Press release
Alcohol Use Disorder Market Outlook 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Revenue, Statistics, Therapies, Prevalence, Companies by DelveInsight
Alcohol Use Disorder Market
The Alcohol Use Disorder market report covers emerging drugs, treatment practices, market share of the individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of opportunities and assess the underlying potential of the market.
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Key Takeaways from the Alcohol Use Disorder Market Report
• According to DelveInsight's analysis, the market size of alcohol use disorder in the 7MM was USD 620 million in 2023.
• As per DelveInsight analysis, the 12-month diagnosed prevalent cases of AUD in the 7MM were found to be approximately 25 million cases in 2023, which are expected to increase by 2034.
• Prominent alcohol use disorder companies working in the market, including Adial Pharmaceuticals, Corcept Therapeutics, Clearmind Medicine, Clairvoyant Therapeutics, Bioprojet, and others, are actively working on innovative alcohol use disorder drugs. 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.
• Some of the key alcohol use disorder treatments include AD04 (ondansetron), CORT 118335 (Miricorilant) (mifepristone), CMND-100, Psilocybin, BP1.3656, and others.
• In May 2025, Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that the FDA has granted Adial's request for an End of Phase 2 meeting to discuss Adial's proposed clinical development plan and seek FDA guidance on the Phase 3 adaptive with enrichment design of the upcoming clinical trial for AD04. The meeting will take place on July 25, 2025. AD04 is the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/drinking day).
• In May 2025, Tempero Bio, Inc. announced results of a Phase 2, Randomized, Investigator and Participant Blinded, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of TMP-301 Treatment in Adult Patients With Alcohol Use Disorder (AUD)
• In April 2025, Eli Lilly and Company announced results of a Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
• In January 2025, Imbrium Therapeutics announced results of a Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
• In November 2024, Adial Pharmaceuticals was granted a patent by the United States Patent and Trademark Office. The patent covers a broader range of genotype combinations identified by the company's proprietary genetic diagnostic for targeted treatment of AUD with AD04, its lead investigational drug candidate. Additionally, in the same month, the company announced positive topline results from the pharmacokinetics (PK) study of AD04. This data will support the optimization of study design elements for the upcoming Phase 3 clinical trial of AD04.
• In August 2024, Adial Pharmaceuticals entered a collaboration with Boudicca, which will assist in developing the technical and regulatory strategies for Adial's companion diagnostic genetic test.
• In July 2024, Adial Pharmaceuticals submitted a new patent application for AD04, targeting the treatment of Alcohol Use Disorder. This patent is expected to protect Adial's key assets until at least 2044 if granted. That same month, Adial Pharmaceuticals advanced to the second cohort in its pharmacokinetics study of AD04 for AUD.
• In July 2024, the US FDA approved the IND application for CMND-100 oral capsule, enabling the company to initiate a Phase I/IIa clinical trial in the US for the treatment of AUD. Additionally, Clearmind Medicine announced a strategic partnership with JS First Sdn. Bhd. to identify global manufacturers and distributors for its innovative MEAI-based alcohol substitute beverages, advancing its international expansion efforts.
• In June 2024, Adial Pharmaceuticals published the previously reported results from its Phase III ONWARD study in the European Journal of Internal Medicine.
Discover which therapies are expected to grab the alcohol use disorder market share @ Alcohol Use Disorder Market Report - https://www.delveinsight.com/sample-request/alcohol-use-disorder-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alcohol Use Disorder Overview
Alcohol use disorder (AUD) is a prevalent substance use disorder marked by excessive and uncontrollable drinking that adversely affects a person's physical, emotional, and social well-being. It can range from mild to severe, depending on the number of symptoms an individual exhibits. Those with AUD may experience both intoxication and withdrawal symptoms, including mood instability, impaired judgment, slurred speech, difficulties with attention or memory, poor coordination, sweating, rapid heart rate, hand tremors, and seizures.
The disorder has various underlying causes, with genetic, physiological, psychological, and social factors all influencing an individual's behavior. Healthcare professionals utilize the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for diagnosing and assessing the severity of AUD, requiring the presence of at least two out of the 11 diagnostic criteria outlined in the DSM-V to confirm a diagnosis.
