Global Breast Biopsy Devices Market to Reach USD 4.21 Billion by 2035 amid Rising Breast Cancer Incidence and Technological Advancements | FMI

The global breast biopsy devices market is projected to witness remarkable growth over the next decade. According to the latest industry analysis, global sales of breast biopsy devices are expected to reach USD 2.47 billion in 2025 and are anticipated to climb to USD 4.21 billion by 2035, expanding at a compound annual growth rate (CAGR) of 5.5%. The market generated revenue of USD 2.34 billion in 2024, marking the beginning of a sustained upward trajectory.

This growth is being driven by the rising prevalence of breast cancer worldwide, a disease that continues to pose a major challenge for healthcare systems. According to the World Health Organization (WHO), breast cancer is one of the most commonly diagnosed cancers among women, representing a substantial share of new cancer cases globally. The American Cancer Society also reports increasing incidence rates, especially in developed and emerging economies, attributed to lifestyle shifts, hormonal changes, and genetic factors.

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Rising Demand for Accurate Diagnostic Tools

The surge in breast cancer cases has placed diagnostic accuracy at the forefront of medical priorities. Breast biopsy devices have become essential tools in modern oncology practices, playing a pivotal role in the early detection and diagnosis of breast abnormalities. The most commonly used biopsy procedures include core needle biopsy (CNB), fine-needle aspiration biopsy (FNAB), and vacuum-assisted biopsy (VAB), each tailored to different diagnostic needs.

The integration of these devices with advanced imaging technologies, such as mammography, ultrasound, and Magnetic Resonance Imaging (MRI), has significantly improved the precision and efficiency of diagnosis. Such technological synergies are expected to further propel market growth, offering improved outcomes for patients through earlier intervention and better-informed treatment strategies.

Government and Institutional Support

Governments and global health organizations continue to emphasize the importance of early cancer detection through mass screening programs. These initiatives, often supported by public healthcare policies, aim to identify suspicious lesions at their earliest stages. Once detected, breast biopsy procedures become critical in confirming the diagnosis and planning the appropriate course of treatment.

This institutional focus on early detection directly translates into growing demand for innovative and reliable breast biopsy devices—creating significant opportunities for manufacturers and healthcare providers alike.

Key Takeaways:

• India is projected to witness the highest CAGR of 5.5% from 2025 to 2035, reflecting strong market momentum and growth potential.
• China (5.1%) and Japan (5.0%) closely follow, highlighting Asia’s growing influence in the global market landscape.
• Australia & New Zealand are also expected to register solid growth at 4.8%, underlining regional advancements and increasing demand.
• Among European countries, Spain (4.1%) leads in growth rate, followed by Germany (3.9%) and France (3.5%).
• The United States, while maintaining market stability, is expected to grow at a moderate 2.9% CAGR, reflecting a mature and saturated market.

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Competitive Landscape and Strategic Developments

Key market players are leveraging innovation and strategic collaborations to strengthen their market presence and address the growing demand for sophisticated biopsy technologies. Notable names in the global breast biopsy devices market include:

• F. Hoffmann-La Roche Ltd.
• GE HealthCare
• Cook Medical Inc.
• Becton Dickinson and Company
• Hologic, Inc.
• Siemens Healthineers
• ARGON MEDICAL
• C.R. Bard, Inc.
• Devicor Medical Products, Inc.
• Leica Biosystems
• Medax Srl Unipersonale
• Planmed Oy
• Scion Medical Technologies, LLC

Recent industry developments highlight the emphasis on innovation. In November 2024, GE HealthCare introduced Pristina Via, a state-of-the-art mammography system designed to enhance screening experiences for both patients and technologists. Pristina Via features a toolset aimed at improving diagnostic accuracy while optimizing workflow efficiency—an innovation that aligns with the broader push toward patient-centered care.

In another significant move, IZI Medical Products, a portfolio company of Shore Capital Partners, expanded its capabilities in soft tissue and breast localization biopsy solutions. In January 2019, it acquired key product assets from Cook Medical, including the Quick-Core® Biopsy Needle and the MReye® Breast Localization Coil, strengthening its position in the breast biopsy market.

Market Segmentation

The breast biopsy devices market is segmented based on product type, indication, end user, and region:

By Product Type:

• Biopsy Needle
• MRI-Guided Biopsy Systems
• Ultrasound-Guided Breast Biopsy Systems
• Vacuum-Assisted Devices (VAD)
• Guide Wire (Localization Wire)
• Breast Biopsy Marker

By Indication:

• Complex Cyst
• Solid Mass
• Suspicious Solid Mass (Fibroadenoma)
• Suspicious Micro-Calcifications

By End User:

• Hospitals
• Specialty Clinics
• Ambulatory Surgical Centers
• Cancer Research Institutes

By Region:

• North America
• Latin America
• Western Europe
• Eastern Europe
• South Asia and Pacific
• East Asia
• Middle East and Africa (MEA)

Outlook and Opportunities

The outlook for the breast biopsy devices market remains strong, underpinned by technological advancements, increasing awareness, and improved access to diagnostic procedures. As breast cancer incidence continues to rise, particularly in low- and middle-income regions, there will be a growing need for affordable, minimally invasive, and accurate biopsy devices.

In the coming years, manufacturers are expected to focus on next-generation devices that integrate artificial intelligence and machine learning for enhanced imaging and predictive capabilities. These advancements will not only boost diagnostic precision but also pave the way for personalized medicine and targeted therapies.

Conclusion

The global breast biopsy devices market stands at the intersection of urgent medical need and technological innovation. With early detection playing a critical role in improving breast cancer survival rates, biopsy devices will remain essential to global health strategies. As the market moves toward USD 4.21 billion in value by 2035, industry stakeholders must continue to invest in research, foster strategic collaborations, and prioritize patient-centered innovation to meet the growing global demand.