Product Code: GVR-4-68040-865-5
U.S. Breast Biopsy Devices Market Summary
The U.S. breast biopsy devices market size was estimated at USD 1.18 billion in 2025 and is anticipated to reach USD 1.60 billion by 2033, growing at a CAGR of 3.9% from 2026 to 2033. The market growth driven by the rising incidence of breast cancer and the consequent emphasis on early detection and accurate diagnosis, which increases the volume of biopsy procedures required in screening and diagnostic pathways.
High awareness among patients and clinicians, supported by structured screening programs and favorable reimbursement landscapes, further propels device adoption. In addition, technological advancements, including minimally invasive core-needle and vacuum-assisted systems, integration with advanced imaging modalities (e.g., ultrasound, MRI, 3D mammography), and AI-enhanced diagnostic workflows, are expanding clinical utility, improving procedural accuracy and patient comfort, and encouraging broader clinical integration.
The rising prevalence of breast cancer in the U.S. directly drives growth in the breast biopsy devices market because a higher number of new and suspected cancer cases increases the demand for diagnostic confirmation through tissue sampling. In the U.S., breast cancer is the most commonly diagnosed cancer among women, with hundreds of thousands of new invasive and non-invasive cases reported annually, prompting more routine screening and follow-up biopsies when abnormalities are detected on imaging. As incidence rates climb and screening programs expand, healthcare providers perform more biopsies to confirm diagnoses, guide treatment decisions, and rule out malignancy, thereby boosting utilization of core-needle, vacuum-assisted, and image-guided breast biopsy devices.
As screening programs such as mammography and MRI expand, more suspicious lesions are detected, necessitating tissue sampling via core-needle or vacuum-assisted biopsy. This sustained rise in diagnostic volumes increases demand for advanced, image-guided biopsy systems in hospitals and ambulatory centers. The link between higher case detection and device innovation is evident in recent industry developments, for instance, in February 2026, Mammotome, a part of Danaher Corporation, introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System, the first system designed to be positioned inside the MRI scanner room at the patient's side during biopsy. By improving clinician coordination and workflow efficiency in MRI-guided procedures, such innovations address the growing procedural burden driven by rising breast cancer prevalence, thereby accelerating technology adoption and overall market growth in the U.S. breast biopsy devices sector.
U.S. Breast Biopsy Devices Market Report Segmentation
This report forecasts revenue growth at the country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the U.S. breast biopsy devices market report based on product, procedure type, guidance technology, and end use:
- Product Type Outlook (Revenue, USD Million, 2021 - 2033)
- Biopsy Guidance Systems
- Biopsy Drivers & Handpieces
- Vacuum-Assisted Biopsy (VAB) Drivers
- Core Needle Biopsy (CNB) Guns
- Biopsy Tables
- Prone Tables
- Upright/Add-on Tables
- Biopsy Consumables
- Needles & Probes
- Site Markers & Clips
- By Shape/Design
- Standard Geometric Markers
- Ring
- Cross
- Ribbon
- Others
- Advanced Anchoring Markers
- Anchor
- Wing, "U" Shape
- Q" Shape
- 3D / Expandable Markers
- 3D Ribbon
- 3D Sphere
- 3D Mesh
- Localization Systems
- Traditional Wires
- Wireless Seeds-RFID/Magnetic
- Other Consumables
- Procedure Type Outlook (Revenue, USD Million, 2021 - 2033)
- Vacuum-Assisted Biopsy (VAB)
- Core Needle Biopsy (CNB)
- Fine Needle Aspiration Biopsy (FNAB)
- Surgical (Open) Biopsy
- Liquid Biopsy
- Guidance Technology Outlook (Revenue, USD Million, 2021 - 2033)
- Ultrasound-Guided
- Mammography / Stereotactic-Guided
- MRI-Guided
- End Use Outlook (Revenue, USD Million; 2021 - 2033)
- Hospitals
- Ambulatory Surgical Centers (ASCs)
- Specialized Breast Care Centers
- Diagnostic Centers/Imaging Centers
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.1.1. Product
- 1.1.2. Procedure Type
- 1.1.3. Guidance Technology
- 1.1.4. End Use
- 1.1.5. Estimates and forecast timeline
- 1.2. Market Definitions
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased Database
- 1.4.2. GVR's Internal Database
- 1.5. Details of primary research
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.1.1. Approach 1: Commodity flow approach
- 1.7.2. Volume price analysis (Model 2)
- 1.7.2.1. Approach 2: Volume price analysis
- 1.8. Research Scope and Assumptions
- 1.8.1. List of Secondary Sources
- 1.8.2. List of Primary Sources
- 1.8.3. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Competitive Insights
Chapter 3. U.S. Breast Biopsy Devices Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Related/Ancillary Market Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Drivers Analysis
