Home > > > Breast Biopsy Market Size to Reach USD 7.12 Billion by 2034, Report Finds

Breast Biopsy Market Size to Reach USD 7.12 Billion by 2034, Report Finds

Author : savi ssd | Published On : 23 Sep 2026

The global breast biopsy market was valued at USD 2.83 billion in 2025 and is projected to grow from USD 3.14 billion in 2026 to USD 7.12 billion by 2034, registering a CAGR of 10.8% during 2026-2034. North America dominated the market with a 38.6% share in 2025, while Asia Pacific is expected to register the fastest CAGR of 9.18%.

  • Market Size (2025): USD 2.83 Billion

  • Market Size (2026): USD 3.14 Billion

  • CAGR (Forecast Period): 10.8%

  • Forecast Year: 2034

  • Projected Market Size (2034): USD 7.12 Billion

  • Dominant Region: North America - 38.6%

  • Fastest Growing Region: Asia Pacific - 9.18% CAGR

Market Overview

Breast biopsy is a diagnostic procedure used to collect breast tissue or cells for laboratory examination when imaging identifies a suspicious abnormality. Core needle biopsy, fine-needle aspiration, vacuum-assisted biopsy, surgical biopsy, and liquid biopsy are among the approaches used to support breast cancer diagnosis and treatment decisions.

The market is also moving toward more precise image-guided procedures, contrast-enhanced mammography, automated systems, and robotic assistance. These technologies are helping healthcare providers improve lesion targeting, tissue acquisition, procedural workflow, and diagnostic accuracy.

Growth Drivers

Expansion of breast cancer screening programs is creating a broader diagnostic pathway for tissue sampling. In September 2025, NHS England reported that more than 2.1 million women underwent breast screening during the previous year, with approximately 18,000 cancers detected through the program, highlighting the role of screening in generating follow-up diagnostic procedures.

Advances in breast imaging are also supporting the use of image-guided biopsy systems. Contrast-enhanced mammography, ultrasound, stereotactic imaging, and MRI can help clinicians identify and target suspicious lesions, supporting more precise tissue sampling across different clinical settings.

Market Challenges

Procedure-related discomfort and complications can affect patient acceptance of breast biopsy procedures. Bruising, bleeding, hematoma, pain, and infection remain potential concerns, particularly when repeat tissue sampling is required.

Accessing small or technically difficult lesions can also create procedural challenges. Lesions located close to the chest wall, skin, implants, or other sensitive structures require precise targeting and adequate tissue retrieval, increasing the importance of accurate localization and specialized biopsy technologies.

Market Opportunities

Liquid biopsy creates an opportunity for diagnostic companies to expand beyond conventional tissue sampling through blood-based molecular assessment. Circulating tumor DNA and other biomarkers can support genomic profiling and may complement tissue biopsy when additional tissue is difficult to obtain.

Advanced biopsy platforms also provide opportunities for medical-device manufacturers to improve procedural efficiency and lesion targeting. Robotic systems, contrast-guided biopsy technologies, and integrated imaging platforms can create new revenue avenues through more automated and precise breast diagnostic workflows.

Segment Analysis

By product, the biopsy needles segment accounted for a 29.4% share in 2025, supported by their widespread use for tissue collection across core needle, fine-needle, and other minimally invasive breast biopsy procedures.

By biopsy type, the liquid breast biopsy segment is projected to grow at a CAGR of 10.36% during 2026-2034, supported by advances in circulating biomarker analysis, molecular diagnostics, and blood-based cancer assessment.

By guidance, the image-guided biopsy segment accounted for an 88.3% share in 2025, reflecting the widespread use of imaging technologies to locate suspicious abnormalities and guide accurate tissue sampling.

By application, the recurrence monitoring segment is expected to grow at a CAGR of 8.49% during 2026-2034, supported by greater emphasis on post-treatment surveillance and early identification of recurrent disease.

By end-user, the hospitals and surgical centers segment accounted for a 51.6% share in 2025, supported by access to advanced diagnostic equipment, trained specialists, surgical capabilities, and comprehensive breast cancer care services.

Regional Analysis

North America led the breast biopsy market with a 38.6% share in 2025, reaching USD 1.09 billion. The region benefits from established breast cancer screening programs, advanced healthcare infrastructure, and broad adoption of image-guided biopsy technologies. The U.S. represents the largest market in the region, while Canada continues to strengthen screening and diagnostic capabilities.

Asia Pacific is projected to record the fastest CAGR of 9.18% during 2026-2034, supported by greater breast cancer awareness, expanding healthcare infrastructure, broader access to diagnostic services, and adoption of advanced imaging and biopsy technologies. China and India represent important regional markets, with investments in cancer screening and specialized diagnostic services supporting market development.

Europe accounted for a 28.4% share in 2025, supported by established screening infrastructure and adoption of minimally invasive diagnostic procedures. Latin America accounted for 6.1%, while the Middle East & Africa represented 4.2% of the global market in 2025, with improvements in cancer-care infrastructure supporting continued market development.

Competitive Landscape

The breast biopsy market includes medical-device manufacturers, diagnostic technology companies, molecular testing providers, and specialized breast-health companies. Competition is shaped by biopsy accuracy, imaging integration, tissue acquisition, workflow efficiency, product safety, regulatory clearances, and technological innovation.

Key companies include:

  • Hologic, Inc.

  • Danaher Corporation

  • Becton, Dickinson and Company

  • QIAGEN

  • Illumina, Inc.

  • Merit Medical Systems

  • Medtronic

  • Bio-Rad Laboratories, Inc.

  • F. Hoffmann-La Roche Ltd

  • Thermo Fisher Scientific, Inc.

  • GE HealthCare

Recent Developments

In January 2026, BD received U.S. FDA 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System, a multi-modality platform designed to provide greater flexibility across breast imaging procedures. Mammotome, a Danaher business, also introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System in February 2026 for use during MRI-guided breast biopsy procedures.

In April 2026, Hologic completed its acquisition by Blackstone and TPG, transitioning to private ownership while continuing its focus on women's health technologies. Hologic also received regulatory progress for its Brevera breast biopsy system during 2026 as it worked toward restoring availability of its 9G biopsy needle.

Future Outlook

The breast biopsy market is expected to maintain strong growth through 2034 as screening programs, advanced breast imaging, and precision diagnostics continue to expand the need for accurate tissue assessment. Image-guided procedures and biopsy needles will remain important components of clinical workflows, while liquid biopsy and advanced molecular diagnostics create additional avenues for innovation.

Robotic assistance, contrast-enhanced mammography-guided biopsy, integrated tissue-imaging systems, and technologies designed for technically difficult lesions are expected to shape product development. Greater emphasis on procedural efficiency, patient comfort, sample quality, and diagnostic precision will also influence competition across the market.

Click to Read the Complete Insights & Report: https://straitsresearch.com/report/breast-biopsy-market

About Straits Research

Straits Research is a global market intelligence and consulting company providing market research, strategic insights, competitive analysis, and advisory services across multiple industries. The company delivers research and consulting solutions that help businesses understand market dynamics, evaluate competitive environments, identify opportunities, and support informed strategic decisions.