Breast Biopsy Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Biopsy Needles, Guidance Systems, Biopsy Tables, Localization Wires, Assay Kits, Liquid Biopsy Instruments, Others), By Procedure (Needle Breast Biopsy, Open Surgical Breast Biopsy, Liquid Breast Biopsy), By Application (Early Cancer Screening, Therapy Selection, Treatment Monitoring, Recurrence Monitoring), By End User (Hospitals & Surgical Centers, Breast Care Centers, Imaging Clinics & Diagnostic Centers), By Region and Competition, 2020-2030F

Market Overview

The Global Breast Biopsy Devices Market, valued at USD 1.02 Billion in 2024, is projected to experience a CAGR of 6.89% to reach USD 1.52 Billion by 2030. Breast biopsy devices are specialized instruments utilized to extract tissue samples from suspicious breast lesions for definitive diagnostic examination, encompassing various needle-based and vacuum-assisted systems guided by imaging modalities. The global market for these devices is primarily driven by the increasing incidence of breast cancer, growing public awareness regarding early detection, and the expanding preference for minimally invasive diagnostic procedures. According to the World Health Organization and IARC, in 2022, an estimated 2.3 million women were diagnosed with breast cancer globally, highlighting the persistent demand for effective diagnostic tools.

Despite robust growth drivers, a significant challenge impeding market expansion involves the substantial cost associated with advanced biopsy procedures and their reliance on expensive imaging modalities, which can restrict access in resource-limited regions.

Key Market Drivers

The global breast biopsy devices market is significantly influenced by the increasing worldwide prevalence of breast cancer, creating a sustained and urgent demand for effective diagnostic solutions. The rising incidence necessitates more frequent and accurate biopsies to confirm diagnoses and guide treatment strategies. According to the World Cancer Research Fund, in 2022, there were 2,296,840 new cases of breast cancer among women globally, underscoring the critical need for advanced diagnostic tools. Concurrently, advancements in minimally invasive breast biopsy technologies are pivotal, offering less traumatic and more precise procedures that enhance patient comfort and diagnostic confidence. Innovations such as vacuum-assisted biopsy systems provide superior tissue sampling capabilities, allowing for larger, more representative specimens to be collected with fewer insertions. This technological progression directly drives market adoption by improving diagnostic accuracy and reducing the need for open surgical biopsies. According to the American College of Radiology, vacuum-assisted devices achieve 98% diagnostic concordance rates with surgical specimens, highlighting their efficacy compared to conventional core needle techniques. These developments address the imperative for accurate and patient-friendly diagnostic methods, propelling the market forward.

Further supporting the market for breast biopsy devices is the consistent investment in cancer research and development. According to the American Cancer Society, in November 2023, it approved funding for 131 new Extramural Discovery Science research and career development grants totaling US$64.5 million, with these grants commencing in 2024, which are expected to advance diagnostic capabilities and treatment options for various cancers, including breast cancer.

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Key Market Challenges

The substantial cost associated with advanced biopsy procedures and their reliance on expensive imaging modalities represents a significant impediment to the growth of the Global Breast Biopsy Devices Market. This financial barrier directly restricts market expansion by limiting the adoption of these essential diagnostic tools, particularly within resource-limited regions and healthcare systems operating under stringent budgetary constraints. The high capital investment required for state-of-the-art imaging equipment, such as specialized mammography units or MRI systems, coupled with the ongoing expenses for maintenance and skilled personnel, renders these advanced diagnostic pathways largely inaccessible to a significant portion of the global healthcare infrastructure.

For example, while the European medical technology market, which encompasses breast biopsy devices, was estimated to be €170 billion in 2024, according to MedTech Europe, the significant cost of advanced diagnostic equipment inherently prevents widespread implementation globally. This affordability challenge forces healthcare providers in economically challenged areas to either defer or forego the acquisition of modern breast biopsy systems, thereby directly constricting the market's potential reach and growth in these underserved populations.

Key Market Trends

The integration of Artificial Intelligence and Machine Learning into breast biopsy devices is transforming diagnostic accuracy and workflow efficiency within the market. These advanced computational methods enhance image analysis, aiding radiologists in identifying subtle anomalies and differentiating between benign and malignant lesions with greater precision. According to a EuroAIM/EuSoMII 2024 survey among members of the European Society of Radiology, 48% of respondents were already utilizing AI or planning its adoption, with a predominant expected impact on breast imaging. This widespread acceptance underscores the growing confidence in AI’s capabilities. For instance, iCAD's FDA-cleared ProFound Detection Version 4.0, highlighted at RSNA 2024, demonstrated a 23% increase in overall cancer detection rates and a 4% rise in invasive cancer detection rates, showcasing the tangible benefits of AI in improving patient outcomes. The continuous development of such intelligent systems is propelling demand for integrated diagnostic solutions.

Another significant trend is the emergence of liquid biopsy for breast cancer detection, representing a paradigm shift towards less invasive diagnostic approaches. Liquid biopsies, which analyze circulating tumor DNA or cells from a blood sample, offer a non-invasive method for early detection, monitoring treatment response, and identifying resistance mutations. Data presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting demonstrated the clinical value of the Guardant360 CDx test, showing that patients with advanced breast cancer who switched therapy based on liquid biopsy results experienced a 56% reduced risk of disease progression or death. This highlights the potential for personalized treatment pathways. Furthermore, Guardant Health announced in May 2025 new capabilities for its Guardant360 Liquid test, including advanced biomarker identification and precise breast cancer subtyping, further solidifying liquid biopsy's role in guiding optimal patient management. These advancements are fostering a new segment within the breast biopsy devices market, focusing on molecular diagnostics.

Segmental Insights

The Biopsy Needles segment is experiencing rapid expansion within the Global Breast Biopsy Devices Market due to several critical factors. The rising worldwide incidence of breast cancer significantly drives the demand for accurate diagnostic procedures. Furthermore, the increasing patient and clinician preference for minimally invasive diagnostic techniques, such as core-needle and vacuum-assisted biopsies, directly fuels the adoption of advanced biopsy needles. Continuous technological advancements in needle design, coupled with enhanced integration with imaging modalities like ultrasound and MRI, improve both diagnostic precision and procedural efficiency, ensuring better tissue collection and reduced patient discomfort.

Regional Insights

North America leads the global breast biopsy devices market, primarily due to its advanced healthcare infrastructure and high incidence of breast cancer. The region benefits from substantial healthcare spending, widespread adoption of minimally invasive diagnostic procedures, and robust government initiatives promoting breast cancer awareness and screening programs. Additionally, the strong presence of key market players who continuously innovate, coupled with favorable reimbursement policies and a well-defined regulatory framework by bodies such as the U. S. Food and Drug Administration (FDA), significantly drives market growth and the early adoption of advanced biopsy technologies. These factors collectively ensure high demand for precise and efficient breast biopsy solutions.

Recent Developments

• In December 2024, Guardant Health presented new research at the San Antonio Breast Cancer Symposium, impacting the liquid biopsy segment of the global breast biopsy devices market. The company and its collaborators shared data demonstrating the benefits of precision oncology tests, including the Guardant Reveal test. This research highlighted the potential for circulating tumor DNA (ctDNA) to predict sensitivity to endocrine therapy and long-term outcomes in HR+ breast cancer, as well as aid in optimizing therapy selection and identifying resistance mutations.

• In December 2024, Hologic showcased several new technologies at the Radiological Society of North America (RSNA) annual meeting, contributing to advancements in the global breast health and biopsy landscape. The company unveiled its Envision Mammography Platform, designed to provide high-speed 3D mammograms, and introduced the next-generation Genius AI Detection PRO solution. This advanced AI technology aims to enhance the accuracy and efficiency of cancer screening, which directly informs the need for and planning of breast biopsy procedures. Hologic also presented its comprehensive suite of breast biopsy and surgical solutions.

• In November 2024, Mammotome introduced the Mammotome AutoCore Single Insertion Core Biopsy System, representing a new product launch within the global breast biopsy devices market. This device is the first automated spring-loaded core needle system designed to enhance efficiency for ultrasound core needle breast biopsies. It features a single-button functionality and automated arming, simplifying the sampling process. The Mammotome AutoCore system received FDA clearance in the United States and was scheduled for domestic availability in early 2025, with future plans for international expansion. This innovation aims to streamline procedures and improve the patient experience.

• In March 2024, Mammotome launched the LumiMARK Biopsy Site Marker, a significant new product for the global breast biopsy devices market. This innovative tissue marker line, which received 510(k) clearance, was designed with enhanced visibility under various imaging modalities, including ultrasound, mammography, and magnetic resonance imaging. The LumiMARK markers are available in three distinct, multifaceted 3D shapes and sizes, enabling radiologists to easily identify and confirm target tissue from any angle. This product was made available to clinicians in the United States in summer 2024.

Key Market Players

• Hologic Inc.
• Danaher Corporation
• Becton, Dickinson and Company
• Argon Medical Devices, Inc.
• Guardant Health, Inc.
• Merit Medical Systems, Inc.
• Neogenomics Laboratories, Inc.
• Sysmex Inostics, Inc.
• Sterylab S.R.L.
• Bio-Rad Laboratories Inc.

Report Scope:

In this report, the Global Breast Biopsy Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Breast Biopsy Devices Market, By Type:

o   Biopsy Needles

o   Guidance Systems

o   Biopsy Tables

o   Localization Wires

o   Assay Kits

o   Liquid Biopsy Instruments

o   Others

• Breast Biopsy Devices Market, By Procedure:

o   Needle Breast Biopsy

o   Open Surgical Breast Biopsy

o   Liquid Breast Biopsy

• Breast Biopsy Devices Market, By Application:

o   Early Cancer Screening

o   Therapy Selection

o   Treatment Monitoring

o   Recurrence Monitoring

• Breast Biopsy Devices Market, By End User:

o   Hospitals & Surgical Centers

o   Breast Care Centers

o   Imaging Clinics & Diagnostic Centers

• Breast Biopsy Devices Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Breast Biopsy Devices Market.

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Company Information

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