Image-Guided Biopsy Market By Imaging Modality (Ultrasound-Guided Biopsy, CT-Guided Biopsy, MRI-Guided Biopsy, Mammography/Stereotactic-Guided Biopsy, PET/Other Image-Guided Biopsy); By Biopsy Type (Core Needle Biopsy, Fine Needle Aspiration, Vacuum-Assisted Biopsy, Surgical/Excisional Biopsy); By Component (Imaging Systems, Biopsy Needles, Guidance Systems, Software and Navigation Platforms, Accessories and Consumables); By Application (Breast Cancer Diagnosis, Lung Cancer Diagnosis, Prostate Cancer Diagnosis, Liver Lesion Diagnosis, Kidney and Other Organ Lesion Diagnosis, Other Cancer and Non-Cancer Applications); By End User (Hospitals, Diagnostic Imaging Centers, Ambulatory Surgical Centers, Specialty Clinics, Research and Academic Institutes); By Geography, Segment Revenue Estimation, Forecast, 2026–2032

How Large Is the Image-Guided Biopsy Market and What Clinical and Technology Developments Are Shaping Its Future?  – (Updated On: 22-Aug-2026)

The Global Image-Guided Biopsy Market was valued at USD 1.27 billion in 2025 and is projected to reach USD 2.01 billion by 2032, expanding at a CAGR of 6.8% during 2026–2032, according to Strategic Market Research.

 

Image-Guided Biopsy Summary

Image-guided biopsy is a minimally invasive diagnostic procedure that combines real-time imaging technologies such as ultrasound, CT, or MRI with needle-based tissue sampling to accurately diagnose abnormal lesions. It enables physicians to target deep or difficult-to-access areas, including breast masses, liver lesions, lung nodules, prostate abnormalities, thyroid nodules, lymph nodes, kidney masses, and bone lesions, while avoiding open surgical procedures.

The procedure helps differentiate benign and malignant conditions, identify infections or inflammatory changes, and guide personalized treatment decisions. Ultrasound-guided biopsy remains widely used for superficial lesions, CT guidance supports deeper anatomical targets, and MRI provides advanced soft-tissue visualization for complex applications.

FDA-cleared technologies include ultrasound-guided biopsy systems, MRI-guided vacuum-assisted breast biopsy platforms, and fusion navigation solutions such as Philips UroNav, which combines pre-biopsy MRI images with real-time ultrasound guidance for targeted prostate biopsy procedures. These systems improve lesion targeting and workflow efficiency by integrating imaging, navigation, and needle guidance.

The technology pipeline is focused on AI-assisted lesion analysis, robotic needle targeting, molecular imaging guidance, and augmented reality navigation. These emerging innovations aim to improve biopsy accuracy, reduce operator variability, and enable more precise diagnosis of complex lesions. As imaging intelligence advances, image-guided biopsy is moving toward increasingly automated and personalized diagnostic procedures.

Image-guided needle biopsy has become a widely adopted diagnostic procedure across hospitals, cancer centers, and specialized imaging facilities worldwide. In the United States, more than 4 million needle biopsy procedures are performed annually, with breast, prostate, lung, liver, thyroid, and renal evaluations representing major clinical applications. Breast biopsy represents one of the largest segments, with approximately 70% of procedures using imaging guidance such as ultrasound or stereotactic techniques.

Globally, image-guided tissue sampling accounts for an estimated 18 million procedures each year. The increasing global cancer burden, with more than 19 million new cancer cases annually, continues to drive demand for accurate tissue diagnosis. Since many cancer diagnoses require pathological confirmation, minimally invasive image-guided biopsy approaches have become a standard diagnostic pathway, particularly in tertiary care hospitals. Ultrasound remains the most commonly used guidance method due to real-time visualization, accessibility, and absence of radiation exposure.

 

Comprehensive Breakdown of Market Structure, Segmentation Insights, and Growth Dynamics in the Image-Guided Biopsy Market

By Imaging Modality

• Ultrasound-Guided Biopsy: Leads modality revenue with a 34.0% share and remains central to breast, thyroid, liver, lymph-node, and superficial soft-tissue procedures.

• CT-Guided Biopsy: Holds 26.0% and remains important for deep lung, bone, abdominal, pelvic, and retroperitoneal targets.

