The global biopsy devices market size was valued at USD 2.51 billion in 2025 and is projected to grow from USD 2.69 billion in 2026 to USD 4.67 billion by 2034, registering a CAGR of 7.13% during the forecast period (2026–2034). North America dominated the biopsy devices market with a share of 42.06% in 2025.
Biopsy devices are medical instruments used to remove tissue or cell samples from the body for microscopic examination and diagnostic evaluation. Common devices include biopsy needles, forceps, punches, vacuum-assisted systems, and other instruments designed to obtain specimens from different organs and tissues. Biopsy devices are tracked under HSN Code 9018 (instruments and appliances used in medical, surgical, dental, or veterinary sciences) and SIC Code 3841 (surgical and medical instruments and apparatus).
The biopsy devices market demand is supported by the increasing use of diagnostic procedures, rising adoption of minimally invasive techniques, growing need for early disease detection, and expanding utilization of image-guided biopsy procedures. Hospitals, diagnostic centers, and healthcare providers are using biopsy needles, forceps, vacuum-assisted devices, and other sampling instruments to obtain tissue specimens, contributing to the biopsy devices market growth.
By Product
By Application
By End User
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Adoption of Robotic-Assisted Biopsy Systems
The biopsy devices market analysis shows that the need for greater precision during tissue sampling is supporting robotic systems that assist with needle positioning and lesion targeting. Robotic guidance can help clinicians perform procedures with more controlled and accurate needle placement. This shift is improving procedural precision in selected image-guided biopsies.
Expansion of Vacuum-Assisted Biopsy Technologies
The need for efficient tissue collection is supporting vacuum-assisted devices that can obtain multiple samples through a single probe insertion. The vacuum mechanism allows continuous tissue removal and can provide larger or more consistent specimens. This development is strengthening the use of advanced sampling methods in biopsy procedures.
Supply chain disruptions are expected to have a substantial impact on the biopsy devices market share, as dependence on specialized biopsy needles, precision components, sterile materials, and qualified medical-device manufacturing can create product shortages and procurement delays. The market is likely to follow a capacity-constrained recovery pattern, as biopsy procedures remain clinically necessary while limited availability of specific devices can restrict procedure scheduling and equipment procurement. The market is expected to grow at a CAGR of 7.13%, but supply chain constraints could approximately lower this by 0.3 percentage points, resulting in short-term growth of around 6.83%. As supply conditions normalize through diversified suppliers, restored manufacturing capacity, improved inventory planning, and more reliable medical-device distribution, biopsy devices market growth is expected to gradually return.
The biopsy devices market forecasts investments directed toward AI-assisted biopsy guidance, advanced imaging technologies, robotic biopsy platforms, and precision sampling systems to improve diagnostic accuracy and support minimally invasive procedures.
Key Investment and Funding Activities in the Biopsy Devices Market, 2026
Biobot Surgical
USD 15.6 million
In June 2026, Biobot Surgical secured USD 15.6 million in funding to accelerate commercialization and U.S. market entry of its Mona Lisa platform, which combines robotic needle guidance with MRI-ultrasound image fusion for targeted prostate biopsy procedures.
BiBBInstruments
USD 4 million
In April 2026, BiBBInstruments raised approximately USD 4 million to accelerate commercialization of its EndoDrill-powered biopsy system, supporting expansion of the device into additional clinical markets and further development of its biopsy technology.
Virchow Medical
In March 2026, Virchow Medical raised USD 4 million in seed financing to complete development of its liquid-specimen biorepository and expand Biopsy Catchment System pilot programs across U.S. medical institutions, supporting improved preservation and downstream molecular analysis of biopsy specimens.
Expansion of Oncology Diagnostics and Image-Guided Biopsy Drive Market
The growing cancer incidence is increasing the number of patients requiring tissue sampling for definitive cancer diagnosis and disease assessment. Greater oncology caseloads are expanding biopsy volumes across hospitals, diagnostic centers, and specialized clinics. This supports demand for core needle biopsy, fine needle aspiration (FNA), and surgical biopsy procedures.
The wider use of imaging modalities such as ultrasound, CT, and MRI is improving the localization of suspicious lesions before tissue sampling. Adoption of image-guided biopsy is enabling physicians to access targeted areas with improved procedural precision. This development increases the use of specialized biopsy needles and diagnostic devices.
