North America Biopsy Device Market Trends & Forecast 2025–2033

Introduction

The healthcare landscape in North America is undergoing a transformative shift, driven by the rising burden of chronic diseases, rapid technological innovation, and a growing emphasis on early diagnosis. Among the critical tools enabling this transformation are biopsy devices—essential instruments used to collect tissue samples for the detection and monitoring of cancer and other serious conditions. As healthcare systems prioritize accuracy, patient comfort, and personalized treatment pathways, the demand for advanced biopsy technologies continues to grow steadily.

According to Renub Research, the North America Biopsy Device Market is expected to reach US$ 1,303.45 million by 2033, up from US$ 835.19 million in 2024, expanding at a compound annual growth rate (CAGR) of 5.07% from 2025 to 2033. This growth reflects a convergence of factors, including increasing cancer incidence, advances in imaging technology, favorable reimbursement policies, and rising awareness regarding early disease detection.

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North America Biopsy Device Market Overview

A biopsy device is a specialized medical instrument used to extract tissue or cell samples from the human body for diagnostic evaluation. These devices play a vital role in identifying malignancies, inflammatory conditions, and other abnormalities affecting organs such as the breast, lung, liver, prostate, and gastrointestinal tract.

Biopsy devices are commonly classified into needle-based systems, vacuum-assisted devices, surgical biopsy instruments, and biopsy guidance systems. To ensure precision and safety, many modern biopsy procedures are supported by imaging technologies such as ultrasound, CT scans, MRI, and stereotactic guidance. The shift toward minimally invasive biopsy techniques has significantly improved patient outcomes by reducing procedural risks, recovery times, and discomfort.

In North America, the biopsy device industry benefits from advanced healthcare infrastructure, high diagnostic standards, and strong adoption of innovative medical technologies. Hospitals and diagnostic centers increasingly rely on biopsy tools to support early-stage disease detection and precision medicine initiatives.

Key Growth Drivers in the North America Biopsy Device Market

Rising Incidence of Cancer

The increasing prevalence of cancer remains the most significant driver of biopsy device demand in North America. According to the American Cancer Society, the United States alone is projected to record 2,041,910 new cancer cases and 618,120 cancer-related deaths in 2025. Breast cancer accounts for nearly 30% of all new cancer diagnoses among women, with an estimated 316,950 new invasive breast cancer cases expected in 2025.

These alarming statistics underscore the critical need for reliable diagnostic tools. Biopsy procedures are often the definitive step in confirming cancer diagnoses, determining tumor type, and guiding treatment planning. As cancer screening programs expand and early detection becomes a clinical priority, the utilization of biopsy devices continues to rise across the region.

Technological Advancements in Biopsy Devices

Technological innovation is reshaping the biopsy device market in North America. The introduction of image-guided biopsy systems, robotic-assisted devices, and vacuum-assisted biopsy technologies has significantly improved diagnostic accuracy while minimizing invasiveness.

Integration with artificial intelligence (AI) and digital pathology platforms further enhances tissue analysis, enabling faster and more precise clinical decision-making. These innovations reduce sampling errors and improve diagnostic confidence for clinicians.

Strategic acquisitions and product launches highlight the industry’s innovation-driven growth. For instance, Trivitron Healthcare’s acquisition of The Kennedy Company in 2022 strengthened its portfolio of breast biopsy and radiation protection solutions in the U.S. market. Such developments illustrate how technology and strategic expansion are accelerating adoption across North America.

Growing Awareness of Early Detection

Public awareness initiatives have played a crucial role in increasing biopsy procedure volumes. Organizations such as the American Cancer Society and the National Breast Cancer Foundation actively promote routine screenings and early diagnosis, encouraging patients to seek timely medical evaluations.

Improved access to healthcare information and evolving clinical guidelines have empowered both patients and physicians to prioritize early diagnostic interventions. As a result, biopsy devices are increasingly used not only in oncology but also in gastroenterology, pulmonology, and urology. This heightened awareness directly contributes to market growth by expanding the patient pool requiring biopsy-based diagnostics.

