US Biopsy Devices Market Research Report By Product Type (Biopsy Guns, Biopsy Guidance System, Biopsy Needles, Biopsy Forceps, Localization Wires, Others), By Application (Breast Biopsy, Prostate Biopsy, Liver Biopsy, Lung Biopsy, Gynecological Biopsy, Others), By Guidance (Ultrasound-Guided Biopsy, Stereotactic Guided Biopsy, MRI-Guided Biopsy, CT Guided Biopsy, Others) and By End User (Hospitals & Clinics, Diagnostic & Imaging Centers, Academic & Research Institutes, Others) - Forecast to 2035

US Biopsy Devices Market Overview

Market Size and Growth

As per MRFR analysis, the US Biopsy Devices Market Size was estimated at 646.8 (USD Million) in 2023. The US Biopsy Devices Market Industry is expected to grow from 688.45 (USD Million) in 2024 to 1,809.23 (USD Million) by 2035. The US Biopsy Devices Market CAGR (growth rate) is expected to be around 9.181% during the forecast period (2025 - 2035).

Key US Biopsy Devices Market Trends Highlighted

The US Biopsy Devices Market is experiencing significant trends driven by technological advancements and a growing population needing diagnostic procedures. Enhanced imaging technologies, including ultrasound, MRI, and CT scans, are improving the precision of biopsy procedures and aiding in the accurate identification of malignant tissues. As the number of cancer cases continues to rise, particularly in the aging population of the US, the demand for these devices is increasing, thus driving market growth. Key market drivers include the increasing incidence of cancer and breast diseases, leading to a heightened focus on early diagnosis and the use of minimally invasive procedures.

The US healthcare system is pivoting towards patient-centered care, which emphasizes rapid and accurate diagnosis with fewer complications, further propelling the adoption of biopsy devices. The rise in research and development activities around biopsy techniques also reflects the ongoing need to innovate in this field. Opportunities in the US market include the expansion of outpatient services and integrating advanced technologies like robotic-assisted biopsy devices, which enhance accuracy and patient comfort. Additionally, the trend towards personalized medicine is creating more demand for precise diagnostic tools, presenting a favorable landscape for new entrants and existing companies to innovate.

Moreover, recent trends in the regulatory landscape, with FDA efforts to streamline the approval process for new biopsy devices and tools, are fostering an environment conducive to market growth. This, combined with rising healthcare expenditures in the US, is leading to more investments in advanced biopsy technologies, solidifying the US as a key player in the global biopsy devices market.

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

US Biopsy Devices Market Drivers

Increasing Incidence of Cancer Cases

The US Biopsy Devices Market Industry is significantly driven by the rising incidence of cancer cases across the nation. According to the American Cancer Society, it is projected that in 2023 alone, approximately 1.9 million new cancer cases will be diagnosed in the United States. This represents a staggering increase over the previous years, suggesting that cancer will continue to be a major health challenge. Given the essential role of biopsy devices in the early diagnosis and treatment of cancer, this trend is expected to propel the demand for such medical devices.

Additionally, organizations like the National Cancer Institute are actively promoting research and development into innovative biopsy techniques, which further supports market growth. The increasing patient population, motivated by heightened awareness and advanced diagnostic technologies, further solidifies the potential of the US Biopsy Devices Market.

Technological Advancements in Biopsy Devices

Technological innovation in biopsy devices is another significant driver for the US Biopsy Devices Market Industry. Recent advancements have led to the development of minimally invasive biopsy techniques, enhancing patient comfort and accuracy in diagnosis. The FDA has recently approved new devices that incorporate robotic assistance and imaging technologies, which improve the precision of biopsy procedures. This increasing adoption of advanced technologies is expected to attract more healthcare providers and patients, consequently boosting market growth.

Institutions such as the Mayo Clinic are actively contributing to the Research and Development of these technologies, promoting higher standards and actualizing more efficient procedures.

