美国肝癌诊断市场规模、份额和趋势分析报告：按测试类型、最终用途和细分市场预测，2025-2033 年

美国肝癌诊断市场趋势：

预计 2024 年美国肝癌诊断市值将达到 31.4 亿美元，到 2033 年将达到 44.4 亿美元，2025 年至 2033 年的复合年增长率为 3.74%。

肝癌和肝内胆管癌仍然是美国沉重的健康负担，预计2025年将新增42,240例病例，死亡30,090例（数据来源于美国美国癌症研究所；美国癌症协会）。美国肝癌诊断市场的发展受到发病率上升的驱动，而发病率的上升与慢性乙型/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关。影像学、基于生物标记的血液检测和分子诊断技术的应用日益广泛，指南早期发现和标靶治疗。

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美国肝癌诊断市场正在经历快速转型，其影响因素包括疾病盛行率的上升、早期检测创新技术的进步以及FDA多项重塑临床实践的核准和认定。根据美国国家癌症研究所 (NCI) 和美国美国协会的数据，预计2025年将新增42,240例肝癌和肝内胆管癌病例，导致约30,090人死亡。肝细胞癌 (HCC) 是最常见的肝癌类型，也是美国成长最快、最致命的癌症之一。由于诊断延迟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) 盛行率上升等潜在风险因素，HCC 的死亡率持续上升。

近期的监管里程碑正在重塑治疗和诊断生态系统。 2025年7月，Sirtex Medical的SIR-Spheres钇-90树脂微球获得美国食品药物管理局（FDA）核准，用于治疗不可切除的肝细胞癌，使其成为美国唯一核准治疗肝细胞癌和转移性结直肠癌的放射栓塞疗法。 DOORwaY90临床试验结果显示其疗效显着，整体缓解率为98.5%，局部肿瘤控制率为100%，这使得SIR-Spheres成为肝臟定向治疗的强大工具。

除了治疗方法的进步，诊断技术也不断开拓新领域。 2025年4月，Mursula Bio的EvoLiver血液检测获得FDA突破性医疗设备认证，用于监测肝硬化高风险患者的肝细胞癌。凭藉MEV01试验的强劲数据，EvoLiver在早期检测中展现出86%的敏感性和88%的特异性，显着优于传统的超音波和甲胎蛋白（AFP）检测。透过捕捉器官特异性细胞外囊泡并应用多组体学物标记物，EvoLiver引入了一种更便捷、非侵入性且高度准确的监测方法，有望改善患者的依从性和治疗效果。

策略联盟进一步阐明了市场发展轨迹。 2025年6月，富士软片医疗系统美国公司与Helio Health合作，将HelioLiver Test与富士软片的μTASWako i30系统结合，推进了一项以血液为基础的HCC早期检测方法。美国CLiMB试验的临床数据显示，与现有方法相比，该方法对早期HCC检测的灵敏度和特异性更高，凸显了人工智慧主导的生物标记组合在扩大监测范围方面的作用。

同时，FUJIFILM医疗美国公司正主导TRACER试验。这是一项由美国国立卫生研究院（NIH）资助的大规模多中心试验，预计将于2024年启动，旨在评估GALAD评分（该评分将生物标誌物AFP、AFP-L3和DCP与患者特征相结合）如何改善高风险患者的早期HCC检测。该试验招募了5500名肝硬化或慢性乙型肝炎患者，旨在检验一种可能降低晚期诊断率的生物标记主导的筛检模型。

产业领导者也正在转向生物标誌物主导的液态切片平台。 2024年5月，Exact Sciences的Oncoguard Liver液态切片检测发表在《临床胃肠病学和肝病学》杂誌上，其早期敏感性为82%，整体敏感性为88%，特异性为87%，超越了目前的AFP和基于超音波的方法。这项检测代表了肝细胞癌监测领域的重要进展，预计将早期检测范围扩大到数百万目前筛检的高风险美国人。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国肝癌诊断市场变数、趋势与范围

• 市场体系展望
  • 母市场展望
  • 相关/辅助市场前景。
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 美国肝癌诊断市场分析工具
  • 产业分析-波特五力分析
  • PESTEL分析

第四章美国肝癌诊断市场依检测类型估计及趋势分析

• 细分仪表板
• 美国肝癌诊断市场趋势分析：检测类型
• 2021-2033 年美国肝癌诊断市场规模及趋势分析（依检测类型）
  • 临床测试市场，2021-2033
  • 影像学诊断
  • 内视镜检查
  • 切片检查

第五章美国肝癌诊断市场最终用途的估计与趋势分析

• 2024 年和 2033 年按最终用途分類的市场份额
• 细分仪表板
• 美国肝癌诊断市场前景（按最终用途）
• 2021-2033年市场规模、预测与趋势分析
• 医院和诊断实验室
• 学术研究机构
• 製药和CRO实验室

第六章 竞争态势

• 主要市场参与企业的近期趋势和影响分析
• 公司/竞争对手分类
• 供应商格局
  • 主要经销商和通路合作伙伴名单
  • 主要客户
  • 2024年主要企业市占率分析
  • 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.

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