유방 생검 기기 시장 : 제품 유형, 시술 유형, 가이던스 기술, 최종사용자별 - 시장 규모, 업계 역학, 기회 분석 및 예측(2026년-2035년)

The global breast biopsy devices market is experiencing strong and sustained demand, with a valuation of approximately USD 1.15 billion in 2025. Over the forecast period, the market is projected to expand significantly, reaching around USD 1.73 billion by 2035, reflecting a compound annual growth rate (CAGR) of 4.19% between 2026 and 2035. This steady growth trajectory highlights the increasing importance of advanced diagnostic technologies in modern healthcare systems worldwide.

A primary factor driving this expansion is the rising global prevalence of breast cancer, which continues to place considerable pressure on healthcare infrastructure. As the number of diagnosed cases increases each year, there is a corresponding need for more efficient, accurate, and widely accessible diagnostic tools. Breast biopsy devices play a critical role in confirming diagnoses and guiding treatment decisions, making them essential components of oncology care pathways.

Noteworthy Market Developments

The breast biopsy devices industry is highly concentrated and intensely competitive, with leading companies continuously investing in research and development, forming strategic technological collaborations, and advancing image-guided precision diagnostics. Hologic Inc. holds a dominant position in the market, supported by its strong expertise in stereotactic imaging integration and a well-established international distribution network.

Danaher Corporation maintains a strong competitive edge through its reputation for engineering excellence and precision-driven tissue sampling technologies. Becton Dickinson commands a significant share of the market through its extensive range of cost-effective disposable needle systems.

Merit Medical Systems has strengthened its presence by targeting independent clinics and outpatient diagnostic facilities with customized hardware bundles. Argon Medical Devices maintains a strong regional influence through its specialization in vacuum-assisted biopsy platforms.

Core Growth Drivers

The global breast biopsy devices market is experiencing substantial demand potential, driven primarily by the rising incidence of disease and the increasing need for accurate and early diagnostic capabilities. As healthcare systems face growing pressure to improve cancer detection outcomes, modern clinical facilities are continuously investing in more advanced imaging and biopsy equipment. This sustained demand reflects a broader global focus on early diagnosis, precision medicine, and improved patient survival rates. Across the world, healthcare systems diagnose approximately 2.3 million new cases of breast cancer each year. This high incidence rate places significant strain on diagnostic infrastructures, requiring hospitals and specialized centers to expand their capacity for screening, imaging, and tissue sampling procedures.

Emerging Opportunity Trends

Image-guided integration is emerging as a key opportunity driving growth in the breast biopsy devices market. This trend reflects the increasing reliance on advanced imaging technologies to improve diagnostic accuracy, enhance procedural precision, and reduce the need for more invasive surgical interventions. As clinical workflows become more technologically advanced, the integration of real-time imaging with biopsy procedures is reshaping how tissue sampling is performed in modern healthcare settings. Technologies such as ultrasound-guided, stereotactic mammography-guided, and MRI-guided biopsy systems continue to dominate the market due to their ability to provide highly accurate lesion localization and targeted tissue sampling.

Barriers to Optimization

False positive results have a significant impact on the broader breast biopsy devices market and the overall global diagnostic ecosystem. When initial screening tests incorrectly indicate the presence of abnormal or malignant tissue, patients are often subjected to additional confirmatory procedures that may not have been medically necessary. This creates a cascading effect within healthcare systems, where further imaging, repeated consultations, and secondary tissue sampling become routine follow-up actions to verify or rule out earlier findings. These inaccuracies place considerable strain on healthcare networks, both operationally and financially.

Detailed Market Segmentation

By product type, Core Needle Biopsy (CNB) systems hold the dominant share in the breast biopsy devices market. This leading position is primarily driven by their strong combination of cost efficiency, clinical reliability, and widespread acceptance across healthcare settings. CNB systems are widely regarded as a standard diagnostic tool for tissue sampling, offering accurate results while maintaining a minimally invasive approach that aligns with modern medical practice.

By procedure type, minimally invasive breast biopsy accounted for a dominant 72% share of the market in 2025. This strong position reflects a broader shift in clinical practice toward less invasive diagnostic approaches that prioritize patient safety, faster recovery, and improved procedural efficiency. Healthcare providers increasingly favor techniques that reduce physical trauma while still delivering highly accurate diagnostic outcomes, making minimally invasive methods the preferred standard in many medical settings.

By guidance technology, ultrasound-guided biopsy held the dominant position in the market in 2025, accounting for approximately 50.4% of the total share. This leadership is largely attributed to its widespread clinical acceptance, safety profile, and effectiveness in enabling precise diagnostic procedures across a range of medical applications. The technique has become a standard approach in many healthcare settings due to its ability to support accurate tissue sampling while minimizing procedural risks.

By end user, hospitals accounted for the dominant share of the market in 2025, representing approximately 48% of total demand. This leadership position is primarily driven by their scale, centralized infrastructure, and ability to manage large volumes of patients requiring advanced diagnostic and treatment services. Hospitals function as the core access point for complex medical care, which naturally positions them as the largest consumers of medical hardware, diagnostic tools, and specialized clinical equipment.

Segment Breakdown

By Product Type

• Core Needle Biopsy Devices
• Vacuum-Assisted Biopsy Devices
• Fine Needle Aspiration (FNA) Devices
• Localization Devices
• Biopsy Guidance Systems

By Procedure Type

• Minimally Invasive Breast Biopsy
• Surgical Breast Biopsy

By Guidance Technology

• Ultrasound-Guided Biopsy
• Stereotactic-Guided Biopsy
• MRI-Guided Biopsy
• Tomosynthesis-Guided Biopsy

By End User

• Hospitals
• Diagnostic Imaging Centers
• Ambulatory Surgical Centers
• Specialty Clinics

By Region

• North America
• The U.S.
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia & New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East & Africa (MEA)
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• North America accounted for the largest revenue share in the global market in 2025, with the United States serving as the primary driver of this dominant regional performance. The region's leadership is strongly supported by its advanced healthcare ecosystem, extensive infrastructure investments, and consistently high levels of healthcare expenditure. The United States, in particular, plays a central role due to its large-scale adoption of advanced medical technologies and its well-established network of hospitals, research institutions, and specialized treatment centers.
• Canada also contributes meaningfully to regional growth, supported by sustained public health investments and government-backed healthcare initiatives. These programs focus on improving diagnostic capabilities, expanding access to advanced treatment options, and strengthening overall healthcare delivery systems. As a result, Canada's healthcare sector provides additional momentum to the broader North American market, complementing the scale and innovation driven by the United States.

Leading Market Participants

• Argon Medical Devices, Inc.
• BD
• Cook
• Danaher Corporation
• Devicor Medical Products, Inc.
• Fujifilm Corporation
• GE HealthCare
• Hoffmann-La Roche Ltd.
• Hologic, Inc.
• Merit Medical Systems, Inc.
• QIAGEN
• Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Breast Biopsy Devices Market

Chapter 2. Research Methodology & Research Framework

• 2.1. Research Objective
• 2.2. Product Overview
• 2.3. Market Segmentation
• 2.4. Qualitative Research
  • 2.4.1. Primary & Secondary Sources
• 2.5. Quantitative Research
  • 2.5.1. Primary & Secondary Sources
• 2.6. Breakdown of Primary Research Respondents, By Region
• 2.7. Assumption for Study
• 2.8. Market Size Estimation
• 2.9. Data Triangulation

Chapter 3. Global Breast Biopsy Devices Market Overview

• 3.1. Industry Value Chain Analysis
  • 3.1.1. Raw Material & Component Suppliers (Needles, Probes, Imaging Components)
  • 3.1.2. Breast Biopsy Device Manufacturers
  • 3.1.3. Imaging & Guidance Technology Providers
  • 3.1.4. Distributors & Medical Device Dealers
  • 3.1.5. Healthcare Providers (Hospitals, Imaging Centers, ASCs, Specialty Clinics)
  • 3.1.6. End Patients
• 3.2. Industry Outlook
  • 3.2.1. Overview of the Global Breast Cancer Diagnostics & Imaging Industry
  • 3.2.2. Shift Toward Minimally Invasive & Image-Guided Biopsy
  • 3.2.3. Regulatory & Reimbursement Landscape (FDA, CE/EU MDR, Coverage Policies)
• 3.3. PESTLE Analysis
• 3.4. Porter's Five Forces Analysis
  • 3.4.1. Bargaining Power of Suppliers
  • 3.4.2. Bargaining Power of Buyers
  • 3.4.3. Threat of Substitutes
  • 3.4.4. Threat of New Entrants
  • 3.4.5. Degree of Competition
• 3.5. Market Growth and Outlook
  • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
  • 3.5.2. Price Trend Analysis, By Product Type

Chapter 4. Global Breast Biopsy Devices Market Analysis

• 4.1. Competition Dashboard
  • 4.1.1. Market Concentration Rate
  • 4.1.2. Company Market Share Analysis (Value %), 2025
  • 4.1.3. Competitor Mapping & Benchmarking

Chapter 5. Global Breast Biopsy Devices Market Analysis

• 5.1. Market Dynamics and Trends
  • 5.1.1. Growth Drivers
  • 5.1.2. Restraints
  • 5.1.3. Opportunity
  • 5.1.4. Key Trends
• 5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 5.2.1. By Product Type
    • 5.2.1.1. Key Insights
      • 5.2.1.1.1. Core Needle Biopsy Devices
      • 5.2.1.1.2. Vacuum-Assisted Biopsy Devices
      • 5.2.1.1.3. Fine Needle Aspiration (FNA) Devices
      • 5.2.1.1.4. Localization Devices
      • 5.2.1.1.5. Biopsy Guidance Systems
  • 5.2.2. By Procedure Type
    • 5.2.2.1. Key Insights
      • 5.2.2.1.1. Minimally Invasive Breast Biopsy
      • 5.2.2.1.2. Surgical Breast Biopsy
  • 5.2.3. By Guidance Technology
    • 5.2.3.1. Key Insights
      • 5.2.3.1.1. Ultrasound-Guided Biopsy
      • 5.2.3.1.2. Stereotactic-Guided Biopsy
      • 5.2.3.1.3. MRI-Guided Biopsy
      • 5.2.3.1.4. Tomosynthesis-Guided Biopsy
  • 5.2.4. By End User
    • 5.2.4.1. Key Insights
      • 5.2.4.1.1. Hospitals
      • 5.2.4.1.2. Diagnostic Imaging Centers
      • 5.2.4.1.3. Ambulatory Surgical Centers
      • 5.2.4.1.4. Specialty Clinics
  • 5.2.5. By Region
    • 5.2.5.1. Key Insights
      • 5.2.5.1.1. North America
        • 5.2.5.1.1.1. The U.S.
        • 5.2.5.1.1.2. Canada
        • 5.2.5.1.1.3. Mexico
      • 5.2.5.1.2. Europe
        • 5.2.5.1.2.1. Western Europe
          • 5.2.5.1.2.1.1. The UK
          • 5.2.5.1.2.1.2. Germany
          • 5.2.5.1.2.1.3. France
          • 5.2.5.1.2.1.4. Italy
          • 5.2.5.1.2.1.5. Spain
          • 5.2.5.1.2.1.6. Rest of Western Europe
        • 5.2.5.1.2.2. Eastern Europe
          • 5.2.5.1.2.2.1. Poland
          • 5.2.5.1.2.2.2. Russia
          • 5.2.5.1.2.2.3. Rest of Eastern Europe
      • 5.2.5.1.3. Asia Pacific
        • 5.2.5.1.3.1. China
        • 5.2.5.1.3.2. India
        • 5.2.5.1.3.3. Japan
        • 5.2.5.1.3.4. Australia & New Zealand
        • 5.2.5.1.3.5. South Korea
        • 5.2.5.1.3.6. ASEAN
        • 5.2.5.1.3.7. Rest of Asia Pacific
      • 5.2.5.1.4. Middle East & Africa (MEA)
        • 5.2.5.1.4.1. Saudi Arabia
        • 5.2.5.1.4.2. South Africa
        • 5.2.5.1.4.3. UAE
        • 5.2.5.1.4.4. Rest of MEA
      • 5.2.5.1.5. South America
        • 5.2.5.1.5.1. Argentina
        • 5.2.5.1.5.2. Brazil
        • 5.2.5.1.5.3. Rest of South America

