Breast Biopsy Devices Market worth US$3,261.7 million by 2030 with 6.5% CAGR | MarketsandMarkets™
DELRAY BEACH, Fla., May 23, 2025 /PRNewswire/ -- The global Breast Biopsy Devices Market, valued at US$2,255.0 million in 2024, is forecasted to grow at a robust CAGR of 6.5%, reaching US$2,384.1 million in 2025 and an impressive US$3,261.7 million by 2030. This growth is primarily driven by the increasing prevalence of breast cancer worldwide, which has heightened the demand for early and accurate diagnostic methods.
Growing awareness of the benefits of early detection, along with the expansion of national screening programs, is encouraging more women to undergo regular breast exams. Technological advancements, such as image-guided biopsy instruments and vacuum-assisted biopsies, and the rise of minimally invasive treatments, have improved diagnostic accuracy while also reducing patient discomfort and recovery time.
Outpatient procedures are becoming increasingly popular among patients, and various factors, including favorable reimbursement policies and a shift toward personalized treatment plans, are contributing to market growth. Together, these elements are driving the adoption and development of advanced breast biopsy technologies globally.
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By Based on products, the global breast biopsy devices market is categorized into several segments: biopsy needles, biopsy equipment, guidance systems, biopsy tables, localization wires, assay kits, liquid biopsy instruments, and other products. Among these, the biopsy needles segment is expected to experience the highest growth rate during the forecast period. This growth can be attributed to the rising incidence of cancer worldwide and the increased demand for accurate diagnostics and testing.
Biopsy needles are utilized in minimally invasive procedures, such as core needle biopsy (CNB) and fine needle aspiration biopsy (FNAB), providing a pain-free method for tissue sampling with shorter recovery times compared to traditional surgical methods. Technological advancements supporting the biopsy needles market include vacuum-assisted and ultrasound-assisted biopsy needle systems and the development of needle systems that incorporate diagnostic imaging techniques, such as ultrasound, CT, and MRI.
By Based on procedure, the breast biopsy devices market is divided into needle breast biopsy, open surgical breast biopsy, and liquid breast biopsy. The liquid breast biopsy segment is expected to experience the highest growth rate during the forecast period. This growth can be attributed to the increasing use of liquid mammary biopsies, which are non-invasive, provide quick results, and allow for real-time analysis of tumor dynamics. Unlike traditional tissue biopsies, liquid biopsies analyze circulating tumor DNA (ctDNA) and circulating tumor cells (CTC) collected from a blood sample. This approach enables early detection, monitoring of treatment responses, and identification of mutations related to drug resistance.
By Based on applications, the global breast biopsy devices market is segmented into four main categories: early cancer screening, therapy selection, treatment monitoring, and recurrence monitoring. In 2024, early cancer screening represented the largest share of the market. The rise in various available screening technologies that enhance detection rates, such as digital mammography, artificial intelligence-assisted imaging, and genetic risk assessments, has contributed to advancements in this area. These innovations lead to higher sensitivity and improved specimen availability. Additionally, strong government initiatives, including public health campaigns and increased awareness among individuals, have resulted in greater accessibility to and participation in routine screenings by patients and wider populations.
By end users, the breast biopsy devices market is divided into hospitals & surgical centers, breast care centers, and imaging clinics & diagnostic centers. In 2024, hospitals & surgical centers were the largest segment in the breast biopsy devices market. This growth is primarily due to their advanced infrastructure, streamlined diagnostic processes, and high patient volumes. Most hospitals and surgical centers are equipped with cutting-edge imaging technologies, such as MRI, ultrasound, and digital mammography, allowing them to conduct biopsy procedures in a more accurate and less invasive manner.
By geography, the breast biopsy devices market is divided into five regions: North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa. In 2024, North America was the market leader. This dominance can be attributed to several factors. The region boasts an exceptional healthcare infrastructure and has higher healthcare spending, which facilitates access to advanced diagnostic techniques, including minimally invasive biopsy procedures.
Additionally, the rates of breast cancer, particularly in the US, are significant. As a result, many individuals seek to detect tumors early, making accurate result interpretation crucial. Furthermore, ongoing government initiatives, such as the Breast and Cervical Cancer Mortality Prevention Act, aim to increase economic opportunities for low-income families. This means enhancing access to screening and diagnostic programs.
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As of 2024, notable market players include Hologic Inc. (US), Danaher Corporation (US), Becton, Dickinson and Company (US), Argon Medical Devices (US), Merit Medical Systems (US), and Menarini-Silicon Biosystems (Italy), among others.
Hologic Inc. (US):
Hologic Inc. is a leading company in the breast biopsy devices market. It is dedicated to women's health and equipped with a wide range of advanced technologies. Its innovative products, such as the Brevera Breast Biopsy System with CorLumina Imaging Technology, utilize real-time imaging along with vacuum-assisted tissue acquisition to enhance diagnostic accuracy and improve the efficiency of biopsy procedures. The company continues to strengthen its position in the market through strategic acquisitions, including SOMATEX Medical Technologies GmbH and Endomag, which expand its capabilities in biopsy site markers and localization technologies. With a strong global presence, substantial resources, a focus on research and development, and a steadfast commitment to innovation, Hologic is well-positioned to remain a leader in breast biopsy solutions.
Becton, Dickinson and Company (US)
Becton, Dickinson and Company (BD) is a leading player in the breast biopsy devices market, offering innovative solutions such as the EnCor Enspire and BD EleVation systems. EnCor Enspire is an advanced, vacuum-assisted breast biopsy system that features an intuitive touchscreen display and real-time visualization of needle activity. It also offers in-breast adaptability, allowing clinicians to adjust tissue density and lesion size without having to reinsert the probe. Its ergonomic design includes a palm-sized handpiece and integrated headlights, enhancing maneuverability across MRI, ultrasound, and stereotactic modalities. Additionally, features like a top-load canister and snap-in tubing cassette simplify setup and inventory management. Complementing this, the BD EleVation system is an ergonomic, handheld, vacuum-assisted instrument designed for ultrasound-guided procedures.
Devicor Medical Products, Inc.
Devicor Medical Products, Inc., a subsidiary of Leica Biosystems and part of Danaher Corporation, is a leading company in the breast biopsy devices market, particularly known for its Mammotome vacuum-assisted biopsy systems. Founded in 2010 after being carved out from Johnson & Johnson, Devicor has expanded its portfolio through strategic acquisitions, including the HydroMARK breast biopsy marker, which enhances its offerings in tissue marking solutions. The company's commitment to minimally invasive procedures and diagnostic excellence has established its reputation among healthcare professionals, with products available in over 50 countries worldwide. Devicor's acquisition by Leica Biosystems has further strengthened its position by combining anatomical pathology solutions with advanced biopsy technologies, facilitating precise breast cancer diagnosis and treatment.
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