Breast Cancer Core Needle Biopsy Market Size, Share and Trends 2026 to 2035

Revenue, 2025

USD 1.03 Bn

Forecast Year, 2035

USD 1.63 Bn

CAGR, 2026 - 2035

4.72%

Report Coverage

Global

What is the Breast Cancer Core Needle Biopsy Market Size?

The global breast cancer core needle biopsy market size accounted for USD 1.03 billion in 2025 and is predicted to increase from USD 1.08 billion in 2026 to approximately USD 1.63 billion by 2035, expanding at a CAGR of 4.72% from 2026 to 2035. Rising screening volumes drive the breast cancer core needle biopsy pump market, preference for minimally invasive tissue sampling, and continuous improvements in imaging-guided diagnostic precision.

Market Highlights

• North America led the breast cancer core needle market and accounted for the largest share of 46.70% in 2025.
• The Asia Pacific is estimated to grow at a CAGR of 5.37% between 2026 and 2035.
• By technology, the ultrasound-based breast biopsy segment captured the biggest market share of 42% in 2025.
• By technology, the CT-based breast biopsy segment is expected to expand with the highest CAGR over the projected period.
• By end-user, the hospitals and diagnostic laboratories companies segment held a dominant market share of 61% in 2024.
• By end-user, the pharmaceutical & biotechnology companies segment is expected to expand at the fastest CAGR from 2026 to 2034.

How Is Breast Cancer Core Needle Biopsy Demand Motivated?

Core Needle Biopsy for breast cancer is a technique to confirm breast cancer without surgery, using the most modern techniques for accuracy and less discomfort. The Breast Cancer Core Needle Biopsy Market will continue to grow as healthcare systems focus on the early, accurate, and low-cost detection of cancer. Increased diagnoses of breast cancer, the introduction of mass screening programs, and improved systems utilized for imaging-guided biopsy are increasing the use of breast cancer core needle biopsy within hospital facilities and diagnostic centres.

Advances in technology are making it easier to obtain accurate results and reduce the need for additional procedures. A growing number of patients prefer these minimally invasive techniques, and the government's push for earlier detection will further encourage growth in this market. There is also an increase in investment by companies in the oncology diagnostic market, and the increasing availability of screening services in many underserved areas is accelerating the growth in demand for Breast Cancer Core Needle Biopsy.

Will AI Revolutionise Core-Needle Breast Biopsy Diagnostics?

AI is changing how breast core-needle biopsy (CNB) is completed by improving histopathologic interpretation, CT of samples, and the risk of upstaging from DCIS to invasive disease. AI models applied to whole-slide images and molecular profiles achieve high sensitivity and low false-negative rates. As a result, pathologists can prioritize cores, and the time from sample collection to report delivery has been shortened. Multicentre studies support this. The NHS has completed a large-scale trial of AI in mammography. At the same time, other countries have implemented diagnostic applications at the regional level, indicating that clinical validation and adoption of AI technology are accelerating across healthcare systems.

AI's ability to identify lesions likely to progress aggressively, guide surgical planning, and recommend neoadjuvant approaches is demonstrated in recent multicentre analyses. Implementing AI technology in underserved countries has the potential to speed up assessments, improve access to remote second opinions, and reduce disparities. Still, it also presents implementation challenges related to regulatory oversight and model transparency.

Which is Major Market Trends Driving Growth of the Breast Cancer Core Needle Biopsy Market?

• Increased use of image-guided biopsy: Ultrasound, magnetic resonance imaging (MRI), anddigital mammography guidance are increasingly being used to help doctors accurately target areas of concern within an area of interest, resulting in fewer repeat biopsies, increased accuracy of diagnosis, and early detection of breast cancer, particularly in high-volume clinical practices.
• Increase minimally invasive techniques: As hospitals and diagnostic facilities continue to shift toward minimally invasive biopsy techniques due to the reduced pain associated with these techniques, reduced length of time for the procedure, and quicker return to regular activities, the number of facilities that utilize core needle systems (CNS) rather than surgical biopsy methods has also increased dramatically.
• Development of vacuum-assisted devices: The newest models of vacuum-assisted core biopsy systems offer improved tissue sampling capabilities, fewer passes needed, and higher levels of accuracy for the diagnosis of complex or small lesions, and have thus become increasingly popular in both outpatient facilities and breast imaging centers.
• Increased adoption of artificial intelligence: By using the latest advancements in Artificial Intelligence (AI) to analyse imaging studies and with the implementation of digital pathology workflows, radiologists can provide a higher level of consistency, more efficient communication with physicians, and quicker turnaround for biopsy-designated findings than was previously possible.

