全球非酒精性脂肪性肝炎生物标记市场规模（按生物标记类型、最终用户、区域范围和预测）

非酒精性脂肪性肝炎生物标记的市场规模和预测

2024 年非酒精性脂肪性肝炎生物标记市场规模价值为 1,350,950 百万美元，预计到 2032 年将达到 10,751,790 百万美元，在 2026-2032 年预测期内的复合年增长率为 29.60%。

非酒精性脂肪性肝炎 (NASH) 生物标记是用于识别、监测和衡量 NASH（一种进行性非酒精性脂肪肝(NAFLD)）严重程度的生物指标。这些生物标记在临床环境中对于检测 NASH 至关重要，NASH 的定义是与饮酒无关的脂肪堆积导致的肝臟发炎和损伤。血清肝酵素、影像学生物标记物以及与肝臟发炎、纤维化和代谢异常相关的特定蛋白质和基因是最常见的生物标记。 NASH 生物标记应用于疾病管理的多个阶段，包括早期诊断、病​​情进展监测、治疗反应评估和个人化治疗方法。

随着全球非酒精性脂肪肝（NAFLD）和METABOLIC INC.肝炎（NASH）的盛行率不断上升，NASH生物标记预计将大幅成长。非酒精性脂肪肝（NAFLD）和脂肪性肝炎（NASH）的盛行率可归因于肥胖、糖尿病和代谢症候群等因素。生物标记研究的进展有望发现更敏感、特异性的指标，以区分基础脂肪变性与NASH，并检测早期子宫肌瘤。

结合基因组学、蛋白质组学和代谢体学等多体学方法，有望提高这些生物标记的准确性，从而实现更有效的风险分层和标靶治疗。随着非侵入性诊断方法的普及，NASH 生物标记有望在全球范围内的开发新药和 NASH 管理中发挥重要作用。

全球非酒精性脂肪性肝炎生物标记市场动态

影响全球非酒精性脂肪性肝炎生物标记市场的关键市场动态是：

关键市场驱动因素

医疗保健支出不断增长：医疗保健支出的不断增长正在推动非酒精性脂肪性肝炎生物标记 (NASH) 市场的成长。根据美国医疗保险和医疗补助服务中心 (CMS) 的数据，预计到 2020 年，美国的医疗保健支出将增加 9.7%，达到 4.1 兆美元，人均支出达到 12,530 美元。预计这一趋势将持续下去，从而为改进 NASH 生物标记等诊断技术提供投资。

NASH盛行率不断上升：非酒精性脂肪性肝炎 (NASH) 盛行率不断上升是生物标记市场的主要驱动力。美国美国糖尿病、消化和肾臟疾病研究所 (NIDDK) 估计，NASH 影响着 3-12% 的美国。此外，2018 年发表在《肝病学》(Hepatology) 上的一项研究预测，2015 年至 2032 年间，美国NASH 的盛行率将上升 63%，达到 2,700 万例。

肥胖盛行率不断上升：肥胖是NASH的主要危险因素，导致对生物标记的需求增加。根据世界卫生组织 (WHO) 的数据，自1975年以来，全球肥胖人数增加了近三倍。 2016年，超过19亿成年人超重，超过6.5亿人肥胖。

主要问题

敏感性和特异性有限：许多目前的非酒精性脂肪性肝炎 (NASH) 生物标记缺乏可靠区分 NASH 与单纯脂肪变性所需的敏感性和特异性，这种限制增加了误诊、过度治疗和早期诊断的可能性，阻碍了有效的疾病管理。

临床试验中的伦理问题：对NASH生物标记进行临床试验可能面临伦理挑战，尤其是在检验需要切片检查等侵入性操作的情况下。招募此类研究的参与者可能很困难，尤其是在非侵入性方法仍处于开发阶段或尚未普及的情况下。

与现有诊断工具的整合：将新的NASH生物标记引入现有诊断系统是一项重大挑战。临床医生可能不愿意采用新的生物标记物，除非它们的性能明显优于肝臟切片检查等现有诊断程序，并且能够无缝整合到临床流程中。

主要趋势

转向非侵入性生物标记：人们对开发非酒精性脂肪性肝炎 (NASH) 的非侵入性生物标记的兴趣日益浓厚。这些生物标记旨在减少对侵入性肝臟切片检查的需求，为患者提供更安全、更便利的选择，同时实现更早的诊断和更频繁的病情发展监测。

多体学方法：多种体学技术（包括基因组学、蛋白质组学、代谢体学和转录组学）的整合正日益普及。透过研究多个生物学层面，研究人员可以识别出全面的生物标记组合，从而为NASH的发病机制和患者风险评估提供更精准、更个人化的见解。

