Breast Biopsy Devices Market Size, Share & Industry Analysis, By Product Type (Core Needle Biopsy (CNB) Systems, Vacuum-Assisted Biopsy (VAB) Systems, Fine Needle Aspiration (FNA) Systems, Biopsy Needles, Specimen Handling Systems and Others), By Guidance System (Ultrasound-guided Biopsy, MRI-guided Biopsy, Mammography-guided Biopsy and Others), By Application (Screening, Diagnostics and Therapy Response Monitoring), By End-User (Hospitals, Specialty Clinics, Diagnostic Centers and Others), and Regional Forecast, 2026-2034

The breast biopsy devices market size was valued at USD 1.51 billion in 2025. The market is projected to grow from USD 1.59 billion in 2026 to USD 2.64 billion by 2034, exhibiting a CAGR of 6.5% during the forecast period.

Breast biopsy devices are tools used to collect tissue from suspicious breast lesions so clinicians can confirm whether the finding is benign or malignant. They include core needle biopsy systems, vacuum-assisted devices, biopsy markers and guidance accessories used with ultrasound, stereotactic mammography or MRI.

The global market is witnessing considerable growth due to rising incidence of breast cancer, emphasis of governments for implementation of breast cancer prevention programs, and extensive investments by market players for new product developments. Moreover, increasing emphasis on patient-friendly workflows along with emphasis on minimal turnaround time for diagnostic output is also expected to drive market growth.

• For instance, in September 2025, Resitu Medical received FDA approval for its RESL09 breast biopsy device. The newly introduced devices is ultrasound guided and offers output with minimal time.

Furthermore, key industry players such as Hologic, Inc., BD, Danaher Corporation, Argon Medical Devices, Inc., and Merit Medical Systems, Inc., operating in the market, are focusing on developing various innovative technologies to support the rising demand for effective screening of breast cancer.

BREAST BIOPSY DEVICES MARKET TRENDS

Shift Toward Smarter Guidance and Better Targeting is a Prominent Trend Observed in Market

A rising preference for smarter guidance systems is a prominent trend currently being observed in the market. Market players are focusing on developing contrast biopsy software and workflow tools that connect detection and targeting more smoothly, reducing friction between imaging and intervention. Moreover, emphasis on refinement of vacuum-assisted and core biopsy platforms to improve ergonomics, speed, and sample handling is also emerging as a market trend.

• For instance, in February 2025, Hologic Inc. received CE approval for its new Affirm, a contrast biopsy software.

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MARKET DYNAMICS

MARKET DRIVERS

Increasing Focus on Minimally Invasive Diagnostics is Boosting Market Growth

Rising preference for minimally invasive diagnostics is a prominent market growth. In addition, core needle and vacuum-assisted biopsies allow multiple samples through a small incision, often in an outpatient setting, which supports faster clinical decisions and better patient experience. Hospitals and breast centers also prioritize reducing repeat procedures, so solutions that improve tissue yield and targeting are gaining higher traction.

• For instance, in December 2024, a group of researchers at the U.K. in collaboration with BioView announced development in new liquid biopsy technique for detection of metastatic breast cancer.  

MARKET RESTRAINTS

Limited Reimbursement Clarity for Newer Biopsy Approaches to Restrict Market Growth

Limited and uncertainties for breast biopsy reimbursement is deterring the global breast biopsy devices market growth. However, there are uncertainties in reimbursement policies for newer approaches such as contrast-enhanced mammography guided biopsy or advanced vacuum-assisted procedures. This creates hesitation among hospitals and imaging centers when investing in upgraded biopsy systems, as return on investment becomes uncertain.

MARKET OPPORTUNITIES

Shift Toward Personalized Breast Cancer Screening and Follow-Up to Offer Market Growth Opportunities

Healthcare systems are increasingly preferring personalized approach for better breast cancer screening. In addition, women are also increasingly demanding personalized way due to factors such as age, family history, breast density, and previous imaging results. This leads to more focused diagnostic follow-up for women who show higher risk or unclear findings, increasing the need for accurate and repeat biopsy procedures. Additionally, rising incidence of breast cancer worldwide is also projected to offer lucrative opportunity for market growth.

