非アルコール性脂肪肝炎バイオマーカーの世界市場規模：バイオマーカータイプ別、エンドユーザー別、地域範囲別、予測

非アルコール性脂肪肝炎バイオマーカーの市場規模と予測

非アルコール性脂肪肝炎バイオマーカーの市場規模は、2024年に1兆3,509億5,000万米ドルと評価され、2026～2032年にかけて29.60%のCAGRで成長し、2032年には10兆7,517億9,000万米ドルに達すると予測されています。

非アルコール性脂肪肝炎（NASH）バイオマーカーは、非アルコール性脂肪肝疾患（NAFLD）の進行性の一種であるNASHの同定、モニタリング、重症度測定に使用される生物学的指標です。これらのバイオマーカーは、アルコール使用とは無関係な脂肪の蓄積によって生じる肝臓の炎症と損傷によって定義されるNASHを検出するために、臨床の場では不可欠です。血清肝酵素、画像バイオマーカー、肝臓の炎症、線維化、代謝異常と関連する特定のタンパク質や遺伝子が最も一般的なバイオマーカーの一つです。NASHバイオマーカーは、早期診断、病勢進行モニタリング、治療効果評価、個別化治療レジメンなど、疾患管理の多くの段階で利用されています。

NASHバイオマーカーは、肥満、糖尿病、メタボリックシンドロームなどの変数に起因するNAFLDとNASHの世界の有病率の上昇に伴い、大きく成長すると予想されます。バイオマーカー調査の進歩により、基本的な脂肪症とNASHを区別し、早期の線維腫を検出できる、より高感度で特異的な指標が同定されると予測されます。

ゲノミクス、プロテオミクス、メタボロミクスなどのマルチオミクス手法を組み合わせることで、これらのバイオマーカーの精度が向上し、より効果的なリスク層別化や標的治療が可能になると期待されます。非侵襲的な診断法が普及するにつれて、NASHバイオマーカーは世界規模での新薬開発やNASH管理に重要な役割を果たすと期待されています。

世界の非アルコール性脂肪肝炎バイオマーカー市場力学

世界の非アルコール性脂肪肝炎バイオマーカー市場を形成している主要市場力学は以下の通りです。

主要市場促進要因

ヘルスケア支出の増加：ヘルスケア支出の増加が非アルコール性脂肪肝炎バイオマーカー（NASH）市場の成長を促進しています。メディケア・メディケイドサービスセンター（CMS）によると、米国のヘルスケア支出は2020年に9.7%増の4兆1,000億米ドル、1人当たり1万2,530米ドルに達します。この動向は今後も続くと予測され、NASHバイオマーカーのような診断技術の向上への投資が可能になります。

NASHの有病率の増加：非アルコール性脂肪肝炎バイオマーカー（NASH）の有病率の増加は、バイオマーカー市場の主要な促進要因です。米国糖尿病・消化器・腎臓病ラボ（NIDDK）は、NASHは米国の個人の3～12％が罹患していると推定しています。さらに、2018年にHepatology誌に発表された研究では、米国におけるNASHの有病率は2015～2032年の間に63%上昇し、2,700万症例に達すると予測されています。

肥満率の増加：肥満はNASHの主要な危険因子であり、バイオマーカーの需要増加につながります。世界保健機関（WHO）によると、世界の肥満は1975年以来約3倍に増加しています。2016年には19億人以上の成人が過体重で、6億5,000万人以上が肥満でした。

主要課題

限られた感度と特異度：現在の非アルコール性脂肪肝炎バイオマーカー（NASH）の多くは、NASHと単純な脂肪症を確実に区別するのに必要な感度と特異度を欠いています。この制約が誤診の可能性を高め、過剰な治療や早期診断ができず、効果的な疾患管理の妨げとなります。

臨床検査における倫理的懸念：特に検証のために肝生検のような侵襲的処置が必要な場合、NASHバイオマーカーの臨床検査を実施することは倫理的に困難です。特に、非侵襲的な方法がまだ開発中であったり、利用できない場合には、このような研究に参加する人を募集することは困難です。

既存の診断ツールとの統合：新しいNASHバイオマーカーを既存の診断システムに導入することは大きな問題です。臨床医は肝生検のような既存の手技を明らかに凌駕し、臨床プロセスに無理なく組み込めるようになるまで、新しいバイオマーカーの導入に二の足を踏む可能性があります。

主要動向

非侵襲的バイオマーカーへのシフト：非アルコール性脂肪肝炎バイオマーカー（NASH）の非侵襲的バイオマーカーの開発に対する関心が高まっています。これらのバイオマーカーは、侵襲的な肝生検の必要性を減らし、患者により安全で便利な選択肢を提供すると同時に、早期診断やより頻繁な疾患発症のモニタリングを可能にすることを目的としています。

マルチオミクス法：ゲノミクス、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、複数のオミクス手法の統合が人気を集めています。複数の生物学的レイヤーを調査することで、研究者はNASHの病態や患者のリスク評価についてより正確で個別化された洞察を提供する包括的なバイオマーカーパネルを同定することができます。

学界と産業の協力：学術機関と製薬企業の連携はますます進んでいます。このような共同研究は、新規診断ツールの開発を加速するために、学術的専門知識と産業のリソースを組み合わせることによって、NASHバイオマーカーの発見、検証、商業化を促進するために不可欠です。

早期NASH検出への注力：NASHを早期段階で検出するためのバイオマーカーの発見が重視されるようになってきています。早期発見により早期の治療が可能となり、肝硬変や肝がんへの病勢進行を回避できる可能性があるため、患者の転帰を改善するためには早期発見が重要です。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主要調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 非アルコール性脂肪肝炎バイオマーカー市場：バイオマーカータイプ別

• 血清バイオマーカー
• 肝線維化バイオマーカー
• 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
• その他のバイオマーカー

第5章 非アルコール性脂肪肝炎バイオマーカー市場：エンドユーザー別

• 製薬企業とCRO
• 研究機関と学術機関
• 病院クリニック
• 診断センター
• その他

第6章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第7章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第8章 競合情勢

• 主要企業
• 市場シェア分析

第9章 企業プロファイル

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

第10章 市場展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第11章 市場展望付録

• 略語リスト
• 供給源と参考文献

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