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

¹ßÇàÀÏ: | ¸®¼­Ä¡»ç: DelveInsight | ÆäÀÌÁö Á¤º¸: ¿µ¹® 200 Pages | ¹è¼Û¾È³» : 2-10ÀÏ (¿µ¾÷ÀÏ ±âÁØ)

    
    
    




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  • ÁÖ¿ä 7°³ ½ÃÀåÀÇ ¾ËÄÚ¿Ã »ç¿ë Àå¾Ö(AUD) 2023³â¿¡ ¾à 6¾ï 2,000¸¸ ´Þ·¯·Î, ±× Áß ¹Ì±¹ÀÌ ¾à 4¾ï 7,500¸¸ ´Þ·¯¸¦ Â÷ÁöÇϰí ÀÖ½À´Ï´Ù.
  • 7´ë ÁÖ¿ä ½ÃÀå¿¡¼­ÀÇ Áßµ¶ À¯º´·ü Áõ°¡, ½Å¾à ÆÄÀÌÇÁ¶óÀÎÀÇ È®´ë, Á¦³×¸¯ Á¦Á¶¾÷üÀÇ Àú°¡ ÀǾàǰ °ø±Þ Âü¿© Áõ°¡ µîÀÌ ¿¹Ãø ±â°£(2024-2034³â) µ¿¾È ¼¼°è AUD Ä¡·áÁ¦ ½ÃÀåÀÇ ÁÖ¿ä ¼ºÀå ÃËÁø¿äÀÎÀ¸·Î ²ÅÇû½À´Ï´Ù.
  • AUD ½ÃÀå¿¡´Â FDA°¡ ½ÂÀÎÇÑ Acamprosate, ANTABUSE(disulfiram), REVIA(°æ±¸¿ë naltrexone), VIVITROL(¼­¹æÇü ÁÖ»çÁ¦ naltrexone) µî 4Á¾ÀÇ ¾à¹°¿ä¹ý ¿Ü¿¡µµ gabapentin, varenicline benzodiazepines, memantine, ondansetron, aripiprazole, suvorexant µîÀÇ ÀûÀÀÁõ ¿Ü Á¦Ç° ¹× Á¦³×¸¯ ÀǾàǰÀÌ Æ÷ÇԵ˴ϴÙ. ¶ÇÇÑ TOPAMAX(topiramate)´Â National Institute on Alcohol Abuse and Alcoholism¿¡ AUD Ä¡·áÁ¦·Î ½ÂÀÎµÈ ¹Ù ÀÖ½À´Ï´Ù.
  • ¶ÇÇÑ SELINCRO(nalmefene)´Â EU¿Í ÀϺ»¿¡¼­ ½ÂÀεǾúÀ¸¸ç, ±ÝÁÖ¸¦ ÇÊ¿ä·Î ÇÏÁö ¾Ê°í ÇÊ¿äÇÒ ¶§ ÇÊ¿äÇÑ ¸¸Å­¸¸ ¾ËÄÚ¿Ã °¥¸ÁÀ» ¾ïÁ¦ÇÏ´Â ÃÖÃÊÀÇ ¾à¹° Áß ÇϳªÀÔ´Ï´Ù. ¶ÇÇÑ ÇÁ¶û½ºÀÇ BACLOCUR(baclofen)À̳ª ÀÌÅ»¸®¾ÆÀÇ ³ªÆ®·ý ¿Á½Ãº£ÀÌÆ®(SMO)¿Í °°Àº ƯÁ¤ ¾à¹°ÀÌ Æ¯Á¤ ±¹°¡¿¡¼­ AUD Ä¡·áÁ¦·Î ½ÂÀεǾú½À´Ï´Ù.
  • AUDÀÇ ³ôÀº À¯º´·ü°ú °ü·Ã ºÎÀÛ¿ë¿¡µµ ºÒ±¸Çϰí ÇöÀç AUD Ä¡·á´Â ¹«ÀÛÀ§ ´ëÁ¶ ½ÃÇè¿¡¼­ Á¦ÇÑµÈ ¼º°ø·üÀ» º¸À̰í ÀÖ½À´Ï´Ù. ¶ÇÇÑ AUD ȯÀÚµéÀº »ó´çÇÑ ÀÌÁú¼ºÀ» °¡Áö°í ÀÖÀ¸¹Ç·Î AUD ȯÀÚ Àüü¸¦ Ä¡·áÇÒ ¼ö ÀÖ´Â ´ÜÀÏ ¾à¹°À» ¼³°èÇÏ´Â °ÍÀº ƯÈ÷ ¾î·Æ½À´Ï´Ù. ±Ý´ÜÀÇ Çʿ伺°ú ±×¿¡ µû¸¥ »çȸÀû ³«ÀÎÀº Ä¡·á ¼øÀÀµµ¿¡µµ ¿µÇâÀ» ¹ÌĨ´Ï´Ù.
  • ±×·¯³ª Adial PharmaceuticalÀÇ AD04(ondansetron), Corcept TherapeuticsÀÇ CORT118335(miricorilant), mifepristone, Clearmind MedicineÀÇ CMND-100 µî ´Ù¾çÇÑ Ä¡·áÁ¦°¡ °³¹ßµÇ°í ÀÖÀ¸¸ç, ½ÃÀå¿¡ ´õ¿í ±àÁ¤ÀûÀÎ ¿µÇâÀ» ¹ÌÄ¥ °ÍÀ¸·Î ¿¹»óµË´Ï´Ù.

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ÇöÀç AUD Ä¡·áÁ¦·Î ½ÂÀÎµÈ ¾à¹°Àº disulfiram, naltrexone(°æ±¸¿ë), acamprosate, VIVITROL µî 4À¯ÇüÀÌ ÀÖ½À´Ï´Ù. À̵é Ä¡·á¹ýÀº ´ëºÎºÐ ¼ö½Ê³âÀü¿¡ ½ÂÀÎµÈ °ÍÀ¸·Î, Á¦³×¸¯ ÀǾàǰÀÌ ½ÃÆÇµÇ°í ÀÖ½À´Ï´Ù. ÇöÀç ¹Ì±¹ÀÇ AUD ½ÃÀåÀº À̵é Ä¡·áÁ¦°¡ ´ëºÎºÐÀ» Â÷ÁöÇϰí ÀÖ½À´Ï´Ù.

1994³â ¹Ì±¹ FDA´Â ¾ËÄÚ¿Ã Áßµ¶ Ä¡·áÁ¦·Î¼­ °¡Àå ¸¹ÀÌ ¿¬±¸µÈ naltrexoneÀº ¹Â ¿ÀÇÇ¿ÀÀÌµå ¼ö¿ëü ±æÇ×Á¦ÀÌÀÚ Ä«ÆÄ µ¨Å¸ ¿ÀÇÇ¿ÀÀÌµå ¼ö¿ëü¿¡µµ ģȭ·ÂÀÌ ÀÖ´Â ¾à¹°·Î, DuPont¿¡¼­ REVIA¶ó´Â »óǰ¸íÀ¸·Î ÆÇ¸ÅµÇ´Â °æ±¸¿ë naltrexoneÀ» ½ÂÀÎÇß½À´Ï´Ù. naltrexoneÀº ¾ËÄڿÿ¡ ´ëÇÑ °¥¸Á°ú À½ÁÖÀ²À» ÇöÀúÇÏ°Ô °¨¼Ò½ÃÄ×À¸³ª, ¾ö°ÝÇÑ ¼øÀÀµµ°¡ ÇÊ¿äÇß½À´Ï´Ù. ÀÌ ¹®Á¦¸¦ ÇØ°áÇϱâ À§ÇØ, naltrexoneÀÇ ¼­¹æÇü ÀúÀå¼Ò°¡ °³¹ßµÇ¾î ¼øÀÀµµ¸¦ Çâ»ó½ÃÄ×°í, 2006³â 4¿ù, ¹Ì±¹ FDA´Â Alkermes°¡ ÆÇ¸ÅÇÏ´Â VIVITROL(¼­¹æÇü ÁÖ»çÁ¦ naltrexone)À» ½ÂÀÎÇß½À´Ï´Ù. ÀÌ¿ù1ȸ ÁÖ»çÇÏ´Â ³¯Æ®·º¼Õ Á¦Á¦´Â 4ÁÖ¸¶´Ù ÇÑ ¹ø¾¿ ±ÙÀ° Áֻ縦 ÅëÇØ ü³»ÀÇ Ä¡·áÁ¦¹° ¼öÁØÀ» À¯ÁöÇÏ´Â µ¥ µµ¿òÀÌ µÇ¾ú½À´Ï´Ù. Ä¡·á ½ÃÀÛ Àü¿¡ ¿ÏÀüÇÑ ±ÝÁÖ¸¦ ¿ä±¸ÇÑ´Ù´Â Á¡ÀÌ ³¯Æ®·º¼ÕÀÇ Å« ´ÜÁ¡ÀÔ´Ï´Ù. FDA°¡ ÆøÀ½À» ÁÙÀ̱â À§ÇØ ±ÇÀåÇÏ´Â 1Â÷ Ä¡·áÁ¦·Î¼­, naltrexoneÀº °í°¡ÀÇ ¾à¹°À̸ç, FDAÀÇ ¶óº§ °æ°í°¡ ÀÖÀ¸¸ç, ½ÃÀå¿¡¼­ÀÇ °¡¿ë¼º¿¡ Å« ¿µÇâÀ» ¹ÌÄ¡°í ÀÖ½À´Ï´Ù.

