非酒精性脂肪性肝炎生物标记市场－全球产业规模、份额、趋势、机会和预测（按类型、最终用户、地区和竞争细分，2020-2030 年）

2024 年全球非酒精性脂肪性肝炎 (NASH) 生物标记市场价值为 18.1 亿美元，预计到 2030 年将达到 62.7 亿美元，复合年增长率为 22.97%。全球代谢紊乱（包括肥胖、胰岛素抗性和第 2 型糖尿病）的盛行率不断上升，持续加速对 NASH 非侵入性可靠诊断工具的需求。随着许多患者的非酒精性脂肪肝病 (NAFLD) 发展为 NASH，肝臟活检的局限性（例如侵入性和取样变异性）引发了人们对基于生物标誌物的诊断方法的兴趣。这些生物标记可实现早期检测、疾病分期和治疗监测。据估计，全球有超过 1.15 亿人受到 NASH 的影响，因此迫切需要可扩展的诊断替代方案。製药业正在临床试验中利用生物标记进行患者分层和疗效追踪。蛋白质体学、代谢组学和转录组学等多组学平台的技术进步，以及人工智慧驱动的分析技术，正在改变生物标记的开发，并帮助精准医疗。跨部门合作进一步推动了这个市场的发展，这些合作专注于整合影像、血液标记和数位平台的综合诊断解决方案。

关键市场驱动因素

代谢紊乱盛行率上升及NASH进展

主要市场挑战

缺乏标准化和临床验证

主要市场趋势

基于多组学的生物标记发现的出现

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按类型（血清生物标记、肝纤维化生物标记、细胞凋亡生物标记、氧化压力生物标记、其他）
  • 按最终用户（製药和 CRO 行业、医院、诊断实验室、学术研究机构）
  • 按公司分类（2024）
  • 按地区
• 市场地图

第六章：北美非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 墨西哥
  • 加拿大

第七章：欧洲非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 韩国
  • 日本
  • 澳洲

第九章：南美洲非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第 10 章：中东和非洲非酒精性脂肪性肝炎生物标记市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 合併与收购（如有）
• 产品发布（如有）
• 最新动态

第十三章：干扰：衝突、流行病与贸易壁垒

第 14 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 15 章：竞争格局

• GENFIT SA
• Prometheus Laboratories Inc.
• Siemens Healthineers AG
• BioPredictive SAS
• Quest Diagnostics Incorporated
• AstraZeneca PLC
• Exalenz Bioscience Ltd.(Meridian Bioscience, Inc.)
• Laboratory Corporation of America Holdings
• Pfizer Inc.
• Bristol-Myers Squibb Company

第 16 章：策略建议

第17章调查会社について・免责事项

The Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market was valued at USD 1.81 Billion in 2024 and is projected to reach USD 6.27 Billion by 2030, growing at a CAGR of 22.97%. Rising global prevalence of metabolic disorders-including obesity, insulin resistance, and type 2 diabetes-continues to accelerate the demand for non-invasive and reliable diagnostic tools for NASH. As non-alcoholic fatty liver disease (NAFLD) advances toward NASH in many patients, the limitations of liver biopsy, such as invasiveness and sampling variability, have driven interest in biomarker-based diagnostics. These biomarkers enable early detection, disease staging, and therapeutic monitoring. With over 115 million people estimated to be affected by NASH globally, there is an urgent need for scalable diagnostic alternatives. The pharmaceutical industry is leveraging biomarkers for patient stratification and efficacy tracking in clinical trials. Technological advancements in multi-omics platforms-such as proteomics, metabolomics, and transcriptomics-along with AI-driven analytics, are transforming biomarker development and enabling precision medicine. This market is further supported by cross-sector collaborations that focus on integrated diagnostic solutions, combining imaging, blood-based markers, and digital platforms.

Key Market Drivers

Rising Prevalence of Metabolic Disorders and NASH Progression

The growing incidence of metabolic conditions such as obesity, insulin resistance, dyslipidemia, hypertension, and type 2 diabetes is significantly boosting the Global NASH Biomarkers Market. Data from the ICMR INDIAB study and NFHS 5 reveal concerning rates of obesity and diabetes, particularly among younger adults, further expanding the at-risk population. As NAFLD progresses silently to NASH, non-invasive biomarker-based diagnostics are gaining traction for early identification and risk assessment. Unlike liver biopsies, biomarkers offer repeatable, safer, and scalable alternatives for detecting liver inflammation and fibrosis. These tools are becoming essential in both clinical care and clinical research, where they enable real-time disease monitoring, guide therapy adjustments, and improve clinical trial design by supporting patient selection and endpoint analysis. The increasing use of multi-biomarker panels-spanning serum, genetic, and imaging data-is enabling more precise diagnosis and advancing the clinical utility of NASH biomarkers in both preventive and therapeutic strategies.

