유방 생검 기기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the breast biopsy devices market size is expected to grow from USD 1.29 billion in 2025 to USD 1.35 billion in 2026 and is forecast to reach USD 1.72 billion by 2031 at 4.95% CAGR over 2026-2031.

This report is Segmented by Product (Breast Biopsy Needles, and More), Procedure (Vacuum Assisted Biopsy, and More), Technique (Image Guided Biopsy [Stereotactic-Guided, and More], and More), Indication (Fibroadenoma, Complex Cyst, and More), End User (Hospitals & Clinics, Breast Care Centers, and More), and Geography (North America, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Breast Biopsy Devices Market Trends and Insights

Rising Prevalence & Awareness of Breast Cancer

Breast-cancer incidence is climbing in younger cohorts, especially in Asia where median onset now falls between ages 50-54, five to seven years earlier than in Western nations. National screening programs broaden the candidate pool for biopsy, yet China's participation rate remains 21.7%, signaling significant unmet need. Urban-rural disparity boosts demand for portable, cost-efficient equipment that can operate in secondary hospitals. Lower fertility rates and lifestyle shifts further elevate risk, making continual growth in biopsy procedures likely irrespective of population aging. Governments in India and Southeast Asia amplify awareness campaigns, accelerating equipment turnover as outpatient facilities invest in automated, AI-assisted systems to meet rising case volumes.

Expanding Reimbursement for Image-Guided Biopsies

Medicare covers percutaneous image-guided breast biopsy for BIRADS III-V lesions, providing a template many private payers and foreign insurers now follow. Vacuum-assisted stereotactic biopsies save USD 741 per case compared with surgical excision, strengthening the economic case for minimally invasive options. Europe's diagnosis-related groups also reward percutaneous sampling, while early directives in Japan and South Korea mirror the U.S. model. AI-based 3-D imaging tools remain variably covered, so vendors that secure billing codes gain a head start. Private-equity-funded imaging chains rely on stable reimbursement streams to finance center expansion and new equipment.

Post-Biopsy Infection & Hematoma Risk

Hematomas develop in up to 94% of patients one week after vacuum-assisted biopsy, though most resolve within 21 days. Clinically significant bleeding affects 6.7% of stereotactic cases, with 96.2% classified as mild. Even minor events fuel patient anxiety and can deter follow-up screening. Infection rates remain low in high-income settings but rise where sterile protocols are inconsistent, prompting cautious rollout of advanced equipment in underserved regions.

Other drivers and restraints analyzed in the detailed report include:

1. Accelerating Shift Toward Vacuum-Assisted Systems
2. AI-Enabled 3-D Imaging and Liquid-Biopsy Adoption
3. Capital Cost & Limited Radiology Capacity

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Breast-biopsy needles retained 42.70% revenue in 2025, a testament to their consumable nature and essential role across every intervention. The breast biopsy devices market size for guidance and imaging systems, although smaller, is forecast to climb at 9.85% CAGR due to AI overlays, robotic controllers and multimodal 3-D visualization that shorten learning curves. Hospitals adopt integrated consoles that combine stereotactic, ultrasound and tomosynthesis modules, allowing seamless switching mid-procedure. Vendors differentiate through user-friendly dashboards, cloud-linked analytics and smaller form factors that fit outpatient suites. Single-use accessory kits are gaining favor among infection-prevention teams, pointing to resilient demand for disposable components linked to each guidance platform.

Healthcare enterprises value the revenue predictability of re-orderable needles but increasingly bundle those consumables with subscription software for workflow analytics. For example, an institution deploying AI-assisted consoles reports a 14% reduction in repeat biopsies, boosting payer confidence and broadening reimbursement eligibility. As guidance platforms carve out larger budgets, cross-selling opportunities multiply, reinforcing a virtuous cycle within the breast biopsy devices market.

Vacuum-assisted biopsy (VAB) commanded 35.10% of breast biopsy devices market share in 2025, prized for extracting contiguous tissue cylinders that support histologic and molecular tests. Cost-effective kits with integrated clip-deployment mechanisms enable in-procedure marking, reducing recalls. Fine-needle aspiration biopsy (FNAB) logs the swiftest growth at 9.05% CAGR, fueled by its role in axillary-node staging and reduced anesthesia requirements. In low-resource settings, FNAB's minimal consumable demand and short dwell time appeal to budget-conscious providers.

Future protocols combine FNAB with rapid onsite cytology to deliver same-day results, trimming surgical waitlists. Early adopters also explore molecular profiling from residual FNAB samples, extending clinical utility beyond cytology and expanding the breast biopsy devices market size attributed to disposables and ancillary reagents.

Complete Report Scope:

• By Product
  • Breast Biopsy Needles
  • Breast Biopsy Tables
  • Guidance/Imaging Systems
  • Localization Wires
  • Assay & Reagent Kits
  • Others
• By Procedure
  • Vacuum-Assisted Biopsy (VAB)
  • Core Needle Biopsy (CNB)
  • Fine Needle Aspiration Biopsy (FNAB)
  • Others
• By Technique
  • Image-Guided Biopsy
    • Stereotactic-Guided
    • Ultrasound-Guided
    • CT-Guided
    • MRI-Guided
  • Liquid-Biopsy Techniques
    • Next-Generation Sequencing
    • PCR-Based
    • Microarray-Based
• By Indication
  • Fibroadenoma
  • Suspicious Micro-calcifications
  • Complex Cyst
  • Recurrent Breast Cancer
  • Invasive Lobular Carcinoma
  • Other Indications
• By End User
  • Breast Care Centres
  • Hospitals & Clinics
  • Diagnostic Centres
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America commanded 42.30% of 2025 revenue behind comprehensive Medicare coverage and a dense network of fellowship-trained breast radiologists. Widely available tomosynthesis, high AI acceptance and payer willingness to reimburse liquid-biopsy companion diagnostics strengthen the region's dominance. Consolidation accelerates innovation: RadNet's acquisition of iCAD channels AI resources into 363 imaging centers, establishing data pipelines to refine algorithm accuracy and maintain the region's technological edge.