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  • AUD ½ÃÀå Á¡À¯À² ºÐÆ÷ : Ä¡·á¹ýº°(2020³â)
  • AUD ½ÃÀå Á¡À¯À² ºÐÆ÷ : Ä¡·á¹ýº°(2034³â)

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  • ÁÖ¿ä °æÀï»ó´ë
  • VIVITROL(naltrexone): Alkermes
  • SELINCRO(nalmefene): Lundbeck/Otsuka Pharmaceuticals

Á¦11Àå ½Å¾à

  • ÁÖ¿ä °æÀï
  • AD04(ondansetron): Adial Pharmaceuticals
  • MN-166(ibudilast): MediciNova
  • CORT 118335(Miricorilant)(mifepristone): Corcept Therapeutics

Á¦12Àå AUD : ½ÃÀå ºÐ¼®

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  • ÁÖ¿ä 7 ½ÃÀåÀÇ AUD ½ÃÀå ±Ô¸ð : Ä¡·á¹ýº°
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Á¦20Àå DelveInsight ¼Ò°³

KSA 25.02.11

Key Highlights:

  • In 2023, total Alcohol Use Disorder market size across the seven major markets (7MM) was around USD 620 million, with the United States contributing approximately USD 475 million of that total.
  • The anticipated rise in addiction prevalence within the 7MM, coupled with the expanding emerging pipeline, and the increasing involvement of generic manufacturers in supplying more affordable pharmaceuticals, are identified as the key drivers expected to propel the global AUD treatment market's growth over the forecast period (2024-2034).
  • The AUD market encompasses a range of off-label and generic products like gabapentin, varenicline, benzodiazepines, memantine, ondansetron, aripiprazole, and suvorexant, alongside the four FDA-approved medication-assisted treatments: Acamprosate, ANTABUSE (disulfiram), REVIA (oral naltrexone), and VIVITROL (extended-release injectable naltrexone). Additionally, TOPAMAX (topiramate) is endorsed by the National Institute on Alcohol Abuse and Alcoholism for AUD treatment.
  • Additionally, SELINCRO (nalmefene) holds approval in the EU and Japan, pioneering as one of the initial drugs to diminish alcohol cravings on an as-needed basis without necessitating abstinence. Furthermore, specific drugs like BACLOCUR (baclofen) in France and Sodium oxybate (SMO) in Italy have received approval in certain countries for the treatment of AUD.
  • Despite the high prevalence and associated adverse effects of AUD, current AUD treatment has limited success in a randomized controlled trial. Further, the considerable heterogeneity of AUD patients makes it especially challenging to design a single drug capable of treating AUD patients as a whole. The need for abstinence and the associated social stigma further impacts the compliance rate of treatment.
  • However, various therapies are being developed such as 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

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.

Alcohol Use Disorder Epidemiology

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.

