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DelveInsight's "Alcohol Use Disorder (AUD) Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of AUD, historical and forecasted epidemiology, as well as the AUD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The AUD market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM AUD market size from 2020 to 2034. The report also covers AUD treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Alcohol Use Disorder Treatment Market
AUD Overview
Alcohol use disorder is a chronic, relapsing condition that is extremely common and is characterized by an inability to control or quit drinking alcohol in the face of significant impairment, distress, or other negative outcomes. Millions of people worldwide are affected by this substance use disorder, which is among the most widespread. Its diverse clinical presentations point to a complicated interplay between biological, psychological, physiological, environmental, and social factors that contribute to the onset and course of the disease. A strong genetic influence predisposes some people to develop AUD. It is a highly heterogeneous condition with complex biology that affects a person physically, emotionally, and socially. It is regulated by numerous genes and gene-by-environment interactions. With a high morbidity and death rate, it poses a serious threat to public health and significantly harms society.
AUD Diagnosis
The US Preventive Services Task Force has recommended three methods to screen for heavy alcohol use. These methods are the AUD Identification Test (AUDIT), the AUDIT-C, or a single question such as "How many times in the past year have you had 5 (for men) or 4 (for women) or more drinks in a day?"
The diagnosis of AUD requires testing an individual based on DSM-V diagnostic criteria, to assess if symptoms of AUD are present. DSM-V lists various potential criteria for AUD, covering four main aspects of alcohol use which are impaired control, social impairment, risky use, and pharmacological effects. The presence of at least two of these symptoms indicates an AUD. DSM-V criteria also help determine the severity of AUD. Based on the number of symptoms present the individual is classified into mild, moderate, and severe cases of AUD.
AUD Treatment
Currently, there are four US FDA-approved medication-assisted treatments for AUD, including Acamprosate, ANTABUSE (disulfiram), REVIA (oral naltrexone), and VIVITROL (extended-release injectable naltrexone). Besides these TOPAMAX (topiramate) is also endorsed by the National Institute on Alcohol Abuse and Alcoholism for the treatment of AUD.
Moreover, SELINCRO (nalmefene) is approved in the EU and Japan and is one of the first drugs that reduces alcohol cravings in individuals on an as-needed basis and does not require abstinence. Other drugs are approved in certain specific countries like BACLOCUR (baclofen) in France and Sodium oxybate (SMO) in Italy. The market for AUD is also inclusive of many off-label and generic products such as gabapentin, varenicline, benzodiazepines, memantine, ondansetron, aripiprazole, and suvorexant, among others.
As the market is derived using a patient-based model, the AUD 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, type-specific cases of AUD, and treated cases of AUD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the AUD report encloses a detailed analysis of AUD-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the AUD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Alcohol Use Disorder Marketed Drugs
VIVITROL (naltrexone): Alkermes
VIVITROL developed by Alkermes along with Cephalon is a non-narcotic microsphere formulation of naltrexone approved for the treatment of alcohol dependence in individuals who abstain from drinking in an outpatient setting and are not actively drinking once treatment is initiated. It is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence. Treatment with VIVITROL is to be used in combination with psychosocial support, such as counseling or group therapy.
It utilizes Alkermes' proprietary polymer-based microsphere injectable extended-release drug delivery technology Medisorb in a once-a-month injectable formulation of naltrexone. This helps in maintaining therapeutic medication levels in the body through a single intramuscular injection every four weeks.
SELINCRO (nalmefene): Lundbeck/Otsuka Pharmaceuticals
SELINCRO (nalmefene) developed by Lundbeck is an opioid receptor antagonist that reduces alcohol consumption by reducing the urge to drink in people accustomed to large amounts of alcohol. It is the first dual-acting opioid system modulator in Japan that acts on the brain's motivational system, which is dysregulated in patients with alcohol dependence.SELINCRO provides a solution for patients by allowing them to take the drug on an as-needed basis, leading to a reduction in their alcohol consumption and the number of HDDs.
Thus, treatment with SELINCRO should be prescribed in combination with ongoing psychosocial monitoring focusing on treatment compliance and reduction of alcohol consumption.
Alcohol Use Disorder Emerging Drugs
AD04 (ondansetron): Adial Pharmaceuticals
AD04 (ondansetron) is a genetically targeted, serotonin-3 (5HT3) receptor antagonist that interrupts the reinforcing effects of alcohol, and thus reduces the urge to drink. AD04 contains an ultra-low dose of ondansetron, which is currently marketed as an anti-emetic for post-operative and post-chemotherapy nausea. AD04 is also believed to have the potential to treat other addictive disorders such as opioid use disorder, gambling, and obesity. The drug candidate has completed the ONWARD Phase III trial showing that AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients and its post hoc analysis results demonstrated patients with specific genotypes responding extremely well to AD04. Moreover, EMA had accepted Adial's Pediatric Investigation Plan for the development of AD04 in the pediatric population.