Device Standardization Gaps and Specialist Shortages Restrain Biopsy Devices Market Expansion
Variations in needle designs, device specifications, and operating procedures can make it difficult for healthcare facilities to maintain consistent biopsy workflows. Differences between core needle biopsy, fine needle aspiration (FNA), and other sampling systems can also be equipment handling and protocol development. Limited standardization can therefore slow broader adoption and integration of biopsy devices.
Limited access to skilled biopsy specialists can restrict the number of healthcare facilities capable of performing advanced tissue sampling procedures. A shortage of trained professionals limits the utilization of image-guided biopsy, core needle biopsy, and interventional radiology services. This workforce gap can constrain the geographic expansion of biopsy device use.
Development of Integrated Biopsy Platforms and Molecular Sampling Technologies Create New Growth Opportunities for Market Players
The development of multi-modal biopsy devices can combine tissue collection with complementary functions such as lesion targeting, specimen handling, or procedural guidance. Integrated designs can reduce the need for separate instruments and simplify workflows. Manufacturers can use this multifunctionality to differentiate their portfolios and develop higher-value diagnostic devices.
Biopsy devices for molecular tissue sampling can support the collection of specimens suitable for biomarker testing and advanced pathology diagnostics. Device designs optimized for specimen quality and downstream molecular analysis can improve compatibility with emerging diagnostic workflows. This product specialization can open opportunities in oncology diagnostics and molecular-focused tissue analysis.
Complex Workflow Integration and Reimbursement Variations Challenge Biopsy Devices Market Growth
Complex integration with existing diagnostic workflows can make deployment of new biopsy devices more difficult across hospitals and diagnostic centers. Compatibility with established imaging, pathology, and data-management systems may require workflow adjustments and additional implementation effort. These integration requirements can slow the introduction of newer technologies into existing clinical environments.
Reimbursement variations across healthcare systems can affect coverage for biopsy procedures and associated diagnostic technologies. Differences in payment policies and eligibility criteria can create uncertainty for providers and increase out-of-pocket expenses for some patients. This variation can therefore limit market penetration across regions and healthcare settings.
The needle-based biopsy instrument segment accounted for a share of 46.32% in 2025, supported by its widespread use for minimally invasive tissue sampling. Its versatility across different biopsy procedures supports its leading position.
The biopsy guidance systems segment is expected to grow at a CAGR of 7.84% during the forecast period, driven by the need for accurate lesion targeting during biopsy procedures.
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The oncology segment accounted for a share of 58.42% in 2025 due to the extensive use of biopsy for cancer diagnosis. Tissue sampling is essential for confirming malignancy and guiding treatment decisions, supporting oncology treatments.
The gastroenterology segment is expected to grow at a CAGR of 6.91% during the forecast period, fueled by biopsy procedures for gastrointestinal and pancreatic conditions.
The hospital segment accounted for a share of 62.48% in 2025, owing to the high volume of diagnostic and interventional procedures. Specialized imaging and pathology facilities further strengthen hospital adoption.
The ambulatory surgical centers segment is expected to grow at a CAGR of 8.12% during the forecast period, propelled by the shift toward minimally invasive outpatient procedures. Shorter procedure times and reduced hospitalization requirements support segment growth.
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Market Dominance Supported by Established Interventional Radiology Procedures
The North America biopsy devices market accounted for the largest regional share of 42.06% in 2025, supported by established advanced interventional radiology and utilization of image-guided tissue sampling procedures.
The U.S. biopsy devices market identifies breast biopsy as a major application area, with stereotactic, ultrasound-guided, and vacuum-assisted systems used for tissue sampling and lesion assessment. In December 2025, the FDA cleared the EnCor EnCompass breast biopsy and tissue removal system, introducing a new biopsy platform to the U.S. market.
The Canada biopsy devices market is driven by the expansion of interventional radiology services, which is supporting image-guided biopsy procedures across various diagnostic specialties. The Canadian Cancer Society identifies MRI-guided and MRI–TRUS fusion biopsy as established approaches for targeting prostate abnormalities, supporting demand for specialized biopsy devices in the country.
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Fastest Growth Driven by Expansion of Cancer Screening Participation and Development of Indigenous Medical Devices
The Asia Pacific biopsy devices market is expected to grow at a CAGR of 10.12% during the forecast period, supported by increasing use of specialized tissue-sampling technologies and expansion of image-guided diagnostic procedures.
Japan’s biopsy devices market is expected to benefit from the government’s target of raising cancer screening participation to 60% and follow-up examination participation to 90% from FY2026, increasing the need for diagnostic procedures such as tissue sampling and biopsy after abnormal screening results.
The China biopsy devices market is shaped by domestic development of specialized puncture and tissue-access instruments. China’s NMPA has approved an innovative transjugular puncture device, demonstrating continued advancement of specialized minimally invasive tissue access technology.
The India biopsy devices market focuses on the development of indigenous medical devices. In May 2026, ICMR transferred indigenous technology supporting cost-effective prostate biopsy decision-making, strengthening affordable biopsy diagnostics in India.
Market Growth Supported by Lung Cancer Screening and Presence of Advanced Interventional Radiology Infrastructure
The Europe biopsy devices market is expected to grow at a CAGR of 5.91% during the forecast period, supported by established cancer screening programs and adoption of minimally invasive procedures.
The UK biopsy devices market is expected to benefit from the NHS plan to expand lung cancer screening, with 1.4 million people set to be invited for lung cancer checks in the next program year. This program is projected to diagnose up to 50,000 cancers by 2035, increasing demand for precise biopsy technologies.
The Germany biopsy devices market benefits from advanced interventional radiology infrastructure and minimally invasive diagnostic procedures. The adoption of endoscopic biopsy techniques is supporting demand for specialized biopsy needles and tissue-sampling systems. Germany launched the government-funded OmoPro project to develop an open, mobile MRI system specifically for transperineal prostate biopsies.
Market Shaped by Modernization of Hospital Facilities
The Latin America biopsy devices market is expected to grow at a CAGR of 6.38% during the forecast period. The regional market is supported by modernization of hospital facilities, expansion of specialized diagnostic services, and greater availability of advanced imaging technologies. Mexico announced plans to establish 20 diagnostic centers, strengthening access to specialized diagnostic services. Brazil’s growing pathology capacity and improvements in tissue analysis workflows are creating demand for biopsy needles, sampling systems, and related equipment.
Specialized Biopsy Applications Strengthen Regional Demand
The Middle East & Africa biopsy devices market is expected to grow at a CAGR of 5.76% during the forecast period, supported by increasing use of bone marrow biopsy and gastroenterology biopsy guidance systems. In the UAE, the Ministry of Health and Prevention introduced national standards for endoscopy services, covering procedures involving specimen acquisition and supporting standardized gastroenterology biopsy practices. In South Africa, public sector hospitals continue to use bone marrow aspiration and trephine biopsy for hematological diagnosis, with academic research supporting improvements in the diagnostic use of these procedures.
The biopsy devices market competitive landscape is moderately concentrated, with participation from global medical-device manufacturers, diagnostic technology companies, surgical instrument suppliers, and regional healthcare-device manufacturers. Leading players such as BD, Boston Scientific Corporation, Hologic, Inc., Cardinal Health, Inc., and Cook Medical LLC are collectively estimated to account for approximately 35–40% of the global biopsy devices market share.
Established participants compete primarily through biopsy-device precision, tissue-acquisition performance, device innovation, and established hospital and physician networks. Emerging, niche, and regional companies in the biopsy devices market ecosystem compete through specialized biopsy systems, minimally invasive designs, improved targeting capabilities, and localized technical support.
August 2026: Invenio Imaging completed enrollment in a landmark study evaluating its NIO Imaging System for lung cancer, which rapidly images fresh, unprocessed biopsy tissue while preserving specimens for downstream pathology and molecular analysis.
March 2026: Mammotome received FDA clearance for its Prima MR Dual Vacuum-Assisted Breast Biopsy System.
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Author's Details
Healthcare Lead
Debashree Bora is a strategic healthcare research professional with nearly eight years of hands on experience in market intelligence, encompassing primary research, secondary research, market estimation, and consulting engagements. She specializes in pharmaceutical, biotechnology, medical devices, healthcare services, clinical trials, and healthcare outsourcing sectors, providing actionable insights on evolving industry trends, regulatory landscapes, competitive dynamics, and market opportunities. Debashree’s research helps global clients evaluate market potential, identify growth opportunities, strengthen commercial strategies, and make informed business decisions.
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