アルコール性肝疾患 (ARLD)：市場洞察・疫学・市場予測 (～2034年)

主なハイライト

• アルコール性肝疾患 (ARLD) の市場規模は予測期間を通して安定した成長が見込まれています。主要7カ国のARLDの市場規模は、診断の向上とLarsucosterolという新たな治療薬の発売により拡大が見込まれます。
• DelveInsightのアナリストは、主要7カ国におけるARLDの総有病者数のうち、約51％が米国の患者であると予測しています。予測では、2023年に米国で診断されたARLD有病者は420万人近くに上ります。
• 主要7カ国では、市場は主に対症療法で構成され、2023年には約1億500万米ドルを創出しました。
• ARLD治療薬市場は、2020年から2034年までのCAGRが約20%と予測され、堅調な成長が見込まれています。このダイナミックな拡大は、高度な治療オプションに対する需要の増加を反映しており、この深刻な病態に対処するための投資が拡大していることを裏付けています。
• 2024年5月、DURECT Corporationは、重症アルコール関連肝炎 (AH) の治療を目的とした同社の最有力候補薬であるlarsucosterolについて、FDAから画期的治療薬 (Breakthrough Therapy) の指定を受けました。この指定は、アンメットメディカルニーズが高い重症AHの治療を変革するlarsucosterolの大きな可能性を示すものです。この認定により、DURECTはその取り組みを推進し、この治療困難な疾患に対する革新的な解決策を提供するのに有利な立場にあります。
• 2024年7月、DURECTはFDAとのタイプBミーティングを開催し、アルコール関連肝炎を対象としたラルスコステロールの計画第III相臨床試験の設計について話し合いました。当社は、この会議の議事録の受領後、第III相臨床試験デザインに関する追加情報を提供する予定です。DURECTの目標は、十分な資金を得ることを前提に、2024年に第III相試験を開始し、2026年後半までにトップラインの結果を出すことです。

アルコール関連肝疾患レポート：インサイト

• 患者集団
• 治療アプローチ
• パイプライン分析
• 市場規模および動向
• 既存および将来の市場機会

アルコール関連肝疾患レポート：主な強み

• 11カ年の予測
• 主要7カ国カバレッジ
• 疫学セグメンテーション
• キークロスコンペティション
• 属性分析
• 市場予測の主な前提因子

アルコール関連肝疾患レポート：評価

• 現在の治療法
• アンメットニーズ
• パイプライン製品のプロファイル
• 市場の魅力
• 定性分析 (SWOT・コンジョイント分析)

当レポートでは、米国、EU4カ国 (ドイツ、フランス、イタリア、スペイン)、英国、日本のアルコール性肝疾患 (ARLD) の市場を調査し、疾患の背景・概要、疫学、治療と管理の概要、市場促進要因と障壁、アンメットニーズ、上市薬およびパイプライン薬のプロファイル、主要国の市場規模の推移・予測、競合情勢などをまとめ、最良の機会を発掘し、市場の潜在力を評価します。

目次

第1章 重要な洞察

第2章 レポート概要

第3章 アルコール性肝疾患 (ARLD) の市場シェア分布：国別

• ARLD治療薬の市場シェア分布：国別：2020年
• ARLD治療薬の市場シェア分布：国別：2034年

第4章 ARLD：疫学と市場の調査手法

第5章 アルコール性肝疾患 (ARLD)：エグゼクティブサマリー

第6章 重要な出来事

第7章 アルコール性肝疾患 (ARLD)：疾患の背景と概要

• ARLDのステージ
• ARLDの病態生理
• ARLDの発症機序
• ARLDの原因とリスク要因
• ARLDの症状
• 診断
  • 診断アルゴリズム
  • 診断ガイドライン
• ARLD治療
  • 治療アルゴリズム
  • 治療ガイドライン

第8章 ARLD：疫学と患者人口

• 主な調査結果
• 仮定と根拠：主要7カ国
• 主要7カ国におけるARLDの有病者数
• 主要7カ国におけるARLDの診断有病者数
• 米国
• EU4カ国・英国
• 日本
  • ARLDの有病者数
  • ARLDの診断有病者数
  • 有病者数：男女別
  • ARLD診断有病者数の分布：線維化ステージ別
  • ARLD診断有病者数の分布：脂肪肝グレード別
  • ARLD診断有病者数の分布：壊死性炎症アクティビティ別

第9章 ARLD：ペイシェントジャーニー

第10章 ARLD：新興医薬品

• キークロスコンペティション
• Larsucosterol (DUR-928): Durect
  • 製品説明
  • その他の開発活動
  • 臨床試験情報
  • 安全性と有効性
  • 製品プロファイル
  • アナリストの見解
• INT-787: Intercept Pharmaceuticals

