North America Breast Biopsy Devices Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Breast Biopsy Devices Market Segmentation, By Product (Biopsy Needles, Biopsy Tables, Biopsy Wires, Guidance Systems, Needle-Based Biopsy Guns, and Others), Technique Type (Fine Needle Aspiration Biopsy, Core Needle Biopsy, Biopsy Markers, MRI-Guided Core Needle Biopsy, Surgical Biopsy, Wire Localization, and Sentinel Node Biopsy), Guidance Technology (Fine Ultrasound-Guided, Mammography-Guided Magnetic Resonance, CT-Guided Biopsy, and Other Image-Guided Breast Biopsy), End User (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers, and Other) - Industry Trends and Forecast to 2032

Breast Biopsy Devices Market Size

• The North America Breast Biopsy Devices market size was valued at USD 1.14 billion in 2024 and is expected to reach USD 1.99 billion by 2032, at a CAGR of 7.20% during the forecast period
• The market growth is largely fuelled by the rising incidence of breast cancer in North America, along with increasing awareness and emphasis on early diagnosis, driving the demand for advanced breast biopsy devices in both hospital and outpatient settings.
• Furthermore, technological advancements in minimally invasive biopsy techniques, coupled with growing healthcare expenditure and patient preference for precise and safer diagnostic methods, are establishing Breast Biopsy Devices as a critical component in modern cancer diagnostics. These converging factors are accelerating the uptake of Breast Biopsy Devices solutions, thereby significantly boosting the industry's growth.

Breast Biopsy Devices Market Analysis

• Breast Biopsy Devices, including advanced technologies such as biopsy needles, tables, wires, and guidance systems, are becoming increasingly vital tools in the early detection and diagnosis of breast cancer across hospitals, diagnostic centers, and ambulatory surgical settings throughout North America, owing to their precision, minimally invasive nature, and improved patient outcomes.
• The escalating demand for Breast Biopsy Devices is primarily fueled by the rising prevalence of breast cancer, robust reimbursement policies, and the growing adoption of image-guided and minimally invasive diagnostic procedures across the U.S. and Canada.
• The U.S. dominates the Breast Biopsy Devices market in North America with the largest revenue share of 89.01% in 2025, characterized by advanced healthcare infrastructure, high awareness levels, substantial healthcare spending, and the early adoption of technologically advanced biopsy techniques, including MRI-guided and stereotactic biopsies.
• The U.S. is expected to be the fastest-growing country in the North America Breast Biopsy Devices market during the forecast period, driven by increasing patient preference for outpatient procedures, expansion of breast cancer screening programs, and a strong presence of key market players continuously launching innovative biopsy systems.
• Core Needle Biopsy is expected to dominate the North America Breast Biopsy Devices market with a market share of 43.2% in 2025, driven by its clinical accuracy, cost-effectiveness, and growing utilization as a standard procedure for diagnosing palpable and non-palpable breast lesions.

Report Scope and Breast Biopsy Devices Market Segmentation

Breast Biopsy Devices Market Trends

“Enhanced Accuracy Through AI and Imaging Integration”

• A significant and accelerating trend in the North America Breast Biopsy Devices market is the deepening integration with artificial intelligence (AI) and advanced imaging technologies such as MRI, ultrasound, and 3D mammography. This fusion of technologies is significantly enhancing diagnostic precision, procedural efficiency, and patient outcomes.

  • For instance, AI-assisted breast biopsy platforms are increasingly being adopted to improve lesion targeting, automate needle positioning, and support radiologists in interpreting complex imaging results more effectively. These intelligent systems help reduce human error and standardize biopsy procedures across clinical settings.

