Breast Biopsy Devices Market Size to Hit USD 1.70 Bn By 2035

Segment Insights

Product Type Insights

Due to the rising popularity of image-guided procedures in both developed and developing countries as well as the development of cutting-edge and distinctive designs, the biopsy needles market is predicted to account for a sizeable portion of the breast biopsy market. Consider the tri-axial needle, which has a cutting needle on the exterior, a pincer needle on the outside, and a sharp style within. Healthcare professionals may cut through tissue without crushing it because of the needle’s shape. Despite its unusual shape, the needle is clearly visible with CT and ultrasonography, which are frequently utilized for biopsy guidance.

Guidance Insights

The Guidance category with respect to liquid biopsy is anticipated to grow the most over the forecast period. A revolutionary technique that is broadening the range of cancer diagnostics is a liquid biopsy. The significant growth of the market may be attributed to the expanding use of cutting-edge NGS-based assays and droplet digital PCR technology for conducting liquid biopsies in the majority of developed nations. To bring new products to market, businesses in the sector are increasing their R&D spending. Thus, ongoing clinical trials and a prospective product pipeline will fuel additional market expansion.

Type Insights

This sector is divided into needle breast and open surgical biopsies according to kind. The first is further divided into vacuum-assisted core biopsy, core-needle aspiration, and both. Due mostly to an increase in demand for less invasive treatments, the fine-needle aspiration category is predicted to have the highest share in 2024. Contrarily, the less invasive vacuum-assisted core biopsy, which entails creating a tiny incision through which the needle is put, followed by sample collection using a vacuum-powered device, is predicted to expand at a high CAGR value throughout the projection period.

Regional Insights

North America accounted for the largest revenue share in the worldwide market in 2025, and it is anticipated that the region would continue to dominate the market during the forecast period. The U.S. and Canada, two of the region’s biggest economies, are the main sources of income for the market value in the area. The prospective market for medical tourism in the area underpins the value of the prevailing regional market.

U.S. Market Trends

The U.S. market is driven by breast cancer awareness, an improved reimbursement system, superior diagnostic centers, and a high number of patients using vacuum-assisted biopsies. The increasing demand for image-guided biopsy procedures in hospitals and outpatient settings in the U.S. More research and initiatives for early detection also spurred market growth.

Why is Europe Growing in the Breast Biopsy Devices Market?

Europe is expected to grow at a considerable CAGR in the upcoming period, owing to the presence of robust screening programs for cancer detection, increased uptake of early diagnosis technologies, and increasing investment in healthcare. Awareness regarding breast biopsy technologies also played an important role in fueling market growth in Europe. In addition, advancements in imaging technology and favorable healthcare policies have also driven growth in the market.

Will Latin America Grow in the Breast Biopsy Devices Market?

Latin America is considered to be a significantly growing area, due to its projected stable growth owing to improved healthcare infrastructure, increased awareness about breast cancer, and growing availability of diagnostic imaging techniques. Private healthcare systems are also playing an instrumental role in driving market growth in the region. Increased focus by governments towards the health of women and improved access to urban healthcare facilities are some other important factors contributing to regional demand.

Breast Biopsy Devices Market Companies

• Cook Medical Incorporated
• Becton,
• Dickinson and Company
• Devicor Medical Products Inc.
• C.R. Bard, Inc., Hologic Inc
• Argon Medical Devices
• Planmed OY
• Encapsule Medical Devices LLC
• Ethicon Endo-Surgery (Johnson and Johnson)

Recent Developments

• In March 2019, Dune Medical Devices revealed the results of the first human test of their smart biopsy device. The smart Biopdy from Dune Medical is a continuous soft tissue biopsy device that provides electrical samples in real time using small key needle detectors. To enhance diagnosis and readout, these electrical pulses are compared to astronomical data. The in-man stage signals the start of a more involved, exhaustive clinical investigation aimed at identifying the precise tissue makeup of the breast.

Segment Covered in the Report

By Product

• Biopsy Needles
• Guidance Systems
• Biopsy Tables
• Localization Wires
• Assay Kits
• Liquid Biopsy Instruments
• Others

By Guidance

• Image-Guided Biopsy
• Mammography-guided Stereotactic Biopsy
• Ultrasound-guided Biopsy
• MRI-guided Biopsy
• Other Guidance Techniques
• Liquid Biopsy
• NGS-based Biopsy
• PCR-based Biopsy
• Microarray-based Biopsy

By Type

• Needle Breast Biopsy
• Core Needle Biopsy (CNB)
• Fine Needle Aspiration Biopsy (FNAB)
• Vacuum-assisted Biopsy (VAB)
• Open Surgical Breast Biopsy
• Excisional
• Incisional
• Liquid Breast Biopsy
• Circulating Tumor Cells
• Circulating Tumor DNA (CtDNA)
• Other Biomarkers

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)

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