Acute Agitation And Aggression - Market Insights, Epidemiology, and Market Forecast - 2034
Description
Key Highlights
The report analyzes the existing treatment practices and unmet medical requirements in acute agitation and aggression. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.
Acute Agitation and Aggression Overview
Acute agitation refers to a state of intense emotional and physical arousal, often marked by inner tension, anxiety, and heightened motor activity. Individuals may appear restless, irritable, confused, or uncooperative, and may exhibit behaviors such as pacing, fidgeting, or making abrupt, dismissive, or hostile remarks. While excessive movement may or may not be present, the underlying sense of distress is typically pronounced.
Aggression represents a more severe and outward expression of agitation, posing a potential risk of harm to oneself or others. It can include verbal threats, shouting, name-calling, physical acts of violence (such as hitting, pushing, or kicking), or destruction of property. Aggressive behavior may be impulsive, driven by intense emotional reactivity, or instrumental, emerging in a deliberate and goal-directed manner.
Acute Agitation and Aggression Diagnosis and Treatment Algorithm
Identifying the etiology of agitation is essential for targeted management. Initial evaluation should include point-of-care glucose, oxygen saturation, and urine toxicology screening. In cases of suspected substance intoxication or withdrawal, blood alcohol level and liver function tests are also indicated. If delirium is suspected, a full diagnostic workup—comprising complete blood count, comprehensive metabolic panel, urinalysis, urine toxicology, and head CT—is necessary to determine the underlying cause. Additional tests should be guided by clinical suspicion and may include a pregnancy test (in women of reproductive age), ammonia (for hepatic encephalopathy), creatinine kinase (for rhabdomyolysis or myopathy), TSH (for thyroid dysfunction), lactate (for sepsis), acetaminophen and salicylate levels (for overdose), and urinalysis with culture (for urinary tract infection or ketosis). Lumbar puncture may be warranted for suspected CNS infections, and ECG should be performed to assess for QTc prolongation or cardiac abnormalities. Further testing should be tailored based on the suspected underlying etiology.
The treatment of acute agitation and aggression focuses on identifying and managing underlying medical causes while ensuring the safety of the patient, staff, and environment. Initial management involves noncoercive de-escalation using therapeutic communication, active listening, and voluntary oral medications. If ineffective and safety is at risk, pharmacologic intervention may be required, with intramuscular agents as a last resort. Medication choice depends on etiology—benzodiazepines for alcohol withdrawal and antipsychotics for intoxication or psychosis. Guidelines from the American College of Emergency Physicians (ACEP), Society of Critical Care Medicine (SCCM), American Psychiatric Association (APA), and International Psychogeriatric Association (IPA) support agents like droperidol, midazolam, olanzapine, and dexmedetomidine, with caution in elderly or cognitively impaired patients. Physical restraints are discouraged due to risks such as rhabdomyolysis, trauma, and prolonged hospitalization. In neurocognitive disorders, agitation may respond to person-centered care or agents like citalopram, trazodone, or atypical antipsychotics.
Acute Agitation and Aggression Epidemiology
The epidemiology section of the acute agitation and aggression market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.
This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of acute agitation and aggression. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.
Key Findings
According to the secondary search, acute agitation was reported in 12.1% to 12.2% of patients with schizophrenia and/or bipolar disorder presenting to emergency departments, while 1.9% to 10% of all patients in emergency departments exhibited acute agitation.
Agitation affects up to 70% of individuals with cognitive decline, with higher rates seen in moderate to severe stages of disease. Its prevalence is estimated at 30–50% in Alzheimer's disease, 30% in dementia with Lewy bodies, 40% in frontotemporal dementia, and 40% in vascular dementia.
According to the secondary search, acute agitation accounted for 4.6% of psychiatric emergencies in Europe.
Across Germany, Spain, and the UK, agitation was reported in 55% of patients with schizophrenia and 66% of those with bipolar disorder.
In Germany, Spain, and the UK, common symptoms reported during agitation episodes included feeling uneasy 64%, restless 63%, and nervous 63%, along with other symptoms such as feeling tense and being unable to sit still.
The epidemiology of acute agitation and aggression is expected to change during the forecast period (2025-2034).
Acute Agitation and Aggression Market Outlook
The acute agitation and aggression therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025–2034).
With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the acute agitation and aggression market in the 7MM is expected to change significantly during the forecast period 2025–2034.
Acute Agitation and Aggression Drug Chapters
Marketed Acute Agitation and Aggression Drugs
IGALMI (dexmedetomidine) sublingual film: BioXcel Therapeutics
IGALMI (dexmedetomidine) sublingual film, developed by BioXcel Therapeutics, is a prescription medicine approved by the US FDA in April 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is administered by placing the film under the tongue or behind the lower lip. The safety and effectiveness of IGALMI have not been established beyond 24 hours after the first dose, and it is not known whether IGALMI is safe and effective in pediatric populations.
REXULTI (brexpiprazole): Otsuka Pharmaceutical/Lundbeck
Brexpiprazole is an atypical antipsychotic with a mechanism of action that is not fully understood. Its clinical effects are believed to result from partial agonism at serotonin 5‑HT₁A and dopamine D₂ receptors, along with antagonism at serotonin 5‑HT₂A receptors. Marketed as REXULTI, it became the first drug approved for the treatment of agitation associated with dementia due to Alzheimer’s disease. In May 2023, the US FDA approved a supplemental application for this indication, and in September 2024, Japan granted approval for REXULTI as an adjunctive therapy for agitation symptoms such as aggression, excessive motor activity, and mood instability in patients with Alzheimer’s dementia, representing its third approved indication in that market.
Emerging Acute Agitation and Aggression Drugs
The acute agitation and aggression market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as AUVELITY, masupirdine, and ITI-1284, among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.
AUVELITY (dextromethorphan-bupropion; AXS-05): Axsome Therapeutics
AXS-05 is an investigational oral therapy developed by Axsome Therapeutics for the treatment of agitation associated with Alzheimer’s disease. It combines dextromethorphan, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, with bupropion, which enhances the bioavailability of dextromethorphan and also functions as a norepinephrine and dopamine reuptake inhibitor. The formulation utilizes Axsome’s proprietary metabolic inhibition technology to optimize drug delivery.
In December 2024, Axsome announced the successful completion of its Phase III clinical program for AXS-05, which included the ADVANCE-1 Phase II/III trial, the ADVANCE-2, ACCORD-1, and ACCORD-2 Phase III trials, as well as an open-label extension study assessing long-term safety and efficacy.
Masupirdine (SUVN-502): Suven Life Sciences
Masupirdine is a highly selective serotonin-6 (5-HT6) receptor antagonist, exhibiting over 1,200-fold greater selectivity for the 5-HT6 receptor compared to the 5-HT2A receptor, providing it with a notable pharmacological advantage over other agents in its class. It is currently being investigated for the treatment of agitation associated with dementia due to Alzheimer’s disease. A Phase III clinical trial assessing its efficacy and safety in this indication is ongoing, with completion anticipated by the end of fiscal year 2026.
ITI-1284: Intra-Cellular Therapies/Johnson & Johnson
ITI-1284 is an oral small molecule dopamine D2 receptor modulator currently in Phase II development for the treatment of agitation associated with Alzheimer’s disease. It is designed to target neuropsychiatric symptoms with a favorable safety and tolerability profile.
In April 2025, Johnson & Johnson completed the acquisition of Intra-Cellular Therapies, securing rights to ITI-1284 as part of its strategy to expand its neuroscience portfolio. The company highlighted ITI-1284 as a key asset with best-in-class potential for managing agitation in Alzheimer’s disease.
Acute Agitation and Aggression Market Segmentation
DelveInsight’s ‘Acute Agitation and Aggression – Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future acute agitation and aggression market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Acute Agitation and Aggression Market Size by Countries
The acute agitation and aggression market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) acute agitation and aggression market, primarily attributed to the country’s higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.
Acute Agitation and Aggression Market Size by Therapies
Acute Agitation and Aggression Market Size by Therapies is categorized into current and emerging markets for the study period 2020–2034.
Acute Agitation and Aggression Drugs Uptake
This section focuses on the sales uptake of potential acute agitation and aggression drugs that have recently been launched or are anticipated to be launched in the acute agitation and aggression market between 2020 and 2034. It estimates the market penetration of acute agitation and aggression drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the acute agitation and aggression market.
The emerging acute agitation and aggression therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the acute agitation and aggression market.
Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on acute agitation and aggression.
Acute Agitation and Aggression Market Access and Reimbursement
DelveInsight’s ‘Acute Agitation and Aggression – Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of acute agitation and aggression.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
KOL Views
To keep up with current acute agitation and aggression market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the acute agitation and aggression domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or acute agitation and aggression market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the acute agitation and aggression unmet needs.
Acute Agitation and Aggression: KOL Insights
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US, University Hospital Tübingen, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, University of Leeds, Leeds, UK, and University of Occupational and Environmental Health, Japan, among others.
“Agitation is a complex and potentially dangerous clinical presentation seen across multiple care settings, from emergency departments to long-term care. Its manifestations—ranging from restlessness and irritability to paranoia and violence—can arise from diverse, often unclear causes. Effective management requires a nuanced, individualized approach that considers the setting, patient factors, and underlying etiology.”
“Agitation frequently arises from conditions like delirium, dementia, and acute psychosis, with delirium—especially its hyperactive and mixed forms—being a key contributor in hospitalized patients. In emergency settings, triggers may include intoxication, metabolic disturbances, or psychiatric decompensation, requiring prompt intervention for safety. Differentiating delirium from dementia is critical, as delirium has a rapid onset and fluctuating course, whereas dementia progresses gradually. When both coexist, managing delirium takes precedence.”
“Effective agitation management starts with ensuring safety and using verbal de-escalation. Clinicians should assess for underlying causes through history and exam, using a calm, structured approach. Oral medication is preferred if needed, with intramuscular options or restraints reserved for severe cases. Tools like BARS aid triage, and red-flag signs or abnormal vitals require urgent attention, especially in nonmedical settings.”
Note: Detailed assessment of KOL Views will be provided in the full report on Acute Agitation and Aggression.
Competitive Intelligence Analysis
We conduct a Competitive and Market Intelligence analysis of the acute agitation and aggression Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.
Acute Agitation and Aggression Pipeline Development Activities
The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for acute agitation and aggression. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging acute agitation and aggression therapies.
Acute Agitation and Aggression Report Insights
1. What are the treatment goals for acute agitation and aggression?
The primary objectives in treating acute agitation and aggression are to ensure safety by preventing injury and minimizing environmental risks, swiftly relieve distress to avert escalation into violence or self‑harm, identify and manage underlying medical or psychiatric causes to prevent recurrence, and restore the patient’s functional baseline for continued engagement in care.
2. What are the challenges in managing acute agitation and aggression?
Managing acute agitation and aggression presents challenges such as rapid escalation of symptoms that outpace thorough assessment, a wide range of underlying causes complicating accurate diagnosis, limited availability of safe and effective rapid‑acting interventions, the risk of medical and ethical complications when employing pharmacologic restraint, the necessity for specialized training and adequate staffing to maintain safety, and environmental constraints that can impede timely de‑escalation efforts.
3. What are the key factors driving the growth of the acute agitation and aggression market?
The acute agitation and aggression market is driven by rising neuropsychiatric and substance‑related agitation, increasing demand for rapid‑onset treatments across care settings, recent regulatory approvals of novel therapies, heightened focus on patient and staff safety, favorable reimbursement, and innovations in delivery systems that enhance speed and ease of use.
4. How will the Acute Agitation and Aggression Market and Epidemiology Forecast Report benefit the clients?
The report will provide comprehensive insights into the current acute agitation and aggression market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.
Please Note: It will take 7-10 business days to complete the report upon order confirmation.
- The acute agitation and aggression market is anticipated to sustain a steady Compound Annual Growth Rate (CAGR) during the forecast period (2025–2034). This growth in market revenue is primarily propelled by a rising prevalence of psychiatric disorders, an aging patient population, and increased R&D in novel therapies.