第11章 ARLD：市場分析

• 主な調査結果
• 主要な前提条件
• 市場見通し
• 主要7カ国の総市場規模
• 主要7カ国の市場規模：治療法別
• 米国
• EU4カ国・英国
• 日本

第12章 主要オピニオンリーダーの見解

第13章 SWOT分析

第14章 ARLD：アンメットニーズ

第15章 市場アクセスと償還

• 米国
• EU4カ国・英国
• 日本

第16章 付録

第17章 レポートの調査手法

第18章 DelveInsightのサービス内容

第19章 免責事項

List of Tables

• Table 1: Summary of ARLD Epidemiology and Market (2020-2034)
• Table 2: Key Events
• Table 3: Percentage of Population who are Heavy Episodic Drinkers (HED)
• Table 4: Total Prevalent Cases of ARLD in the 7MM (2020-2034)
• Table 5: Total Diagnosed Prevalent Cases of ARLD in the 7MM (2020-2034)
• Table 6: Total Prevalent Cases of ARLD in the US (2020-2034)
• Table 7: Total Diagnosed Prevalent Cases of ARLD in the US (2020-2034)
• Table 8: Gender-specific Diagnosed Prevalent Cases of ARLD in the US (2020-2034)
• Table 9: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in the US (2020-2034)
• Table 10: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in the US (2020-2034)
• Table 11: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in the US (2020-2034)
• Table 12: Total Prevalent Cases of ARLD in Germany (2020-2034)
• Table 13: Total Diagnosed Prevalent Cases of ARLD in Germany (2020-2034)
• Table 14: Gender-specific Diagnosed Prevalent Cases of ARLD in Germany (2020-2034)
• Table 15: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Germany (2020-2034)
• Table 16: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Germany (2020-2034)
• Table 17: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Germany (2020-2034)
• Table 18: Total Prevalent Cases of ARLD in France (2020-2034)
• Table 19: Total Diagnosed Prevalent Cases of ARLD in France (2020-2034)
• Table 20: Gender-specific Diagnosed Prevalent Cases of ARLD in France (2020-2034)
• Table 21: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in France (2020-2034)
• Table 22: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in France (2020-2034)
• Table 23: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in France (2020-2034)
• Table 24: Total Prevalent Cases of ARLD in Italy (2020-2034)
• Table 25: Total Diagnosed Prevalent Cases of ARLD in Italy (2020-2034)
• Table 26: Gender-specific Diagnosed Prevalent Cases of ARLD in Italy (2020-2034)
• Table 27: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Italy (2020-2034)
• Table 28: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Italy (2020-2034)
• Table 29: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Italy (2020-2034)
• Table 30: Total Prevalent Cases of ARLD in Spain (2020-2034)
• Table 31: Total Diagnosed Prevalent Cases of ARLD in Spain (2020-2034)
• Table 32: Gender-specific Diagnosed Prevalent Cases of ARLD in Spain (2020-2034)
• Table 33: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Spain (2020-2034)
• Table 34: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Spain (2020-2034)
• Table 35: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Spain (2020-2034)
• Table 36: Total Prevalent Cases of ARLD in the UK (2020-2034)
• Table 37: Total Diagnosed Prevalent Cases of ARLD in the UK (2020-2034)
• Table 38: Gender-specific Diagnosed Prevalent Cases of ARLD in the UK (2020-2034)
• Table 39: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in the UK (2020-2034)
• Table 40: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in the UK (2020-2034)
• Table 41: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in the UK (2020-2034)
• Table 42: Total Prevalent Cases of ARLD in Japan (2020-2034)
• Table 43: Total Diagnosed Prevalent Cases of ARLD in Japan (2020-2034)
• Table 44: Gender-specific Diagnosed Prevalent Cases of ARLD in Japan (2020-2034)
• Table 45: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Japan (2020-2034)
• Table 46: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Japan (2020-2034)
• Table 47: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Japan (2020-2034)
• Table 48: Comparison of Emerging Drugs Under Development
• Table 49: DUR-928, Clinical Trial Description, 2024
• Table 50: INT-787, Clinical Trial Description, 2024
• Table 51: Cellgram_LC, Clinical Trial Description, 2024
• Table 52: Key Market Forecast Assumptions for Larsucosterol (DUR-928)
• Table 53: Total Market Size of ARLD in the 7MM, in USD million (2020-2034)
• Table 54: Market Size of ARLD by Therapies in the 7MM, in USD million (2020-2034)
• Table 55: Total Market Size of ARLD in the US, in USD million (2020-2034)
• Table 56: Market Size of ARLD by Therapies in the US, in USD million (2020-2034)
• Table 57: Total Market Size of ARLD in Germany, in USD million (2020-2034)
• Table 58: Market Size of ARLD by Therapies in Germany, in USD million (2020-2034)
• Table 59: Total Market Size of ARLD in France, in USD million (2020-2034)
• Table 60: Market Size of ARLD by Therapies in France, in USD million (2020-2034)
• Table 61: Total Market Size of ARLD in Italy, in USD million (2020-2034)
• Table 62: Market Size of ARLD by Therapies in Italy, in USD million (2020-2034)
• Table 63: Total Market Size of ARLD in Spain, in USD million (2020-2034)
• Table 64: Market Size of ARLD by Therapies in Spain, in USD million (2020-2034)
• Table 65: Total Market Size of ARLD in the UK, in USD million (2020-2034)
• Table 66: Market Size of ARLD by Therapies in the UK, in USD million (2020-2034)
• Table 67: Total Market Size of ARLD in EU4 and the UK, in USD million (2020-2034)
• Table 68: Market Size of ARLD by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 69: Total Market Size of ARLD in Japan, in USD million (2020-2034)
• Table 70: Market Size of ARLD by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Spectrum of ARLD
• Figure 2: Stages of ARLD Based on the Amount of Alcohol Consumption
• Figure 3: Schematic Depiction of the role of Kupffer cells (KCs) and Hepatic Stellate Cells (HSCs) in Promoting Alcohol-induced Inflammatory Changes and Progression to Fibrosis and Cirrhosis
• Figure 4: Hepatic Metabolism of Ethanol Associated With Oxidative Stress
• Figure 5: Hepatic Metabolism of Ethanol Associated With Oxidative Stress
• Figure 6: Risk Factors
• Figure 7: Common Symptoms of ARLD
• Figure 8: Algorithm for Diagnosis and Therapeutic Decision of Patients With ARLD
• Figure 9: Diagnostic Algorithm of ARLD
• Figure 10: Grade of Recommendations
• Figure 11: Treatment Approaches for ARLD
• Figure 12: Therapeutic Algorithm for the Long-term Management of ARLD
• Figure 13: Treatment Algorithm of Alcoholic Hepatitis
• Figure 14: Level of Evidence
• Figure 15: Grade of Recommendations
• Figure 16: Total Prevalent Cases of ARLD in the 7MM (2020-2034)
• Figure 17: Total Diagnosed Prevalent Cases of ARLD in the 7MM (2020-2034)
• Figure 18: Total Prevalent Cases of ARLD in the US (2020-2034)
• Figure 19: Total Diagnosed Prevalent Cases of ARLD in the US (2020-2034)
• Figure 20: Gender-specific Diagnosed Prevalent Cases of ARLD in the US (2020-2034)
• Figure 21: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in the US (2020-2034)
• Figure 22: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in the US (2020-2034)
• Figure 23: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in the US (2020-2034)
• Figure 24: Total Prevalent Cases of ARLD in Germany (2020-2034)
• Figure 25: Total Diagnosed Prevalent Cases of ARLD in Germany (2020-2034)
• Figure 26: Gender-specific Diagnosed Prevalent Cases of ARLD in Germany (2020-2034)
• Figure 27: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Germany (2020-2034)
• Figure 28: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Germany (2020-2034)
• Figure 29: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Germany (2020-2034)
• Figure 30: Total Prevalent Cases of ARLD in France (2020-2034)
• Figure 31: Total Diagnosed Prevalent Cases of ARLD in France (2020-2034)
• Figure 32: Gender-specific Diagnosed Prevalent Cases of ARLD in France (2020-2034)
• Figure 33: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in France (2020-2034)
• Figure 34: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in France (2020-2034)
• Figure 35: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in France (2020-2034)
• Figure 36: Total Prevalent Cases of ARLD in Italy (2020-2034)
• Figure 37: Total Diagnosed Prevalent Cases of ARLD in Italy (2020-2034)
• Figure 38: Gender-specific Diagnosed Prevalent Cases of ARLD in Italy (2020-2034)
• Figure 39: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Italy (2020-2034)
• Figure 40: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Italy (2020-2034)
• Figure 41: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Italy (2020-2034)
• Figure 42: Total Prevalent Cases of ARLD in Spain (2020-2034)
• Figure 43: Total Diagnosed Prevalent Cases of ARLD in Spain (2020-2034)
• Figure 44: Gender-specific Diagnosed Prevalent Cases of ARLD in Spain (2020-2034)
• Figure 45: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Spain (2020-2034)
• Figure 46: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Spain (2020-2034)
• Figure 47: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Spain (2020-2034)
• Figure 48: Total Prevalent Cases of ARLD in the UK (2020-2034)
• Figure 49: Total Diagnosed Prevalent Cases of ARLD in the UK (2020-2034)
• Figure 50: Gender-specific Diagnosed Prevalent Cases of ARLD in the UK (2020-2034)
• Figure 51: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in the UK (2020-2034)
• Figure 52: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in the UK (2020-2034)
• Figure 53: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in the UK (2020-2034)
• Figure 54: Total Prevalent Cases of ARLD in Japan (2020-2034)
• Figure 55: Total Diagnosed Prevalent Cases of ARLD in Japan (2020-2034)
• Figure 56: Gender-specific Diagnosed Prevalent Cases of ARLD in Japan (2020-2034)
• Figure 57: Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Japan (2020-2034)
• Figure 58: Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Japan (2020-2034)
• Figure 59: Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Japan (2020-2034)
• Figure 60: Patient Journey
• Figure 61: Total Market Size of ARLD in the 7MM, in USD million (2020-2034)
• Figure 62: Market Size of ARLD by Therapies in the 7MM, in USD million (2020-2034)
• Figure 63: Total Market Size of ARLD in the US, in USD million (2020-2034)
• Figure 64: Market Size of ARLD by Therapies in the US, in USD million (2020-2034)
• Figure 65: Total Market Size of ARLD in Germany, in USD million (2020-2034)
• Figure 66: Market Size of ARLD by Therapies in Germany, in USD million (2020-2034)
• Figure 67: Total Market Size of ARLD in France, in USD million (2020-2034)
• Figure 68: Market Size of ARLD by Therapies in France, in USD million (2020-2034)
• Figure 69: Total Market Size of ARLD in Italy, in USD million (2020-2034)
• Figure 70: Market Size of ARLD by Therapies in Italy, in USD million (2020-2034)
• Figure 71: Total Market Size of ARLD in Spain, in USD million (2020-2034)
• Figure 72: Market Size of ARLD by Therapies in Spain, in USD million (2020-2034)
• Figure 73: Total Market Size of ARLD in the UK, in USD million (2020-2034)
• Figure 74: Market Size of ARLD by Therapies in the UK, in USD million (2020-2034)
• Figure 75: Total Market Size of ARLD in EU4 and the UK, in USD million (2020-2034)
• Figure 76: Market Size of ARLD by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 77: Total Market Size of ARLD in Japan, in USD million (2020-2034)
• Figure 78: Market Size of ARLD by Therapies in Japan, in USD million (2020-2034)
• Figure 79: SWOT Analysis
• Figure 80: Unmet Needs
• Figure 81: Health Technology Assessment
• Figure 82: Reimbursement Process in Germany
• Figure 83: Reimbursement Process in France
• Figure 84: Reimbursement Process in Italy
• Figure 85: Reimbursement Process in Spain
• Figure 86: Reimbursement Process in the United Kingdom
• Figure 87: Reimbursement Process in Japan

