美国乳癌诊断市场：市场规模、份额、趋势分析（按产品、类型、应用和最终用途划分）、细分市场预测（2025-2033 年）

市场规模与趋势：

据估计，2024 年美国乳癌诊断市值为 22.6 亿美元，预计到 2033 年将达到 45.3 亿美元，2025 年至 2033 年的复合年增长率为 8.21%。

这一增长是由乳癌发病率的上升以及政府为提高筛检和诊断率而采取的日益增多的倡议所推动的。例如，根据美国癌症协会统计，乳癌是美国女性最常见的癌症（不包括皮肤癌），每年约占女性新增癌症病例的30%。据估计，到2025年，美国将新增316,950例侵袭性乳癌病例和59,080例乳管原位癌（DCIS）病例。令人痛心的是，预计将有42,170名女性死于该疾病。乳癌发病率的上升推动了对先进诊断技术的需求，例如乳房X光摄影、基因检测和人工智慧辅助成像。公众意识的提高、政府措施的推进以及保险覆盖范围的扩大将进一步促进美国筛检计画和创新诊断技术的普及。

美国市场受益于高发病率、强有力的政策措施和快速的技术创新。乳癌仍是美国女性最常见的癌症，美国癌症协会预测，到2025年，美国将新增超过316,950例侵袭性乳癌病例。年轻族群发病率的上升，以及人们对早期检测重要性的日益重视，正在推动对先进诊断工具的需求。美国政府和研究机构正积极透过津贴和资助来促进技术创新。例如，2024年1月，威尔康奈尔医学院获得了美国津贴240万美元的拨款，用于检验Syantra DX液态切片测试。这是一种主导人工智慧的血液筛检解决方案，有望显着改善乳房组织緻密的女性以及服务不足和高风险族群的就医途径。非侵入性、经济高效的检测方法的普及有望提高早期检出率，减少过度治疗，并将市场需求从传统影像学转向液态切片技术。

创新术中诊断解决方案的推出也正在改变乳癌的治疗方式。 2025年1月，Lumicell公司发布了Lumi系统，这是第一个获得FDA核准的乳房肿瘤切除术的即时萤光引导成像工具。透过将Lumisite光学成像技术与直接视觉化系统（DVS）相结合，外科医生可以在手术中识别并切除癌变组织，从而最大限度地减少再次手术的需要，并改善患者的治疗效果。这些进步不仅提高了手术的精准度，也降低了长期的医疗成本。包括罗氏、赛默飞世尔科技、凯杰、BD和丹纳赫在内的行业主要企业正在大力投资监管核准和合作，以扩大其市场份额。例如，罗氏的PATHWAY HER2 (4B5)检测已获得FDA核准，用于HER2低表达的转移性乳癌患者，最近又获准用于符合ENHERTU疗法条件的HER2超低表达转移性乳癌患者，这进一步强化了精准诊断在治疗选择中的作用。同样，PreludeDx 的 DCISionRT 检测于 2025 年获得 FDA 突破性医疗器材认定，使医生能够为导管原位癌 (DCIS) 患者制定个人化的治疗方案，避免不必要的干预。

在美国，切片检查仍然是一项基础诊断方法，每年进行超过100万例活检，其中约20%最终确诊为恶性肿瘤。针刺活检，包括细针穿刺、粗针穿刺和真空辅助切片检查，由于其微创性和患者依从性优于切片检查病例的90%以上。 2024年11月，Mammotome公司推出了AutoCore单次穿刺活检系统，该系统透过即时视觉化、单次穿刺取样和非接触式检体转移提高了效率。同时，液态切片也迅速普及。 2024年10月，FDA核准FoundationOne Liquid CDx作为Itobevi的伴随诊断试剂，用于携带PIK3CA突变的HR阳性、HER2阴性患者。这些进展凸显了美国诊断市场向微创、精准检测解决方案发展的大趋势。

目录

第一章 分析方法和范围

第二章执行摘要

第三章 市场因素、趋势与范围

• 市场关联性展望
  • 母市场展望
  • 相关/附随市场展望
• 市场趋势与展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 商业环境分析
  • PESTEL 分析
  • 波特五力分析
• 新冠疫情影响分析

第四章 按类型进行业务分析

• 乳癌诊断市场：按类型分類的趋势分析（2024 年和 2033 年）
• 影像
  • 影像市场（2021-2033）
• 切片检查
  • 切片检查市场（2021-2033）
• 基因组检测
  • 基因组检测市场（2021-2033）
• 血液检查
  • 血液检测市场（2021-2033）
• 其他的
  • 其他市场（2021-2033 年）

第五章：依产品进行业务分析

• 乳癌诊断市场：按产品分類的趋势分析（2024 年和 2033 年）
• 基于平台的产品
  • 次世代定序市场（2021-2033）
  • 微阵列市场（2021-2033）
  • PCR市场（2021-2033年）
  • 其他市场（2021-2033 年）
• 设备类产品
  • 影像市场（2021-2033）
  • 切片检查市场（2021-2033）

第六章：按应用程式进行业务分析

• 乳癌诊断市场：按应用领域分類的趋势分析（2024 年和 2033 年）
• 筛检
  • 筛检市场（2021-2033）
• 诊断与预测
  • 诊断与预测市场（2021-2033）
• 预后
  • 预测市场（2021-2033）
• 研究
  • 研究市场（2021-2033）

第七章 依最终用途进行业务分析

• 乳癌诊断市场：按最终用途分類的趋势分析（2024 年和 2033 年）
• 医院和诊所
  • 医院和诊所市场（2021-2033 年）
• 医学实验室/诊断中心
  • 医疗实验室和诊断中心市场（2021-2033）
• 其他的
  • 其他市场（2021-2033 年）

第八章 竞争情势

• 公司分类
• 策略规划
  • 企业收购
  • 商业伙伴关係
  • 新平台推出
  • 其他的
• 公司简介/上市公司
  • Hologic Inc.
  • Genomic Health（Exact Sciences Corporation）
  • BD
  • Danaher
  • Koninklijke Philips NV
  • QIAGEN
  • Thermo Fisher Scientific Inc
  • Myriad Genetics
  • Argon Medical Devices, Inc.
  • F. Hoffmann-La Roche Ltd.

Market Size & Trends:

The U.S. breast cancer diagnostics market size was estimated at USD 2.26 billion in 2024 and is projected to reach USD 4.53 billion by 2033, registering a CAGR of 8.21% from 2025 to 2033. The growth can be attributed to the increasing prevalence of breast cancer and rising government initiatives to increase the screening & diagnostic rate. For instance, according to the American Cancer Society, Breast cancer remains the most prevalent cancer among women in the U.S., excluding skin cancers, accounting for nearly 30% of all new female cancer cases annually. In 2025, an estimated 316,950 new cases of invasive breast cancer and 59,080 cases of ductal carcinoma in situ (DCIS) were diagnosed. Tragically, 42,170 women are expected to die from the disease. The increasing incidence of breast cancer fuels demand for advanced diagnostic technologies such as mammography, genetic testing, and AI-powered imaging. Rising awareness, government initiatives, and expanding insurance coverage further stimulate the adoption of screening programs and innovative diagnostics across the U.S.

The market in the U.S. is supported by a high disease prevalence, strong policy initiatives, and rapid technological innovation. Breast cancer remains the most common cancer among U.S. women, with the American Cancer Society projecting over 316,950 invasive cases in 2025. Rising incidence in younger demographics, coupled with growing awareness about the importance of early detection, is fueling demand for advanced diagnostic tools. The U.S. government and research institutions are actively promoting innovation through grants and funding. For example, in January 2024, Weill Cornell Medicine received a $2.4 million Department of Defense grant to validate the Syantra DX liquid biopsy test, an AI-driven blood-based screening solution that could significantly improve access for women with dense breast tissue, underserved populations, and high-risk groups. The availability of non-invasive, cost-effective tests is expected to improve early detection, reduce aggressive treatments, and shift market demand away from traditional imaging toward liquid biopsy technologies.

The launch of innovative intraoperative diagnostic solutions is also transforming breast cancer care. In January 2025, Lumicell introduced the LumiSystem, the first FDA-approved real-time fluorescence-guided imaging tool for lumpectomy procedures. By integrating the LUMISIGHT optical imaging agent with the Direct Visualization System (DVS), surgeons are able to identify and remove cancerous tissue intraoperatively, thereby minimizing the need for repeat surgeries and improving patient outcomes. Such advancements not only enhance surgical precision but also reduce long-term healthcare costs. Key industry players, including Roche, Thermo Fisher Scientific, QIAGEN, BD, and Danaher, are investing heavily in regulatory approvals and partnerships to expand their market presence. For instance, Roche's PATHWAY HER2 (4B5) test has been granted successive FDA approvals, first for identifying HER2-low and more recently HER2-ultralow metastatic breast cancer patients eligible for ENHERTU therapy, further strengthening the role of precision diagnostics in treatment selection. Similarly, PreludeDx's DCISionRT test received FDA Breakthrough Device designation in 2025, enabling physicians to personalize treatment decisions for ductal carcinoma in situ (DCIS) patients and avoid unnecessary interventions.

Biopsy remains a fundamental diagnostic method in the U.S., with more than 1 million procedures conducted annually, of which around 20% confirm malignancy. Needle-based biopsies-comprising fine needle aspiration, core needle, and vacuum-assisted biopsies-represent over 90% of cases due to their minimally invasive nature and higher patient compliance compared to surgical biopsies. The segment is witnessing notable innovation, with Mammotome introducing the AutoCore Single Insertion Core Biopsy System in November 2024, which improves efficiency through real-time visualization, single insertion sampling, and touchless specimen transfer. At the same time, liquid biopsy is rapidly gaining ground, with the FDA approval of FoundationOne Liquid CDx in October 2024 as a companion diagnostic for Itovebi, targeting HR-positive, HER2-negative patients with PIK3CA mutations. These advancements highlight a broader trend toward minimally invasive and precision-guided testing solutions in the U.S. diagnostics market.

U.S. Breast Cancer Diagnostics Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest trends in each of the sub-segments from 2021-2033. For this study, Grand View Research has segmented the U.S. breast cancer diagnostics market report by type, product, application, and end use:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Imaging
• Biopsy
• Genomic Tests
• Blood Tests
• Others
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Platform-based products
  • Next Generation Sequencing
  • Microarrays
  • PCR
  • Others
• Instrument-based products
  • Imaging
  • Biopsy
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Screening
• Diagnostic & Predictive
• Prognostic
• Research
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics
• Medical labs & Diagnostics Centers
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Market Definitions
• 1.2. Regional Scope
• 1.3. Estimates and Forecast Timeline
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Data Visualization
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Type and Product Snapshot
• 2.3. Application and End-use Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. 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 Trends and Outlook
• 3.3. Market Dynamics
  • 3.3.1. Market Driver Analysis
  • 3.3.2. Market Restraint Analysis
• 3.4. Business Environment Analysis
  • 3.4.1. PESTLE Analysis
  • 3.4.2. Porter's Five Forces Analysis
• 3.5. COVID-19 Impact Analysis

Chapter 4. Type Business Analysis

• 4.1. Breast Cancer Diagnostics Market: Type Movement Analysis, 2024 & 2033
• 4.2. Imaging
  • 4.2.1. Imaging Market, 2021 - 2033 (USD Million)
• 4.3. Biopsy
  • 4.3.1. Biopsy Market, 2021 - 2033 (USD Million)
• 4.4. Genomic Tests
  • 4.4.1. Genomic Tests Market, 2021 - 2033 (USD Million)
• 4.5. Blood Tests
  • 4.5.1. Blood Tests Market, 2021 - 2033 (USD Million)
• 4.6. Others
  • 4.6.1. Others Market, 2021 - 2033 (USD Million)

Chapter 5. Product Business Analysis

• 5.1. Breast Cancer Diagnostics Market: Product Movement Analysis, 2024 & 2033
• 5.2. Platform-based products
  • 5.2.1. Next-generation Sequencing Market, 2021 - 2033 (USD Million)
  • 5.2.2. Microarrays Market, 2021 - 2033 (USD Million)
  • 5.2.3. PCR Market, 2021 - 2033 (USD Million)
  • 5.2.4. Others Market, 2021 - 2033 (USD Million)
• 5.3. Instrument-based products
  • 5.3.1. Imaging Market, 2021 - 2033 (USD Million)
  • 5.3.2. Biopsy Market, 2021 - 2033 (USD Million)

Chapter 6. Application Business Analysis

• 6.1. Breast Cancer Diagnostics Market: Application Movement Analysis, 2024 & 2033
• 6.2. Screening
  • 6.2.1. Screening Market, 2021 - 2033 (USD Million)
• 6.3. Diagnostic & Predictive
  • 6.3.1. Diagnostic & Predictive Market, 2021 - 2033 (USD Million)
• 6.4. Prognostic
  • 6.4.1. Prognostic Market, 2021 - 2033 (USD Million)
• 6.5. Research
  • 6.5.1. Research Market, 2021 - 2033 (USD Million)

Chapter 7. End-use Business Analysis

• 7.1. Breast Cancer Diagnostics Market: End-use Movement Analysis, 2024 & 2033
• 7.2. Hospitals & Clinics
  • 7.2.1. Hospitals & Clinics Market, 2021 - 2033 (USD Million)
• 7.3. Medical labs & Diagnostics Centers
  • 7.3.1. Medical labs & Diagnostics Centers Market, 2021 - 2033 (USD Million)
• 7.4. Others
  • 7.4.1. Others Market, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Strategy Mapping
  • 8.2.1. Acquisition
  • 8.2.2. Collaborations
  • 8.2.3. New Platform Launches
  • 8.2.4. Others
• 8.3. Company Profiles/Listing
  • 8.3.1. Hologic Inc.
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Platform Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Genomic Health (Exact Sciences Corporation)
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Platform Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. BD
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Platform Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Danaher
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Platform Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Koninklijke Philips N.V
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Platform Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. QIAGEN
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Platform Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Thermo Fisher Scientific Inc
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Platform Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Myriad Genetics
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Platform Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Argon Medical Devices, Inc.
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Platform Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. F. Hoffmann-La Roche Ltd.
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Platform Benchmarking
    • 8.3.10.4. Strategic Initiatives

List of Tables

• TABLE 1 List of secondary sources
• TABLE 2 List of abbreviations
• TABLE 3 U.S. Breast Cancer Diagnostics Market, by Type, 2021 - 2033 (USD Million)
• TABLE 4 U.S. Breast Cancer Diagnostics Market, by Product, 2021 - 2033 (USD Million)
• TABLE 5 U.S. Breast Cancer Diagnostics Market by Application, 2021 - 2033 (USD Million)
• TABLE 6 U.S. Breast Cancer Diagnostics Market by End-use, 2021 - 2033 (USD Million)

List of Figures

• FIG. 1 Market Research Process
• FIG. 2 Information Procurement
• FIG. 3 Primary Research Pattern
• FIG. 4 Market Research Approaches
• FIG. 5 Value Chain-Based Sizing & Forecasting
• FIG. 6 Market Formulation & Validation
• FIG. 7 Market Segmentation
• FIG. 8 Market Snapshot, 2024
• FIG. 9 Market Trends & Outlook
• FIG. 10 Market Driver Relevance Analysis (Current & Future Impact)
• FIG. 11 Market Restraint Relevance Analysis (Current & Future Impact)
• FIG. 12 SWOT Analysis, By Factor (Political & Legal, Economic, And Technological)
• FIG. 13 Porter's Five Forces Analysis
• FIG. 14 Market Penetration & Growth Prospect Mapping, 2024
• FIG. 15 U.S. Breast Cancer Diagnostics Market: Type Movement Analysis
• FIG. 16 U.S. Imaging Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 17 U.S. Biopsy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 18 U.S. Genomic Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 19 U.S. Blood Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 20 U.S. Other Tests Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 21 U.S. Breast Cancer Diagnostics Market: Product Movement Analysis
• FIG. 22 U.S. Platform-Based Products Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 23 U.S. Imaging Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 24 U.S. Biopsy Products Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 25 U.S. Instrument-Based Products Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 26 U.S. Microarrays Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 27 U.S. PCR Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 28 U.S. Next Generation Sequencing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 29 U.S. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 30 U.S. Breast Cancer Diagnostics Market: Application Movement Analysis
• FIG. 31 U.S. Screening Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 32 U.S. Diagnostic & Predictive Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 33 U.S. Prognostic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 34 U.S. Research Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 35 U.S. Breast Cancer Diagnostics Market: End-Use Movement Analysis
• FIG. 36 U.S. Hospitals & Clinics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 37 U.S. Medical Labs & Diagnostics Centers Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• FIG. 38 U.S. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)