미국의 비알코올성 지방간염(NASH) 바이오마커 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the united states non-Alcoholic steatohepatitis (NASH) biomarkers market size is projected to be USD 1.02 billion in 2025, USD 1.27 billion in 2026, and reach USD 3.81 billion by 2031, growing at a CAGR of 24.51% from 2026 to 2031.

This report is Segmented by Biomarker Class (Direct Fibrosis Biomarkers, Hepatocyte Injury and Apoptosis Biomarkers, Metabolic Biomarkers, and More), Application (Clinical Diagnosis and Staging, Screening and Secondary Risk Stratification, and More), and End User (Pharmaceutical and CRO Industry, Hospitals and More). Market Forecasts are Provided in Terms of Value (USD).

United States Non-alcoholic Steatohepatitis (NASH) Biomarkers Market Trends and Insights

Rising MASH Therapy-Linked Fibrosis Testing Demand

The FDA approval of resmetirom in March 2024 created the first clear therapy-linked testing pathway for patients with non-cirrhotic MASH and moderate-to-advanced fibrosis. Because prescribing moved into real clinical practice without a universal biopsy requirement, blood-based and imaging-based tests became the practical gatekeepers for treatment eligibility in the United States NASH biomarkers market. That shift matters because a therapy decision now drives biomarker demand directly, rather than leaving testing tied mainly to specialist workups or clinical trials. As additional MASH therapies move closer to commercialization, each approval will widen the pool of patients needing non-invasive staging and repeat reassessment. This makes growth in the United States NASH biomarkers market cumulative, since every new treatment adds another layer of testing demand across diagnosis, access, and follow-up.

Guideline-Backed Non-Invasive Triage Pathways

The AASLD January 2025 guidance established FIB-4 as the preferred first-tier blood-based test for advanced fibrosis assessment, with ELF used as a sequential marker, which gave clinicians a national framework for structured triage. The same guidance stated revised FIB-4 thresholds and reported pooled specificity of 0.94 for ruling in advanced fibrosis, which supports broader use across primary care, endocrinology, and gastroenterology. AASLD also advised against using blood-based markers for tracking fibrosis progression over time, which leaves room for imaging platforms to expand within the monitoring portion of the United States NASH biomarkers market. The EASL-EASD-EASO 2024 guideline reinforced this direction through a multi-step pathway based on FIB-4, followed by elastography, and it also recognized NIS2+ for identifying at-risk MASH. Together, these documents reduce pathway ambiguity for large health systems and make testing volumes more durable even as the competitive mix of panels and platforms continues to change.

Uneven Payer Reimbursement For Proprietary Panels

Commercial momentum has outpaced reimbursement alignment for many proprietary biomarker panels in the United States NASH biomarkers market. Blue Cross Blue Shield of Tennessee has excluded several hepatic fibrosis panels from coverage, while CMS proposed a MolDX framework that limits coverage to settings where FIB-4 and imaging elastography are indeterminate. In 2026, CMS established an initial pricing framework for NASHnext, but GENFIT described that step as an early milestone rather than full reimbursement maturity. Emerging molecular and proteomic tests also face CLIA and MolDX technical assessment requirements before they can scale, which slows onboarding even when analytical performance is promising. This leaves developers with demand visibility but uneven revenue realization, especially when payer policy still favors simpler first-line pathways before proprietary panels are considered.

Other drivers and restraints analyzed in the detailed report include:

1. Pharma And CRO Biomarker-Enrichment Spending
2. Demand For Repeatable Biopsy-Sparing Monitoring
3. Biopsy Still Anchors Some Confirmatory Decisions

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Direct fibrosis biomarkers held 33.31% of the United States NASH biomarkers market size in 2025, which reflects their established role in specialist workups, risk stratification, and trial screening. This lead rests on the broad clinical familiarity of FIB-4, ELF, PRO-C3, and proprietary composite panels that are already embedded in hepatology practice and trial design. AASLD and EASL guidance supports that position because both frameworks place fibrosis-oriented tools early in the patient pathway, which keeps them close to referral and treatment decisions. Siemens Healthineers strengthened this class through automated ELF availability on Atellica IM and ADVIA Centaur systems, and Roche added routine lab scalability with the Elecsys PRO-C3 launch on cobas. Hepatocyte injury and apoptosis markers such as CK-18 and M30 remain relevant in exploratory and CRO settings, but their routine clinical pathway is still less established than fibrosis-focused tests in the United States NASH biomarkers industry.

Metabolic and lipidomic biomarkers are projected to expand at a 26.38% CAGR through 2031, which makes them the fastest-growing class within the United States NASH biomarkers market. OWLiver and related lipid-based approaches have shown clinically useful discrimination of at-risk MASH through combined lipid profiling and metabolic variables, which improves their relevance for upstream case finding. Proteomic models have also advanced quickly, with a serum protein risk score and broader multi-protein signatures posting strong validation performance across fibrosis stages. Inflammatory markers and genomic panels are still more common in enrichment and response-prediction work, where sponsors value multi-analyte depth even before routine reimbursement is available. Imaging biomarkers remain the most regulation-sensitive modality in the United States NASH biomarkers industry, because FDA movement on FibroScan VCTE and cT1 directly affects how monitoring tools compete with blood-based panels.

Complete Report Scope:

• By Biomarker Class
  • Direct fibrosis biomarkers
  • Hepatocyte injury and apoptosis biomarkers
  • Metabolic and lipidomic biomarkers
  • Inflammatory biomarkers
  • Genomic and transcriptomic biomarkers
  • Imaging biomarkers
  • Others
• By Application
  • Clinical diagnosis and staging
  • Screening and secondary risk stratification
  • Therapeutic monitoring and response assessment
  • Other Applications
• By End User
  • Pharmaceutical and CRO industry
  • Hospitals and clinics
  • Diagnostic laboratories and reference labs
  • Other End Users

List of Companies Covered in this Report:

1. BioPredictive
2. CIMA Sciences
3. DiaPharma Group
4. Echosens
5. Fibronostics
6. Fujifilm Healthcare Americas
7. GENFIT
8. HistoIndex
9. LabCorp
10. Mayo Clinic Laboratories
11. Nordic Bioscience
12. PacificDx
13. PathAI
14. Perspectum
15. Prometheus Laboratories
16. Quest Diagnostics
17. Roche
18. Siemens Healthineers

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising MASH therapy-linked fibrosis testing demand
  • 4.2.2 Guideline-backed non-invasive triage pathways
  • 4.2.3 Pharma and CRO biomarker-enrichment spending
  • 4.2.4 Demand for repeatable biopsy-sparing monitoring
  • 4.2.5 VA and IDN liver-pathway deployment
  • 4.2.6 Automated assays and AI-assisted readouts
• 4.3 Market Restraints
  • 4.3.1 Uneven payer reimbursement for proprietary panels
  • 4.3.2 Biopsy still anchors some confirmatory decisions
  • 4.3.3 Obesity-related elastography and discordance limits
  • 4.3.4 NASH to MASH coding and terminology transition
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Biomarker Class
  • 5.1.1 Direct fibrosis biomarkers
  • 5.1.2 Hepatocyte injury and apoptosis biomarkers
  • 5.1.3 Metabolic and lipidomic biomarkers
  • 5.1.4 Inflammatory biomarkers
  • 5.1.5 Genomic and transcriptomic biomarkers
  • 5.1.6 Imaging biomarkers
  • 5.1.7 Others
• 5.2 By Application
  • 5.2.1 Clinical diagnosis and staging
  • 5.2.2 Screening and secondary risk stratification
  • 5.2.3 Therapeutic monitoring and response assessment
  • 5.2.4 Other Applications
• 5.3 By End User
  • 5.3.1 Pharmaceutical and CRO industry
  • 5.3.2 Hospitals and clinics
  • 5.3.3 Diagnostic laboratories and reference labs
  • 5.3.4 Other End Users

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 BioPredictive
  • 6.3.2 CIMA Sciences
  • 6.3.3 DiaPharma Group
  • 6.3.4 Echosens
  • 6.3.5 Fibronostics
  • 6.3.6 Fujifilm Healthcare Americas
  • 6.3.7 GENFIT
  • 6.3.8 HistoIndex
  • 6.3.9 Labcorp
  • 6.3.10 Mayo Clinic Laboratories
  • 6.3.11 Nordic Bioscience
  • 6.3.12 PacificDx
  • 6.3.13 PathAI
  • 6.3.14 Perspectum
  • 6.3.15 Prometheus Laboratories
  • 6.3.16 Quest Diagnostics
  • 6.3.17 Roche Diagnostics
  • 6.3.18 Siemens Healthineers

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment