Breast Cancer Core Needle Biopsy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented by Technology (MRI-Based Breast Biopsy, Ultrasound-Based Breast Biopsy, Mammography-Based (Stereotactic) Breast Biopsy, CT-Based Breast Biopsy, Other Image Based Breast Biopsy), By End Use (Hospitals & Diagnostic Laboratories, Pharmaceutical & Biotechnology companies, Academic & Research Institutes), and By Region, Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.10 Billion
CAGR (2026-2031)	9.39%
Fastest Growing Segment	MRI-Based Breast Biopsy
Largest Market	North America
Market Size (2031)	USD 1.88 Billion

Market Overview

The Global Breast Cancer Core Needle Biopsy Market will grow from USD 1.10 Billion in 2025 to USD 1.88 Billion by 2031 at a 9.39% CAGR. Breast cancer core needle biopsy is a medical procedure involving the percutaneous extraction of tissue samples using a hollow needle to histologically evaluate suspicious mammary lesions for malignancy. The global market for this diagnostic modality is primarily driven by the increasing incidence of breast cancer and a distinct clinical shift toward minimally invasive procedures that offer reduced patient morbidity compared to open surgical excision. Furthermore, the expansion of government funded mammography screening programs continues to identify a higher volume of anticipated abnormalities that require definitive tissue confirmation, thereby sustaining the demand for accurate biopsy interventions.

However, market expansion faces a significant challenge regarding the high capital expenditure required for advanced image guidance systems which limits accessibility in cost sensitive healthcare regions. This economic barrier is particularly concerning given the escalating burden of the disease that necessitates efficient diagnostic workflows. According to the American Cancer Society, in 2024, an estimated 310,720 new cases of invasive breast cancer will be diagnosed in women in the United States. This substantial incidence rate highlights the urgent need for accessible diagnostic solutions even as financial constraints impede the broader adoption of premium biopsy technologies.

Key Market Drivers

The escalating global burden of breast malignancies serves as the foundational catalyst for the core needle biopsy market, creating a direct correlation between disease prevalence and procedural volume. As the frequency of suspected lesions rises, healthcare systems are compelled to scale their diagnostic capabilities to manage the influx of patients requiring definitive histological verification. This prevalence compels medical providers to rely heavily on core needle biopsy as the standard of care for investigating abnormalities before therapeutic intervention, ensuring that tissue sampling keeps pace with detection rates. According to the World Health Organization, February 2024, in the 'Global Cancer Burden' press release, there were an estimated 2.3 million new cases of breast cancer diagnosed globally in 2022. This trajectory ensures a sustained necessity for efficient tissue sampling devices to manage the growing caseload effectively.

Parallel to rising incidence, the expansion of public and private screening initiatives significantly amplifies the identification of non-palpable lesions that require image-guided sampling. Enhanced screening protocols are detecting subtle abnormalities in wider demographic groups, necessitating immediate biopsy for characterization and diagnosis. Regulatory bodies are increasingly updating guidelines to capture at-risk populations earlier, which directly expands the patient pool requiring diagnostic follow-up. According to the U.S. Preventive Services Task Force, April 2024, in the 'Final Recommendation Statement', women are now advised to start biennial screening mammography at age 40, a policy shift designed to address increasing diagnoses in younger cohorts. This focus on early detection is critical because, according to the National Breast Cancer Foundation, in 2024, when breast cancer is detected early in the localized stage, the 5-year relative survival rate is 99%.

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Key Market Challenges

The high capital expenditure required for advanced image guidance systems presents a significant barrier to the growth of the global breast cancer core needle biopsy market. Healthcare facilities in cost-sensitive regions frequently encounter budgetary limitations that prevent the acquisition of essential equipment such as stereotactic or magnetic resonance imaging guidance units. This financial constraint limits the ability of medical providers to adopt minimally invasive biopsy procedures, forcing reliance on older or less precise diagnostic methods. Consequently, the market experiences reduced penetration rates in developing economies where healthcare infrastructure spending is restricted.

The inability to procure these diagnostic technologies directly hampers the capacity to manage the severe burden of breast cancer effectively. This economic hurdle creates a disconnect between the availability of diagnostic solutions and the patient populations that require them. According to the American Cancer Society, in 2024, approximately 42,250 deaths from breast cancer were projected to occur in the United States. This statistical projection highlights the critical nature of the disease and illustrates how financial barriers to accessing accurate biopsy instrumentation can impede the diagnostic workflows necessary to mitigate mortality rates.

Key Market Trends

The rising adoption of vacuum-assisted core biopsy technologies is fundamentally altering the procedural landscape by addressing the clinical need for larger, high-quality tissue samples that traditional spring-loaded devices cannot consistently provide. This shift is technically driven by the requirement to excise contiguous specimens from complex lesions or microcalcifications, thereby reducing the rate of histological underestimation and the necessity for re-biopsy. Manufacturers are responding to this demand by engineering devices with expanded capabilities to maximize tissue volume during a single insertion. According to Drug and Device World, October 2025, in the 'Resitu wins FDA clearance for breast biopsy device' article, the newly authorized RESL09 vacuum-assisted device features a probe diameter of up to 9mm, a specification designed to enable the extraction of significantly larger tissue specimens for precise diagnostic analysis compared to standard instruments.

Simultaneously, the market is experiencing a robust integration of advanced image-guidance modalities, particularly 3D tomosynthesis and MRI, which are becoming essential for targeting non-palpable lesions. This trend represents a move away from standalone biopsy mechanisms toward comprehensive diagnostic ecosystems where the biopsy unit is seamlessly paired with real-time imaging gantries to enhance targeting accuracy and workflow efficiency. The commercial momentum of this sector is evidenced by the strong financial performance of major players diversifying their breast health portfolios to include these sophisticated guidance systems. According to Medical Device Network, July 2024, in the 'Hologic posts 2.7% increase in revenue for Q3 2024' article, the company's breast health segment reported a revenue increase of 6.9%, reflecting the sustained provider demand for integrated imaging and interventional solutions that support these advanced diagnostic procedures.

Segmental Insights

The MRI-based breast biopsy segment currently represents the fastest-growing category within the global breast cancer core needle biopsy market. This accelerated expansion is largely attributed to the high sensitivity of magnetic resonance imaging, which enables the detection of lesions often invisible to mammography or ultrasound, particularly in patients with dense breast tissue. Clinicians increasingly rely on this modality to perform precise sampling for high-risk individuals. Additionally, continuous product clearances by regulatory authorities such as the U.S. Food and Drug Administration support the wider integration of MRI-compatible biopsy systems into standard diagnostic practice.

Regional Insights

North America maintains a dominant position in the global breast cancer core needle biopsy market, driven by a high prevalence of breast cancer and widespread adoption of early screening programs. The region benefits from established healthcare infrastructure and favorable reimbursement structures that improve patient access to diagnostic services. Additionally, the United States Food and Drug Administration supports market stability through rigorous product approval and safety monitoring, encouraging the integration of verified diagnostic tools. These factors, combined with the strong local presence of key industry manufacturers, consolidate North America’s leadership in this sector.

Recent Developments

• In October 2025, Resitu Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RESL09 breast biopsy device. This handheld, single-use instrument utilizes a vacuum-assisted technique to obtain large, high-quality tissue samples for the diagnostic analysis of breast abnormalities. Designed for minimally invasive procedures, the device allows surgeons to excise lesions up to 9mm in diameter through a small incision under ultrasound guidance. The clearance facilitates the company's plan for a phased global rollout, commencing with a limited launch in select regions of the United States.
• In November 2024, Devicor Medical Products, Inc., operating as Mammotome, launched the Mammotome AutoCore Single Insertion Core Biopsy System. This device is the first spring-loaded core needle biopsy system to feature automated arming and tissue collection with single-button functionality. The system was designed to improve efficiency in ultrasound-guided breast biopsies by reducing procedural steps and enabling one-handed operation. The device facilitates touchless tissue transfer, as samples are automatically moved from the needle aperture to a collection cup, allowing the physician to maintain visual focus on the lesion throughout the procedure.
• In September 2024, Mammotome introduced significant enhancements to its Mammotome Revolve Dual Vacuum-Assisted Breast Biopsy System. The upgraded platform features improvements to the control module, user interface, and cart, which were engineered to optimize workflow efficiency and ease of use for clinicians. The system retains its proprietary tissue management technology that automatically organizes specimens in touch-free chambers and offers a user-controlled variable aperture for adjusting to different lesion sizes. These updates were aimed at streamlining biopsy procedures and ensuring the acquisition of high-quality tissue samples for diagnosis.
• In May 2024, Hologic, Inc. introduced a new 7-gauge needle for its Brevera Breast Biopsy System in the European market. This product addition expanded the range of disposable biopsy needles available to radiologists, providing an option for obtaining larger tissue samples during breast biopsy procedures. The Brevera system integrates tissue acquisition, real-time imaging, and verification into a single platform, designed to streamline the workflow and reduce procedure time. The launch of the larger gauge needle was intended to enhance the versatility of the system for various clinical needs in the diagnosis of breast cancer.

Key Market Players

• Intact Medical Corporation
• Ethicon Endo Surgery
• Galini SRL
• Leica Biosystems Nussloch GmbH
• Hologic Inc.
• Argon Medical Devices
• Encapsule Medical Devices LLC.
• Cook Medical Incorporated
• Becton & Dickinson Company
• C.R. Bard, Inc.

By End Use	By Region
Hospitals & Diagnostic Laboratories Pharmaceutical & Biotechnology companies Academic & Research Institutes	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

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

• Breast Cancer Core Needle Biopsy Market, By End Use:

• Hospitals & Diagnostic Laboratories
• Pharmaceutical & Biotechnology companies
• Academic & Research Institutes

• Breast Cancer Core Needle Biopsy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE