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市場調查報告書

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2069640

乳房切片器材市場：按產品類型、手術類型、導引技術和最終用戶分類－市場規模、產業動態、機會分析和預測（2026-2035 年）

Breast Biopsy Devices Market: By Product Type, Procedure Type, Guidance Technology, End User - Market Size, Industry Dynamics, Opportunity Analysis And Forecast For 2026-2035

出版日期: 2026年06月08日 | 出版商:

Astute Analytica | 英文 320 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

全球乳房切片設備市場在強勁且持續的需求支撐下，預計2025年市場規模將達到約11.5億美元。在預測期內，該市場預計將顯著成長，到2035年將達到約17.3億美元，2026年至2035年的年複合成長率（CAGR）為4.19%。這一穩定成長的趨勢凸顯了先進診斷技術在全球現代醫療保健系統中日益成長的重要性。

推動這項擴張的主要因素是全球乳癌發生率的上升，這持續對醫療基礎設施造成沉重負擔。隨著確診病例逐年增加，對更有效率、更準確、更普及的診斷工具的需求也日益成長。乳房切片設備在確診和製定治療方案方面發揮著至關重要的作用，已成為癌症治療過程中不可或缺的一部分。

顯著的市場趨勢

乳房切片設備產業高度集中且競爭異常激烈。領先企業致力於持續投資研發、建構策略技術合作關係，並推動影像引導精準診斷技術的發展。 Hologic 公司憑藉其在立體定位影像整合的雄厚實力和完善的國際分銷網路，佔市場主導地位。

丹納赫公司憑藉其卓越的工程技術和精準的組織取樣技術，保持著強大的競爭優勢。貝克頓·迪金森公司則憑藉其種類繁多、成本績效高效的一次性針頭系統，佔了相當大的市場佔有率。

Merit Medical Systems 透過提供客製化的硬體套裝，面向獨立診所和門診診斷機構，不斷擴大其市場佔有率。 Argon Medical Devices 則專注於真空輔助切片檢查平台，在當地保持強大的市場地位。

主要成長要素

全球乳房切片設備市場需求潛力巨大，主要促進因素是乳癌發生率的上升以及對精準早期診斷能力日益成長的需求。隨著醫療系統面臨提高癌症篩檢效果的壓力，現代臨床機構不斷投資更先進的影像和切片檢查設備。這種持續的需求反映了全球對早期診斷、精準醫療和提高患者存活率的日益關注。全球醫療系統每年診斷出約230萬例新增乳癌病例。如此高的發病率給診斷基礎設施帶來了沉重負擔，要求醫院和專科機構擴展其在篩檢、影像和組織取樣方面的能力。

新機會的趨勢

影像導引技術正成為推動乳房切片設備市場成長的關鍵機會。這一趨勢反映出人們越來越依賴先進的影像技術來提高診斷準確性、最佳化操作流程並減少高侵入性手術的需求。隨著臨床工作流程的技術化程度不斷提高，即時影像與切片檢查流程的整合正在改變現代醫療保健中組織採集的方式。超音波引導、立體定位乳房X光攝影引導和磁振造影引導等技術能夠極為精確地定位病灶並實現標靶切片檢查採集，因此持續推動著市場發展。

最佳化障礙

假陽性結果對整個乳房切片設備市場和全球診斷生態系統都產生了重大影響。當初次篩檢錯誤地提示有異常或惡性組織時，患者往往會接受一些並非醫學上必要的額外確認性檢查。這會在醫療系統中產生連鎖反應，促使進一步影像檢查、重複檢查和二次組織取樣成為常規的後續措施，以檢驗或排除先前的觀察。這種不準確性為醫療網路帶來了沉重的營運和財務負擔。

產業價值鏈分析
產業展望
- 全球乳癌診斷與影像產業概覽
- 過渡到微創、影像引導切片檢查
- 監理情勢與報銷趨勢（FDA、CE/EU MDR、保險覆蓋政策）
PESTLE分析
波特五力分析
市場成長及前景
- 2020-2035年市場收入估算與預測
- 價格趨勢分析：依產品類型

第4章：全球乳房切片設備市場分析

競爭對手儀表板
- 市場集中度
- 企業市場占有率分析，2025 年
- 競爭對手分析與基準測試

第5章：全球乳房切片設備市場分析

市場動態和趨勢
- 成長要素
- 抑制因子
- 機會
- 主要趨勢
市場規模及預測，2020-2035年
- 依產品類型
  - 關鍵見解
    - 粗針穿刺切片裝置
    - 真空輔助切片檢查裝置
    - 細針穿刺（FNA）裝置
    - 位置追蹤設備
    - 切片檢查引導系統
- 依技術類型
  - 關鍵見解
    - 微創乳房切片
    - 乳房切片活體組織切片
- 按類別分類的導航技術
  - 關鍵見解
    - 超音波引導下切片檢查
    - 立體定位引導切片檢查
    - 磁振造影引導切片檢查
    - 斷層合成誘導切片檢查
- 最終用戶
  - 關鍵見解
    - 醫院
    - 診斷影像中心
    - 門診手術中心
    - 專科診所
- 按地區
  - 關鍵見解
    - 北美洲
      - 美國
      - 加拿大
      - 墨西哥
    - 歐洲
      - 西歐
        
        英國
        德國
        法國
        義大利
        西班牙
        其他西歐國家
      - 東歐
        
        波蘭
        俄羅斯
        其他東歐國家
    - 亞太地區
      - 中國
      - 印度
      - 日本
      - 澳洲和紐西蘭
      - 韓國
      - ASEAN
      - 其他亞太國家
    - 中東和非洲（MEA）
      - 沙烏地阿拉伯
      - 南非
      - UAE
      - 其他中東和非洲國家
    - 南美洲
      - 阿根廷
      - 巴西
      - 其他南美國家

第6章：北美市場分析

第7章：歐洲市場分析

第8章：亞太市場分析

第9章：中東和非洲市場分析

第10章：南美市場分析

第11章：公司簡介

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

第12章附錄

簡介目錄

Product Code: AA06261821

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