비알코올성 지방간염 바이오마커 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측, 유형별, 최종사용자별, 지역별, 경쟁별(2020-2030년)
Non-alcoholic Steatohepatitis Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By End User, By Region and Competition, 2020-2030F
상품코드:1748775
리서치사:TechSci Research
발행일:2025년 06월
페이지 정보:영문 183 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 비알코올성 지방간염(NASH) 바이오마커 시장은 2024년에 18억 1,000만 달러로 평가되며, 2030년에는 62억 7,000만 달러에 달하며, CAGR 22.97%로 성장할 것으로 예측됩니다.
비만, 인슐린 저항성, 2형 당뇨병을 포함한 대사성 질환이 전 세계에서 확산되면서 비침습적이고 신뢰할 수 있는 비알코올성 지방간염(NASH) 진단 툴에 대한 수요가 급증하고 있습니다. 비알코올성 지방간질환(NAFLD)이 많은 환자에서 NASH로 진행됨에 따라 간 생검의 침습성, 샘플링의 편차 등 한계로 인해 바이오마커 기반 진단에 대한 관심이 높아지고 있습니다. 이러한 바이오마커는 조기 발견, 병기 결정 및 치료 모니터링에 도움을 줄 수 있습니다. 전 세계에서 1억 1,500만 명 이상이 NASH를 앓고 있는 것으로 추정되며, 확장 가능한 대체 진단 약품이 절실히 요구되고 있습니다. 제약업계는 바이오마커를 활용하여 임상시험에서 환자 계층화 및 유효성 추적에 활용하고 있습니다. 단백질체학, 대사체학, 전사체학 등 멀티오믹스 플랫폼의 기술 발전과 AI 기반 분석은 바이오마커 개발에 변화를 가져왔으며, 정밀의료를 가능하게 하고 있습니다. 이 시장은 또한 영상 진단, 혈액 기반 마커, 디지털 플랫폼을 결합한 통합 진단 솔루션에 중점을 둔 분야 간 협력에 의해 지원되고 있습니다.
시장 개요
예측 기간
2026-2030
시장 규모 : 2024년
18억 1,000만 달러
시장 규모 : 2030년
62억 7,000만 달러
CAGR : 2025-2030년
22.97%
급성장 부문
간섬유증 바이오마커
최대 시장
북미
시장 성장 촉진요인
대사이상과 NASH 진행의 유병률 증가
주요 시장 이슈
표준화 및 임상 검증 부족
주요 시장 동향
멀티오믹스 기반 바이오마커 탐색의 등장
목차
제1장 개요
제2장 조사 방법
제3장 개요
제4장 고객의 소리
제5장 세계의 비알코올성 지방간염 바이오마커 시장 전망
시장 규모·예측
금액별
시장 점유율·예측
유형별(혈청 바이오마커, 간섬유증 바이오마커, 아포토시스 바이오마커, 산화 스트레스 바이오마커, 기타)
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.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 1.81 Billion
Market Size 2030
USD 6.27 Billion
CAGR 2025-2030
22.97%
Fastest Growing Segment
Hepatic Fibrosis Biomarkers
Largest Market
North America
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.
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