Market Scope

Segment Insights

Technology Insights

Why Ultrasound-based Breast Biopsy is the Leading Technology in the Breast Cancer Core Needle Biopsy Market?

Ultrasound-based Breast Biopsy: The segment currently leads the breast biopsy market because it is widely accessible, provides real-time imaging, guides accurate needle placement regardless of breast tissue density, does not emit ionizing radiation, and costs considerably less than other procedures, and takes less time than other procedures to perform, making it the method of choice for routine clinical use. Additionally, because it easily integrates into the hospital's workflow, it further solidifies its position as the primary diagnostic breast biopsy method.

CT-based Breast Biopsy: The segment represents the fastest growing segment of the breast biopsy market because of its unique characteristics, including excellent cross-sectional imaging capabilities, the ability to locate and provide clear images of more complicated and/or deeper lesions not be clearly detected by other imaging modalities, and its use in combination with improved CT-guided needle systems. The increase in the number of advanced oncology centers adopting CT-guided breast biopsy will drive further demand for this type of guideline for breast biopsy.

End Use Insights

Why Hospitals & Diagnostic Laboratories are the Dominant End User?

Hospitals & Diagnostic Laboratories: This segment has become the leading end-user of core needle biopsies due to their comprehensive imaging systems, radiologist expertise, and capability to perform high volumes of core needle biopsies. The hospitals' integrated model of care enables rapid disease diagnosis, coordination of pathology and follow-up treatment, and delivery of all imaging services in an efficient and timely manner. The ability of hospitals and diagnostic labs to provide reimbursement for core needle biopsies also supports their position as the primary sites for performing these procedures for breast cancer.

Pharmaceutical & Biotechnology Companies: This segment has increasingly used core needle biopsies in clinical trials and the development of targeted therapies. Thus, there is a greater need for biopsy samples in research and development settings due to the growing focus on tissue biomarker identification and molecular profiling, as well as on precision medicine. As a result, these types of companies rely heavily on high-quality biopsy samples to validate new drugs and develop companion diagnostics to personalize therapeutic approaches for patients.

Regional Insights

How Big is the North America Breast Cancer Core Needle Biopsy Market Size?

The North America breast cancer core needle biopsy market size is estimated at USD 481.01 million in 2025 and is projected to reach approximately USD 764.47 million by 2035, with a 4.74% CAGR from 2026 to 2035.

What Factors Have Driven the Dominance of The Breast Cancer Core Needle Biopsy Market In North America?

North America is at the forefront of the core needle biopsy sector used to diagnose breast cancer. Through a combination of comprehensive screening networks, strong oncology referral pathways, and reimbursement structures that encourage the routine use of minimally invasive diagnostic methods, North America remains a leader. The high incidence of breast cancer creates increased demand for diagnostic testing. As many of these cancers are detected through screening at earlier stages, there is a growing need for image guidance in CNB procedures to confirm the diagnosis.

Furthermore, North America's extensive network of advanced imaging centers, interventional radiologists trained to perform CNB procedures, and established networks of pathologists enable rapid adoption of new biopsy devices. In addition, due to strong guidance from regulatory agencies and close collaboration between providers and manufacturers, North America's core-needle biopsy procedures are becoming the standard diagnostic method for abnormal breast masses.

What is the Size of the U.S. Breast Cancer Core Needle Biopsy Market?

The U.S. breast cancer core needle biopsy market size is calculated at USD 363.16 million in 2025 and is expected to reach nearly USD 573.35 million in 2035, accelerating at a strong CAGR of 4.67% between 2026 and 2035.

U.S. Breast Cancer Core Needle Biopsy Market Trends

The United States leads the region because of its significant clinical demand. The American Cancer Society's estimates for 2025 are that there will be 316,950 invasive breast cancer cases and 42,170 breast cancer deaths. Due to this ongoing need, the U.S. will continue to rely on the utility of core needle procedures for diagnosing breast cancer. Additionally, with ongoing device innovation, such as the November 2024 release of the Mammotome AutoCore device (the first FDA-cleared, automated, spring-loaded, single-insertion device), it will be available for use nationwide in early 2025. As technology advances, U.S. oncologists will continue to see a growing demand for breast cancer diagnostic procedures that use advanced biopsy methods.

What makes Asia Pacific the fastest Growing Region in the Breast Cancer Core Needle Biopsy Market?

