Global Biopsy Devices Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Needle-Based biopsy Instruments - [Core Biopsy Devices, Aspiration Biopsy Needle & Vacuum-Assisted Biopsy Devices], Procedure Trays , Localization Wires, and OthersBy Procedure Type;
Surgical Biopsy and Needle BiopsyBy Guidance Technique;
Ultrasound Guided Biopsy, Stereotactic Guided Biopsy, MRI Guided Biopsy, and OthersBy Application;
Breast Biopsy, Lung Biopsy, Colorectal Biopsy , Prostate Biopsy, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Biopsy Devices Market Overview
Biopsy Devices Market (USD Million)
Biopsy Devices Market was valued at USD 2,543.23 million in the year 2024. The size of this market is expected to increase to USD 3,905.62 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 6.3%.
Global Biopsy Devices Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 6.3 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 6.3 % |
Market Size (2024) | USD 2,543.23 Million |
Market Size (2031) | USD 3,905.62 Million |
Market Concentration | Medium |
Report Pages | 376 |
Major Players
- C. R. Bard, Inc.
- Hologic Inc
- Becton
- Dickinson and Company
- Devicor Medical Products, Inc.
- Cook Medical
- Boston Scientific Corporation
- Intact Medical Corporation
- Gallini Medical
- TSK Laboratory Europe B.V.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Biopsy Devices Market
Fragmented - Highly competitive market without dominant players
The growing urgency to detect diseases like cancer at earlier stages is significantly accelerating the demand for biopsy devices. These tools now account for over 65% of critical diagnostic evaluations in oncology, highlighting their indispensable role in modern healthcare protocols.
Innovation in Biopsy Technology Supporting Better Outcomes
Advancements in biopsy device technology, including the integration of high-resolution imaging and navigation systems, are improving procedural accuracy. Around 55% of newly launched biopsy instruments now feature enhanced precision systems, enabling safer and faster diagnoses.
Preference Shifting to Less Invasive Techniques
Minimally invasive biopsy options are rapidly becoming the standard in diagnostics, reducing procedural complications and patient recovery time. Currently, about 60% of biopsies are performed using less invasive, image-guided approaches, minimizing the need for surgical interventions.
Healthcare Infrastructure Development Fuels Device Adoption
The increasing allocation of healthcare budgets toward diagnostic capabilities is advancing the adoption of biopsy technologies. Over 50% of hospitals and diagnostic centers are actively investing in biopsy equipment upgrades, aiming for better diagnostic throughput and efficiency.
Smart Technologies Reshaping Biopsy Procedures
Cutting-edge technologies such as robotics and AI are streamlining biopsy procedures with features like automated targeting and analytics support. Nearly 40% of development pipelines in the sector are focused on these smart enhancements, improving both clinician efficiency and diagnostic accuracy.
Biopsy Devices Market Recent Developments
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In 2024, BD merged with a leading medical device innovator to develop next-generation biopsy instruments, enhancing its global market presence.
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In 2023, Medtronic acquired a biotech company focused on advanced biopsy device technologies, aiming to expand its minimally invasive diagnostic solutions.
Biopsy Devices Market Segment Analysis
In this report, the Biopsy Devices Market has been segmented by Product, Applicationt, Procedure Type, Guidance Technique, and Geography.
Biopsy Devices Market, Segmentation by Product
The Biopsy Devices Market has been segmented by Product into Needle-based biopsy Instruments, lung biopsy market, biopsy needle market size, ,tissue biopsy market, Procedure Trays, Localization Wires, and Others.
Needle-based Biopsy Instruments
The needle-based biopsy instruments segment dominates the market, driven by the increasing incidence of cancer and minimally invasive diagnostic procedures. These tools account for nearly 45% of the biopsy devices market, thanks to their precision and ease of use. Demand is further boosted by rising awareness about early disease detection and technological improvements in needle design.
Lung Biopsy Market
The lung biopsy market is witnessing steady growth due to the global surge in respiratory disorders, particularly lung cancer. Approximately 20% of the biopsy procedures are conducted for lung-related diagnoses. The rise in CT-guided and bronchoscopic techniques has improved the accuracy and safety of lung biopsies, making them more widely adopted in both developed and emerging regions.