• MRI-Guided Biopsy: Holds 15.0% and records the fastest modality CAGR of 8.2% as high-contrast targeting expands in breast and complex tissue procedures.

• Mammography/Stereotactic-Guided Biopsy: Represents 17.0% and is closely tied to nonpalpable breast lesions, calcifications, and mammographic abnormalities.

• PET/Other Image-Guided Biopsy: Accounts for 8.0% and supports specialized fusion-guided and metabolically targeted procedures.

 

By Biopsy Type

• Core Needle Biopsy: Leads with 43.0% because larger tissue cores support histology, immunohistochemistry, and molecular analysis.

• Fine Needle Aspiration: Represents 24.0% and remains relevant to thyroid, lymph-node, and other cytology-based procedures.

• Vacuum-Assisted Biopsy: Holds 21.0% and records the fastest biopsy-type CAGR of 8.4%, supported by larger sample volumes and breast-imaging integration.

• Surgical/Excisional Biopsy: Accounts for 12.0% and remains necessary where percutaneous tissue sampling is inconclusive or complete excision is clinically preferred.

 

By Component

• Imaging Systems: Lead component revenue with a 35.0% share because ultrasound, CT, MRI, and mammography infrastructure underpins procedure delivery.

• Biopsy Needles: Represent 25.0% and provide recurring disposable revenue across high-volume procedural settings.

• Guidance Systems: Hold 16.0% as targeting, registration, and positioning technologies become more integrated with biopsy procedures.

• Software & Navigation Platforms: Represent 14.0% and lead component growth at a 9.1% CAGR through fusion imaging, robotic navigation, and procedure planning.

• Accessories & Consumables: Account for 10.0%, including coaxial introducers, markers, localization products, and other procedure-specific disposables.

 

By Application

• Breast Cancer Diagnosis: Leads applications with 31.0% because multiple imaging modalities and biopsy technologies are used across the breast diagnostic pathway.

• Lung Cancer Diagnosis: Represents 22.0% as CT-guided biopsy and robotic bronchoscopy address pulmonary nodules across different anatomical locations.

• Prostate Cancer Diagnosis: Holds 17.0% and records an 8.2% CAGR as MRI-targeted and MRI/ultrasound fusion procedures expand.

• Liver Lesion Diagnosis: Accounts for 12.0%, with ultrasound and CT selected according to lesion depth and visibility.

• Kidney and Other Organ Lesion Diagnosis: Represents 9.0% and relies primarily on percutaneous image-guided tissue acquisition.

• Other Cancer and Non-Cancer Applications: Hold 9.0% across lymph-node, musculoskeletal, inflammatory, and other tissue-sampling indications.

 

By End User

• Hospitals: Lead with 48.0% because they combine imaging equipment, interventional radiology, pathology, surgery, and oncology services.

• Diagnostic Imaging Centers: Represent 23.0% and benefit from outpatient image-guided diagnostic workflows.

• Ambulatory Surgical Centers: Hold 14.0% and record the fastest end-user CAGR of 8.1% as appropriate minimally invasive procedures move outside inpatient settings.

• Specialty Clinics: Account for 10.0%, particularly across breast and urology-focused diagnostic services.

• Research and Academic Institutes: Represent 5.0% and remain important in evaluating fusion imaging, robotics, advanced tissue acquisition, and translational oncology applications.

 

Transforming Diagnostic Precision: The Evolving Competitive Landscape of Imaging Modalities in Image-Guided Biopsy

Ultrasound-guided biopsy accounted for 34.0% of the Image-Guided Biopsy Market, representing USD 431.8 million in 2025, and is projected to expand at a CAGR of 6.5% during 2026–2032. Real-time needle visualization, absence of ionizing radiation, comparatively low infrastructure requirements, and wide application across breast, thyroid, lymph nodes, liver, and soft tissue support its leading position. A 2024 review reported diagnostic accuracy of 88%–95.1% for ultrasound-guided liver biopsy, 87%–93% for soft-tissue sarcoma biopsy, and approximately 94%–95% for suspicious lymph-node sampling. Products such as Merit Medical's TEMNO devices incorporate echogenic markings to improve ultrasound visibility, while Hologic's Celero and Sertera products are designed for ultrasound-guided breast biopsy.

