Breast Cancer Core Needle Biopsy Market By Biopsy Type (Fine Needle Core Biopsy, Vacuum-Assisted Core Biopsy, Image-Guided Core Biopsy, Automated Core Biopsy), By Guidance Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, MRI-Guided Biopsy, CT-Guided Biopsy, Others), By Needle Type (Automated Core Biopsy Needles, Semi-Automated Core Biopsy Needles, Disposable Biopsy Needles, Reusable Biopsy Needles), By Application (Tumor Detection, Tumor Grading & Staging, Post-Treatment Assessment, Research & Clinical Studies, Others), By End User (Hospitals, Diagnostic Centers, Ambulatory Surgical Centers, Specialty Clinics, Academic & Research Institutes, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

---

What trends will shape the Breast Cancer Core Needle Biopsy Market in the coming years?

The Breast Cancer Core Needle Biopsy Market accounted for USD 872.40 Million in 2024 and USD 914.10 Million in 2025 is expected to reach USD 1458.07 Million by 2035, growing at a CAGR of around 4.78% between 2025 and 2035. The core needle biopsy breast cancer market is targeted at diagnostic equipment and procedures that help to remove suspicious breast lesions to get the exact diagnosis of cancer. The reason core needle biopsy is highly favored over surgical biopsy is that it is less invasive, less expensive, and has a shorter recovery time. The fact that breast cancer is one of the most prevalent cancers in women worldwide is growing the market due to the high demand for early and accurate diagnosis. Awareness among people on breast cancer screening programs, government programs that detect cancer, and growing infrastructural healthcare facilities are also increasing uptake.

New technologies, such as vacuum-aided core needle biopsy apparatuses and biopsy techniques guided by images, are improving the accuracy of diagnosis. Moreover, the increase in the demand for outpatient procedures and decreased hospitalization justifies the application of such devices. Nevertheless, issues such as the possibility of false negative results and inexperienced specialists in the developing areas may slow down growth. In general, further growth of the market is anticipated since early diagnosis and minimally invasive diagnosis are still very important in enhancing the outcome of breast cancer.

What do industry experts say about the Breast Cancer Core Needle Biopsy market trends?

“AI integration in breast cancer core needle biopsy is transforming diagnostics, enabling more accurate tissue analysis and reducing repeat procedures.”

• Dr. Anant Madabhushi, Professor of Biomedical Engineering, Emory University

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Breast Cancer Core Needle Biopsy market?

How is the rising global prevalence of breast cancer boosting biopsy demand?

The current increase in the prevalence of breast cancer globally is a major force in the breast cancer core needle biopsy market because it is a direct contributor to the necessity of providing early and accurate diagnostic methods. Since breast cancer is the most commonly diagnosed cancer in women, healthcare systems have been focusing on early detection procedures to enhance the survival rates. Core needle biopsy has emerged as the most appropriate method since it is minimally invasive, reliable, and capable of giving adequate tissue samples on which pathological examination can be done.

The World Health Organization (WHO) estimates that breast cancer is the most common cancer in the world because a total of 2.3 million women were diagnosed with it in 2020. This increased pressure has increased the significance of screening regimes and diagnostic pathways, which depend much on biopsy procedures. The early diagnosis of the disease by way of biopsy is not only helpful in timely treatment but also lessens the total cost burden of care systems. The growing rate of prevalence guarantees the ongoing need for sophisticated biopsy equipment and imaging-guided methods in hospitals, clinics, and diagnostic facilities. Consequently, manufacturers are emphasizing innovation to satisfy the escalating needs of diagnostics in the world.

Why are minimally invasive biopsy methods preferred over surgical procedures today?

Less invasive approaches to biopsy are becoming more popular than surgery and, therefore, act as a strong influence on the breast cancer core needle biopsy market. Such procedures, which include vacuum-assisted or image-guided core biopsies, cause minimal pain to the patient, minimize the chances of complications, and result in faster recovery in comparison to the traditional way of performing surgical biopsies. They are also affordable and may be conducted in an outpatient facility, not necessarily hospitalizing the patient, which is advantageous to the patients and medical professionals. Notably, they offer correct sampling of tissues with minimum scarring and, therefore, enhance the level of patient adherence and compliance to diagnostic measures.

The National Cancer Institute (NCI) has indicated core needle biopsy as the standard first-line test to be used as a diagnostic procedure in the event of suspicious breast lesions, as it avoids the use of more invasive surgical biopsy in most instances. This recommendation highlights the increased clinical dependence on less invasive methods. As the costs of healthcare keep increasing and the focus on patient-centered care grows, the number of these approaches is steadily growing. Their effectiveness and precision are not only able to improve the diagnostic results but also to meet the current healthcare objectives of the reduction of invasiveness and the improvement of the quality of care.

How do false negatives and sampling errors limit biopsy reliability overall?

A major limitation to the breast cancer core needle biopsy market is false negatives and sampling errors that may compromise the validity of the diagnostic results. The biopsy needle can also be ineffective in taking representatives of the lesion, particularly in situations where the tumor is small, heterogeneous, or is in an inaccessible location. This may lead to false-negative reports and consequent delay in early diagnosis and treatment, which may aggravate patient outcomes. Moreover, the operator skill and technique also vary and increase the possibility of sampling errors, especially in facilities with less expertise.

Although the imaging-guided methods have been able to enhance the accuracy, some of the types of lesions, including microcalcifications or diffuse abnormalities, are difficult to detect. Such limitations in diagnosis can contribute to the recurrence of the procedure, which increases the costs and other anxieties among patients. Since the level of confidence in biopsy accuracy holds the key, the issue of false negatives means that the wider use of the technique is restricted, particularly in those areas that have fewer resources, more highly developed imaging, and qualified specialists. Therefore, it is still a challenge to overcome these diagnostic inconsistencies to enhance the role of core needle biopsy in detecting breast cancer.

How can medical tourism expand access to advanced biopsy diagnostics globally?

The strong potential of medical tourism in the breast cancer core needle biopsy market is that patients in areas that have a weak health care system can seek high-end diagnostic services in other countries. Some of the challenges that many developing countries encounter are a lack of imaging technologies, qualified professionals, and high costs of equipment that limit the availability of tools to diagnose breast cancer on time and in an accurate manner. Medical tourism exposes patients to the healthcare systems of countries that have highly developed healthcare facilities that contain state-of-the-art facilities, such as the vacuum-assisted and image-guided techniques of core needle biopsy.

This not only guarantees early and accurate diagnosis, but also offers continuity of the treatment under a single roof. The international patients are drawn to popular medical tourism destinations in Asia, Latin America, and Eastern Europe as these countries can provide high-quality diagnostics at relatively lower prices than Western countries. The development of the specialized cancer care facilities within these areas also contributes to the availability of advanced biopsy services. With the increased awareness of early cancer detection, medical tourism is likely to fill the gaps in healthcare by increasing access to minimally invasive diagnostic procedures. This presents major prospects to the manufacturers and the healthcare providers as they strive to fulfill the ever-increasing global demand.

Why are disposable single-use biopsy needles gaining demand in diagnostics?

Single-use biopsy needles are on the rise in breast cancer diagnostics, presenting a major opportunity to the breast cancer core needle biopsy market. The devices reduce the chances of cross-contamination and infection, which will result in increased patient safety and compliance with high standards of hygiene in hospitals and diagnostic centers. They also do not require the use of sterilization processes and save time, as well as lowering the cost of operation of healthcare providers. The increased interest in infection control in the world, and especially following the COVID-19 pandemic, has increased the transition toward single-use medical devices.

Also, the single-use needles offer consistent operation with no chance of wear and tear that reusable needles have, which contributes to a higher rate of diagnostic accuracy. Healthcare authorities and regulatory bodies are also advising the use of disposable biopsy instruments to enhance the quality of patient care. The rising usage in the developed and emerging markets underlines the need to have safer and more effective biopsy solutions. With rising sensitization on the issue of infection prevention and efficient workflow, the disposable single-use biopsy needles are projected as a good market expansion point.

What are the key market segments in the Breast Cancer Core Needle Biopsy industry?

Based on the Biopsy Type, the Breast Cancer Core Needle Biopsy Market is classified into Fine Needle Core Biopsy, Vacuum-Assisted Core Biopsy, Image-Guided Core Biopsy, and Automated Core Biopsy. The strongest segment of the breast cancer core needle biopsy market is the Vacuum-Assisted Core Biopsy (VAB). This method is commonly used since it enables the collection of multiple tissue samples with a single insertion, which enhances the accuracy of the diagnosis, as opposed to conventional core biopsies. Its low invasiveness has minimized the patient discomfort and recovery duration, and therefore, it is a desirable option for clinical practice. Specifically, VAB is highly applicable in the detection of non-palpable lesions, which can only be identified under imaging, under which there is an enhanced and reliable detection of cancer early.

Repeat procedures are also reduced minimally by the method, thus saving patients and health care providers time and cost. Due to the development of technologies, vacuum-assisted devices have blended with the modes of imaging, such as ultrasound, MRI, and stereotactic guidance, thus increasing their efficiency. The increasing focus on diagnosing the disease at its early stages and the need to apply precision medicine further stimulate the implementation of the VAB. This technique is being prioritized in more hospitals, diagnostic centers, and specialty clinics as a way of ensuring better results in the diagnosis of breast cancer. All in all, VAB is still dominating the market with its efficiency, accuracy, and ease of use.

Based on the Guidance Technique, the Breast Cancer Core Needle Biopsy Market is classified into Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, MRI-Guided Biopsy, CT-Guided Biopsy, and Others. The Ultrasound-Guided Biopsy segment is the dominant one in the breast cancer core needle biopsy market. This process is very desirable because of its ability and real-time imaging that enables physicians to identify and target the suspicious lesions in the breast accurately. It is minimally invasive, less expensive, and faster than MRI or CT-guided techniques and is available in both highly developed and low-resource healthcare facilities. It is also more comfortable for patients since they are not exposed to radiation and can be carried out as outpatients.

It is mainly through ultrasound-guided biopsies that palpable and non-palpable lesions can be accurately biopsied to ensure that the clinical use of this tool has a wide scope. The increased access to this technique in smaller diagnostic centers and clinics has been further increased by the increasing applications of portable ultrasound machines. It has the capacity to direct the vacuum-assisted biopsies, thus making it more accurate in diagnosing and eliminating recurrent processes. Further, incorporation of high-level imaging technology with ultrasound remains to reinforce its position in the early detection of breast cancer. In sum, ultrasound-guided biopsy is the most popular method because it is accurate, safe, inexpensive, and simple to use in daily clinical practice.

Which regions are leading the Breast Cancer Core Needle Biopsy market, and why?

The North American breast cancer core needle biopsy market is characterized by good healthcare systems, high availability of high-resolution diagnostic devices, and a well-established focus on early cancer diagnosis. High awareness level amongst patients and healthcare providers is also an advantage in the region and is made possible by routine screening programs and guidelines encouraging minimally invasive procedures of biopsy. The use of image-guided systems, vacuum-assisted systems, and continuous technological advances has increased the uptake of the systems in hospitals and diagnostic centers. The insurance cover and reimbursement systems also promote the application of core needle biopsy instead of surgical options.

Professionally trained personnel and specialized cancer care facilities are an added advantage to the regional market environment as well. The upward trend in outpatient diagnostic test procedures is in line with the demand to pay more attention to the comfort and efficacy of patients. Innovation in the region is promoted by research partnerships and clinical tests, and ensures that the market will be dynamic and progressive. On the whole, the North American region holds a privileged role via its combined method of cancer diagnostics and pathways of treatment.

The Asia Pacific breast cancer core needle biopsy market is growing at a rate that can be regarded as growing exponentially, owing to the growing awareness of breast cancer and the growing number of people participating in breast cancer screening programs. Demand in the region is increasing faster than the demand for global diagnostic procedures due to urbanization and better access to healthcare. Developing countries are also investing in the latest imaging and biopsy systems, and this means that they have a market to exploit.

The increasing trend of cases of breast cancer has resulted in increased interest in early detection, which has promoted the use of core needle biopsy. The use of higher-level diagnostic services is also being supported by medical tourism in various countries. But there are still inequalities in the healthcare infrastructure and access to professionals in some of the regions. The government programs and partnerships with international healthcare organizations are also enhancing the diagnostic capacities. In general, the Asian Pacific is a high-growth potential market whose focus has changed to early, correct, and cost-effective cancer diagnosis.  

What does the competitive landscape of the Breast Cancer Core Needle Biopsy market look like?

The breast cancer core needle biopsy market structure is a combination of international industry giants in medical technologies, as well as niche diagnostic equipment producers. Becton, Dickinson and Company (BD), Hologic, Inc., and Devicor Medical Products, Inc. are the companies that control the market with innovative biopsy systems and well-developed distribution networks. Further competition is provided by Argon Medical Devices, Cook Medical, and Cardinal Health because they can provide a broad range of biopsy and interventional products. Medtronic, Boston Scientific, and Olympus Corporation are large entities in the healthcare technology industry that are also using their innovation strengths to enhance their presence in this industry.

Players like the FUJIFILM Holdings Corporation and Leica Biosystems, which specialize in imaging and pathology, can provide value-added services in integrated diagnostic solutions. Specialized biopsy instruments that meet the requirements of clinicians are offered by niche companies such as INRAD Inc., STERYlab S.r.l., and Merit Medical Systems, Inc. The presence of such established brands as C.R. Bard, Inc. creates a legacy presence, which guarantees good brand recall. On the whole, the market displays a high level of competition that can be explained by product innovations, strategic partnerships, and increased focus on minimally invasive diagnostics of breast cancer.

Breast Cancer Core Needle Biopsy Market, Company Shares Analysis, 2024

To explore in-depth analysis in this report - Request Sample Report

Which recent mergers, acquisitions, or product launches are shaping the Breast Cancer Core Needle Biopsy industry?

• In November 2024, Mammotome introduced the Mammotome AutoCore, a core biopsy device designed for breast tissue examinations. The system offers significant advantages over traditional core needle devices by streamlining procedures for healthcare providers and improving the patient experience. By reducing biopsy time, it enables physicians to perform procedures more efficiently, enhancing both clinical outcomes and patient comfort.
• In November 2024, researchers at the Center for Global Women's Health Technologies received USD 10.4 million in funding for breast cancer research. The project aims to reduce mortality and improve access to breast cancer diagnosis and treatment worldwide.

Report Coverage:

By Biopsy Type

• Fine Needle Core Biopsy
• Vacuum-Assisted Core Biopsy
• Image-Guided Core Biopsy
• Automated Core Biopsy

By Guidance Technique

• Ultrasound-Guided Biopsy
• Stereotactic-Guided Biopsy
• MRI-Guided Biopsy
• CT-Guided Biopsy
• Others

By Needle Type

• Automated Core Biopsy Needles
• Semi-Automated Core Biopsy Needles
• Disposable Biopsy Needles
• Reusable Biopsy Needles

By Application

• Tumor Detection
• Tumor Grading & Staging
• Post-Treatment Assessment
• Research & Clinical Studies
• Others

By End User

• Hospitals
• Diagnostic Centers
• Ambulatory Surgical Centers
• Specialty Clinics
• Academic & Research Institutes
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Becton, Dickinson and Company (BD)
• Hologic, Inc.
• Devicor Medical Products, Inc.
• Argon Medical Devices, Inc.
• Cook Medical
• Cardinal Health
• Medtronic plc
• Boston Scientific Corporation
• Olympus Corporation
• FUJIFILM Holdings Corporation
• Leica Biosystems
• INRAD Inc.
• STERYLAB S.r.l.
• Merit Medical Systems, Inc.
• C.R. Bard, Inc.

Frequently Asked Questions (FAQs)