Biopsy Needle Market Size
The biopsy needle market holds a significant share in the overall diagnostic device landscape, with fine-needle aspiration and core-needle biopsy seeing increasing preference. This sub-segment contributes to around 30% of total biopsy procedures globally. The growing demand for accurate and minimally invasive diagnostic tools plays a crucial role in this market’s expansion.
Tissue Biopsy Market
The tissue biopsy market is essential in cancer diagnostics and disease staging. With technological advancements in imaging and sampling precision, tissue biopsies represent nearly 25% of diagnostic biopsies worldwide. Increasing hospital and pathology lab investments are accelerating market penetration and accessibility in diverse healthcare settings.
Procedure Trays
Procedure trays enhance clinical efficiency by providing a ready-to-use, sterile setup for biopsy procedures. They contribute to approximately 10% of the market and are increasingly favored in outpatient settings and ambulatory surgical centers due to their convenience and time-saving benefits.
Localization Wires
Localization wires are crucial for accurately identifying and marking the biopsy target area, especially in breast and soft tissue procedures. They hold about 8% market share, supported by the growing number of image-guided biopsy techniques that demand precise tissue localization.
Others
The others category includes ancillary tools such as biopsy forceps and vacuum-assisted devices, accounting for the remaining 7% of the market. This segment benefits from ongoing innovation and the increasing application of advanced imaging-guided biopsies in complex diagnostic cases.
Biopsy Devices Market, Segmentation by Application
The Biopsy Devices Market has been segmented by Application into Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy, and Others.
Breast Biopsy
The breast biopsy segment commands a significant share of the biopsy devices market, representing approximately 30% of total applications. This dominance is attributed to the high global prevalence of breast cancer and the increasing use of imaging-guided biopsies such as stereotactic and ultrasound-guided techniques. Enhanced awareness and screening programs are driving early diagnosis and boosting demand.
Lung Biopsy
Lung biopsy procedures account for around 20% of biopsy applications, largely due to rising lung cancer incidence and advancements in minimally invasive diagnostic methods. Techniques like CT-guided and bronchoscopic lung biopsies offer accurate tissue sampling, contributing to wider adoption across both developed and emerging healthcare markets.
Colorectal Biopsy
The colorectal biopsy segment holds approximately 15% of the market share. It is primarily driven by increased colorectal cancer screening and surveillance, especially in aging populations. Technological enhancements in colonoscopy-assisted biopsy tools are also promoting efficiency and diagnostic precision in gastrointestinal evaluations.
Prostate Biopsy
The prostate biopsy market constitutes about 18% of biopsy applications. The prevalence of prostate cancer, particularly among men over 50, has led to greater use of transrectal ultrasound (TRUS)-guided biopsies. The trend towards early-stage detection and better urological imaging tools continues to fuel this segment’s growth.
Others
The others category, encompassing liver, kidney, thyroid, and skin biopsies, represents the remaining 17% of the application market. Ongoing improvements in image-guided and minimally invasive techniques are facilitating broader use of biopsies across a wider range of conditions and anatomical sites.
Biopsy Devices Market, Segmentation by Procedure Type
The Biopsy Devices Market has been segmented by Procedure Type Surgical Biopsy and Needle Biopsy.
Surgical Biopsy
The surgical biopsy procedure type holds a notable position in the market, accounting for approximately 35% of all biopsy procedures globally. This method is often used when a larger or more intact tissue sample is required for precise pathological analysis. Despite being more invasive, it remains essential for complex or ambiguous diagnostic cases. Its use is prevalent in hospital settings, especially for deep tissue and internal organ biopsies.
Needle Biopsy
The needle biopsy segment dominates the biopsy procedure market, making up about 65% of global procedures due to its minimally invasive nature and quick recovery time. It includes core needle and fine-needle aspiration techniques, which are increasingly preferred for their accuracy and reduced patient discomfort. Advancements in image-guided technologies have further propelled the widespread adoption of this procedure type.
Biopsy Devices Market, Segmentation by Guidance Technique
The Biopsy Devices Market has been segmented by Guidance Technique into Ultrasound Guided Biopsy, Stereotactic Guided Biopsy, MRI Guided Biopsy, and Others.