Growing Awareness and Educational Initiatives

Heightened awareness regarding the importance of early cancer detection is fueling the US Biopsy Devices Market Industry. Various health organizations, including the Centers for Disease Control and Prevention, have launched several educational initiatives that educate the public about the significance of routine screenings and biopsies. Through campaigns and outreach programs, there is a noticeable uptick in the number of patients opting for these diagnostic procedures.

The emphasis on preventive healthcare is reflected in the increasing participation rates in cancer screening programs, thereby directly impacting the demand for biopsy services. This growing consciousness among the public not only enhances patient outcomes but also underscores the market's prospects for sustained growth.

US Biopsy Devices Market Segment Insights

Biopsy Devices Market Product Type Insights

The US Biopsy Devices Market, focusing on the Product Type segment, reveals a diverse and evolving landscape with several critical components that cater to various clinical needs. Biopsy Guns, recognized for their precision and efficacy, are widely used for obtaining tissue samples and account for a significant portion of the market due to their effectiveness in minimally invasive procedures. Biopsy Guidance Systems enhance the accuracy of biopsies, particularly in complex anatomical areas, and are increasingly adopted to improve patient outcomes and enhance procedural efficiency, which reflects a growing trend towards the integration of advanced imaging technologies within healthcare.

Biopsy Needles, fundamental in tissue sampling, show a steady demand given their essential role across various biopsy methods. These devices are vital for ensuring adequate sample quality and quantity, hence influencing the overall adaptability of biopsy practices in the US healthcare system. Biopsy Forceps, utilized predominantly in gastrointestinal procedures, play an essential role in ensuring targeted biopsies, particularly in diagnosing cancers and other diseases effectively. Localization Wires are pivotal in assisting surgeons during procedures, enhancing the excision of tumors with accuracy, which echoes a broader trend in precision medicine where tailored interventions are prioritized.

The "Others" category encompasses various innovative devices and tools that are emerging within the market, reflecting ongoing advancements and research in biopsy technologies. The market's competitive landscape is further shaped by the increasing incidence of cancer and other chronic diseases in the US, driving demand for reliable and efficient biopsy devices. As these diagnostic tools continue to evolve with technological innovations, the opportunities for improved diagnostics and better patient care in the healthcare industry will expand significantly. The US Biopsy Devices Market, with its various product types, showcases the industry's responsiveness to the changing healthcare needs, indicating a robust growth potential driven by advancements in medical technology and shifting patient requirements in diagnostic procedures.

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

Biopsy Devices Market Application Insights

The Application segment of the US Biopsy Devices Market is witnessing significant evolution driven by advancements in medical technology and increasing cancer prevalence. In particular, Breast Biopsy procedures are essential due to the high incidence of breast cancer in women, making early detection and diagnosis crucial. Prostate Biopsy is equally prominent, especially among older male populations, as prostate cancer remains a leading concern. Liver and Lung Biopsy applications are vital for diagnosing associated malignancies, addressing critical health issues prevalent in the US.

Gynecological Biopsies also play a significant role in women's health, contributing to early detection of various conditions. The segmentation in this market reflects a comprehensive understanding of patient needs and clinical practices, driving innovations aimed at improving diagnostic accuracy and patient outcomes. The US Biopsy Devices Market data indicates a growing focus on minimally invasive procedures, which are generally associated with less recovery time and lower healthcare costs, enhancing patient preferences and market growth. Overall, as healthcare technologies continue to improve, the significance of each application is expected to increase, underscoring the importance of targeted diagnostics in oncology and other medical fields.

Biopsy Devices Market Guidance Insights

The Guidance segment within the US Biopsy Devices Market plays a crucial role in enhancing the accuracy and efficiency of biopsy procedures, which are vital for cancer diagnosis and monitoring. With an increasing prevalence of cancer in the US, there is an evident demand for advanced diagnostic technologies. Various techniques such as Ultrasound-Guided Biopsy and Stereotactic Guided Biopsy are gaining traction due to their ability to provide real-time imaging, facilitating precise needle placement and minimizing patient discomfort.

MRI-Guided Biopsy is significant as it allows for the visualization of soft tissues, aiding in the diagnosis of tumors that may not be detectable through other means. Furthermore, CT Guided Biopsy remains an important method due to its high-resolution images, enabling targeted sampling of tissues in complex anatomical regions. Each of these guidance techniques addresses unique clinical needs, with their growing adoption driven by technological advancements and an increasing number of outpatient procedures, ultimately contributing to improved patient outcomes in the US Biopsy Devices Market landscape. With the rapid evolution of imaging technologies, the Guidance segment will continue to advance, providing quality data and enhancing the overall efficacy of biopsy procedures.

Biopsy Devices Market End User Insights

The End User segment of the US Biopsy Devices Market plays a crucial role in shaping the landscape of healthcare diagnostics in the region. Hospitals and clinics serve as primary providers of biopsy procedures, benefiting from advanced technologies and a continuous influx of patients requiring diagnostic services. Diagnostic and imaging centers, on the other hand, are integral to enhancing the accuracy and efficiency of biopsy procedures by utilizing sophisticated imaging techniques, thus improving patient outcomes and reducing the risks associated with invasive procedures.

Academic and research institutes contribute significantly by driving innovation and developing new biopsy devices through extensive research and clinical trials, fostering advancements in this industry. Furthermore, the 'Others' category embodies various healthcare settings that also utilize biopsy devices, ensuring comprehensive patient care across diverse demographics. The growing prevalence of cancer cases and advancements in minimally invasive biopsy techniques fuel the demand across all End User categories, allowing for early detection and better treatment plans, which are essential for improving survival rates in patients. With the US healthcare system placing a premium on diagnostic accuracy and patient-centered care, the End User segment is positioned to continue its pivotal role in the growth and evolution of the US Biopsy Devices Market.

US Biopsy Devices Market Key Players and Competitive Insights

The US Biopsy Devices Market is characterized by a dynamic competitive landscape marked by innovation, technological advancements, and evolving regulatory standards. Key players are focused on enhancing clinical outcomes through the development of advanced biopsy technologies, such as needle-based, vacuum-assisted, and image-guided biopsy systems, catering to a range of clinical applications from oncology to gastroenterology. As healthcare providers increasingly emphasize minimally invasive procedures, the demand for efficient and precise biopsy devices is on the rise, prompting firms to invest significantly in research and development. The competitive rivalry is further intensified by mergers and acquisitions, strategic partnerships, and collaborations aimed at expanding product portfolios, enhancing market reach, and streamlining operational efficiencies. This competitive environment requires companies to continuously adapt to market needs while ensuring compliance with safety regulations and addressing the challenges of reimbursement policies.

Exact Sciences stands out in the US Biopsy Devices Market with a strong emphasis on innovative products and services designed to improve cancer detection and diagnosis. The company measures its strengths through a commitment to research and development, leading to the introduction of cutting-edge technologies that enhance precision and reliability in biopsy procedures. Exact Sciences has established a notable presence in the market by aligning its strategic initiatives with the growing demand for less invasive testing and improved patient outcomes. Through collaborations with healthcare providers and clinical institutions, the company has fortified its reputation and provided a range of solutions tailored to meet specific clinical needs within the US healthcare system. Its approachable platform for obtaining biopsy samples positions it favorably among healthcare professionals aiming for accurate diagnoses, thereby contributing to its competitive edge.

Hologic is recognized for its significant contributions to the US Biopsy Devices Market with a robust array of key products and services that specialize in women's health, particularly in breast biopsy and tissue sampling techniques. The company has developed a diverse portfolio, including advanced vacuum-assisted biopsy systems, which not only enhance procedural efficiency but also aim to improve clinical outcomes. Hologic's strength lies in its extensive market presence and continuous innovation, supported by strategic mergers and acquisitions that have broadened its capabilities and expanded its technological base. The company's commitment to maintaining high-quality standards and developing comprehensive training programs for healthcare professionals has solidified its positioning in the market. By prioritizing research tailored specifically to the needs of the US healthcare system, Hologic has established itself as a leader in the biopsy devices sector, fostering trust among clinicians and patients alike through reliable and effective diagnostic tools.

Key Companies in the US Biopsy Devices Market Include

• Exact Sciences


• Hologic


• C. R. Bard


• Medtronic


• Boston Scientific


• Abbott Laboratories


• Thermo Fisher Scientific


• Cardinal Health


• Stratec Biomedical


• Siemens Healthineers


• Greiner BioOne


• Fujifilm Holdings


• Biopsy Sciences


• Cook Medical


• Becton Dickinson

US Biopsy Devices Market Industry Developments

The US Biopsy Devices Market has seen significant developments recently, with companies like Exact Sciences and Hologic advancing their research and product offerings. In August 2023, Medtronic announced the launch of a new biopsy device aimed at improving sample accuracy and patient comfort, a move appreciated amidst a growing public focus on minimally invasive procedures. Meanwhile, Abbott Laboratories is making strides in early cancer detection technologies that are poised to revolutionize the market landscape. In September 2023, Boston Scientific expanded its portfolio by acquiring a small oncology-focused firm, which enhances its capabilities within the biopsy device segment.

Growth within the sector has also been bolstered by collaborations among leading entities such as Fujifilm Holdings and Cardinal Health, focusing on integrating digital solutions for more efficient biopsy procedures. Economic factors have driven increased investments in healthcare technologies, which were reflected in the projected growth of the US Biopsy Devices Market valuation, indicating a trend towards greater accessibility and innovation in biopsy solutions over the last few years. The market has continued to evolve with new entries and technological advancements, highlighting its importance in the broader context of healthcare diagnostics in the United States.

US Biopsy Devices Market Segmentation Insights

Biopsy Devices Market Product Type Outlook

• Biopsy Guns


• Biopsy Guidance System


• Biopsy Needles


• Biopsy Forceps


• Localization Wires


• Others

Biopsy Devices Market Application Outlook

• Breast Biopsy


• Prostate Biopsy


• Liver Biopsy


• Lung Biopsy


• Gynecological Biopsy


• Others

Biopsy Devices Market Guidance Outlook

• Ultrasound-Guided Biopsy


• Stereotactic Guided Biopsy


• MRI-Guided Biopsy


• CT Guided Biopsy


• Others

Biopsy Devices Market End User Outlook

• Hospitals & Clinics


• Diagnostic & Imaging Centers


• Academic & Research Institutes


• Others

Report Attribute/Metric Source:	Details
MARKET SIZE 2018	646.8(USD Million)
MARKET SIZE 2024	688.45(USD Million)
MARKET SIZE 2035	1809.23(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)	9.181% (2025 - 2035)
REPORT COVERAGE	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR	2024
MARKET FORECAST PERIOD	2025 - 2035
HISTORICAL DATA	2019 - 2024
MARKET FORECAST UNITS	USD Million
KEY COMPANIES PROFILED	Exact Sciences, Hologic, C. R. Bard, Medtronic, Boston Scientific, Abbott Laboratories, Thermo Fisher Scientific, Cardinal Health, Stratec Biomedical, Siemens Healthineers, Greiner BioOne, Fujifilm Holdings, Biopsy Sciences, Cook Medical, Becton Dickinson
SEGMENTS COVERED	Product Type, Application, Guidance, End User
KEY MARKET OPPORTUNITIES	Minimally invasive procedures expansion, Technological advancements in imaging, Rising cancer prevalence, Increasing demand for outpatient services, Development of automation in biopsies
KEY MARKET DYNAMICS	technological advancements, increasing cancer prevalence, rising healthcare expenditure, growing demand for minimally invasive procedures, supportive reimbursement policies
COUNTRIES COVERED	US