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市場調查報告書
商品編碼
1813912

美國肝癌診斷市場規模、佔有率和趨勢分析報告：按測試類型、最終用途和細分市場預測，2025-2033 年

U.S. Liver Cancer Diagnostics Market Size, Share & Trends Analysis Report By Test Type, By End-use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10個工作天內

價格

美國肝癌診斷市場趨勢：

預計 2024 年美國肝癌診斷市值將達到 31.4 億美元，到 2033 年將達到 44.4 億美元，2025 年至 2033 年的複合年成長率為 3.74%。

肝癌和肝內膽管癌仍然是美國沉重的健康負擔，預計2025年將新增42,240例病例，死亡30,090例（數據來源於美國美國癌症研究所；美國癌症協會）。美國肝癌診斷市場的發展受到發病率上升的驅動，而發病率的上升與慢性乙型/丙型肝炎感染、酒精性肝病、非酒精性脂肪性肝病 (NAFLD) 和肥胖症的盛行率上升有關。影像學、基於生物標記的血液檢測和分子診斷技術的應用日益廣泛，指南早期發現和標靶治療。

請索取此報告的免費樣本以供參考。

美國肝癌診斷市場正在經歷快速轉型，其影響因素包括疾病盛行率的上升、早期檢測創新技術的進步以及FDA多項重塑臨床實踐的核准和認定。根據美國國家癌症研究所 (NCI) 和美國美國協會的數據，預計2025年將新增42,240例肝癌和肝內膽管癌病例，導致約30,090人死亡。肝細胞癌 (HCC) 是最常見的肝癌類型，也是美國成長最快、最致命的癌症之一。由於診斷延遲以及乙型肝炎和丙型肝炎、酒精性肝病、肥胖以及非酒精性脂肪性肝病 (NAFLD) 盛行率上升等潛在風險因素，HCC 的死亡率持續上升。

近期的監管里程碑正在重塑治療和診斷生態系統。 2025年7月，Sirtex Medical的SIR-Spheres釔-90樹脂微球獲得美國食品藥物管理局（FDA）核准，用於治療不可切除的肝細胞癌，使其成為美國唯一核准治療肝細胞癌和轉移性結直腸癌的放射栓塞療法。 DOORwaY90臨床試驗結果顯示其療效顯著，整體緩解率為98.5%，局部腫瘤控制率為100%，這使得SIR-Spheres成為肝臟定向治療的強大工具。

除了治療方法的進步，診斷技術也不斷開拓新領域。 2025年4月，Mursula Bio的EvoLiver血液檢測獲得FDA突破性醫療設備認證，用於監測肝硬化高風險患者的肝細胞癌。憑藉MEV01試驗的強勁數據，EvoLiver在早期檢測中展現出86%的敏感性和88%的特異性，顯著優於傳統的超音波和甲胎蛋白（AFP）檢測。透過捕捉器官特異性細胞外囊泡並應用多組體學物標記物，EvoLiver引入了一種更便捷、非侵入性且高度準確的監測方法，有望改善患者的依從性和治療效果。

策略聯盟進一步闡明了市場發展軌跡。 2025年6月，富士軟片醫療系統美國公司與Helio Health合作，將HelioLiver Test與富士軟片的μTASWako i30系統結合，推進了一項以血液為基礎的HCC早期檢測方法。美國CLiMB試驗的臨床數據顯示，與現有方法相比，該方法對早期HCC檢測的靈敏度和特異性更高，凸顯了人工智慧主導的生物標記組合在擴大監測範圍方面的作用。

同時，FUJIFILM醫療美國公司正主導TRACER試驗。這是一項由美國國立衛生研究院（NIH）資助的大規模多中心試驗，預計將於2024年啟動，旨在評估GALAD評分（該評分將生物標記AFP、AFP-L3和DCP與患者特徵相結合）如何改善高風險患者的早期HCC檢測。該試驗招募了5500名肝硬化或慢性乙型肝炎患者，旨在檢驗一種可能降低晚期診斷率的生物標記主導的篩檢模型。

