Global Breast Biopsy Devices Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Breast Biopsy Devices Market Size

• The global breast biopsy devices market size was valued at USD 2.89 billion in 2024 and is expected to reach USD 5.13 billion by 2032, at a CAGR of 7.45% during the forecast period
• This growth is driven by factors such as the by increasing breast cancer prevalence, advancements in biopsy techniques, and rising demand for minimally invasive procedures

Breast Biopsy Devices Market Analysis

• Breast biopsy devices are essential tools used to diagnose breast cancer by removing tissue samples from suspicious areas of the breast for further examination. These devices include needle-based and vacuum-assisted biopsy systems
• The demand for breast biopsy devices is primarily driven by the rising incidence of breast cancer, increased awareness of early detection, and the growing preference for minimally invasive procedures
• North America is expected to dominate the breast biopsy devices market with a market share of 43.6%, due to advanced healthcare infrastructure, high adoption of cutting-edge biopsy technologies, and strong presence of key market players
• Asia-Pacific is expected to be the fastest growing region in the breast biopsy devices market, during the forecast period due to rapid expansion of healthcare infrastructure, increasing awareness about breast cancer, and rising demand for early diagnostic procedures
• Needle-based biopsy guns segment is expected to dominate the market with a market share of 43.6% due to its minimally invasive nature, faster procedure times, and high accuracy in tissue sampling. In addition, their widespread adoption in both hospital and outpatient settings for diagnosing breast abnormalities further boosts segment growth

Report Scope and Breast Biopsy Devices Market Segmentation      

Breast Biopsy Devices Market Trends

“Advancements in Biopsy Techniques & Image-Guided Systems for Enhanced Accuracy”

• One prominent trend in the breast biopsy devices market is the increasing integration of advanced image-guided systems, such as ultrasound and MRI-guided biopsies, to improve the precision and accuracy of biopsy procedures
• These innovations enhance the ability to precisely target suspicious tissue, allowing for better tissue sample collection and improving diagnostic outcomes 
  • For instance, MRI-guided core needle biopsies offer high-resolution imaging for detecting small or deep tumors that may be difficult to locate using traditional methods
• These advancements are revolutionizing the biopsy process, reducing patient discomfort, and contributing to better early detection and treatment outcomes, further driving the demand for more sophisticated biopsy devices with cutting-edge imaging capabilities

Breast Biopsy Devices Market Dynamics

Driver

“Rising Incidence of Breast Cancer and Growing Awareness for Early Detection”

• The increasing incidence of breast cancer globally is a major driver for the rising demand for breast biopsy devices. Early detection through biopsy plays a crucial role in diagnosing cancer at its initial stages, which is vital for improving treatment outcomes
• With the growing awareness about the importance of breast cancer screening, more women are opting for regular mammograms and biopsy procedures to detect suspicious lumps or abnormalities at an early stage
• The global push for breast cancer awareness and early screening programs, supported by both governmental and non-governmental organizations, has led to more women seeking timely diagnostic services

For instance,

• In 2020, the World Health Organization (WHO) reported that breast cancer accounted for 24.5% of all cancer cases in women worldwide, making it the most common cancer. The increasing number of breast cancer cases, combined with improved diagnostic capabilities, is driving the need for advanced biopsy technologies 
• Consequently, the growing incidence of breast cancer and the demand for early detection and accurate diagnosis are contributing significantly to the rising demand for advanced breast biopsy devices

Opportunity

“Integration of Artificial Intelligence in Breast Biopsy for Enhanced Precision and Efficiency”

• AI-powered breast biopsy devices are poised to revolutionize the market by enhancing precision, automating tasks, and improving diagnostic accuracy. AI algorithms can assist in analyzing imaging results, ensuring that surgeons can make more informed decisions during biopsy procedures
• AI integration can assist in the analysis of mammograms, ultrasound, and MRI scans, allowing for quicker identification of abnormalities, which aids in the timely detection of breast cancer.
• These systems can also analyze tissue samples, improving accuracy in detecting cancerous cells and reducing the likelihood of false negatives or positives

For instance,

• In In a study published in 2024, AI algorithms were found to have the potential to detect breast cancer in mammograms with a higher level of accuracy than radiologists, significantly reducing the time needed for diagnosis. AI can also track changes in tissue over time, improving the ability to monitor patients and make timely adjustments to treatment plans 
• The use of AI in breast biopsy devices can further enhance patient outcomes by providing real-time feedback during the procedure, minimizing errors, and reducing the need for repeat biopsies, ultimately improving the efficiency and success of the diagnostic process

Restraint/Challenge

“High Equipment Costs Hindering Market Penetration”

• The high cost of advanced breast biopsy devices poses a significant challenge to market growth, particularly in low- and middle-income countries. These devices, including advanced biopsy needles, guidance systems, and vacuum-assisted biopsy technologies, can be prohibitively expensive for smaller clinics and hospital
• The price range for these devices can vary from thousands to tens of thousands of dollars, which can create financial barriers for healthcare facilities with limited budgets, hindering their ability to upgrade to newer, more accurate systems
• Smaller clinics or diagnostic centers may be forced to continue using outdated or less efficient equipment due to budget constraints, which can compromise the quality of patient care and delay timely diagnosis and treatment

For instance,

• In 2023, a report by the World Health Organization (WHO) highlighted that the high cost of breast cancer diagnostic tools, including biopsy devices, contributes to disparities in cancer detection and treatment across different regions, particularly in low-income settings where access to healthcare is limited 
• Consequently, these financial challenges can limit the widespread adoption of advanced breast biopsy technologies, thereby restricting market growth and the ability to provide optimal care to all patients

Breast Biopsy Devices Market Scope

The market is segmented on the basis of product, technique type, guidance technology, and end user.

In 2025, the needle-based biopsy guns is projected to dominate the market with a largest share in product segment

The needle-based biopsy guns segment is expected to dominate the breast biopsy devices market with the largest share of 43.6% in 2025 due to its minimally invasive nature, faster procedure times, and high accuracy in tissue sampling. In addition, their widespread adoption in both hospital and outpatient settings for diagnosing breast abnormalities further boosts segment growth

The fine ultrasound-guided is expected to account for the largest share during the forecast period in guidance technology market

In 2025, fine ultrasound-guided segment is expected to dominate the market with the largest market share of 50.4% due to its real-time imaging capability, cost-effectiveness, and non-invasive nature. It also offers better accessibility and accuracy in detecting breast lesions, making it the preferred choice for both patients and healthcare providers

Breast Biopsy Devices Market Regional Analysis

“North America Holds the Largest Share in the Breast Biopsy Devices Market”

• North America dominates the breast biopsy devices market with a market share of estimated 43.6%, driven, by advanced healthcare infrastructure, high adoption of cutting-edge biopsy technologies, and strong presence of key market players
• U.S. holds a market share of 40%, due to the high prevalence of breast cancer, increasing demand for early detection, and continuous innovations in biopsy techniques. The availability of comprehensive healthcare coverage and reimbursement policies also supports market growth
• The rising adoption of minimally invasive biopsy procedures, combined with the presence of leading medical device companies, strengthens the region’s dominance
• In addition, the increasing focus on improving breast cancer diagnosis and the growing awareness of breast cancer screening in North America are fueling the market’s expansion

“Asia-Pacific is Projected to Register the Highest CAGR in the Breast Biopsy Devices Market”

• Asia-Pacific is expected to witness the highest growth rate in the breast biopsy devices market, driven by rapid expansion of healthcare infrastructure, increasing awareness about breast cancer, and rising demand for early diagnostic procedures
• Countries such as China, India, and Japan are emerging as key markets for breast biopsy devices due to the growing number of breast cancer cases and increasing adoption of advanced medical technologies
• Japan, with its advanced healthcare system and high adoption of medical technology, remains a key market for premium breast biopsy devices, particularly for early-stage breast cancer detection and biopsy procedures
• India is projected to register the highest CAGR in the breast biopsy devices market, driven by the expansion of healthcare infrastructure, rising prevalence of breast cancer, and growing awareness about the importance of early diagnosis and treatment

Breast Biopsy Devices Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

The Major Market Leaders Operating in the Market Are:

• Hologic, Inc. (U.S.)
• BD (U.S.)
• Siemens Healthineers AG  (Germany)
• GE HealthCare. (U.S.)
• Cook (U.S.)
• Stryker (U.S.)
• Devicor Medical Products, Inc. (U.S.)
• Argon Medical Devices, Inc. (U.S.)
• Planmed Oy (Finland)
• C.R. Bard, Inc. (U.S.)
• Carestream Health. (U.S.)
• FUJIFILM Corporation (Japan)
• Canon Medical Systems Corporation (Japan)
• Konica Minolta Business Solutions India Private Limited. (Japan)
• Hitachi Medical Systems (Japan)
• Koninklijke Philips N.V., (Netherlands)
• Medtronic (Ireland)
• Abbott (U.S.)
• Boston Scientific Corporation (U.S.)
• Zimmer Biomet (U.S.)

Latest Developments in Global Breast Biopsy Devices Market

• In January 2025, Hologic announced the commercial launch of its Affirm Prone Biopsy System in North America. This system enhances the precision of breast biopsies by providing more accurate tissue samples while increasing patient comfort. The system is designed for use with 3D mammography, offering superior imaging and guiding precision during biopsy procedures
• In October 2024, GE Healthcare unveiled its Pristina Dueta, an innovative breast biopsy device that incorporates a unique, patient-controlled compression feature. This breakthrough design allows patients to adjust the compression level during the biopsy, which minimizes discomfort while enhancing the overall accuracy of the biopsy process. The system is designed for use with advanced imaging technologies and is aimed at improving the overall experience and diagnostic outcomes
• In September 2024, Siemens Healthineers announced the launch of its Mammomat Revelation with Biopsy Option in Europe. This system combines digital breast tomosynthesis with an advanced biopsy attachment, enabling precise targeting of abnormalities with minimal discomfort. The device aims to improve early breast cancer detection and biopsy accuracy, focusing on patient-centric care
• In December 2024, Cook Medical introduced a new line of biopsy needles, designed for both fine-needle aspiration (FNA) and core needle biopsies, equipped with a novel safety feature to reduce risk during the procedure. These devices are expected to provide greater precision and safety, benefiting both patients and healthcare professionals by minimizing complications and improving overall biopsy outcomes
• In March 2021, IZI Medical Products, LLC ("IZI") launched The Quick-Core Auto Biopsy System for the purpose of soft tissue biopsy. Quick-Core Auto is known to be a lightweight, completely automatic biopsy equipment offering precision, reliability, and quality of IZI's Quick-Core semi-automatic biopsy system

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