CT-guided biopsy represented 26.0% of the market, or USD 330.2 million in 2025, and is projected to grow at a CAGR of 6.9%. CT is particularly valuable for pulmonary, osseous, abdominal, pelvic, and other deep targets where ultrasound does not provide a reliable acoustic window. Published evidence places CT-guided lung biopsy diagnostic accuracy at approximately 71%–95%, liver biopsy at 80%–95%, and bone biopsy at 58%–94%, although performance varies with lesion location and operator skill. Merit Medical's TEMNO portfolio includes CT-compatible depth markings, while coaxial systems from companies such as BD support repeated tissue acquisition through a single access tract.

MRI-guided biopsy generated 15.0% of the Image-Guided Biopsy Market, representing USD 190.5 million in 2025, and is projected to expand at the fastest modality CAGR of 8.2%. MRI offers high soft-tissue contrast and is particularly useful for lesions that are poorly visualized using ultrasound or conventional mammography. Its commercial role also extends into fusion workflows, where previously acquired MRI is registered with real-time ultrasound. Hologic's ATEC vacuum-assisted system can be used under MRI guidance, while Philips UroNav integrates pre-biopsy prostate MRI with live ultrasound to improve targeted prostate sampling.

Mammography/Stereotactic-Guided Biopsy accounted for 17.0% of the market, equivalent to USD 215.9 million in 2025, and is projected to grow at a CAGR of 6.4%. The segment is closely tied to nonpalpable breast lesions, suspicious calcifications, and abnormalities detected mammographically without a dependable ultrasound correlate. Hologic's Affirm systems integrate stereotactic and tomosynthesis-guided targeting with Brevera, Eviva, and ATEC devices, creating a tightly connected breast-imaging and biopsy workflow. CMS also maintains national coverage for qualifying stereotactic and ultrasound-guided percutaneous breast biopsies, reinforcing an established U.S. reimbursement pathway.

PET/Other Image-Guided Biopsy accounted for 8.0% of the Image-Guided Biopsy Market, representing USD 101.6 million in 2025, and is projected to expand at a CAGR of 7.5%. PET/CT and multimodality fusion are mainly used when metabolic information helps identify viable or otherwise difficult biopsy targets. The 2024 review reported diagnostic accuracy of 86.1% for PET/CT/ultrasound fusion biopsy across multiple anatomical sites, but cost and image co-registration requirements restrict routine use compared with ultrasound and CT.

 

Revenue Leaders and High-Growth Biopsy Technologies Driving Value in the Image-Guided Biopsy Market

Core Needle Biopsy accounted for 43.0% of the market, representing USD 546.1 million in 2025, and is projected to expand at a CAGR of 6.9%. Core devices obtain larger tissue fragments than FNA, making them better suited to histology, immunohistochemistry, and many molecular tests. This positioning is becoming more important as oncology diagnostics require adequate tissue for biomarker characterization. BD's Max-Core disposable instrument is compatible with the TruGuide coaxial biopsy needle, while Merit Medical's CorVocet is designed to obtain full-core specimens and includes an echo-enhanced tip for image-guided procedures.

Fine Needle Aspiration accounted for 24.0% of the Image-Guided Biopsy Market, or USD 304.8 million in 2025, and is projected to grow at a CAGR of 5.6%. FNA remains useful where cytological assessment is sufficient, particularly for thyroid nodules, lymph nodes, and selected superficial lesions. Its slower growth relative to core biopsy reflects the smaller amount of tissue obtained, which can limit extensive histological or molecular analysis in complex oncology cases.

Vacuum-Assisted Biopsy represented 21.0% of the market, valued at USD 266.7 million in 2025, and is the fastest-growing biopsy-type segment with an 8.4% CAGR. Vacuum systems use negative pressure and a rotating cutting mechanism to obtain multiple larger cores through a single insertion, which is particularly useful in breast procedures. A clinical review reported that vacuum-assisted breast biopsy can reduce histological underestimation, false-negative results, and repeat biopsy compared with conventional core sampling. Hologic's ATEC, Eviva, and Brevera portfolio gives the company broad exposure to this segment across stereotactic, ultrasound, and MRI-linked workflows.

Surgical/Excisional Biopsy accounted for 12.0% of the Image-Guided Biopsy Market, representing USD 152.4 million in 2025, and is projected to expand at a CAGR of 5.9%. Surgical sampling remains clinically relevant when percutaneous biopsy is nondiagnostic, lesion architecture must be assessed more completely, or excision is part of the treatment plan. Its comparatively slower growth reflects the established preference for minimally invasive image-guided sampling when adequate diagnostic tissue can be obtained percutaneously.

 

Key Value-Capturing Components Driving Growth Across the Image-Guided Biopsy Market

Imaging Systems represented 35.0% of the Image-Guided Biopsy Market, equivalent to USD 444.5 million in 2025, and are projected to expand at a CAGR of 6.3%. Ultrasound, CT, MRI, mammography, and hybrid imaging systems provide the infrastructure on which image-guided procedures depend. In the United States, OECD data report 86 CT, MRI, and PET units per million population compared with an OECD average of 51, providing a substantial installed base for image-guided intervention. Hologic's Dimensions mammography systems and Philips' imaging platforms illustrate how vendors can connect diagnostic imaging with subsequent procedural guidance.

Biopsy Needles accounted for 25.0% of the market, representing USD 317.5 million in 2025, and are projected to grow at a CAGR of 6.8%. This segment benefits from recurring procedure-linked consumption and the need for different gauges, lengths, firing mechanisms, and imaging-visible features. BD's Max-Core, Merit Medical's CorVocet and TEMNO families, and Argon Medical's BioPince Ultra illustrate competition around specimen quality, coaxial access, ultrasound visibility, and procedural control.

Guidance Systems generated 16.0% of the Image-Guided Biopsy Market, or USD 203.2 million in 2025, and are projected to expand at a CAGR of 7.2%. Guidance products improve lesion targeting through stereotactic coordinates, electromagnetic tracking, fusion registration, robotic positioning, or dedicated biopsy attachments. Hologic's Affirm platform calculates breast lesion coordinates for stereotactic procedures, while Philips UroNav uses electromagnetic tracking and MR/ultrasound registration for prostate biopsy.

Software & Navigation Platforms accounted for 14.0% of the market, representing USD 177.8 million in 2025, and are projected to record the fastest component CAGR of 9.1%. The segment is becoming more commercially important as biopsy shifts from simple image visualization toward procedure planning, target registration, robotic navigation, and intraprocedural confirmation. Intuitive's PlanPoint software creates a three-dimensional airway tree from CT data and plans a route to pulmonary nodules, while Philips UroNav registers diagnostic MRI with live ultrasound for prostate procedures.

Accessories & Consumables represented 10.0% of the Image-Guided Biopsy Market, or USD 127.0 million in 2025, and are projected to expand at a CAGR of 6.6%. Coaxial introducers, biopsy markers, specimen containers, localization products, and other single-use accessories create recurring revenue around capital imaging and biopsy systems. Hologic's breast portfolio includes marking and localization products, while BD, Merit, and Argon offer coaxial components that enable repeated sampling through one access tract.

 

High-Growth Clinical Applications Driving Demand and Expanding Procedural Opportunities in the Image-Guided Biopsy Market

Breast Cancer Diagnosis accounted for 31.0% of the Image-Guided Biopsy Market, representing USD 393.7 million in 2025, and is projected to expand at a CAGR of 6.9%. The American Cancer Society projects approximately 321,910 new invasive breast cancer cases and another 60,730 ductal carcinoma in situ cases among U.S. women in 2026. Breast biopsy also supports one of the widest combinations of imaging modalities, including ultrasound, stereotactic mammography, tomosynthesis, MRI, and contrast-enhanced mammography. Hologic's Affirm, ATEC, Eviva, Brevera, Celero, and Sertera portfolios position the company across multiple points in this diagnostic workflow.

Lung Cancer Diagnosis accounted for 22.0% of the market, representing USD 279.4 million in 2025, and is projected to grow at a CAGR of 7.5%. Approximately 229,410 new U.S. lung cancer cases are projected in 2026, and tissue diagnosis increasingly needs to support both histological classification and biomarker testing. CT-guided transthoracic biopsy remains established for accessible lesions, while robotic bronchoscopy is expanding the procedure mix for small peripheral nodules. Intuitive reported approximately 144,100 Ion biopsy procedures in 2025 compared with around 95,500 in 2024, showing rapid clinical adoption of robotic-assisted pulmonary sampling.

