PUBLISHER: Grand View Research | PRODUCT CODE: 1908606
PUBLISHER: Grand View Research | PRODUCT CODE: 1908606
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 8.8% from 2026 to 2033. The growth can be attributed to the increasing prevalence of cancer and rising government initiatives to increase the screening and diagnostic rates.
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 U.S. 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. In addition, 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. 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 have 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 advancements in technology, 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.
Moreover, In February 2025, Agendia, Inc. announced that the National Institute for Sickness and Invalidity Insurance (INAMI-RIZIV) in Brussels has 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 Universite 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."
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 2021-2033. For this report, Grand View Research has segmented the breast cancer diagnostics market by type, product, application end use, and region.