+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)
Sale

Breast Biopsy Device Market - Global Forecast 2025-2032

  • PDF Icon

    Report

  • 185 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 6011423
UP TO OFF until Jan 01st 2026
1h Free Analyst Time
1h Free Analyst Time

Speak directly to the analyst to clarify any post sales queries you may have.

The breast biopsy device market is rapidly evolving, propelled by technology advancements and policy shifts that demand attention from senior healthcare executives and medtech leaders seeking to navigate complexities and growth opportunities in modern diagnostics.

Market Snapshot: Growth and Direction in the Breast Biopsy Device Market

The global breast biopsy device market is entering a phase of accelerated expansion, with robust growth projected between 2024 and 2032. This expansion is fueled by increased investments in precision oncology, heightened focus on early cancer detection, and tangible innovation in device capabilities. Market momentum is further enhanced by regulatory developments and evolving reimbursement landscapes, making this sector a priority for healthcare systems, device manufacturers, and investors.

Scope & Segmentation: In-Depth View of Technologies, Products, and Geographies

  • Product Types: Includes assay kits, biopsy needles, biopsy tables, guidance systems, and localization wires designed to optimize diagnostic yields and expand procedural options for clinicians.
  • Procedure Types: Covers core needle biopsy, fine needle aspiration, and vacuum assisted biopsy, each chosen according to lesion complexity and clinical objectives.
  • Techniques: Encompasses MRI guided, stereotactic, tomosynthesis guided, and ultrasound guided systems, catering to settings across outpatient clinics and tertiary care centers.
  • Categories: Distinguishes automated and manual biopsy devices, highlighting the rising shift toward automation.
  • Applications: Addresses both benign and malignant lesion diagnosis, supporting personalized medicine pathways and optimized patient management.
  • End Users: Spans ambulatory surgery centers, diagnostic imaging centers, and hospitals, all integral to driving device adoption and market volume.
  • Distribution Channels: Analyzes the balance between offline and online sales, with digital procurement channels gaining ground.
  • Geographies: Includes regional coverage across the Americas (United States, Canada, Mexico, Brazil, Argentina, and others), Europe, the Middle East & Africa (Europe, United Kingdom, Germany, France, Russia, and more), and Asia-Pacific (China, India, Japan, Australia, among others).
  • Company Analysis: Examines strategic moves, alliances, and innovations from leading players such as General Electric Company, Hologic, Inc., Siemens AG, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., FUJIFILM Corporation, and others.

Key Takeaways for Decision Makers

  • Technological innovations, such as AI integration and advanced imaging, are streamlining diagnostic workflows and improving lesion targeting.
  • Automation and modular device configurations are enabling efficiency gains, improved throughput, and easier integration into diverse clinical settings.
  • Segmented demand indicates a preference for minimally invasive and patient-centric solutions, with ambulatory centers and diagnostic imaging clinics driving new growth.
  • Strategic partnerships and co-development projects between manufacturers, research institutions, and technology providers are accelerating market differentiation.
  • Cloud-based analytics and robust post-market surveillance frameworks are supporting real-time quality assurance and compliance with rising regulatory expectations.

Tariff Impact: Navigating Policy and Supply Chain Shifts

Newly imposed tariffs in the United States are compelling manufacturers to adapt supply chain models, with localization and diversification efforts becoming crucial. Healthcare providers are responding through consortium purchasing and closer cooperation with domestic suppliers, while global players leverage trade agreements to mitigate potential cost pressures and sustain equipment access.

Methodology & Data Sources

This report employs a rigorous mixed-methods approach, combining direct interviews with clinicians, procurement leaders, and industry executives with secondary analysis of peer-reviewed journals, regulatory datasets, and proprietary market frameworks. Verified regional procedure volumes and device trends are integrated for a comprehensive perspective.

Why This Report Matters

  • Enables data-driven investment and procurement decisions by quantifying competitive dynamics and technology adoption.
  • Guides strategy around market entry, product development, and tariff navigation for multinational and regional players.
  • Delivers actionable intelligence to enhance alignment between emerging product innovations and unmet clinical or operational needs.

Conclusion

The breast biopsy device market presents both significant challenges and actionable opportunities as clinical, technological, and policy forces reshape industry priorities. Stakeholders equipped with this insight can navigate complexity and proactively drive strategic growth.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Growing adoption of AI-powered imaging guidance in vacuum-assisted breast biopsy devices
5.2. Expansion of ultrasound-guided core needle biopsy solutions for point-of-care breast diagnosis
5.3. Rising demand for minimally invasive stereotactic biopsy systems with 3D imaging integration
5.4. Advancements in biopsy needle design for improved patient comfort and reduced procedure time
5.5. Integration of digital pathology platforms for real-time analysis of breast biopsy samples
5.6. Surge in adoption of portable breast biopsy devices in emerging markets to enhance accessibility
5.7. 3D stereotactic biopsy systems combining robotic precision with lower radiation exposure
5.8. Ergonomically optimized biopsy needles reducing patient discomfort and procedural times
5.9. Mobile breast biopsy units driving early detection initiatives in underserved regions
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Breast Biopsy Device Market, by Product
8.1. Assay Kits
8.2. Biopsy Needles
8.3. Biopsy Tables
8.4. Guidance Systems
8.5. Localization Wires
9. Breast Biopsy Device Market, by Procedure Type
9.1. Core Needle Biopsy
9.2. Fine Needle Aspiration
9.3. Vacuum Assisted Biopsy
10. Breast Biopsy Device Market, by Technique
10.1. MRI Guided
10.2. Stereotactic
10.3. Tomosynthesis Guided
10.4. Ultrasound Guided
11. Breast Biopsy Device Market, by Category
11.1. Automated Biopsy Devices
11.2. Manual Biopsy Devices
12. Breast Biopsy Device Market, by Application
12.1. Benign Lesion Diagnosis
12.2. Malignant Lesion Diagnosis
13. Breast Biopsy Device Market, by End User
13.1. Ambulatory Surgery Centers
13.2. Diagnostic Imaging Centers
13.3. Hospitals
14. Breast Biopsy Device Market, by Distribution Channel
14.1. Offline Sales
14.2. Online Sales
15. Breast Biopsy Device Market, by Region
15.1. Americas
15.1.1. North America
15.1.2. Latin America
15.2. Europe, Middle East & Africa
15.2.1. Europe
15.2.2. Middle East
15.2.3. Africa
15.3. Asia-Pacific
16. Breast Biopsy Device Market, by Group
16.1. ASEAN
16.2. GCC
16.3. European Union
16.4. BRICS
16.5. G7
16.6. NATO
17. Breast Biopsy Device Market, by Country
17.1. United States
17.2. Canada
17.3. Mexico
17.4. Brazil
17.5. United Kingdom
17.6. Germany
17.7. France
17.8. Russia
17.9. Italy
17.10. Spain
17.11. China
17.12. India
17.13. Japan
17.14. Australia
17.15. South Korea
18. Competitive Landscape
18.1. Market Share Analysis, 2024
18.2. FPNV Positioning Matrix, 2024
18.3. Competitive Analysis
18.3.1. Advin Health Care
18.3.2. Argon Medical Devices, Inc.
18.3.3. Becton, Dickinson and Company
18.3.4. Cook Group Incorporated
18.3.5. Danaher Corporation
18.3.6. FUJIFILM Corporation
18.3.7. General Electric Company
18.3.8. Halma plc
18.3.9. Hologic, Inc
18.3.10. INRAD Inc.
18.3.11. Medline Industries, LP
18.3.12. Medtronic PLC
18.3.13. Merit Medical Systems, Inc.
18.3.14. Ningbo Xinwell Medical Technology Co., LTD.
18.3.15. PAJUNK GmbH
18.3.16. Planmeca Oy
18.3.17. Point Blank Medical
18.3.18. Siemens AG
18.3.19. SNVL Varay Laborix
18.3.20. STERYLAB S.r.l.
18.3.21. Suretech Medical Inc.
18.3.22. Thermo Fisher Scientific Inc.
18.3.23. Trivitron Healthcare
18.3.24. Vector Medical, Inc.
18.3.25. Zamar Care

Companies Mentioned

The companies profiled in this Breast Biopsy Device market report include:
  • Advin Health Care
  • Argon Medical Devices, Inc.
  • Becton, Dickinson and Company
  • Cook Group Incorporated
  • Danaher Corporation
  • FUJIFILM Corporation
  • General Electric Company
  • Halma plc
  • Hologic, Inc
  • INRAD Inc.
  • Medline Industries, LP
  • Medtronic PLC
  • Merit Medical Systems, Inc.
  • Ningbo Xinwell Medical Technology Co., LTD.
  • PAJUNK GmbH
  • Planmeca Oy
  • Point Blank Medical
  • Siemens AG
  • SNVL Varay Laborix
  • STERYLAB S.r.l.
  • Suretech Medical Inc.
  • Thermo Fisher Scientific Inc.
  • Trivitron Healthcare
  • Vector Medical, Inc.
  • Zamar Care

Table Information