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    US Biopsy Devices Market

    ID: MRFR/MED/18046-HCR
    100 Pages
    Garvit Vyas
    October 2025

    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

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    US Biopsy Devices Market Infographic
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    US Biopsy Devices Market Summary

    The US Biopsy Devices market is projected to grow from 688.5 million USD in 2024 to 1809.2 million USD by 2035, indicating robust growth potential.

    Key Market Trends & Highlights

    US Biopsy Devices Key Trends and Highlights

    • The US Biopsy Devices market is valued at 688.5 million USD in 2024.
    • By 2035, the market is expected to reach 1809.2 million USD, reflecting a substantial increase.
    • The market is anticipated to grow at a compound annual growth rate (CAGR) of 9.18% from 2025 to 2035.
    • Growing adoption of advanced imaging technologies due to increasing prevalence of cancer is a major market driver.

    Market Size & Forecast

    2024 Market Size 688.5 (USD Million)
    2035 Market Size 1809.2 (USD Million)
    CAGR (2025-2035) 9.18%

    Major Players

    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 Trends

    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, Market Research Future Database and Analyst Review

    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, Market Research Future 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.

    Get more detailed insights about 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 market include

    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.

    Market Segmentation

    Biopsy Devices Market End User Outlook

    • Hospitals & Clinics
    • Diagnostic & Imaging Centers
    • Academic & Research Institutes
    • Others

    Biopsy Devices Market Guidance Outlook

    • Ultrasound-Guided Biopsy
    • Stereotactic Guided Biopsy
    • MRI-Guided Biopsy
    • CT Guided Biopsy
    • Others

    Biopsy Devices Market Application Outlook

    • Breast Biopsy
    • Prostate Biopsy
    • Liver Biopsy
    • Lung Biopsy
    • Gynecological Biopsy
    • Others

    Biopsy Devices Market Product Type Outlook

    • Biopsy Guns
    • Biopsy Guidance System
    • Biopsy Needles
    • Biopsy Forceps
    • Localization Wires
    • Others

    Report Scope

    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

    FAQs

    What is the projected market size of the US Biopsy Devices Market in 2024?

    The US Biopsy Devices Market is expected to be valued at 688.45 million USD in 2024.

    What is the expected market value of the US Biopsy Devices Market by 2035?

    By 2035, the market is projected to reach a value of 1809.23 million USD.

    What is the expected compound annual growth rate (CAGR) for the US Biopsy Devices Market between 2025 and 2035?

    The market is expected to grow at a CAGR of 9.181% from 2025 to 2035.

    Which product type is projected to be the largest segment in the US Biopsy Devices Market by 2035?

    By 2035, Biopsy Needles are expected to be the largest segment, valued at 650.0 million USD.

    Which companies are considered major players in the US Biopsy Devices Market?

    Major players include Exact Sciences, Hologic, C. R. Bard, and Medtronic among others.

    What is the expected market size for Biopsy Guns in 2024?

    In 2024, the market size for Biopsy Guns is projected to be 150.0 million USD.

    What valuation is the Biopsy Guidance System anticipated to reach by 2035?

    The Biopsy Guidance System is expected to reach a value of 250.0 million USD by 2035.

    What are the growth drivers for the US Biopsy Devices Market?

    Key growth drivers include advancements in technology and increasing incidence of cancer and metabolic disorders.

    What are some challenges that may impact the US Biopsy Devices Market?

    Challenges may include regulatory hurdles and the high costs associated with biopsy procedures.

    How does the market size for Localization Wires compare between 2024 and 2035?

    Localization Wires are projected to grow from 68.45 million USD in 2024 to 159.23 million USD by 2035.

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