全球非酒精性脂肪性肝炎生物標記市場規模（按生物標記類型、最終用戶、區域範圍和預測）

非酒精性脂肪性肝炎生物標記的市場規模和預測

2024 年非酒精性脂肪性肝炎生物標記市場規模價值為 1,350,950 百萬美元，預計到 2032 年將達到 10,751,790 百萬美元，在 2026-2032 年預測期內的複合年成長率為 29.60%。

非酒精性脂肪性肝炎 (NASH) 生物標記是用於識別、監測和衡量 NASH（一種進行性非酒精性脂肪肝(NAFLD)）嚴重程度的生物指標。這些生物標記在臨床環境中對於檢測 NASH 至關重要，NASH 的定義是與飲酒無關的脂肪堆積導致的肝臟發炎和損傷。血清肝酵素、影像學生物標記物以及與肝臟發炎、纖維化和代謝異常相關的特定蛋白質和基因是最常見的生物標記。 NASH 生物標記應用於疾病管理的多個階段，包括早期診斷、病​​情進展監測、治療反應評估和個人化治療方法。

隨著全球非酒精性脂肪肝（NAFLD）和METABOLIC INC.肝炎（NASH）的盛行率不斷上升，NASH生物標記預計將大幅成長。非酒精性脂肪肝（NAFLD）和脂肪性肝炎（NASH）的盛行率可歸因於肥胖、糖尿病和代謝症候群等因素。生物標記研究的進展有望發現更敏感、特異性的指標，以區分基礎脂肪變性與NASH，並檢測早期子宮肌瘤。

結合基因組學、蛋白質組學和代謝體學等多體學方法，有望提高這些生物標記的準確性，從而實現更有效的風險分層和標靶治療。隨著非侵入性診斷方法的普及，NASH 生物標記有望在全球範圍內的開發新藥和 NASH 管理中發揮重要作用。

全球非酒精性脂肪性肝炎生物標記市場動態

影響全球非酒精性脂肪性肝炎生物標記市場的關鍵市場動態是：

關鍵市場促進因素

醫療保健支出不斷成長：醫療保健支出的不斷成長正在推動非酒精性脂肪性肝炎生物標記 (NASH) 市場的成長。根據美國醫療保險和醫療補助服務中心 (CMS) 的數據，預計到 2020 年，美國的醫療保健支出將增加 9.7%，達到 4.1 兆美元，人均支出達到 12,530 美元。預計這一趨勢將持續下去，從而為改進 NASH 生物標記等診斷技術提供投資。

NASH盛行率不斷上升：非酒精性脂肪性肝炎 (NASH) 盛行率不斷上升是生物標記市場的主要驅動力。美國美國糖尿病、消化和腎臟疾病研究所 (NIDDK) 估計，NASH 影響著 3-12% 的美國。此外，2018 年發表在《肝病學》(Hepatology) 上的一項研究預測，2015 年至 2032 年間，美國NASH 的盛行率將上升 63%，達到 2,700 萬例。

肥胖盛行率不斷上升：肥胖是NASH的主要危險因素，導致對生物標記的需求增加。根據世界衛生組織 (WHO) 的數據，自1975年以來，全球肥胖人數增加了近三倍。 2016年，超過19億成年人超重，超過6.5億人肥胖。

主要問題

敏感性和特異性有限：許多目前的非酒精性脂肪性肝炎 (NASH) 生物標記缺乏可靠區分 NASH 與單純脂肪變性所需的敏感性和特異性，這種限制增加了誤診、過度治療和早期診斷的可能性，阻礙了有效的疾病管理。

臨床試驗中的倫理問題：對NASH生物標記進行臨床試驗可能面臨倫理挑戰，尤其是在檢驗需要切片檢查等侵入性操作的情況下。招募此類研究的參與者可能很困難，尤其是在非侵入性方法仍處於開發階段或尚未普及的情況下。

與現有診斷工具的整合：將新的NASH生物標記引入現有診斷系統是一項重大挑戰。臨床醫生可能不願意採用新的生物標記物，除非它們的性能明顯優於肝臟切片檢查等現有診斷程序，並且能夠無縫整合到臨床流程中。

主要趨勢

轉向非侵入性生物標記：人們對開發非酒精性脂肪性肝炎 (NASH) 的非侵入性生物標記的興趣日益濃厚。這些生物標記旨在減少對侵入性肝臟切片檢查的需求，為患者提供更安全、更便利的選擇，同時實現更早的診斷和更頻繁的病情發展監測。

多體學方法：多種體學技術（包括基因組學、蛋白質組學、代謝體學和轉錄組學）的整合正日益普及。透過研究多個生物學層面，研究人員可以識別出全面的生物標記組合，從而為NASH的發病機制和患者風險評估提供更精準、更個人化的見解。

產學合作：學術機構與製藥公司的合作日益增加。此類合作對於推動NASH生物標記的發現、檢驗和商業化至關重要，因為它可以將學術專長與產業資源結合，從而加速新型診斷工具的開發。

關注早期NASH檢測：人們越來越重視尋找生物標記物來檢測早期NASH。早期檢測是改善患者預後的關鍵，因為它可以更早進行治療，並有可能避免進展為肝硬化和肝癌。

目錄

第1章 引言

• 市場定義
• 市場區隔
• 調查方法

第2章執行摘要

• 主要發現
• 市場概覽
• 市場亮點

第3章市場概述

• 市場規模和成長潛力
• 市場趨勢
• 市場促進因素
• 市場限制
• 市場機會
• 波特五力分析

4. 非酒精性脂肪性肝炎生物標記市場（依生物標記類型）

• 血清生物標記
• 肝纖維化生物標記
• 細胞凋亡生物標記
• 氧化壓力生物標記
• 其他生物標記

5. 非酒精性脂肪性肝炎生物標記市場（依最終用戶分類）

• 製藥公司和 CRO
• 研究和學術機構
• 醫院診所
• 診斷中心
• 其他

第6章區域分析

• 北美洲
• 美國
• 加拿大
• 墨西哥
• 歐洲
• 英國
• 德國
• 法國
• 義大利
• 亞太地區
• 中國
• 日本
• 印度
• 澳洲
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中東和非洲
• 南非
• 沙烏地阿拉伯
• 阿拉伯聯合大公國

第7章市場動態

• 市場促進因素
• 市場限制
• 市場機會
• COVID-19 市場影響

第8章 競爭態勢

• 主要企業
• 市場佔有率分析

第9章 公司簡介

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

第10章 市場展望與機會

• 新興技術
• 未來市場趨勢
• 投資機會

第11章 市場展望 附錄

• 簡稱列表
• 來源和參考文獻

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