Furthermore, Adial provided a business update following favorable comments from the US and EU regulatory meetings and planned to bring AD04 to registration with the FDA in the third quarter of 2025. Adial will need to conduct two Phase III trials with AD04, where the active arm of patients will be compared to the placebo and the second trial may include a biomarker-negative patient arm to satisfy any ongoing questions from the regulators regarding efficacy parameters. The company also engaged The Keswick Group to advance the partnering activities for further clinical development of AD04. The company posted regarding peer-reviewed publication highlighting promising safety data and high patient compliance in a clinical trial of AD04 as a potential treatment for AUD.
Recently, Adial Pharmaceuticals was granted a key patent from the US Patent and Trademark Office. This patent expands Adial's intellectual property protection and covers the combination of the company's proprietary genetic diagnostic to identify patients with specific genotypes for genetically targeted treatment of AUD and other drug dependencies, such as opioid use disorder (OUD).
CORT 118335 (miricorilant): Corcept Therapeutics
CORT118335 is a glucocorticoid receptor (GR) antagonist being developed for the treatment of AUD. The GR antagonist decreased alcohol consumption in dependence during acute withdrawal and protracted abstinence. However, the regulation of CeA synaptic GABA transmission by GR is currently unknown. Corcept Therapeutics with academic collaboration with the University of Chicago is trying to augment development efforts for the treatment of AUD.
A Phase II trial by Scripps Research Institute in collaboration with NIAAA was completed for the treatment of moderate or severe AUD with CORT118335. However further update from the company is awaited. Additionally, the company is also investigating mifepristone in AUD patients and has completed a trial in collaboration with Johns Hopkins University and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Miricorilant is also being investigated for non-alcoholic steatohepatitis.
MN-166 (ibudilast): MediciNova
MN-166 (ibudilast) is a novel, first-in-class, non-opioid glial cell modulator that inhibits phosphodiesterases (PDE) -4 and PDE-10 and macrophage migration inhibitory factor (MIF). It leads to a decrease in pro-inflammatory cytokines. Ibudilast is being developed to treat AUD through its anti-inflammatory and pro-neurotrophic mechanisms. It is an orally bioavailable, small-molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1B, TNF-a, and IL-6 and upregulates the anti-inflammatory cytokine IL-10. It is a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation.
The drug candidate has completed Phase II (IIa, IIb) trials for the treatment of AUD in collaboration with UCLA Addictions Laboratory (funded by NIAAA/ NIDA). In the recently completed Phase IIb trial, MN-166 (ibudilast) treatment was not superior to the placebo for reducing percent heavy drinking days. The company plans on future discussions, and further analyses, including subgroup analyses, to determine the future direction of MN-166 and AUD.
In addition, MediciNova is also developing MN-166 for various other conditions such as degenerative cervical myelopathy, progressive MS, ALS, acute respiratory distress syndrome (ARDS) caused by COVID-19, chemotherapy-induced peripheral neuropathy (CIPN), glioblastoma (GBM), and methamphetamine dependence. MN-166 is marketed to treat post-stroke complications and bronchial asthma. Furthermore, the company has received from EPO a Notice of Intention to Grant a patent for a pending application that covers MN-166 (ibudilast) for the treatment of AUD. Once issued, the granted patent will expire by May 2037.
Alcohol Use Disorder Drug Class Insights
Alcohol use disorder (AUD) treatment involves a variety of medication classes that target different facets of the condition, such as curbing alcohol cravings, addressing withdrawal symptoms, and fostering abstinence. Baclofen and topiramate, although initially developed for other purposes, have shown promise in reducing alcohol cravings and promoting abstinence in some AUD patients. Additionally, adjunctive therapies like benzodiazepines and antidepressants are commonly utilized to manage alcohol withdrawal symptoms like anxiety, insomnia, and seizures, while Vitamin B1 (Thiamine) is prescribed to address thiamine deficiency, which is prevalent in individuals with AUD and can lead to neurological complications.
AUD also has economic consequences, costing a substantial amount annually. Current pharmaceutical and behavioral treatments may assist patients in reducing alcohol use or facilitating alcohol abstinence.
At present, four approved therapies for the treatment of AUD include disulfiram, Naltrexone (oral), acamprosate, and VIVITROL. Most of these therapies were approved decades ago and have their generics in the market. The current AUD market in the US is dominated by these therapies.
Naltrexone, the best-studied of the approved medications, is an antagonist of the mu-opioid receptor with an additional affinity for kappa and delta opioid receptors. In 1994, the US FDA approved oral naltrexone sold by DuPont under the brand name REVIA for the treatment of alcoholism. Though it significantly reduced alcohol craving and drinking rates it required strict compliance. To address this issue the extended-release depot formulation of naltrexone was developed to improve adherence. In April 2006, the US FDA approved VIVITROL (naltrexone for extended-release injectable suspension) marketed by Alkermes. This once-a-month injectable formulation of naltrexone helped in maintaining therapeutic medication levels in the body through a single intramuscular injection every four weeks. The demand for complete abstinence before the treatment is started is the major disadvantage of Naltrexone. Though an FDA-recommended first-line treatment that reduces binge drinking, naltrexone is a costly drug with an FDA label warning that significantly impacts its market availability.
Another decade-old approved drug, Acamprosate, the first approved treatment for alcohol dependence in Europe, is often considered an 'artificial alcohol' or a 'functional glutamate antagonist. Multiple meta-analyses have found acamprosate to reduce alcohol consumption compared to placebo and increase the cumulative duration of abstinence. It is FDA-approved for abstinence maintenance in AUD patients who are abstinent when beginning treatment. Usually administered as the first line of treatment it is best for maintaining sobriety once the patient has achieved abstinence.
ANTABUSE (disulfiram), the first US FDA-approved (in 1951) medication for AUD treatment, is the oldest drug in the AUD market. it is an oral aldehyde dehydrogenase inhibitor that acts by blocking the metabolism of alcohol. NICE guidelines suggest that disulfiram should be used as a second-line treatment when other approved medications fail. However, there is no consensus on the trial methodology for assessing the efficacy of disulfiram since it cannot be appraised fairly in double-blind, RCTs due to its mechanism of action.
Besides these SELINCRO (nalmefene) developed by Lundbeck is approved in the EU and Japan and addresses the need for abstinence in AUD patients. Being the drug that addresses the major unmet of abstinence, it has shown immense success in the European and Japanese markets. However, it has not been approved for sale in the US.
The considerable heterogeneity of AUD patients makes it especially challenging to design a single drug capable of treating AUD patients as a whole. Current pharmacotherapies are often characterized by limited efficacy and there is a large treatment gap in alcohol dependence with the current treatments only moderately effective in preventing relapse. The need for abstinence and the associated social stigma further complicates the treatment regime.
However, the expected launch of potential therapies that include Adial Pharmaceutical's AD04 (ondansetron), Corcept Therapeutics' CORT118335 (miricorilant), mifepristone, Clearmind Medicine's CMND-100, and others that shall further create a positive impact on the market size during the forecast period [2024-2034].
According to DelveInsight, the overall dynamics of the AUD market are anticipated to change in the coming years owing to the expected launch of emerging therapies.
Alcohol Use Disorder Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Corcept Therapeutic's CORT 118335 (miricorilant), a glucocorticoid receptor (GR) antagonist being developed for the treatment of AUD. The GR antagonist decreased alcohol consumption in dependence during acute withdrawal and protracted abstinence. With protracted abstinence and a fortnight treatment regime, it addresses the major reasons for low adherence to the current treatment.
Alcohol Use Disorder Pipeline Development Activities
The report provides insights into different Alcohol Use Disorder Clinical trials within Phase III, Phase II, and Phase 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 emerging therapies for AUD.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on AUD's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Medical University of South Carolina, Brown University School of Public Health, University of California-San Diego, Second University of Naples, University of Fukui, and Mie University Graduate School of Medicine were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or AUD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
According to physicians, a primary challenge in AUD treatment lies in its complex nature. AUD involves biological, psychological, and social factors, making it a multifaceted condition to address effectively. Treatment often requires a comprehensive approach that combines medical interventions, therapy, and support systems tailored to the individual's needs. Additionally, the stigma associated with alcohol misuse can hinder individuals from seeking help, further complicating the treatment process.
According to a KOL in the US, millions of Americans suffer from AUD but only a small proportion seek treatment. FDA-approved medications for AUD, such as disulfiram, acamprosate, and oral and injectable naltrexone, are used in clinical practice, though not in large numbers, despite their clear benefits on healthcare utilization and costs.
As per another KOL, medication-assisted treatment, behavioral therapies, detoxification, and psychosocial support from rehab and support groups are available treatment options for AUD. Disulfiram, naltrexone (oral), acamprosate, and nalmefene are approved treatments for AUD.
In another KOL in Japan, Reduced drinking is a popular alternative treatment objective among many people and medical professionals in Japan, even if abstinence continues to be the primary treatment goal among doctors.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Attribute Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in AUD trials, one of the most important primary outcome measures is complete eschar removal.
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
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
The VIVITROL Co-pay Savings Program covers up to USD 500 per month of co-pay or deductible expenses for eligible patients with a VIVITROL prescription. Any individual with a prescription for VIVITROL who is 18 years or older is eligible for the VIVITROL Co-pay Savings Program card. It includes both patients with commercial health insurance or those with no insurance and also those who pay cash. However, those using federal or state healthcare including Medicare (Medicare Part D or Medicare Advantage plans), Medicaid (Medicaid Managed Care or Alternative Benefit Plans under the Affordable Care Act), Medigap, Veterans Administration, Department of Defense, TRICARE, or any state-funded programs such as medical or pharmaceutical assistance programs and residential correctional programs to cover, in whole or in part, the cost of their VIVITROL prescription are not included in the VIVITROL Co-pay Savings Program.
Scope of the Alcohol Use Disorder Market Report
Key Questions Answered In The Alcohol Use Disorder Market Report:
Alcohol Use Disorder Market Insights
Alcohol Use Disorder Epidemiology Insights
Current Alcohol Use Disorder Treatment Scenario, Marketed Drugs, and Emerging Therapies
Reasons to Buy Alcohol Use Disorder Market Report:market
To be continued.....
To be continued.....