The U.S. breast cancer diagnostics market size is calculated at USD 7,809 million in 2024 and is predicted to attain around USD 16,703 million by 2034, expanding at a CAGR of 7.9% from 2025 to 2034.
U.S. Breast Cancer Diagnostics Market Report Highlights
- By Type, the imaging segment dominated the market with the largest share in 2024.
- By Type, the blood tests segment is anticipated to grow during the forecast period.
- By product, the instruments-based products segment dominated the U.S. breast cancer diagnostics market in 2024.
- By product, the platform-based products segment is expected to be the fastest growing during the forecast period.
- By application, the diagnostic and predictive application segment dominated the market with the highest revenue share in 2024.
- By application, the prognostic application segment is expected to grow fastest during the forecast period.
- By end use, the hospitals & clinics end-use segment dominated the U.S. breast cancer diagnostics market in 2024.
- By end use, the medical labs & diagnostics centers segment is anticipated to grow at the fastest growth rate over the forecast period.
Industry Valuation and Growth Rate Projection
| Industry Worth |
Details |
| Market Size in 2025 |
USD 8,426 Million |
| Market Size by 2034 |
USD 16,703 Million |
| Market Growth Rate from 2025 to 2034 |
CAGR of 7.9% |
The U.S. breast cancer diagnostics market refers to the production, distribution, and use of breast cancer diagnostics in which mammograms are used commonly to screen for breast cancer. If a screening mammogram finds something concerning, you may have another mammogram to look at the area more closely. This more detailed mammogram is called a diagnostic mammogram. It may used to look closely at both breasts. Breast cancer is also commonly diagnosed by a breast biopsy, which involves taking a sample of breast tissue from a suspicious area and sending it to a laboratory for microscopic examination by a pathologist, a doctor who specializes in identifying signs of disease. Recent reports from the American Cancer Society show that 2% of women will develop invasive breast cancer by the age of 50. Early detection through screening will lead to catching breast cancers at a stage where they are still treatable and curable.
The rising adoption of digital breast tomosynthesis (DBT) led to a strong demand for advanced breast cancer screening technologies. The advantages of DBT are well established. As compared to two-dimensional digital mammography (DM), DBTs show a higher rate of detection of in-situ cancers, with more accurate identification of biologically significant diseases while mitigating overdiagnosis. The higher sensitivity of DBT for architectural distortion allows increased diagnosis of invasive cancers overall and particularly enhances the visibility of invasive lobular cancers. DBT has improved the sensitivity and specificity of mammography, yielding a sustainable increase in the detection of invasive cancer. This unique technique provides a dual benefit to patients screened for breast cancer, which is driving the growth of the U.S. breast cancer diagnostics market.
Advancements in diagnosis and treatment in breast cancer diagnostics contribute to the growth of the U.S. breast cancer diagnostics market. Diagnostic testing is a rapidly evolving space in the biotechnology field due to advances in research and technological innovations. As new diagnostic tools emerge, they allow healthcare professionals to catch previously undetectable cancers, paving the way for early treatment and remission. The advancements in imaging technologies have enhanced the ability of clinicians to detect, diagnose, and treat conditions while also allowing patients to avoid more invasive procedures. Diagnosis plays an important role in clinical decision-making. Access to timely and effective diagnostic services and high-quality care, reducing waiting times for treatment and enhancing health outcomes. Early diagnosis is also an important public health strategy due to delays in identifying patients with infectious diseases or promoting spread. These advances have considerably enhanced disease diagnosis, treatment, and management, enhancing patient outcomes and quality of life.
Artificial intelligence (AI) integration and advancements in breast cancer treatments are driving the growth of the U.S. breast cancer diagnostics market. Digital breast tomosynthesis (DBT) screening exam, also known as 3D mammography, has become the best practice for women’s health for breast cancer detecting technology. Breast tomosynthesis differs from traditional mammograms in how the image of the breast is obtained and, more importantly, viewed. Advancements in cancer diagnosis include advances in imaging, histopathology, and molecular diagnostic technologies, as well as an integrated and complementary approach to many testing methods, which is an essential part of driving the continued advancements of the clinical diagnosis and treatment of cancer. Artificial intelligence is transforming breast cancer management by improving imaging, pathology, and personalized treatment. In imaging, AI can enhance the accuracy of cancer detection in mammography, MRIs, and ultrasounds, rivaling expert radiologists. Implementing artificial intelligence is beneficial to the radiologist’s diagnostics process for identifying breast cancer using ultrasound. Artificial intelligence systems can check images against the standards to distinguish what is normal and what is not.
According to research, the National Cancer Institute-supported AI imaging algorithms enhance breast cancer detection on mammography and can also help predict the long-term risk of invasive breast cancers. NCI scientists are using AI to improve cervical and prostate cancer screening, which is driving the growth of the U.S. breast cancer diagnostics market. NCI’s mission is to lead, conduct, and support cancer research across the country to innovate scientific knowledge and help all people live longer and healthier.