Prostate Cancer Diagnosis represented 17.0% of the Image-Guided Biopsy Market, valued at USD 215.9 million in 2025, and is projected to record an 8.2% CAGR. The American Cancer Society estimates approximately 333,830 new U.S. prostate cancer cases in 2026, while incidence increased by about 3% annually from 2014 through 2022. MRI-targeted and MRI/ultrasound fusion approaches are changing the technical profile of prostate sampling by allowing suspicious MRI-defined regions to be targeted during real-time ultrasound. Philips UroNav supports both transrectal and transperineal workflows and integrates MRI-derived targets into the live biopsy procedure.

Liver Lesion Diagnosis accounted for 12.0% of the Image-Guided Biopsy Market, representing USD 152.4 million in 2025, and is projected to grow at a CAGR of 6.7%. Ultrasound and CT remain the primary modalities because the choice can be matched to lesion depth, visualization, and surrounding anatomy. Published evidence places ultrasound-guided liver biopsy diagnostic accuracy at approximately 88%–95.1% and CT-guided liver biopsy at around 80%–95%, keeping both modalities commercially relevant.

Kidney and Other Organ Lesion Diagnosis represented 9.0% of the market, equivalent to USD 114.3 million in 2025, and is projected to expand at a CAGR of 6.4%. Percutaneous core biopsy is used when imaging alone cannot adequately characterize a renal or other organ lesion or when pathology is needed before selecting surgery, ablation, systemic therapy, or surveillance. Multi-organ devices such as Merit Medical's CorVocet and TEMNO platforms support this category through different gauge and length configurations.

Other Cancer and Non-Cancer Applications accounted for 9.0% of the Image-Guided Biopsy Market, representing USD 114.3 million in 2025, and are projected to expand at a CAGR of 5.5%. The segment includes lymph-node, musculoskeletal, inflammatory, infectious, and other soft-tissue sampling procedures. Growth is more moderate because these applications are distributed across many smaller clinical pathways rather than concentrated in a few high-volume oncology indications.

 

Care Setting Dynamics Reshaping Revenue Flow Across the Image-Guided Biopsy Market

Hospitals accounted for 48.0% of the Image-Guided Biopsy Market, representing USD 609.6 million in 2025, and are projected to expand at a CAGR of 6.7%. Hospitals retain the largest share because they combine CT, MRI, ultrasound, mammography, interventional radiology, pathology, pulmonology, urology, surgery, and oncology services. They are also the primary setting for complex CT-guided, MRI-guided, and robotic procedures requiring anesthesia, advanced imaging, or multidisciplinary support.

Diagnostic Imaging Centers represented 23.0% of the market, valued at USD 292.1 million in 2025, and are projected to grow at a CAGR of 7.5%. Imaging centers can efficiently perform breast and other percutaneous biopsies when diagnostic imaging and tissue sampling are integrated in the same outpatient pathway. Their commercial position is strongest in markets with established imaging reimbursement and sufficient procedure volume to support dedicated intervention capability.

Ambulatory Surgical Centers accounted for 14.0% of the Image-Guided Biopsy Market, representing USD 177.8 million in 2025, and are projected to record the fastest end-user CAGR of 8.1%. Minimally invasive biopsy techniques can often be performed without inpatient admission, particularly when general hospital-level resources are unnecessary. CMS identifies ambulatory surgical center services among the benefit categories applicable to its national coverage policy for qualifying percutaneous image-guided breast biopsy, supporting an established outpatient procedure pathway in the United States.

Specialty Clinics represented 10.0% of the market, or USD 127.0 million in 2025, and are projected to grow at a CAGR of 6.2%. Breast centers and urology practices are particularly relevant because ultrasound-guided breast procedures and MRI/ultrasound fusion prostate biopsy can be organized within specialty-focused diagnostic pathways without requiring full inpatient infrastructure.

Research and Academic Institutes accounted for 5.0% of the Image-Guided Biopsy Market, representing USD 63.5 million in 2025, and are projected to expand at a CAGR of 5.8%. Academic centers play a disproportionate role in evaluating fusion imaging, robotic navigation, advanced image registration, novel tissue-sampling methods, and biopsy protocols designed to obtain material for genomic research.

