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, along with 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 including 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 estimated at 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 with other major markets, including the EU4 countries, the United Kingdom, and Japan.
  • There were 25.6 million 12-month 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.
  • 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.
  • Among therapies in the US, VIVITROL (naltrexone) held the highest market share in 2025, while AD04 is projected to capture the largest market share by 2036.

Discover more about the Alcohol Use Disorder market forecast @
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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 alcohol use disorder market is expected to benefit from increasing diagnosis and treatment uptake.

Rising Focus on Harm Reduction and Personalized Care

Shifts in treatment paradigms toward harm reduction strategies, personalized therapy, and combination approaches involving behavioral and pharmacological interventions are creating new opportunities in the AUD market and encouraging greater adoption of approved therapies.

Strong AUD Clinical Trial Activity

Several companies are advancing therapies through clinical development. Key pipeline candidates 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, and dual GLP-1/glucagon receptor agonism, highlights significant opportunities for developers to enter a space with high unmet need and 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 trends underscore growing momentum toward recovery and improved alcohol-related health outcomes.

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.

Learn more about the late-stage AUD assets that 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

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 established a genetic biomarker-based diagnostic assay to identify patients most likely to benefit from AD04. This test was implemented in the large-scale ONWARD randomized controlled trial and is expected to play a role in future studies, supporting regulatory approval and commercialization alongside AD04.

Eli Lilly and Company's Brenipatide

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

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 neuroinflammatory mechanisms associated with the disorder.

Altimmune's Pemvidutide

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.

The anticipated launch of these emerging alcohol use disorder therapies is expected to transform the AUD market landscape in the coming years. As these therapies continue to mature and potentially gain regulatory approval, they could reshape treatment approaches and create opportunities for medical innovation and market growth.

To know more about companies working on GLP-1 drugs for AUD @ Alcohol Use Disorder Medication

Recent Developments in the Alcohol Use Disorder Market

  • March 2026: Adial Pharmaceuticals entered into a collaboration framework agreement with Molteni Farmaceutici for a proposed exclusive partnership covering the commercialization of AD04 in Europe.
  • 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. The patent, once granted, is expected to protect Adial's core assets through at least 2045.
  • 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.
  • 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 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 and increase 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 AUD 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 approximately 10.6% in 2021 to 9.7% in 2025.

The alcohol use disorder market report provides epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:

  • 12-month 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 the addressable patient population for AUD drugs @ Alcohol Use Disorder Treatment Options

Alcohol Use Disorder Market Report Metrics

  • Study Period: 2022–2036 
  • Coverage: 7MM
  • Key Companies: Adial Pharmaceuticals, Eli Lilly and Company, MediciNova, Imbrium Therapeutics, Altimmune, Tempero Bio, Nxera Pharma, Alkermes, The Pop Test, Palisades Therapeutics, and others 
  • Key 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
  • KOLs' Views on Alcohol Use Disorder
  • Alcohol Use Disorder Market Access and Reimbursement

Discover more about 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
  7. Disease Background and Overview of Alcohol Use Disorder (AUD)
  8. Treatment of Alcohol Use Disorder (AUD)
  9. Epidemiology and Patient Population of Alcohol Use Disorder (AUD)
  10. Patient Journey of Alcohol Use Disorder (AUD)
  11. Marketed AUD Therapies
  12. Emerging AUD Therapies
  13. Alcohol Use Disorder Market: The 7MM Market Analysis
  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 key AUD companies, including Adial Pharmaceuticals, Solvonis Therapeutics, MediciNova, Kinnov Therapeutics, Tonix Pharmaceuticals, Afasci Inc., Tempero Bio, Clearmind Medicine, BioCorRx, BioXcel Therapeutics, Biomed Industries, Lophora, and others.

GLP-1 Agonists Market

GLP-1 Agonists Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report delivers an in-depth understanding of 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, and Sanofi, among others.

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