North America Biopsy Device Market Trends & Forecast 2025–2033

North America Biopsy Device Market Overview

According to Renub Research Latest Report North America Biopsy Device Market was valued at USD 835.19 million in 2024 and is projected to reach USD 1,303.45 million by 2033, growing at a CAGR of 5.07% between 2025 and 2033. The market growth is driven by the rising prevalence of cancer, increasing awareness of early detection, technological innovations in biopsy procedures, and the growing demand for precision medicine and minimally invasive diagnostics.

Biopsy devices are essential tools used to extract tissue or cellular samples from organs such as the breast, lung, prostate, liver, or gastrointestinal tract to diagnose abnormalities, particularly cancer. These devices include needle-based systems, vacuum-assisted devices, biopsy forceps, and guidance systems that utilize advanced imaging technologies like MRI, CT scans, and ultrasound for accuracy and patient comfort.

With healthcare systems increasingly emphasizing early diagnosis and personalized medicine, the adoption of biopsy devices has risen significantly. Additionally, reimbursement policies, technological advancements, and growing healthcare expenditure are creating a favorable environment for market expansion.

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Growth Drivers of the North America Biopsy Device Market

1. Rising Cancer Incidence

The increasing prevalence of cancer in North America is a key driver of the biopsy device market. According to the American Cancer Society, in 2025, the U.S. is expected to witness 2,041,910 new cancer cases and 618,120 cancer-related deaths. Breast cancer remains the most common cancer among women, with an estimated 316,950 new invasive breast cancer cases projected in 2025.

This growing incidence underscores the need for early and precise diagnostic tools. Biopsy devices, particularly minimally invasive and image-guided systems, are critical for early detection, accurate diagnosis, and treatment planning. The rising cancer burden thus fuels demand for advanced biopsy solutions.

2. Technological Advancements

Technological innovation is significantly propelling the North American biopsy device market. Robotic-assisted devices, vacuum-assisted systems, and image-guided biopsy solutions improve accuracy, efficiency, and patient comfort. Integration with AI and digital pathology enhances diagnostic precision and clinical decision-making.

For example, in March 2022, Trivitron Healthcare acquired The Kennedy Company (US), a leading manufacturer of acoustic barriers and radiation protective equipment. This strategic move allowed Trivitron to expand its breast biopsy product offerings and strengthen its market presence in the U.S. Such technological developments are accelerating the adoption of advanced biopsy systems and improving patient outcomes across North America.

3. Increased Awareness of Early Disease Detection

Public health campaigns, educational programs, and institutional initiatives are raising awareness about early cancer detection. Organizations such as the National Breast Cancer Foundation and the American Cancer Society actively promote regular screenings and early diagnosis.

Physicians, guided by updated clinical protocols, are increasingly recommending biopsies for suspicious lesions, further boosting demand for reliable, minimally invasive biopsy devices. This heightened awareness encourages hospitals and diagnostic centers to invest in state-of-the-art biopsy technology, contributing to market growth.

Challenges in the North America Biopsy Device Market

1. High Cost of Advanced Biopsy Devices

Sophisticated biopsy equipment, including robotic-assisted and image-guided systems, involves significant investment in equipment, maintenance, and staff training. Smaller hospitals and diagnostic centers may find these costs prohibitive, limiting access to advanced diagnostics. Financial constraints and variable insurance coverage can also discourage adoption, hindering market expansion.

2. Regulatory and Reimbursement Challenges

Stringent FDA approval processes and complex reimbursement policies pose additional hurdles. Regulatory compliance can delay product launches, and inconsistent reimbursement coverage can limit patient access. These challenges may discourage manufacturers from investing in new innovations, thereby restraining market growth.

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Country-wise Market Analysis

United States

The U.S. is the largest market for biopsy devices in North America, driven by high cancer incidence, advanced healthcare infrastructure, and technological adoption.

Recent Developments: In May 2023, Argon Medical Devices launched the SuperCore Advantage semi-automatic biopsy device, enhancing tissue sampling efficiency. In February 2023, TransMed7 announced the Concorde US ultrasound-guided biopsy system for breast biopsies, highlighting increased innovation and investment.

Market Drivers: High awareness of early detection, strong reimbursement policies, and advanced imaging facilities contribute to robust market growth.