- The increasing cases of acute agitation and aggression may be attributed to a combination of factors, including a rising burden of neuropsychiatric disorders, escalating substance use, and age‑related cognitive decline.
- IGALMI and REXULTI exemplify distinct approved approaches to agitation: IGALMI’s sublingual film offers rapid, noninvasive relief for schizophrenia‑ and bipolar‑related episodes but lacks data beyond 24 hours and in children, while REXULTI addresses aggression and hyperactivity in Alzheimer’s dementia, reflecting expansion of antipsychotic labels into neurodegenerative agitation.
- A gap remains for a single intervention that delivers both rapid onset and durable control, demonstrating safety across psychiatric, neurodegenerative, and pediatric populations with minimal adverse effects.
- The future market for acute agitation and aggression will be highly competitive, with multiple entrants—Axsome Therapeutics’ AUVELITY, Suven Life Sciences’ masupirdine, and Intra‑Cellular Therapies/Johnson & Johnson’s ITI‑1284—advancing through development. As these emerging therapies gain approval, market dynamics are set to intensify and overall growth is projected to accelerate at a significant CAGR.
- In April 2025, Suven Life Sciences presented updated clinical data and outlined development plans for masupirdine’s Phase III program at the American Academy of Neurology (AAN) Annual Meeting.
The report analyzes the existing treatment practices and unmet medical requirements in acute agitation and aggression. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.
Acute Agitation and Aggression Overview
Acute agitation refers to a state of intense emotional and physical arousal, often marked by inner tension, anxiety, and heightened motor activity. Individuals may appear restless, irritable, confused, or uncooperative, and may exhibit behaviors such as pacing, fidgeting, or making abrupt, dismissive, or hostile remarks. While excessive movement may or may not be present, the underlying sense of distress is typically pronounced.
Aggression represents a more severe and outward expression of agitation, posing a potential risk of harm to oneself or others. It can include verbal threats, shouting, name-calling, physical acts of violence (such as hitting, pushing, or kicking), or destruction of property. Aggressive behavior may be impulsive, driven by intense emotional reactivity, or instrumental, emerging in a deliberate and goal-directed manner.
Acute Agitation and Aggression Diagnosis and Treatment Algorithm
Identifying the etiology of agitation is essential for targeted management. Initial evaluation should include point-of-care glucose, oxygen saturation, and urine toxicology screening. In cases of suspected substance intoxication or withdrawal, blood alcohol level and liver function tests are also indicated. If delirium is suspected, a full diagnostic workup—comprising complete blood count, comprehensive metabolic panel, urinalysis, urine toxicology, and head CT—is necessary to determine the underlying cause. Additional tests should be guided by clinical suspicion and may include a pregnancy test (in women of reproductive age), ammonia (for hepatic encephalopathy), creatinine kinase (for rhabdomyolysis or myopathy), TSH (for thyroid dysfunction), lactate (for sepsis), acetaminophen and salicylate levels (for overdose), and urinalysis with culture (for urinary tract infection or ketosis). Lumbar puncture may be warranted for suspected CNS infections, and ECG should be performed to assess for QTc prolongation or cardiac abnormalities. Further testing should be tailored based on the suspected underlying etiology.
The treatment of acute agitation and aggression focuses on identifying and managing underlying medical causes while ensuring the safety of the patient, staff, and environment. Initial management involves noncoercive de-escalation using therapeutic communication, active listening, and voluntary oral medications. If ineffective and safety is at risk, pharmacologic intervention may be required, with intramuscular agents as a last resort. Medication choice depends on etiology—benzodiazepines for alcohol withdrawal and antipsychotics for intoxication or psychosis. Guidelines from the American College of Emergency Physicians (ACEP), Society of Critical Care Medicine (SCCM), American Psychiatric Association (APA), and International Psychogeriatric Association (IPA) support agents like droperidol, midazolam, olanzapine, and dexmedetomidine, with caution in elderly or cognitively impaired patients. Physical restraints are discouraged due to risks such as rhabdomyolysis, trauma, and prolonged hospitalization. In neurocognitive disorders, agitation may respond to person-centered care or agents like citalopram, trazodone, or atypical antipsychotics.
Acute Agitation and Aggression Epidemiology
The epidemiology section of the acute agitation and aggression market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.
This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of acute agitation and aggression. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.
Key Findings
According to the secondary search, acute agitation was reported in 12.1% to 12.2% of patients with schizophrenia and/or bipolar disorder presenting to emergency departments, while 1.9% to 10% of all patients in emergency departments exhibited acute agitation.
Agitation affects up to 70% of individuals with cognitive decline, with higher rates seen in moderate to severe stages of disease. Its prevalence is estimated at 30–50% in Alzheimer's disease, 30% in dementia with Lewy bodies, 40% in frontotemporal dementia, and 40% in vascular dementia.
According to the secondary search, acute agitation accounted for 4.6% of psychiatric emergencies in Europe.
Across Germany, Spain, and the UK, agitation was reported in 55% of patients with schizophrenia and 66% of those with bipolar disorder.
In Germany, Spain, and the UK, common symptoms reported during agitation episodes included feeling uneasy 64%, restless 63%, and nervous 63%, along with other symptoms such as feeling tense and being unable to sit still.
The epidemiology of acute agitation and aggression is expected to change during the forecast period (2025-2034).
Acute Agitation and Aggression Market Outlook
The acute agitation and aggression therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025–2034).
With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the acute agitation and aggression market in the 7MM is expected to change significantly during the forecast period 2025–2034.
Acute Agitation and Aggression Drug Chapters
Marketed Acute Agitation and Aggression Drugs
IGALMI (dexmedetomidine) sublingual film: BioXcel Therapeutics
IGALMI (dexmedetomidine) sublingual film, developed by BioXcel Therapeutics, is a prescription medicine approved by the US FDA in April 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. It is administered by placing the film under the tongue or behind the lower lip. The safety and effectiveness of IGALMI have not been established beyond 24 hours after the first dose, and it is not known whether IGALMI is safe and effective in pediatric populations.
REXULTI (brexpiprazole): Otsuka Pharmaceutical/Lundbeck
Brexpiprazole is an atypical antipsychotic with a mechanism of action that is not fully understood. Its clinical effects are believed to result from partial agonism at serotonin 5‑HT₁A and dopamine D₂ receptors, along with antagonism at serotonin 5‑HT₂A receptors. Marketed as REXULTI, it became the first drug approved for the treatment of agitation associated with dementia due to Alzheimer’s disease. In May 2023, the US FDA approved a supplemental application for this indication, and in September 2024, Japan granted approval for REXULTI as an adjunctive therapy for agitation symptoms such as aggression, excessive motor activity, and mood instability in patients with Alzheimer’s dementia, representing its third approved indication in that market.
Emerging Acute Agitation and Aggression Drugs
The acute agitation and aggression market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as AUVELITY, masupirdine, and ITI-1284, among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.
AUVELITY (dextromethorphan-bupropion; AXS-05): Axsome Therapeutics
AXS-05 is an investigational oral therapy developed by Axsome Therapeutics for the treatment of agitation associated with Alzheimer’s disease. It combines dextromethorphan, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, with bupropion, which enhances the bioavailability of dextromethorphan and also functions as a norepinephrine and dopamine reuptake inhibitor. The formulation utilizes Axsome’s proprietary metabolic inhibition technology to optimize drug delivery.
In December 2024, Axsome announced the successful completion of its Phase III clinical program for AXS-05, which included the ADVANCE-1 Phase II/III trial, the ADVANCE-2, ACCORD-1, and ACCORD-2 Phase III trials, as well as an open-label extension study assessing long-term safety and efficacy.
Masupirdine (SUVN-502): Suven Life Sciences
Masupirdine is a highly selective serotonin-6 (5-HT6) receptor antagonist, exhibiting over 1,200-fold greater selectivity for the 5-HT6 receptor compared to the 5-HT2A receptor, providing it with a notable pharmacological advantage over other agents in its class. It is currently being investigated for the treatment of agitation associated with dementia due to Alzheimer’s disease. A Phase III clinical trial assessing its efficacy and safety in this indication is ongoing, with completion anticipated by the end of fiscal year 2026.
