North America Biopsy Device Market to Hit $1.30B by 2033 | 5.1% CAGR

North America Biopsy Device Market Trends

The North America Biopsy Device Market is projected to reach US$ 1,303.45 million by 2033, rising from US$ 835.19 million in 2024, growing at a CAGR of 5.07% from 2025 to 2033. The market expansion is fueled by the increasing prevalence of cancer, heightened awareness about early detection, technological innovations in imaging and minimally invasive diagnostics, an aging population, supportive reimbursement policies, and the rising demand for precision medicine. Together, these factors are creating a strong environment for the adoption of advanced biopsy solutions across North America.

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Market Overview

A biopsy is a medical procedure in which tissue samples are collected from the body to detect abnormalities such as cancer or other diseases. Biopsy devices are critical in ensuring early and accurate diagnoses, guiding treatment decisions, and monitoring disease progression. The devices can be needle-based systems (fine needle aspiration, core needle, vacuum-assisted), forceps, or surgical biopsy instruments, and they are often complemented by image-guidance technologies such as MRI, ultrasound, stereotactic systems, and CT scans.

In North America, where healthcare infrastructure is advanced, the adoption of such devices is high. Key factors driving adoption include:

• The rising cancer burden across the U.S., Canada, and Mexico.
• Technological integration such as AI-assisted diagnostics, robotic biopsy tools, and digital pathology.
• Favorable reimbursement frameworks that reduce the financial burden on patients and healthcare providers.
• Growing emphasis on personalized medicine, where biopsy plays a central role in tailoring therapies to individual patients.

With early detection being crucial for survival rates, biopsy devices are positioned as indispensable tools in oncology and other medical specialties.

Growth Drivers

1. Rising Cancer Incidence

Cancer remains one of the leading causes of mortality in North America. According to the American Cancer Society, approximately 2,041,910 new cases and 618,120 deaths from cancer are expected in the United States in 2025. Breast, lung, and prostate cancers account for a large proportion of these cases.

• Breast cancer alone is projected to account for 316,950 new invasive cases among women in 2025.
  This rising burden underscores the need for accurate and minimally invasive diagnostic techniques such as image-guided biopsy. The demand for biopsy devices is therefore directly proportional to cancer prevalence, making oncology a core growth driver of the industry.

2. Technological Advancements

Advancements in biopsy devices are improving diagnostic accuracy, patient comfort, and clinical efficiency. Key developments include:

• Vacuum-assisted biopsy systems that collect larger and more reliable tissue samples.
• Robotic-assisted biopsy tools that enhance precision in hard-to-reach areas.
• AI integration and digital pathology that improve diagnostic decision-making and reduce turnaround times.
• Improved imaging guidance systems (CT, MRI, ultrasound, stereotactic) that minimize invasiveness.

For instance, Trivitron Healthcare’s acquisition of The Kennedy Company in 2022 expanded its U.S. portfolio with advanced breast biopsy products. Similarly, companies like TransMed7 and Argon Medical Devices are introducing next-generation semi-automatic and vacuum-assisted devices, accelerating market growth.

3. Increased Awareness & Early Detection Initiatives

Public health campaigns and cancer awareness programs are promoting early detection, which relies heavily on biopsies. Organizations such as the American Cancer Society and the National Breast Cancer Foundation play critical roles in educating populations about screening and diagnostic procedures. Patients are increasingly seeking biopsies as part of preventive care, while physicians are proactively recommending them for ambiguous imaging results. This shift has created sustained demand for advanced and less invasive biopsy tools.

4. Personalized & Precision Medicine

The rise of precision medicine—tailoring treatments to an individual’s genetic, molecular, and cellular profile—has increased the demand for accurate tissue sampling. Biopsy devices are indispensable in this approach, as they provide the biological material needed for genomic, molecular, and biomarker testing. This trend will continue to fuel growth as more therapies become biomarker-driven.

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Market Challenges

High Cost of Advanced Biopsy Devices

While technology enhances diagnostic accuracy, it also raises costs. Robotic-assisted biopsy devices and sophisticated image-guidance systems involve high acquisition and maintenance expenses. Smaller hospitals and diagnostic centers often struggle to afford such investments, limiting widespread adoption. Training requirements and operating costs further add to the financial burden.

Regulatory & Reimbursement Barriers

The FDA’s strict approval process for medical devices ensures safety but often delays product launches. Moreover, reimbursement policies differ across states and healthcare systems. While some advanced devices are fully covered, others face limited or delayed reimbursement. These challenges can discourage manufacturers from investing in innovation and slow adoption by healthcare providers.

Country-Level Insights

United States

The U.S. dominates the North American biopsy device market, driven by its high cancer incidence, advanced healthcare infrastructure, and continuous product innovation.

• In May 2023, Argon Medical Devices launched the SuperCore Advantage, a semi-automatic biopsy device that improves tissue sample capacity.
• In February 2023, TransMed7 introduced the Concorde US, an ultrasound-guided vacuum-assisted biopsy system designed to enhance breast biopsy accuracy.

These innovations, combined with strong reimbursement policies and a focus on early cancer detection, make the U.S. the fastest-growing market in the region.

Canada

In Canada, cancer is also a leading cause of mortality, creating a strong demand for biopsy devices. Canadian healthcare emphasizes early detection and personalized care, leading to increased adoption of robotic-assisted and image-guided systems. Hospitals and diagnostic centers are progressively integrating advanced biopsy technologies, supported by government healthcare spending.

Mexico

Mexico’s biopsy device market is smaller but expanding quickly. Rising cancer incidence, improvements in healthcare infrastructure, and the availability of minimally invasive technologies are driving demand. Multinational companies are entering the Mexican market with advanced biopsy solutions, catering to local hospitals and private diagnostic facilities. The expansion of private healthcare in Mexico also supports the adoption of modern biopsy devices.

Market Segmentation

By Product

• Needle-Based Guns
• Biopsy Guidance Systems
• Biopsy Needles
• Biopsy Forceps
• Others

By Application

• Breast Biopsy
• Lung Biopsy
• Prostate Biopsy
• Liver Biopsy
• Gastroenterology Biopsy
• Others

By Technology

• CT Scan Guided
• Stereotactic Guided
• Ultrasound Guided
• MRI Guided
• Others

By End User

• Hospitals
• Diagnostic & Imaging Centers
• Others

By Country

• United States
• Canada
• Mexico
• Rest of North America

Competitive Landscape

The North American biopsy device market is highly competitive, with global and regional players investing in product innovation, partnerships, and acquisitions. The leading companies include:

• Cardinal Health, Inc.
• Hologic, Inc.
• Danaher Corporation
• Becton, Dickinson and Company (BD)
• Boston Scientific Corporation
• Medtronic plc.
• Olympus Corporation
• CONMED Corporation

These companies focus on expanding their biopsy portfolios, integrating imaging technologies, and enhancing patient comfort through minimally invasive solutions. Mergers, acquisitions, and R&D investments are common strategies to maintain market leadership.

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Future Outlook (2025–2033)

The North American biopsy device market is poised for steady growth over the forecast period, with a CAGR of 5.07%. Key trends shaping the future include:

• Greater adoption of AI-powered biopsy analysis for faster and more accurate diagnoses.
• Integration with digital pathology platforms, enabling remote and collaborative diagnostics.
• Expansion of robotic-assisted biopsy systems for precision in complex procedures.
• Growing role of liquid biopsy as a complementary tool, although tissue biopsy devices will remain dominant.
• Increasing emphasis on patient-friendly and outpatient biopsy procedures, reducing hospital stays and costs.

With rising cancer incidence, supportive policies, and continuous innovation, biopsy devices will remain at the heart of North America’s fight against cancer.

Conclusion

The North America Biopsy Device Market is entering a period of strong growth, driven by cancer prevalence, technological progress, healthcare modernization, and awareness about early diagnosis. While challenges such as high device costs and regulatory hurdles exist, the demand for accurate, minimally invasive, and patient-friendly diagnostic tools will ensure continued adoption. The U.S. will remain the largest market, while Canada and Mexico will experience steady growth as healthcare systems invest in modern diagnostic solutions.

By 2033, with a projected valuation of US$ 1,303.45 million, biopsy devices will continue to play a transformative role in healthcare, enabling precision medicine and improving survival outcomes for millions across North America.

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