Summary

Breast Cancer Diagnostics Market Summary

The global breast cancer diagnostics market size was estimated at USD 5.48 billion in 2024 and is projected to reach USD 11.36 billion by 2033, growing at a CAGR of 8.6% from 2025 to 2033. The growth can be attributed to the increasing prevalence of cancer and rising government initiatives to increase the screening and diagnostic rate.

The increasing incidence of breast cancer is expected to drive the breast cancer diagnostics market. According to the American Cancer Society’s Breast Cancer Facts & Figures 2024, breast cancer remained the most commonly diagnosed cancer among women in the United States. In 2024, an estimated 310,720 new cases of invasive breast cancer were expected to be diagnosed, along with 55,720 cases of ductal carcinoma in situ (DCIS).

Several factors contributed to the increasing incidence of breast cancer, including aging populations, lifestyle changes, genetic predisposition, and environmental influences. As life expectancy increased, more women reached ages where breast cancer risk was higher. Moreover, risk factors such as obesity, sedentary lifestyles, hormonal therapies, and delayed childbearing were linked to a greater likelihood of developing breast cancer. Increased awareness and improved screening programs also led to a rise in reported cases, as more cancers were detected at earlier stages. With the growing number of breast cancer cases, the need for effective and accurate diagnostic technologies expanded. Mammography remained the gold standard for breast cancer screening, but advancements in digital breast tomosynthesis (DBT), contrast-enhanced mammography, ultrasound, MRI, and molecular diagnostic tests drove market growth. The integration of AI in imaging interpretation further improved early detection capabilities, enhancing accuracy while reducing false positives and negatives. In addition, liquid biopsy and biomarker-based diagnostics emerged as non-invasive tools for detecting breast cancer and monitoring treatment response.

Healthcare systems worldwide increased investments in breast cancer screening programs to address the rising burden. Governments and private healthcare providers expanded access to diagnostic services, particularly in developing regions where screening rates had historically been lower. The focus on early detection and personalized medicine accelerated the adoption of next-generation sequencing (NGS), genetic testing, and companion diagnostics. As breast cancer incidence continued to rise, the breast cancer diagnostics market experienced sustained growth. Ongoing technological advancements, combined with greater awareness and improved accessibility to screening, drove demand for innovative diagnostic solutions that enabled earlier and more accurate cancer detection.

The increasing reimbursement and insurance coverage for breast cancer testing is anticipated to drive market growth. Government agencies in various countries, such as the German Federal Joint Committee, have approved tests for nationwide reimbursement. In the U.S., Medicaid, Medicare, and third-party payer benefit plans cover the cost of breast cancer genetic testing, including BRCA1 and BRCA2 tests, increasing the number of procedures conducted globally. Furthermore, Medicare Part B covers 80% of the cost of one mammogram and digital mammogram screening per year for women aged 40 and older.

In February 2025, Agendia, Inc. announced that the National Institute for Sickness and Invalidity Insurance (INAMI-RIZIV) in Brussels expanded the reimbursement criteria for MammaPrint, now covering its use in the neoadjuvant setting. Effective January 1, 2025, this decision allows full reimbursement for patients with HR+/HER2-negative early-stage breast cancer, enabling genomic testing on core needle biopsies to guide neoadjuvant treatment decisions. This expansion marks a significant step forward in providing patients with more personalized care. Professor Martine Piccart, Honorary Professor of Oncology at the Université Libre de Bruxelles, highlighted the impact of this advancement, stating, "The ability to use MammaPrint on core needle biopsy specimens in Belgium represents a major milestone for personalized breast cancer treatment. The benefits of neoadjuvant therapy are substantial, especially when guided by MammaPrint, as it enables physicians to tailor treatment plans more precisely. This can lead to less extensive surgical procedures when the appropriate treatment is selected."

MammaPrint has demonstrated strong performance in the neoadjuvant setting, particularly through studies like FLEX (NCT03053193), a prospective, real-world observational breast cancer study utilizing whole transcriptome analysis. The assay has shown high concordance between matched surgical resection samples and core needle biopsy specimens, reinforcing its clinical utility. This expanded indication underscores the critical role of genomic testing in breast cancer management, supporting more precise treatment strategies. Chief Executive Officer at Agendia, emphasized the significance of this reimbursement expansion, stating, "The broader reimbursement of MammaPrint represents a major step forward in the fight against breast cancer. This decision ensures that more women in Belgium likely to access to Agendia’s advanced diagnostic solutions, which serve as the foundation for personalized treatment decisions. We are grateful for INAMI-RIZIV’s recognition of the importance of precision medicine and look forward to continuing our commitment to improving outcomes for breast cancer patients in Belgium.