產業領導者也正在轉向生物標記主導的液態切片平台。 2024年5月，Exact Sciences的Oncoguard Liver液態切片檢測發表在《臨床胃腸病學和肝病學》雜誌上，其早期敏感性為82%，整體敏感性為88%，特異性為87%，超越了目前的AFP和基於超音波的方法。這項檢測代表了肝細胞癌監測領域的重要進展，預計將早期檢測範圍擴大到數百萬目前篩檢的高風險美國人。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國肝癌診斷市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場前景。
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 美國肝癌診斷市場分析工具
    • 產業分析-波特五力分析
    • PESTEL分析

第4章美國肝癌診斷市場依檢測類型估計及趨勢分析

  • 細分儀表板
  • 美國肝癌診斷市場趨勢分析：檢測類型
  • 2021-2033 年美國肝癌診斷市場規模及趨勢分析（依檢測類型）
    • 臨床測試市場，2021-2033
    • 影像學診斷
    • 內視鏡檢查
    • 切片檢查

第5章美國肝癌診斷市場最終用途的估計與趨勢分析

  • 2024 年和 2033 年按最終用途分類的市場佔有率
  • 細分儀表板
  • 美國肝癌診斷市場前景（按最終用途）
  • 2021-2033年市場規模、預測與趨勢分析
  • 醫院和診斷實驗室
  • 學術研究機構
  • 製藥和CRO實驗室

第6章 競爭態勢

  • 主要市場參與企業的近期趨勢和影響分析
  • 公司/競爭對手分類
  • 供應商格局
    • 主要經銷商和通路合作夥伴名單
    • 主要客戶
    • 2024年主要企業市佔率分析
    • Abbott Laboratories
    • Thermo Fisher Scientific, Inc.
    • F. Hoffmann-La Roche Ltd.
    • Qiagen NV
    • Siemens Healthineers
    • Becton, Dickinson &Company
    • Illumina, Inc.
    • Epigenomics AG
    • Koninklijke Philips NV
    • Fujifilm Medical Systems USA, Inc.
Product Code: GVR-4-68040-290-2

U.S. Liver Cancer Diagnostics Market Trends:

The U.S. liver cancer diagnostics market size was estimated at USD 3.14 billion in 2024 and is projected to reach USD 4.44 billion by 2033, growing at a CAGR of 3.74% from 2025 to 2033. In the United States, liver and intrahepatic bile duct cancers remain a major health burden, with an estimated 42,240 new cases and 30,090 deaths projected in 2025 (National Cancer Institute; American Cancer Society). The U.S. liver cancer diagnostics market is driven by rising incidence linked to chronic hepatitis B/C infections, alcohol-related liver disease, and the growing prevalence of non-alcoholic fatty liver disease (NAFLD) and obesity. Increasing adoption of imaging modalities, biomarker-based blood tests, and molecular diagnostics is enhancing early detection and guiding targeted therapies, strengthening demand for advanced diagnostic solutions.

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The U.S. liver cancer diagnostics market is experiencing rapid transformation, shaped by rising disease incidence, increasing innovation in early detection, and multiple FDA-backed approvals and designations that are reshaping clinical practice. According to the National Cancer Institute (NCI) and the American Cancer Society, an estimated 42,240 new cases of liver and intrahepatic bile duct cancer are expected to be diagnosed in 2025, with approximately 30,090 deaths projected in the same year. Hepatocellular carcinoma (HCC), the most common form of liver cancer, remains one of the fastest growing and deadliest cancers in the country, with mortality rates continuing to escalate due to late-stage detection and underlying risk factors such as hepatitis B and C, alcoholic liver disease, obesity, and the rising prevalence of non-alcoholic fatty liver disease (NAFLD).