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 7MM. 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 market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• 12-month Diagnosed Prevalent Cases of AUD
• Gender-specific Diagnosed Prevalent Cases of AUD
• Type-specific Diagnosed Prevalent Cases of AUD
Download the report to understand which factors are driving alcohol use disorder epidemiology trends @ Alcohol Use Disorder Epidemiological Insights - https://www.delveinsight.com/report-store/alcohol-use-disorder-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alcohol Use Disorder Treatment Market
Management strategies for patients with alcohol use disorder must be customized based on several factors, including the patient's presenting issues, the extent and duration of alcohol use, the severity of dependence, any co-occurring substance use disorders, physical and mental health conditions, and the patient's motivation to change. It is crucial to begin the management process by engaging the patient and understanding their initial treatment goals.
The primary aim of AUD treatment is typically either complete abstinence or a significant reduction in heavy drinking. Current treatment options include medication-assisted therapy, behavioral interventions, detoxification, and psychosocial support from rehabilitation programs and support groups. While psychosocial interventions are the cornerstone of treatment, the high rates of relapse indicate that combining pharmacotherapy with psychosocial counseling and support is the most effective approach.
At present, there are four medications approved by the US FDA for medication-assisted treatment of AUD: Acamprosate, disulfiram (ANTABUSE), oral naltrexone (REVIA), and extended-release injectable naltrexone (VIVITROL). Additionally, topiramate (TOPAMAX) is recognized by the National Institute on Alcohol Abuse and Alcoholism as a treatment option for AUD.
In Europe and Japan, nalmefene (SELINCRO) is approved and is among the first medications that can reduce alcohol cravings on an as-needed basis without necessitating abstinence. Other medications, such as baclofen (BACLOCUR) in France and sodium oxybate (SMO) in Italy, have also received approval in specific countries. Furthermore, the AUD market includes various off-label and generic products, including gabapentin, varenicline, benzodiazepines, memantine, ondansetron, aripiprazole, and suvorexant, among others.
Learn more about the market of alcohol use disorder @ Alcohol Use Disorder Treatment Market - https://www.delveinsight.com/sample-request/alcohol-use-disorder-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alcohol Use Disorder Emerging Drugs and Companies
Various therapies are being developed such as Adial Pharmaceutical's AD04 (ondansetron), Corcept Therapeutics' CORT118335 (miricorilant), Clearmind Medicine's CMND-100, and others that shall further create a positive impact on the market.
AD04 (ondansetron) is a serotonin-3 (5HT3) receptor antagonist designed to target specific genetic profiles, disrupting alcohol's reinforcing effects and thereby reducing the urge to drink. It contains an ultra-low dose of ondansetron, commonly used as an anti-emetic for nausea following surgery or chemotherapy. AD04 also shows potential in treating other addictive behaviors such as opioid use disorder, and obesity.
In 2024, Adial Pharmaceuticals advanced AD04 for alcohol use disorder (AUD), with the Phase III ONWARD trial showing a significant reduction in heavy drinking days within a genetically targeted subgroup. A post hoc analysis highlighted the drug's strong efficacy in patients with certain genotypes.
Additionally, the European Medicines Agency (EMA) approved Adial's Pediatric Investigation Plan (PIP) for AD04, marking a key regulatory achievement.
CORT118335 is a glucocorticoid receptor (GR) antagonist being developed to treat alcohol use disorder. It has been shown to reduce alcohol consumption in individuals with dependence during both acute withdrawal and extended abstinence periods. However, the role of GR in regulating GABA transmission in the central amygdala (CeA) is still unclear.
Corcept Therapeutics has completed a Phase II clinical trial of CORT118335 in patients with moderate to severe AUD, in collaboration with the Scripps Research Institute and the National Institute on Alcohol Abuse and Alcoholism. Additionally, a Phase I clinical trial for AUD treatment is underway in partnership with Johns Hopkins University.
CMND-100 is a compound based on MEAI (5-methoxy-2-aminoindane, also known as 5-MeO-AI or Chaperon) being developed for the treatment of alcohol use disorder (AUD). MEAI is a novel, psychoactive, non-hallucinogenic molecule that has been shown to reduce cravings for alcohol while providing a mild, alcohol-like euphoria. It works by interacting with the 5-HT1a and 5-HT2a serotonergic receptors.
Clearmind Medicine recently received approval from the Israeli Ministry of Health to begin a Phase I/IIa clinical trial to evaluate MEAI in AUD patients. While the trial has demonstrated safety and efficacy in preclinical studies, it is not yet recruiting, with an expected start date in April 2024 in the US and Israel.
The other pipeline therapies for alcohol use disorder include
• Psilocybin: Clairvoyant Therapeutics
• BP1.3656: Bioprojet
The anticipated launch of these emerging therapies are poised to transform the alcohol use disorder market landscape in the coming years. As these cutting-edge 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 alcohol use disorder clinical trials, visit @ Alcohol Use Disorder Treatment Drugs - https://www.delveinsight.com/sample-request/alcohol-use-disorder-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Alcohol Use Disorder Market Dynamics
The alcohol use disorder market dynamics are anticipated to change in the coming years. Given the high rates of alcohol addiction and alcohol use disorder, which are contributing to increased mortality, there is a pressing need for effective treatments. This need presents opportunities for companies to introduce new therapies to the market.
Recent advancements in understanding the neurobiological, genetic, epigenetic, psychological, social, and environmental factors critical to the etiology and treatment of AUD offer companies the chance to implement this knowledge in clinical practice and evaluate potential drugs targeting novel pathways. Ultimately, expanding patient access to pharmacotherapeutic options is essential for the AUD population.
Furthermore, many potential therapies are being investigated for the treatment of alcohol use disorder, and it is safe to predict that the treatment space will significantly impact the alcohol use disorder market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the alcohol use disorder market in the 7MM.
However, several factors may impede the growth of the alcohol use disorder market. The most common treatments for AUD aim to achieve abstinence and typically include psychological and social interventions. However, underdiagnosis and under-treatment remain prevalent due to factors such as stigma, gender barriers, and others.
The development of new treatment protocols for AUD is further complicated by challenges in accurately measuring alcohol consumption patterns in patients and the numerous end-organ comorbidities associated with excessive alcohol use. Additionally, country-specific epidemiologic data on diagnosis, severity, and treatment are limited due to changes in AUD diagnostic criteria from DSM-IV to DSM-V.
Moreover, alcohol use disorder treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the alcohol use disorder market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the alcohol use disorder market growth.
To know more about alcohol use disorder companies and drugs, visit @ Alcohol Use Disorder Drugs Market - https://www.delveinsight.com/sample-request/alcohol-use-disorder-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Scope of the Alcohol Use Disorder Market Report
• Study Period: 2020-2034
• Alcohol Use Disorder Report Coverage: 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
• Alcohol Use Disorder Market Size in 2023: USD 620 Million
• Key Alcohol Use Disorder Companies: Adial Pharmaceuticals, Corcept Therapeutics, Clearmind Medicines, Clairvoyant Therapeutics, Alkermes, Lundbeck, Otsuka Pharmaceuticals, and others
• Key Alcohol Use Disorder Therapies: AD04 (ondansetron), CORT 118335 (Miricorilant) (mifepristone), CMND-100, Psilocybin, BP1.3656, VIVITROL, SELINCRO, and others
• Alcohol Use Disorder Therapeutic Assessment: Alcohol Use Disorder current marketed and emerging therapies
• Alcohol Use Disorder Market Dynamics: Conjoint Analysis of Emerging Alcohol Use Disorder Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Alcohol Use Disorder Market Access and Reimbursement
Table of Contents
1. Alcohol Use Disorder Market Key Insights
2. Alcohol Use Disorder Market Report Introduction
3. Alcohol Use Disorder Market Overview at a Glance
4. Alcohol Use Disorder Market Executive Summary
5. Disease Background and Overview
6. Alcohol Use Disorder Treatment and Management
7. Alcohol Use Disorder Epidemiology and Patient Population
8. Patient Journey
9. Alcohol Use Disorder Marketed Drugs
10. Alcohol Use Disorder Emerging Drugs
11. Seven Major Alcohol Use Disorder Market Analysis
12. Alcohol Use Disorder Market Outlook
13. Potential of Current and Emerging Therapies
14. KOL Views
15. Unmet Needs
16. SWOT Analysis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
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