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Psychosis in Parkinson's and Alzheimer's Disease Market Poised for Growth Through 2034 as Late-Stage Pipeline Candidates Target a Long-Standing Treatment Gap - DelveInsight
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Key Facts of the Psychosis in Parkinson's and Alzheimer's Disease Market Report
• In July 2026, Acadia Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). The company also completed enrollment in the Phase II portion of the RADIANT clinical program, with topline results expected in September to October 2026, while Phase III screening and enrollment are underway.
• The 7MM market for psychosis in Parkinson's disease and Alzheimer's disease was valued at approximately USD 1,290 million in 2023 and is projected to keep growing through 2034.
• Around 6.9 million people across the 7MM had diagnosed psychosis in Parkinson's disease and Alzheimer's disease in 2023, with the US making up about 34% of cases, Japan roughly 31%, and Germany around 11%.
• Growth is being driven by a wave of investigational therapies advancing through the pipeline, including Karuna Therapeutics' KarXT (xanomeline-trospium), Sunovion Pharmaceuticals' Ulotaront (SEP-363856), and Intra-Cellular Therapies' ITI-1284.
• An aging population is expected to push up rates of both Parkinson's disease and Alzheimer's disease, in turn increasing demand for psychosis-specific treatment and encouraging more patient-centered management approaches.
• A major unmet need persists: while Acadia's NUPLAZID (pimavanserin) is approved for Parkinson's disease psychosis, no therapy is yet approved specifically for psychosis in Alzheimer's disease, and the field still lacks reliable biomarkers or convenient screening tools, which contributes to underdiagnosis.
• Total diagnosed prevalent cases of Parkinson's disease across the 7MM reached about 2.6 million in 2023, split roughly 45% in the US, 45% across EU4 and the UK combined, and 10% in Japan.
• Within EU4 and the UK, Germany carried the largest Parkinson's disease population (~487 thousand cases), followed by France (~223 thousand), while Spain had the fewest (~150 thousand).
• The US alone accounted for about 6.3 million diagnosed Alzheimer's disease cases in 2023.
• Females represented about 65% of diagnosed Alzheimer's disease cases in the US in 2023, versus 35% for males.
• Japan recorded roughly 2.1 million diagnosed cases of Alzheimer's disease psychosis in 2023, a figure expected to grow at a CAGR of about 1.9% through 2034, while diagnosed Parkinson's disease psychosis cases in Japan stood at around 37 thousand.
• NUPLAZID held the largest share of the US market among current therapies in 2023, generating roughly USD 562 million in revenue.
• Key Psychosis in Parkinson's Disease and Alzheimer's Disease Market Players: Karuna Therapeutics, Sunovion Pharmaceuticals, Intra-Cellular Therapies, Acadia Pharmaceuticals, and others.
• Key Psychosis in Parkinson's Disease and Alzheimer's Disease Therapies: NUPLAZID (pimavanserin), KarXT (xanomeline-trospium), Ulotaront (SEP-363856), ITI-1284, FANAPT (iloperidone), and others in development.
Psychosis in Parkinson's and Alzheimer's Disease Overview
The National Institute of Mental Health defines psychosis as a cluster of symptoms marking some loss of contact with reality, disrupting a person's thoughts and perceptions to the point where distinguishing real from unreal becomes difficult. It can stem from idiopathic causes, underlying medical conditions such as neurodegenerative disease, or toxic exposure to substances or medications. In Parkinson's disease, psychosis commonly presents as visual hallucinations alongside auditory hallucinations, delusions, depression, and anxiety, and is linked to greater morbidity, longer nursing-home stays, and reduced quality of life. In Alzheimer's disease, psychosis typically emerges alongside progressive cognitive decline and is similarly marked by hallucinations and delusions.
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Psychosis in Parkinson's and Alzheimer's Disease Diagnosis
Diagnosis rests primarily on clinical evaluation, frequently supplemented by caregiver reports, since psychosis in these settings lacks a definitive lab test or biomarker. In Parkinson's disease, psychotic symptoms can emerge either from disease progression itself or as a side effect of medication, while in Alzheimer's disease, psychosis tends to track alongside the degree of cognitive decline.
Psychosis in Parkinson's and Alzheimer's Disease Epidemiology
The epidemiology chapter of the report tracks historical and forecasted trends across the 7MM from 2020 to 2034, segmented across the following categories:
Epidemiology Segmentation
• Diagnosed Prevalent Cases of Parkinson's Disease
• Diagnosed Prevalent Cases of Alzheimer's Disease
• Gender-specific Cases of Parkinson's Disease
• Gender-specific Cases of Alzheimer's Disease
• Age-specific Cases of Parkinson's Disease
• Age-specific Cases of Alzheimer's Disease
• Diagnosed Prevalent Cases of Psychosis in Parkinson's Disease
• Diagnosed Prevalent Cases of Psychosis in Alzheimer's Disease
• Among EU4 and the UK, age-specific Parkinson's disease cases in 2023 broke down to roughly 18 thousand in patients under 50, 62 thousand in the 50-59 bracket, 338 thousand in the 60-69 bracket, and 773 thousand in patients 70 and older - a distribution expected to shift upward in volume as overall Parkinson's disease prevalence rises through 2034.