• AI integration in Breast Biopsy Devices enables features such as real-time imaging analytics, predictive diagnostics, and automated workflow support. For example, certain platforms utilize machine learning algorithms to detect and prioritize suspicious lesions, while also offering enhanced guidance for core needle and MRI-guided biopsies.
• The seamless integration of Breast Biopsy Devices with hospital information systems (HIS), PACS, and radiology workflow tools facilitates centralized access to imaging data, biopsy history, and patient records—enabling radiologists and surgeons to make faster, data-driven decisions and streamline interdepartmental collaboration.
• This trend toward more intelligent, data-integrated, and image-guided biopsy systems is fundamentally reshaping the standard of care in breast diagnostics. Consequently, companies such as Hologic and Siemens Healthineers are developing AI-enabled biopsy platforms with automated targeting, enhanced needle guidance, and integration with cloud-based diagnostic software.
• The demand for Breast Biopsy Devices that offer seamless AI and imaging system integration is growing rapidly across hospitals, diagnostic centers, and ambulatory surgical units, as clinicians increasingly prioritize precision medicine, workflow optimization, and minimally invasive diagnostic solutions. 

Breast Biopsy Devices Market Dynamics

Driver

“Growing Need Due to Rising Breast Cancer Incidence and Advancements in Diagnostic Technology”

• The increasing prevalence of breast cancer across North America, coupled with rising awareness about early detection and diagnosis, is a significant driver for the heightened demand for Breast Biopsy Devices

  • For instance, according to the American Cancer Society, approximately 1 in 8 women in the U.S. will develop invasive breast cancer over the course of her lifetime. This high incidence rate emphasizes the need for accurate and minimally invasive diagnostic tools, propelling market growth

• As healthcare providers focus on early-stage diagnosis to improve treatment outcomes, Breast Biopsy Devices offer advanced capabilities such as image-guided targeting, real-time tissue sampling, and reduced procedure times—providing a substantial improvement over traditional open surgical biopsy methods
• Furthermore, the integration of digital imaging technologies and AI-based guidance systems with biopsy devices is enhancing diagnostic precision and workflow efficiency, making them essential tools in modern breast cancer diagnostics.
• The preference for minimally invasive techniques, growing adoption of outpatient procedures, and increasing investments by hospitals and diagnostic centers in upgrading their biopsy capabilities are key factors propelling the adoption of Breast Biopsy Devices across the North American healthcare ecosystem

Restraint/Challenge

“Concerns Regarding Procedural Complexity and High Equipment Costs”

• Concerns surrounding the procedural complexity and the high cost of advanced breast biopsy systems present a significant challenge to widespread market adoption, particularly among smaller healthcare facilities and rural clinics.

  • For instance, MRI-guided breast biopsies, while highly accurate, require specialized infrastructure, trained personnel, and costly imaging systems—factors that can limit their availability to larger urban hospitals and academic centers.

• The need for continuous training of radiologists and interventional specialists to operate sophisticated biopsy technologies also adds to operational burden, especially in regions facing a shortage of skilled healthcare professionals.
• Additionally, high initial costs associated with installing stereotactic or vacuum-assisted biopsy systems can be a deterrent for budget-constrained institutions. This can limit market penetration despite clinical demand, especially in underfunded or underserved areas.
• While ongoing technological advancements and strategic partnerships are helping lower production costs and improve ease of use, addressing these challenges through government funding, insurance coverage expansion, and simplified device interfaces will be crucial for unlocking full market potential across North America.

Breast Biopsy Devices Market Scope

The market is segmented on the basis product, technique type, guidance technology, and end user.

• By Product

On the basis of product, the breast biopsy devices market is segmented into biopsy needles, biopsy tables, biopsy wires, guidance systems, needle-based biopsy guns, and others. The biopsy needles segment dominates the largest market revenue share of 38.5% in 2025, driven by their critical role in both core needle and fine needle aspiration procedures. These needles are essential for extracting tissue samples with minimal invasiveness, and their compatibility with various imaging techniques enhances diagnostic accuracy. The segment benefits from continual innovations such as vacuum-assisted designs and improved tip geometries that facilitate precision targeting of lesions.