Recent regulatory milestones are reshaping the treatment and diagnostics ecosystem. In July 2025, Sirtex Medical's SIR-Spheres Y-90 resin microspheres received FDA approval for the treatment of unresectable HCC, making it the only radioembolization therapy approved for both HCC and metastatic colorectal cancer in the United States. Results from the DOORwaY90 clinical trial demonstrated outstanding efficacy, with an overall response rate of 98.5% and a 100% local tumor control rate, positioning SIR-Spheres as a powerful tool in liver-directed therapies.

Complementing therapeutic advances, diagnostics are also breaking new ground. In April 2025, Mursla Bio's EvoLiver blood test received FDA breakthrough device designation for surveillance of HCC in patients with high-risk cirrhosis, marking the first such test in over five years. Backed by strong data from the MEV01 trial, EvoLiver demonstrated 86% sensitivity and 88% specificity in early-stage detection, significantly outperforming traditional ultrasound and AFP testing. By capturing organ-specific extracellular vesicles and employing multiomics biomarkers, EvoLiver introduces a more convenient, non-invasive, and highly accurate surveillance method with the potential to transform patient adherence and outcomes.

Strategic collaborations further highlight the market's trajectory. In June 2025, FUJIFILM Medical Systems U.S.A. and Helio Health partnered to advance blood-based assays for early HCC detection, leveraging the HelioLiver Test in combination with Fujifilm's µTASWako i30 system. Clinical data from the U.S. CLiMB trial showed higher sensitivity and specificity for early-stage HCC detection compared to existing modalities, underscoring the role of AI-driven biomarker panels in broadening surveillance access.

In parallel, FUJIFILM Healthcare Americas is leading the TRACER study, a large-scale, multi-center NIH-funded trial launched in 2024, evaluating the GALAD score, which combines biomarkers AFP, AFP-L3, and DCP with patient demographics to improve early HCC detection in high-risk patients. By enrolling 5,500 participants with cirrhosis or chronic hepatitis B, the study aims to validate biomarker-driven screening models that could reduce the rate of late-stage diagnoses.

Industry leaders are also focusing on biomarker-driven liquid biopsy platforms. In May 2024, Exact Sciences' Oncoguard Liver liquid biopsy test, published in Clinical Gastroenterology and Hepatology, demonstrated 82% early-stage sensitivity and 88% overall sensitivity with 87% specificity, outperforming current AFP- and ultrasound-based methods. This test represents a significant advancement in HCC surveillance, with the potential to extend early detection to millions of at-risk Americans who remain unscreened.

U.S. Liver Cancer Diagnostics Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. liver cancer diagnostics market report based on the test type, and end use:

  • Test type Outlook (Revenue, USD Million, 2021 - 2033)
  • Laboratory Tests
    • Biomarkers
    • Oncofetal and Glycoprotein Antigens
    • Enzymes and Isoenzymes
    • Growth Factors and Receptors
    • Molecular Markers
    • Pathological Biomarkers
    • Blood Tests
  • Imaging
  • Endoscopy
  • Biopsy
  • End use Outlook (Revenue, USD Million, 2021 - 2033)
  • Hospitals & Diagnostic Laboratories
  • Academic & Research Institutes
  • Pharmaceutical & CRO Laboratories

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Test type
    • 1.2.2. End Use
    • 1.2.3. Regional scope
    • 1.2.4. Estimates and forecasts timeline.
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased database
    • 1.4.2. GVR's internal database
    • 1.4.3. Secondary sources
    • 1.4.4. Primary research
    • 1.4.5. Details of primary research
  • 1.5. Information or Data Analysis
    • 1.5.1. Data analysis models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Approach 1: Commodity flow approach
    • 1.7.3. Volume price analysis (Model 2)
    • 1.7.4. Approach 2: Volume price analysis
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Test type outlook
    • 2.2.2. End Use outlook
    • 2.2.3. Regional outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Liver Cancer Diagnostics Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook.
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
      • 3.2.1.1. Increasing Incidence of Liver Cancer
      • 3.2.1.2. Technological Advancements
      • 3.2.1.3. Extensive R&D For Developing Novel Testing Solutions
    • 3.2.2. Market restraint analysis
      • 3.2.2.1. High Cost of Diagnostic imaging
  • 3.3. U.S. Liver Cancer Diagnostics Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
    • 3.3.2. PESTEL Analysis

