Alcohol Use Disorder Market Insight, Epidemiology And Market Forecast - 2034

Key Highlights

AUD is a growing global health concern with rising prevalence, especially in the US and parts of Europe. This rise is largely driven by increasing work-related stress, lifestyle changes, anxiety, and greater exposure to medications that may lead to dependency.

The 12-month prevalence of AUD demonstrates regional differences. Asian countries including Japan report relatively low rates of AUD, attributed to cultural norms, and generally lower alcohol consumption per capita. In contrast, the United States exhibits markedly higher prevalence, with recent estimates suggesting ~28 million Americans are affected by AUD due to more permissive cultural attitudes toward drinking.

Sustained abstinence is challenging, with a high risk of relapse even after initial recovery. Combining counseling, self-help groups, and pharmacotherapy, not relying on medication alone, is essential for long-term success. Clinical guidelines from NIAAA and APA emphasize a holistic, multi-modal treatment approach.

Many medications show beneficial short-term effects, but longer-term abstinence rates remain low, often due to AEs, poor adherence, or relapse triggered by stress and anxiety.

ANTABUSE, approved in 1951, was the first FDA-approved pharmacotherapy for alcohol dependence, marked the beginning of medical intervention in AUD, and remained the sole option for decades. After that, CAMPRAL got approval in 2O06 in the US.

A key hurdle in AUD drug development is the lengthy timeline from discovery to FDA approval. For instance, naltrexone took 15 years to progress from preclinical research in 1980 to approval in 1995, while acamprosate required 17 years, from its initial animal studies in 1987 to FDA approval in 2004.

Currently approved therapies include CAMPRAL (acamprosate), ANTABUSE (disulfiram), REVIA (oral naltrexone), VIVITROL (extended-release injectable naltrexone), SELINCRO (nalmefene), and BACLOCUR (baclofen).

Current AUD treatment typically lacks validated biomarkers to guide therapy choices. This limits personalized treatment and prolongs a trial-and-error approach. However, emerging drugs like AD04 (Adial Pharmaceuticals) introduce genetically targeted, biomarker-based precision therapy via oral dosing (twice-daily); in the future, they are planning to upgrade to once-daily dosing.

However, Adial Pharmaceuticals is advancing AD04, a genetically targeted oral precision therapy currently in clinical trials. The drug is administered twice daily, with plans to transition to once-daily dosing. AD04 is positioned as the only late-stage asset in this space, with a potential launch expected by 2027.

Emerging drugs focus on novel mechanisms of action with different routes of administration, such as intranasal (BPL-003), oral (AD04), and subcutaneous (Mazdutide), promising improved adherence and outcomes.

Promising candidates like CMND-100, BXCL501, and PT150 are advancing through early-stage development, broadening the therapeutic landscape with novel mechanisms aimed at improving outcomes in AUD.

DelveInsight’s “Alcohol Use Disorder (AUD) – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the AUD, historical and forecasted epidemiology as well as the AUD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

AUD market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM AUD market size from 2020 to 2034. The report also covers current AUD treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain) and the United Kingdom

Japan

Study Period: 2020–2034

Alcohol Use Disorder (AUD) Understanding and Treatment Algorithm

AUD Overview

AUD is a chronic brain condition marked by the inability to control alcohol use despite harmful consequences. It varies in severity and is diagnosed based on criteria like cravings, tolerance, and withdrawal. AUD affects millions globally and is more common in men, though rates are rising among women and youth. Key risk factors include genetics, mental health issues, and early alcohol exposure. It leads to serious health problems such as liver disease, cardiovascular complications, and cognitive decline. Treatment includes behavioral therapy, medications, and support groups, but there remains a need for better diagnostics, personalized care, and reduced stigma. Early intervention and comprehensive, long-term support can significantly improve recovery outcomes.

AUD Diagnosis

The diagnosis of AUD is primarily clinical and based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). A person must meet at least two out of eleven criteria within a 12-month period, which assess patterns such as impaired control over drinking, social or interpersonal problems related to alcohol use, risky use, tolerance, and withdrawal symptoms. Clinicians often use validated screening tools like the AUDIT (Alcohol Use Disorders Identification Test) or CAGE questionnaire to assess severity and impact. In addition to interviews and self-reported drinking behavior, biological markers such as Gamma-glutamyl transferase (GGT), Carbohydrate-deficient transferrin (CDT), and Phosphatidylethanol (PEth) can support diagnosis, monitor relapse, or confirm abstinence particularly in clinical, legal, or occupational settings. However, these markers are not definitive and are best used alongside clinical assessment. Early and accurate diagnosis is crucial to initiating appropriate treatment and improving long-term outcomes.

