Alcohol Use Disorder Market to Grow Rapidly at a 13.6% CAGR by 2034 Owing to Rising Disease Prevalence, Significant Advancements in Genetically-targeted Therapies, along with Innovative Treatments such as GLP-1 Receptor Agonists | DelveInsight
The alcohol use disorder (AUD) 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, increasing awareness, and reduced stigma are expected to boost access and adoption, driving significant CAGR growth from 2025 to 2034.
LAS VEGAS, Nov. 20, 2025 /PRNewswire/ -- DelveInsight's 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 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Alcohol Use Disorder Market Summary
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Key Factors Driving the Growth of the Alcohol Use Disorder Market
Rising Prevalence of Alcohol Use Disorder
Increasing rates of alcohol consumption worldwide, coupled with lifestyle changes and stress-related factors, have led to a growing number of individuals diagnosed with AUD. The 12-month diagnosed prevalent cases of alcohol use disorder are expected to reach 39 million by 2034 in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan]. This rise is primarily driven by increasing work-related stress, lifestyle changes, anxiety, and greater exposure to medications that may lead to dependency.
Growing Awareness and Early Alcohol Use Disorder 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 Investment in R&D and Strong Alcohol Use Disorder Pipeline
Pharmaceutical companies are investing heavily in research and development (R&D) to develop novel treatments and combination therapies targeting AUD. The pipeline of AUD possesses few potential drugs. However, there is a positive outlook for the therapeutics market, with expectations of growth. Companies such as Adial Pharmaceuticals (AD04), Beckley Psytech, Atai Life Sciences (BPL-003), MediciNova (MN-166), Imbrium Therapeutics (Sunobinop), and others are actively engaged in mid- and late-stage research and development efforts for AUD.
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.
Alcohol Use Disorder Market Analysis
AUD is a prevalent and complex condition with diverse treatment objectives, including either complete abstinence or harm reduction. Treatment strategies encompass behavioral interventions, such as cognitive-behavioral therapy (CBT), motivational enhancement therapy, and 12-step programs, as well as pharmacological options like disulfiram, naltrexone, and acamprosate. Over the past seven decades, the FDA has approved four medications for AUD: CAMPRAL (acamprosate), ANTABUSE (disulfiram), REVIA (oral naltrexone), and VIVITROL (extended-release injectable naltrexone). Most of these treatments require patients to achieve abstinence before starting therapy. From the 1950s through the early 1990s, pharmacological treatment for alcohol dependence was limited to ANTABUSE, the first FDA-approved AUD medication in 1951, marketed by Odyssey Pharmaceuticals.
In practical clinical settings, SELINCRO has shown advantages over VIVITROL due to its flexible, as-needed dosing, easier integration into primary care, and suitability for non-abstinence-based approaches. By contrast, VIVITROL remains underutilized despite FDA approval, largely because it requires full abstinence, carries high costs, and suffers from limited prescriber engagement.
Despite the availability of effective treatments, AUD continues to be significantly undertreated. A substantial treatment gap exists due to low awareness, insufficient screening, inadequate treatment infrastructure, and persistent stigma. Only a small proportion of patients receive FDA-approved medications, and slow regulatory processes, limited industry investment, and high clinical trial failure rates further impede the development of new therapies.
Alcohol Use Disorder Competitive Landscape
Some of the AUD drugs in clinical trials include AD04 (Adial Pharmaceuticals), Sunobinop (Imbrium Therapeutics [subsidiary of Purdue Pharma]), BPL-003 (Beckley Psytech and Atai Life Sciences), Ibudilast (MediciNova), TMP-301/HTL0014242 (Tempero Bio and Nxera Pharma), Pemvidutide (Altimmune), and others.
AD04 is a genetically targeted therapy under investigation for treating AUD and is currently in a Phase III clinical trial. The therapy targets specific genotypes, which are identified through the company's proprietary companion diagnostic genetic test. According to Adial Pharmaceuticals' annual presentation, the company plans to discuss the study design, protocol, and statistical analysis plan with the FDA on July 29, 2025, with a potential commercial launch of AD04 anticipated by 2027. According to a December 2024 SEC filing, Adial intends to initiate the Phase III trial in the latter half of 2025, complete production of sufficient drug product, and initiate the revalidation of the companion diagnostic for inclusion in the trial.
BPL-003, developed by Beckley Psytech, is a proprietary intranasal 5-MeO-DMT benzoate formulation delivered via a nasal spray device previously used in an approved drug. It is designed to produce rapid and lasting effects from a single dose with minimal clinic time and is being developed for Treatment-Resistant Depression (TRD) and AUD. BPL-003 is protected by composition-of-matter patents in the US, UK, and Europe, with additional claims pending worldwide. A recent open-label Phase IIa trial in patients with moderate-to-severe AUD was completed.
In January 2025, Beckley Psytech reported positive top-line results from the Phase IIa study, showing that BPL-003 produced significant and sustained reductions in alcohol consumption and heavy drinking days (HDDs) for up to three months after a single dose. These results were presented at the 87th Annual Scientific Meeting of the US College on Problems of Drug Dependence (CPDD) in New Orleans from June 14–18, 2025.
The anticipated launch of these emerging therapies is poised to transform the AUD market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the AUD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
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Recent Developments in the Alcohol Use Disorder Market
What is Alcohol Use Disorder?
AUD is a persistent brain disorder characterized by an inability to control alcohol consumption despite negative consequences. Its severity can range widely and is diagnosed using criteria such as cravings, tolerance, and withdrawal symptoms. AUD affects millions worldwide and is more prevalent in men, although its incidence is increasing among women and younger populations. Major risk factors include genetic predisposition, mental health conditions, and early alcohol exposure. The disorder can result in serious health issues, including liver disease, heart problems, and cognitive decline. Treatment typically involves behavioral therapies, medications, and support groups, yet challenges remain in improving diagnostics, offering personalized care, and reducing stigma. Early intervention combined with comprehensive, long-term support can greatly enhance recovery outcomes.
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 United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The alcohol use disorder treatment market report offers epidemiological analysis for the study period 2020–2034 in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan], segmented into:
Alcohol Use Disorder Market Report Metrics
Details
Study Period
2020–2034
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Alcohol Use Disorder Market CAGR
13.6 %
Alcohol Use Disorder Market Size in 2024
USD 1.1 Billion
Key Alcohol Use Disorder Companies
Adial Pharmaceuticals, Beckley Psytech and Atai Life Sciences, MediciNova, Imbrium Therapeutics (subsidiary of Purdue Pharma), Tempero Bio, Nxera Pharma, Altimmune, Alkermes, Lundbeck, Otsuka Pharmaceuticals, and others
Key Alcohol Use Disorder Therapies
AD04 (ondansetron), BPL-003 (intranasal 5-MeO-DMT benzoate/mebufotenin benzoate), MN-166 (ibudilast), Sunobinop (V117957), TMP-301/HTL0014242, Pemvidutide, VIVITROL, SELINCRO, and others
Scope of the Alcohol Use Disorder Market Report
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Table of Contents
1
Alcohol Use Disorder Market Key Insights
2
Alcohol Use Disorder Market Report Introduction
3
Executive Summary of AUD
4
Key Events
4.1
Upcoming Key Catalysts
4.2
News Flow
4.3
Scientific Meeting Highlights
4.4
Key Transactions, Agreements, and Collaborations
5
Alcohol Use Disorder Epidemiology and Market Forecast Methodology
6
AUD Market Overview at a Glance
6.1
Clinical Landscape (Analysis by Molecule Type, Phase, and Route of Administration)
6.2
Market Share of AUD by Therapies (%) in the 7MM in 2024
6.3
Market Share of AUD by Therapies (%) in the 7MM in 2034
7
Disease Background and Overview
7.1
Introduction
7.2
Alcohol Use Disorder Symptoms
7.3
Alcohol Use Disorder Risk Factors
7.4
Alcohol Use Disorder Pathophysiology
7.5
Types of Alcoholics
7.6
Alcohol Use Disorder Diagnosis
7.7
Alcohol Use Disorder Biomarkers
8
Alcohol Use Disorder Treatment
8.1
Treatment Guidelines
9
Alcohol Use Disorder Epidemiology and Patient Population
9.1
Key Findings
9.2
Assumptions and Rationale
9.3
12-month Diagnosed Prevalent Cases of AUD in the 7MM
9.4
Total Treated Cases of AUD in the 7MM
9.5
The United States
9.5.1
12-month Diagnosed Prevalent Cases of AUD in the US
9.5.2
Gender-specific Diagnosed Prevalent Cases of AUD in the US
9.5.3
Age-specific Diagnosed Prevalent Cases of AUD in the US
9.5.4
Severity-specific Diagnosed Prevalent Cases of AUD in the US
9.6
EU4 and the UK
9.6.1
12-month Diagnosed Prevalent Cases of AUD in EU4 and the UK
9.6.2
Gender-specific Diagnosed Prevalent Cases of AUD in EU4 and the UK
9.6.3
Age-specific Diagnosed Prevalent Cases of AUD in EU4 and the UK
9.6.4
Severity-specific Diagnosed Prevalent Cases of AUD in EU4 and the UK
9.7
Japan
9.7.1
12-month Diagnosed Prevalent Cases of AUD in Japan
9.7.2
Gender-specific Diagnosed Prevalent Cases of AUD in Japan
9.7.3
Age-specific Diagnosed Prevalent Cases of AUD in Japan
9.7.4
Severity-specific Diagnosed Prevalent Cases of AUD in Japan
10
Alcohol Use Disorder Patient Journey
11
Marketed Alcohol Use Disorder Drugs
11.1
Key Competitors
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 Views
11.3
SELINCRO (nalmefene): Lundbeck/Otsuka Pharmaceuticals
12
Emerging Alcohol Use Disorder Therapies
12.1
Key Competitors
12.2
AD04 (ondansetron): Adial Pharmaceuticals
12.2.1
Product Description
12.2.2
Other Developmental Activities
12.2.3
Summary of Clinical Trial
12.2.4
Clinical Development
12.2.4.1
Clinical Trials Information
12.2.5
Safety and Efficacy
12.2.6
Analyst Views
12.3
BPL-003 (intranasal 5-MeO-DMT benzoate/mebufotenin benzoate): Beckley Psytech and Atai Life Sciences
12.4
MN-166 (ibudilast): MediciNova
12.5
Sunobinop (V117957): Imbrium Therapeutics (subsidiary of Purdue Pharma)
12.6
TMP-301/HTL0014242: Tempero Bio and Nxera Pharma
12.7
Pemvidutide: Altimmune
13
Alcohol Use Disorder Market: 7MM Market Analysis
13.1
Key Findings
13.2
AUD Market Outlook
13.3
Conjoint Analysis
13.4
Key AUD Market Forecast Assumptions
13.4.1
Cost Assumptions and Rebates
13.4.2
Pricing Trends
13.4.3
Analogue Assessment
13.4.4
Launch Year and Therapy Uptake
13.5
Total Market Size of AUD in the 7MM
13.6
Total Market Size of AUD by Therapies in the 7MM
13.7
The United States AUD Market Size
13.7.1
Total Market Size of AUD in the US
13.7.2
Total Market Size of AUD by Therapies in the US
13.8
EU4 and the UK AUD Market Size
13.9
Japan AUD Market Size
14
AUD Market Unmet Needs
15
AUD Market SWOT Analysis
16
KOL Views on AUD
17
AUD Market Access and Reimbursement
17.1
United States
17.2
EU4 and the UK
17.3
Japan
17.4
AUD Market Access and Reimbursement
18
Appendix
18.1
Bibliography
18.2
Report Methodology
19
DelveInsight Capabilities
20
Disclaimer
21
About DelveInsight
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