Alcohol Use Disorder Market Set to Expand at a 12.1% CAGR During the Forecast Period (2026–2036), Owing to the Emergence of Novel Mechanisms Such as 5-HT3 Pathway, NOP Receptor, mGluR5 NAM, and Other | DelveInsight
The alcohol use disorder market is set to grow due to unmet clinical needs, limited efficacy of current therapies, and rising demand for better-tolerated treatments. Expanding label indications, new regulatory approvals of therapies such as AD04 (ondansetron) (Adial Pharmaceuticals), Brenipatide (LY3537031) (Eli Lilly and Company), MN-166 (ibudilast) (MediciNova), Sunobinop (V117957) [Imbrium Therapeutics (subsidiary of Purdue Pharma)], Pemvidutide (Altimmune), TMP-301/HTL0014242 (Tempero Bio and Nxera Pharma), and others, increasing awareness, and reduced stigma are expected to boost access and adoption, driving significant market growth.
New York, USA, June 08, 2026 (GLOBE NEWSWIRE) -- Alcohol Use Disorder Market Set to Expand at a 12.1% CAGR During the Forecast Period (2026–2036), Owing to the Emergence of Novel Mechanisms Such as 5-HT3 Pathway, NOP Receptor, mGluR5 NAM, and Other | DelveInsight
The alcohol use disorder market is set to grow due to unmet clinical needs, limited efficacy of current therapies, and rising demand for better-tolerated treatments. Expanding label indications, new regulatory approvals of therapies such as AD04 (ondansetron) (Adial Pharmaceuticals), Brenipatide (LY3537031) (Eli Lilly and Company), MN-166 (ibudilast) (MediciNova), Sunobinop (V117957) [Imbrium Therapeutics (subsidiary of Purdue Pharma)], Pemvidutide (Altimmune), TMP-301/HTL0014242 (Tempero Bio and Nxera Pharma), and others, increasing awareness, and reduced stigma are expected to boost access and adoption, driving significant market growth.
Recently published Alcohol Use Disorder Market Insights report includes a comprehensive understanding of current treatment practices, alcohol use disorder 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].
Alcohol Use Disorder Market Summary
- The market size for alcohol use disorder was found to be USD 1.1 billion in the 7MM in 2025.
- The United States accounted for the largest alcohol use disorder treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- There were 25.6 million 12-months diagnosed prevalent cases of AUD in the US in 2025, which are projected to decrease by 2036.
- Key alcohol use disorder companies, including Adial Pharmaceuticals, Eli Lilly and Company, MediciNova, Imbrium Therapeutics (subsidiary of Purdue Pharma), Altimmune, Tempero Bio, Nxera Pharma, The Pop Test & Palisades Therapeutics, and others, are actively working on innovative alcohol use disorder drugs.
- Some of the key alcohol use disorder therapies in clinical trials include AD04 (ondansetron), Brenipatide (LY3537031), MN-166 (ibudilast), Sunobinop (V117957), Pemvidutide, TMP-301/HTL0014242, PT150, and others. These novel alcohol use disorder therapies are anticipated to enter the alcohol use disorder market in the forecast period and are expected to change the market.
- Among all the therapies in the US, VIVITROL (naltrexone) holds the highest market share in 2025, while by 2036, AD04 is projected to capture the largest market.
Discover why is the AUD market underpenetrated despite high prevalence @ https://www.delveinsight.com/report-store/alcohol-use-disorder-market
Key Factors Driving the Growth of the Alcohol Use Disorder Market
- Growing Awareness and Early AUD Diagnosis: Public health campaigns, physician education, and increased awareness about the harmful effects of alcohol abuse are contributing to earlier diagnosis and intervention. As more patients seek treatment, the AUD market growth is positively impacted.
- Rising Focus on Harm Reduction and Personalized Care: Shifts in treatment paradigms toward harm reduction strategies, personalized therapy, and combination approaches (behavioral + pharmacological) are creating new opportunities in the AUD market, encouraging higher adoption of approved therapies.
- Strong AUD Clinical Trial Activity: Some of the drugs in the pipeline include AD04 (Adial Pharmaceuticals), Sunobinop (Imbrium Therapeutics [subsidiary of Purdue Pharma]), Ibudilast (MediciNova), TMP-301/HTL0014242 (Tempero Bio and Nxera Pharma), Pemvidutide (Altimmune), PT150 (The Pop Test & Palisades Therapeutics), and others.
Aparna Thakur, project manager of forecasting at DelveInsight, said that the exploration of novel mechanisms in AUD treatment such as 5-HT3 antagonism, NOP receptor modulation, mGluR5 NAM activity, dual GLP-1/glucagon receptor agonism highlights significant opportunities for other developers to enter a space with high unmet need and to differentiate their pipelines through innovative, non-traditional targets.