  • As per DeveInsight analysis, in 2023, 12-month diagnosed prevalent cases of AUD in the 7MM were found to be 25 million cases, which are expected to increase by 2034.
  • The estimates suggest a highest 12-month diagnosed prevalence of AUD in the US with nearly 14 million cases in 2023. Increasing stress, anxiety, and depression, compounded by economic instability, social isolation, and trauma, are likely to boost alcohol consumption as people turn to it for solace, potentially leading to a rise in alcohol use disorder cases.
  • Among the EU4 and the UK, Germany had the highest number of diagnosed prevalent cases of AUD accounting for approximately 2 million cases, with Spain reporting the lowest diagnosed prevalent cases, approximately 1 million. These cases are expected to rise by 2034 primarily due to the heightened focus on research and clinical trials for the disease.
  • According to estimates based on DelveInsight's epidemiology model for AUD, the gender distribution of the disease suggests a male predominance across the 7MM, with approximately 9 million males and 5 million female cases in the US in 2023.
  • In 2023, around 4.5% of Japan's population was diagnosed with AUD. However, these cases are expected to change during the forecast period (2024-2034) with shifts in cultural attitudes towards alcohol consumption, leading to increased alcohol use and misuse in Japan
  • According to estimates based on DelveInsight's epidemiology model for AUD, in 2023, young adults comprised the largest portion, with roughly 370 million cases, followed by young antisocial cases at nearly 242 million. Intermediate familial and functional types each accounted for approximately 219 million cases, while chronic severe cases were the least prevalent in Japan.

Alcohol Use Disorder Drug Chapters

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.

Alcohol Use Disorder Market Outlook

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.

  • In 2023, the total market size of AUD in the 7MM was approximately USD 620 million, out of which the US accounted for approximately USD 475 million.
  • DelveInsight's analysts estimate that the market is expected to show positive growth, with growing awareness about AUD as a serious health condition and reduced stigma surrounding mental health issues may encourage more individuals to seek treatment for their alcohol-related problems during the forecast period (2024-2034).
  • Among the EU4 and the UK, Germany holds the highest market size of around USD 37 million followed by the UK, and France with approximately USD 27 million, and USD 26 million respectively. These numbers are expected to change during the forecast period (2024-2034) driven by the ongoing research and development efforts that may lead to the discovery of more effective medications and therapies for treating AUD, expanding the range of treatment options available to patients.
  • The AUD market size in Japan accounted for nearly 2% of the total 7MM market size in 2023, these numbers are expected to change by 2034.

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

  • The report covers a segment of key events, an executive summary, descriptive overview of AUD, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, 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 market.

Alcohol Use Disorder Report Insights

  • Alcohol Use Disorder Patient Population
  • Alcohol Use Disorder Therapeutic Approaches
  • Alcohol Use Disorder Pipeline Analysis
  • Alcohol Use Disorder Market Size and Trends
  • Existing and Future Market Opportunity

Alcohol Use Disorder Report Key Strengths

  • 11 years Forecast
  • The 7MM Coverage
  • Alcohol Use Disorder Epidemiology Segmentation
  • Key Cross Competition
  • Attribute analysis
  • Alcohol Use Disorder Drugs Uptake
  • Key Alcohol Use Disorder Market Forecast Assumptions

Alcohol Use Disorder Report Assessment

  • Current Alcohol Use Disorder Treatment Practices
  • Alcohol Use Disorder Unmet Needs
  • Alcohol Use Disorder Pipeline Product Profiles
  • Alcohol Use Disorder Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)
  • Alcohol Use Disorder Market Drivers
  • Alcohol Use Disorder Market Barriers

Key Questions Answered In The Alcohol Use Disorder Market Report:

Alcohol Use Disorder Market Insights

  • What was the AUD market share (%) distribution in 2020 and what it would look like in 2034?
  • What was the total market size of AUD by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
  • How will AD04 (ondansetron), and MN-166 (ibudilast) affect the treatment paradigm of AUD?
  • How will VIVITROL (naltrexone) compete with upcoming products?
  • Which drug is going to be the largest contributor by 2034?
  • What are the pricing variations among different geographies for approved and marketed therapies?
  • How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Alcohol Use Disorder Epidemiology Insights

  • What are the disease risks, burdens, and unmet needs of AUD? What will be the growth opportunities across the 7MM concerning the patient population with AUD?
  • What is the historical and forecasted AUD patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
  • Out of the above-mentioned countries, which country would have the highest diagnosed prevalent AUD population during the forecast period (2023-2034)?
  • What factors are factors contributing to the growth of AUD cases?

Current Alcohol Use Disorder Treatment Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for the treatment of AUD? What are the current guidelines for treating AUD in the US and Europe?
  • How many companies are developing therapies for the treatment of AUD?
  • How many emerging therapies are in the mid-stage and late stage of development for treating AUD?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • What is the cost burden of current treatment on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of approved therapies?
  • What is the 7MM historical and forecasted market of AUD?

Reasons to Buy Alcohol Use Disorder Market Report:market

  • 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 in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies for AUD, barriers to accessibility of approved therapy, 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.

Table of Contents

1 Key Insights

2 Report Introduction

3 AUD Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of AUD by Therapies in 2020
  • 3.2. Market Share (%) Distribution of AUD by Therapies in 2034

4 AUD Market: Future Perspective

5 Executive Summary of AUD

6 Key Events

7 Disease Background and Overview

  • 7.1. Introduction to AUD
  • 7.2. Definitions
  • 7.3. Causes and risk factors
  • 7.4. Subtypes of Alcoholics
  • 7.5. Pathophysiology
    • 7.5.1. Neuroimmune Activation in the Pathology of Alcoholism
  • 7.6. Genetics of AUD
  • 7.7. Diagnosis
  • 7.8. Biomarkers
  • 7.9. Treatment and Management
    • 7.9.1. Treatment Guidelines
      • 7.9.1.1. American Psychiatric Association Guidelines
      • 7.9.1.2. NICE Guidelines

8 Epidemiology and Patient Population

  • 8.1. Key Findings
  • 8.2. Methodology of Epidemiology
  • 8.3. Assumptions and Rationale: the 7MM
    • 8.3.1. 12-month Diagnosed Prevalent Cases of AUD
    • 8.3.2. Gender-specific Diagnosed Prevalent Cases of AUD
    • 8.3.3. Type-specific cases of AUD
    • 8.3.4. Treated Cases of AUD
  • 8.4. Total 12-month Diagnosed Prevalent Cases of AUD in the 7MM
  • 8.5. The US
    • 8.5.1. 12-month Diagnosed Prevalent Cases of AUD in the US
    • 8.5.2. Gender-specific Diagnosed Prevalent Cases of AUD in the US
    • 8.5.3. Type-specific Diagnosed Prevalent Cases of AUD in the US
  • 8.6. EU4 and the UK
    • 8.6.1. 12-month Diagnosed Prevalent Cases of AUD in EU4 and the UK
    • 8.6.2. Gender-specific Diagnosed Prevalent Cases of AUD in EU4 and the UK
    • 8.6.3. Type-specific Diagnosed Prevalent Cases of AUD in EU4 and the UK
    • 8.6.4. Germany
      • 8.6.4.1 12-month diagnosed prevalent cases of AUD in Germany
      • 8.6.4.2 Gender-specific Diagnosed Prevalent Cases of AUD in Germany
      • 8.6.4.3 Type-specific Diagnosed Prevalent Cases of AUD in Germany
    • 8.6.5. France
      • 8.6.5.1 12-month diagnosed prevalent cases of AUD in France
      • 8.6.5.2 Gender-specific Diagnosed Prevalent Cases of AUD in France
      • 8.6.5.3 Type-specific Diagnosed Prevalent Cases of AUD in France
    • 8.6.6. Italy
      • 8.6.6.1 12-month diagnosed prevalent cases of AUD in Italy
      • 8.6.6.2 Gender-specific Diagnosed Prevalent Cases of AUD in Italy
      • 8.6.6.3 Type-specific Diagnosed Prevalent Cases of AUD in Italy
    • 8.6.7. Spain
      • 8.6.7.1 12-month diagnosed prevalent cases of AUD in Spain
      • 8.6.7.2 Gender-specific Diagnosed Prevalent Cases of AUD in Spain
      • 8.6.7.3 Type-specific Diagnosed Prevalent Cases of AUD in Spain
    • 8.6.8. The UK
      • 8.6.8.1 12-month diagnosed prevalent cases of AUD in the UK
      • 8.6.8.2 Gender-specific Diagnosed Prevalent Cases of AUD in the UK
      • 8.6.8.3 Type-specific Diagnosed Prevalent Cases of AUD in the UK
  • 8.7. Japan
    • 8.7.1. 12-month Diagnosed Prevalent Cases of AUD in Japan
    • 8.7.2. Gender-specific Diagnosed Prevalent Cases of AUD in Japan
    • 8.7.3. Type-specific Diagnosed Prevalent Cases of AUD in Japan

9 Patient Journey

10 Marketed Drugs

  • 10.1. Key Competitors
  • 10.2. VIVITROL (naltrexone): Alkermes
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestone
    • 10.2.3. Other Development Activities
    • 10.2.4. Clinical Trial Information
    • 10.2.5. Safety and Efficacy
    • 10.2.6. Product Profile
  • 10.3. SELINCRO (nalmefene): Lundbeck/Otsuka Pharmaceuticals
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestone
    • 10.3.3. Other Development Activities
    • 10.3.4. Clinical Trial Information
    • 10.3.5. Safety and Efficacy
    • 10.3.6. Product Profile

To be continued.....

11 Emerging Drugs

  • 11.1. Key Cross Competition
  • 11.2. AD04 (ondansetron): Adial Pharmaceuticals
    • 11.2.1. Product Description
    • 11.2.2. Other Development Activities
    • 11.2.3. Clinical Development
    • 11.2.4. Clinical Trial Information
    • 11.2.5. Safety and Efficacy
    • 11.2.6. Product Profile
    • 11.2.7. Analysts' Views
  • 11.3. MN-166 (ibudilast): MediciNova
    • 11.3.1. Product Description
    • 11.3.2. Other Development Activities
    • 11.3.3. Clinical Development
    • 11.3.4. Clinical Trial Information
    • 11.3.5. Safety and Efficacy
    • 11.3.6. Product Profile
    • 11.3.7. Analysts' Views
  • 11.4. CORT 118335 (Miricorilant) (mifepristone): Corcept Therapeutics
    • 11.4.1. Product Description
    • 11.4.2. Clinical Development
    • 11.4.3. Clinical Trial Information
    • 11.4.4. Safety and Efficacy
    • 11.4.5. Product Profile
    • 11.4.6. Analysts' Views

11 Emerging Drugs

  • 11.1. Key Cross Competition
  • 11.2. AD04 (ondansetron): Adial Pharmaceuticals
    • 11.2.1. Product Description
    • 11.2.2. Other Development Activities
    • 11.2.3. Clinical Development

To be continued.....

12 AUD: Market Analysis

  • 12.1. Key Findings
  • 12.2. Methodology of AUD Market
  • 12.3. Key Market Forecast Assumptions
  • 12.4. Market Outlook
  • 12.5. Conjoint Analysis
  • 12.6. Market Size of AUD in the 7MM
  • 12.7. Market Size of AUD by Therapies in the 7MM
  • 12.8. Market Size of AUD in the US
    • 12.8.1. Total Market Size of AUD
    • 12.8.2. Market Size of AUD by Therapies
  • 12.9. Market Size of AUD in EU4 and the UK
    • 12.9.1. Total Market Size of AUD
    • 12.9.2. Market Size of AUD by Therapies
    • 12.9.3 Germany
      • 12.9.3.1 Total Market Size of AUD
      • 12.9.3.2 Market Size of AUD by Therapies
    • 12.9.4. France
      • 12.9.4.1 Total Market Size of AUD
      • 12.9.4.2 Market Size of AUD by Therapies
    • 12.9.5. Italy
      • 12.9.5.1 Total Market Size of AUD
      • 12.9.5.2 Market Size of AUD by Therapies
    • 12.9.6. Spain
      • 12.9.6.1 Total Market Size of AUD
      • 12.9.6.2 Market Size of AUD by Therapies
    • 12.9.7. The UK
      • 12.9.7.1 Total Market Size of AUD
      • 12.9.7.2 Market Size of AUD by Therapies
  • 12.10. Market Size of AUD in Japan
    • 12.10.1. Total Market Size of AUD
    • 12.10.2. Market Size of AUD by Therapies

13 KOL Views

  • 13.1. The United States
  • 13.2. EU4 and the UK
  • 13.3. Japan

14 SWOT Analysis

15 Unmet Needs

16 Market Access and Reimbursement

  • 16.1 The United States
    • 16.1.1 Center for Medicare & Medicaid Services (CMS)
  • 16.2 EU4 and the UK
    • 16.2.1 Germany
    • 16.2.2 France
    • 16.2.3 Italy
    • 16.2.4 Spain
    • 16.2.5 The United Kingdom
  • 16.3 Japan
    • 16.3.1 MHLW

17 Appendix

  • 17.1. Bibliography
  • 17.2. Acronyms and Abbreviations
  • 17.3. Report Methodology

18 DelveInsight Capabilities

19 Disclaimer

20 About DelveInsight

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