Global Breast Biopsy Devices Market Size study & Forecast, by Product, Procedure, Application, End User and Regional Forecasts 2022-2032

Description

The Global Breast Biopsy Devices Market, valued at approximately USD 2.23 billion in 2024, is projected to expand at a robust CAGR of 6.50% between 2025 and 2035. Breast biopsy devices play a pivotal role in diagnosing and monitoring breast cancer, enabling clinicians to obtain accurate tissue or fluid samples for pathological examination. These devices, spanning from advanced vacuum-assisted biopsy systems to minimally invasive fine-needle aspiration kits, have evolved to offer greater precision, reduced patient discomfort, and faster turnaround times. The market's momentum is being propelled by a rising global prevalence of breast cancer, the growing emphasis on early detection, and the increasing integration of image-guided procedures that significantly enhance diagnostic accuracy. Technological innovations-particularly in automated, ultrasound, and MRI-guided systems-are further transforming biopsy workflows, making them more efficient and accessible.

The rising awareness about the importance of early-stage cancer detection has encouraged healthcare providers worldwide to invest in advanced diagnostic technologies, thereby elevating the demand for breast biopsy devices. Global cancer incidence data highlights the scale of the challenge-according to the WHO, breast cancer remains the most diagnosed cancer among women, accounting for over 2.3 million new cases annually. In addition, liquid biopsy technologies, such as circulating tumor cells (CTC) and circulating tumor DNA (ctDNA) testing, are emerging as complementary tools for monitoring disease progression, relapse, and therapeutic response. The shift towards minimally invasive and real-time diagnostic methods is not only driving product innovation but also opening up lucrative opportunities for device manufacturers to capture untapped market segments. However, high procedural costs, limited reimbursement policies in certain countries, and the shortage of skilled professionals capable of performing advanced biopsy techniques may pose challenges to sustained adoption.

Geographically, North America currently dominates the global market, supported by a mature healthcare infrastructure, high screening participation rates, and a strong network of specialized oncology centers. The United States, in particular, benefits from robust research and development funding, leading to frequent product launches and clinical trials in breast cancer diagnostics. Europe holds the second-largest share, driven by strong government-backed cancer screening initiatives and a focus on enhancing diagnostic accuracy through digital pathology and AI-assisted imaging. The Asia Pacific region is anticipated to exhibit the fastest growth during the forecast period, buoyed by rising healthcare expenditure, rapidly improving diagnostic infrastructure, and increasing public health awareness campaigns in populous countries such as China and India. Meanwhile, Latin America and the Middle East & Africa are steadily emerging as growth frontiers, supported by expanding private healthcare networks and gradual improvements in early cancer detection programs.

Major market players included in this report are:

Hologic, Inc.
Becton, Dickinson and Company
Devicor Medical Products, Inc. (part of Leica Biosystems)
Siemens Healthineers AG
Fujifilm Holdings Corporation
Cook Medical LLC
Planmed Oy
Argon Medical Devices, Inc.
Aurora Imaging Technology, Inc.
Scion Medical Technologies, LLC
C.R. Bard, Inc. (Becton, Dickinson and Company)
Bio-Rad Laboratories, Inc.
Genomic Health, Inc.
Roche Diagnostics
Thermo Fisher Scientific Inc.

Global Breast Biopsy Devices Market Report Scope:

Historical Data - 2023, 2024
Base Year for Estimation - 2024
Forecast period - 2025-2035
Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Product:

Needle (Core, FNAB, VAB)
Equipment
Wire
Guidance system
Table
Assay kit

By Procedure:

Needle
Liquid (CTC, CTDNA)
Open

By Application:

Screening
Monitoring

By End User:

Hospital
Clinic

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Rest of Europe (ROE)
Asia Pacific
China
India
Japan
Australia
South Korea
Rest of Asia Pacific (RoAPAC)
Latin America
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa

Key Takeaways:

Market Estimates & Forecast for 10 years from 2025 to 2035.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.