Chapter 4. U.S. Liver Cancer Diagnostics Market: Test Type Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Liver Cancer Diagnostics Market: Test Type Movement Analysis
  • 4.3. U.S. Liver Cancer Diagnostics Market Size & Trend Analysis, by test type, 2021 to 2033 (USD Million)
    • 4.3.1. Laboratory Tests Market, 2021 - 2033 (USD MILLION)
      • 4.3.1.1. Biomarkers
        • 4.3.1.1.1. biomarkers market, 2021 - 2033 (USD million)
          • 4.3.1.1.1.1. Oncofetal and Glycoprotein Antigens
            • 4.3.1.1.1.1.1. oncofetal and glycoprotein antigens market, 2021 - 2033 (USD million)
          • 4.3.1.1.1.2. Enzymes and Isoenzymes
            • 4.3.1.1.1.2.1. Enzymes and isoenzymes market, 2021 - 2033 (USD million)
          • 4.3.1.1.1.3. Growth Factors and Receptors
            • 4.3.1.1.1.3.1. Growth factors and receptors market, 2021 - 2033 (USD million)
          • 4.3.1.1.1.4. Molecular Markers
            • 4.3.1.1.1.4.1. Molecular markers market, 2021 - 2033 (USD million)
          • 4.3.1.1.1.5. Pathological Biomarkers
            • 4.3.1.1.1.5.1. Pathological biomarkers market, 2021 - 2033 (USD million)
      • 4.3.1.2. Blood Tests
        • 4.3.1.2.1. Blood tests market, 2021 - 2033 (USD million)
    • 4.3.2. Imaging
      • 4.3.2.1. Imaging Market, 2021 - 2033 (USD million)
    • 4.3.3. Endoscopy
      • 4.3.3.1. Endoscopy Market, 2021 - 2033 (USD million)
    • 4.3.4. Biopsy
      • 4.3.4.1. Biopsy Market, 2021 - 2033 (USD million)

Chapter 5. U.S. Liver Cancer Diagnostics Market: End Use Estimates & Trend Analysis

  • 5.1. End Use Market Share, 2024 & 2033
  • 5.2. Segment Dashboard
  • 5.3. U.S. Liver Cancer Diagnostics Market by End Use Outlook
  • 5.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
  • 5.5. Hospitals & Diagnostic Laboratories
    • 5.5.1. Hospitals & Diagnostic Laboratories market, 2021 - 2033 (USD million)
  • 5.6. Academic & Research Institutes
    • 5.6.1. Academic & Research Institutes Market, 2021 - 2033 (USD million)
  • 5.7. Pharmaceutical & CRO Laboratories
    • 5.7.1. Pharmaceutical & CRO Laboratories market, 2021 - 2033 (USD million)

