非アルコール性脂肪肝炎バイオマーカー市場- 世界の産業規模、シェア、動向、機会、予測、タイプ別、エンドユーザー別、地域別、競合別、2020～2030年

世界の非アルコール性脂肪肝炎（NASH）バイオマーカー市場は、2024年に18億1,000万米ドルと評価され、2030年には62億7,000万米ドルに達し、CAGR 22.97％で成長すると予測されています。

肥満、インスリン抵抗性、2型糖尿病を含む代謝異常の世界の蔓延が、非侵襲的で信頼性の高いNASH診断ツールの需要を加速させています。非アルコール性脂肪性肝疾患（NAFLD）が多くの患者でNASHへと進行するにつれ、侵襲性やサンプリングのばらつきといった肝生検の限界が、バイオマーカーに基づく診断への関心を高めています。これらのバイオマーカーにより、早期発見、病期分類、治療モニタリングが可能となります。世界中で1億1,500万人以上がNASHに罹患していると推定されており、スケーラブルな代替診断薬が急務となっています。製薬業界は、臨床試験における患者の層別化と有効性の追跡にバイオマーカーを活用しています。プロテオミクス、メタボロミクス、トランスクリプトミクスなどのマルチオミクス・プラットフォームの技術的進歩は、AI主導の分析とともにバイオマーカー開発に変革をもたらし、精密医療を可能にしています。この市場はさらに、画像診断、血液ベースのマーカー、デジタルプラットフォームを組み合わせた統合診断ソリューションに重点を置く分野横断的な協力関係によって支えられています。

市場促進要因

代謝異常とNASHの進行の有病率の上昇

主な市場課題

標準化と臨床検証の欠如

主要市場動向

マルチオミクスに基づくバイオマーカー探索の出現

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • タイプ別（血清バイオマーカー、肝線維症バイオマーカー、アポトーシスバイオマーカー、酸化ストレスバイオマーカー、その他）
  • エンドユーザー別（製薬・CRO業界、病院、診断ラボ、学術調査機関）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州の非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域の非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米の非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの非アルコール性脂肪肝炎バイオマーカー市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 混乱：紛争、パンデミック、貿易障壁

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 競合情勢

• 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

第16章 戦略的提言

第17章 調査会社について・免責事項

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