Alcohol Use Disorder Market Analysis
- The United States has witnessed a significant decline in AUD, along with corresponding reductions in binge drinking, heavy alcohol consumption, and underage drinking among individuals aged 12–20 years. These encouraging trends underscore a growing momentum toward recovery and improved alcohol-related health outcomes in 2024.
- The treatment landscape for AUD began with the approval of ANTABUSE (disulfiram) in 1951, the first FDA-approved medication for alcohol dependence. For many years, it remained the only pharmacological option available, laying the foundation for medical management of AUD.
- Although several therapies have since been approved, including acamprosate, disulfiram, naltrexone, VIVITROL, SELINCRO, and baclofen, treatment uptake remains substantially low, leaving a significant proportion of affected individuals untreated.
- Currently available pharmacotherapies for AUD include CAMPRAL (acamprosate), ANTABUSE (disulfiram), REVIA (oral naltrexone), VIVITROL (extended-release injectable naltrexone), SELINCRO (nalmefene), and BACLOCUR (baclofen). The widespread availability of generic formulations for most of these medications has improved patient access and affordability.
- While the AUD pipeline remains relatively limited, the therapeutic market is expected to expand in the coming years. Several companies are advancing innovative candidates through clinical development, including Adial Pharmaceuticals (AD04), MediciNova (MN-166), Altimmune (pemvidutide), Imbrium Therapeutics (sunobinop), Tempero Bio and Nxera Pharma (TMP-301/HTL0014242), and The Pop Test & Palisades Therapeutics (PT150), among others, reflecting continued efforts to address unmet needs in AUD treatment.
Learn more about which late-stage AUD assets could transform the market @ Alcohol Use Disorder Treatment Market
Alcohol Use Disorder Competitive Landscape
Some of the AUD drugs under development include AD04 (ondansetron) (Adial Pharmaceuticals), Brenipatide (LY3537031) (Eli Lilly and Company), MN-166 (ibudilast) (MediciNova), Sunobinop (V117957) [Imbrium Therapeutics (subsidiary of Purdue Pharma)], Pemvidutide (Altimmune), TMP-301/HTL0014242 (Tempero Bio and Nxera Pharma), PT150 (The Pop Test & Palisades Therapeutics), and others.
Adial Pharmaceuticals’ AD04 is a genetically guided therapy being developed for the treatment of AUD. The candidate is currently under evaluation in a Phase III clinical trial targeting individuals with specific genetic profiles, identified through Adial’s proprietary companion diagnostic test. The company has already established a genetic biomarker-based diagnostic assay to identify patients most likely to benefit from AD04. This test was successfully implemented in the large-scale ONWARD randomized controlled trial and is expected to play a key role in future studies, supporting regulatory approval and commercialization alongside AD04.
Eli Lilly and Company’s Brenipatide is a biologic therapy that functions as a dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It is being investigated as a potential treatment for AUD and is currently in Phase III clinical development. Developed by Eli Lilly, Brenipatide represents the company’s expansion into indications beyond obesity, including alcohol use disorder, opioid dependence, and asthma.
MediciNova’s MN-166 is an orally administered small-molecule agent that inhibits phosphodiesterase-4 (PDE4) and modulates inflammatory cytokines such as macrophage migration inhibitory factor (MIF). The therapy is presently undergoing Phase II clinical evaluation for AUD and is being explored for its potential to address the underlying neuroinflammatory mechanisms associated with the disorder.
Altimmune’s Pemvidutide is an investigational peptide-based therapy designed as a balanced 1:1 dual agonist of GLP-1 and glucagon receptors. The candidate is being developed across multiple indications, including Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (AALD), and obesity, reflecting its broad therapeutic potential in metabolic and liver-related disorders.
The anticipated launch of these emerging alcohol use disorder therapies are poised to transform the Alcohol Use Disorder market landscape in the coming years. As these cutting-edge alcohol use disorder therapies continue to mature and gain regulatory approval, they are expected to reshape the alcohol use disorder market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about which companies are working on GLP-1 drugs for AUD, visit @ Alcohol Use Disorder Medication
Recent Developments in the Alcohol Use Disorder Market
- In March 2026, Adial Pharmaceuticals had entered into a collaboration framework agreement with Molteni Farmaceutici for a proposed exclusive partnership covering the commercialization of AD04 in Europe.
- In January 2026, Adial Pharmaceuticals announced the publication of the international patent application for AD04, filed in July 2024. AD04 is the Company’s lead investigational genetically targeted serotonin-3 receptor antagonist therapeutic agent for the treatment of AUD in heavy drinking patients (defined as < 10 drinks/drinking day). The patent, once granted, is expected to protect Adial’s core assets through at least 2045.
- In November 2025, Altimmune announced the completion of patient enrollment in RECLAIM, a Phase II clinical trial evaluating pemvidutide in adults with AUD. The trial is evaluating pemvidutide in approximately 100 patients across sites in the US. Altimmune expects to announce topline results from the trial in 2026.
- In July 2025, Clearmind Medicine announced the expansion of its Phase I/IIa clinical trial evaluating CMND-100 for AUD, marked by the activation of an additional site at Johns Hopkins University School of Medicine and the enrollment of the first participant at this location.
What is Alcohol Use Disorder?
Alcohol use disorder (AUD) is a chronic relapsing brain disorder characterized by an impaired ability to control or stop alcohol consumption despite adverse social, occupational, or health consequences. The condition ranges from mild to severe and is associated with physical dependence, tolerance, withdrawal symptoms, and compulsive alcohol-seeking behavior. AUD can significantly impact an individual's mental and physical health, increasing the risk of liver disease, cardiovascular disorders, neurological complications, depression, and premature mortality.
Alcohol Use Disorder Epidemiology Segmentation
The alcohol use disorder epidemiology section provides insights into the historical and current Alcohol Use Disorder patient pool and forecasted trends for the leading markets. The 12-month diagnosed prevalence of AUD in the United States has shown a modest decline in recent years, decreasing from ~10.6% in 2021 to ~9.7% in 2025.
The alcohol use disorder market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets segmented into:
- 12-months Diagnosed Prevalent Cases of AUD
- Gender-specific Diagnosed Prevalent Cases of AUD
- Age-specific Diagnosed Prevalent Cases of AUD
- Severity-specific Diagnosed Prevalent Cases of AUD
- Total Treated Cases of AUD
Download the report to understand what is the addressable patient population for AUD drugs @ Alcohol Use Disorder Treatment Options
| Alcohol Use Disorder Market Report Metrics | Details |
| Study Period | 2022–2036 |
| Alcohol Use Disorder Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Alcohol Use Disorder Market CAGR | 12.1% |
| Alcohol Use Disorder Market Size in 2025 | USD 1.1 Billion |
| Key Alcohol Use Disorder Companies | Adial Pharmaceuticals, Eli Lilly and Company, MediciNova, Imbrium Therapeutics (subsidiary of Purdue Pharma), Altimmune, Tempero Bio, Nxera Pharma, Alkermes, The Pop Test & Palisades Therapeutics, and others |
| Key Alcohol Use Disorder Therapies | AD04 (ondansetron), Brenipatide (LY3537031), MN-166 (ibudilast), Sunobinop (V117957), Pemvidutide, TMP-301/HTL0014242, PT150, VIVITROL, and others |
Scope of the Alcohol Use Disorder Market Report
- Alcohol Use Disorder Patient Population Forecast
- Alcohol Use Disorder Therapeutics Market Size
- Alcohol Use Disorder Pipeline Analysis
- Alcohol Use Disorder Market Size and Trends
- Alcohol Use Disorder Market Opportunity
- Alcohol Use Disorder Market Unmet Needs
- KOL’s Views on Alcohol Use Disorder
- Alcohol Use Disorder Market Access and Reimbursement
Discover more about what are the most promising alcohol use disorder drugs in development @ Alcohol Use Disorder Clinical Trials
Table of Contents
| 1 | Alcohol Use Disorder Market Key Insights |
| 2 | Alcohol Use Disorder Market Report Introduction |
| 3 | Executive Summary of Alcohol Use Disorder (AUD) |
| 4 | Key Events |
| 5 | Epidemiology and Market Forecast Methodology |
| 6 | Alcohol Use Disorder (AUD) Market Overview at a Glance |
| 6.1 | Clinical Landscape (Analysis by Molecule Type, Phase, and Route of Administration [RoA]) |
| 6.2 | Market Share of AUD by Therapies (%) in the US in 2025 |
| 6.3 | Market Share of AUD by Therapies (%) in the US in 2036 |
| 7 | Disease Background and Overview of Alcohol Use Disorder (AUD) |
| 7.1 | Introduction |
| 7.2 | Symptoms |
| 7.3 | Risk Factors |
| 7.4 | Pathophysiology |
| 7.5 | Types of Alcoholics |
| 7.6 | Diagnosis |
| 7.7 | Biomarkers |
| 8 | Treatment of Alcohol Use Disorder (AUD) |
| 8.1 | Treatment Guidelines of Alcohol Use Disorder (AUD) |
| 9 | Epidemiology and Patient Population of Alcohol Use Disorder (AUD) |
| 9.1 | Key Findings |
| 9.2 | Assumptions and Rationale |
| 9.3 | The United States |
| 9.3.1 | 12-months Diagnosed Prevalent Cases of AUD in the US |
| 9.3.2 | Gender-specific Diagnosed Prevalent Cases of AUD in the US |
| 9.3.3 | Age-specific Diagnosed Prevalent Cases of AUD in the US |
| 9.3.4 | Severity-specific Diagnosed Prevalent Cases of AUD in the US |
| 9.3.5 | Total Treated Cases of AUD in the US |
| 9.4 | EU4 and the UK |
| 9.5 | Japan |
| 10 | Patient Journey of Alcohol Use Disorder (AUD) |
| 11 | Marketed AUD Therapies |
| 11.1 | Marketed Competitive Landscape of Alcohol Use Disorder (AUD) |
| 11.2 | VIVITROL (naltrexone): Alkermes |
| 11.2.1 | Product Description |
| 11.2.2 | Regulatory Milestones |
| 11.2.3 | Other Developmental Activities |
| 11.2.4 | Summary of Pivotal Trials |
| 11.2.5 | Analyst’s View |
| 12 | Emerging AUD Therapies |
| 12.1 | Emerging Competitive Landscape of Alcohol Use Disorder (AUD) |
| 12.2 | AD04 (ondansetron): Adial Pharmaceuticals |
| 12.2.1 | Product Description |
| 12.2.2 | Other Developmental Activities |
| 12.2.3 | Clinical Development |
| 12.2.3.1 | Clinical Trials Information |
| 12.2.4 | Safety and Efficacy |
| 12.2.5 | Analyst’s View |
| 12.3 | Brenipatide (LY3537031): Eli Lilly and Company |
| 12.4 | MN-166 (ibudilast): MediciNova |
| 12.5 | Sunobinop (V117957): Imbrium Therapeutics (subsidiary of Purdue Pharma) |
| 12.6 | Pemvidutide: Altimmune |
| 12.7 | TMP-301/HTL0014242: Tempero Bio and Nxera Pharma |
| 13 | Alcohol Use Disorder Market: The 7MM Market Analysis |
| 13.1 | Key Findings |
| 13.2 | Alcohol Use Disorder Market Outlook |
| 13.3 | Conjoint Analysis |
| 13.4 | Key Market Forecast Assumptions |
| 13.5 | The United States Alcohol Use Disorder Market |
| 13.5.1 | Total Market Size of AUD in the US |
| 13.5.2 | Total Market Size of AUD by Therapies in the US |
| 13.6 | EU4 and the UK Alcohol Use Disorder Market |
| 13.7 | Japan Alcohol Use Disorder Market |
| 14 | Unmet Needs of Alcohol Use Disorder (AUD) |
| 15 | SWOT Analysis of Alcohol Use Disorder (AUD) |
| 16 | KOL Views of Alcohol Use Disorder (AUD) |
| 17 | Market Access and Reimbursement of Alcohol Use Disorder (AUD) |
| 18 | Bibliography |
| 19 | Alcohol Use Disorder Market Report Methodology |
Related Reports
Alcohol Use Disorder Clinical Trial Analysis
Alcohol Use Disorder Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key AUD companies, including Adial Pharmaceuticals, Solvonis Therapeutics, MediciNova, Kinnov Therapeutics, Tonix Pharmaceuticals, Afasci Inc., Tempero Bio, Clearmind Medicine, BioCorRx, BioXcel Therapeutics, Kinnov Therapeutics, Biomed Industries, Lophora, and others.
GLP-1 Agonists Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key GLP-1 agonists companies, including Eli Lilly and Company, Boehringer Ingelheim, Novo Nordisk, Amgen, Viking Therapeutics, Regor Therapeutics, Carmot Therapeutics, Roche, GlaxoSmithKline, Sanofi, and others.
Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SUD companies including BioXcel Therapeutics, NFL Biosciences, STALICLA, Embera NeuroTherapeutics, PleoPharma, Kinnov Therapeutics, Imbrium Therapeutics, Atai Life Sciences, Beckley Psytech, and others.
Cocaine Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CUD companies, including STALICLA, Embera NeuroTherapeutics, and others.
Opioid Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key OUD companies, including Indivior PLC, Alkermes, Orexo AB, Titan Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Mallinckrodt Pharmaceuticals, BioDelivery Sciences International Inc., Viatris Inc., Pfizer, Inc., Hikma Pharmaceuticals PLC, Camurus, and others.
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