 

Precision Oncology, Fusion Imaging, and Robotic Navigation as the New Growth Engine of the Image-Guided Biopsy Market

Precision oncology is changing the commercial specification of a successful biopsy. Tissue now frequently needs to support histology, immunohistochemistry, genomic profiling, and other biomarker tests rather than only confirm malignancy. A tertiary oncology-center study reported that image-guided biopsy procedures increased from 500 in 2014/15 to 659 in 2017/18, while 5% of patients in the later period underwent repeat biopsy to obtain additional tissue for genetic analysis or research. This increases the value of devices that obtain larger intact cores and minimize fragmentation.

Full-core sampling has therefore become an important product-development theme. Merit Medical's CorVocet is designed to obtain full-core specimens and incorporates an echo-enhanced tip for image-guided placement. Argon Medical's BioPince Ultra uses a tri-axial core-cut-and-capture mechanism and is designed to reduce crush artifact and tissue fragmentation, directly addressing specimen-quality requirements that matter for advanced pathology testing.

Fusion imaging is adding software value to conventional procedure equipment. MRI/ultrasound fusion is particularly important in prostate biopsy because MRI can identify suspicious regions before the procedure while ultrasound provides live procedural imaging. The 2024 review reported approximately 84% diagnostic accuracy for MRI/ultrasound fusion prostate biopsy in the evidence it assessed and noted that fewer cores may be required, although registration complexity and cost remain limitations.

Robotic bronchoscopy is creating a new competitive layer in lung biopsy. Intuitive's Ion system uses pre-procedure CT planning, a 3.5 mm articulating catheter, fiber-optic shape sensing, and compatible Flexision biopsy needles to access peripheral lung nodules through the airways. The platform can also integrate with cone-beam CT and other advanced imaging to help address CT-to-body divergence and confirm tool position. FDA records confirm the system is Class II and has been cleared through the 510(k) process rather than approved as a PMA device.

 

Regional Healthcare Ecosystems Driving Adoption, Access, and Technological Maturity in the Image-Guided Biopsy Market

North America accounted for 39.0% of the Image-Guided Biopsy Market, representing USD 495.3 million in 2025, and is projected to expand at a CAGR of 6.5%. The region combines high cancer diagnosis volumes, broad CT and MRI capacity, mature breast imaging, interventional radiology, advanced urology, and expanding robotic bronchoscopy. OECD reports 86 CT, MRI, and PET units per million population in the United States compared with an OECD average of 51. Companies such as Hologic, Intuitive Surgical, and Philips support the region through integrated breast biopsy, robotic lung biopsy, and MRI/ultrasound prostate fusion technologies.

Europe represented 28.0% of the Image-Guided Biopsy Market, valued at USD 355.6 million in 2025, and is projected to grow at a CAGR of 6.1%. Western and Northern European health systems have mature interventional radiology, breast imaging, and specialist oncology infrastructure, while advanced fusion and MRI-guided procedures remain more concentrated in tertiary centers. Recent product activity includes Hologic's February 2025 CE marking of Affirm Contrast Biopsy Software, allowing tissue targeting from contrast-enhanced mammography and broadening the company's European interventional breast portfolio.

Asia Pacific accounted for 23.0% of the market, representing USD 292.1 million in 2025, and is projected to record the fastest regional CAGR of 8.3%. The region combines highly imaging-intensive health systems with countries that have much more limited scanner capacity. OECD reports 184 CT, MRI, and PET units per million population in Japan versus an OECD average of 51; separate Asia-Pacific data report more than 115 CT scanners per million in Japan compared with fewer than one per million in several lower-resource countries. This creates a two-tier market in which advanced MRI, stereotactic, and fusion systems coexist with much broader utilization of ultrasound and conventional core-biopsy devices.

Latin America represented 6.0% of the Image-Guided Biopsy Market, valued at USD 76.2 million in 2025, and is projected to expand at a CAGR of 6.9%. Procedure capability is concentrated in larger private hospitals, academic institutions, oncology centers, and breast-imaging facilities with established ultrasound and CT equipment. Products that integrate with existing imaging platforms and use standardized disposable biopsy needles have a broader commercial pathway than dedicated MRI-guided or robotic systems, which remain concentrated in higher-volume tertiary centers.

