Agitation in Alzheimer's Disease Therapeutics Market Size across the 7MM surpassed USD 600 Million in 2025 and It is projected to grow at a CAGR of ~15% by 2036, estimates DelveInsight

DelveInsight's "Agitation in Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast-2036′′ report offers an in-depth understanding of the Agitation in Alzheimer's Disease, historical and forecasted epidemiology as well as the Agitation in Alzheimer's Disease market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Key Takeaways from the Agitation in Alzheimer's Disease Market Report
• The total number of Agitation in Alzheimer's Disease Diagnosed Cases in the 7MM is ~11 million in 2025.
• According to DelveInsight's estimates, in the United States, Agitation in Alzheimer's Disease Diagnosed Cases are predominantly made up of females, accounting for ~ 3 million cases in 2025.
• Agitation in Alzheimer's Disease Diagnosed Cases across EU4 and the UK were predominantly female, accounting for approximately 2 million cases in 2025, with a gender distribution of about 30% male and 70% female.
• The leading Agitation in Alzheimer's Disease Companies such as Bristol-Myers Squibb, Suven Life Sciences, Axsome Therapeutics, Exciva GmbH, IGC Pharma, Johnson and Johnson, Teikoku Pharma, Ono Pharma, Neumora Therapeutics and others.
• Promising Agitation in Alzheimer's Disease Therapies such as AXS-05, AVP-786, IGC-AD1 and others.

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Agitation in Alzheimer's Disease Epidemiology Segmentation in the 7MM
• Total Diagnosed Prevalent Cases of Alzheimer's Disease.
• Total Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
• Gender-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
• Age-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's disease.
• Total Treated Cases of Agitation in Alzheimer's Disease

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Agitation in Alzheimer's Disease Approved Therapies
• Brexpiprazole (REXULTI); Otsuka Pharmaceutical/Lundbeck
Brexpiprazole, discovered by Otsuka and co-developed with Lundbeck is the first approved drug for managing agitation associated with dementia due to Alzheimer's disease. It operates through a mechanism of serotonin-dopamine activity modulation and its efficacy is believed to stem from partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, alongside antagonist effects on serotonin 5-HT2A receptors.

Agitation in Alzheimer's Disease Pipeline Analysis
• Melatonin/tetrahydrocannabinol (IGC-AD1): IGC Pharma
IGC-AD1 (melatonin/tetrahydrocannabinol) is an investigational combination therapy developed by IGC Pharma for agitation associated with Alzheimer's disease. It combines melatonin to modulate neuroinflammation, neuronal signaling, and circadian rhythms, aiming to reduce agitation and improve behavioral symptoms in patients with limited treatment options.

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Agitation in Alzheimer's Disease Drugs Landscape
Brexpiprazole (REXULTI): An atypical antipsychotic approved in multiple regions for the treatment of agitation associated with Alzheimer's disease, brexpiprazole delivers clinically meaningful symptom improvement through balanced serotonin-dopamine modulation. Its comparatively favorable tolerability profile supports use in a vulnerable elderly population, offering a more refined therapeutic option in an area historically limited by safety and efficacy constraints. The emergence of the first approved therapy marks an initial shift in the management of agitation in Alzheimer's disease from broad, off-label symptom control toward a more targeted, indication-specific approach, while ongoing innovation continues to explore mechanism-driven strategies to improve durability and safety of clinical outcomes.

Agitation in Alzheimer's Disease Market Outlook
The Agitation in Alzheimer's Disease Treatment Landscape remains highly heterogeneous and setting-dependent, with outcomes influenced as much by caregiver environment, comorbidity burden, and clinician preference as by underlying disease severity. Despite evolving evidence, care continues to rely heavily on off-label antipsychotic use, careful dose titration, and close safety monitoring, resulting in substantial variability in treatment patterns and patient outcomes across regions. These limitations are driving a strategic shift toward more targeted and better-tolerated therapies, improved behavioral assessment frameworks, and precision-based approaches aimed at standardizing care, minimizing safety burden, and achieving more consistent and durable symptom control.

Agitation in Alzheimer's Disease Drugs Uptake
• Masupirdine (SUVN-502): Suven Life Sciences
A selective 5-HT6 receptor antagonist, masupirdine, is designed to modulate serotonergic pathways implicated in neuropsychiatric symptoms of Alzheimer's disease. It reflects a shift toward non-dopaminergic mechanisms for agitation, aiming to deliver symptomatic stabilization with a potentially improved tolerability profile compared to conventional antipsychotics. Masupirdine (SUVN-502) is currently in a global Phase III trial for agitation in Alzheimer's disease dementia, with expected completion by the end of 2026 and topline data anticipated in Q1/Q2 2027.

• AUVELITY (AXS-05): Axsome Therapeutics
A multimodal NMDA receptor antagonist and sigma-1 receptor agonist combination in Phase III, AUVELITY targets glutamatergic and neuroplasticity pathways associated with behavioral disturbances. Its development highlights growing interest in rapid-acting, mechanism-driven CNS therapies that may address agitation alongside broader neuropsychiatric symptom domains. Axsome Therapeutics reported that the US FDA accepted its sNDA for AUVELITY for the treatment of agitation associated with Alzheimer's disease and granted the application Priority Review designation, with a PDUFA target action date set for April 30, 2026.

• EXV-801 ± Dextromethorphan: Exciva GmbH
A combination neuroactive therapeutic platform in Phase II/III, EXV-802, with or without EXV-801, is being explored for its potential to modulate multiple CNS signaling pathways linked to agitation. This approach exemplifies the trend toward combinatorial or multi-target strategies aimed at enhancing efficacy while maintaining functional tolerability in complex behavioral syndromes. In November 2024, Exciva GmbH reported that its lead candidate EXV-802 received FTD from the US FDA for the treatment of agitation associated with Alzheimer's disease.

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Scope of the Agitation in Alzheimer's Disease Market Report
• Coverage: 7MM
• Study Period: 2022-2036
• Agitation in Alzheimer's Disease Companies- Bristol-Myers Squibb, Suven Life Sciences, Axsome Therapeutics, Exciva GmbH, IGC Pharma, Johnson and Johnson, Teikoku Pharma, Ono Pharma, Neumora Therapeutics and others.
• Agitation in Alzheimer's Disease Therapies- AXS-05, AVP-786, IGC-AD1 and others.
• Agitation in Alzheimer's Disease Therapeutic Assessment: Agitation in Alzheimer's Disease current marketed and Agitation in Alzheimer's Disease emerging therapies
• Agitation in Alzheimer's Disease Market Dynamics: Agitation in Alzheimer's Disease market drivers and Agitation in Alzheimer's Disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Agitation in Alzheimer's Disease Unmet Needs, KOL's views, Analyst's views, Agitation in Alzheimer's Disease Market Access and Reimbursement

Table of Contents
1. Agitation in Alzheimer's Disease Market Report Introduction
2. Executive Summary for Agitation in Alzheimer's Disease
3. SWOT analysis of Agitation in Alzheimer's Disease
4. Agitation in Alzheimer's Disease Patient Share Overview at a Glance
5. Agitation in Alzheimer's Disease Market Overview at a Glance
6. Agitation in Alzheimer's Disease Background and Overview
7. Agitation in Alzheimer's Disease Epidemiology and Patient Population
8. Country-Specific Patient Population of Agitation in Alzheimer's Disease
9. Agitation in Alzheimer's Disease Current Treatment and Medical Practices
10. Agitation in Alzheimer's Disease Unmet Needs
11. Agitation in Alzheimer's Disease Emerging Therapies
12. Agitation in Alzheimer's Disease Market Outlook
13. Country-Wise Agitation in Alzheimer's Disease Market Analysis
14. Agitation in Alzheimer's Disease Market Access and Reimbursement of Therapies
15. Agitation in Alzheimer's Disease Market Drivers
16. Agitation in Alzheimer's Disease Market Barriers
17. Agitation in Alzheimer's Disease Appendix
18. Agitation in Alzheimer's Disease Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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