U.S. Biopsy Devices Market to Reach USD 1.81 Billion by 2035, Driven by Technological Innovation and Cancer Diagnostics Growth

The U.S. biopsy devices market, valued at USD 688.5 million in 2024, is projected to reach USD 1,809.2 million by 2035, growing at a CAGR of 9.18% according to DataM Intelligence. Biopsy devices play a crucial role in modern diagnostics, enabling early identification of cancers and other diseases through minimally invasive tissue sampling. Advances in image-guided procedures, robotics, and vacuum-assisted biopsy systems are enhancing precision, safety, and patient comfort-key factors that continue to drive the market's rapid expansion.

Growing cancer prevalence, an aging population, and rising demand for early, accurate diagnostics are shaping the future of the U.S. biopsy devices market. The country's strong healthcare infrastructure, combined with regulatory support from the FDA and rising investment in R&D by major players such as Exact Sciences, Hologic, and Medtronic, positions the U.S. as a global leader in biopsy device innovation and adoption.

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Key Highlights from the Report

➤ U.S. biopsy devices market projected to grow at a 9.18% CAGR from 2025 to 2035.
➤ Market value expected to increase from USD 688.5 million in 2024 to USD 1,809.2 million by 2035.
➤ Growth fueled by the rising incidence of cancer and adoption of imaging-based biopsies.
➤ Biopsy guns and needles remain the most widely used products for tissue sampling.
➤ FDA initiatives to streamline approvals are accelerating product innovation and commercialization.
➤ Expanding outpatient care and patient-centered diagnostics are reshaping market dynamics.

Market Segmentation

By product type, biopsy guns hold a dominant share due to their precision and suitability for minimally invasive sampling. Biopsy guidance systems, incorporating MRI, CT, and ultrasound imaging, are increasingly preferred for complex anatomical procedures, significantly improving procedural accuracy. Biopsy needles continue to be indispensable across applications, while vacuum-assisted and robot-enhanced designs represent the latest evolution in device reliability and speed.

In terms of application, breast biopsy remains the largest segment, driven by the high prevalence of breast cancer among women in the U.S. Prostate, liver, and lung biopsy devices also witness strong demand, reflecting the growing importance of early detection in oncology. Gynecological and gastrointestinal biopsies contribute to the diversification of device applications, supporting diagnostic precision across specialties.

By guidance technique, ultrasound-guided biopsies lead adoption owing to their real-time imaging capabilities, followed closely by MRI- and CT-guided procedures for enhanced visualization of soft tissue lesions. The segment continues to benefit from advancements in digital imaging systems that reduce complications and improve accuracy.

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Regional Insights

Biopsy device utilization is strongest in regions with advanced healthcare ecosystems such as the Northeast and West Coast, home to leading academic medical centers and research institutions. States like California, Massachusetts, and New York maintain high adoption rates due to early integration of advanced imaging systems and diagnostic innovation. Meanwhile, Southern and Midwestern states are recording growth through expanding hospital networks and outpatient diagnostic centers.

Rising healthcare spending, improved insurance coverage for diagnostic procedures, and the proliferation of ambulatory surgical centers across the U.S. are further enhancing access to biopsy technologies nationwide.

Market Dynamics

Market Drivers

The increasing prevalence of cancer, coupled with greater reliance on early diagnostics, continues to drive the adoption of biopsy devices. Growing patient preference for minimally invasive procedures and advanced imaging integration enhances precision and recovery, supporting rapid market expansion.

Market Restraints

High device costs, reimbursement challenges, and the need for specialized training among clinicians remain key barriers to adoption. Delays in FDA clearance or inconsistent clinical validation standards may also limit smaller firms' market access.

Market Opportunities

The rise of robotic-assisted and image-guided biopsy systems, alongside expanding outpatient diagnostics, presents significant growth potential. Integration with digital health tools and data analytics offers additional opportunities for personalized and precision diagnostics.

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Reasons to Buy the Report

✔ Detailed analysis of growth drivers, restraints, and emerging technology opportunities.
✔ Insight into key product segments, applications, and guidance methods shaping market trends.
✔ Competitive landscape coverage of major manufacturers and innovators.
✔ Comprehensive forecast through 2035 highlighting revenue and market share shifts.
✔ Evaluation of regulatory reforms and their impact on device adoption in U.S. healthcare.

Frequently Asked Questions (FAQs)
◆ How large is the U.S. biopsy devices market in 2024 and what is its projection by 2035?
◆ What is the CAGR of the U.S. biopsy devices market from 2025 to 2035?
◆ Who are the leading companies driving growth in the U.S. biopsy devices market?
◆ Which biopsy products and guidance technologies are in highest demand?
◆ Which regions in the U.S. hold the largest share in biopsy technology adoption?

Company Insights
Exact Sciences

Hologic

C. R. Bard

Medtronic

Boston Scientific

Abbott Laboratories

Thermo Fisher Scientific

Cardinal Health

Stratec Biomedical

Siemens Healthineers

Greiner BioOne

Fujifilm Holdings

Cook Medical

Becton Dickinson

Recent Developments:

August 2023: Medtronic launched a new biopsy system focusing on sample accuracy and patient comfort for minimally invasive procedures.

September 2023: Boston Scientific acquired an oncology-focused firm to expand its biopsy device portfolio and reinforce its presence in diagnostic technologies.

Conclusion
The U.S. biopsy devices market is entering a transformative growth phase, driven by a combination of rising cancer incidence, technological innovation, and increasing preference for minimally invasive diagnostics. With a strong research ecosystem, supportive regulatory pathways, and growing investment in digital and robotic biopsy systems, the market is projected to expand at a steady 9.18% CAGR, reaching USD 1.81 billion by 2035. As healthcare providers continue emphasizing early detection and precision medicine, biopsy devices remain central to the future of medical diagnostics and personalized healthcare in the U.S.

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