Asia-Pacific is the fastest-growing territory at 9.35% CAGR because governments subsidize nationwide screening programs and younger median onset mandates earlier intervention. China's goal to screen 6 million women per year opens a vast addressable population while revealing logistic gaps that favor portable biopsy carts. Japan pilots magnetic seed localization and low-dose tomosynthesis to reduce radiation anxiety, while South Korea extends national insurance to AI-assisted ultrasound, stimulating equipment upgrades. As middle-income economies scale digital health platforms, regional suppliers collaborate with Western OEMs to customize low-footprint devices, ensuring sustained growth for the breast biopsy devices market.

Europe records steady gains thanks to CE-marked innovations and diagnosis-related group payments that reward minimally invasive therapy. Germany expands outpatient quotas for stereotactic procedures, freeing inpatient capacity. Meanwhile, Eastern European countries tap EU structural funds to modernize imaging suites, narrowing technology gaps within the bloc.

South America and the Middle East & Africa trail but exhibit pockets of acceleration. Brazil introduces tele-pathology pilots that shorten report cycles, whereas Gulf Cooperation Council states subsidize tomosynthesis for nationals. Infrastructure constraints and currency volatility remain hurdles, yet creative financing-such as pay-per-use models-shows promise for broadening access and nurturing the breast biopsy devices market.

1. Hologic
2. Becton Dickinson & Co.
3. Danaher Corp.
4. Roche
5. Argon Medical Devices
6. Merit Medical Systems
7. Menarini-Silicon Biosystems
8. NeoGenomics
9. Sysmex Inostics
10. Bio-Rad Laboratories
11. QIAGEN
12. Exact Sciences Corp.
13. Guardant Health
14. Intact Medical (Philips)
15. Boston Scientific
16. Cook Group
17. Olympus Corp.
18. Cardinal Health
19. B. Braun
20. Sterylab S.R.L.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Prevalence & Awareness Of Breast Cancer
  • 4.2.2 Expanding Reimbursement For Image-Guided Biopsies
  • 4.2.3 Accelerating Shift Toward Vacuum-Assisted Systems
  • 4.2.4 AI-Enabled 3-D Imaging Improves Lesion Localisation
  • 4.2.5 Growing Demand For Liquid Biopsy Companion Diagnostics
• 4.3 Market Restraints
  • 4.3.1 Post-Biopsy Infection & Hematoma Risk
  • 4.3.2 High Capital Cost Of Stereotactic Tables
  • 4.3.3 Limited Radiology Capacity In Low-Income Regions
• 4.4 Supply-Chain Analysis
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Bargaining Power of Suppliers
  • 4.6.2 Bargaining Power of Buyers/Consumers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Breast Biopsy Needles
  • 5.1.2 Breast Biopsy Tables
  • 5.1.3 Guidance/Imaging Systems
  • 5.1.4 Localization Wires
  • 5.1.5 Assay & Reagent Kits
  • 5.1.6 Others
• 5.2 By Procedure
  • 5.2.1 Vacuum-Assisted Biopsy (VAB)
  • 5.2.2 Core Needle Biopsy (CNB)
  • 5.2.3 Fine Needle Aspiration Biopsy (FNAB)
  • 5.2.4 Others
• 5.3 By Technique
  • 5.3.1 Image-Guided Biopsy
    • 5.3.1.1 Stereotactic-Guided
    • 5.3.1.2 Ultrasound-Guided
    • 5.3.1.3 CT-Guided
    • 5.3.1.4 MRI-Guided
  • 5.3.2 Liquid-Biopsy Techniques
    • 5.3.2.1 Next-Generation Sequencing
    • 5.3.2.2 PCR-Based
    • 5.3.2.3 Microarray-Based
• 5.4 By Indication
  • 5.4.1 Fibroadenoma
  • 5.4.2 Suspicious Micro-calcifications
  • 5.4.3 Complex Cyst
  • 5.4.4 Recurrent Breast Cancer
  • 5.4.5 Invasive Lobular Carcinoma
  • 5.4.6 Other Indications
• 5.5 By End User
  • 5.5.1 Breast Care Centres
  • 5.5.2 Hospitals & Clinics
  • 5.5.3 Diagnostic Centres
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Hologic Inc.
  • 6.3.2 Becton Dickinson & Co.
  • 6.3.3 Danaher Corp.
  • 6.3.4 F. Hoffmann-La Roche Ltd.
  • 6.3.5 Argon Medical Devices
  • 6.3.6 Merit Medical Systems
  • 6.3.7 Menarini-Silicon Biosystems
  • 6.3.8 NeoGenomics
  • 6.3.9 Sysmex Inostics
  • 6.3.10 Bio-Rad Laboratories
  • 6.3.11 Qiagen
  • 6.3.12 Exact Sciences Corp.
  • 6.3.13 Guardant Health Inc.
  • 6.3.14 Intact Medical (Philips)
  • 6.3.15 Boston Scientific Corp.
  • 6.3.16 Cook Medical LLC
  • 6.3.17 Olympus Corp.
  • 6.3.18 Cardinal Health Inc.
  • 6.3.19 B. Braun Melsungen AG
  • 6.3.20 Sterylab S.R.L.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment