Biopsy Devices Market Set to Grow Steadily Through 2032, Driven by Rising Cancer Incidence and Minimally Invasive Innovation – DelveInsight | Boston Scientific, Medtronic, BD, Hologic
(Albany, US), September 27, 2026 – DelveInsight’s report on the “Biopsy Devices Market” provides a comprehensive overview of the global biopsy devices landscape, highlighting key trends, growth drivers, challenges, and opportunities shaping the industry. The global biopsy devices market size is expected to increase from USD 5,813.16 million in 2024 to USD 10,812.77 million by 2032, growing at a CAGR of 8.09% during the forecast period from 2025 to 2032.
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Some of the key facts of the Biopsy Devices Market Report:
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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.
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In April 2025, ArteraAI Prostate received de novo marketing authorization, an AI tool analyzing digital pathology from biopsy slides to predict long-term outcomes and guide treatment strategies.
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In February 2025, Ibex Medical Analytics received FDA 510(k) clearance for its Ibex Prostate Detect AI-powered digital pathology software to aid detection of prostate cancer from biopsy tissue.
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In January 2025, Biobot Surgical’s Mona Lisa 2.0 robotic system obtained CE certification for prostate biopsy and ablation, enabling real-time needle trajectory adjustments.
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The global biopsy devices market is projected to grow from USD 5,813.16 million in 2024 to USD 10,812.77 million by 2032, at a CAGR of 8.09%.
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North America is expected to dominate the market in 2024, accounting for approximately 41% of the total share.
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Needle-based Biopsy Instruments are anticipated to dominate the product type segment, accounting for around 39% of the share in 2024.
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Breast Biopsy is anticipated to dominate the application segment, accounting for around 30% of the market share in 2024.
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Hospitals are expected to hold the largest end-user share in 2024.
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In July 2025, Selio Medical earned FDA clearance for its Pre-B. Seal device, designed to reduce post-lung biopsy pneumothorax.
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In July 2025, Mendaera secured FDA clearance for its handheld robotic needle delivery system for fine-needle aspiration (FNA) biopsies.
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In January 2025, Biobot Surgical’s Mona Lisa 2.0 robotic system, designed for prostate biopsy and ablation, obtained CE certification.
Biopsy Devices Market Overview
Biopsy devices are specialized medical instruments used to extract tissue or cell samples from a patient’s body for laboratory examination. Their primary purpose is to diagnose diseases, most notably cancer, but they are also used to investigate other conditions such as infections, inflammation, and immune disorders. As biopsy remains the gold standard for confirming cancer diagnoses, rising suspected and confirmed cancer cases have led to a significant surge in biopsy procedures, further amplified by global screening programs and regular mammography.
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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), there were approximately 102,000 incident cases of triple-negative breast cancer (TNBC) in the 7MM in 2023, while global breast cancer incidence stood at 2,296,841 cases in 2022 and is projected to reach 3,364,291 cases by 2045.
The market is being propelled by growing adoption of minimally invasive biopsy methods such as core needle biopsy, fine-needle aspiration, and vacuum-assisted biopsy, which are often image-guided and enable high-accuracy tissue sampling while minimizing trauma. 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, designed for prostate biopsy and ablation, received CE certification, integrating real-time needle trajectory adjustments to enhance precision.
Biopsy Devices Market Restraints and Challenges
Despite strong growth drivers, the market faces several restraints. The high cost of advanced devices, such as image-guided and robot-assisted systems, limits affordability, particularly for smaller healthcare facilities and emerging economies. Risk of complications and patient anxiety around bleeding and tissue trauma can hinder adoption. Stringent and time-consuming regulatory processes delay product launches and stifle innovation, especially for startups, while growing competition from alternative diagnostics such as liquid biopsies and advanced imaging poses a long-term challenge. A shortage of skilled professionals trained on complex devices further impedes widespread adoption.
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Biopsy Devices Market Segment Analysis
By Product Type: Needle-based biopsy instruments – including core needle, fine-needle aspiration (FNA), and vacuum-assisted biopsy (VAB) needles – are anticipated to dominate with around 39% share in 2024, owing to their minimally invasive nature, high diagnostic accuracy, and use across the breast, lung, prostate, liver, and kidney. Continuous advancements such as sharper tips, ergonomic handles, single-use disposables, and automated integration are enhancing accuracy and reducing complications; in July 2025, Mendaera secured FDA clearance for its handheld robotic needle delivery system for FNA procedures.
