The global breast cancer diagnostics market size was estimated at USD 5.86 Billion in 2025 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.
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, the analyst 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
- Instrument-based products
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
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Market Variables, Trends, & Scope
Chapter 4. Type Business Analysis
Chapter 5. Product Business Analysis
Chapter 6. Application Business Analysis
Chapter 7. End Use Business Analysis
Chapter 8. Regional Business Analysis
Chapter 9. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this Breast Cancer Diagnostics market report include:- ologic Inc.
- enomic Health (Exact Sciences Corporation)
- D
- anaher
- oninklijke Philips N.V.
- IAGEN
- hermo Fisher Scientific Inc.
- rgon Medical Devices, Inc.
- yriad Genetics
- . Hoffmann-La Roche Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 130 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 5.86 Billion |
| Forecasted Market Value ( USD | $ 11.36 Billion |
| Compound Annual Growth Rate | 8.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