The guidance systems segment is anticipated to witness the fastest growth rate of 19.4% from 2025 to 2032, fueled by the rising preference for image-guided biopsies and the demand for real-time accuracy. These systems—integrated with ultrasound, MRI, and stereotactic platforms—help ensure precise localization of suspicious tissues, reduce sampling errors, and shorten procedure times, thereby improving clinical outcomes.

• By Technique Type

On the basis of technique type, the market is segmented into fine needle aspiration biopsy, core needle biopsy, biopsy markers, MRI-guided core needle biopsy, surgical biopsy, wire localization, and sentinel node biopsy. The core needle biopsy segment held the largest market revenue share in 2025, owing to its widespread use as the gold standard for diagnosing breast abnormalities. Its minimally invasive nature, ability to extract sufficient tissue, and lower risk compared to surgical procedures make it the preferred choice among clinicians.

The MRI-guided core needle biopsy segment is expected to witness the fastest CAGR from 2025 to 2032, driven by its superior imaging capabilities for detecting non-palpable and complex lesions. As MRI becomes more integrated into routine breast cancer diagnostics, its guidance in biopsies ensures enhanced accuracy in lesion targeting, especially in high-risk patients.

• By Guidance Technology

On the basis of guidance technology, the market is segmented into ultrasound-guided, mammography-guided, magnetic resonance-guided, CT-guided biopsy, and other image-guided breast biopsy. The ultrasound-guided biopsy segment accounted for the largest market revenue share in 2025, attributed to its real-time imaging capability, cost-effectiveness, and widespread availability. It is particularly effective for guiding needle placement in cystic or solid palpable lesions and is commonly used in both hospitals and ambulatory settings.

The magnetic resonance-guided biopsy segment is projected to witness the fastest CAGR from 2025 to 2032, as MR imaging is increasingly adopted for patients with dense breast tissue or inconclusive mammograms. The precision and sensitivity of MRI contribute to more accurate diagnoses, especially in high-risk screening programs.

• By End User

On the basis of end user, the market is segmented into hospitals, ambulatory surgical centers, diagnostic centers, and others.

The hospital segment holds the largest market revenue share in 2025, driven by the concentration of advanced diagnostic technologies, skilled professionals, and integrated imaging and biopsy workflows in these settings. Hospitals serve as referral centers for complex cases requiring MRI or stereotactic biopsies and play a leading role in early detection programs. The ambulatory surgical centers segment is expected to witness the fastest growth from 2025 to 2032, owing to the increasing shift toward outpatient procedures and the cost-efficiency of these settings. ASCs offer faster turnaround, reduced patient wait times, and minimally invasive biopsy procedures under local anesthesia, making them attractive for both patients and healthcare providers.

Breast Biopsy Devices Market Regional Analysis

• U.S. dominates the Breast Biopsy Devices market with the largest revenue share of 79.04% in 2024, driven by the increasing prevalence of breast cancer, advanced healthcare infrastructure, and early adoption of minimally invasive diagnostic technologies.
• The country’s favorable reimbursement landscape, extensive breast cancer screening programs (such as mammography mandates under the Affordable Care Act), and rising awareness about early detection significantly contribute to the dominance of the U.S. market.
• Furthermore, strong research and development activity, along with the presence of leading medical device manufacturers such as Hologic, BD, and Stryker, enhances the availability of advanced biopsy systems including vacuum-assisted and MRI-guided technologies.
• The adoption of image-guided biopsy procedures in ambulatory settings and hospitals is also on the rise due to their higher accuracy and reduced patient trauma, thereby fueling overall market growth in the U.S.