• For instance, in according to a data published by the Breast Cancer Research Foundation, the incidence of breast cancer amongst women below age 50 years has grown by an estimated 1.4% each year from 2012-2022.

MARKET CHALLENGES

Managing Rising Diagnostic Volumes Without Increasing Turnaround Times to Pose a Critical Challenge to Market Growth

Handling the increasing number of diagnostic breast biopsies without extending reporting timelines is one of the challenge for market growth. As screening programs expand and imaging detects more early-stage lesions, biopsy volumes rise faster than staffing and pathology capacity. Moreover, even when biopsy procedures are performed efficiently, downstream steps lead to bottlenecking of process, eventually hampering the overall turnaround time.

Segmentation Analysis

By Product Type

Substantial Adoption of Core Needle Biopsy Due to Wide Applications to Propel Segmental Growth

Based on the product type, the market is divided into core needle biopsy (CNB) systems, vacuum-assisted biopsy (VAB) systems, fine needle aspiration (FNA) systems, biopsy needles, specimen handling systems and others.

The core needle biopsy (CNB) systems segment is anticipated to account for the largest breast biopsy devices market share. This segment growth is attributed to its minimally invasive nature and reliable solid tissue cores analysis. In addition, the product also benefits broad range of lesion types along with high compatibility and common imaging guidance.

• For instance, in May 2025, Stratipath announced launch of new AI-based system which is highly compatible with core needle biopsy products and also received CE approval.

The hepatitis D segment is anticipated to rise with a CAGR of 14.63% over the forecast period.  

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By Guidance System

Cost Efficiency of Ultrasound-guided Systems to Boost Segment Growth

Based on guidance system, the market is segmented into ultrasound-guided biopsy, MRI-guided biopsy, mammography-guided biopsy and others.

In 2025, the ultrasound-guided biopsy segment dominated the global market. Factors such as faster processing of technology, widely availability and cost-efficiency are prominently driving the market growth. In addition, continual focus of market players on new product development is also projected to accelerate segment growth during the forecast period.

• For instance, in June 2025, Olympus Corporation announced launch of its new SecureFlex, a single-use needle biopsy device. The product is used with ultrasound endoscope.

The MRI-guided biopsy segment is projected to grow at a CAGR of 7.2% over the forecast period. 

By Application

Substantial Incidence of Breast Cancer Worldwide to Drive Diagnostics Segment Growth

Based on the application, the market is segmented into screening, diagnostics and therapy response monitoring.

The diagnostics segment is anticipated to witness a dominating market share over the forecast period. Extensively increasing incidence of breast cancer coupled with improved access to healthcare infrastructure is expected to boost segment growth. In addition, rising investments to offer better diagnostic procedures is also projected to drive segment growth.

• For instance, in November 2024, BioMark Diagnostics Inc. announced expansion of its new liquid biopsy technology for breast cancer diagnostics.

The therapy response monitoring segment is projected to grow at a CAGR of 7.2% over the forecast period. 

By End-User

Availability of Advanced Diagnostics Infrastructure Coupled with High Diagnostics Procedure Volume in Hospital to Boost Segment Growth

Based on end-user, the market is segmented into hospitals, specialty clinics, diagnostic centers, and others.

The hospital segment dominated the global market. This high market share is driven by significant diagnostic procedure volume in hospitals. In addition, there is a high preference for hospital amongst patients due to availability of technologically advanced instruments and systems. These factors are estimated to accelerate segment growth during the forecast period. Furthermore, the segment held 48.1% share in 2025.

In addition, specialty clinics are projected to grow at a CAGR of 6.7% during the study period.

Breast Biopsy Devices Market Regional Outlook

By geography, the market is categorized into Europe, North America, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America held the dominant share in 2024, valuing at USD 0.58 billion, and also maintained the leading share in 2025, with USD 0.62 billion. The market in North America is expected to increase due to increasing diagnostic rates of breast cancer and growing prevalence of breast cancer conditions in the region. These factors, coupled with robust healthcare and substantial investment in research and development are enabling market growth.

U.S Breast Biopsy Devices Market

Based on North America’s strong contribution and the U.S. dominance within the region, the U.S. market can be analytically approximated at around USD 0.56 billion in 2026, accounting for roughly 34.9% of global sales.

Europe

Europe is projected to record a growth rate of 6.0% in the coming years, which is the second highest among all regions and reach a valuation of USD 0.43 billion by 2026. The region is estimated to have widespread government screening activities to contain breast cancer and increasing national support schemes to advance access to critical treatment.

U.K Breast Biopsy Devices Market

The U.K. market in 2026 is estimated at around USD 0.07 billion, representing roughly 6.0% of revenue.

Germany Breast Biopsy Devices Market

Germany’s market is projected to reach approximately USD 0.10 billion in 2026, equivalent to around 6.4% of global sales.

Asia Pacific

Asia Pacific is estimated to reach USD 0.36 billion in 2026 and secure the position of the third-largest region in the market. In the region, India and China are both estimated to reach USD 0.08 billion and USD 0.12 billion, respectively in 2026. Increasing prevalence of breast cancer coupled with rising demand for advanced biopsy devices to drive the Asia Pacific market during the forecast period.

Japan Breast Biopsy Devices Market

The Japan market in 2026 is estimated at around USD 0.06 billion, accounting for roughly 3.9% of global revenues.

China Breast Biopsy Devices Market

China’s market is projected to be one of the largest worldwide, with 2026 revenues estimated at around USD 0.08 billion, representing roughly 7.4% of global sales.

India Breast Biopsy Devices Market

The India market in 2026 is estimated at around USD 0.08 billion, accounting for roughly 5.0% of global devices revenues.

Latin America and Middle East & Africa

The Latin America and Middle East & Africa regions are expected to witness moderate growth in this market space during the forecast period. The Latin America market is set to reach a valuation of USD 0.10 billion in 2026. WHO-supported national breast cancer control plans, along with improved diagnostic capabilities, are anticipated to enhance access to treatment in these regions. In the Middle East & Africa, the GCC is set to reach a value of USD 0.02 billion in 2026.

South Africa Breast Biopsy Devices Market

The South Africa market is projected to reach around USD 0.01 billion in 2026, representing roughly 0.5% of revenues.

COMPETITIVE LANDSCAPE

Key Industry Players

Focus on Expanding Product Portfolio by Key Players to Propel Market Progress

The global market holds a semi-consolidated market structure, constituting prominent players such as Hologic, Inc., BD, Danaher Corporation, Argon Medical Devices, Inc., and Merit Medical Systems, Inc. The significant market share of these companies is due to numerous strategic activities, including collaboration among operating entities to advance research activities through various ongoing clinical trials.

For instance, in August 2022, Mammotome announced launch of its first vaccum-assisted breast biopsy device. The device is specifically designed for lesion excision.

Other notable players in the global market include Hoffmann-La Roche Ltd., QIAGEN, Cook, and Devicor Medical Products, Inc. These companies are expected to prioritize new product launches and collaborations to increase their global market share during the forecast period.

LIST OF KEY BREAST BIOPSY DEVICES COMPANIES PROFILED

• Hologic, Inc. (U.S.)
• BD (U.S.)
• Danaher Corporation (U.S.)
• Argon Medical Devices, Inc. (U.S.)
• Merit Medical Systems, Inc. (U.S.)
• Fujifilm Corporation (Japan)
• Hoffmann-La Roche Ltd. (Switzerland)
• QIAGEN (Netherlands)
• Cook (U.S.)
• Devicor Medical Products, Inc. (U.S.)
• GE HealthCare (U.S.)

KEY INDUSTRY DEVELOPMENTS

• June 2025: Cardinal Health entered into strategic collaboration with Citius Oncology for product distribution.
• April 2024: Hologic Inc. announced its plan to acquire Endomagnetics for USD 310M.
• February 2024: Mammotome announced launch of its new AutoCore core needle biopsy system which is specially designed for streamlining of single-insertion breast biopsy procedures.
• March 2023: TransMed7 introduced the VacuPac accessory which adds a self-contained vacuum system to its vacuum-assisted breast biopsy devices.
• May 2023: Argon Medical Devices announced launch of its new product called SuperCore Advantage, a semi-automatic biopsy instrument. The company has strengthened its soft tissue biopsy portfolio in the U.S.
• January 2021: Hologic Inc. announced its plan to acquire SOMATEX to consolidate its presence in breast biopsy market.

REPORT COVERAGE

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Report Scope & Segmentation