Further details related to country-based variations in diagnosis are provided in the report…

AUD Treatment

The treatment of AUD involves a comprehensive, individualized approach that addresses both the physical and psychological aspects of addiction. It typically includes a combination of behavioral therapies, pharmacological interventions, and psychosocial support. Common behavioral therapies such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Contingency Management help individuals modify their drinking behavior and develop coping strategies. The FDA-approved medications like Naltrexone (oral or extended-release injectable), Acamprosate, and Disulfiram are used to reduce cravings, maintain abstinence, or deter alcohol use. In some cases, off-label medications like topiramate or baclofen may also be prescribed. Support groups such as Alcoholics Anonymous (AA) and SMART Recovery provide peer support and accountability. Integrated treatment is essential for patients with co-occurring mental health disorders. While many respond well to these interventions, relapse is common, highlighting the need for ongoing support, personalized care plans, and improved access to long-term treatment options.

Note: Further Details are provided in the final report

Alcohol Use Disorder (AUD) Epidemiology

The epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and total treated cases of AUD covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

Among the 7MM, the US reported the highest number of 12-month prevalent cases in 2024, totaling approximately 29 million. This high burden is attributed to stable prevalence rates over time, compounded by population growth, increased alcohol use in certain subgroups.

In the US, AUD affects roughly 70% of males and 30% of females.

In EU4 and the UK, the higher prevalence of AUD among individuals aged 45–64 years can be attributed to cumulative exposure to alcohol over time. Alcohol use remains socially accepted in this group, often delaying recognition of harmful patterns and contributing to sustained use and related harm.

In Japan, the highest number of AUD cases was accounted for by severe AUD, with approximately 517,000 cases. This reflects delayed diagnosis and highlights the urgent need for early detection to prevent health complications and reduce system burden.

Alcohol Use Disorder (AUD) Drug Chapters

The drug chapter segment of the AUD report encloses a detailed analysis of marketed and emerging drugs of late-stage (Phase III, Phase II, Phase I) pipeline drugs. It also deep dives into the AUD pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. VIVITROL and SELINCRO are the key approved therapies with currently no generics available for the treatment of AUD, while later phase like AD04 and BPL-003 are showing great efficacy, aiming to enhance competition with differentiated benefits and expanding market share in the near future.

Marketed Drugs

VIVITROL (naltrexone): Alkermes

VIVITROL is the first and only extended-release medication for the treatment of alcohol dependence. It is a once-monthly, intramuscular injectable medication indicated for patients who are able to abstain from drinking alcohol in an outpatient setting prior to beginning treatment. It got approved by US FDA in 2006 for the treatment of patient with alcohol dependence.

In August 2023, Alkermes announced that the company entered into a settlement agreement with Teva Pharmaceuticals to resolve the ongoing patent litigation between the parties in the US District Court for the District of New Jersey related to VIVITROL. The company has granted Teva a license under US Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning January 15, 2027, or earlier under certain customary circumstances.

SELINCRO (nalmefene): Lundbeck/Otsuka Pharmaceuticals

SELINCRO is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (>60g/day for men, >40g/day for women) without physical withdrawal symptoms and who do not require immediate detoxification. SELINCRO should be the reduction of alcohol consumption.

In February 2013, EC granted marketing authorization to Lundbeck valid throughout the EU for SELINCRO as a treatment for the reduction of alcohol consumption in adult patients with alcohol dependence with high-risk alcohol consumption.

Emerging Drugs

AD04 (ondansetron): Adial Pharmaceuticals

AD04 is a genetically targeted therapeutic agent for the treatment of AUD and is currently being investigated in a Phase III clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which are to be identified using the company’s proprietary companion diagnostic genetic test.

According to Adial Pharmaceuticals’ presentations published in June 2025, the company anticipates achieving the potential commercial launch of AD04 by 2027.

According to the SEC filing published in December 2024, Adial Pharmaceuticals plans to initiate a Phase III study of AD04 in the second-half of 2025, complete the production of sufficient drug product for the trial, and commence the revalidation process for its companion diagnostic to be included in the Phase III study.

BPL-003 (intranasal 5-MeO-DMT benzoate/mebufotenin benzoate): Beckley Psytech and Atai Life Science

BPL-003 is Beckley Psytech’s synthetic, proprietary intranasal formulation of 5-MeO-DMT benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short time in the clinic, and is being investigated as a potential therapy for Treatment-resistant Depression (TRD) and AUD.

In January 2025, Beckley Psytech announced the positive top-line findings from their open-label Phase IIa study of BPL-003 in patients with moderate-to-severe AUD. The results showed that treatment with BPL-003 can induce meaningful and sustained reductions in alcohol use and HDDs for up to 3 months following a single dose.

In January 2024, Beckley Psytech announced it had received a strategic investment from Atai Life Sciences, aiming to transform the treatment of mental health disorders. This strategic investment and collaboration aim to accelerate the development of Beckley Psytech’s two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai’s mental health innovation platform.

Drug Class Insights

Currently, the market includes a range of therapeutic options for AUD, such as opioid antagonists (VIVITROL), and GABA-B receptor agonists, along with other established classes. Meanwhile, novel therapies like 5HT3 receptor antagonist (AD04), glucagon dual receptor agonists (Pemvidutide), agents that stimulate the serotonin system (BPL-003 and CMND-100), and other emerging mechanisms are under development to expand treatment choices.

