非酒精性脂肪性肝炎治疗市场－全球产业规模、份额、趋势、机会、预测：按药物类型、最终用户、地区和竞争格局划分，2021-2031年

全球非酒精性脂肪性肝炎治疗市场预计将大幅成长，从 2025 年的 23.9 亿美元成长到 2031 年的 88.4 亿美元，复合年增长率为 24.36%。

该市场涉及旨在减轻代谢紊乱引起的肝臟发炎和纤维化的药物干预措施，其主要驱动因素是全球肥胖和第2型糖尿病盛行率的上升，而这些疾病需要临床治疗以预防肝硬化。此外，近期标靶治疗的监管核准证实了该领域的商业性可行性，并推动了投资。肝臟基金会估计，到2025年，美国将有900万至1500万成年人受到代谢紊乱相关性脂肪性肝炎的影响。

然而，快速的市场扩张受到诊断复杂性的限制，难以准确识别合格的患者，尤其是目前仍将侵入性肝臟切片检查作为确诊进行性纤维化的黄金标准。这项要求严重阻碍了筛检和治疗的广泛发展，使患者预后复杂化，并限制了诊断率。因此，对侵入性操作的依赖限制了新兴治疗方法的潜在收入来源，并减缓了新治疗方法的整体商业性化。

市场驱动因素

推动全球非酒精性脂肪性肝炎 (NAF) 治疗市场扩张的主要因素是肥胖和代谢併发症的日益普遍。这是因为代谢功能障碍会导致肝臟脂肪堆积和发炎。体重指数 (BMI) 和肝病同时上升，导致需要药物治疗的患者群体迅速扩大，随着全球生活方式相关风​​险因素的恶化，对有效治疗方法的需求预计将持续增长。世界卫生组织 (WHO) 在《2024 年世界肥胖日》报告中强调了这一紧迫性，该报告指出，截至 2022 年，全球有超过 10 亿人肥胖，凸显了针对肝纤维化代谢根本原因的治疗方法的必要性。

同时，强大的后期临床开发平臺和一系列历史性的监管核准推动了市场发展，这些都展现了该领域的商业性潜力，加速了从支持性治疗到标靶疾病修正治疗的转变。一系列监管核准刺激了进一步的投资；例如，2024年3月，Madrigal Pharmaceuticals宣布其首个核准疗法Lezdifra的批发价格定为每年47,400美元，从而建立了一个明确的收入模式。临床创新也十分活跃，勃林格殷格翰于2024年2月宣布，在II期临床试验中，接受sulfodutide治疗的患者中高达83%的病情得到了显着改善。

市场挑战

全球非酒精性脂肪性肝炎治疗市场成长的主要障碍在于诊断过程的复杂性，而这种复杂性又依赖侵入性肝臟切片检查。这些手术耗费资源且风险较高，阻碍了广泛的人群筛检，延误了纤维化的临床确诊，并在患者识别过程中造成了严重的瓶颈。这种对侵入性「黄金标准」的依赖，使得无法及时识别那些明显需要药物治疗的患者，人为地低估了符合处方治疗条件的患者人数，使其与实际疾病患病率不符。

这种持续存在的缺口显着限制了已通过核准治疗方法的获利能力，因为如果没有检验的患者群体，市场就无法扩张。根据全球河流研究所（Global River Institute）预测，截至2024年，全球约95%的代谢紊乱相关性脂肪性肝炎（MASH）患者仍未被确诊。如此低的诊断率直接阻碍了商业性化应用，因为当绝大多数目标族群未被临床确诊时，製药公司就无法有效地实现治疗产品的获利。

市场趋势

GLP-1受体促效剂的问世标誌着市场的一个变革性转折点，将治疗重点从以肝臟为中心的标靶治疗转向全身代谢调节。这种方法利用肠泌素类似药物来解决潜在的代谢因素，例如胰岛素阻抗和脂毒性，并在后期临床试验中展现出显着疗效，确立了这些药物作为未来治疗模式的基础。例如，2024年11月，诺和诺德公司报告称，在其III期ESSENCE试验中，接受2.4 mgSemaglutide肽治疗的成年患者中有62.9%实现了脂肪性肝炎的缓解，且未出现纤维化加重，与安慰剂组的34.1%相比，差异显着。

同时，非侵入性诊断生物标记的引入正在重塑临床开发和患者分层，减少了对组织学检验的依赖。製药开发商正在利用影像学和循环标记来加强替代终点的验证，以简化受试者招募流程并监测治疗检验，同时避免与切片检查相关的操作风险。 Akero Therapeutics公司在2024年11月发布的一项研究结果印证了这一趋势。研究发现，在接受50毫克依非韦伦治疗的患者中，超过40%的患者在包括FibroScan和ELF评分在内的三个独立指标上显示出肝纤维化的消退，而安慰剂组的比例为0%。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：非酒精性脂肪性肝炎治疗的全球市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 药物类型（维生素E和PIOGLITAZONE、奥贝胆酸（OCA）、雷尼菲拉诺、Semaglutide肽、瑞美替洛、Aramchol、塞尼克利维罗克等）
  • 依最终用户（医院药局、零售药局/专科药局、其他）划分
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美非酒精性脂肪性肝炎治疗市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国别分析
  • 我们
  • 加拿大
  • 墨西哥

