The global breast biopsy devices market is experiencing strong momentum due to rising breast cancer screening rates, increasing adoption of minimally invasive biopsy procedures, and continuous innovation in image-guided diagnostic technologies. Major companies are focusing on vacuum-assisted biopsy systems, AI-powered imaging integration, MRI-guided procedures, and enhanced patient comfort solutions to strengthen their market positions.
The global breast biopsy market is projected to reach USD 3270.9 million by 2030 from USD 2,384.2 million in 2025 at a CAGR of 6.5% from 2025 to 2030. The global breast biopsy devices market is witnessing significant growth driven by rising breast cancer prevalence, increasing adoption of minimally invasive diagnostic procedures, and continuous technological advancements in imaging-guided biopsy systems.
10 Leading Breast Biopsy Devices Companies Shaping Innovation and Market Growth
1. Hologic
Hologic remains one of the dominant players in breast health and biopsy technologies. Its advanced biopsy platforms, including the Affirm and Brevera systems, are widely used for stereotactic and tomosynthesis-guided procedures. The company continues to invest heavily in AI-enabled breast imaging and minimally invasive diagnostics.
2. BD
BD is strengthening its position through innovative vacuum-assisted biopsy technologies such as the EnCor platform. In 2026, the company received FDA clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System, enhancing its multi-modality imaging capabilities.
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3. Mammotome
Mammotome, part of Danaher, is a recognized innovator in vacuum-assisted breast biopsy systems. The company recently introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System, designed for in-room MRI-guided procedures, improving workflow efficiency and patient-centered care.
4. GE HealthCare
GE HealthCare plays a crucial role in breast imaging and biopsy guidance technologies. Its advanced mammography and ultrasound platforms support precise lesion localization and minimally invasive breast biopsy procedures across hospitals and diagnostic centers worldwide.
5. Siemens Healthineers
Siemens Healthineers continues expanding its breast imaging portfolio with integrated diagnostic solutions that support high-precision biopsy workflows. Its imaging-guided systems are increasingly adopted in advanced oncology and breast care centers.
6. Cook Medical
Cook Medical is known for its comprehensive range of biopsy needles and minimally invasive diagnostic devices. The company maintains a strong presence in hospitals and interventional radiology settings with reliable biopsy access technologies.
7. Merit Medical Systems
Merit Medical Systems is gaining traction in the biopsy devices market through specialized soft tissue biopsy instruments and interventional oncology solutions designed to improve procedural accuracy and patient outcomes.
8. Argon Medical Devices
Argon Medical continues expanding its biopsy portfolio with innovative semi-automatic biopsy instruments such as SuperCore Advantage. The company focuses on improving tissue sampling precision and physician usability.
9. Fujifilm Healthcare
Fujifilm Healthcare leverages its imaging expertise to support advanced breast diagnostics and image-guided biopsy procedures. Its growing focus on digital healthcare solutions is enhancing diagnostic efficiency and workflow integration.
10. Planmed Oy
Planmed Oy is recognized for specialized mammography and breast imaging systems that support accurate biopsy guidance. The company continues to strengthen its footprint in Europe and emerging healthcare markets.
Key Trends Driving Market Growth
- Rising global breast cancer prevalence and screening programs
- Increasing preference for minimally invasive biopsy procedures
- Growth in MRI-guided and vacuum-assisted biopsy technologies
- AI integration in breast imaging and diagnostics
- Faster workflow solutions improving patient experience and diagnostic accuracy
- Expansion of outpatient and ambulatory diagnostic centers
Future Outlook
The breast biopsy devices market is expected to witness continued innovation as companies focus on precision diagnostics, automation, real-time imaging integration, and patient-centered technologies. Strategic collaborations, FDA clearances, and AI-driven advancements are likely to intensify competition and accelerate market expansion over the coming years.
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