foothold in the market, differentiation from already established therapies is a primary requirement for the late-phase and recently approved therapies not specifically targeting schizophrenia subpopulations with high unmet need—including new oral atypical antipsychotics (e.g., Alkermes’s Lybalvi), new LAIs (e.g., Janssen’s paliperidone six-month depot, Teva’s TV-46000), and other agents with novel mechanisms of action (e.g., Sunovion / Sumitomo Dainippon Pharma / Otsuka’s ulotaront [SEP-363856], Karuna Therapeutics’ KarXT). Although the potential of therapies in development to treat the negative symptoms of schizophrenia or the cognitive impairment associated with schizophrenia (CIAS) remains to be seen in late-phase studies, some agents had promising results in mid-phase clinical studies and could earn blockbuster sales, such as Acadia Pharmaceuticals’ pimavanserin and Boehringer Ingelheim’s BI 425809.
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 percentage of diagnosed lifetime prevalent schizophrenia patients receive drug treatment? How large are the schizophrenia subpopulations with negative symptoms or cognitive impairment?
- What are the greatest areas of unmet need? Which late-phase therapies have the potential to fulfill these needs?
- How will novel emerging therapies be positioned in the schizophrenia treatment algorithm?
Geographies: United States, EU5, Japan.
Primary research: 26 country-specific interviews with thought-leading psychiatrists, supported by survey data collected for this and other Clarivate research.
Epidemiology: Diagnosed prevalence of schizophrenia by country, segmented by positive symptoms, negative symptoms, and cognitive impairment; drug-treated prevalence of schizophrenia by country.
Forecast: Ten-year, annualized, drug-level sales and patient share of key schizophrenia therapies through 2031, segmented by brands / generics.
Emerging therapies: Phase III / PR: 11 drugs. Coverage of select Phase II and Phase I products.
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.
Solution Enhancement: Disease Landscape & Forecast will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold. Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Schizophrenia - Landscape & Forecast - Disease Landscape & Forecast
- Key updates
- May 2023
- Q4 2022
- November 2022
- October 2022
- Q3 2022
- September 2022
- Q2 2022
- June 2022
- May 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Key findings
- Schizophrenia - Key findings - September 2022
- March 2022
- February 2022
- January 2022
- Schizophrenia - Key findings - September 2022
- Market outlook
- Key findings
- Market share of drug classes for schizophrenia: 2021
- Market share of drug classes for schizophrenia: 2031
- Schizophrenia SWOT analysis
- 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: 2021 and 2031
- Major-market sales in schizophrenia by drug class: 2021-2031
- Major-market patient share by drug class and drug-treated patients in schizophrenia: 2021-2031
- Major-market brand and generic sales in schizophrenia: 2021-2031
- Major-market brand and generic patient share in schizophrenia: 2021-2031
- Drug-class-specific trends
- Major-market sales of key oral atypical antipsychotics in schizophrenia: 2021-2031
- Patient share of key oral atypical antipsychotics for schizophrenia in the United States: 2021-2031
- Patient share of key oral atypical antipsychotics for schizophrenia in the EU5: 2021-2031
- Patient share of key oral atypical antipsychotics for schizophrenia in Japan: 2020-2030
- Major-market sales of LAIs of key atypical antipsychotics in schizophrenia: 2021-2031
- Patient share of LAIs of atypical antipsychotics for schizophrenia in the United States: 2021-2031
- Patient share of LAIs of atypical antipsychotics for schizophrenia in the EU5: 2021-2031
- Patient share of LAIs of atypical antipsychotics for schizophrenia in Japan: 2021-2031
- Sales of ulotaront (SEP-363856) for schizophrenia by region: 2021-2031
- Patient share of ulotaront (SEP-363856) for schizophrenia by region: 2021-2031
- Sales of dexmedetomidine sublingual film (Igalmi) in schizophrenia in the United States: 2021-2031
- Patient share of dexmedetomidine sublingual film (Igalmi) in schizophrenia in the United States: 2021-2031
- Sales of KarXT in schizophrenia in the United States: 2021-2031
- Patient share of KarXT in schizophrenia in the United States: 2021-2031
- Sales of BI 425809 in schizophrenia by region: 2021-2031
- Patient share of BI 425809 in schizophrenia by region: 2021-2031
- Key findings
- Forecast
- Market Forecast Assumptions - Schizophrenia (2021-2031) - September 2022
- Market Forecast Dashboard - Schizophrenia (2021-2031) - September 2022
- Etiology and pathophysiology
- Disease overview
- Genetic factors
- Environmental factors
- Environmental risk factors
- Biochemical risk factors for CIAS
- Biochemical factors
- Key pathways and drug targets
- Abnormalities in brain structure and function
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition
- Methods
- Sources used for lifetime prevalence estimates of schizophrenia
- Diagnosed lifetime prevalent cases of schizophrenia: 2021-2031
- Disease definition
- Methods
- Sources used for symptom status of schizophrenia
- Positive symptom cases of schizophrenia: 2021-2031
- Negative symptom cases of schizophrenia: 2021-2031
- Disease definition
- Methods
- Sources used for lifetime prevalence estimates of schizophrenia
