Biopsy Devices Market Size, Share, and Industry Analysis, By Product (Needle-based Biopsy Instruments, Visualization Systems, Brush Biopsy Instruments, Biopsy Accessories, and Robotic Biopsy Devices), By Technology (Ultrasound-guided Biopsy, Stereotactic-guided Biopsy, and Others), By Application (Oncology, Gastroenterology, Bone and Bone Marrow Biopsy, and Others), By End-user (Hospitals & ASCs, Diagnostic Imaging Centers, Specialty Clinics, and Others), and Regional Forecast till 2032

The biopsy devices market is experiencing substantial growth driven by rising global cancer burden, technological advancements in minimally invasive diagnostic procedures, and increasing adoption of image-guided biopsy techniques. These advanced devices are enabling more precise tissue sampling for accurate cancer diagnosis and staging, with innovations in needle technologies, visualization systems, and robotic-guided procedures improving patient outcomes while reducing procedural complications.

• For instance, according to WHO data from 2024, there were an estimated 20 million new cancer cases and 9.7 million cancer deaths globally in 2022, with projections indicating this will reach 35 million new cases by 2050 - a 77% increase.

Biopsy Devices Market Driver

Rising Global Cancer Burden to Propel Market Growth

The increasing incidence of cancer worldwide has significantly driven demand for advanced biopsy devices across all anatomical sites. According to WHO data, lung cancer remains the most commonly occurring cancer globally, with 2.5 million new cases (12.4% of total), followed by breast cancer with 2.3 million cases (11.6%). The aging population is particularly contributing to this surge, as approximately 1 in 5 people develop cancer in their lifetime, with the majority of cases occurring in individuals aged 65 and older.

This substantial cancer burden necessitates precise diagnostic capabilities, for which tissue biopsy remains the gold standard for definitive cancer diagnosis. Early detection through effective biopsy procedures is crucial for improving treatment outcomes and patient survival rates..

Advancement in Image-guided and Robotic Biopsy Technologies

The evolution from traditional surgical biopsies to minimally invasive, image-guided procedures has transformed cancer diagnosis. Modern robotic biopsy systems using reinforcement learning algorithms demonstrate needle angle tracking accuracy of 0.446° with 0.002 mm insertion resolution. Real-time MRI-guided stereotactic biopsy systems provide neurosurgeons with visual confirmation of biopsy sites and allow real-time adjustments, with average procedure times of 165 minutes.

Stereotactic breast biopsy systems achieve 97% accuracy for malignant lesions using mammographic guidance with computer analysis, enabling precise targeting of non-palpable breast lesions. These systems represent significant improvements over traditional methods, offering real-time visualization, absence of ionizing radiation, better patient comfort, and shorter procedure times.

Biopsy Devices Market Restraint

High Cost and Complexity of Advanced Biopsy Systems

Advanced biopsy systems with image-guidance, robotic assistance, and automated features carry substantial acquisition and operational costs. Robotic biopsy systems, while offering enhanced precision, require significant capital investment and specialized training for healthcare professionals. The complexity of modern procedures demands highly skilled radiologists and specialized support staff, increasing operational expenses.

Multi-modal fusion imaging techniques, while improving diagnostic accuracy, require sophisticated equipment and extended procedure times, creating barriers to widespread adoption, particularly in resource-constrained regions. These financial constraints limit accessibility among smaller healthcare facilities and emerging markets where cost-effectiveness remains a primary consideration.

Potential Complications and Patient Safety Concerns

Although modern biopsy procedures are generally safe, they carry inherent risks that impact patient outcomes. Pneumothorax rates in lung biopsies range from 2.6% to 30%, with moderate bleeding occurring in 4% to 78% of procedures. Bone marrow biopsies, essential for hematologic malignancy diagnosis, are widely regarded as being among the more painful procedures experienced by patients.

False-negative results remain a clinical challenge, with brush cytology showing sensitivity rates of only 26% and specificity of 97% in cervical lesion evaluation. The psychological impact of inconclusive results can cause significant patient distress and may lead to additional procedures.

Biopsy Devices Market Opportunity

Integration of Artificial Intelligence and Robotic Guidance Systems

The incorporation of AI and robotics into biopsy procedures presents significant growth opportunities. Fully automated robotic-assisted systems for positioning and insertion of commercial biopsy instruments demonstrate superior precision while reducing operator dependency. These systems can function in both teleoperated and autonomous modes, offering enhanced standardization and reproducibility.

AI-enabled imaging fusion techniques combining ultrasound, CT, and MRI guidance improve biopsy accuracy by providing real-time tissue characterization and needle tracking. The development of robotic navigation systems aims to minimize procedure times, reduce needle manipulations, radiation exposure, and complications while enabling the treatment of larger and more complex tumors.

Expansion in Ambulatory Surgery Centers and Minimally Invasive Procedures

The shift toward outpatient biopsy procedures in ambulatory surgery centers (ASCs) represents a significant market opportunity. According to the research paper published on the National Center for Biotechnology Information (NCBI), prostate biopsy ranks as the second most performed procedure in office-based surgery centers. In contrast, colonoscopy with biopsy contributes 4.3% of all ASC charges with an average cost of USD 2,073. Additionally, esophagogastroduodenoscopy with biopsy represents the fourth most performed procedure at ASCs, contributing 3.9% of all payments with an average charge of USD 1,806. This trend reflects healthcare system efforts to optimize resource utilization while improving patient convenience and reducing costs.

Segmentation

Key Insights 

The report covers the following key insights:

• Prevalence of Cancer, By Key Countries/Region, 2024
• Key Industry Developments (Mergers, Acquisitions & Partnerships)
• New Product Launch/Approvals, By Key Players
• Technological Advancements in Biopsy Devices

Analysis by Product

By product, the market is divided into needle-based biopsy instruments, visualization systems, brush biopsy instruments, biopsy accessories, and robotic biopsy devices.

Needle-based biopsy instruments are expected to account for the largest market share during the forecast period. Core needle biopsy systems demonstrate diagnostic accuracy of 97% for malignant lesions while providing tissue architecture preservation essential for comprehensive pathological analysis. Vacuum-assisted biopsy devices show superior performance with complete lesion removal rates of 87% for lesions ≤20mm and the ability to obtain multiple contiguous specimens with a single needle insertion.

Additionally, fine needle aspiration (FNA) devices using thin 22-25 gauge needles offer minimal patient discomfort and quick outpatient procedures, making them ideal for initial diagnostic workups of thyroid nodules, lymph nodes, and breast masses.

Analysis by Technology

By technology, the market is divided into ultrasound-guided biopsy, stereotactic-guided biopsy, and others.

Ultrasound-guided biopsy systems hold the largest market share due to real-time visualization capabilities, absence of ionizing radiation, better patient comfort, and shorter procedure times. Stereotactic-guided biopsy systems demonstrate significant growth, particularly for breast applications where mammographic guidance with computer analysis enables precise targeting of non-palpable lesions and microcalcifications. Furthermore, MRI-guided stereotactic biopsy procedures achieve high technical success rates of 99.10% with superior soft tissue contrast for complex anatomical locations. These advanced imaging techniques are expanding capabilities for previously inaccessible lesions.

Analysis by Application

By application, the market is divided into oncology, gastroenterology, bone and bone marrow biopsy, and others.

Oncology represents the largest segment, driven by the global cancer burden of 20 million new cases annually, according to the WHO data. Moreover, breast cancer applications show particular strength due to 2.3 million women affected annually worldwide, with breast cancer remaining the leading cancer type in women across 157 of 185 countries.

Bone and bone marrow biopsy applications demonstrate significant growth potential driven by hematologic malignancies requiring definitive tissue diagnosis. Additionally, advancements in the devices are expected to drive the segmental market in the near future. For instance, powered bone marrow biopsy systems produce superior-sized specimens (mean volume 49.1±21.5 mm³) compared to manual devices (11.0±10.8 mm³) with significantly less patient pain.

Analysis by End-user

By end-user, the market is divided into hospitals & ASCs, diagnostic imaging centers, specialty clinics, and others.

Hospitals and ambulatory surgery centers (ASCs) represent the largest market segment due to comprehensive cancer care capabilities and advanced imaging infrastructure. ASCs show substantial growth as minimally invasive biopsy procedures shift toward outpatient settings, with prostate biopsy ranking among the top five procedures performed in office-based surgery centers.

Diagnostic imaging centers demonstrate strong growth as dedicated facilities expand interventional capabilities to meet increasing demand for image-guided procedures. This trend reflects healthcare optimization efforts while maintaining safety and efficacy standards.

Regional Analysis

By region, the market is divided into North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America.

North America maintains the largest biopsy devices market share, driven by advanced healthcare infrastructure, comprehensive cancer screening programs, and early adoption of innovative technologies. The region benefits from robust reimbursement systems supporting advanced diagnostic procedures and extensive clinical research activities.

Europe demonstrates strong market growth with emphasis on population-based cancer screening programs and standardized biopsy protocols. Countries achieve high screening coverage rates, driving demand for advanced biopsy technologies across multiple cancer types.

Asia Pacific is expected to exhibit the highest growth rate during the forecast period, driven by rapidly expanding healthcare infrastructure, increasing cancer awareness, and growing elderly populations. Countries such as China and India, accounting for 18.4% and 5.4% of global cancer cases, respectively, represent significant opportunities for biopsy device manufacturers.

Key Players Covered

The global biopsy devices market features both established medical device manufacturers and innovative technology companies developing next-generation solutions. Major players are expanding their portfolios through strategic acquisitions, product launches, and partnerships.

The report includes profiles of the following key players:

• Hologic Inc. (U.S.)
• Becton Dickinson and Company  (U.S.)
• Cook Medical  (U.S.)
• Merit Medical Systems (U.S.)
• Mammotome (U.S.)
• Teleflex Incorporated (U.S.)
• Boston Scientific Corporation (U.S.)
• Argon Medical Devices (U.S.)
• TSK Laboratory (Japan)

Key Industry Developments

• October 2025: Olympus Corporation launched SecureFlex, a single-use fine needle biopsy device designed for EUS-FNB procedures, commercially available in Europe and Japan, with subsequent global rollout planned.
• October 2025: CND Life Sciences received FDA Breakthrough Device Designation for its Syn-One Test, a skin biopsy-based diagnostic tool for aiding the diagnosis of synucleinopathies in patients aged 40 years and older.
• May 2024: Hologic launched a new 7-gauge disposable needle for its Brevera Breast Biopsy System in Europe, expanding the suite of Brevera disposable biopsy needles to provide radiologists with more options for capturing larger tissue samples.
• May 2024: Cook Medical launched the EchoTip ClearCore™ EUS Biopsy Needle in the United States, featuring a Franseen tip made of cobalt chromium alloy for enhanced flexibility and controlled precision in gastrointestinal lesion biopsies.
• March 2024: Cook Medical obtained FDA clearance for an expanded pediatric indication for its Liver Access and Biopsy Set (LABS), now approved for use in adolescents, children, and infants in addition to adults.