Key Market Challenges

Lack of Standardization and Clinical Validation

A major constraint for the NASH biomarker market is the lack of standardization and widespread clinical validation. Despite a growing pool of potential biomarkers, few have achieved regulatory approval or consistent use in clinical practice due to variability in study outcomes, assay formats, and patient heterogeneity. This inconsistency makes it difficult for physicians to rely on biomarker data as definitive diagnostic or prognostic tools, reinforcing dependence on liver biopsy. Furthermore, regulatory agencies demand high standards of accuracy, reproducibility, and clinical correlation, which are challenging to meet without robust, multi-phase clinical validation. Fragmentation across research efforts-where academic institutions and companies pursue proprietary solutions-further hinders the development of universal standards and complicates comparative evaluation. This lack of harmonization delays market entry and restricts biomarker adoption, requiring coordinated global frameworks and collaborative initiatives to ensure consistency, validation, and data interoperability across platforms and studies.

Key Market Trends

Emergence of Multi-Omics-Based Biomarker Discovery

The growing adoption of multi-omics approaches is reshaping the NASH biomarker landscape by offering a comprehensive understanding of disease mechanisms. Unlike traditional methods that rely on single markers, multi-omics strategies integrate genomic, proteomic, metabolomic, lipidomic, and transcriptomic data to identify complex biomarker signatures. These approaches allow for more accurate differentiation between NAFLD, early-stage NASH, and advanced fibrosis. Metabolomics and lipidomics, in particular, uncover liver-specific metabolic dysfunctions, while transcriptomic profiling helps detect gene expression patterns linked to hepatic inflammation and stress. As these datasets are processed using AI and machine learning, researchers can generate robust biomarker panels tailored to disease subtypes and progression stages. This trend supports personalized diagnostics, better disease stratification, and targeted therapy monitoring, making multi-omics tools essential in advancing non-invasive, high-precision NASH diagnostics.

Key Market Players

• GENFIT SA
• Prometheus Laboratories Inc.
• Siemens Healthineers AG
• BioPredictive S.A.S.
• Quest Diagnostics Incorporated
• AstraZeneca PLC
• Exalenz Bioscience Ltd. (Meridian Bioscience, Inc.)
• Laboratory Corporation of America Holdings
• Pfizer Inc.
• Bristol-Myers Squibb Company

Report Scope

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

Non-alcoholic Steatohepatitis Biomarkers Market, By Type:

• Serum Biomarkers
• Hepatic Fibrosis Biomarkers
• Apoptosis Biomarkers
• Oxidative Stress Biomarkers
• Others

Non-alcoholic Steatohepatitis Biomarkers Market, By End User:

• Pharma & CRO Industry
• Hospitals
• Diagnostic Labs
• Academic Research Institutes

Non-alcoholic Steatohepatitis Biomarkers 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 Biomarkers Market.

Available Customizations

Global Non-alcoholic Steatohepatitis Biomarkers 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, and Trends

4. Voice of Customer

5. Global Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, Oxidative Stress Biomarkers, Others)
  • 5.2.2. By End User (Pharma & CRO Industry, Hospitals, Diagnostic Labs, Academic Research Institutes)
  • 5.2.3. By Company (2024)
  • 5.2.4. By Region
• 5.3. Market Map

6. North America Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By 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 Biomarkers 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 Type
      • 6.3.1.2.2. By End User
  • 6.3.2. Mexico Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 6.3.2.2.2. By End User
  • 6.3.3. Canada Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 6.3.3.2.2. By End User

7. Europe Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By End User
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 7.3.1.2.2. By End User
  • 7.3.2. Germany Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 7.3.2.2.2. By End User
  • 7.3.3. United Kingdom Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 7.3.3.2.2. By End User
  • 7.3.4. Italy Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 7.3.4.2.2. By End User
  • 7.3.5. Spain Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 7.3.5.2.2. By End User

8. Asia-Pacific Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By 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 Biomarkers 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 Type
      • 8.3.1.2.2. By End User
  • 8.3.2. India Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 8.3.2.2.2. By End User
  • 8.3.3. South Korea Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 8.3.3.2.2. By End User
  • 8.3.4. Japan Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 8.3.4.2.2. By End User
  • 8.3.5. Australia Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 8.3.5.2.2. By End User

9. South America Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By End User
  • 9.2.3. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 9.3.1.2.2. By End User
  • 9.3.2. Argentina Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 9.3.2.2.2. By End User
  • 9.3.3. Colombia Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 9.3.3.2.2. By End User

10. Middle East and Africa Non-alcoholic Steatohepatitis Biomarkers Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By End User
  • 10.2.3. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 10.3.1.2.2. By End User
  • 10.3.2. Saudi Arabia Non-alcoholic Steatohepatitis Biomarkers 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 Type
      • 10.3.2.2.2. By End User
  • 10.3.3. UAE Non-alcoholic Steatohepatitis Biomarkers 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 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. Disruptions: Conflicts, Pandemics and Trade Barriers

14. Porters 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. GENFIT SA
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Products & Services
  • 15.1.4. Financials (As Reported)
  • 15.1.5. Recent Developments
  • 15.1.6. Key Personnel Details
  • 15.1.7. SWOT Analysis
• 15.2. Prometheus Laboratories Inc.
• 15.3. Siemens Healthineers AG
• 15.4. BioPredictive S.A.S.
• 15.5. Quest Diagnostics Incorporated
• 15.6. AstraZeneca PLC
• 15.7. Exalenz Bioscience Ltd.(Meridian Bioscience, Inc.)
• 15.8. Laboratory Corporation of America Holdings
• 15.9. Pfizer Inc.
• 15.10. Bristol-Myers Squibb Company

16. Strategic Recommendations

17. About Us & Disclaimer