By Application: Breast biopsy is anticipated to dominate with around 30% share in 2024, driven by the rising global incidence of breast cancer and the role of breast biopsy as the gold standard for confirming abnormal mammography or ultrasound findings. In May 2024, Hologic launched a disposable 7-gauge breast biopsy needle as part of its Brevera breast biopsy system in Europe, complementing its existing 9-gauge option.
By End-User: Hospitals are expected to hold the largest share in 2024 due to high procedure volumes, availability of advanced imaging and biopsy technologies, and the presence of skilled healthcare professionals.
North America Biopsy Devices Market Trends
North America is projected to dominate the global market in 2024 with approximately 41% share, owing to high cancer prevalence, well-established healthcare infrastructure, strong adoption of advanced diagnostic technologies, and favorable reimbursement policies. According to DelveInsight estimates (2024), new incidence cases of breast cancer in North America were 306,308 in 2022, projected to rise to 384,262 by 2045. Technological innovations such as vacuum-assisted biopsy systems, robotic-assisted platforms, and advanced image-guided techniques, along with AI-driven digital pathology, are enhancing precision and workflow efficiency – for instance, in January 2025, Roche received FDA 510(k) clearance for its VENTANA DP 600 slide scanner.
Europe Biopsy Devices Market Trends
Europe is playing a significant role in market growth due to rising cancer prevalence. According to DelveInsight estimates (2024), new incidence cases of breast cancer in Europe were 557,533 in 2022, projected to increase to 600,705 by 2045. Strong healthcare infrastructure, growing adoption of advanced diagnostic technologies, supportive government initiatives, and increased investment in cancer research are further fueling demand for core needle, vacuum-assisted, and image-guided biopsy techniques.
Asia-Pacific Biopsy Devices Market Trends
Asia-Pacific is emerging as a major growth driver due to rising cancer prevalence, increasing awareness of early disease detection, and improving access to advanced healthcare technologies. Rapidly expanding healthcare infrastructure, growing diagnostic investments, government-led screening initiatives, and rising healthcare spending in countries like China, India, and Japan are creating strong demand for minimally invasive and image-guided biopsy procedures.
Competitive Landscape of the Biopsy Devices Market
The competitive landscape is characterized by moderate to high concentration, with 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, focusing on vacuum-assisted and image-guided systems, while regional and niche players gain traction through cost-effective solutions targeting emerging markets. Strategic collaborations, acquisitions, and regulatory approvals continue to intensify competition.
Key Factors Driving the Biopsy Devices Market
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Increasing Cancer Incidence and Chronic Diseases: Rising global prevalence of cancer and other chronic conditions requiring tissue analysis is fueling demand for accurate, timely diagnosis.
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Increasing Demand for Minimally Invasive Procedures: Preference for reduced pain, shorter recovery, and greater accuracy is boosting adoption of needle-based, image-guided, and vacuum-assisted techniques.
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Increasing Technological Advancements: Vacuum-assisted systems, image-guided techniques, robotic-assisted procedures, and liquid biopsy innovations are enhancing diagnostic accuracy, speed, and patient safety.
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Scope of the Biopsy Devices Market Report
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Study Period: 2022–2032
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Base Year: 2024
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Forecast Period: 2025–2032
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Biopsy Devices Market CAGR: 8.09%
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Biopsy Devices Market Segments: by Product Type, by Application, by End-User, and by Geography
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Biopsy Devices Regional Scope: North America, Europe, Asia Pacific, Middle East, Africa, and South America
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Biopsy Devices Country Scope: U.S., Canada, Mexico, Germany, United Kingdom, France, Italy, Spain, China, Japan, India, Australia, South Korea, and key countries
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Key Companies: 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
Table of Content
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Biopsy Devices Market Report Introduction
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Biopsy Devices Market Executive Summary
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Biopsy Devices Market Key Factors Analysis
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Impact Analysis
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Regulatory Analysis
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Biopsy Devices Market Porter’s Five Forces Analysis
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Biopsy Devices Market Assessment
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Competitive Landscape
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Startup Funding & Investment Trends
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Biopsy Devices Market Company and Product Profiles
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KOL Views
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Project Approach
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About DelveInsight
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Disclaimer & Contact Us
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