Biopsy Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032

Biopsy Devices Market Summary

• The global biopsy devices market is expected to increase from USD 5,813.16 million in 2024 to USD 10,812.77 million by 2032, reflecting strong and sustained growth.
• The global biopsy devices market is growing at a CAGR of 8.09% during the forecast period from 2025 to 2032.
• The market of biopsy devices is being primarily driven by the rising incidence of cancer, such as breast, lung, prostate, and colorectal cancer, among others, increasing demand for minimally invasive procedures, increasing technological advancements in devices, and an increase in product development activities among the key market players.
• The leading companies operating in the biopsy devices market include Boston Scientific Corporation, Cardinal Health, Medtronic, BD, Cook, Devicor Medical Products Inc., B. Braun Melsungen AG, ARGON MEDICAL, OLYMPUS CORPORATION, FUJIFILM, INRAD Inc., Hologic Inc., C. R. Bard, Dr. Japan Co Ltd., Limaca-medical, Owlstone Medical Ltd., Zamar Care, KOELIS, ST. STONE MEDICAL DEVICES PVT LTD, Iscon Surgicals Ltd., and others.
• North America is expected to dominate the overall biopsy devices market due to the high prevalence of cancer, well-established healthcare infrastructure, strong adoption of advanced diagnostic technologies, and favorable reimbursement policies. The region also benefits from the presence of leading medical device manufacturers and ongoing R&D investments, which drive the availability of innovative biopsy solutions. Additionally, increasing awareness and government-led cancer screening programs further strengthen North America's leading position in the global market.
• In the product type segment of the biopsy devices market, the needle-based biopsy instruments category is estimated to account for the largest market share in 2024.

Factors Contributing to the Growth of the Biopsy Devices Market

• Increasing Cancer Incidence and Chronic Diseases leading to a surge in biopsy devices: The primary driver of the biopsy devices market is the rising global prevalence of cancer. As cancer is a leading cause of death worldwide, the need for accurate and timely diagnosis is paramount. Biopsies remain the gold standard for confirming a cancer diagnosis and determining its stage, which is crucial for effective treatment planning. Additionally, the growing incidence of other chronic conditions that require tissue analysis, such as various gastrointestinal, inflammatory, and neurological diseases, further fuels the demand for biopsy devices.
• Increasing demand for minimally invasive procedures is escalating the market for biopsy devices: The growing preference for minimally invasive procedures is escalating the biopsy devices market, as patients and healthcare providers seek options that offer reduced pain, shorter recovery time, lower complication risks, and greater accuracy. This shift has boosted the adoption of needle-based, image-guided, and vacuum-assisted biopsy techniques, driving consistent market growth.
• Increasing technological advancements in biopsy devices: Increasing technological advancements in biopsy devices, such as vacuum-assisted systems, image-guided techniques, robotic-assisted procedures, and liquid biopsy innovations, are enhancing diagnostic accuracy, speed, and patient safety. These innovations are making biopsies more efficient and less invasive, thereby accelerating the adoption of advanced biopsy devices in clinical practice.

Biopsy Devices Market Report Segmentation

This biopsy devices market report offers a comprehensive overview of the global biopsy devices market, highlighting key trends, growth drivers, challenges, and opportunities. It covers detailed market segmentation by Product Type (Needle-based Biopsy Instruments, Biopsy Guidance Systems, Robotic Biopsy Devices, and Biopsy Accessories), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy, and Others), End-User (Hospitals, Diagnostic & Imaging Centers, and Others), and geography. The report provides valuable insights into the competitive landscape, regulatory environment, and market dynamics across major markets, including North America, Europe, and Asia-Pacific. Featuring in-depth profiles of leading industry players and recent product innovations, this report equips businesses with essential data to identify market potential, develop strategic plans, and capitalize on emerging opportunities in the rapidly growing biopsy devices market.

Biopsy devices are specialized medical instruments used to extract tissue or cell samples from a patient's body for laboratory examination. The primary purpose of these devices is to diagnose diseases, most notably cancer, but they are also used to investigate a variety of other conditions, such as infections, inflammation, and immune disorders.

The biopsy devices market is being collectively boosted by the rising incidence of cancers such as breast, lung, prostate, and colorectal, which is driving the need for accurate diagnosis. At the same time, the growing demand for minimally invasive procedures and technological advancements like vacuum-assisted and image-guided systems are improving efficiency and patient outcomes. Additionally, increased product development activities by key players are expanding the availability of innovative solutions, together fuelling strong market growth.

What are the latest Biopsy Devices Market Dynamics and Trends?