The Middle East & Africa accounted for 4.0% of the market, representing USD 50.8 million in 2025, and is projected to expand at a CAGR of 6.4%. Gulf markets support advanced CT, MRI, mammography, and specialist intervention, while many African health systems face more substantial imaging-equipment and workforce constraints. WHO notes that many low- and lower-middle-income countries cannot afford advanced imaging equipment and frequently lack trained imaging personnel. Ultrasound-compatible biopsy products therefore have broader practical reach across the region, while fusion, MRI-guided, and robotic technologies are concentrated in specialist centers.

 

Competitive Transformation Across the Image-Guided Biopsy Market: From Device-Centric Tools to Integrated Diagnostic Ecosystems

Competition in the Image-Guided Biopsy Market is shifting from individual needle design toward control of larger portions of the procedure workflow. Traditional biopsy-device manufacturers compete on tissue quality, needle visibility, coaxial access, gauge selection, and ease of deployment. Breast-health companies integrate imaging, targeting, vacuum-assisted sampling, markers, and localization, while technology companies increasingly compete through fusion software, robotic navigation, image registration, and intraprocedural confirmation.

Hologic
Hologic has one of the most vertically integrated breast-biopsy portfolios. Its products include Affirm upright and prone biopsy guidance systems, ATEC, Brevera, and Eviva vacuum-assisted devices, and Celero and Sertera ultrasound-guided core biopsy products. Its Endomag acquisition added Magseed, Magtrace, and Sentimag for localization and lymphatic tracing, extending the portfolio beyond tissue acquisition into the subsequent surgical pathway. Affirm Contrast Biopsy received FDA 510(k) clearance in October 2020 and CE marking in February 2025. Hologic's latest 2026 filing also disclosed that the stop-ship affecting Brevera 9 Gauge Needles could remain prolonged, making alternative products such as Eviva relevant to portfolio continuity.

BD
BD competes primarily through recurring core-biopsy and coaxial products rather than imaging capital. The Max-Core disposable core biopsy instrument provides one-handed cocking, different gauge and length configurations, and compatibility with the TruGuide coaxial biopsy needle. Its commercial position is strongest in high-volume conventional biopsy procedures where radiology departments require standardized, single-use devices compatible with existing ultrasound or CT workflows.

Merit Medical Systems
Merit Medical has a broad soft-tissue biopsy portfolio spanning CorVocet, TEMNO, TEMNO Evolution, TEMNO Elite, Achieve, and Tru-Cut devices. CorVocet emphasizes full-core tissue acquisition and image visibility, while TEMNO products provide echogenic markings, adjustable or variable notch options, and coaxial access. This breadth allows Merit to address liver, kidney, breast, lung, prostate, thyroid, lymph-node, and other soft-tissue procedures without relying on a single anatomical application.

Argon Medical Devices
Argon Medical competes through products such as BioPince Ultra and SuperCore. BioPince Ultra uses a tri-axial core-cut-and-capture mechanism to obtain a full cylindrical specimen and is designed to reduce crush artifact and tissue fragmentation. Variable throw lengths and optional echogenic coaxial introducers support different lesion sizes and imaging approaches. Its differentiation is particularly relevant as molecular pathology places greater value on intact tissue volume and specimen quality.

Intuitive Surgical
Intuitive Surgical expands the market beyond conventional transthoracic needle biopsy through the Ion Endoluminal System. Ion combines PlanPoint CT-based procedure planning with robotic catheter control, fiber-optic shape sensing, direct airway visualization, and Flexision biopsy needles for peripheral pulmonary targets. FDA records classify Ion as a Class II bronchoscope system and show multiple 510(k) clearances, including additional clearances in 2025. The platform's approximately 144,100 biopsy procedures in 2025 demonstrate meaningful commercialization of robotic-assisted lung tissue acquisition.

Philips
Philips participates in targeted prostate biopsy through UroNav, an MR/ultrasound fusion system designed for biopsy and focal-therapy guidance. The platform aligns prior diagnostic prostate MRI with real-time ultrasound, displays segmented anatomy and suspicious targets, and visualizes the needle pathway during the procedure. It supports both transrectal and transperineal approaches and can be used with Philips DynaCAD Urology, positioning the company around integrated imaging, informatics, and procedural navigation rather than disposable biopsy instruments.