Overall technological advancements, along with increasing reimbursement and insurance coverage, have significantly improved breast cancer diagnostics, leading to earlier detection, targeted treatments, and improved patient outcomes. Ongoing research and development efforts are essential to enhance breast cancer diagnostics further as technology continues to evolve.

Global Breast Cancer Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the global breast cancer diagnostics market report based on type, product, application, end use, and region:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Imaging
• Biopsy
• Genomic Tests
• Blood Tests
• Others
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Platform-based products
o Next Generation Sequencing
o Microarrays
o PCR
o Others
• Instrument-based products
o Imaging
o 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
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Denmark
o Sweden
o Norway
• Asia Pacific
o Japan
o China
o India
o Australia
o South Korea
o Thailand
• Latin America
o Brazil
o Argentina
• Middle East and Africa
o South Africa
o Saudi Arabia
o UAE
o Kuwait

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Table of Contents

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. Platform-based Products Market, 2021 - 2033 (USD Million)
5.2.2. Next Generation Sequencing
5.2.2.1. Next Generation Sequencing market, 2021 - 2033 (USD Million)
5.2.3. Microarrays
5.2.3.1. Microarrays market, 2021 - 2033 (USD Million)
5.2.4. PCR
5.2.4.1. PCR market, 2021 - 2033 (USD Million)
5.2.5. Others
5.2.5.1. Others market, 2021 - 2033 (USD Million)
5.3. Instrument-based products
5.3.1. Instrument-based Products Market, 2021 - 2033 (USD Million)
5.3.2. Imaging
5.3.2.1. Imaging market, 2021 - 2033 (USD Million)
5.3.3. Biopsy
5.3.3.1. 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. Regional Business Analysis
8.1. Regional Market Snapshot
8.2. North America
8.2.1. North America Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.2.2. U.S.
8.2.2.1. U.S. Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.2.2.2. Key Country Dynamics
8.2.2.3. Regulatory Framework
8.2.2.4. Competitive Scenario
8.2.3. Canada
8.2.3.1. Canada Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.2.3.2. Key Country Dynamics
8.2.3.3. Regulatory Framework
8.2.3.4. Competitive Scenario
8.2.4. Mexico
8.2.4.1. Mexico Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.2.4.2. Key Country Dynamics
8.2.4.3. Regulatory Framework
8.2.4.4. Competitive Scenario
8.3. Europe
8.3.1. Europe Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.2. Germany
8.3.2.1. Germany Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.2.2. Key Country Dynamics
8.3.2.3. Regulatory Framework
8.3.2.4. Competitive Scenario
8.3.3. UK
8.3.3.1. UK Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.3.2. Key Country Dynamics
8.3.3.3. Regulatory Framework
8.3.3.4. Competitive Scenario
8.3.4. France
8.3.4.1. France Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.4.2. Key Country Dynamics
8.3.4.3. Regulatory Framework
8.3.4.4. Competitive Scenario
8.3.5. Italy
8.3.5.1. Italy Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.5.2. Key Country Dynamics
8.3.5.3. Regulatory Framework
8.3.5.4. Competitive Scenario
8.3.6. Spain
8.3.6.1. Spain Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.6.2. Key Country Dynamics
8.3.6.3. Regulatory Framework
8.3.6.4. Competitive Scenario
8.3.7. Denmark
8.3.7.1. Denmark Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.7.2. Key Country Dynamics
8.3.7.3. Regulatory Framework
8.3.7.4. Competitive Scenario
8.3.8. Sweden
8.3.8.1. Sweden Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.8.2. Key Country Dynamics
8.3.8.3. Regulatory Framework
8.3.8.4. Competitive Scenario
8.3.9. Norway
8.3.9.1. Norway Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.3.9.2. Key Country Dynamics
8.3.9.3. Regulatory Framework
8.3.9.4. Competitive Scenario
8.4. Asia Pacific
8.4.1. Asia Pacific Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.2. Japan
8.4.2.1. Japan Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.2.2. Key Country Dynamics
8.4.2.3. Regulatory Framework
8.4.2.4. Competitive Scenario
8.4.3. China
8.4.3.1. China Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.3.2. Key Country Dynamics
8.4.3.3. Regulatory Framework
8.4.3.4. Competitive Scenario
8.4.4. India
8.4.4.1. India Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.4.2. Key Country Dynamics
8.4.4.3. Regulatory Framework
8.4.4.4. Competitive Scenario
8.4.5. South Korea
8.4.5.1. South Korea Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.5.2. Key Country Dynamics
8.4.5.3. Regulatory Framework
8.4.5.4. Competitive Scenario
8.4.6. Australia
8.4.6.1. Australia Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.6.2. Key Country Dynamics
8.4.6.3. Regulatory Framework
8.4.6.4. Competitive Scenario
8.4.7. Thailand
8.4.7.1. Thailand Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.4.7.2. Key Country Dynamics
8.4.7.3. Regulatory Framework
8.4.7.4. Competitive Scenario
8.5. Latin America
8.5.1. Latin America Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.5.2. Key Country Dynamics
8.5.3. Regulatory Framework
8.5.4. Competitive Scenario
8.5.5. Brazil
8.5.5.1. Brazil Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.5.5.2. Key Country Dynamics
8.5.5.3. Regulatory Framework
8.5.5.4. Competitive Scenario
8.5.6. Argentina
8.5.6.1. Argentina Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.5.6.2. Key Country Dynamics
8.5.6.3. Regulatory Framework
8.5.6.4. Competitive Scenario
8.6. MEA
8.6.1. MEA Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.6.2. South Africa
8.6.2.1. South Africa Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.6.2.2. Key Country Dynamics
8.6.2.3. Regulatory Framework
8.6.2.4. Competitive Scenario
8.6.3. Saudi Arabia
8.6.3.1. Saudi Arabia Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.6.3.2. Key Country Dynamics
8.6.3.3. Regulatory Framework
8.6.3.4. Competitive Scenario
8.6.4. UAE
8.6.4.1. UAE Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.6.4.2. Key Country Dynamics
8.6.4.3. Regulatory Framework
8.6.4.4. Competitive Scenario
8.6.5. Kuwait
8.6.5.1. Kuwait Breast Cancer Diagnostics Market, 2021 - 2033 (USD Million)
8.6.5.2. Key Country Dynamics
8.6.5.3. Regulatory Framework
8.6.5.4. Competitive Scenario
Chapter 9. Competitive Landscape
9.1. Company Categorization
9.2. Strategy Mapping
9.2.1. Acquisition
9.2.2. Collaborations
9.2.3. New Platform Launches
9.2.4. Others
9.3. Company Profiles/Listing
9.3.1. Hologic Inc.
9.3.1.1. Company Overview
9.3.1.2. Financial Performance
9.3.1.3. Platform Benchmarking
9.3.1.4. Strategic Initiatives
9.3.2. Genomic Health (Exact Sciences Corporation)
9.3.2.1. Company Overview
9.3.2.2. Financial Performance
9.3.2.3. Platform Benchmarking
9.3.2.4. Strategic Initiatives
9.3.3. BD
9.3.3.1. Company Overview
9.3.3.2. Financial Performance
9.3.3.3. Platform Benchmarking
9.3.3.4. Strategic Initiatives
9.3.4. Danaher
9.3.4.1. Company Overview
9.3.4.2. Financial Performance
9.3.4.3. Platform Benchmarking
9.3.4.4. Strategic Initiatives
9.3.5. Koninklijke Philips N.V
9.3.5.1. Company Overview
9.3.5.2. Financial Performance
9.3.5.3. Platform Benchmarking
9.3.5.4. Strategic Initiatives
9.3.6. QIAGEN
9.3.6.1. Company Overview
9.3.6.2. Financial Performance
9.3.6.3. Platform Benchmarking
9.3.6.4. Strategic Initiatives
9.3.7. Thermo Fisher Scientific Inc
9.3.7.1. Company Overview
9.3.7.2. Financial Performance
9.3.7.3. Platform Benchmarking
9.3.7.4. Strategic Initiatives
9.3.8. Myriad Genetics
9.3.8.1. Company Overview
9.3.8.2. Financial Performance
9.3.8.3. Platform Benchmarking
9.3.8.4. Strategic Initiatives
9.3.9. Argon Medical Devices, Inc.
9.3.9.1. Company Overview
9.3.9.2. Financial Performance
9.3.9.3. Platform Benchmarking
9.3.9.4. Strategic Initiatives
9.3.10. F. Hoffmann-La Roche Ltd.
9.3.10.1. Company Overview
9.3.10.2. Financial Performance
9.3.10.3. Platform Benchmarking
9.3.10.4. Strategic Initiatives