The U.S. market for breast cancer diagnostic devices will surpass $2 billion by 2020, driven by the growing prevalence of breast cancer, an aging patient population, and an increasing awareness of breast cancer and the need for early diagnosis, according to market research firm Pharmaion.
In addition, a favorable reimbursement environment is encouraging people to visit diagnostic laboratories and hospitals for breast cancer screening, Pharmaion's report claims. The sector will also be propelled by technological advances such as contrast-enhanced mammography, novel breast cancer diagnostic biomarkers, vacuum-assisted biopsy, and computer-aided detection for mammography, the company said.
Pharmaion segmented the U.S. breast cancer diagnostic devices market into three categories: screening and diagnostic imaging devices, lab diagnostic devices, and other. Screening and diagnostic imaging devices dominated the U.S. breast cancer diagnostic devices market in 2014, and the category is projected to continue its leadership position through 2020, according to the company.
On a regional basis, the southern region of the U.S. was the leading regional market for breast cancer diagnostic devices, followed by the Midwest, Pharmaion said.











![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&fit=crop&h=112&q=70&w=112)