Canada

Canada’s biopsy device market is expanding steadily due to growing cancer incidence, technological innovations, and the adoption of minimally invasive procedures.

Market Trends: Hospitals and diagnostic centers increasingly employ robotic-assisted and image-guided systems to improve precision and patient outcomes.

Drivers: A healthcare system emphasizing personalized medicine and early detection encourages adoption of advanced biopsy solutions for breast, lung, and prostate cancers.

Mexico

Mexico is an emerging market, with growth supported by rising cancer cases, expanding healthcare infrastructure, and increased use of minimally invasive biopsy techniques.

Market Trends: Needle-based biopsies and image-guided devices are increasingly used for early diagnosis and personalized treatment.

Opportunities: International medical device companies are introducing cutting-edge solutions, driving the adoption of biopsy technologies in urban healthcare centers.

Market Segmentation Analysis

By Product

Needle-Based Guns: Widely used for core and fine-needle aspiration biopsies.

Biopsy Guidance Systems: Include image-guided systems for enhanced diagnostic accuracy.

Biopsy Needles: Core tools for tissue sampling in multiple clinical applications.

Biopsy Forceps: Used in endoscopic and gastrointestinal biopsies.

Others: Include vacuum-assisted and surgical biopsy instruments.

By Application

Breast Biopsy: Most prominent application due to high breast cancer prevalence.

Lung Biopsy: Increasing demand due to rising lung cancer cases.

Prostate Biopsy: Driven by awareness of early prostate cancer detection.

Liver Biopsy: Used for hepatocellular carcinoma and chronic liver diseases.

Gastroenterology Biopsy: Expanding for GI cancer detection and treatment monitoring.

Others: Include biopsies for kidney, skin, and soft tissue conditions.

By Technology

CT Scan Guided: High precision in thoracic and abdominal biopsies.

Stereotactic Guided: Widely used for breast biopsies.

Ultrasound Guided: Non-invasive, real-time imaging for multiple organs.

MRI Guided: High-resolution guidance for complex tissue sampling.

Others: Include robotic-assisted and hybrid imaging systems.

By End User

Hospitals: Primary consumers of advanced biopsy devices.

Diagnostic & Imaging Centers: Increasing adoption due to outpatient procedures.

Others: Include specialized clinics and research institutions.

Key Market Trends

Image-Guided Biopsies: Rising preference for ultrasound, CT, and MRI-guided devices for accuracy.

Minimally Invasive Procedures: Patient comfort and faster recovery drive needle-based and vacuum-assisted systems.

Integration with AI and Digital Pathology: Enhances diagnostic accuracy and clinical decision-making.

Precision Medicine: Biopsy devices support tailored treatment strategies in oncology.

Robotic-Assisted Systems: Improve efficiency, tissue yield, and patient safety.

Competitive Landscape and Key Players

Cardinal Health, Inc.: Offers a range of biopsy needles and guidance systems, focusing on innovation and workflow efficiency.

Hologic, Inc.: Leader in breast biopsy devices, emphasizing minimally invasive procedures and imaging integration.

Danaher Corporation: Develops diagnostic and tissue sampling technologies for various cancer types.

Becton, Dickinson and Company: Offers needle-based and automated biopsy systems, focusing on clinical accuracy.

Boston Scientific Corporation: Innovates in image-guided and robotic-assisted biopsy devices.

Medtronic plc.: Provides vacuum-assisted and guided biopsy technologies, supporting personalized medicine initiatives.

Olympus Corporation: Supplies endoscopic biopsy forceps and imaging systems, expanding in gastrointestinal applications.

CONMED Corporation: Specializes in minimally invasive and surgical biopsy instruments, focusing on efficiency and patient safety.

These companies are investing in R&D, strategic acquisitions, and advanced product launches to capitalize on growing demand for accurate, minimally invasive biopsy procedures.

Conclusion

The North America Biopsy Device Market is poised for steady growth from 2025 to 2033, driven by rising cancer incidence, early detection awareness, technological innovation, and adoption of minimally invasive procedures.

While challenges such as high device costs, regulatory hurdles, and reimbursement complexities remain, continued innovation, AI integration, and favorable healthcare policies are expected to overcome these barriers.

With the growing emphasis on precision medicine and early intervention, biopsy devices remain critical tools in oncology and diagnostic workflows, ensuring accurate, efficient, and patient-friendly tissue sampling across North America.

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