Key Highlights:

• The Alcohol-related Liver Disease market size is projected to witness consistent growth throughout the forecast period (2024-2034). The market size of Alcohol-related Liver Disease in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies, namely, Larsucosterol.
• DelveInsight's analyst projects that among the total prevalent cases of ARLD in 7MM approximately 51% of cases were from the US. As per our estimations, in 2023, the US accounted for nearly 4.2 million diagnosed prevalent cases of ARLD.
• In the 7MM, the market mainly consisted of supportive care, which generated nearly USD 105 million in 2023.
• The market for therapeutics targeting Alcohol-related Liver Disease is projected to experience robust growth, with an anticipated CAGR of approximately 20% from 2020 to 2034. This dynamic expansion reflects increasing demand for advanced treatment options and underscores the growing investment in addressing this serious condition.
• In May 2024, DURECT Corporation received Breakthrough Therapy designation from the FDA for larsucosterol, its top candidate aimed at treating severe alcohol-associated hepatitis (AH). This designation highlights the significant potential of larsucosterol to transform the management of severe AH, a condition with significant unmet medical needs. With this prestigious recognition, DURECT is well-positioned to advance its efforts and provide innovative solutions for this difficult-to-treat disease.
• In July 2024, DURECT held a Type B meeting with the FDA to discuss the design of its planned Phase III clinical trial of larsucosterol in alcohol-associated hepatitis that, if successful, could support a potential NDA filing. The Company plans to provide additional details of the Phase III trial design following receipt of the written minutes from this meeting. DURECT's goal is to initiate its Phase III trial in 2024, subject to obtaining sufficient funding, with topline results expected by the second half of 2026.

