查看購物車
  • Simplified Chinese
  • English
  • Japanese
封面
市場調查報告書
商品編碼
1842220

美國乳癌診斷市場：市場規模、佔有率、趨勢分析（按產品、類型、應用和最終用途分類）、細分市場預測（2025-2033 年）

U.S. Breast Cancer Diagnostics Market Size, Share & Trends Analysis Report By Product (Platform-based, Instrument-based), By Type (Imaging, Biopsy, Genomic Tests, Blood Tests), By Application, 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

市場規模與趨勢：

據估計，2024 年美國乳癌診斷市值為 22.6 億美元，預計到 2033 年將達到 45.3 億美元，2025 年至 2033 年的複合年成長率為 8.21%。

這一成長是由乳癌發病率的上升以及政府為提高篩檢和診斷率而採取的日益增多的舉措所推動的。例如，根據美國癌症協會統計，乳癌是美國女性最常見的癌症（不包括皮膚癌），每年約佔女性新增癌症病例的30%。據估計，到2025年，美國將新增316,950例侵襲性乳癌病例和59,080例乳管原位癌（DCIS）病例。令人痛心的是，預計將有42,170名女性死於該疾病。乳癌發病率的上升推動了對先進診斷技術的需求，例如乳房X光攝影、基因檢測和人工智慧輔助成像。公眾意識的提高、政府措施的推進以及保險覆蓋範圍的擴大將進一步促進美國篩檢計畫和創新診斷技術的普及。

美國市場受益於高發病率、強力的政策措施和快速的技術創新。乳癌仍是美國女性最常見的癌症，美國癌症協會預測，到2025年，美國將新增超過316,950例侵襲性乳癌病例。年輕族群發病率的上升，以及人們對早期檢測重要性的日益重視，正在推動對先進診斷工具的需求。美國政府和研究機構正積極透過津貼和資助來促進技術創新。例如，2024年1月，威爾康奈爾醫學院獲得了美國津貼240萬美元的撥款，用於檢驗Syantra DX液態切片測試。這是一種主導人工智慧的血液篩檢解決方案，有望顯著改善乳房組織緻密的女性以及服務不足和高風險族群的就醫途徑。非侵入性、經濟高效的檢測方法的普及有望提高早期檢出率，減少過度治療，並將市場需求從傳統影像學轉向液態切片技術。

創新術中診斷解決方案的推出也正在改變乳癌的治療方式。 2025年1月，Lumicell公司發布了Lumi系統，這是第一個獲得FDA核准的乳房腫瘤切除術的即時螢光引導成像工具。透過將Lumisite光學成像技術與直接視覺化系統（DVS）相結合，外科醫生可以在手術中識別並切除癌變組織，從而最大限度地減少再次手術的需要，並改善患者的治療效果。這些進步不僅提高了手術的精準度，也降低了長期的醫療成本。包括羅氏、賽默飛世爾科技、凱傑、BD和丹納赫在內的行業主要企業正在大力投資監管核准和合作，以擴大其市場佔有率。例如，羅氏的PATHWAY HER2 (4B5)檢測已獲得FDA核准，用於HER2低表達的轉移性乳癌患者，最近又獲準用於符合ENHERTU療法條件的HER2超低表達轉移性乳癌患者，這進一步強化了精準診斷在治療選擇中的作用。同樣，PreludeDx 的 DCISionRT 檢測於 2025 年獲得 FDA 突破性醫療器材認定，使醫生能夠為導管原位癌 (DCIS) 患者制定個人化的治療方案，避免不必要的干涉。

在美國，切片檢查仍然是一項基礎診斷方法，每年進行超過100萬例活體組織切片，其中約20%最終確診為惡性腫瘤。針刺活體組織切片，包括細針穿刺、粗針穿刺和真空輔助切片檢查，由於其微創性和患者依從性優於切片檢查病例的90%以上。 2024年11月，Mammotome公司推出了AutoCore單次穿刺活體組織切片系統，該系統透過即時視覺化、單次穿刺取樣和非接觸式檢體轉移提高了效率。同時，液態切片也迅速普及。 2024年10月，FDA核准FoundationOne Liquid CDx作為Itobevi的伴隨診斷試劑，用於攜帶PIK3CA突變的HR陽性、HER2陰性患者。這些進展凸顯了美國診斷市場向微創、精準檢測解決方案發展的大趨勢。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章 市場因素、趨勢與範圍

  • 市場關聯性展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場趨勢與展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 商業環境分析
    • PESTEL 分析
    • 波特五力分析
  • 新冠疫情影響分析

第4章 按類型進行業務分析

  • 乳癌診斷市場：按類型分類的趨勢分析（2024 年和 2033 年）
  • 影像
    • 影像市場（2021-2033）
  • 切片檢查
    • 切片檢查市場（2021-2033）
  • 基因組檢測
    • 基因組檢測市場（2021-2033）
  • 血液檢查
    • 血液檢測市場（2021-2033）
  • 其他
    • 其他市場（2021-2033 年）

第5章：依產品進行業務分析

  • 乳癌診斷市場：按產品分類的趨勢分析（2024 年和 2033 年）
  • 基於平台的產品
    • 次世代定序市場（2021-2033）
    • 微陣列市場（2021-2033）
    • PCR市場（2021-2033年）
    • 其他市場（2021-2033 年）
  • 設備類產品
    • 影像市場（2021-2033）
    • 切片檢查市場（2021-2033）

第6章：按應用程式進行業務分析

  • 乳癌診斷市場：按應用領域分類的趨勢分析（2024 年和 2033 年）
  • 篩檢
    • 篩檢市場（2021-2033）
  • 診斷與預測
    • 診斷與預測市場（2021-2033）
  • 預後
    • 預測市場（2021-2033）
  • 研究
    • 研究市場（2021-2033）

第7章 依最終用途進行業務分析

  • 乳癌診斷市場：按最終用途分類的趨勢分析（2024 年和 2033 年）
  • 醫院和診所
    • 醫院和診所市場（2021-2033 年）
  • 醫學實驗室/診斷中心
    • 醫療實驗室和診斷中心市場（2021-2033）
  • 其他
    • 其他市場（2021-2033 年）

第8章 競爭情勢

  • 公司分類
  • 策略規劃
    • 企業收購
    • 商業夥伴關係
    • 新平台推出
    • 其他
  • 公司簡介/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.
Product Code: GVR-4-68040-726-1

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)