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Psychosis in Parkinson's and Alzheimer's Disease Drugs Uptake and Pipeline Development Activities
The drug-uptake section of the report tracks how both recently launched and soon-to-launch therapies are being adopted, comparing patient share and projected sales across products.
As an example, Ulotaront (SEP-363856) is projected to reach the US market by 2027 with a fast anticipated uptake curve.
The pipeline section further catalogs candidates across Phase I, II, and III, alongside collaboration, licensing, and patent activity among the companies developing them.
Psychosis in Parkinson's and Alzheimer's Disease Therapies and Key Companies
• NUPLAZID (pimavanserin): Acadia Pharmaceuticals
• KarXT (xanomeline-trospium): Karuna Therapeutics
• Ulotaront (SEP-363856): Sunovion Pharmaceuticals
• ITI-1284: Intra-Cellular Therapies
Psychosis in Parkinson's and Alzheimer's Disease Market Outlook
More than half of all Alzheimer's disease patients are estimated to experience psychotic symptoms at some point in their illness. Antipsychotic medications remain the standard treatment, generally used alongside caregiver support and cognitive behavioral therapy. In the absence of firm guidelines, pimavanserin at 34 mg/day is typically the starting therapy given its FDA approval and favorable safety profile; clozapine and quetiapine serve as alternatives when pimavanserin is ineffective or unavailable, though each carries its own tolerability trade-offs - clozapine requiring regular blood monitoring due to agranulocytosis risk, and quetiapine sometimes falling short on efficacy. Because current options remain limited by side-effect burden, there is significant urgency around developing targeted therapies, particularly for Alzheimer's disease psychosis, where no approved option yet exists.
Discover more about therapies set to shape the psychosis in Parkinson's and Alzheimer's disease market @ Psychosis in Parkinson's and Alzheimer's Disease Treatment Landscape:
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Scope of the Psychosis in Parkinson's and Alzheimer's Disease Market Report
• Study Period: 2020-2034
• Forecast Period: 2024-2034
• Coverage: 7MM
• Key Players: Karuna Therapeutics, Sunovion Pharmaceuticals, Intra-Cellular Therapies, Acadia Pharmaceuticals, and others
• Key Therapies: NUPLAZID (pimavanserin), KarXT (xanomeline-trospium), Ulotaront (SEP-363856), ITI-1284, FANAPT (iloperidone), and others in development
• Market Analysis: KOL views, attribute analysis, SWOT analysis, unmet needs
• Competitive Intelligence: SWOT analysis, conjoint analysis, market entry strategies
• Additional Coverage: unmet needs, market access and reimbursement (including US Medicare Part D coverage considerations for NUPLAZID), and KOL insights drawn from 50+ contacted and 15+ interviewed opinion leaders at institutions including the University of Texas Health Science Center, Harvard Medical School, University of Cologne, Università di Palermo, King's College, and Fukujuji Hospital
Table of Contents
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Key Insights
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Report Introduction
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Overview
• Psychosis in Parkinson's Disease and Alzheimer's Disease Epidemiology and Market Forecast Methodology
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Executive Summary
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Key Events
• Psychosis in Parkinson's Disease and Alzheimer's Disease Background and Overview
• Psychosis in Parkinson's Disease and Alzheimer's Disease Patient Journey
• Psychosis in Parkinson's Disease and Alzheimer's Disease Epidemiology and Patient Population
• Psychosis in Parkinson's Disease and Alzheimer's Disease Marketed Drugs
• Psychosis in Parkinson's Disease and Alzheimer's Disease Emerging Drugs
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Analysis (7MM)
• Psychosis in Parkinson's Disease and Alzheimer's Disease Key Opinion Leaders (KOL) Views
• Psychosis in Parkinson's Disease and Alzheimer's Disease SWOT Analysis
• Psychosis in Parkinson's Disease and Alzheimer's Disease Unmet Needs
• Psychosis in Parkinson's Disease and Alzheimer's Disease Market Access and Reimbursement
• Appendix
• DelveInsight Capabilities
• Disclaimer
• About DelveInsight
Company Name: DelveInsight Business Research LLP
Contact Person: Kanishk Kumar
Email: info@delveinsight.com
Phone: 9650213330
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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