Breast Cancer Core Needle Biopsy Market Size Analysis:

The Breast Cancer Core Needle Biopsy Market size was valued at USD 809.40 million in 2023 and is expected to reach USD 1357.70 million by 2032, growing at a CAGR of 8.32% from 2024-2032.

The report presents a detailed review of important statistical information in the Breast Cancer Core Needle Biopsy Market, noting important trends in the industry. It analyzes breast cancer cases involving core needle biopsy incidence and prevalence in 2023, giving a data-informed view of diagnostic demand. The study also assesses the use of image-guided biopsy methods, coupled with regulatory approvals and compliance patterns, to evaluate technological growth and market trends. Additionally, regional healthcare expenditures on breast cancer diagnosis and hospital vs. outpatient use of biopsy equipment provide significant insights into infrastructure and access patterns.

The U.S. Breast Cancer Core Needle Biopsy Market size was USD 264.81 million in 2023 and is expected to reach USD 435.27 million by 2032, growing at a CAGR of 5.69% over the forecast period of 2024-2032.

The U.S. Breast Cancer Core Needle Biopsy Market is experiencing steady growth due to the increasing prevalence of breast cancer and the rising demand for minimally invasive diagnostic procedures. Advancements in imaging technologies, such as ultrasound and MRI-guided biopsies, are enhancing the accuracy and efficiency of core needle biopsies. Additionally, growing awareness about early cancer detection and the adoption of advanced biopsy techniques in healthcare facilities are driving market expansion. The presence of key medical device manufacturers and continuous innovations in biopsy instruments further contribute to the market's growth.

Breast Cancer Core Needle Biopsy Market Dynamics

Drivers

• Rising Incidence of Breast Cancer Leading to Increased Biopsy Procedures is propelling the market growth.

The increasing incidence of breast cancer is a major growth driver for the breast cancer core needle biopsy market. As per the American Cancer Society (ACS), in 2023, an estimated 297,790 new cases of invasive breast cancer were diagnosed among women in the United States. Early detection is important to enhance survival rates, thus boosting the demand for less invasive diagnostic procedures such as core needle biopsy. The World Health Organization (WHO) underlines that there has been a growth in detections of breast cancer due to programs of screening and heightened awareness, which require accurate and effective biopsy methods. Progress in ultrasound-guided and vacuum-assisted core needle biopsies in the recent past has further improved the accuracy of diagnosis of breast cancer, prompting their extensive use in hospitals and diagnostic centers across the globe.

• Ongoing advances in biopsy technology are fueling the use of core needle biopsy in the diagnosis of breast cancer.

The development of vacuum-assisted core needle biopsy (VAB) and image-guided biopsy systems has greatly enhanced accuracy with decreased procedural discomfort. In November 2024, Mammotome introduced the Mammotome AutoCore Single Insertion Core Biopsy System, increasing efficiency through a single-step approach. Besides this, AI-assisted imaging systems are also being coupled with digital breast tomosynthesis (DBT) to better target lesions. All these technologies are simplifying biopsy procedures, eliminating false negatives, and helping diagnose conditions sooner. The surge in demand for minimally invasive and real-time diagnostic methods across cancer screening initiatives is also fuelling the uptake of core needle biopsy procedures and turning them into the go-to alternative to surgery.

Restraint

• High Cost and Limited Accessibility in Developing Regions are restraining the market growth.

One of the significant constraints in the Breast Cancer Core Needle Biopsy Market is the expense of biopsy procedures and poor availability in developing countries. Although core needle biopsy (CNB) is less invasive and an accurate diagnostic procedure, the expense of image-guided biopsies, advanced vacuum-assisted biopsy systems, and related pathology tests can be too high for patients in low- and middle-income countries (LMICs). As per the WHO, more than 70% of deaths from breast cancer take place in these areas due to delayed diagnosis and economic conditions. Furthermore, the absence of specialized diagnostic facilities, trained personnel, and an insufficient healthcare infrastructure also limits widespread use of core needle biopsy. The above limitations necessitate the use of low-cost biopsy technologies and government-sponsored screening programs for the improvement of early detection of breast cancer in underprivileged groups.

Opportunities

• The use of artificial intelligence (AI) and digital pathology is a big opportunity in the Breast Cancer Core Needle Biopsy Market.

