The North America Biopsy Device Market is expected to reach US$ 1.30 billion by 2033 from US$ 835.19 million in 2024, with a CAGR of 5.07% from 2025 to 2033. Increasing rates of cancer, increased awareness regarding early detection, development in imaging technology, minimally invasive treatments, an aging population, positive reimbursement policies, and increased demands for precision medicine and tailored healthcare solutions are the primary drivers of the North American biopsy device market.
The North American market for biopsy devices is growing because of several significant factors. The demand for early and accurate diagnosis is increasing with the increasing incidence of cancer, particularly breast, lung, and prostate cancers. Patient comfort and precision are improved by technological advances such as image-guided and minimally invasive biopsy procedures. Broader utilization of biopsy devices is facilitated by favorable reimbursement practices and increased healthcare expenditure. Growth in the market is also facilitated by the rise of personalized treatment, an increasing population with an age-related risk of chronic disease, and rising awareness of early detection of diseases. Diagnostic performance and growth in the market are also promoted by continued innovation and interfacing with AI and digital pathology.
North America Biopsy Device Industry Overview
A biopsy device is a medical tool used to take samples of tissues from the body for examination, typically to discover abnormalities such as cancer. Doctors are able to obtain tissue or cells from organs such as the liver, lungs, prostate, or breast through the use of these devices. Examples of biopsy device types include vacuum-assisted devices, surgical biopsy devices, and needle-based systems (core needle, fine needle aspiration). To ensure accuracy, they are often guided by imaging techniques like MRI, CT, or ultrasound. In a minimally invasive and efficient manner, biopsy devices play a crucial role in early disease detection, treatment planning, and monitoring of therapy progress.The North American market for biopsy devices is growing because of several significant factors. The demand for early and accurate diagnosis is increasing with the increasing incidence of cancer, particularly breast, lung, and prostate cancers. Patient comfort and precision are improved by technological advances such as image-guided and minimally invasive biopsy procedures. Broader utilization of biopsy devices is facilitated by favorable reimbursement practices and increased healthcare expenditure. Growth in the market is also facilitated by the rise of personalized treatment, an increasing population with an age-related risk of chronic disease, and rising awareness of early detection of diseases. Diagnostic performance and growth in the market are also promoted by continued innovation and interfacing with AI and digital pathology.
Growth Drivers for the North America Biopsy Device Market
Rising Cancer Incidence
The demand for biopsy tools is significantly spurred by the growing rate of cancer in North America. The American Cancer Society suggests that there would be 618,120 deaths and 2,041,910 new cases of cancer in the US during the year 2025. Approximately 30% of the total new cancers occurring in females each year are breast cancers and, therefore, it is the most common disorder among women. It is predicted to see 316,950 new female invasive breast cancer cases in 2025. All this growth in cancer cases highlights the significance of biopsy devices in detecting cancer and planning therapy early on. The North American market for biopsy devices is on the rise due to biopsy procedures, specifically image-guided and minimally invasive, being essential for accurate detection of cancer.Technological Advancements
The North American market for biopsy devices is growing largely as a result of technological advancements that make diagnostic procedures more accurate, efficient, and less invasive. Examples of advances include robotic biopsy tools, vacuum-assisted devices, and image-guided biopsy systems, which have significantly improved accuracy and reduced patient pain. AI and digital pathology combined further enhance clinical decision-making and diagnostic capabilities. Trivitron Healthcare acquired all of The Kennedy Company (US), a renowned manufacturer of acoustic barriers and radiation protective equipment, in March 2022. Trivitron can offer Kennedy's customers state-of-the-art breast biopsy products and expand its market share in the United States through this strategic move. These acquisitions underscore the greater emphasis on market growth and technological innovation, which is accelerating the adoption of advanced biopsy solutions in North American healthcare settings. These advancements drive market growth and directly enhance patient outcomes.Increased Awareness
The North American biopsy device market is being fueled largely by increased awareness of the importance of early disease detection, particularly for cancer. Individuals are increasingly empowered to get immediate medical check-ups due to public health initiatives, educational initiatives, and accessibility to medical information. More biopsy procedures are conducted due to institutions such as the National Breast Cancer Foundation and the American Cancer Society encouraging early detection and regular check-ups. Through the aid of evolving clinical guidelines, physicians are also getting more active in recommending biopsies for uncertain results. Thus, there is growing demand for reliable and least invasive biopsy devices. Such greater awareness inspires the adoption of state-of-the-art diagnostic technology across healthcare systems and boosts the outcome of early intervention.Challenges in the North America Biopsy Device Market
High Cost of Advanced Biopsy Devices
The high price of sophisticated biopsy equipment is a major deterrent to their broad use in North America. Robotic-assisted and image-guided biopsy technologies, for example, demand a large equipment, maintenance, and training expenditure. These instruments are frequently out of reach for smaller hospitals and diagnostic facilities, which restricts access to state-of-the-art diagnostic services. Furthermore, financial limitations and uneven payment guidelines may deter medical professionals from implementing more advanced, effective biopsy methods.Regulatory and Reimbursement Challenges
Securing reimbursement and navigating intricate regulatory constraints are two major obstacles in the North American biopsy device business. The FDA's stringent approval procedures for new gadgets may cause a delay in their release onto the market. Furthermore, different devices have different reimbursement rules; some have limited coverage, while others have delayed reimbursement. These concerns can limit market growth and accessibility by discouraging manufacturers from investing in innovation and making it more difficult for healthcare providers to adopt the newest technologies.United States Biopsy Device Market
The growing incidence of cancer, improvements in minimally invasive techniques, and the need for early diagnosis are driving growth in the U.S. biopsy instrument industry. The SuperCore Advantage semi-automatic biopsy equipment, a soft tissue biopsy product from Argon Medical Devices, was unveiled in May 2023. It increases tissue sample capacity, hence increasing diagnostic efficiency and accuracy. TransMed7 also revealed intentions to launch the Concorde US ultrasound-guided biopsy devices in February 2023. The purpose of these vacuum-assisted, automated tools is to enhance breast biopsy techniques. The U.S. biopsy device market is expanding due to these advancements and a robust healthcare system, making it a vibrant and competitive area of the medical business.Canada Biopsy Device Market
The rising incidence of cancer, improvements in diagnostic technology, and a move toward less intrusive procedures are all contributing factors to the growth of the Canadian biopsy instrument market. Innovations that offer greater precision and better patient outcomes, like robotic-assisted devices and image-guided biopsy systems, are helping the industry. Furthermore, the need for biopsy tools is growing for a number of diseases, such as lung, prostate, and breast cancers. Hospitals and diagnostic facilities in Canada are increasingly using modern biopsy technology due to the country's healthcare system, which places a high priority on early detection and individualized medicine.Mexico Biopsy Device Market
The market for biopsy devices in Mexico is expanding due to factors such rising cancer rates, improvements in diagnostic tools, and a move toward less intrusive techniques. The use of a variety of biopsy procedures, such as needle-based biopsies and image-guided devices, has increased due to the growing need for early cancer identification and individualized therapy. The industry also benefits from the availability of sophisticated biopsy tools that can be used to treat a variety of diseases, such as lung, prostate, and breast cancer. By launching cutting-edge solutions, major international medical device businesses are significantly contributing to the market's growth. The extensive usage of these diagnostic instruments is also a result of advancements in Mexico's healthcare system.North America Biopsy Device Market Segments:
Product
- Needle-Based Guns
- Biopsy Guidance Systems
- Biopsy Needles
- Biopsy Forceps
- Others
Application
- Breast Biopsy
- Lung Biopsy
- Prostate Biospy
- Liver Biopsy
- Gastroenterology Biopsy
- Others
Technology
- CT Scan
- Stereotactic Guided
- Ultrasound Guided
- MRI Guided
- Others
End User
- Hospitals
- Diagnostic & Imaging Center
- Others
Countries
- Canada
- United States
- Mexico
- Rest of North America
All companies have been covered from 4 viewpoints:
- Overview
- Key Persons
- Recent Developments
- Financial Insights
Key Players Analyzed
- Cardinal Health, Inc.
- Hologic, Inc.
- Danaher Corporation
- Becton, Dickinson and Company
- Boston Scientific Corporation
- Medtronic plc.
- Olympus Corporation
- CONMED Corporation
Table of Contents
1. Introduction3. Executive Summary
2. Research & Methodology
4. Market Dynamics
5. North America Biopsy Devices Market
6. North America Biopsy Devices Market Share Analysis
7. Product
8. Application
9. Technology
10. End User
11. Countries
12. Porter’s Five Forces Analysis
13. SWOT Analysis
14. Key Players Analysis
Companies Mentioned
• Cardinal Health, Inc.• Hologic, Inc.
• Danaher Corporation
• Becton, Dickinson and Company
• Boston Scientific Corporation
• Medtronic plc.
• Olympus Corporation
• CONMED Corporation
Methodology
In this report, for analyzing the future trends for the studied market during the forecast period, the publisher has incorporated rigorous statistical and econometric methods, further scrutinized by secondary, primary sources and by in-house experts, supported through their extensive data intelligence repository. The market is studied holistically from both demand and supply-side perspectives. This is carried out to analyze both end-user and producer behavior patterns, in the review period, which affects price, demand and consumption trends. As the study demands to analyze the long-term nature of the market, the identification of factors influencing the market is based on the fundamentality of the study market.
Through secondary and primary researches, which largely include interviews with industry participants, reliable statistics, and regional intelligence, are identified and are transformed to quantitative data through data extraction, and further applied for inferential purposes. The publisher's in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of their recommendations and advice.
Primary Research
The primary purpose of this phase is to extract qualitative information regarding the market from the key industry leaders. The primary research efforts include reaching out to participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions. The publisher also established professional corporate relations with various companies that allow us greater flexibility for reaching out to industry participants and commentators for interviews and discussions, fulfilling the following functions:
- Validates and improves the data quality and strengthens research proceeds
- Further develop the analyst team’s market understanding and expertise
- Supplies authentic information about market size, share, growth, and forecast
The researcher's primary research interview and discussion panels are typically composed of the most experienced industry members. These participants include, however, are not limited to:
- Chief executives and VPs of leading corporations specific to the industry
- Product and sales managers or country heads; channel partners and top level distributors; banking, investment, and valuation experts
- Key opinion leaders (KOLs)
Secondary Research
The publisher refers to a broad array of industry sources for their secondary research, which typically includes, however, is not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Patent and regulatory databases for understanding of technical & legal developments
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic new articles, webcasts, and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | May 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 835.19 Million |
| Forecasted Market Value ( USD | $ 1300 Million |
| Compound Annual Growth Rate | 5.0% |
| Regions Covered | North America |
| No. of Companies Mentioned | 8 |