The biopsy devices market is witnessing accelerated growth, primarily driven by the rising global burden of cancer, including breast, lung, and prostate cancers. According to DelveInsight's estimates (2024), in 2023, there were approximately 102,000 incident cases of triple-negative breast cancer (TNBC) in the 7MM. Furthermore, global breast cancer incidence stood at 2,296,841 cases in 2022 and is projected to reach 3,364,291 cases by 2045, highlighting the urgent need for accurate and scalable diagnostic tools.

As biopsy remains the gold standard for confirming cancer diagnoses, the rising number of suspected and confirmed cancer cases has led to a significant surge in biopsy procedures. This trend is further amplified by the global push toward early detection through screening programs and regular mammography, which increases the demand for precise, safe, and minimally invasive biopsy solutions.

The market is being propelled by the growing adoption of minimally invasive biopsy methods, such as core needle biopsy, fine-needle aspiration, and vacuum-assisted biopsy. These techniques, often image-guided, enable high-accuracy tissue sampling while minimizing trauma to surrounding tissues, making them preferable in both hospital and outpatient settings. This shift toward less invasive diagnostics is reshaping clinical practice and fueling continuous technological innovation.

Product development and regulatory milestones are also playing a pivotal role. For instance, in January 2025, Biobot Surgical's Mona Lisa 2.0 robotic system received CE certification. Specifically designed for prostate biopsy and ablation, the system integrates real-time needle trajectory adjustments, thereby enhancing precision and reducing the risk of tissue injury. Similar advancements in robotics, imaging integration, and AI-assisted biopsy guidance are expected to expand the scope and efficiency of biopsy procedures across multiple cancer types.

Looking ahead, the increasing cancer incidence, combined with technological innovation, patient preference for minimally invasive techniques, and strong product pipelines, will continue to propel the biopsy devices market forward, making it a critical segment of the cancer diagnostics landscape.

The biopsy devices market, despite its strong growth drivers, faces several significant restraints and challenges. A primary concern is the high cost of advanced devices, such as image-guided and robot-assisted systems, which limits their affordability and accessibility, particularly for smaller healthcare facilities and in emerging economies. The risk of complications and patient anxiety, including concerns about bleeding and tissue trauma, can also hinder adoption and cause patients to delay or refuse a necessary procedure. Furthermore, the market is constrained by stringent regulatory processes that are time-consuming and expensive, delaying product launches and stifling innovation, especially for startups. The growing competition from alternative diagnostic methods, such as liquid biopsies and advanced imaging, poses a long-term challenge to the traditional tissue biopsy segment. Lastly, a shortage of skilled professionals who are trained to use these complex devices creates a bottleneck, impeding the widespread adoption of new technologies.

Biopsy Devices Market Segment Analysis

Biopsy Devices Market by Product Type (Needle-based Biopsy Instruments, Biopsy Guidance Systems, Robotic Biopsy Devices, and Biopsy Accessories), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy, and Others), End-User (Hospital, Diagnostic Centers, Imaging Centers, and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

By Product Type: Needle-based Biopsy Instruments Category Dominates the Market

Within the product type segment of the biopsy devices market, needle-based biopsy instruments are anticipated to dominate, accounting for around 39% of the share in 2024, as needle-based procedures remain the most widely adopted and trusted method for tissue sampling. Biopsy needles based instruments, including core needle, fine-needle aspiration (FNA), and vacuum-assisted biopsy (VAB) needles, are increasingly preferred due to their minimally invasive nature, high diagnostic accuracy, and patient comfort compared to surgical biopsies. These needle instruments enable precise and reliable tissue extraction from various organs such as the breast, lung, prostate, liver, and kidney, making them essential across oncology, infectious disease diagnosis, and transplant monitoring. The rising global burden of cancers, particularly breast and prostate, has fueled the demand for core and vacuum-assisted needles, which are often used in combination with imaging modalities like ultrasound, MRI, and CT scans for guided procedures.

Furthermore, continuous technological advancements in needle design, such as sharper tips, ergonomic handles, single-use disposables, and integration with automated systems, are enhancing accuracy, reducing complications, and increasing efficiency for clinicians. For instance, in July 2025, Mendaera secured FDA clearance for its handheld robotic needle delivery system, designed to enhance precision in fine-needle aspiration (FNA) biopsies, among other minimally invasive procedures. Thus, the factors mentioned above are expected to boost the category, thereby boosting the overall market of biopsy devices across the globe.