ITI-1284: Intra-Cellular Therapies/Johnson & Johnson
ITI-1284 is an oral small molecule dopamine D2 receptor modulator currently in Phase II development for the treatment of agitation associated with Alzheimer’s disease. It is designed to target neuropsychiatric symptoms with a favorable safety and tolerability profile.
In April 2025, Johnson & Johnson completed the acquisition of Intra-Cellular Therapies, securing rights to ITI-1284 as part of its strategy to expand its neuroscience portfolio. The company highlighted ITI-1284 as a key asset with best-in-class potential for managing agitation in Alzheimer’s disease.
Acute Agitation and Aggression Market Segmentation
DelveInsight’s ‘Acute Agitation and Aggression – Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future acute agitation and aggression market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Acute Agitation and Aggression Market Size by Countries
The acute agitation and aggression market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) acute agitation and aggression market, primarily attributed to the country’s higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.
Acute Agitation and Aggression Market Size by Therapies
Acute Agitation and Aggression Market Size by Therapies is categorized into current and emerging markets for the study period 2020–2034.
Acute Agitation and Aggression Drugs Uptake
This section focuses on the sales uptake of potential acute agitation and aggression drugs that have recently been launched or are anticipated to be launched in the acute agitation and aggression market between 2020 and 2034. It estimates the market penetration of acute agitation and aggression drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the acute agitation and aggression market.
The emerging acute agitation and aggression therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the acute agitation and aggression market.
Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on acute agitation and aggression.
Acute Agitation and Aggression Market Access and Reimbursement
DelveInsight’s ‘Acute Agitation and Aggression – Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of acute agitation and aggression.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
KOL Views
To keep up with current acute agitation and aggression market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the acute agitation and aggression domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or acute agitation and aggression market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the acute agitation and aggression unmet needs.
Acute Agitation and Aggression: KOL Insights
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US, University Hospital Tübingen, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, University of Leeds, Leeds, UK, and University of Occupational and Environmental Health, Japan, among others.
“Agitation is a complex and potentially dangerous clinical presentation seen across multiple care settings, from emergency departments to long-term care. Its manifestations—ranging from restlessness and irritability to paranoia and violence—can arise from diverse, often unclear causes. Effective management requires a nuanced, individualized approach that considers the setting, patient factors, and underlying etiology.”
“Agitation frequently arises from conditions like delirium, dementia, and acute psychosis, with delirium—especially its hyperactive and mixed forms—being a key contributor in hospitalized patients. In emergency settings, triggers may include intoxication, metabolic disturbances, or psychiatric decompensation, requiring prompt intervention for safety. Differentiating delirium from dementia is critical, as delirium has a rapid onset and fluctuating course, whereas dementia progresses gradually. When both coexist, managing delirium takes precedence.”
“Effective agitation management starts with ensuring safety and using verbal de-escalation. Clinicians should assess for underlying causes through history and exam, using a calm, structured approach. Oral medication is preferred if needed, with intramuscular options or restraints reserved for severe cases. Tools like BARS aid triage, and red-flag signs or abnormal vitals require urgent attention, especially in nonmedical settings.”
Note: Detailed assessment of KOL Views will be provided in the full report on Acute Agitation and Aggression.
Competitive Intelligence Analysis
We conduct a Competitive and Market Intelligence analysis of the acute agitation and aggression Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.
Acute Agitation and Aggression Pipeline Development Activities
The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for acute agitation and aggression. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging acute agitation and aggression therapies.
Acute Agitation and Aggression Report Insights
- Acute Agitation and Aggression Patient Population
- Therapeutic Approaches
- Acute Agitation and Aggression Pipeline Analysis
- Acute Agitation and Aggression Market Size and Trends
- Acute Agitation and Aggression Market Opportunities
- Impact of Upcoming Therapies
- 10 Years Forecast
- The 7MM Coverage
- Acute Agitation and Aggression Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Acute Agitation and Aggression Market
- Acute Agitation and Aggression Drugs Uptake
- Acute Agitation and Aggression Current Treatment Practices
- Unmet Needs
- Acute Agitation and Aggression Pipeline Product Profiles
- Acute Agitation and Aggression Market Attractiveness
- How common is acute agitation and aggression?