- 3.2.1.1. Increasing burden of breast cancer
- 3.2.1.2. Expansion of breast cancer screening programs
- 3.2.1.3. Technological advancements in imaging-guided biopsy
- 3.2.2. Market Restraints Analysis
- 3.2.2.1. High cost of advanced biopsy technologies
- 3.2.2.2. Limited access to diagnostic facilities in low-resource settings
- 3.2.3. Market Opportunity Analysis
- 3.2.3.1. Expansion of screening programs in emerging economies
- 3.2.3.2. Growth of minimally invasive and rapid diagnostic technologies
- 3.2.3.3. Integration with next-generation imaging and AI
- 3.2.3.4. Expansion of outpatient and ambulatory care
- 3.2.3.5. Rising demand for personalized and precision diagnostics
- 3.2.4. Market Challenge Analysis
- 3.2.4.1. Patient anxiety and procedure hesitation
- 3.2.4.2. Limited skilled workforce
- 3.3. U.S. Breast Biopsy Devices Market Analysis Tools
- 3.3.1. Porter's Analysis
- 3.3.1.1. Bargaining power of the suppliers
- 3.3.1.2. Bargaining power of the buyers
- 3.3.1.3. Threats of substitution
- 3.3.1.4. Threats from new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic and Social landscape
- 3.3.2.3. Technological landscape
- 3.3.2.4. Environmental landscape
- 3.3.2.5. Legal landscape
Chapter 4. U.S. Breast Biopsy Devices Market: Product Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. U.S. Breast Biopsy Devices Market: Product Movement Analysis, 2025 & 2033 (USD Million)
- 4.3. U.S. Breast Biopsy Devices Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
- 4.3.1. Biopsy Guidance Systems
- 4.3.1.1. Biopsy guidance systems market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.2. Biopsy Drivers & Handpieces
- 4.3.2.1. Biopsy drivers & handpieces market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.2.2. Vacuum-assisted biopsy (VAB) drivers
- 4.3.2.2.1. Vacuum-assisted biopsy (VAB) drivers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.2.3. Core needle biopsy (CNB) guns
- 4.3.2.3.1. Core needle biopsy (CNB) guns market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.2.3.2. Automated
- 4.3.2.3.2.1. Automated market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.2.3.3. Semi-automated
- 4.3.2.3.3.1. Semi-automated market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.3. Biopsy tables
- 4.3.3.1. Biopsy tables market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.3.2. Prone tables
- 4.3.3.2.1. Prone tables market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.3.3. Upright/add-on tables
- 4.3.3.3.1. Upright/add-on tables market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4. Biopsy consumables
- 4.3.4.1. Biopsy consumables market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.2. Needles & probes
- 4.3.4.2.1. Needles & probes market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3. Site markers & clips
- 4.3.4.3.1. Site markers & clips market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.2. By shape/design
- 4.3.4.3.2.1. By shape/design market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.3. Standard geometric markers
- 4.3.4.3.3.1. Standard geometric markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.3.2. Ring
- 4.3.4.3.3.2.1. Ring market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.3.3. Cross
- 4.3.4.3.3.3.1. Cross market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.3.4. Ribbon
- 4.3.4.3.3.4.1. Ribbon market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.3.5. Others
- 4.3.4.3.3.5.1. Others markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.4. Advanced anchoring markers
- 4.3.4.3.4.1. Advanced anchoring markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.4.2. Anchor
- 4.3.4.3.4.2.1. Anchor markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.4.3. Wing, "U" shape
- 4.3.4.3.4.3.1. Wing, "U" shape market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.4.4. "Q" shape
- 4.3.4.3.4.4.1. "Q" shape markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.5. 3D / expandable markers
- 4.3.4.3.5.1. 3D / expandable markers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.5.2. 3D ribbon
- 4.3.4.3.5.2.1. 3D ribbon market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.5.3. 3D sphere
- 4.3.4.3.5.3.1. 3D Sphere market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.3.5.4. 3D Mesh
- 4.3.4.3.5.4.1. 3D Mesh market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.4. Localization systems
- 4.3.4.4.1. Localization systems market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.4.2. Traditional wires
- 4.3.4.4.2.1. Traditional wires market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.4.4.3. Wireless Seeds-RFID/magnetic
- 4.3.4.4.3.1. Wireless seeds-RFID/magnetic market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 4.3.5. Other Consumables
- 4.3.5.1. Other consumables market revenue estimates and forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. Breast Biopsy Devices Market: Procedure Type Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. U.S. Breast Biopsy Devices Market: Procedure Type Movement Analysis, 2025 & 2033 (USD Million)
- 5.3. U.S. Breast Biopsy Devices Market Size & Trend Analysis, by Procedure Type, 2021 to 2033 (USD Million)
- 5.3.1. Vacuum-Assisted Biopsy (VAB)
- 5.3.1.1. Vacuum-assisted biopsy (VAB) market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 5.3.2. Core Needle Biopsy (CNB)
- 5.3.2.1. Core needle biopsy (CNB) market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 5.3.3. Fine Needle Aspiration Biopsy (FNAB)
- 5.3.3.1. Fine needle aspiration biopsy (FNAB) market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 5.3.4. Surgical (Open) Biopsy
- 5.3.4.1. Surgical (open) biopsy market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 5.3.5. Liquid Biopsy
- 5.3.5.1. Liquid biopsy market revenue estimates and forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. Breast Biopsy Devices Market: Guidance Technology Estimates & Trend Analysis
- 6.1. Segment Dashboard
- 6.2. U.S. Breast Biopsy Devices Market: Guidance Technology Movement Analysis, 2025 & 2033 (USD Million)
- 6.3. U.S. Breast Biopsy Devices Market Size & Trend Analysis, by Guidance Technology, 2021 to 2033 (USD Million)
- 6.3.1. Ultrasound-Guided
- 6.3.1.1. Ultrasound-guided market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 6.3.2. Mammography / Stereotactic-Guided
- 6.3.2.1. Mammography / stereotactic-guided market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 6.3.3. MRI-Guided
- 6.3.3.1. MRI-guided market revenue estimates and forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. Breast Biopsy Devices Market: End Use Estimates & Trend Analysis
- 7.1. Segment Dashboard
- 7.2. U.S. Breast Biopsy Devices Market: End Use Movement Analysis, 2025 & 2033 (USD Million)
- 7.3. U.S. Breast Biopsy Devices Market Size & Trend Analysis, by End Use 2021 to 2033 (USD Million)
- 7.3.1. Hospitals
- 7.3.1.1. Hospitals market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 7.3.2. Ambulatory Surgical Centers (ASCs)
- 7.3.2.1. Ambulatory surgical centers (ASCs) market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 7.3.3. Specialized Breast Care Centers
- 7.3.3.1. Specialized breast care centers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
- 7.3.4. Diagnostic Centers/Imaging Centers
- 7.3.4.1. Diagnostic centers/imaging centers market revenue estimates and forecasts, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
- 8.1. Recent Developments & Impact Analysis by Key Market Participants
- 8.2. Company Categorization
- 8.3. Company Market Share Analysis, 2025
- 8.4. Company Heat Map Analysis
- 8.5. Strategy Mapping
- 8.5.1. Expansion
- 8.5.2. Mergers & Acquisition
- 8.5.3. Partnerships & Collaborations
- 8.5.4. New Product Launches
- 8.5.5. Research And Development
- 8.5.6. Company Profiles
- 8.5.7. Hologic, Inc.
- 8.5.7.1. Company overview
- 8.5.7.2. Financial performance
- 8.5.7.3. Product Benchmarking
- 8.5.7.4. Strategic initiatives
- 8.5.8. Mammotome (Danaher)
- 8.5.8.1. Company overview
- 8.5.8.2. Financial performance
- 8.5.8.3. Product Benchmarking
- 8.5.8.4. Strategic initiatives
- 8.5.9. BD
- 8.5.9.1. Company overview
- 8.5.9.2. Financial performance
- 8.5.9.3. Product Benchmarking
- 8.5.9.4. Strategic initiatives
- 8.5.10. Argon Medical
- 8.5.10.1. Company overview
- 8.5.10.2. Financial performance
- 8.5.10.3. Product Benchmarking
- 8.5.10.4. Strategic initiatives
- 8.5.11. Merit Medical Systems
- 8.5.11.1. Company overview
- 8.5.11.2. Financial performance
- 8.5.11.3. Product Benchmarking
- 8.5.11.4. Strategic initiatives
- 8.5.12. GE HealthCare
- 8.5.12.1. Company overview
- 8.5.12.2. Financial performance
- 8.5.12.3. Product Benchmarking
- 8.5.12.4. Strategic initiatives
- 8.5.13. Cook Medical
- 8.5.13.1. Company overview
- 8.5.13.2. Financial performance
- 8.5.13.3. Product Benchmarking
- 8.5.13.4. Strategic initiatives
- 8.5.14. MOLLI Surgical (Stryker)
- 8.5.14.1. Company overview
- 8.5.14.2. Financial performance
- 8.5.14.3. Product Benchmarking
- 8.5.14.4. Strategic initiatives
- 8.5.15. Planmed Oy
- 8.5.15.1. Company overview
- 8.5.15.2. Financial performance
- 8.5.15.3. Product Benchmarking
- 8.5.15.4. Strategic initiatives
- 8.5.16. Siemens Healthineers
- 8.5.16.1. Company overview
- 8.5.16.2. Financial performance
- 8.5.16.3. Product Benchmarking
- 8.5.16.4. Strategic initiatives
- 8.5.17. Fujifilm Healthcare
- 8.5.17.1. Company overview
- 8.5.17.2. Financial performance
- 8.5.17.3. Product Benchmarking
- 8.5.17.4. Strategic initiatives
- 8.5.18. INRAD
- 8.5.18.1. Company overview
- 8.5.18.2. Financial performance
- 8.5.18.3. Product Benchmarking
- 8.5.18.4. Strategic initiatives
- 8.5.19. Resitu Medical
- 8.5.19.1. Company overview
- 8.5.19.2. Financial performance
- 8.5.19.3. Product Benchmarking
- 8.5.19.4. Strategic initiatives
- 8.5.20. TransMed7, LLC.
- 8.5.20.1. Company overview
- 8.5.20.2. Financial performance
- 8.5.20.3. Product Benchmarking
- 8.5.20.4. Strategic initiatives