产学合作：学术机构与製药公司的合作日益增加。此类合作对于推动NASH生物标记的发现、检验和商业化至关重要，因为它可以将学术专长与产业资源结合，从而加速新型诊断工具的开发。

关注早期NASH检测：人们越来越重视寻找生物标记物来检测早期NASH。早期检测是改善患者预后的关键，因为它可以更早进行治疗，并有可能避免进展为肝硬化和肝癌。

目录

第一章 引言

• 市场定义
• 市场区隔
• 调查方法

第二章执行摘要

• 主要发现
• 市场概览
• 市集亮点

第三章市场概述

• 市场规模和成长潜力
• 市场趋势
• 市场驱动因素
• 市场限制
• 市场机会
• 波特五力分析

4. 非酒精性脂肪性肝炎生物标记市场（依生物标记类型）

• 血清生物标记
• 肝纤维化生物标记
• 细胞凋亡生物标誌物
• 氧化压力生物标誌物
• 其他生物标誌物

5. 非酒精性脂肪性肝炎生物标记市场（依最终用户划分）

• 製药公司和 CRO
• 研究和学术机构
• 医院诊所
• 诊断中心
• 其他的

第六章区域分析

• 北美洲
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利
• 亚太地区
• 中国
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东和非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯聯合大公国

第七章市场动态

• 市场驱动因素
• 市场限制
• 市场机会
• COVID-19 市场影响

第八章 竞争态势

• 主要企业
• 市场占有率分析

第九章 公司简介

• Siemens Healthineers
• QIAGEN
• Genfit SA
• Metabolon Inc.
• NGM Biopharmaceuticals
• Perspectum Diagnostics
• Promethera Biosciences
• Glympse Bio
• Galectin Therapeutics
• Exalenz Bioscience.

第十章 市场展望与机会

• 新兴技术
• 未来市场趋势
• 投资机会

第十一章 市场展望 附录

• 简称列表
• 来源和参考文献

Non-Alcoholic Steatohepatitis Biomarkers Market Size And Forecast

Non-Alcoholic Steatohepatitis Biomarkers Market size was valued at USD 1350.95 Billion in 2024 and is projected to reach USD 10751.79 Billion by 2032, growing at a CAGR of 29.60% from 2026 to 2032.

Non-alcoholic steatohepatitis (NASH) biomarkers are biological indicators used to identify, monitor, and measure the severity of NASH, a progressive kind of non-alcoholic fatty liver disease (NAFLD). These biomarkers are essential in clinical settings for detecting NASH, which is defined by liver inflammation and damage produced by fat buildup that is unrelated to alcohol use. Serum liver enzymes, imaging biomarkers, and specific proteins or genes linked to liver inflammation, fibrosis, and metabolic dysregulation are among the most common biomarkers. NASH biomarkers are used at many stages of disease management, including early diagnosis, disease progression monitoring, therapeutic response evaluation, and individualized treatment regimens.

NASH biomarkers are expected to grow significantly as the global prevalence of NAFLD and NASH rises, owing to variables such as obesity, diabetes, and metabolic syndrome. Advances in biomarker research are predicted to lead to the identification of more sensitive and specific indicators capable of distinguishing between basic steatosis and NASH, as well as detecting early-stage fibroids.

The combination of multi-omics methods, such as genomics, proteomics, and metabolomics, is expected to improve the precision of these biomarkers, allowing for more effective risk stratification and targeted therapy. As non-invasive diagnostic methods gain popularity, NASH biomarkers are expected to play an important role in the development of novel medicines and NASH management on a global scale.

Global Non-Alcoholic Steatohepatitis Biomarkers Market Dynamics

The key market dynamics that are shaping the global non-alcoholic steatohepatitis biomarkers market include:

Key Market Drivers:

Rising Healthcare Expenditure: Rising healthcare spending is driving the growth of the non-alcoholic steatohepatitis biomarkers (NASH) biomarkers market. According to the Centers for Medicare and Medicaid Services (CMS), healthcare spending in the United States increased by 9.7% in 2020 to $4.1 trillion, or $12,530 per person. This trend is projected to continue, allowing for more investment in improved diagnostic techniques such as NASH biomarkers.

Increasing Prevalence of NASH: The increased prevalence of non-alcoholic steatohepatitis biomarkers (NASH) is a key driver of the biomarker market. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) estimates that NASH affects 3-12% of individuals in the United States. Furthermore, a study published in Hepatology in 2018 anticipated that the prevalence of NASH in the United States would rise by 63% between 2015 and 2032, reaching 27 million cases.

Growing Obesity Rates: Obesity is a key risk factor for NASH, leading to increased demand for biomarkers. The World Health Organization (WHO) claims that global obesity has nearly tripled since 1975. In 2016, more than 1.9 billion adults were overweight, with over 650 million obese.

Key Challenges:

Limited Sensitivity and Specificity: Many current non-alcoholic steatohepatitis biomarkers (NASH) biomarkers lack the sensitivity and specificity required to reliably distinguish NASH from simple steatosis. This constraint increases the likelihood of misdiagnosis, resulting in either excessive therapies or the inability to diagnose the condition early, which can impede effective disease management.

Ethical Concerns in Clinical Trials: Conducting clinical trials for NASH biomarkers involves ethical difficulties, especially when invasive procedures like liver biopsies are required for validation. Recruiting people for such research can be difficult, particularly when non-invasive options are still in development or unavailable.

Integration with Existing Diagnostic Tools: Introducing new NASH biomarkers into existing diagnostic systems is a substantial problem. Clinicians may be reticent to adopt new biomarkers until they clearly outperform existing procedures, such as liver biopsies, and can be effortlessly integrated into clinical processes.

Key Trends:

Shift Toward Non-Invasive Biomarkers: There is an increasing interest in developing non-invasive biomarkers for non-alcoholic steatohepatitis biomarkers (NASH). These biomarkers aim to reduce the need for invasive liver biopsies, providing patients with safer and more convenient options while also allowing for earlier diagnosis and more frequent monitoring of disease development.

Multi-Omics Methods: The integration of multiple omics methods, such as genomics, proteomics, metabolomics, and transcriptomics, is gaining popularity. By examining several biological layers, researchers can identify comprehensive biomarker panels that provide more precise and personalized insights into NASH pathology and patient risk assessment.

Collaboration Between Academia and Industry: Academic institutions and pharmaceutical corporations are increasingly working together. These collaborations are critical for furthering the discovery, validation, and commercialization of NASH biomarkers by combining academic expertise with industry resources to speed up the development of novel diagnostic tools.

Focus on Early-Stage NASH Detection: There is a growing emphasis on discovering biomarkers to detect NASH in its early phases. Early identification is critical for better patient outcomes because it allows for earlier care and may avoid disease progression to cirrhosis or liver cancer.

Global Non-Alcoholic Steatohepatitis Biomarkers Market Regional Analysis

Here is a more detailed regional analysis of the Global Non-Alcoholic Steatohepatitis Biomarkers Market:

North America:

North America dominates the Non-Alcoholic Steatohepatitis (NASH) Biomarkers market, and this is projected to continue in the coming years due to a number of major drivers. One of the most important variables is the high prevalence of NASH and related disorders in the region. The prevalence of NASH in the United States, for instance, is likely to climb considerably, with instances increasing by 63% from 16.5 million in 2015 to 27 million by 2032. This increase in patient numbers coincides with rising obesity rates, which is a major risk factor for NASH. Obesity rates in the United States increased from 30.5% in 1999-2000 to 42.4% in 2017-2018, growing the at-risk population and generating demand for more effective diagnostic methods, including biomarkers.

Furthermore, North America's predominance in the NASH Biomarkers market is driven by significant R&D investments and rising healthcare costs. The region's advanced healthcare infrastructure, along with major R&D investment, particularly from institutions such as the National Institutes of Health (NIH), which boosted its liver disease research budget by 25% between 2015 and 2020, is propelling biomarker development forward. Furthermore, rising healthcare spending, which is expected to reach $4.1 trillion in the United States alone by 2020, promotes the use of new diagnostic technologies. These reasons ensure that North America continues to lead the global NASH Biomarkers market.

Asia Pacific:

The Asia-Pacific area is rapidly developing as the fastest-growing market for Nonalcoholic Steatohepatitis (NASH) biomarkers, owing to a large increase in the prevalence of NASH and related disorders. The prevalence of NASH in Asia-Pacific is expanding at an alarming rate, with predictions ranging from 12.5% in 2016 to 18.3% by 2032. This corresponds to nearly 574 million NASH cases in the region by 2032. Coupled with rising obesity rates-in some Pacific Island countries, obesity rates approach 50% of the adult population-demand for reliable diagnostic biomarkers is increasing. The rising incidence of type 2 diabetes, another major risk factor for NASH, fuels this demand since the region's diabetic population is predicted to grow dramatically in the future years.

Increased healthcare expenditures and improved healthcare infrastructure are driving growth in the Asia-Pacific NASH biomarkers market. As healthcare spending rises across the area, aided by economic growth and government initiatives, there is an increasing ability to adopt modern diagnostic tools. In East Asia and the Pacific, health expenditure as a percentage of GDP has continually increased, allowing for increasing investment in innovative diagnostic tools like NASH biomarkers. Asia-Pacific is a dynamic and fast-expanding market for NASH biomarkers, owing to rising disease prevalence, rising obesity and diabetes rates, and increased healthcare spending.

Global Non-Alcoholic Steatohepatitis Biomarkers Market: Segmentation Analysis

The Global Non-Alcoholic Steatohepatitis Biomarkers Market is Segmented on the basis of Type of Biomarker, End-User, And Geography.

Non-Alcoholic Steatohepatitis Biomarkers Market, By Type of Biomarker

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

Based on Type of Biomarker, the Non-Alcoholic Steatohepatitis Biomarkers Market is fragmented into Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, and Oxidative Stress Biomarkers. Serum biomarkers currently lead the non-alcoholic steatohepatitis (NASH) biomarker market due to its simplicity, accessibility, and dependability. Hepatic fibrosis biomarkers are growing the fastest. This is due to they provide important information regarding the course of NASH, which is used to assess disease severity and guide therapy decisions. As our understanding of NASH pathophysiology improves, demand for hepatic fibrosis biomarkers is likely to rise further, making them a promising component of the NASH biomarkers market.

Non-Alcoholic Steatohepatitis Biomarkers Market, By End-User

• Pharmaceutical Companies and Cros
• Research Institutes and Academics
• Hospitals & Clinics
• Diagnostic Centers

Based on End-User, the Non-Alcoholic Steatohepatitis Biomarkers Market is segmented into Pharmaceutical Companies and Cros, Research Institutes and Academics, and Diagnostic Centers. Pharmaceutical companies and CROs now lead the non-alcoholic steatohepatitis (NASH) biomarkers market due to large investment in R&D, extensive resources, and emphasis on creating new diagnostic and treatment techniques. Hospitals and clinics are growing the fastest. This is because they are the key consumers of NASH biomarkers for patient diagnosis, monitoring, and treatment. As the frequency of NASH rises, so will the demand for biomarkers in hospitals and clinics, fueling market expansion in this category.

Non-Alcoholic Steatohepatitis Biomarkers Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World
• On the basis of Geography, the Global Non-Alcoholic Steatohepatitis Biomarkers Market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America presently dominates the non-alcoholic steatohepatitis (NASH) biomarker market owing to its advanced healthcare infrastructure, intensive R&D activities, and high prevalence of obesity and type 2 diabetes, both of which are key risk factors for NASH. Asia-Pacific is seeing the highest development in the NASH biomarkers market, owing to increased illness awareness, rising healthcare spending, and the region's expanding obesity and diabetes incidence.

Key Players

The "Global Non-Alcoholic Steatohepatitis Biomarkers Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Amphenol Corporation, GE Healthcare, Inc., Honeywell International, Inc. Proteus Digital Health, Keller America, Masimo, Stanley Healthcare, Tekscan, Sensirion, Siemens Corporation, Analog Devices, Medtronics PLC, STMicroelectronics, On Semiconductor Corporation, NXP Semiconductors, Omron Corporation, TDK Sensors, TE Connectivity, Texas Instruments, and First Sensor. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Non-Alcoholic Steatohepatitis Biomarkers Market Recent Developments
• In September 2024, GENFIT announced a Nature Medicine publication validating the performance of its NASH Diagnostic Technology.
• In August 2024, Prometheus Laboratories announced a collaboration with Fresenius Kabi on Anser(R) Testing.
• In September 2024, Siemens Healthineers gained FDA certification for the MAGNETOM Viato. Magnetic Resonance Scanner on the Go.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Non-Alcoholic Steatohepatitis Biomarkers Market, By Type Of Biomarker

• Serum biomarkers
• Hepatic fibrosis biomarkers
• Apoptosis biomarkers
• Oxidative stress biomarkers
• Other biomarkers

5. Non-Alcoholic Steatohepatitis Biomarkers Market, By End User

• Pharmaceutical companies and CROs
• Research institutes and academics
• Hospitals & clinics
• Diagnostic centers
• Others

6. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

7. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

8. Competitive Landscape

• Key Players
• Market Share Analysis

9. Company Profiles

• Siemens Healthineers
• QIAGEN
• Genfit SA
• Metabolon Inc.
• NGM Biopharmaceuticals
• Perspectum Diagnostics
• Promethera Biosciences
• Glympse Bio
• Galectin Therapeutics
• Exalenz Bioscience.

10. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

11. Appendix

• List of Abbreviations
• Sources and References