Canada Breast Biopsy Devices Market Insight

The Canada Breast Biopsy Devices market is projected to expand at a substantial CAGR throughout the forecast period, driven by the growing incidence of breast cancer and increased investments in public health diagnostics. Canada’s national health strategy emphasizes early cancer detection, and provinces have rolled out organized breast screening programs (such as Ontario Breast Screening Program), boosting demand for advanced biopsy systems. Additionally, rising awareness about the benefits of minimally invasive biopsies over surgical alternatives and the growing availability of MRI-guided and stereotactic-guided techniques in diagnostic centers are contributing to market expansion. Strong regulatory standards set by Health Canada and increasing collaborations with U.S.-based device companies further support the growth of innovative biopsy technologies in the Canadian market

Mexico Breast Biopsy Devices Market Insight

The Mexico Breast Biopsy Devices market is anticipated to grow at a noteworthy CAGR during the forecast period, fueled by improvements in healthcare infrastructure, urbanization, and increasing government focus on cancer care. The launch of national programs for cancer detection and awareness campaigns (such as "Octubre Rosa") are encouraging women to undergo routine breast screening and diagnostic procedures, thereby driving demand for biopsy devices. While access to advanced biopsy systems is currently limited to urban and private healthcare facilities, ongoing public-private partnerships and foreign investments in medical technologies are expected to broaden device accessibility across regions. Increased training of radiologists and pathologists, along with the incorporation of ultrasound and mammography-guided biopsy solutions, is anticipated to further accelerate the adoption of breast biopsy devices in Mexico. 

Breast Biopsy Devices Market Share

The Breast Biopsy Devices industry is primarily led by well-established companies, including:

• Hologic, Inc. (U.S.)
• BD (U.S.)
• Siemens Healthineers AG  (Germany)
• GE HealthCare. (U.S.)
• Cook (U.S.)
• Stryker (U.S.)
• Devicor Medical Products, Inc. (U.S.)
• Argon Medical Devices, Inc. (U.S.)
• Planmed Oy (Finland)
• C.R. Bard, Inc. (U.S.)
• Carestream Health. (U.S.)
• FUJIFILM Corporation (Japan)
• Hitachi Medical Systems (Japan)
• Koninklijke Philips N.V., (Netherlands)
• Medtronic (Ireland)
• Abbott (U.S.)
• Boston Scientific Corporation (U.S.)
• Zimmer Biomet (U.S.)

Latest Developments in North America Breast Biopsy Devices Market

• In April 2024, Hologic, Inc., a global leader in women’s health, announced the U.S. FDA clearance of its new Brevera Breast Biopsy System with CorLumina imaging technology. This all-in-one system streamlines the biopsy process by combining tissue acquisition, real-time imaging, and verification in a single step, reducing procedure time and enhancing patient comfort. The development underscores Hologic’s ongoing commitment to innovation in image-guided breast biopsy solutions and improving workflow efficiency in clinical settings.
• In March 2024, BD (Becton, Dickinson and Company) launched the BD UltraCore Biopsy Device in North America, targeting enhanced precision for core needle biopsy procedures. The device features a dual-spring system that improves tissue capture while minimizing patient trauma. The launch aligns with the rising demand for minimally invasive biopsy tools and supports BD’s expansion in the high-growth breast diagnostics segment.
• In February 2024, Stryker Corporation announced a strategic partnership with multiple ambulatory surgical centers (ASCs) across the U.S. to deploy its advanced breast biopsy navigation software, designed to assist surgeons in more accurately locating and sampling suspicious lesions. This partnership reflects the growing role of software-enabled biopsy guidance in improving diagnostic accuracy and supporting outpatient breast cancer diagnostics.
• In January 2024, Siemens Healthineers introduced an upgraded version of its MAMMOMAT Revelation system in the Canadian market, integrated with 3D-guided breast biopsy capability. The system provides automated breast density assessment and biopsy planning tools, enabling radiologists to perform complex biopsies with increased confidence and efficiency. This expansion strengthens Siemens’ footprint in the Canadian diagnostic imaging and biopsy equipment sector.
• In December 2023, Devicor Medical Products (a Leica Biosystems company) received Health Canada approval for its MammoMARK Biopsy Site Marker, an advanced tissue marking solution used post-biopsy for site localization in follow-up treatments. The launch is expected to improve accuracy in surgical planning and reinforces Devicor’s leadership in post-biopsy care and tissue marking technologies in the North American region.

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