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市場調査レポート
商品コード
1632485
アルコール性肝炎市場 - 市場の洞察、疫学、市場予測:2034年Alcoholic Hepatitis - Market Insight, Epidemiology, and Market Forecast - 2034 |
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アルコール性肝炎市場 - 市場の洞察、疫学、市場予測:2034年 |
出版日: 2025年01月01日
発行: DelveInsight
ページ情報: 英文 200 Pages
納期: 2~10営業日
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2023年、主要7ヶ国のアルコール性肝炎有病者数は約110万人と診断されました。このうち米国が23%、EU4と英国が63%、日本が14%を占めています。アルコール性肝炎市場は着実に成長し、2024年から2034年までのCAGRは6%です。このような主要7ヶ国の拡大は、遺伝的影響や飲酒などのライフスタイル要因別発症率の上昇に加え、ラルスコステロールやINT-787などの革新的な治療薬のイントロダクションが牽引しています。アルコール性肝炎における効果的な薬物療法については、現在FDAが承認した治療法がないため、大きなアンメット・ニーズが存在します。このギャップは、罹患患者の臨床転帰を改善し死亡率を減少させるための革新的な薬剤開発が緊急に必要であることを強調しています。
2022年11月、インターセプトは肝臓学会(The Liver Meeting)において、INT-787の健康成人における良好な安全性および忍容性プロファイルを示すファースト・イン・ヒト試験データを発表しました。
アルコール性肝炎における重大な市場障壁は、疾患の重症度を正確に同定し、層別化する強固な診断ツールがないことです。この限界は早期介入の妨げとなり、臨床試験への患者登録を減少させ、標的治療の開発を妨げ、最終的には治療成績と市場成長の可能性に影響を及ぼします。
アルコール性肝炎は、過度のアルコール摂取に起因する肝臓の炎症を特徴とし、典型的には数十年にわたる1日約8~10杯の大量飲酒歴が特徴的です。患者はしばしば、発熱、食欲不振、体重減少、疲労、全身の脱力感、悪心、嘔吐、進行性の黄疸などの臨床症状を呈します。主な危険因子は、長期にわたるアルコール乱用、男性、高齢、肝臓疾患の併発などです。病因には、アルコールが肝細胞に及ぼす毒性作用が関与しており、酸化ストレス、炎症反応、その後の肝障害を引き起こします。この複雑な要因の相互作用がアルコール性肝炎の病態生理に寄与しており、効果的な予防および管理戦略の必要性を強調しています。
アルコール性肝炎の診断には、病歴、身体所見、検査項目を総合的に評価することが必要です。臨床医は患者の飲酒歴を確認し、飲酒量、種類、最近の摂取量の増加(多くの場合、生活上の重大なストレスと関連している)に注意しなければなりません。身体所見には、肝腫大、黄疸、腹水が含まれます。臨床検査では通常、アスパラギン酸アミノトランスフェラーゼ(AST)とアラニンアミノトランスフェラーゼ(ALT)の比が1.5を超え、血清ビリルビン値が2mg/dLを超えます。γ-グルタミルトランスフェラーゼ(GGT)や平均赤血球容積(MCV)などのマーカーも診断の裏付けとなります。顕著な白血球増加と総コレステロール値の低値(100mg/dL未満)は予後不良を示すことがあります。不確実な症例では、テクネチウム硫黄コロイド肝脾スキャンのような画像診断法を用いて非侵襲的にAHを確認することができます。
当レポートでは、主要7ヶ国におけるアルコール性肝炎市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
The list of tables is not exhaustive; the final content may vary
The list of figures is not exhaustive; the final content may vary
DelveInsight's "Alcoholic Hepatitis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of alcoholic hepatitis, historical and forecasted epidemiology, as well as the alcoholic hepatitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The alcoholic hepatitis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM alcoholic hepatitis market size from 2020 to 2034. The report also covers alcoholic hepatitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Alcoholic Hepatitis overview
Alcoholic hepatitis is characterized by inflammation of the liver resulting from excessive alcohol intake, typically marked by a history of heavy drinking, approximately 8-10 drinks per day over several decades. Patients often present with clinical features such as fever, anorexia, weight loss, fatigue, generalized weakness, nausea, vomiting, and progressive jaundice. Key risk factors include prolonged alcohol abuse, male gender, older age, and the presence of coexisting liver diseases. The etiology involves the toxic effects of alcohol on liver cells, leading to oxidative stress, inflammatory responses, and subsequent liver damage. This complex interplay of factors contributes to the pathophysiology of alcoholic hepatitis, underscoring the need for effective prevention and management strategies.
Alcoholic Hepatitis diagnosis
The diagnosis of alcoholic hepatitis involves a comprehensive evaluation of clinical history, physical examination, and targeted laboratory tests. Clinicians must ascertain the patient's alcohol consumption history, noting the volume, type, and recent increases in intake, often linked to significant life stressors. Physical findings may include hepatomegaly, jaundice, and ascites. Laboratory tests typically reveal an elevated aspartate aminotransferase (AST) to alanine aminotransferase (ALT) ratio greater than 1.5, alongside elevated serum bilirubin levels exceeding 2 mg/dL. Additional markers, such as gamma-glutamyltransferase (GGT) and mean corpuscular volume (MCV), may support the diagnosis. A pronounced leukocytosis and low total cholesterol levels (<100 mg/dL) can indicate a poor prognosis. In uncertain cases, imaging modalities like a technetium sulfur colloid liver-spleen scan may be employed to confirm AH noninvasively, while liver biopsy is rarely indicated unless to clarify discrepancies in alcohol consumption history. Further details related to country-based variations are provided in the report...
Alcoholic Hepatitis treatment
The treatment landscape for alcoholic hepatitis (AH) primarily involves strategies such as complete alcohol abstinence, nutritional support, and pharmacological interventions, including corticosteroids and pentoxifylline, along with liver transplantation for eligible patients. Corticosteroids are regarded as the standard of care for patients with severe AH who do not exhibit signs of concomitant sepsis; however, only approximately 40% of patients qualify for this therapy. The absence of effective pharmaceutical options for the remaining patient population highlights a critical gap in the treatment paradigm. Significant advancements in therapeutic development targeting this unmet need are anticipated to profoundly transform the market landscape during the forecast period, emphasizing the necessity for innovative solutions.
As the market is derived using a patient-based model, the Alcoholic Hepatitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of alcoholic hepatitis, total diagnosed prevalent cases of alcoholic hepatitis, gender-specific diagnosed prevalent cases of alcoholic hepatitis, and severity-specific diagnosed prevalent cases of alcoholic hepatitis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
Emerging Drugs
Larsucosterol: Durect Corporation
Larsucosterol, an endogenous sulfated oxysterol and epigenetic modulator, regulates gene expression by inhibiting DNA methyltransferases (DNMT1, DNMT3a, DNMT3b), addressing epigenetic dysregulation seen in acute conditions like alcoholic hepatitis (AH) and chronic diseases like MASH. In April 2024, DURECT Corporation announced topline results from the Phase IIb AHFIRM trial, demonstrating a compelling efficacy signal with a clinically relevant 90-day mortality reduction of 41% for the 30 mg dose and 35% for the 90 mg dose compared to standard of care. The FDA granted Breakthrough Therapy Designation to larsucosterol for severe AH in May 2024. DURECT plans to present these results at the EASL Congress 2024 and hold an End of Phase 2 (EOP2) meeting with the FDA to discuss the Phase III registration trial design in the first quarter of 2024.
INT-787: Intercept Pharmaceuticals
INT-787, developed by Intercept Pharmaceuticals, is a selective FXR agonist under investigation for severe alcohol-associated hepatitis (sAH). By activating FXR, INT-787 modulates bile acid metabolism and reduces liver inflammation. Alcohol-related liver disease, which is now the leading cause for liver transplant listings in the US, has seen a rise in sAH cases requiring transplantation. In May 2024, Intercept announced that nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease would be presented at the EASL Congress in Milan (June 5-8). Results showed INT-787 was well tolerated in healthy subjects, with most treatment-emergent adverse events being mild and no treatment-limiting or serious adverse events reported.
Drug Class Insights
The treatment of alcoholic hepatitis involves several drug classes aimed at reducing inflammation and liver damage. Corticosteroids, such as prednisolone, are the standard of care for severe AH, reducing inflammation but with limited eligibility due to infection risks. Antioxidants like N-acetylcysteine are used to combat oxidative stress in the liver. Pentoxifylline, a phosphodiesterase inhibitor, helps reduce inflammation and fibrosis, though its efficacy is debated. TNF-alpha inhibitors, such as infliximab, target inflammation pathways but are not widely recommended due to safety concerns. Emerging therapies include epigenetic modulators like Larsucosterol, and FXR agonists such as INT-787, which aim to address underlying liver dysfunction and inflammation.
The treatment landscape for alcoholic hepatitis primarily involves abstinence, nutritional support, corticosteroids, pentoxifylline, and liver transplantation. Despite corticosteroids being the standard of care for severe AH patients without sepsis, only about 40% of patients are eligible for this therapy, leaving significant unmet needs. Emerging therapies like Larsucosterol and INT-787 are poised to address these gaps. Larsucosterol, an endogenous sulfated oxysterol and epigenetic modulator, inhibits DNA methyltransferases, regulating gene expression and addressing epigenetic dysregulation in AH and MASH. INT-787, a selective FXR agonist, modulates bile acid metabolism and reduces liver inflammation in severe alcohol-associated hepatitis (sAH).
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Larsucosterol is expected to enter the US market in 202X and is projected to have a medium uptake during the forecast period.
Alcoholic Hepatitis Pipeline Development Activities
The report provides insights into different therapeutic candidates in 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 Alcoholic Hepatitis.
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 Alcoholic Hepatitis 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 Department of Internal Medicine, Division of Gastroenterology, Virginia Commonwealth University School of Medicine; Department of Internal Medicine, University of Texas Medical Branch, Galveston, United States, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Alcoholic Hepatitis 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
As per the KOLs from the US, Although there is not one specific sign or symptom related to alcoholic hepatitis (AH), a constellation of symptoms and signs can help make the diagnosis of AH with reasonable accuracy. Documentation of chronic and active alcohol abuse is paramount in making a diagnosis of AH. Clinical presentation after abstinence for more than 3 m should raise doubts about the diagnosis of AH and dictate the need for considering other causes of liver disease, decompensation of alcoholic cirrhosis, sepsis, and malignancy as the cause of the patient's clinical profile.
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 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.
Conjoint 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.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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
The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Alcoholic Hepatitis report insights
Alcoholic Hepatitis report key strengths
Alcoholic Hepatitis report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
The table of contents is not exhaustive; the final content may vary.