Global Breast Biopsy Devices Market Size study & Forecast, by Product (Needle: Core, FNAB, VAB; Equipment, Wire, Guidance system, Table, Assay kit), Procedure (Needle, Liquid: CTC, CTDNA; Open), Application (Screening, Monitoring), End User (Hospital, Cli

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

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.

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