The market for Alcohol-related Liver Disease (ARLD) is driven by several key factors, including a rising prevalence of alcohol consumption and increasing awareness of liver health. Innovative treatments and growing research investments are also contributing to market expansion. However, challenges such as limited reimbursement options, high treatment costs, and stringent regulatory requirements pose significant barriers. Additionally, the substantial unmet need for effective therapies in managing ARLD highlights a critical gap in current treatment offerings, presenting substantial opportunities for companies to develop novel solutions and meet the demands of a large patient population.

DelveInsight's "Alcohol-related Liver Disease (ARLD) Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the ARLD, historical and forecasted epidemiology and the Alcohol-related Liver Disease therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Alcohol-related Liver Disease market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Alcohol-related Liver Disease market size from 2020 to 2034. The report also covers current Alcohol-related Liver Disease treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Alcohol-related Liver Disease Treatment Market

Alcohol-related Liver Disease Overview

ARLD is a medical condition encompassing liver manifestations arising from excess alcohol intake. Alcoholic liver disease covers a spectrum of disorders, beginning from the fatty liver, progressing at times to alcoholic hepatitis, and culminating in alcoholic cirrhosis, which is the most advanced and irreversible form of liver injury related to the consumption of alcohol. The amount of alcohol intake is the most important cause and risk factor for developing ARLD. Other disease modifiers that influence the development and progression of ARLD include alcohol-related factors (i.e., pattern of drinking, predominant type of alcoholic beverage consumed), environmental factors (presence of undernutrition/obesity, co-existence of chronic hepatitis B or C, and cigarette smoking), and genetic/epigenetic factors.

Symptoms of ARLD are not evident during the early phase and arise after the liver is badly damaged. Some common symptoms include feeling sick, weight loss, loss of appetite, yellowing of the whites of the eyes or skin (jaundice), swelling in the ankles and tummy, confusion or drowsiness, vomiting blood or passing blood in stools, and others.

ARLD Diagnosis

Diagnosing alcohol-related liver disease requires a detailed patient history with supportive laboratory and imaging studies. There is no specific test for alcohol-related liver disease, but if the diagnosis is suspected, liver tests (prothrombin time [PT]; serum bilirubin, aminotransferase, and albumin levels) and CBC are done to detect signs of liver injury and anemia. Imaging tests of the liver are not routinely needed for diagnosis. Because features of hepatic steatosis, alcoholic hepatitis, and cirrhosis overlap, describing the precise findings is more useful than assigning patients to a specific category, which can only be determined by liver biopsy.

ARLD Treatment

Management of ARLD includes abstinence, nutrition/diet modifications, pharmacotherapy, and liver transplantation. Abstinence is the hallmark of therapy for ARLD, and nutritional therapy is the first line of therapeutic intervention. The role of steroids in patients with moderate to severe alcoholic hepatitis is gaining acceptance. Despite abstinence, liver transplantation for alcohol-associated cirrhosis is considered for all patients with decompensated liver disease (ascites, spontaneous bacterial peritonitis, variceal bleeding, and hepatic encephalopathy).

Emerging treatments for ALD are currently in the process of development. These encompass farnesoid X receptor (FXR) agonists, interleukin 1 beta inhibitors, DNA methylation inhibitors, and other options.

Alcohol-related Liver Disease Epidemiology

As the market is derived using the patient-based model, the Alcohol-related Liver Disease epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Alcohol-related Liver Disease (ARLD), Total Diagnosed Prevalent Cases of Alcohol-related Liver Disease (ARLD), Gender-specific Diagnosed Prevalent cases of Alcohol-related Liver Disease (ARLD), Distribution of Diagnosed Prevalent cases of Alcohol-related Liver Disease (ARLD) by Fibrosis Stage, Distribution of Diagnosed Prevalent cases of Alcohol-related Liver Disease (ARLD) by Fatty Liver Grade, Distribution of Diagnosed Prevalent cases of Alcohol-related Liver Disease (ARLD) by Necroinflammatory activity 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 DelveInsight's estimations, the total prevalent cases of Alcohol-related Liver Disease in the 7MM was approximately 41 million cases in 2023 and are projected to decrease during the forecast period.