- What are the key findings of acute agitation and aggression epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020–2034)?
- What are the currently available treatments for acute agitation and aggression?
- What are the disease risk, burden, and unmet needs of acute agitation and aggression?
- At what CAGR is the acute agitation and aggression market and its epidemiology is expected to grow in the 7MM during the forecast period (2025–2034)?
- How would the unmet needs impact the acute agitation and aggression market dynamics and subsequently influence the analysis of the related trends?
- What would be the forecasted patient pool of acute agitation and aggression in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
- Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025–2034)?
- How many companies are currently developing therapies for the treatment of acute agitation and aggression?
- The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the acute agitation and aggression Market.
- Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
- Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
- Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
- To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
- Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
1. What are the treatment goals for acute agitation and aggression?
The primary objectives in treating acute agitation and aggression are to ensure safety by preventing injury and minimizing environmental risks, swiftly relieve distress to avert escalation into violence or self‑harm, identify and manage underlying medical or psychiatric causes to prevent recurrence, and restore the patient’s functional baseline for continued engagement in care.
2. What are the challenges in managing acute agitation and aggression?
Managing acute agitation and aggression presents challenges such as rapid escalation of symptoms that outpace thorough assessment, a wide range of underlying causes complicating accurate diagnosis, limited availability of safe and effective rapid‑acting interventions, the risk of medical and ethical complications when employing pharmacologic restraint, the necessity for specialized training and adequate staffing to maintain safety, and environmental constraints that can impede timely de‑escalation efforts.
3. What are the key factors driving the growth of the acute agitation and aggression market?
The acute agitation and aggression market is driven by rising neuropsychiatric and substance‑related agitation, increasing demand for rapid‑onset treatments across care settings, recent regulatory approvals of novel therapies, heightened focus on patient and staff safety, favorable reimbursement, and innovations in delivery systems that enhance speed and ease of use.
4. How will the Acute Agitation and Aggression Market and Epidemiology Forecast Report benefit the clients?
The report will provide comprehensive insights into the current acute agitation and aggression market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.
Please Note: It will take 7-10 business days to complete the report upon order confirmation.
Table of Contents
200 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. Market Overview at a Glance
- 3.1.. Market Share (%) Distribution by Therapies in 2024
- 3.2.. Market Share (%) Distribution by Therapies in 2034
- 4. Epidemiology and Market Methodology
- 5. Executive Summary
- 6. Key Events
- 7. Disease Background and Overview
- 7.1.. Introduction
- 7.2. Types
- 7.3.. Causes
- 7.4.. Pathophysiology
- 7.5.. Symptoms
- 7.6.. Risk Factor
- 7.7.. Diagnosis
- 7.7.1.. Diagnostic Algorithm
- 7.7.2.. Diagnostic Guidelines
- 7.8.. Treatment and Management
- 7.8.1.. Treatment Algorithm
- 7.8.2.. Treatment Guidelines
- 8. Epidemiology and Patient Population
- 8.1. Key Findings
- 8.2. Assumptions and Rationale: The 7MM
- 8.3. Total Prevalent Cases of Acute Agitation and Aggression in the 7MM
- 8.4. Total Diagnosed Prevalent Cases of Acute Agitation and Aggression in the 7MM
- 8.5. The US
- 8.5.1. Total Prevalent Cases of Acute Agitation and Aggression
- 8.5.2. Total Diagnosed Prevalent Cases of Acute Agitation and Aggression
- 8.5.3. Comorbidities-associated Cases of Acute Agitation and Aggression
- 8.5.4. Symptom-specific Cases of Acute Agitation and Aggression
- 8.5.5. Treated Cases of Acute Agitation and Aggression
- 8.6. EU4 and the UK
- 8.6.1. Total Prevalent Cases of Acute Agitation and Aggression
- 8.6.2. Total Diagnosed Prevalent Cases of Acute Agitation and Aggression
- 8.6.3. Comorbidities-associated Cases of Acute Agitation and Aggression
- 8.6.4. Symptom-specific Cases of Acute Agitation and Aggression
- 8.6.5. Treated Cases of Acute Agitation and Aggression
- 8.7. Japan
- 8.7.1. Total Prevalent Cases of Acute Agitation and Aggression
- 8.7.2. Total Diagnosed Prevalent Cases of Acute Agitation and Aggression
- 8.7.3. Comorbidities-associated Cases of Acute Agitation and Aggression
- 8.7.4. Symptom-specific Cases of Acute Agitation and Aggression
- 8.7.5. Treated Cases of Acute Agitation and Aggression
- 9. Patient Journey
- 10. Marketed Therapies
- 10.1. Key Cross Competition
- 10.2. IGALMI (dexmedetomidine): BioXcel Therapeutics
- 10.2.1. Drug Description
- 10.2.2. Regulatory Milestones
- 10.2.3. Other Development Activities
- 10.2.4. Clinical Trials Information
- 10.2.5. Safety and Efficacy
- 10.3. REXULTI (brexpiprazole): Otsuka Pharmaceutical/Lundbeck
- 10.3.1. Drug Description
- 10.3.2. Regulatory Milestones
- 10.3.3. Other Development Activities
- 10.3.4. Clinical Trials Information
- 10.3.5. Safety and Efficacy
- To be continued in the report….
