Breast Biopsy Devices Market Size & Share, by Application (Early Cancer Detection, Differential Diagnosis, Tumor Identification, Lymph Node Biopsy, Recurrence Monitoring); Guidance Technique; Product; End user; Biopsy Type - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2026-2035

Breast Biopsy Devices Market - Regional Analysis

North America Market Insights

North America is anticipated to hold the largest revenue share of 40.5% in the breast biopsy devices market during the analyzed tenure. Supportive healthcare policies and widespread use of advanced technologies are the key factors behind this leadership. This can be testified by GE HealthCare in April 2025 stated that it is showcasing its latest breast cancer detection innovations at the 2025 Society of Breast Imaging Symposium, which includes the Pristina Via mammography system that remarkably enhances diagnostic accuracy and patient comfort. The company is also distributing DeepHealth’s SmartMammo, which is an AI-powered tool designed to improve radiology efficiency and accuracy in breast cancer screening.

The U.S. is augmenting its leadership in the breast biopsy devices market on account of increasing healthcare expenditure, favorable reimbursement policies, and strong government support for cancer research.  As per the February 2025 NIH article, the breast cancer screening in the country led to a cost of approximately USD 11 billion on a yearly basis, wherein only about 37% of eligible women were screened each year.  Besides, the projections based on different screening guidelines show that total national screening costs could range widely from USD 8 billion to USD 30 billion, depending on various factors.

Canada's breast biopsy devices market is also continuously growing, backed by universal coverage, a strong focus on preventive care, and continued innovations in this field. For instance, in August 2023, iCAD, Inc. announced that Health Canada had granted a device license for its ProFound Risk 2.0, which is an AI-powered breast cancer risk assessment tool. The company further stated that the product is designed for use with both 2D and 3D mammography and provides accurate predictions, hence strengthening the country’s position in this field.

Mammography Utilization in the U.S. (Women ages 50-74 in 2022)

Source: KFF

APAC Market Insights

Asia Pacific is identified as the fastest-growing region in the breast biopsy devices market over the analyzed tenure from 2026 to 2035. The region’s upliftment in this field is effectively attributable to the rapidly growing populations and healthcare systems. Besides, the prominent countries across this region are increasingly adopting advanced screening technologies such as digital mammography and AI-driven risk assessment tools to improve early detection rates. Furthermore, the government and private sector entities are constantly putting efforts into expanding screening programs and promoting education.

China is solidifying its position in the regional breast biopsy devices market owing to the increasing investments and public health campaigns. As per the NIH clinical study published in February 2024, a meta-analysis involving 10.72 million women across 35 studies revealed that population-based breast cancer screening in the country displayed a shows lower cancer detection rates but a higher proportion of early-stage detection when compared to opportunistic screening. Furthermore, the combined BUS+MAM group showed a CDR of 3.29% and an early-stage detection rate of 88.18%.

There is a huge exposure for the breast biopsy devices market in India, efficiently backed by government initiatives and NGO programs promoting mammography and clinical breast exams. In February 2025, MoHFW reported that over 14 crore (140 million) women have been screened for breast cancer at Ayushman Aarogya Mandirs, wherein 289 oncology drugs are being provided at up to 50% discount through AMRIT Pharmacies, saving approximately ₹6,567 crore (USD 791 million) for 5.8 crore (58 million) patients, hence suitable for standard market growth.

Ayushman Arogya Mandirs Operationalized by State (as of July 2024)

Source: MoHFW

Europe Market Insights

Europe is maintaining steady progression in the breast biopsy devices market, highly driven by the massive consumer pool and increasing awareness about early detection. The region also benefits from the presence of central countries, each contributing to a greater potential to capitalize. For instance, in January 2025, Aiosyn reported that its Aiosyn Mitosis Breast is the first AI-powered mitosis detection solution, have received CE mark certification under the region’s In Vitro Diagnostic Regulation, marking a significant milestone in breast cancer diagnostics.

The U.K. is gaining enhanced recognition in the regional breast biopsy devices market owing to the increased public awareness and government support for breast cancer screening programs. In February 2025, the country’s government launched an AI trial called EDITH that involved nearly 700,000 women nationwide to test artificial intelligence tools that are designed to detect breast cancer earlier and more accurately. Besides, this will be conducted across 30 NHS screening sites, which are equipped with advanced AI technologies to assist radiologists.

Germany is maintaining its strong position in the market, extensively supported by its well-established healthcare infrastructure and proactive administrative efforts to strengthen the country’s cancer care. In February 2025, Mammotome and Sirius Medical, together, announced that they had entered into an exclusive partnership to distribute the Sirius Pintuition System across the country, which aims to enhance breast cancer surgical outcomes by providing surgeons with advanced tools for precise tumor localization.