By Application: Breast Biopsy Category Dominates the Market

Within the application segment of the biopsy devices market, breast biopsies are anticipated to dominate, accounting for around 30% of the market share in 2024, as breast biopsy procedures are playing a pivotal role in boosting the overall market of biopsy devices, primarily due to the rising global incidence of breast cancer, which is one of the most common cancers among women. As breast biopsy remains the gold standard for confirming diagnosis after abnormal findings in mammography or ultrasound, the growing emphasis on early detection and screening programs is driving demand for advanced biopsy technologies. Additionally, the minimally invasive techniques such as core needle biopsy, fine-needle aspiration, and vacuum-assisted breast biopsy (VABB) are increasingly preferred over surgical biopsies because they provide high diagnostic accuracy, reduced patient discomfort, and faster recovery times. For instance, in May 2024, Hologic launched a disposable 7-gauge breast biopsy needle as part of its Brevera breast biopsy system in Europe. This complements their existing 9-gauge option, allowing clinicians more flexibility to choose appropriate needle sizes for enhanced diagnostic accuracy and patient comfort. The Brevera system uniquely integrates tissue acquisition, real-time imaging, and post-biopsy handling in a single workflow.

Collectively, these factors make breast biopsy a key driver in expanding the overall biopsy devices market.

By End-User: Hospitals Dominate the Market

In the biopsy devices market, hospitals are expected to hold the largest end-user share in 2024 due to the high volume of diagnostic procedures performed, availability of advanced imaging and biopsy technologies, and presence of skilled healthcare professionals. Hospitals also serve as primary centers for cancer diagnosis, screening programs, and complex minimally invasive procedures, making them the dominant setting for biopsy device adoption.

Biopsy Devices Market Regional Analysis

North America Biopsy Devices Market Trends

North America is projected to dominate the global biopsy devices market in 2024, accounting for approximately 41% of the total share, due to the high prevalence of cancer, well-established healthcare infrastructure, strong adoption of advanced diagnostic technologies, and favorable reimbursement policies. The region also benefits from the presence of leading medical device manufacturers and ongoing R&D investments, which drive the availability of innovative biopsy solutions. Additionally, increasing awareness and government-led cancer screening programs further strengthen North America's leading position in the global market.

According to the DelveInsight estimates (2024), in North America, in 2022, the estimated new incidence cases of breast cancer were 306,308, and the projections are estimated to increase to 384,262 by 2045. Minimally invasive techniques such as core needle biopsy, fine-needle aspiration, and vacuum-assisted breast biopsy (VABB) are increasingly preferred over surgical breast biopsies because they provide high diagnostic accuracy, reduced patient discomfort, and faster recovery times, thereby boosting the overall market of biopsy devices across the region.

Additionally, technological innovations such as vacuum-assisted biopsy (VAB) systems, robotic-assisted platforms, and advanced image-guided techniques (ultrasound, MRI, CT) have enhanced precision, minimized sampling errors, and reduced repeat procedures. The rise of liquid biopsy is expanding non-invasive cancer detection, complementing traditional tissue methods. Integration of AI and digital pathology is improving workflow efficiency, real-time decision-making, and diagnostic accuracy, while modern devices are becoming more ergonomic, disposable, and outpatient-friendly, supporting the shift toward minimally invasive care. For instance, in January 2025, Roche received FDA 510(k) clearance for its VENTANA DP 600 slide scanner, enabling high-resolution digital pathology with AI support for precision oncology.

Therefore, the factors mentioned above are expected to drive the growth of the biopsy devices market in North America.

Europe Biopsy Devices Market Trends

Europe is playing a significant role in driving the growth of the biopsy devices market, due to the rising prevalence of cancer. According to the DelveInsight estimates (2024), in North America, in 2022, the estimated new incidence cases of breast cancer were 557,533, and the projections are estimated to increase to 600,705 by 2045. With breast cancer being one of the most commonly diagnosed cancers among women worldwide, the need for reliable biopsy techniques such as core needle biopsy, vacuum-assisted biopsy, and image-guided biopsy has surged. Additionally, strong healthcare infrastructure and a growing adoption of advanced diagnostic technologies. Supportive government initiatives, increased investment in cancer research, and widespread availability of minimally invasive biopsy techniques are further fueling demand. Moreover, Europe's emphasis on early disease detection and personalized medicine is boosting the uptake of innovative biopsy devices across hospitals and diagnostic centers.

Asia-Pacific Biopsy Devices Market Trends

Asia-Pacific is emerging as a major growth driver for the biopsy devices market due to the rising prevalence of cancer, increasing awareness about early disease detection, and improving access to advanced healthcare technologies. Rapidly expanding healthcare infrastructure, growing investments in diagnostic facilities, and government-led screening initiatives are further supporting market adoption. Additionally, the region's large patient pool, coupled with rising healthcare spending in countries like China, India, and Japan, is creating strong demand for minimally invasive and image-guided biopsy procedures. Global players are also expanding their presence in the region through partnerships and product launches, positioning Asia-Pacific as a key hub for future biopsy device market growth.

Who are the major players in the biopsy devices market?

The following are the leading companies in the biopsy devices market. These companies collectively hold the largest market share and dictate industry trends.

• Boston Scientific Corporation
• Cardinal Health
• Medtronic
• BD
• Cook
• Devicor Medical Products Inc.
• B. Braun Melsungen AG
• ARGON MEDICAL
• OLYMPUS CORPORATION
• FUJIFILM Corporation
• INRAD Inc.
• Hologic Inc.
• C. R. Bard
• Dr. Japan Co. Ltd.
• Limaca-medical
• Owlstone Medical Ltd.
• Zamar Care
• KOELIS
• ST. STONE MEDICAL DEVICES PVT LTD
• Iscon Surgicals Ltd.
• Others

How is the competitive landscape shaping the biopsy devices market?

The competitive landscape of the biopsy devices market is characterized by moderate to high concentration, with a few global players such as Becton Dickinson, Hologic, Boston Scientific, Devicor (Leica Biosystems/Danaher), and Cook Medical holding significant market shares. These companies compete on innovation, product portfolios, and global reach, often focusing on technological advancements like vacuum-assisted and image-guided systems to strengthen their positions. At the same time, regional and niche players are gaining traction by offering cost-effective solutions and targeting emerging markets. Strategic collaborations, acquisitions, and regulatory approvals are further intensifying competition, as companies aim to expand clinical applications and capture growing demand for minimally invasive diagnostic procedures, particularly in cancer care.

Recent Developmental Activities in the Biopsy Devices Market

• In July 2025, Selio Medical earned FDA clearance for its Pre-B. Seal device, the first of its kind to reduce post-lung biopsy pneumothorax by pre-sealing the biopsy site, improving safety and enabling same-day patient discharge.
• In April 2025, ArteraAI Prostate received de novo marketing authorization. It is an AI tool that analyzes digital pathology from biopsy slides to predict long-term outcomes (10-year metastasis/mortality risk), guiding treatment strategies. Includes a Predetermined Change Control Plan for updates without new submissions.
• In February 2025, Ibex Medical Analytics received FDA 510(k) clearance for its Ibex Prostate Detect AI-powered digital pathology software, designed to analyze prostate tissue biopsies and aid in detecting prostate cancer.
• In January 2025, Biobot Surgical's Mona Lisa 2.0 robotic system obtained CE certification in January 2025. Designed for prostate biopsy and ablation, it enables real-time needle trajectory adjustments to enhance precision and reduce tissue injury risk.

Biopsy Devices Market Segmentation

• Biopsy Devices Product Type Exposure
• Needle-based Biopsy Instruments
• Biopsy Guidance Systems
• Robotic Biopsy Devices
• Biopsy Accessories
• Biopsy Devices Application Exposure
• Breast Biopsy
• Lung Biopsy
• Colorectal Biopsy
• Prostate Biopsy
• Others
• Biopsy Devices End-Users Exposure
• Hospitals
• Diagnostic Centers
• Imaging Centers
• Ambulatory Surgical Centers
• Biopsy Devices Geography Exposure
• North America Biopsy Devices Market
• United States Biopsy Devices Market
• Canada Biopsy Devices Market
• Mexico Biopsy Devices Market
• Europe Biopsy Devices Market
• United Kingdom Biopsy Devices Market
• Germany Biopsy Devices Market
• France Biopsy Devices Market
• Italy Biopsy Devices Market
• Spain Biopsy Devices Market
• Rest of Europe Biopsy Devices Market
• Asia-Pacific Biopsy Devices Market
• China Biopsy Devices Market
• Japan Biopsy Devices Market
• India Biopsy Devices Market
• Australia Biopsy Devices Market
• South Korea Biopsy Devices Market
• Rest of Asia-Pacific Biopsy Devices Market
• Rest of the World Biopsy Devices Market
• South America Biopsy Devices Market
• Middle East Biopsy Devices Market
• Africa Biopsy Devices Market

Impact Analysis

AI-Powered Innovations and Applications:

AI-powered innovations are having a profound and transformative impact on the biopsy devices market, fundamentally reshaping diagnostic accuracy, procedural efficiency, and the role of the pathologist. By integrating AI into various stages of the biopsy workflow, companies are creating smarter and more precise devices. For instance, AI algorithms in digital pathology can analyze tissue slides with exceptional speed and accuracy, detecting subtle cellular abnormalities and reducing diagnostic errors, as demonstrated by the FDA-cleared Paige Prostate system. Furthermore, AI is being integrated into the biopsy procedure itself through AI-enabled image guidance, which helps surgeons to precisely target suspicious tissue, leading to a higher "first-pass yield" and reducing the need for repeat procedures. AI is also a critical component of advanced robotic-assisted biopsy systems, enabling automated needle navigation and real-time feedback that improves precision, especially in hard-to-reach areas. Ultimately, the ability of AI to integrate and analyze vast datasets from biopsies, medical images, and genomic information is a key step towards personalized medicine, helping clinicians create tailored treatment plans and streamlining the entire diagnostic pathway.

U.S. Tariff Impact Analysis on Biopsy Devices Market:

The new U.S. tariffs on imported goods are creating a significant and multifaceted impact on the global biopsy devices market. By raising the cost of essential components and finished products sourced from countries like China, these tariffs are directly increasing production expenses for manufacturers. This forces companies to either absorb the costs, which erodes profit margins, or pass them on to healthcare providers and, ultimately, patients, potentially leading to higher prices for procedures. In response to this, companies are strategically re-evaluating and diversifying their global supply chains to reduce reliance on heavily taxed countries. While this may incentivize some domestic production, it is a costly and logistically challenging endeavor that disproportionately affects smaller companies. The tariffs' impact is felt across all segments, from high-value robotic systems to high-volume consumables, creating a volatile and uncertain market landscape that could jeopardize the affordability and adoption of these essential medical devices.

How This Analysis Helps Clients

• Cost Management: By understanding the tariff landscape, clients can anticipate cost increases and adjust pricing strategies accordingly, ensuring profitability.
• Supply Chain Optimization: Clients can identify alternative sourcing options and diversify their supply chains to reduce dependency on high-tariff regions, enhancing resilience.
• Regulatory Navigation: Expert guidance on navigating the evolving regulatory environment helps clients maintain compliance and avoid potential legal challenges.
• Strategic Planning: Insights into tariff impacts enable clients to make informed decisions about manufacturing locations, partnerships, and market entry strategies.

Key takeaways from the Biopsy Devices market report study

• Market size analysis for the current biopsy devices market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the biopsy devices market.
• Various opportunities available for the other competitors in the biopsy devices market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current biopsy devices market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for the biopsy devices market growth in the future?

Frequently Asked Questions for the Biopsy Devices Market

1. What is the growth rate of the biopsy devices market?

• The biopsy devices market is estimated to grow at a CAGR of 8.09% during the forecast period from 2025 to 2032.

2. What is the market for biopsy devices?

• The biopsy devices market was valued at USD 5,813.16 million in 2024, and is expected to reach USD 10,812.77 million by 2032.

3. Which region has the highest share in the biopsy devices market?

• North America is expected to dominate the overall biopsy devices market due to the high prevalence of cancer, well-established healthcare infrastructure, strong adoption of advanced diagnostic technologies, and favorable reimbursement policies. The region also benefits from the presence of leading medical device manufacturers and ongoing R&D investments, which drive the availability of innovative biopsy solutions. Additionally, increasing awareness and government-led cancer screening programs further strengthen North America's leading position in the global market.

4. What are the drivers for the biopsy devices market?

• The biopsy devices market is being collectively boosted by the rising incidence of cancers such as breast, lung, prostate, and colorectal, which is driving the need for accurate diagnosis. At the same time, the growing demand for minimally invasive procedures and technological advancements like vacuum-assisted and image-guided systems are improving efficiency and patient outcomes. Additionally, increased product development activities by key players are expanding the availability of innovative solutions, together fuelling strong market growth.

5. Who are the key players operating in the biopsy devices market?

• Some of the key market players operating in the biopsy devices market include Boston Scientific Corporation, Cardinal Health, Medtronic, BD, Cook, Devicor Medical Products Inc., B. Braun Melsungen AG, ARGON MEDICAL, OLYMPUS CORPORATION, FUJIFILM, INRAD Inc., Hologic Inc., C. R. Bard, Dr. Japan Co Ltd., Limaca-medical, Owlstone Medical Ltd., Zamar Care, KOELIS, ST. STONE MEDICAL DEVICES PVT LTD, Iscon Surgicals Ltd., and others.