Asia Pacific (APAC) continues to be the fastest growing market for breast cancer due to the increase in breast cancer screening, modernization of hospitals and medical services, and the increased investment in radiology and pathology infrastructure. Cities are developing Rural Health Programs (RHPs) to improve access to mammography and ultrasound, increasing the number of early breast abnormalities that require confirmation with less invasive techniques.

Government agencies and private providers are replacing all their imaging equipment, developing standard clinical pathways, and increasing the number of professionals qualified to read and interpret mammograms and ultrasounds. With stronger infrastructure and the growth of reimbursement systems, APAC markets will shift rapidly from surgical to image-guided core needle biopsies, thereby sustaining the market's significant growth.

China Breast Cancer Core Needle Biopsy Market Trends

China is a driver of regional growth through the modernization of hospitals, screening large cohorts, and the rapid expansion of advanced imaging facilities in major cities. The national government of China is launching pilot screening programs and strengthening the oncology referral process, thereby increasing biopsy volumes. Domestic manufacturers have been developing breast biopsy products to provide more affordable, reliable access to breast biopsy devices. The early adoption of advanced core needle technology in tier-one and tier-two cities will help shape China's regional clinical practices for breast cancer.

How Europe is Entering a New Era of Breast Cancer Core Needle Biopsy?

Europe has experienced consistent growth due to organised screening programmes, advanced diagnostic systems, and a culture of consistently applying clinical guidelines. Most breast screening programmes deliver advanced breast imaging solutions with early detection of breast abnormalities and a predictable demand for minimally invasive image-guided core needle biopsy. The continued development of advanced radiology networks, integrated pathology workflows, and a coordinated multidisciplinary palliative approach has enabled rapid conversion of lesions identified by mammography and ultrasound to minimally invasive biopsy.

Along with the regulatory uniformity, the preference for clinical validation has enabled the most efficient distribution and adoption of minimally invasive devices. Therefore, with the ageing population, long-term investment in public health systems, and the establishment of certified breast centres in many countries, Europe will continue to be the leader in the use of modern biopsy systems.

Germany Breast Cancer Core Needle Biopsy Market Trends

Germany is the leader in Europe in advanced breast imaging technology and structured breast centres, and offers consistent reimbursement for image-guided systems. Additionally, Germany has strong quality assurance programmes, has been active in clinical research, and has an effective procurement programme, which will enable the rapid integration of upgraded core needle systems. Thus, Germany has set a benchmark for all other European markets regarding standards of diagnostic intervention in breast cancer.

What makes the Middle East and Africa an emerging region?

The emergence of the Middle Eastern and African regions is due, in large part, to growing levels of private healthcare and digital imaging technology in specific urban centers across Africa and the Gulf States. The establishment of several private hospital systems, the increasing number of medical tourism facilities, and the growing interest in digital imaging systems are creating opportunities for greater use of minimally invasive biopsy procedures. Through awareness campaigns, early detection initiatives, and dedicated training programs, breast cancer awareness and detection rates are improving throughout the region.

Global partnerships with manufacturers of imaging devices, mobile (i.e., portable) imaging platforms, and targeted workforce-training programs will address gaps in radiology resources, thereby creating an environment in which compact, cost-efficient Core Needle biopsy systems are readily adaptable across a variety of healthcare settings.

UAE Breast Cancer Core Needle Biopsy Market Trends

South Africa is the region's leader in terms of a well-developed oncology network, several tertiary surgical centers, and developed diagnostic-imaging resources in key metropolitan areas. The availability of centralized pathology services, expanded training programs, and continued investment by both public- and private-sector organizations creates the foundation for expanding the use of image-guided Core Needle biopsy, making South Africa a model or clinical resource for sub-Saharan Africa.

Breast Cancer Core Needle Biopsy Market Value Chain

Top Key Players in Breast Cancer Core Needle Biopsy Market and their Offerings

• Intact Medical Corporation
• Ethicon Surgical Technologies
• Gallini SRL
• Leica Biosystems Nussloch GmbH
• Hologic, Inc.
• Argon Medical Devices
• Encapsule Medical Devices LLC
• Cook Medical Incorporated
• Becton, Dickinson and Company
• C.R. Bard, Inc.

Segments Covered in the Report

By Technology

• MRI-based Breast Biopsy
• Ultrasound-based Breast Biopsy
• Mammography-based Breast Biopsy
• CT-based Breast Biopsy
• Other Image-Based Breast Biopsy

By End-use

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

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa