Agitation in Alzheimer's Disease Market: Epidemiology, Pipeline, Companies Working, DelveInsight | Eli Lilly and Co, BioVie Inc, AB Science SA, Annovis Bio Inc, Cognition Therapeutics Inc, Coya Therap

The Agitation in Alzheimer's Disease market size is projected to experience a consistent CAGR during the forecast period (2024-2034), due to several factors. The key driver is an increase in the aging population, particularly in developed countries where the prevalence of Alzheimer's disease is higher.

Emerging therapies for Agitation in Alzheimer's Disease, including TransCon hGH, HyTropin (GX-H9), Somatrogon, and others, are anticipated to drive significant growth in the market over the coming years.

DelveInsight has launched a new report on "Agitation in Alzheimer's Disease - Market Insights, Epidemiology, and Market Forecast-2034" that delivers 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, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Agitation in Alzheimer's Disease Market Report:

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In Europe, the prevalence of agitation among Alzheimer's patients has been reported to range between 24% and 88%, with nearly half of the studies (47%) indicating rates of 50% or higher.

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The Agitation in Alzheimer's Disease market is projected to grow at a steady CAGR from 2024 to 2034, largely driven by the rising aging population, especially in developed nations where Alzheimer's prevalence is higher. With increasing life expectancy, the number of individuals affected by Alzheimer's and associated symptoms like agitation is expected to rise significantly.

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Epidemiological data highlights agitation as a common manifestation in Alzheimer's disease, though prevalence varies due to differences in diagnostic criteria and study methodologies. It is estimated that up to 50% of Alzheimer's patients experience agitation at some point during their illness.

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Management of agitation in Alzheimer's disease continues to pose major challenges due to the lack of early detection tools, targeted therapies, and curative options. Currently, REXULTI (brexpiprazole) remains the only FDA-approved treatment specifically indicated for agitation associated with Alzheimer's-related dementia.

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Several pharmaceutical companies are actively pursuing new therapeutic options. Key players such as Johnson & Johnson, Otsuka, IGC Pharma, and BioXcel are advancing promising candidates, including AXS-05 (Axsome Therapeutics), AVP-786 (Otsuka), and IGC-AD1 (IGC Pharma), which are anticipated to enter the market within the forecast period and reshape the treatment landscape.

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In March 2025, BioXcel Therapeutics, Inc. reported that the U.S. FDA had completed the inspection of a trial site involved in its TRANQUILITY II Phase 3 study under 21 C.F.R. 20.64(d)(3), issuing the Establishment Inspection Report.

Key benefits of the Agitation in Alzheimer's Disease market report:

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Agitation in Alzheimer's Disease market report covers a descriptive overview and comprehensive insight of the Agitation in Alzheimer's Disease Epidemiology and Agitation in Alzheimer's Disease market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan.)

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The Agitation in Alzheimer's Disease market report provides insights on the current and emerging therapies.

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Agitation in Alzheimer's Disease market report provides a global historical and forecasted market covering drug outreach in 7MM.

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The Agitation in Alzheimer's Disease market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Agitation in Alzheimer's Disease market.

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Agitation in Alzheimer's Disease Overview

As Alzheimer's disease advances, many individuals develop symptoms of agitation or aggression. Agitation is characterized by restlessness and anxiety, making it difficult for the person to stay calm. This may present as pacing, sleep disturbances, or aggressive behaviors such as verbal outbursts or attempts to cause harm. Consequently, agitation is one of the most common and distressing symptoms of Alzheimer's, often leading to disruptive behavior.

Managing agitation in Alzheimer's is challenging due to its multifactorial origins. Biological factors such as neurotransmitter imbalances and structural brain changes play a significant role, while medical issues including pain, infections, sleep problems, confusion, and side effects from medications can further aggravate symptoms. Additionally, psychological stressors like fear or perceived threats often act as triggers.

Both patients and caregivers often require comprehensive support to cope with agitation and aggression. While non-pharmacological interventions can be effective, targeted medications and therapeutic strategies are also used to ease symptoms and enhance overall quality of life.

Agitation in Alzheimer's Disease Market Outlook

The primary goal in treating agitation associated with Alzheimer's disease is to manage symptoms and improve patients' overall well-being. Current strategies often rely on antipsychotic medications such as risperidone and quetiapine; however, these drugs are linked to risks including sedation, metabolic complications, and a higher risk of strokes in older adults. Alongside medications, non-pharmacological interventions like music therapy, aromatherapy, and structured daily routines play an important role in reducing aggression and offering safer alternatives.

Most drug therapies for agitation in Alzheimer's target dopamine and serotonin receptors to help alleviate behavioral disturbances. Therefore, effective management typically combines both pharmacological and non-pharmacological approaches within a comprehensive care plan.

Commonly prescribed medications include risperidone, quetiapine, aripiprazole, carbamazepine, citalopram, gabapentin, prazosin, trazodone, lorazepam, and cyproterone acetate. While these treatments may help control symptoms, they also pose risks such as falls, sedation, and metabolic side effects.

Currently, REXULTI (brexpiprazole) is the only FDA-approved therapy for agitation linked to Alzheimer's dementia. It works through a multimodal mechanism-acting as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors, and as an antagonist at serotonin 5-HT2A receptors-helping regulate mood and behavior more effectively.

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Agitation in Alzheimer's Disease Marketed Drugs

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REXULTI (brexpiprazole): Otsuka Pharmaceuticals

Agitation in Alzheimer's Disease Emerging Drugs

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AXS-05: Axsome Therapeutics

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AVP-786: Otsuka Pharmaceutical Development & Commercialization

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BXCL501: BioXcel Therapeutics

Scope of the Agitation in Alzheimer's Disease Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Agitation in Alzheimer's Disease Companies: Eli Lilly and Co, BioVie Inc, AB Science SA, Annovis Bio Inc, Cognition Therapeutics Inc, Coya Therapeutics Inc, Actinogen Medical Limited, AC Immune SA, Biogen Inc, Longeveron Inc, and others

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Agitation in Alzheimer's Disease Therapeutic Assessment: Agitation in Alzheimer's Disease current marketed and Agitation in Alzheimer's Disease emerging therapies

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Agitation in Alzheimer's Disease Market Dynamics: Agitation in Alzheimer's Disease market drivers and Agitation in Alzheimer's Disease market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Agitation in Alzheimer's Disease Unmet Needs, KOL's views, Analyst's views, Agitation in Alzheimer's Disease Market Access and Reimbursement

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

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 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. 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 (2020-2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Agitation in Alzheimer's Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Agitation in Alzheimer's Disease Pipeline Insights, DelveInsight

"Agitation in Alzheimer's Disease Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Agitation in Alzheimer's Disease market. A detailed picture of the Agitation in Alzheimer's Disease pipeline landscape is provided, which includes the disease overview and Agitation in Alzheimer's Disease treatment guidelines.

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