 

Clinical Barriers, Infrastructure Gaps, and Procedural Limitations Reshaping Growth in the Image-Guided Biopsy Market

Access to advanced imaging remains one of the main structural constraints. Ultrasound-guided procedures can be implemented relatively broadly, but CT, MRI, PET, fusion imaging, and robotic bronchoscopy require progressively larger investments in equipment, service, specialist staffing, and procedure-room infrastructure. WHO continues to identify both equipment affordability and shortages of trained imaging personnel as barriers in lower-resource health systems.

Modality-specific clinical limitations also affect purchasing and procedure selection. Ultrasound is operator dependent and cannot reliably visualize all deep lesions. CT provides strong anatomical targeting but exposes patients to ionizing radiation and, in transthoracic procedures, pneumothorax remains an important complication. The 2024 review reported pneumothorax rates of approximately 17%–26% across CT-guided lung-biopsy studies. MRI provides strong soft-tissue contrast but has higher equipment and workflow requirements, while fusion imaging adds registration complexity.

Specimen adequacy is another commercial constraint. Accurate targeting does not eliminate repeat procedures if the acquired tissue is insufficient for pathology or molecular analysis. The shift toward biomarker-driven oncology therefore increases scrutiny of core size, fragmentation, tissue handling, and biopsy-device performance. This favors products designed around full-core sampling and multi-pass coaxial access but can also increase procedural complexity.

Robotic systems face an additional health-economic hurdle because hospitals must justify capital acquisition, servicing, disposable use, anesthesia requirements, and procedural training against established CT-guided and conventional bronchoscopic alternatives. Their commercial position will depend increasingly on whether clinical evidence demonstrates sufficient improvements in diagnostic yield, safety, workflow, or downstream patient management.

 

Key Forces Redefining the Image-Guided Biopsy Market Landscape Through 2032

The image-guided biopsy market is still mainly driven by ultrasound (34%) and CT scans, with core needle biopsy being the most used type (43%). Hospitals remain the biggest users, accounting for 48% of demand, and breast cancer diagnosis is the leading application (31%).

However, the fastest growth is coming from newer technologies. MRI-guided biopsy is growing at 8.2% CAGR, vacuum-assisted biopsy at 8.4%, and software and navigation systems at the fastest rate of 9.1%. Prostate biopsy procedures are also rising quickly (8.2% CAGR), while Asia Pacific is the fastest-growing region at 8.3% due to expanding imaging infrastructure.

 

Image-Guided Biopsy Market Report Coverage Table

Report Attribute	Details
Forecast Period	2026 – 2032
Market Size Value in 2025	USD 1.27 Billion
Revenue Forecast in 2032	USD 2.01 Billion
Overall Growth Rate	CAGR of 6.8% (2026 – 2032)
Base Year for Estimation	2025
Historical Data	2019 – 2024
Unit	USD Million, CAGR (2026 – 2032)
Segmentation	By Imaging Modality, By Biopsy Type, By Component, By Application, By End User, By Geography
By Imaging Modality	Ultrasound-Guided Biopsy, CT-Guided Biopsy, MRI-Guided Biopsy, Mammography/Stereotactic-Guided Biopsy, PET/Other Image-Guided Biopsy
By Biopsy Type	Core Needle Biopsy, Fine Needle Aspiration, Vacuum-Assisted Biopsy, Surgical/Excisional Biopsy
By Component	Imaging Systems, Biopsy Needles, Guidance Systems, Software and Navigation Platforms, Accessories and Consumables
By Application	Breast Cancer Diagnosis, Lung Cancer Diagnosis, Prostate Cancer Diagnosis, Liver Lesion Diagnosis, Kidney and Other Organ Lesion Diagnosis, Other Cancer and Non-Cancer Applications
By End User	Hospitals, Diagnostic Imaging Centers, Ambulatory Surgical Centers, Specialty Clinics, Research and Academic Institutes
By Region	North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Canada, UK, Germany, France, Italy, China, Japan, South Korea, India, Brazil, Mexico, Saudi Arabia, UAE, South Africa
Market Drivers	Increasing global cancer burden, rising demand for minimally invasive tissue diagnosis, expanding precision oncology and biomarker testing, growing adoption of fusion imaging and robotic navigation, and movement of suitable procedures toward outpatient care settings
Customization Option	Available upon request