Ultrasound Guided Biopsy
Ultrasound guided biopsy is the most widely adopted technique, accounting for approximately 40% of the global biopsy procedures. It is highly preferred due to its real-time imaging capability, affordability, and non-ionizing nature. This method is especially popular in breast, thyroid, and liver biopsies, where precise targeting is essential for accurate diagnosis.
Stereotactic Guided Biopsy
Stereotactic guided biopsy represents around 25% of the biopsy guidance market. It uses a three-dimensional coordinate system to locate small lesions, often in breast tissue. The high precision and effectiveness of this method make it a preferred choice for microcalcification and non-palpable lesion assessment.
MRI Guided Biopsy
MRI guided biopsy holds a share of approximately 15% in the guidance technique segment. It is especially useful for soft tissue evaluation and complex anatomical regions, such as the brain and prostate. Though costlier, its superior image clarity drives its demand in high-accuracy diagnostic settings.
Others
The others category, including CT-guided and fluoroscopy-guided biopsies, makes up the remaining 20% of the market. These techniques are often used when ultrasound or MRI is not suitable, offering flexibility across diverse clinical scenarios and anatomical locations.
Biopsy Devices Market, Segmentation by Geography
In this report, the Biopsy Devices Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Regions and Countries Analyzed in this Report
Biopsy Devices Market Share (%), by Geographical Region
North America
North America dominates the biopsy devices market, holding a market share of approximately 38%. This leadership is driven by advanced healthcare infrastructure, high awareness of early cancer diagnosis, and strong reimbursement frameworks. The U.S. remains the largest contributor, with significant investment in minimally invasive diagnostic technologies.
Europe
Europe follows with around 27% market share, supported by growing adoption of image-guided biopsy procedures and government initiatives for cancer screening. Countries like Germany, the UK, and France are major hubs due to increased healthcare funding and a rising elderly population that demands early-stage diagnostics.
Asia Pacific
Asia Pacific is the fastest-growing region, accounting for about 22% of the market. Rapid urbanization, rising healthcare expenditure, and increased cancer incidence—particularly in China, India, and Japan—are accelerating biopsy adoption. Technological advancements and expanded healthcare access are fueling this upward trajectory.
Middle East and Africa
Middle East and Africa contribute approximately 7% to the biopsy devices market. Although growth is slower due to limited infrastructure, increasing healthcare investments and awareness programs in the GCC and South Africa are gradually improving diagnostics accessibility in the region.
Latin America
Latin America holds about 6% of the market, with Brazil and Mexico leading the regional adoption. Growing demand for cancer diagnostics, improving healthcare systems, and medical tourism are supporting the market’s expansion, despite some economic and regulatory challenges.
Biopsy Devices Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Biopsy Devices Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Growing cancer screening initiatives
- Technological advancements in minimally invasive devices
- Rising prevalence of chronic diseases
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Increasing outpatient diagnostic procedures - The growing number of outpatient diagnostic procedures is significantly accelerating the demand for modern biopsy devices. As healthcare systems shift toward minimally invasive techniques that ensure faster recovery and improved patient convenience, biopsy tools suited for outpatient use have seen a rise in adoption. This trend is largely supported by the increasing focus on early disease detection, especially in oncology and chronic conditions.
Modern biopsy instruments are being designed for speed, precision, and portability, making them ideal for use in ambulatory settings. Clinics and diagnostic centers benefit from these advanced devices, which allow for quicker diagnosis and treatment planning while avoiding costly hospital stays. As more people seek accessible diagnostic solutions, the relevance of reliable biopsy technologies continues to rise.
Growing patient awareness, combined with initiatives by healthcare providers to expand preventive screening programs, is further fueling the demand. Moreover, advances in image-guided biopsy tools have made the procedure more accurate and efficient, reinforcing their role in modern outpatient care systems.
This movement toward decentralized diagnostics positions biopsy devices as a critical tool in transforming patient care. The ability to perform safe, accurate, and cost-effective procedures outside traditional hospitals is expected to sustain long-term growth for the biopsy devices market.
Restraints:
- Risk of procedural complications
- Stringent regulatory approvals
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Limited access in remote areas - Despite technological progress, a major challenge facing the biopsy devices market is the limited access to diagnostic tools in remote areas. Many rural regions lack the essential infrastructure, including specialized facilities and trained healthcare professionals, which are crucial for performing accurate biopsy procedures.
