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

• According to DelveInsight's analysis, the market size for AUD was found to be USD 1.1 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] in 2024.
• The United States accounted for the largest AUD  treatment market size, approximately 89% of the total market size in the 7MM in 2024, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• As per DelveInsight analysis, there were approximately 37 million 12-month diagnosed prevalent cases of AUD  across the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan], in 2024. 
• AUD among European adolescents and young adults has shown a slightly declining or stable trend, with overall drinking decreasing. This shift reflects evolving social norms, increased health awareness, and the impact of public health initiatives aimed at reducing harmful drinking behaviors.
• Currently, there are no approved treatments specifically tailored to the severity of AUD; most patients receive uniform therapeutic approaches regardless of individual risk profiles. However, the treatment landscape is evolving with several promising candidates in the pipeline targeting moderate-to-severe AUD. Emerging therapies such as BPL-003, Sunobinop, TMP-301/HTL0014242, and Pemvidutide are being actively evaluated in clinical trials
• Despite the availability of approved therapies, a significant treatment gap persists in AUD, with fewer than 10% of affected individuals receiving appropriate intervention. This underscores the urgent need to enhance access, awareness, and adoption of effective treatment options to better address this widespread and underserved condition.
• Leading AUD companies developing emerging therapies, such as Adial Pharmaceuticals (AD04), Beckley Psytech and Atai Life Sciences (BPL-003), MediciNova (Ibudilast), Imbrium Therapeutics (subsidiary of Purdue Pharma) (Sunobinop), Tempero Bio and Nxera Pharma (TMP-301/HTL0014242), Altimmune (Pemvidutide), and others, are developing new therapies that can be available in the AUD market in the coming years. 

Discover the new alcohol use disorder treatment @ Alcohol Use Disorder Treatment Market

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.

Discover more about the alcohol use disorder drugs market @ Alcohol Use Disorder Drugs 

Recent Developments in the Alcohol Use Disorder Market

• In a presentation delivered in June 2025, Imbrium Therapeutics indicated that results from the Phase II trial of sunobinop for treating moderate-to-severe AUD are expected in 2026. The company also projected a potential US launch of Sunobinop in 2030.

• According to a news release in June 2025, a University of California, Los Angeles (UCLA) clinical trial found that ibudilast did not significantly reduce alcohol consumption compared to a placebo; however, the drug demonstrated a positive effect among female participants.
• In June 2025, Imbrium Therapeutics presented updates on its pipeline developments at the BIO International Convention held on Wednesday, June 18. The company is actively seeking strategic partnerships to advance the development of its investigational therapeutics targeting multiple indications across diverse disease areas, including genitourinary disorders, substance use disorders, and oncology.
• In May 2025, Altimmune enrolled the first subject in the RECLAIM Phase II trial evaluating the efficacy and safety of pemvidutide in subjects with AUD.
• In March 2025, Tempero Bio announced the closing of a USD 70 million Series B financing. The financing was led by 8VC with participation from Aditum Bio, Khosla Ventures, and other investors. The proceeds will be used to advance TMP-301 through two Phase II clinical trials for AUD and cocaine use disorder, as well as Phase III-enabling activities and preclinical studies for additional indications and formulations.

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:

• 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

Scope of the Alcohol Use Disorder Market Report

• Alcohol Use Disorder Therapeutic Assessment: AUD  current marketed and emerging therapies
• Alcohol Use Disorder Market Dynamics: Key Market Forecast Assumptions of Emerging Alcohol Use Disorder Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Alcohol Use Disorder Market Access and Reimbursement

Download the report to understand the etiology of alcohol use disorder @ Alcohol Use Disorder 

Table of Contents

Related Reports

Alcohol Use Disorder Clinical Trial Analysis

Alcohol Use Disorder Pipeline Insight – 2025 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, among others.

Substance Use Disorder Market

Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 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, among others.

Cocaine Use Disorder Market

Cocaine Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 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, among others.

Opioid Use Disorder Market

Opioid Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 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, among others.

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