Aging Population and Precision Medicine Demand

North America’s aging population is another important growth catalyst. Older adults face a higher risk of cancer and chronic diseases, increasing the demand for diagnostic procedures. Simultaneously, the shift toward precision medicine—where treatments are tailored based on individual genetic and pathological profiles—has increased reliance on biopsy-derived tissue samples.

Biopsy devices provide the biological insights required for targeted therapies, making them indispensable in modern healthcare delivery.

Challenges Facing the North America Biopsy Device Market

High Cost of Advanced Biopsy Technologies

Despite technological progress, the high cost of advanced biopsy systems remains a notable challenge. Robotic-assisted and image-guided devices require substantial investment in equipment, staff training, and maintenance. Smaller hospitals and outpatient diagnostic centers may find it difficult to adopt these technologies, limiting market penetration in certain regions.

Regulatory and Reimbursement Barriers

Stringent regulatory approval processes imposed by agencies such as the U.S. Food and Drug Administration (FDA) can delay the commercialization of new biopsy devices. In addition, reimbursement policies vary by procedure and device type, creating financial uncertainty for healthcare providers. These factors can slow innovation and restrict access to cutting-edge diagnostic solutions.

Country-Level Market Insights

United States Biopsy Device Market

The United States dominates the North American biopsy device market due to its high cancer prevalence, advanced healthcare infrastructure, and strong innovation ecosystem. Continuous product development supports market growth. In May 2023, Argon Medical Devices introduced the SuperCore Advantage semi-automatic biopsy system, designed to enhance tissue sampling efficiency. Similarly, TransMed7 announced the launch of Concorde US ultrasound-guided biopsy devices in February 2023, aimed at improving breast biopsy outcomes.

These advancements, combined with favorable reimbursement frameworks, position the U.S. as a highly competitive and rapidly evolving market.

Canada Biopsy Device Market

Canada’s biopsy device market is expanding steadily, supported by a healthcare system focused on early diagnosis and patient-centered care. The increasing adoption of image-guided and minimally invasive biopsy technologies has improved diagnostic accuracy for breast, lung, and prostate cancers.

Hospitals and diagnostic centers across Canada are investing in modern biopsy solutions to support precision medicine initiatives, driving consistent market growth.

Mexico Biopsy Device Market

Mexico represents an emerging growth opportunity within North America. Rising cancer incidence, healthcare infrastructure improvements, and increasing access to advanced diagnostic tools are fueling market expansion. International medical device manufacturers are introducing innovative biopsy solutions tailored to the country’s growing diagnostic needs.

Government efforts to strengthen healthcare delivery and promote early cancer detection further support biopsy device adoption in Mexico.

North America Biopsy Device 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 America biopsy device market is highly competitive, with leading players focusing on innovation, strategic acquisitions, and geographic expansion. Each company is analyzed based on overview, key personnel, recent developments, and financial insights.

Key Market Players Include:

Cardinal Health, Inc.

Hologic, Inc.

Danaher Corporation

Becton, Dickinson and Company

Boston Scientific Corporation

Medtronic plc

Olympus Corporation

CONMED Corporation

These companies continue to invest heavily in research and development to introduce next-generation biopsy solutions that enhance diagnostic accuracy and patient safety.

Final Thoughts

The North America biopsy device market is on a strong growth trajectory, supported by rising cancer incidence, technological innovation, and increasing emphasis on early diagnosis and personalized healthcare. With the market projected to grow from US$ 835.19 million in 2024 to US$ 1,303.45 million by 2033, biopsy devices will remain a cornerstone of modern diagnostic medicine.

As healthcare systems evolve, continued advancements in minimally invasive technologies, AI integration, and imaging guidance will further shape the market’s future. Companies that prioritize innovation, affordability, and regulatory compliance are well-positioned to capitalize on emerging opportunities across the North American region.