Opioid antagonists

Opioid antagonists work by blocking opioid receptors in the brain, specifically the mu-opioid receptors, which are responsible for the rewarding and reinforcing effects of substances like alcohol and opioids. When an opioid antagonist (e.g., naltrexone or naloxone) binds to these receptors, it prevents endogenous opioids (like endorphins) or exogenous opioids (like heroin or morphine) from activating them. In the context of AUD, opioid antagonists help reduce the pleasurable effects and cravings associated with alcohol consumption by blunting the dopamine release that normally occurs when drinking. This mechanism supports abstinence and lowers the risk of relapse, particularly in individuals with strong physiological cravings or a history of heavy drinking.

Alcohol Use Disorder (AUD) Market Outlook

Alcohol Use Disorder is a common, complex condition with varied treatment goals, either abstinence or harm reduction. Treatment options include behavioral therapies (CBT, motivational enhancement, 12-step programs) and pharmacotherapies (disulfiram, naltrexone, acamprosate). Over the past 70 years, the FDA has approved four medications for AUD. These medications are CAMPRAL (acamprosate), ANTABUSE (disulfiram), REVIA (oral naltrexone), and VIVITROL (extended-release injectable naltrexone). Most of these therapies require abstinence before initiating therapy. From the 1950s until the early 1990s, the pharmacotherapy for alcohol dependence consisted only of ANTABUSE (disulfiram), the first US FDA-approved (in 1951) medication for AUD treatment, marketed by Odyssey Pharmaceuticals. Despite the availability of effective treatments, AUD remains critically undertreated due to a wide treatment gap driven by a lack of awareness, limited screening, inadequate treatment infrastructure, and pervasive stigma. Only a small fraction receive FDA-approved medications, and slow regulatory processes, low industry investment, hinder the development of new therapies, and high failure rates in clinical trials.

Various therapies are being developed, including AD04 (Adial Pharmaceuticals), Sunobinop (Imbrium Therapeutics), BPL-003 (Beckley Psytech), ibudilast (MediciNova), TMP-301 (Tempero Bio), and Pemvidutide (Altimmune), which will address the unmet need for AUD. Most candidates are oral formulations, with AD04 being the only late-stage (Phase III) asset. BPL-003 stands out as the only intranasal option currently in the pipeline.

The total market size of AUD in the United States was approximately USD 971 million in 2024 and is projected to increase during the forecast period (2025–2034).

As per DelveInsight’s analysis, by 2034, among the therapies, the highest revenue is expected to be generated by AD04 in the EU4 and the UK.

Key updates

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.

According to a recent presentation by Imbrium Therapeutics in June 2025, the company anticipates results from the Phase II trial of sunobinop for the treatment of moderate-to-severe AUD in 2026.

According to the June 2025 presentation, Imbrium Therapeutics anticipates the initial launch of sunobinop in the US in 2030.

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.

Alcohol Use Disorder (AUD) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

In real-world settings, SELINCRO has outperformed VIVITROL due to flexible, as-needed dosing, easier integration into primary care, and its compatibility with non-abstinence-based strategies. In contrast, VIVITROL, though approved in the US, remains underutilized due to its requirement for full abstinence, high costs, and limited engagement from prescribers.

Further detailed analysis of emerging therapies drug uptake in the report…

Alcohol Use Disorder (AUD) Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, II, and I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for AUD emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including MD, PhD, Senior Researcher, and others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as U University of Trieste, National Institute on Alcohol Abuse and Alcoholism, University of North Carolina, University of Mississippi Medical Center etc. were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or AUD market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement is a crucial factor that affects the drug’s access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

US

The VIVITROL Co-pay Savings Program covers up to USD 500 per month toward co-pay expenses for eligible patients with a VIVITROL prescription.

Also, 99% of people with insurance are covered for VIVITROL, including most government and commercial plans, and complete treatment guidance is provided to patients by Vivitrol2gether patient support services.

Scope of the Report

The report covers a segment of key events, an executive summary, and a descriptive overview of AUD, explaining its causes, signs and symptoms, and currently available therapies.

Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential, and treatment guidelines.

Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.

A detailed review of the AUD market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM AUD.

Alcohol Use Disorder (AUD) Report Insights

Patient Population

Therapeutic Approaches

AUD Pipeline Analysis

AUD Market Size and Trends

Existing and future Market Opportunity

Alcohol Use Disorder (AUD) Report Key Strengths

Ten Years Forecast

The 7MM Coverage

AUD Epidemiology Segmentation

Key Cross Competition

Conjoint analysis

Drugs Uptake and Key Market Forecast Assumptions

Alcohol Use Disorder (AUD) Report Assessment

Current Treatment Practices

Unmet Needs

Pipeline Product Profiles

Analyst Views

Market Attractiveness

Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

What is the historical and forecasted AUD patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?

What was the total AUD market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?

What are the pricing variations among different geographies for approved and off-label therapies?

How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

What are the current and emerging options for treating AUD?

How many companies are developing therapies to treat AUD?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the AUD 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.

Understand the existing market opportunities 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 approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.

Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.

To understand Key Opinion Leaders’ perspectives 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. Show more