Chapter 6. Competitive Landscape

  • 6.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 6.2. Company/Competition Categorization
  • 6.3. Vendor Landscape
    • 6.3.1. List of key distributors and channel partners
    • 6.3.2. Key customers
    • 6.3.3. Key company market share analysis, 2024
    • 6.3.4. Abbott Laboratories
      • 6.3.4.1. Company overview
      • 6.3.4.2. Financial performance
      • 6.3.4.3. Services benchmarking
      • 6.3.4.4. Strategic initiatives
    • 6.3.5. Thermo Fisher Scientific, Inc.
      • 6.3.5.1. Company overview
      • 6.3.5.2. Financial performance
      • 6.3.5.3. Services benchmarking
    • 6.3.6. F. Hoffmann-La Roche Ltd.
      • 6.3.6.1. Strategic initiatives
      • 6.3.6.2. Company overview
      • 6.3.6.3. Financial performance
      • 6.3.6.4. Services benchmarking
      • 6.3.6.5. Strategic initiatives
    • 6.3.7. Qiagen N.V.
      • 6.3.7.1. Company overview
      • 6.3.7.2. Financial performance
      • 6.3.7.3. Services benchmarking
      • 6.3.7.4. Strategic initiatives
    • 6.3.8. Siemens Healthineers
      • 6.3.8.1. Company overview
      • 6.3.8.2. Financial performance
      • 6.3.8.3. Services benchmarking
      • 6.3.8.4. Strategic initiatives
    • 6.3.9. Becton, Dickinson & Company
      • 6.3.9.1. Company overview
      • 6.3.9.2. Financial performance
      • 6.3.9.3. Services benchmarking
      • 6.3.9.4. Strategic initiatives
    • 6.3.10. Illumina, Inc.
      • 6.3.10.1. Company overview
      • 6.3.10.2. Financial performance
      • 6.3.10.3. Services benchmarking
      • 6.3.10.4. Strategic initiatives
    • 6.3.11. Epigenomics AG
      • 6.3.11.1. Company overview
      • 6.3.11.2. Financial performance
      • 6.3.11.3. Services benchmarking
      • 6.3.11.4. Strategic initiatives
    • 6.3.12. Koninklijke Philips N.V.
      • 6.3.12.1. Company overview
      • 6.3.12.2. Financial performance
    • 6.3.13. Fujifilm Medical Systems U.S.A., Inc.
      • 6.3.13.1. Services benchmarking
      • 6.3.13.2. Strategic initiatives
      • 6.3.13.3. Company overview
      • 6.3.13.4. Financial performance
      • 6.3.13.5. Services benchmarking
      • 6.3.13.6. Strategic initiatives

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. Liver cancer diagnostics market, by test type, 2021 - 2033 (USD Million)
  • Table 3 U.S. Liver cancer diagnostics market, by end user, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Primary interviews in U.S.
  • Fig. 5 Market research approaches
  • Fig. 6 Value-chain-based sizing & forecasting
  • Fig. 7 QFD modeling for market share assessment
  • Fig. 8 Market formulation & validation
  • Fig. 9 U.S. Liver cancer diagnostics market: market outlook
  • Fig. 10 Liver cancer diagnostics competitive insights
  • Fig. 11 Parent market outlook
  • Fig. 12 Related/ancillary market outlook
  • Fig. 13 Penetration and growth prospect mapping
  • Fig. 14 Industry value chain analysis
  • Fig. 15 U.S. Liver cancer diagnostics market driver impact
  • Fig. 16 U.S. Liver cancer diagnostics market restraint impact
  • Fig. 17 U.S. Liver cancer diagnostics market strategic initiatives analysis
  • Fig. 18 U.S. Liver cancer diagnostics market: Test type movement analysis
  • Fig. 19 U.S. Liver cancer diagnostics market: Test type outlook and key takeaways
  • Fig. 20 Laboratory Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 21 Biomarkers Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 22 Oncofetal and Glycoprotein Antigens Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 23 Enzymes and Isoenzymes Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 24 Growth Factors and Receptors Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 25 Molecular Markers Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 26 Pathological Biomarkers Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 27 Blood Tests Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 28 Imaging Liver Cancer Diagnostics estimates and forecast, 2021 - 2033
  • Fig. 29 Endoscopy Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 30 Biopsy Liver Cancer Diagnostics market estimates and forecast, 2021 - 2033
  • Fig. 31 U.S. Liver cancer diagnostics market: End use movement analysis
  • Fig. 32 U.S. Liver cancer diagnostics market: End use outlook and key takeaways
  • Fig. 33 Hospitals & Diagnostic Laboratories market estimates and forecasts, 2021 - 2033
  • Fig. 34 Academic and Research Institutes market estimates and forecasts, 2021 - 2033
  • Fig. 35 Pharmaceutical & CRO Laboratories market estimates and forecasts, 2021 - 2033
  • Fig. 36 Market share of key market players- U.S. Liver cancer diagnostics market