• The total diagnosed prevalent cases of Alcohol-related Liver Disease in the 7MM was approximately 8.2 million cases in 2023 and are projected to decline during the forecast period
• Among the 7MM, EU4 and the UK accounted for nearly 2.3 million diagnosed prevalent cases of ARLD, and these cases are expected to decrease during the forecast period (2024-2034).
• Among EU4 and the UK, Germany had the highest diagnosed prevalent population of ARLD, with ~0.9 million cases, followed by the UK and France in 2023. On the other hand, Italy had the lowest diagnosed prevalent population in EU4 and the UK in 2023.
• In Japan, there were around 1.7 million diagnosed prevalent cases of ARLD in 2023. These cases are expected to decrease at a significant CAGR.
• Gender-specific diagnosed prevalent cases of ARLD showed that males were more affected by ARLD than females in the 7MM in 2023.
• F3 stage had the highest number of diagnosed prevalent cases (~2 million) followed by the F0 Stage (~1.9 million) in the 7MM.
• Among the diagnosed ARLD cases classified from Grade 0 to Grade 3 based on fatty liver involvement, guiding treatment choices accordingly, Grade 1 had the highest number of diagnosed prevalent cases (~2.8 million) of ARLD in the 7MM followed by Grade 2 (~2.1 million), Grade 0 (~2 million), and Grade 3 (~1.3 million) in 2023.
• Based on the Necroinflammatory activity, cases were divided into two subtypes, Non-alcoholic hepatitis and Alcoholic hepatitis. Nearly 6 million cases for individuals without alcoholic hepatitis and ~2.3 million cases for those with alcoholic hepatitis were reported in 2023, in the 7MM.

Alcohol-related Liver Disease Drug Chapters

The drug chapter segment of the Alcohol-related Liver Disease report encloses a detailed analysis of Alcohol-related Liver Disease marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands Alcohol-related Liver Disease 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.

ARLD Emerging Drugs

Larsucosterol: Durect

Larsucosterol, or "DUR-928" by Durect is an innovative compound currently in clinical development and serves as the central focus of the company's Epigenetic Regulator Program. This orally bioavailable, naturally occurring small molecule has shown substantial regulatory capabilities in lipid metabolism, stress response, inflammation, and cell survival through laboratory and animal investigations. The ongoing research is dedicated to unlocking larsucosterol's potential as a therapeutic option for alcohol-associated hepatitis (AH), a critical and life-threatening liver ailment for which no approved treatments currently exist. Currently, the drug is in Phase II of clinical development as per the company's pipeline.

Data from the Company's Phase IIb AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH, were featured in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 in June 2024, in Milan, Italy. This was the first presentation of the AHFIRM data at a medical meeting. Top line data from the study were previously announced in 2023.

INT-787: Intercept Pharmaceuticals

INT-787 is Intercept's next-generation farnesoid X receptor (FXR) agonist; 16-fold more water soluble than OCA2. Its characteristics provide an opportunity to explore its potential in diseases involving the gut and the liver, such as severe alcohol-associated hepatitis (sAH). INT-787 is currently being evaluated in a Phase IIa proof-of-concept study.

Alcohol-related Liver Disease Market Outlook

Alcohol-related Liver Disease has a diverse treatment classification associated with the disease landscape. ARLD treatment aims to mitigate symptoms through abstinence, diet modifications, pharmacological interventions, (TIPS) procedures, and liver transplantation as needed.

Supportive care options (corticosteroids or pentoxifylline) are major revenue generators in the current treatment landscape.

The market for Alcohol-related Liver Disease is expected to experience positive growth with the approval of potential drugs like Larsucosterol.

• Out of the 7MM, the United States dominated the market in 2023, representing the largest share at 61%.
• In 2023, EU4 and the UK captured an estimated USD 23 million, which is anticipated to increase at a substantial CAGR. Among the European countries, Germany covered the largest market share in 2023, followed by the UK, and France. Spain and Italy accounted for the least market in the same year.
• Japan alone represented approximately 17% of the total ARLD market in 2023, projected to increase at a CAGR during the study period.
• The total market size of the ARLD treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments.

Alcohol-related Liver Disease Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Larsucosterol in the US is expected to be launched by 2025.

Alcohol-related Liver Disease Pipeline Development Activities

The report provides insights into ARLD clinica trials within Phase III, Phase II, and Phase I stage. 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 Alcohol-related Liver Disease emerging therapies.

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 the secondary research. Industry Experts were contacted for insights on Alcohol-related Liver Disease evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore; Die Medizinische Klinik I, University of Frankfurt, Frankfurt am Main, Germany; Hepatology and Gastroenterology, ASST Grande Ospedale Metropolitano Niguarda, Milan Italy; Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan, and others.

Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Alcohol-related Liver Disease market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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 approved and 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.

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

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 further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the ARLD Therpeutics Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of Alcohol-related Liver Disease (ARLD), 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 and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Alcohol-related Liver Disease (ARLD) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 Alcohol-related Liver Disease (ARLD) market.

Alcohol-related Liver Disease Report Insights

• Patient Population
• Therapeutic Approaches
• Alcohol-related Liver Disease Pipeline Analysis
• Alcohol-related Liver Disease Market Size and Trends
• Existing and Future Market Opportunity

Alcohol-related Liver Disease Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Alcohol-related Liver Disease Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Alcohol-related Liver Disease Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered In The ARLD ARLD Market Report:

ARLD Market Insights

• What was the Alcohol-related Liver Disease (ARLD) total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Alcohol-related Liver Disease (ARLD)?
• What are the patents of emerging therapies for ARLD?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Alcohol-related Liver Disease (ARLD)? What will be the growth opportunities across the 7MM concerning the patient population of Alcohol-related Liver Disease (ARLD)?
• What is the historical and forecasted Alcohol-related Liver Disease (ARLD) patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which country is more prevalent for Alcohol-related Liver Disease (ARLD) and why?
• What factors are affecting the diagnosis of the indication?

Current ARLD Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Alcohol-related Liver Disease (ARLD)? What are the current guidelines for treating Alcohol-related Liver Disease (ARLD) in the US and Europe?
• How many companies are developing therapies for treating Alcohol-related Liver Disease (ARLD)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Alcohol-related Liver Disease (ARLD)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Alcohol-related Liver Disease (ARLD)?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Alcohol-related Liver Disease (ARLD)?

Reasons to Buy ARLD Market Forecast Report

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Alcohol-related Liver Disease (ARLD) 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.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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. Alcohol-related Liver Disease (ARLD) Market Share Distribution by Country

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

4. Methodology of ARLD Epidemiology and Market

5. Executive Summary of Alcohol-related Liver Disease (ARLD)

6. Key Events

7. Disease Background and Overview: Alcohol-related Liver Disease (ARLD)

• 7.1. Introduction
• 7.2. Stages of ARLD
• 7.3. Pathophysiology of ARLD
• 7.4. Pathogenesis of ARLD
• 7.5. Causes and Risk Factors of ARLD
• 7.6. Symptoms of ARLD
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
    • 7.7.2.1. EASL Clinical Practice Guidelines: Management of Alcohol-related Liver Disease
• 7.8. ARLD Treatment
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines
    • 7.8.2.1. AASLD Guidelines: Diagnosis and Treatment of Alcohol-associated Liver Disease
    • 7.8.2.2. EASL Clinical Practice Guidelines: Management of Alcohol-related Liver Disease
    • 7.8.2.3. Italian Society on Alcohol (SIA): Management of End-stage alcohol-related Liver Disease and Severe Acute Alcohol-related Hepatitis
    • 7.8.2.4. ACG Clinical Guideline: Alcoholic Liver Disease

8. ARLD Epidemiology and Patient Population

• 8.1. Key Finding
• 8.2. Assumption and Rationale: 7MM
  • 8.2.1. Prevalent Cases of ARLD
  • 8.2.2. Diagnosed Prevalent Cases of ARLD
  • 8.2.3. Gender-specific Diagnosed Prevalent Cases of ARLD
  • 8.2.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage
  • 8.2.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade
  • 8.2.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity
• 8.3. Total Prevalent Cases of ARLD in the 7MM
• 8.4. Total Diagnosed Prevalent Cases of ARLD in the 7MM
• 8.5. The United States
  • 8.5.1. Total Prevalent Cases of ARLD in the US
  • 8.5.2. Total Diagnosed Prevalent Cases of ARLD in the US
  • 8.5.3. Gender-specific Diagnosed Prevalent Cases of ARLD in the US
  • 8.5.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in the US
  • 8.5.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in the US
  • 8.5.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in the US
• 8.6. EU4 and the UK
  • 8.6.1. Germany
    • 8.6.1.1. Total Prevalent cases of ARLD in Germany
    • 8.6.1.2. Total Diagnosed Prevalent Cases of ARLD in Germany
    • 8.6.1.3. Gender-specific Diagnosed Prevalent Cases of ARLD in Germany
    • 8.6.1.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Germany
    • 8.6.1.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Germany
    • 8.6.1.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Germany
  • 8.6.2. France
    • 8.6.2.1. Total Prevalent cases of ARLD in France
    • 8.6.2.2. Total Diagnosed Prevalent Cases of ARLD in France
    • 8.6.2.3. Gender-specific Diagnosed Prevalent Cases of ARLD in France
    • 8.6.2.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in France
    • 8.6.2.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in France
    • 8.6.2.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in France
  • 8.6.3. Italy
    • 8.6.3.1. Total Prevalent cases of ARLD in Italy
    • 8.6.3.2. Total Diagnosed Prevalent Cases of ARLD in Italy
    • 8.6.3.3. Gender-specific Diagnosed Prevalent Cases of ARLD in Italy
    • 8.6.3.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Italy
    • 8.6.3.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Italy
    • 8.6.3.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Italy
  • 8.6.4. Spain
    • 8.6.4.1. Total Prevalent cases of ARLD in Spain
    • 8.6.4.2. Total Diagnosed Prevalent Cases of ARLD in Spain
    • 8.6.4.3. Gender-specific Diagnosed Prevalent Cases of ARLD in Spain
    • 8.6.4.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Spain
    • 8.6.4.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Spain
    • 8.6.4.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Spain
  • 8.6.5. The UK
    • 8.6.5.1. Total Prevalent cases of ARLD in The UK
    • 8.6.5.2. Total Diagnosed Prevalent Cases of ARLD in The UK
    • 8.6.5.3. Gender-specific Diagnosed Prevalent Cases of ARLD in The UK
    • 8.6.5.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in The UK
    • 8.6.5.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in The UK
    • 8.6.5.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in The UK
• 8.7. Japan
  • 8.7.1. Total Prevalent cases of ARLD in Japan
  • 8.7.2. Total Diagnosed Prevalent Cases of ARLD in Japan
  • 8.7.3. Gender-specific Diagnosed Prevalent Cases of ARLD in Japan
  • 8.7.4. Distribution of Diagnosed Prevalent Cases of ARLD by Fibrosis Stage in Japan
  • 8.7.5. Distribution of Diagnosed Prevalent Cases of ARLD by Fatty Liver Grade in Japan
  • 8.7.6. Distribution of Diagnosed Prevalent Cases of ARLD by Necroinflammatory Activity in Japan

9. ARLD Patient Journey

10. ARLD Emerging Drug

• 10.1. Key Cross Competition
• 10.2. Larsucosterol (DUR-928): Durect
  • 10.2.1. Product Description
  • 10.2.2. Other Developmental Activities
  • 10.2.3. Clinical Trials Information
  • 10.2.4. Safety and Efficacy
  • 10.2.5. Product Profile
  • 10.2.6. Analysts' Views
• 10.3. INT-787: Intercept Pharmaceuticals
  • 10.3.1. Product Description
  • 10.3.2. Other Developmental Activities
  • 10.3.3. Clinical Trials Information
  • 10.3.4. Product Profile
  • 10.3.5. Analysts' Views

11. ARLD: Market Analysis

• 11.1. Key Findings
• 11.2. Key Market Forecast Assumptions
• 11.3. Market Outlook
• 11.4. Total Market Size of ARLD in the 7MM
• 11.5. Market Size of ARLD by Therapies in the 7MM
• 11.6. Market Size of ARLD in the United States
  • 11.6.1. Total Market Size of ARLD
  • 11.6.2. Market Size of ARLD by Therapies in the United States
• 11.7. Market Size of ARLD in EU4 and the UK
  • 11.7.1. Market Size of ARLD in Germany
    • 11.7.1.1. Total Market Size of ARLD
    • 11.7.1.2. Market Size of ARLD by Therapies in Germany
  • 11.7.2. Market Size of ARLD in France
    • 11.7.2.1. Total Market Size of ARLD
    • 11.7.2.2. Market Size of ARLD by Therapies in France
  • 11.7.3. Market Size of ARLD in Italy
    • 11.7.3.1. Total Market Size of ARLD
    • 11.7.3.2. Market Size of ARLD by Therapies in Italy
  • 11.7.4. Market Size of ARLD in Spain
    • 11.7.4.1. Total Market Size of ARLD
    • 11.7.4.2. Market Size of ARLD by Therapies in Spain
  • 11.7.5. Market Size of ARLD in the UK
    • 11.7.5.1. Total Market Size of ARLD
    • 11.7.5.2. Market Size of ARLD by Therapies in the UK
• 11.8. Market Size of ARLD in Japan
  • 11.8.1. Total Market Size of ARLD
  • 11.8.2. Market Size of ARLD by Therapies in Japan

12. Key Opinion Leaders' Views

13. SWOT Analysis

14. ARLD Unmet Needs

15. Market Access and Reimbursement

• 15.1. The United States
  • 15.1.1. Centre for Medicare and Medicaid Services (CMS)
• 15.2. In EU4 and the UK
  • 15.2.1. Germany
  • 15.2.2. France
  • 15.2.3. Italy
  • 15.2.4. Spain
  • 15.2.5. The United Kingdom
• 15.3. Japan
  • 15.3.1. MHLW

16. Appendix

• 16.1. Bibliography
• 16.2. Acronyms and Abbreviations

17. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer