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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

    As per analysis, the US biopsy devices market Size was estimated at 590.1 USD Million in 2024. The US biopsy devices market is projected to grow from 624.5 USD Million in 2025 to 1100.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 5.83% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US biopsy devices market is experiencing robust growth driven by technological advancements and increasing demand for minimally invasive procedures.

    • Technological advancements in biopsy devices are enhancing diagnostic accuracy and patient outcomes.
    • The rising demand for minimally invasive procedures is propelling market growth, particularly in the largest segment of needle biopsy devices.
    • Regulatory support and streamlined approvals are facilitating faster market entry for innovative biopsy technologies.
    • Key market drivers include the increasing incidence of cancer and the growing geriatric population, which are significantly influencing market dynamics.

    Market Size & Forecast

    2024 Market Size 590.1 (USD Million)
    2035 Market Size 1100.0 (USD Million)

    Major Players

    Becton Dickinson and Company (US), Boston Scientific Corporation (US), Medtronic plc (IE), Hologic, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), Siemens Healthineers AG (DE), Fujifilm Holdings Corporation (JP), Cardinal Health, Inc. (US)

    US Biopsy Devices Market Trends

    The biopsy devices market is currently experiencing notable advancements driven by technological innovations and increasing demand for minimally invasive procedures. The integration of automation and robotics into biopsy devices enhances precision and reduces patient discomfort, which appears to be a key factor influencing adoption rates among healthcare providers. Furthermore, the growing prevalence of cancer and other chronic diseases necessitates the use of effective diagnostic tools, thereby propelling the market forward. As healthcare systems evolve, the emphasis on early detection and accurate diagnosis is likely to further stimulate growth in this sector. In addition, regulatory bodies are actively working to streamline the approval processes for new biopsy devices, which may encourage innovation and expedite the introduction of advanced products into the market. The focus on patient safety and improved outcomes is paramount, leading to the development of devices that not only meet clinical needs but also align with patient preferences. Overall, the biopsy devices market is poised for continued expansion, driven by technological advancements, regulatory support, and an increasing emphasis on early diagnosis and treatment options.

    Technological Advancements

    The biopsy devices market is witnessing rapid technological advancements, particularly in imaging and automation. Innovations such as ultrasound-guided biopsies and robotic-assisted systems enhance accuracy and efficiency, potentially leading to better patient outcomes. These developments are likely to attract more healthcare facilities to adopt modern biopsy techniques.

    Rising Demand for Minimally Invasive Procedures

    There is a growing trend towards minimally invasive procedures within the biopsy devices market. Patients and healthcare providers alike prefer techniques that reduce recovery time and minimize discomfort. This shift is driving the development of new devices that align with these preferences, suggesting a potential for increased market growth.

    Regulatory Support and Streamlined Approvals

    Regulatory bodies are increasingly focused on facilitating the approval process for new biopsy devices. This support may encourage innovation and the introduction of advanced technologies into the market. As regulations evolve, the potential for rapid deployment of new products could significantly impact the biopsy devices market.

    US Biopsy Devices Market Drivers

    Growing Geriatric Population

    The growing geriatric population in the United States is a significant driver for the biopsy devices market. As individuals age, the risk of developing various health conditions, including cancer, increases. The U.S. Census Bureau projects that by 2030, all baby boomers will be older than 65, leading to a substantial rise in healthcare needs. This demographic shift is likely to result in an increased demand for diagnostic procedures, including biopsies, to manage age-related diseases effectively. Consequently, the biopsy devices market is expected to expand as healthcare systems adapt to cater to the needs of an aging population, ensuring timely and accurate diagnoses through advanced biopsy techniques.

    Rising Healthcare Expenditure

    Rising healthcare expenditure in the United States is another critical driver for the biopsy devices market. With healthcare spending projected to reach $6 trillion by 2027, there is a growing emphasis on investing in advanced medical technologies, including biopsy devices. This increase in funding allows healthcare facilities to acquire state-of-the-art equipment and improve diagnostic capabilities. Furthermore, as insurance coverage expands and more patients gain access to healthcare services, the demand for biopsy procedures is likely to rise. The biopsy devices market stands to benefit from this trend, as increased healthcare expenditure facilitates the adoption of innovative biopsy technologies, ultimately enhancing patient care and outcomes.

    Increasing Incidence of Cancer

    The rising incidence of cancer in the United States is a primary driver for the biopsy devices market. According to the American Cancer Society, approximately 1.9 million new cancer cases are expected to be diagnosed in 2025. This alarming trend necessitates the use of biopsy devices for accurate diagnosis and treatment planning. As healthcare providers seek to improve patient outcomes, the demand for advanced biopsy techniques is likely to increase. The biopsy devices market is thus positioned to benefit from this growing need, as early detection through biopsies can significantly enhance survival rates. Furthermore, the increasing awareness of cancer screening programs is expected to further propel the market, as more individuals seek diagnostic procedures to identify potential malignancies at an earlier stage.

    Enhanced Awareness and Education

    Enhanced awareness and education regarding the importance of early cancer detection are driving the biopsy devices market. Public health campaigns and educational initiatives have significantly increased knowledge about the benefits of regular screenings and biopsies. As individuals become more informed about their health, they are more likely to seek diagnostic procedures, leading to a higher demand for biopsy devices. This trend is particularly evident in high-risk populations, where proactive health management is crucial. The biopsy devices market is thus experiencing growth as healthcare providers respond to this heightened awareness by offering more accessible and advanced biopsy options, ultimately contributing to improved patient outcomes.

    Technological Innovations in Biopsy Devices

    Technological innovations are transforming the biopsy devices market, leading to enhanced accuracy and efficiency in diagnostic procedures. Recent advancements include the development of automated biopsy systems and imaging-guided techniques, which improve the precision of tissue sampling. The integration of artificial intelligence in imaging analysis is also gaining traction, potentially increasing the reliability of biopsy results. As a result, healthcare providers are increasingly adopting these advanced technologies, which could lead to a projected market growth of approximately 8% annually over the next five years. The biopsy devices market is thus experiencing a paradigm shift, as these innovations not only streamline the biopsy process but also enhance patient safety and comfort.

    Market Segment Insights

    By Product Type: Biopsy Guns (Largest) vs. Biopsy Guidance System (Fastest-Growing)

    The US biopsy devices market exhibits diverse segmentation within the product types, with biopsy guns commanding the largest market share owing to their prominent application in various biopsy procedures. Following behind, biopsy needles and biopsy forceps contribute significantly but do not match the widespread use and acceptance of biopsy guns. Biopsy guidance systems, although smaller in share, show promising growth trends as they enhance the precision and effectiveness of biopsy procedures. Growth trends in the US biopsy devices market are largely driven by the increasing prevalence of cancer and the subsequent demand for accurate diagnostic tools. Innovations in technology, particularly in biopsy guidance systems, are paving the way for their rapid adoption. The drive towards minimally invasive procedures and enhanced patient outcomes are primary factors propelling the acceptance and growth of emerging and established products alike, reshaping the competitive landscape.

    Biopsy Guns (Dominant) vs. Biopsy Guidance Systems (Emerging)

    Biopsy guns have established themselves as the dominant force in the US biopsy devices market due to their reliability and efficiency in various diagnostic biopsies. They are engineered for precise tissue sampling, catering to a broad range of clinical practices. In contrast, biopsy guidance systems represent the emerging segment, offering advanced imaging technology and navigation capabilities to ensure accurate biopsy execution. This technological advancement addresses the increased demand for accuracy in diagnostics, enabling healthcare providers to improve patient outcomes. Both segments play crucial roles in the market, with biopsy guns leading in traditional applications while guidance systems are gaining traction as essential tools in modern biopsy procedures.

    By Application: Breast Biopsy (Largest) vs. Prostate Biopsy (Fastest-Growing)

    In the US biopsy devices market, breast biopsy holds the largest share, reflecting its significance in early cancer detection and diagnosis. Following closely are prostate biopsies, liver biopsies, and lung biopsies, with each segment contributing to the diverse applications of biopsy devices. Gynecological biopsies and others also represent crucial segments, although they hold comparatively smaller market shares. Overall, the distribution showcases a robust segmentation driven by disease prevalence and technological advancements. Growth trends indicate a steady increase in prostate biopsy devices, driven by rising incidences of prostate cancer and heightened awareness of male health issues. Advancements in imaging technology and needle biopsy techniques enhance the accuracy and safety of these procedures. Breast biopsies will continue to dominate, propelled by ongoing research and innovations that refine diagnostic capabilities. Furthermore, an aging population is expected to drive demand across all segments as the need for early detection increases.

    Breast Biopsy (Dominant) vs. Prostate Biopsy (Emerging)

    Breast biopsy plays a dominant role in the US biopsy devices market, pivotal for early intervention in breast cancer cases. It benefits from solid clinical guidelines and continuous technological upgrades, making it a preferred choice among healthcare professionals. Its wide acceptance is reflected in the consistent demand for various types of breast biopsy devices, including vacuum-assisted and core needle biopsy tools. Conversely, prostate biopsy, as an emerging segment, is witnessing rapid growth due to the increasing prevalence of prostate cancer and enhanced awareness of men's health. Innovations in transrectal and transperineal biopsy techniques are improving outcomes, contributing to its status as the fastest-growing application. This dynamic creates a competitive landscape, with both segments evolving to meet the changing needs of healthcare providers and patients.

    By Guidance Technique: Ultrasound-guided biopsy (Largest) vs. MRI-guided biopsy (Fastest-Growing)

    In the US biopsy devices market, the ultrasound-guided biopsy segment holds the largest market share due to its widespread adoption across various healthcare settings. This technique is favored for its real-time imaging capabilities, allowing for accurate needle placement. Meanwhile, MRI-guided biopsies, while currently smaller in share, are rapidly gaining traction as advancements in imaging technology improve their accessibility and efficacy. Growth trends indicate a robust increase in demand for minimally invasive procedures, with healthcare providers increasingly favoring techniques that reduce patient recovery time and enhance diagnostic accuracy. The rising prevalence of cancer and other conditions necessitating biopsies further drives the market. Additionally, innovations in imaging technologies bolster the growth of MRI-guided biopsies, making them a significant focus for future market development.

    Ultrasound-guided biopsy (Dominant) vs. MRI-guided biopsy (Emerging)

    Ultrasound-guided biopsy remains the dominant technique in the US biopsy devices market, mainly due to its cost-effectiveness and efficiency in various clinical applications. It is especially prevalent in guiding needle insertion for breast, prostate, and thyroid biopsies, relying on real-time ultrasound imaging. In contrast, MRI-guided biopsy is emerging as a key player, particularly in cases where other techniques may fall short, such as in accessing lesions located in difficult-to-reach areas. This method is distinguished by its high-resolution imaging capabilities, which enable precise targeting of tissue for sampling. As adoption grows, particularly in specialized oncology settings, MRI-guided biopsies are anticipated to gain a more significant foothold in the market.

    By End User: Hospitals & Clinics (Largest) vs. Diagnostic & Imaging Centers (Fastest-Growing)

    In the US biopsy devices market, hospitals and clinics hold the largest market share, driven by the increasing prevalence of chronic diseases and the rising demand for diagnostic procedures. This segment benefits from advanced healthcare infrastructure and a high patient flow, resulting in significant utilization of biopsy devices. In contrast, diagnostic and imaging centers are experiencing rapid growth as these facilities expand their service offerings and adopt cutting-edge technologies. This growth is particularly fueled by a preference for outpatient procedures and advancements in imaging techniques. The growth trends for these segments indicate a robust competition and innovation landscape. The hospital and clinic segment's dominance is supported by strong operational capabilities, while diagnostic and imaging centers are emerging as vital players due to their specialized services and technological advancements. Factors such as regulatory support, reimbursement policies, and increasing patient awareness are further driving the traction within both segments.

    Hospitals & Clinics (Dominant) vs. Diagnostic & Imaging Centers (Emerging)

    The hospitals and clinics segment is characterized by established networks, comprehensive care models, and a diverse patient demographic, which fosters a consistent demand for biopsy procedures. This dominance is underscored by significant investments in infrastructure and training to enhance procedural efficiency. On the other hand, diagnostic and imaging centers are rapidly advancing by incorporating innovative diagnostic tools and specialized services tailored to patient needs. Their agility in adopting new technologies, alongside a growing preference for less invasive procedures among patients, positions them as an emerging force in the market. Together, these segments reflect a dynamic interplay of established and innovative care paradigms that are shaping the landscape of biopsy devices.

    Get more detailed insights about US Biopsy Devices Market

    Key Players and Competitive Insights

    The biopsy devices market is characterized by a dynamic competitive landscape, driven by technological advancements and increasing demand for minimally invasive procedures. Key players such as Becton Dickinson and Company (US), Hologic, Inc. (US), and Thermo Fisher Scientific Inc. (US) are strategically positioned to leverage innovation and expand their market presence. Becton Dickinson and Company (US) focuses on enhancing its product portfolio through continuous research and development, while Hologic, Inc. (US) emphasizes its commitment to women's health, particularly in breast cancer diagnostics. Thermo Fisher Scientific Inc. (US) appears to be concentrating on integrating advanced technologies into its biopsy solutions, thereby shaping a competitive environment that prioritizes innovation and specialized offerings.

    In terms of business tactics, companies are increasingly localizing manufacturing to reduce lead times and optimize supply chains. The market structure is moderately fragmented, with several players vying for market share. This fragmentation allows for diverse offerings, yet the collective influence of major companies like Abbott Laboratories (US) and Siemens Healthineers AG (DE) is significant, as they drive trends and set benchmarks for quality and innovation.

    In October 2025, Hologic, Inc. (US) announced the launch of a new biopsy device designed to improve accuracy in breast cancer detection. This strategic move is likely to enhance Hologic's competitive edge by addressing the growing demand for precise diagnostic tools. The introduction of this device not only reinforces Hologic's commitment to innovation but also aligns with the increasing focus on early detection and personalized medicine.

    In September 2025, Thermo Fisher Scientific Inc. (US) expanded its partnership with a leading healthcare provider to enhance the distribution of its biopsy devices across the US. This collaboration is expected to streamline access to advanced diagnostic tools, thereby potentially increasing market penetration. Such partnerships may also facilitate the integration of cutting-edge technologies, further solidifying Thermo Fisher's position in the market.

    In August 2025, Becton Dickinson and Company (US) completed the acquisition of a smaller biotech firm specializing in biopsy technologies. This acquisition is indicative of Becton Dickinson's strategy to bolster its capabilities in the biopsy segment, allowing for a more comprehensive product offering. The integration of innovative technologies from the acquired firm could enhance Becton Dickinson's competitive positioning and expand its market reach.

    As of November 2025, current trends in the biopsy devices market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in diagnostic processes. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise. The competitive differentiation is likely to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability. This shift suggests that companies that prioritize R&D and strategic partnerships will be better positioned to thrive in the evolving market.

    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.

    Future Outlook

    US Biopsy Devices Market Future Outlook

    The biopsy devices market is projected to grow at a 5.83% CAGR from 2024 to 2035, driven by technological advancements, increasing cancer prevalence, and rising demand for minimally invasive procedures.

    New opportunities lie in:

    • Development of AI-driven diagnostic tools for enhanced accuracy
    • Expansion of telemedicine services for remote biopsy consultations
    • Investment in biodegradable biopsy devices to meet sustainability goals

    By 2035, the market is expected to achieve substantial growth, driven by innovation and evolving healthcare needs.

    Market Segmentation

    US Biopsy Devices Market End User Outlook

    • hospitals & clinics
    • diagnostic & imaging centers
    • academic & research institutes
    • others

    US Biopsy Devices Market Application Outlook

    • breast biopsy
    • prostate biopsy
    • liver biopsy
    • lung biopsy
    • gynecological biopsy
    • others

    US Biopsy Devices Market Product Type Outlook

    • biopsy guns
    • biopsy guidance system
    • biopsy needles
    • biopsy forceps
    • localization wires
    • others

    US Biopsy Devices Market Guidance Technique Outlook

    • ultrasound-guided biopsy
    • stereotactic guided biopsy
    • MRI-guided biopsy
    • CT guided biopsy
    • others

    Report Scope

    MARKET SIZE 2024 590.1(USD Million)
    MARKET SIZE 2025 624.5(USD Million)
    MARKET SIZE 2035 1100.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 5.83% (2024 - 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 Becton Dickinson and Company (US), Boston Scientific Corporation (US), Medtronic plc (IE), Hologic, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), Siemens Healthineers AG (DE), Fujifilm Holdings Corporation (JP), Cardinal Health, Inc. (US)
    Segments Covered Product Type, Application, Guidance Technique, End User
    Key Market Opportunities Advancements in minimally invasive techniques enhance growth potential in the biopsy devices market.
    Key Market Dynamics Technological advancements and regulatory changes drive innovation and competition in the biopsy devices market.
    Countries Covered US

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    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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