Chapter 1. Global Breast Biopsy Devices Market Report Scope & Methodology

1.1. Research Objective
1.2. Research Methodology
- 1.2.1. Forecast Model
- 1.2.2. Desk Research
- 1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
- 1.4.1. Market Definition
- 1.4.2. Market Segmentation
1.5. Research Assumption
- 1.5.1. Inclusion & Exclusion
- 1.5.2. Limitations
- 1.5.3. Years Considered for the Study

Chapter 2. Executive Summary

2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings

Chapter 3. Global Breast Biopsy Devices Market Forces Analysis

3.1. Market Forces Shaping The Global Breast Biopsy Devices Market (2024-2035)
3.2. Drivers
- 3.2.1. Rising global breast cancer incidence and expanded screening programs.
- 3.2.2. Technological advancements in image-guided, minimally invasive and vacuum-assisted biopsy systems.
3.3. Restraints
- 3.3.1. High procedural and device costs coupled with limited reimbursement in certain countries.
- 3.3.2. Shortage of trained clinicians and diagnostic infrastructure in emerging markets.
3.4. Opportunities
- 3.4.1. Emergence and integration of liquid biopsy (CTC, ctDNA) for monitoring and complementary diagnostics.
- 3.4.2. Rapid expansion and healthcare modernization in Asia Pacific and other emerging regions.

Chapter 4. Global Breast Biopsy Devices Industry Analysis

4.1. Porter's 5 Forces Model
- 4.1.1. Bargaining Power of Buyer
- 4.1.2. Bargaining Power of Supplier
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
4.2. Porter's 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
- 4.3.1. Political
- 4.3.2. Economical
- 4.3.3. Social
- 4.3.4. Technological
- 4.3.5. Environmental
- 4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Breast Biopsy Devices Market Size & Forecasts by Product 2025-2035

5.1. Market Overview
5.2. Global Breast Biopsy Devices Market Performance - Potential Analysis (2025)
5.3. Needle (Core, FNAB, VAB)
- 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.3.2. Market size analysis, by region, 2025-2035
5.4. Equipment
- 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.4.2. Market size analysis, by region, 2025-2035
5.5. Wire
- 5.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.5.2. Market size analysis, by region, 2025-2035
5.6. Guidance system
- 5.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.6.2. Market size analysis, by region, 2025-2035
5.7. Table
- 5.7.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.7.2. Market size analysis, by region, 2025-2035
5.8. Assay kit
- 5.8.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.8.2. Market size analysis, by region, 2025-2035

Chapter 6. Global Breast Biopsy Devices Market Size & Forecasts by Procedure 2025-2035

6.1. Market Overview
6.2. Global Breast Biopsy Devices Market Performance - Potential Analysis (2025)
6.3. Needle Procedure
- 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.3.2. Market size analysis, by region, 2025-2035
6.4. Liquid Procedure (CTC, ctDNA)
- 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.4.2. Market size analysis, by region, 2025-2035
6.5. Open Procedure
- 6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.5.2. Market size analysis, by region, 2025-2035

Chapter 7. Global Breast Biopsy Devices Market Size & Forecasts by Region 2025-2035