AI-based diagnostic equipment can improve the accuracy of biopsy interpretation, computerize image analysis, and help detect malignancies at an early stage. AI-assisted pathology enhanced breast cancer detection rates by 12-15% compared to conventional methods, as per a 2023 JAMA study. Moreover, digital pathology platforms facilitate distant diagnostics, where skilled pathologists can examine biopsy samples remotely, enhancing access to high-quality cancer diagnostics in underserved areas. With the growing usage of AI-based biopsy interpretation software and machine learning algorithms, market participants are anticipated to leverage AI-based innovations to streamline workflow, minimize diagnostic mistakes, and maximize treatment planning for breast cancer patients.

Challenges

• Variability in Biopsy Accuracy and False-Negative Rates is challenging the market growth.

A primary problem with the Breast Cancer Core Needle Biopsy Market is inconsistency in biopsy precision as well as false-negative rates. Although core needle biopsy (CNB) is common in breast lesion diagnosis, research suggests that false-negative rates vary between 2% and 10%, contingent on tumor heterogeneity, technical procedure, and operator proficiency. In situations where small or non-palpable lesions are not well sampled, CNB can result in inconclusive results, delayed diagnoses, and the possibility of disease progression. Another drawback is that image-guided biopsies like ultrasound- or MRI-guided CNB also need specialized training, and variability in the execution of the procedure can compromise diagnostic reliability. Resolving this challenge mandates technical innovations in biopsy needle design, artificial intelligence-based biopsy navigation, and uniform training programs for pathologists and radiologists to enhance diagnostic accuracy.

Breast Cancer Core Needle Biopsy Market Segmentation Analysis

By Technology

The Ultrasound-Based Breast Biopsy segment dominated the breast cancer core needle biopsy market with a 40.12% market share in 2023 because of its high availability, affordability, and real-time imaging. Ultrasound-guided procedures are more accessible, less painful for patients, and quicker compared to other technologies such as stereotactic and MRI-guided biopsies, and hence are the most preferred by both patients and healthcare professionals. Furthermore, ultrasound does not use ionizing radiation, as opposed to mammography-based biopsies, which is especially useful for younger women and patients who need repeated imaging. The increasing demand for minimally invasive therapies, rising incidence of breast cancer, and technological improvement in high-resolution ultrasound imaging further drove the dominance of the segment. The American College of Radiology (ACR) and the National Comprehensive Cancer Network (NCCN) endorse ultrasound-guided biopsies as the first-line strategy for breast lesions suspected to have cancer, further enhancing their universal acceptance in clinical practice.

By End-Use

The Hospitals & Diagnostic Laboratories segment dominated the Breast Cancer Core Needle Biopsy Market with 58.31% market share in 2023 because of the large patient influx, presence of specialized oncologists and radiologists, and sophisticated diagnostic facilities. These centers are the main referral points for breast cancer screening, biopsy procedures, and follow-up diagnostics, ensuring early and accurate detection of the disease. Moreover, the existence of integrated healthcare systems, government-financed screening programs, and insurance reimbursement for diagnostic procedures led more patients to opt for biopsies in hospitals and accredited diagnostic laboratories. The rising prevalence of breast cancer globally and increasing knowledge about early detection further extended the segment's dominance in the market.

The Academic & Research Institutes segment will see the fastest growth during the forecast period, owing to increased investment in cancer research, biopsy technology advancements, and clinical trials on early and non-invasive breast cancer detection. Growing partnerships between universities, biotech companies, and medical device manufacturers are propelling innovation in precision biopsy methods, AI-based imaging, and liquid biopsy options. Additionally, government and private financing programs for breast cancer screening innovation, biomarker research, and personalized medicine are driving the research applications of core needle biopsy devices at an accelerated rate. The need for enhancing diagnostic precision and less invasive biopsy techniques will persistently drive this segment's growth, and hence, it is a major driver of future market growth.

Breast Cancer Core Needle Biopsy Market Regional Insights

North America dominated the breast cancer core needle biopsy market with a 45.24% market share in 2024 based on its superior health infrastructure, heavy breast cancer patient burden, and first-time movers in newer biopsy devices. As stated by the American Cancer Society, the United States alone reported nearly 297,790 newly diagnosed breast cancers in 2023, placing demands on precision diagnostic modalities like the core needle biopsy (CNB) devices. Also, the availability of major medical device companies, strong reimbursement policies, and high prevalence of image-guided biopsy procedures further consolidate the region's leadership. Government support in the form of the National Cancer Institute's (NCI) funding for breast cancer research and early detection programs has also helped in the increasing use of CNB devices. Additionally, enhanced patient awareness, availability to specialty diagnostic centers, and ongoing technological innovation make North America the market leader.

The Asia Pacific region is witnessing the fastest growth in the breast cancer core needle biopsy market with 5.31% CAGR throughout the forecast period because of the growing prevalence of breast cancer, rising healthcare spending, and improving access to diagnostic care. These nations, such as China, India, and Japan, are seeing an increase in breast cancer cases, primarily due to changes in lifestyle, delayed childbearing, and demographic aging. The World Health Organization (WHO) reports that breast cancer is the leading female cancer in Asia and demands a greater use of early diagnostic aids like CNB. Also, governments are investing in cancer screening programs, and private healthcare sectors are increasing diagnostic imaging centers, fueling market growth. The growing use of minimally invasive biopsy procedures, increased medical tourism, and increased awareness of breast cancer detection drive the market in the region.

Breast Cancer Core Needle Biopsy Market Key Players

• Hologic, Inc. (Eviva Breast Biopsy System, Celero Vacuum-Assisted Breast Biopsy Device)

• Becton, Dickinson and Company (BD) (EnCor Ultra Breast Biopsy System, EnCor Enspire Biopsy System)

• Mammotome (Mammotome Biopsy System, Mammotome Revolve Dual Vacuum-Assisted Biopsy System)

• Resitu Medical (Resitu Breast Biopsy Device, Core Needle Biopsy Device)

• Siemens Healthineers (MAMMOMAT Inspiration Biopsy Unit, MAMMOMAT Revelation Biopsy System)

• Stryker Corporation (Core Needle Biopsy Devices, Vacuum-Assisted Biopsy Systems)

• Cook Medical (EchoTip Ultra Breast Biopsy Needle, Quick-Core Biopsy Needle)

• Argon Medical Devices, Inc. (SuperCore Biopsy Instrument, Tru-Core II Automatic Biopsy Instrument)

• B. Braun Melsungen AG (Sterican Biopsy Needles, Vacuette Multiple Use Drawing Needle)

• Cardinal Health (Achieve Automatic Biopsy Device, Temno Biopsy System)

• Medtronic plc (Osteo-Site Bone Biopsy Needle, Kyphon Biopsy Device)

• CareFusion Corporation (Max-Core Disposable Core Biopsy Instrument, Mission Disposable Core Biopsy Instrument)

• SOMATEX Medical Technologies GmbH (SOMATEX Vacuum-Assisted Breast Biopsy System, SOMATEX Core Needle Biopsy Device)

• Devicor Medical Products, Inc. (Neoprobe Gamma Detection System, Mammotome Elite Biopsy System)

• Fujifilm Holdings Corporation (Fujifilm Biopsy System, Aspire Breast Biopsy Unit)

• GE Healthcare (Senographe Pristina Biopsy, SenoClaire Biopsy System)

• Philips Healthcare (MicroDose SI Biopsy, Affiniti 70 Biopsy Guidance)

• Nikon Corporation (Nikon Biopsy Imaging Systems, Eclipse Ci-L Plus Biopsy Microscope)

• Hitachi Medical Systems (HI VISION Preirus Biopsy, ARIETTA 850 Biopsy System)

• Planmed Oy (Planmed Nuance Biopsy Unit, Planmed Clarity Guide)

Suppliers (These suppliers provide key raw materials such as medical-grade plastics, polymers, and coatings used in the manufacturing of biopsy needles, vacuum-assisted devices, and imaging components) in the Breast Cancer Core Needle Biopsy Market

• Mitsubishi Chemical Holdings Corporation

• 3M Company

• Covestro AG

• DuPont de Nemours, Inc.

• Evonik Industries AG

• Toray Industries, Inc.

• BASF SE

• Celanese Corporation

• Eastman Chemical Company

• Sumitomo Chemical Co., Ltd.

Recent Development in the Breast Cancer Core Needle Biopsy Market

• November 2024 – Mammotome unveiled the introduction of the Mammotome AutoCore Single Insertion Core Biopsy System, the first automated spring-loaded core needle biopsy system to be launched in the marketplace. This new product launch signifies Mammotome's continued dedication to furthering breast biopsy technology and optimizing patient care results.

• In December 2024, Hologic presented new research at the RSNA's 110th Scientific Assembly and Annual Meeting. The study emphasized that Hologic Genius AI Detection 2.0 software achieves consistent performance across a wide range of patient populations, reaffirming the company's commitment to reducing bias in breast cancer detection.