第七章：欧洲非酒精性脂肪性肝炎治疗市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国别分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区非酒精性脂肪性肝炎治疗市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国别分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲非酒精性脂肪性肝炎治疗市场展望

• 市场规模及预测
• 市占率及预测
• 中东与非洲：国别分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲非酒精性脂肪性肝炎治疗市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国别分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 促进因素
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 近期趋势

第十三章：全球非酒精性脂肪性肝炎治疗市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的议价能力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Intercept Pharmaceuticals Inc.
• Galmed Research & Development Ltd.
• INVENTIVA SA
• AbbVie Inc.
• Galectin Therapeutics Inc.
• Madrigal Pharmaceuticals Inc.
• NGM Biopharmaceuticals Inc.
• Novo Nordisk A/S
• Bristol Myers Squibb
• Gilead Sciences Inc.

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Non-Alcoholic Steatohepatitis Treatment Market is projected to experience substantial growth, expanding from USD 2.39 Billion in 2025 to USD 8.84 Billion by 2031 at a CAGR of 24.36%. This market involves pharmaceutical interventions aimed at mitigating liver inflammation and fibrosis caused by metabolic dysfunction, driven largely by the rising global prevalence of obesity and type 2 diabetes which necessitates clinical management to prevent cirrhosis. Furthermore, the sector's commercial viability has been confirmed by recent regulatory approvals of targeted therapeutics, stimulating investment; the American Liver Foundation estimated that metabolic dysfunction-associated steatohepatitis would affect between nine and 15 million adults in the United States in 2025.

However, rapid market expansion is hindered by the diagnostic complexity involved in accurately identifying eligible patients, specifically the continued reliance on invasive liver biopsies as the gold standard for confirming advanced fibrosis. This requirement creates a significant barrier to widespread screening and treatment adoption, complicating the patient journey and limiting diagnosis rates. Consequently, the dependence on invasive procedures restricts the accessible revenue base for emerging therapies and slows the overall commercial uptake of new treatments.

Market Driver

The primary catalyst expanding the Global Non-Alcoholic Steatohepatitis Treatment Market is the escalating prevalence of obesity and metabolic comorbidities, as metabolic dysfunction leads to liver fat accumulation and inflammation. The synchronization between rising body mass index and liver disease creates a rapidly growing patient pool that requires pharmacological intervention, ensuring sustained demand for effective therapeutics as lifestyle-related risk factors intensify globally. This urgency is highlighted by the World Health Organization's 'World Obesity Day 2024' release, which noted that over one billion people worldwide were living with obesity in 2022, underscoring the need for treatments targeting the metabolic roots of liver fibrosis.

Simultaneously, the market is propelled by a robust late-stage clinical pipeline and historic regulatory approvals that have validated the sector's commercial potential, accelerating the transition from supportive care to targeted disease-modifying therapies. Successful regulatory outcomes have encouraged further investment; for instance, Madrigal Pharmaceuticals reported in March 2024 that the wholesale acquisition cost for Rezdiffra, the first approved treatment, was set at USD 47,400 annually, establishing a tangible revenue model. Clinical innovation remains active, as evidenced by Boehringer Ingelheim's February 2024 statement that up to 83 percent of patients treated with survodutide achieved significant disease improvement in Phase II trials.

Market Challenge

A substantial obstacle to the growth of the Global Non-Alcoholic Steatohepatitis Treatment Market is the diagnostic complexity associated with the reliance on invasive liver biopsies. Because these procedures are resource-intensive and carry risks, they deter widespread population screening and delay the clinical confirmation of fibrosis, creating a severe bottleneck in the patient identification process. This reliance on an invasive gold standard prevents the timely categorization of individuals who explicitly require pharmaceutical intervention, keeping the volume of patients eligible for prescription therapies artificially low relative to actual disease prevalence.

This persistent gap significantly restricts the revenue potential for approved treatments, as the market cannot expand without a validated patient base. According to the Global Liver Institute, approximately 95 percent of individuals affected by metabolic dysfunction-associated steatohepatitis remained undiagnosed globally in 2024. This extremely low diagnosis rate directly hampers commercial uptake, as pharmaceutical companies are unable to effectively monetize their therapeutic products when the vast majority of the target demographic has not been clinically identified to receive treatment.

Market Trends

The integration of GLP-1 receptor agonists represents a transformative shift in the market, moving the therapeutic focus from exclusively liver-centric targets to systemic metabolic regulation. By leveraging incretin mimetics to address underlying metabolic drivers such as insulin resistance and lipotoxicity, this approach has demonstrated robust efficacy in late-stage clinical evaluations, establishing these agents as cornerstones of future treatment paradigms. For example, Novo Nordisk reported in November 2024 that 62.9 percent of adults treated with semaglutide 2.4 mg in the Phase 3 ESSENCE trial achieved resolution of steatohepatitis without worsening fibrosis, compared to only 34.1 percent of those receiving a placebo.

Simultaneously, the adoption of non-invasive diagnostic biomarkers is reshaping clinical development and patient stratification by reducing reliance on histological verification. Pharmaceutical developers are increasingly validating surrogate endpoints using imaging and circulating markers to streamline trial recruitment and monitor therapeutic response without the procedural risks of biopsies. This trend is illustrated by Akero Therapeutics' November 2024 announcement, which stated that over 40 percent of participants treated with efruxifermin 50mg showed regression of liver fibrosis across three orthogonal measures, including FibroScan and the ELF score, compared to zero percent for the placebo group.

Key Market Players

• Intercept Pharmaceuticals Inc.
• Galmed Research & Development Ltd.
• INVENTIVA S.A.
• AbbVie Inc.
• Galectin Therapeutics Inc.
• Madrigal Pharmaceuticals Inc.
• NGM Biopharmaceuticals Inc.
• Novo Nordisk A/S
• Bristol Myers Squibb
• Gilead Sciences Inc.

Report Scope

In this report, the Global Non-Alcoholic Steatohepatitis Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Non-Alcoholic Steatohepatitis Treatment Market, By Drug Type

• Vitamin E and Pioglitazone
• Obeticholic Acid (OCA)
• Lanifibranor
• Semaglutide
• Resmetirom
• Aramchol
• Cenicriviroc
• Others

Non-Alcoholic Steatohepatitis Treatment Market, By End-User

• Hospital Pharmacies
• Retail and Specialty Pharmacies
• Others

Non-Alcoholic Steatohepatitis Treatment Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-Alcoholic Steatohepatitis Treatment Market.

Available Customizations:

Global Non-Alcoholic Steatohepatitis Treatment Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Drug Type (Vitamin E and Pioglitazone, Obeticholic Acid (OCA), Lanifibranor, Semaglutide, Resmetirom, Aramchol, Cenicriviroc, Others)
  • 5.2.2. By End-User (Hospital Pharmacies, Retail and Specialty Pharmacies, Others)
  • 5.2.3. By Region
  • 5.2.4. By Company (2025)
• 5.3. Market Map

6. North America Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Drug Type
  • 6.2.2. By End-User
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Drug Type
      • 6.3.1.2.2. By End-User
  • 6.3.2. Canada Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Drug Type
      • 6.3.2.2.2. By End-User
  • 6.3.3. Mexico Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Drug Type
      • 6.3.3.2.2. By End-User

7. Europe Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Drug Type
  • 7.2.2. By End-User
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Drug Type
      • 7.3.1.2.2. By End-User
  • 7.3.2. France Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Drug Type
      • 7.3.2.2.2. By End-User
  • 7.3.3. United Kingdom Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Drug Type
      • 7.3.3.2.2. By End-User
  • 7.3.4. Italy Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Drug Type
      • 7.3.4.2.2. By End-User
  • 7.3.5. Spain Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Drug Type
      • 7.3.5.2.2. By End-User

8. Asia Pacific Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Drug Type
  • 8.2.2. By End-User
  • 8.2.3. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Drug Type
      • 8.3.1.2.2. By End-User
  • 8.3.2. India Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Drug Type
      • 8.3.2.2.2. By End-User
  • 8.3.3. Japan Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Drug Type
      • 8.3.3.2.2. By End-User
  • 8.3.4. South Korea Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Drug Type
      • 8.3.4.2.2. By End-User
  • 8.3.5. Australia Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Drug Type
      • 8.3.5.2.2. By End-User

9. Middle East & Africa Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Drug Type
  • 9.2.2. By End-User
  • 9.2.3. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Drug Type
      • 9.3.1.2.2. By End-User
  • 9.3.2. UAE Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Drug Type
      • 9.3.2.2.2. By End-User
  • 9.3.3. South Africa Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Drug Type
      • 9.3.3.2.2. By End-User

10. South America Non-Alcoholic Steatohepatitis Treatment Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Drug Type
  • 10.2.2. By End-User
  • 10.2.3. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Drug Type
      • 10.3.1.2.2. By End-User
  • 10.3.2. Colombia Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Drug Type
      • 10.3.2.2.2. By End-User
  • 10.3.3. Argentina Non-Alcoholic Steatohepatitis Treatment Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Drug Type
      • 10.3.3.2.2. By End-User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Non-Alcoholic Steatohepatitis Treatment Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Intercept Pharmaceuticals Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Galmed Research & Development Ltd.
• 15.3. INVENTIVA S.A.
• 15.4. AbbVie Inc.
• 15.5. Galectin Therapeutics Inc.
• 15.6. Madrigal Pharmaceuticals Inc.
• 15.7. NGM Biopharmaceuticals Inc.
• 15.8. Novo Nordisk A/S
• 15.9. Bristol Myers Squibb
• 15.10. Gilead Sciences Inc.

16. Strategic Recommendations

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