7.1. Breast Biopsy Devices Market, Regional Market Snapshot
7.2. Top Leading & Emerging Countries
7.3. North America Breast Biopsy Devices Market
- 7.3.1. U.S. Breast Biopsy Devices Market
  - 7.3.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.3.1.2. Procedure breakdown size & forecasts, 2025-2035
- 7.3.2. Canada Breast Biopsy Devices Market
  - 7.3.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.3.2.2. Procedure breakdown size & forecasts, 2025-2035
7.4. Europe Breast Biopsy Devices Market
- 7.4.1. UK Breast Biopsy Devices Market
  - 7.4.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.1.2. Procedure breakdown size & forecasts, 2025-2035
- 7.4.2. Germany Breast Biopsy Devices Market
  - 7.4.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.2.2. Procedure breakdown size & forecasts, 2025-2035
- 7.4.3. France Breast Biopsy Devices Market
  - 7.4.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.3.2. Procedure breakdown size & forecasts, 2025-2035
- 7.4.4. Spain Breast Biopsy Devices Market
  - 7.4.4.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.4.2. Procedure breakdown size & forecasts, 2025-2035
- 7.4.5. Italy Breast Biopsy Devices Market
  - 7.4.5.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.5.2. Procedure breakdown size & forecasts, 2025-2035
- 7.4.6. Rest of Europe Breast Biopsy Devices Market
  - 7.4.6.1. Product breakdown size & forecasts, 2025-2035
  - 7.4.6.2. Procedure breakdown size & forecasts, 2025-2035
7.5. Asia Pacific Breast Biopsy Devices Market
- 7.5.1. China Breast Biopsy Devices Market
  - 7.5.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.1.2. Procedure breakdown size & forecasts, 2025-2035
- 7.5.2. India Breast Biopsy Devices Market
  - 7.5.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.2.2. Procedure breakdown size & forecasts, 2025-2035
- 7.5.3. Japan Breast Biopsy Devices Market
  - 7.5.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.3.2. Procedure breakdown size & forecasts, 2025-2035
- 7.5.4. Australia Breast Biopsy Devices Market
  - 7.5.4.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.4.2. Procedure breakdown size & forecasts, 2025-2035
- 7.5.5. South Korea Breast Biopsy Devices Market
  - 7.5.5.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.5.2. Procedure breakdown size & forecasts, 2025-2035
- 7.5.6. Rest of APAC Breast Biopsy Devices Market
  - 7.5.6.1. Product breakdown size & forecasts, 2025-2035
  - 7.5.6.2. Procedure breakdown size & forecasts, 2025-2035
7.6. Latin America Breast Biopsy Devices Market
- 7.6.1. Brazil Breast Biopsy Devices Market
  - 7.6.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.6.1.2. Procedure breakdown size & forecasts, 2025-2035
- 7.6.2. Mexico Breast Biopsy Devices Market
  - 7.6.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.6.2.2. Procedure breakdown size & forecasts, 2025-2035
7.7. Middle East and Africa Breast Biopsy Devices Market
- 7.7.1. UAE Breast Biopsy Devices Market
  - 7.7.1.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.1.2. Procedure breakdown size & forecasts, 2025-2035
- 7.7.2. Saudi Arabia (KSA) Breast Biopsy Devices Market
  - 7.7.2.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.2.2. Procedure breakdown size & forecasts, 2025-2035
- 7.7.3. South Africa Breast Biopsy Devices Market
  - 7.7.3.1. Product breakdown size & forecasts, 2025-2035
  - 7.7.3.2. Procedure breakdown size & forecasts, 2025-2035

Chapter 8. Competitive Intelligence

8.1. Top Market Strategies
8.2. Hologic, Inc.
- 8.2.1. Company Overview
- 8.2.2. Key Executives
- 8.2.3. Company Snapshot
- 8.2.4. Financial Performance (Subject to Data Availability)
- 8.2.5. Product/Services Port
- 8.2.6. Recent Development
- 8.2.7. Market Strategies
- 8.2.8. SWOT Analysis
8.3. Becton, Dickinson and Company (BD)
8.4. Devicor Medical Products, Inc. (Leica Biosystems)
8.5. Siemens Healthineers AG
8.6. Fujifilm Holdings Corporation
8.7. Cook Medical LLC
8.8. Planmed Oy
8.9. Argon Medical Devices, Inc.
8.10. Aurora Imaging Technology, Inc.
8.11. Scion Medical Technologies, LLC
8.12. Bio-Rad Laboratories, Inc.
8.13. Genomic Health, Inc.
8.14. Roche Diagnostics
8.15. Thermo Fisher Scientific Inc.