- 11. Emerging Therapies
- 11.1. Key Cross Competition
- 11.2. AUVELITY (dextromethorphan-bupropion; AXS-05): Axsome Therapeutics
- 11.2.1. Drug Description
- 11.2.2. Other Development Activities
- 11.2.3. Clinical Trials Information
- 11.2.4. Safety and Efficacy
- 11.2.5. Analysts’ Views
- 11.3. Masupirdine (SUVN-502): Suven Life Sciences
- 11.3.1. Drug Description
- 11.3.2. Other Development Activities
- 11.3.3. Clinical Trials Information
- 11.3.4. Safety and Efficacy
- 11.3.5. Analysts’ Views
- 11.4. ITI-1284: Intra-Cellular Therapies/Johnson & Johnson
- 11.4.1. Drug Description
- 11.4.2. Other Development Activities
- 11.4.3. Clinical Trials Information
- 11.4.4. Safety and Efficacy
- 11.4.5. Analysts’ Views
- To be continued in the report….
- 12. Acute Agitation and Aggression: Seven Major Market Analysis
- 12.1. Key Findings
- 12.2. Key Market Forecast Assumptions
- 12.2.1. Cost Assumptions and Rebates
- 12.2.2. Pricing Trends
- 12.2.3. Analogue Assessment
- 12.2.4. Launch Year and Therapy Uptake
- 12.3. Market Outlook
- 12.4. Attribute Analysis
- 12.5. Total Market Size of Acute Agitation and Aggression in the 7MM
- 12.6. Market Size of Acute Agitation and Aggression by Therapies in the 7MM
- 12.7. The US Market Size
- 12.7.1. Total Market Size of Acute Agitation and Aggression
- 12.7.2. Market Size of Acute Agitation and Aggression by Therapies
- 12.8. Market Size of Acute Agitation and Aggression in the EU4 and the UK
- 12.8.1. Total Market Size of Acute Agitation and Aggression
- 12.8.2. Market Size of Acute Agitation and Aggression by Therapies
- 12.9.. Japan Market Size
- 12.9.1. Total Market Size of Acute Agitation and Aggression
- 12.9.2. Market Size of Acute Agitation and Aggression by Therapies
- 13. Key Opinion Leaders’ Views
- 14. Unmet Needs
- 15. SWOT Analysis
- 16. Acute Agitation and Aggression Market Access and Reimbursement
- 16.1. United States
- 16.1.1. Centre for Medicare and Medicaid Services (CMS)
- 16.2. EU4 and the UK
- 16.2.1. Germany
- 16.2.2. France
- 16.2.3. Italy
- 16.2.4. Spain
- 16.2.5. United Kingdom
- 16.3. Japan
- 16.3.1. MHLW
- 17. Appendix
- 17.1. Bibliography
- 17.2. Abbreviations and Acronyms
- 17.3. Report Methodology
- 18. DelveInsight Capabilities
- 19. Disclaimer
- 20. About DelveInsight
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