- Diagnosed lifetime prevalent cases with cognitive impairment: 2021-2031
- Number of lifetime diagnosed and drug-treated prevalent cases of schizophrenia in the major pharmaceutical markets: 2021-2031 (thousands)
- Key findings
- 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
- Timeline of launches of key drugs for schizophrenia in the United States
- Atypical antipsychotics
- Impact of receptor-binding on efficacy / safety profile of select atypical antipsychotics
- Advantages and disadvantages of oral aripiprazole
- Advantages and disadvantages of aripiprazole one-month 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
- Expert insight: brexpiprazole
- Advantages and disadvantages of cariprazine
- Ongoing clinical development of cariprazine
- 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 Lybalvi
- 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 and six-month depots
- 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
- Potential advantages and disadvantages of risperidone one-month depot: risperidone ISM (Okedi)
- Expert insight: risperidone
- Advantages and disadvantages of ziprasidone
- Advantages and disadvantages of typical antipsychotics
- Expert insight: typical antipsychotics
- Advantages and disadvantages of dexmedetomidine sublingual film
- Expert insight: dexmedetomidine sublingual film
- Medical practice
- Overview
- 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
- Key findings
- 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
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- Key emerging therapies
- Key therapies in development for schizophrenia
- Estimated launch dates of key emerging therapies for the treatment of schizophrenia
- Pimavanserin profile
- Analysis of the clinical development program for pimavanserin
- Expert insight: pimavanserin
- Expectations for launch and sales opportunity of pimavanserin in schizophrenia
- Likely uses of pimavanserin for the treatment of schizophrenia
- Brilaroxazine profile
- Analysis of the clinical development program for brilaroxazine
- Expert insight: brilaroxazine
- Expectations for launch and sales opportunity of brilaroxazine in schizophrenia
- TEV-44749
- BI 425809 profile
- Analysis of the clinical development program for BI 425809
- Expert insight: BI 425809
- Expectations for launch and sales opportunity of BI 425809 in schizophrenia
- Likely uses of BI 425809 for the treatment of schizophrenia
- Ulotaront (SEP-363856) profile
- Analysis of the clinical development program for ulotaront (SEP-363856)
- Expert insight: ulotaront (SEP-363856)
- Expectations for launch and sales opportunity of ulotaront (SEP-363856) in schizophrenia
- Likely uses of ulotaront (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
- Expert insight: KarXT
- Expectations for launch and sales opportunity of KarXT in schizophrenia
- Likely uses of KarXT for the treatment of schizophrenia
- Evenamide profile
- Analysis of the clinical development program for evenamide
- Expert insight: evenamide
- Expectations for launch and sales opportunity of evenamide in schizophrenia
- Valbenazine profile
- Analysis of the clinical development program for valbenazine
- Expert insight: valbenazine
- Expectations for launch and sales opportunity of valbenazine in schizophrenia
- Early-phase pipeline analysis
- Select compounds in early-phase development for schizophrenia
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- Bibliography
- Key updates
Himanshu Jain, M.S.(Pharm.), Senior Manager, CNS and Ophthalmology. He has authored content for psychiatry and ophthalmology indications, including forecasting markets for schizophrenia, depression, and dry eye disease. He has about 15 years of experience working in market research and consulting firms. He earned his master’s degree in Pharmacology & Toxicology from the National Institute of Pharmaceutical Education and Research and holds an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.
Riya Kanakhara, B.Tech., Associate Healthcare Research & Data Analyst, CNS and Ophthalmology. Ms. Kanakhara has substantial experience in market research and has produced competitive intelligence reports in multiple therapy areas, including oncology, ophthalmology, neurology, and psychiatry. She has also prepared post-conference reports for conferences such as the American Academy of Neurology. She holds a bachelor’s degree in biotechnology from Amity University in India.
Shayan Chakraborty is a senior healthcare research and data analyst on the CNS/Ophthalmology Disorders team at Clarivate. In this role, he oversees the team’s syndicated research stream in neurology, with a core focus on migraine. He has several years of experience working in the pharmaceutical industry providing analytical support in various therapy areas, including oncology, vaccines, specialty pharma, and rare diseases.
Prior to joining Clarivate, he was an assistant manager at WNS Global Services, where he was responsible for providing analytical and forecasting support to Global Vaccine Business Insight partners for early-phase products. He holds a bachelor’s degree in biotechnology from West Bengal University of Technology and a master’s degree in biotechnology and biochemical engineering from the Indian Institute of Technology, Kharagpur. Currently, he is pursuing India’s first full-time online bachelor’s degree in data science and programming from the Indian Institute of Technology, Madras.