Chapter 6. North America Market Analysis

• 6.1. Market Dynamics and Trends
  • 6.1.1. Growth Drivers
  • 6.1.2. Restraints
  • 6.1.3. Opportunity
  • 6.1.4. Key Trends
• 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 6.2.1. Key Insights
    • 6.2.1.1. By Product Type
    • 6.2.1.2. By Procedure Type
    • 6.2.1.3. By Guidance Technology
    • 6.2.1.4. By End User
    • 6.2.1.5. By Country

Chapter 7. Europe Market Analysis

• 7.1. Market Dynamics and Trends
  • 7.1.1. Growth Drivers
  • 7.1.2. Restraints
  • 7.1.3. Opportunity
  • 7.1.4. Key Trends
• 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 7.2.1. Key Insights
    • 7.2.1.1. By Product Type
    • 7.2.1.2. By Procedure Type
    • 7.2.1.3. By Guidance Technology
    • 7.2.1.4. By End User
    • 7.2.1.5. By Country

Chapter 8. Asia Pacific Market Analysis

• 8.1. Market Dynamics and Trends
  • 8.1.1. Growth Drivers
  • 8.1.2. Restraints
  • 8.1.3. Opportunity
  • 8.1.4. Key Trends
• 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 8.2.1. Key Insights
    • 8.2.1.1. By Product Type
    • 8.2.1.2. By Procedure Type
    • 8.2.1.3. By Guidance Technology
    • 8.2.1.4. By End User
    • 8.2.1.5. By Country

Chapter 9. Middle East & Africa Market Analysis

• 9.1. Market Dynamics and Trends
  • 9.1.1. Growth Drivers
  • 9.1.2. Restraints
  • 9.1.3. Opportunity
  • 9.1.4. Key Trends
• 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 9.2.1. Key Insights
    • 9.2.1.1. By Product Type
    • 9.2.1.2. By Procedure Type
    • 9.2.1.3. By Guidance Technology
    • 9.2.1.4. By End User
    • 9.2.1.5. By Country

Chapter 10. South America Market Analysis

• 10.1. Market Dynamics and Trends
  • 10.1.1. Growth Drivers
  • 10.1.2. Restraints
  • 10.1.3. Opportunity
  • 10.1.4. Key Trends
• 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 10.2.1. Key Insights
    • 10.2.1.1. By Product Type
    • 10.2.1.2. By Procedure Type
    • 10.2.1.3. By Guidance Technology
    • 10.2.1.4. By End User
    • 10.2.1.5. By Country

Chapter 11. Company Profile (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)

• 11.1. Argon Medical Devices, Inc.
• 11.2. BD
• 11.3. Cook
• 11.4. Danaher Corporation
• 11.5. Devicor Medical Products, Inc.
• 11.6. Fujifilm Corporation
• 11.7. GE HealthCare
• 11.8. Hoffmann-La Roche Ltd.
• 11.9. Hologic, Inc.
• 11.10. Merit Medical Systems, Inc.
• 11.11. QIAGEN
• 11.12. Other Prominent Players

Chapter 12. Annexure

• 12.1. List of Secondary Sources
• 12.2. Key Country Markets- Macro Economic Outlook/Indicators