This lack of access leads to delays in diagnosis and, in some cases, missed opportunities for early intervention in life-threatening diseases such as cancer. Patients in underserved regions often need to travel long distances for diagnostic care, creating barriers that discourage timely medical attention.
Additionally, the absence of skilled radiologists and technical staff further hinders the adoption of advanced biopsy systems in these areas. While mobile diagnostic units and telemedicine solutions offer promise, their limited implementation prevents widespread impact on healthcare outcomes in rural settings.
Improving access through infrastructure development and capacity building will be essential to address this challenge. Until such improvements become widespread, this factor will remain a significant restraint on market expansion, particularly in developing regions.
Opportunities:
- Development of needle-free biopsy tools
- Integration with imaging technologies
- Rising demand in emerging markets
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Personalized biopsy and diagnostic solutions - The push toward personalized healthcare is opening new avenues for innovation in biopsy devices. As precision medicine gains momentum, there's an increasing demand for diagnostic solutions that provide in-depth insights into a patient's molecular and genetic profile. This makes biopsy tools that support targeted diagnostics more essential than ever.
Biopsy technologies are evolving to integrate advanced features such as real-time analysis, minimally invasive sample collection, and AI-driven interpretation. These innovations enable physicians to tailor treatment plans based on individual biological characteristics, significantly improving patient outcomes.
Emerging techniques like liquid biopsies, robotic-assisted procedures, and image-guided sampling are reshaping diagnostic workflows. These methods reduce patient discomfort, speed up diagnosis, and increase diagnostic accuracy—making them ideal for modern personalized care settings.
With the global shift toward individualized treatment plans, companies investing in smart, adaptive biopsy devices stand to benefit. The ability to meet the demands of personalized medicine while maintaining high efficiency presents a compelling opportunity for future market growth.
Biopsy Devices Market Competitive Landscape Analysis
Key players in Biopsy Devices Market include:
- C. R. Bard, Inc.
- Hologic Inc
- Becton
- Dickinson and Company
- Devicor Medical Products, Inc.
- Cook Medical
- Boston Scientific Corporation
- Intact Medical Corporation
- Gallini Medical
- TSK Laboratory Europe B.V.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Product Type
- Market Snapshot, By Guidance Technique
- Market Snapshot, By Application
- Market Snapshot, By Region
- Biopsy Devices Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Growing cancer screening initiatives
- Technological advancements in minimally invasive devices
- Rising prevalence of chronic diseases
- Increasing outpatient diagnostic procedures
- Restraints
- Risk of procedural complications
- Stringent regulatory approvals
- Limited access in remote areas
- Opportunities
- Development of needle-free biopsy tools
- Integration with imaging technologies
- Rising demand in emerging markets
- Personalized biopsy and diagnostic solutions
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Biopsy Devices Market, By Product, 2021 - 2031 (USD Million)
- Needle-based biopsy Instruments
- Core Biopsy Devices
- Aspiration Biopsy Needles
- Vacuum-Assisted Biopsy Devices
- Procedure Trays
- Localization Wires
- Others
- Needle-based biopsy Instruments
- Biopsy Devices Market, By Procedure Type, 2021 - 2031 (USD Million)
- Surgical Biopsy
- Needle Biopsy
- Biopsy Devices Market, By Guidance Technique, 2021 - 2031 (USD Million)
- Ultrasound Guided Biopsy
- Stereotactic Guided Biopsy
- MRI Guided Biopsy
- Others.
- Biopsy Devices Market, By Application, 2021 - 2031 (USD Million)
- Breast Biopsy
- Lung Biopsy
- Colorectal Biopsy
- Prostate Biopsy
- Others
- Biopsy Devices Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Biopsy Devices Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- C. R. Bard, Inc.
- Hologic Inc
- Becton, Dickinson and Company
- Devicor Medical Products, Inc.
- Cook Medical
- Boston Scientific Corporation
- Intact Medical Corporation
- Gallini Medical
- TSK Laboratory Europe B.V.
- Company Profiles
- Analyst Views
- Future Outlook of the Market