Agitation in Alzheimer's Disease Market to Register Immense Growth at a CAGR of 14.9% During the Forecast Period (2026-2036) | DelveInsight
The recent approval of Axsome Therapeutics' AUVELITY has transformed the agitation in Alzheimer's disease market. The emergence of investigational therapies, including IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline–trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others, is also transforming the agitation in Alzheimer's disease treatment landscape through novel and diverse mechanisms of action. These advancing therapies are anticipated to broaden available treatment choices and support the ongoing evolution of the market.
LAS VEGAS, June 11, 2026 /PRNewswire/ -- Recently published Agitation in Alzheimer's Disease Market Insights report includes a comprehensive understanding of current treatment practices, agitation in Alzheimer's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Agitation in Alzheimer's Disease Market Summary
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Key Factors Driving the Growth of the Agitation in Alzheimer's Disease Market
Ramandeep Singh, a neurology expert at DelveInsight, said that with increasing clinical and commercial momentum, the space is poised for substantial evolution, and by 2036, COBENFY is expected to emerge as the leading revenue-generating therapy across the 7MM for this indication.
Agitation in Alzheimer's Disease Market Analysis
Agitation in Alzheimer's Disease Competitive Landscape
Some of the agitation in Alzheimer's disease drugs under development include IGC-AD1 (IGC Pharma), Masupirdine (SUVN-502) (Suven Life Sciences), EXV-801 ± Dextromethorphan (Exciva GmbH), COBENFY (KarXT; xanomeline–trospium chloride) (Bristol Myers Squibb/Karuna Therapeutics), and others.
IGC Pharma's IGC-AD1 (melatonin/tetrahydrocannabinol) is an investigational combination therapy for agitation linked to Alzheimer's disease. By integrating THC with melatonin, the therapy is designed to influence neuroinflammatory pathways, neuronal communication, and circadian rhythm regulation, to alleviate agitation and improve behavioral outcomes in patients who currently have limited therapeutic options.
Suven Life Sciences' Masupirdine, a selective 5-HT6 receptor antagonist, represents a non-dopaminergic strategy aimed at stabilizing symptoms through serotonin pathway modulation. Its global Phase III study had reached nearly 50% enrollment by November 2025, and topline findings are expected in Q1/Q2 2027.
Meanwhile, Bristol Myers Squibb/Karuna Therapeutics' COBENFY, which has already generated significant interest in schizophrenia treatment, is being explored for agitation in Alzheimer's disease via muscarinic receptor modulation, offering a cholinergic mechanism that may also support cognitive function.
Exciva GmbH's EXV-802, an advanced Phase II/III neuroactive therapy candidate under investigation both as a standalone treatment and in combination with EXV-801 to address multiple CNS signaling pathways associated with agitation. This reflects an industry-wide move toward multi-target and combination-based therapeutic strategies intended to enhance efficacy while maintaining functional tolerability in complex neurobehavioral conditions. In November 2024, EXV-802 also received Fast Track Designation from the US FDA for the treatment of agitation associated with Alzheimer's disease.
The anticipated launch of these emerging therapies are poised to transform the agitation in Alzheimer's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the agitation in Alzheimer's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about which pipeline drugs could transform agitation in Alzheimer's disease treatment @ Agitation in Alzheimer's Disease Drugs
Recent Developments in the Agitation in Alzheimer's Disease Market
What is Agitation in Alzheimer's Disease?
Agitation in Alzheimer's disease refers to a cluster of behavioral and emotional symptoms characterized by excessive restlessness, irritability, aggression, emotional distress, or inappropriate verbal and physical behaviors that occur in individuals with Alzheimer's-related dementia. It is one of the most common neuropsychiatric manifestations of the disease and can include pacing, shouting, resistance to care, wandering, verbal outbursts, or physical aggression. Agitation often arises from a combination of cognitive decline, impaired communication, environmental stressors, unmet physical or emotional needs, and underlying neurobiological changes associated with disease progression. These symptoms can significantly impair quality of life, increase caregiver burden, accelerate institutionalization, and complicate disease management, making agitation a major clinical challenge in Alzheimer's disease care.
Agitation in Alzheimer's Disease Epidemiology Segmentation
The agitation in Alzheimer's disease epidemiology section provides insights into the historical and current agitation in Alzheimer's disease patient pool and forecasted trends for the leading markets. According to DelveInsight's estimates, in the United States, diagnosed cases of agitation in Alzheimer's disease are predominantly made up of females, accounting for ~3 million cases in 2025.
The agitation in Alzheimer's disease treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
Agitation in Alzheimer's Disease Market Report Metrics
Details
Study Period
2022–2036
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Agitation in Alzheimer's Disease Market CAGR
14.9 %
Agitation in Alzheimer's Disease Market Size in 2025
USD 600 Million
Key Agitation in Alzheimer's Disease Companies
IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, Otsuka Pharmaceutical, Lundbeck, Axsome Therapeutics, and others
Key Agitation in Alzheimer's Disease Therapies
IGC-AD1, Masupirdine (SUVN-502), EXV-801 ± Dextromethorphan, COBENFY (KarXT; xanomeline–trospium chloride), REXULTI, AUVELITY, and others
Scope of the Agitation in Alzheimer's Disease Market Report
Download the report to understand the top emerging therapies in agitation in Alzheimer's disease @ Agitation in Alzheimer's Disease Market Analysis
Table of Contents
1
Agitation in Alzheimer's Disease Market Key Insights
2
Agitation in Alzheimer's Disease Market Report Introduction
3
Agitation in Alzheimer's Disease Market Overview at a Glance
3.1
Market Share (%) Distribution of Agitation in Alzheimer's Disease by Therapies in the 7MM in 2025
3.2
Market Share (%) Distribution of Agitation in Alzheimer's Disease by Therapies in the 7MM in 2036
4
Executive Summary
5
Key Events
5.1
Key Transactions and Collaborations
5.2
News Flow
6
Disease Background and Overview
6.1
Introduction
6.2
Type and Severity
6.3
Etiology
6.4
Risk Factors
6.5
Signs and Symptoms
6.6
Common Manifestations of Agitation
6.7
Pathophysiology
6.8
Diagnosis
6.9
Treatment and Management
6.10
Diagnosis and Treatment Guidelines
7
Epidemiology and Market Forecast Methodology
8
Epidemiology and Patient Population
8.1
Key Findings
8.2
Assumptions and Rationale: The 7MM
8.2.1
Diagnosed Prevalent Cases of Alzheimer's Disease
8.2.2
Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease
8.2.3
Gender-specific Diagnosed Prevalent Cases
8.2.4
Age-specific Diagnosed Prevalent Cases
8.2.5
Total Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the 7MM
8.3
The US
8.3.1
Total Diagnosed Prevalent Cases of Alzheimer's Disease in the US
8.3.2
Total Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US
8.3.3
Gender-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US
8.3.4
Age-specific Diagnosed Prevalent Cases of Agitation in Alzheimer's Disease in the US
8.3.5
Total Treated Cases of Agitation in Alzheimer's Disease in the US
8.4
EU4 and the UK
8.5
Japan
9
Patient Journey
10
Marketed Agitation in Alzheimer's Disease Therapies
10.1
Brexpiprazole (REXULTI): Otsuka Pharmaceutical/Lundbeck
10.1.1
Product Description
10.1.2
Regulatory Milestones
10.1.3
Other Developmental Activities
10.1.4
Summary of Pivotal Trials
10.1.5
Analyst Views
10.2
AUVELITY: Axsome Therapeutics
The list will be continued in the final report..
11
Emerging Agitation in Alzheimer's Disease Drugs
11.1
Competitive Landscape: Emerging Drugs
11.2
IGC-AD1: IGC Pharma
11.2.1
Drug Description
11.2.2
Other Developmental Activities
11.2.3
Clinical Development Activity
11.2.4
Safety and Efficacy
11.2.5
Analyst Views
11.3
Masupirdine (SUVN-502): Suven Life Sciences
11.4
EXV-801 ± Dextromethorphan: Exciva GmbH
11.5
COBENFY (KarXT; xanomeline–trospium chloride): Bristol Myers Squibb/Karuna Therapeutics
The list will be continued in the final report..
12
Agitation in Alzheimer's Disease Market – The 7MM Market Analysis
12.1
Key Findings
12.2
Key Agitation in Alzheimer's Disease Market Forecast Assumptions
12.3
Market Outlook
12.4
Conjoint Analysis
12.5
Market Size of Agitation in Alzheimer's Disease in the 7MM
12.6
Market Size of Agitation in Alzheimer's Disease by Therapies in the 7MM
12.7
The United States Agitation in Alzheimer's Disease Market Size
12.7.1
Total Market Size of Agitation in Alzheimer's Disease in the US
12.7.2
Market Size of Agitation in Alzheimer's Disease by Therapies in the US
12.8
EU4 and the UK Agitation in Alzheimer's Disease Market Size
12.9
Japan Agitation in Alzheimer's Disease Market Size
13
Key Opinion Leaders' Views
14
Unmet Needs
15
SWOT Analysis
16
Market access and reimbursement
16.1
The United States
16.2
EU4 and the UK
16.3
Japan
16.4
Market Access and Reimbursement of Agitation in Alzheimer's Disease Therapies
17
Bibliography
18
Agitation in Alzheimer's Disease Market Report Methodology
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