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DelveInsight’s “Biopsy Devices Market Insights, Competitive Landscape, and Market Forecast-2032” report delivers an in-depth understanding of the market dynamics, competitive landscape, key growth drivers, emerging technologies, and future opportunities shaping the global biopsy devices industry.

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Key Takeaways from the Biopsy Devices Market Report

• 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.

• Rising incidence of cancers such as breast, lung, prostate, and colorectal cancer is significantly increasing demand for accurate diagnostic solutions.

• Growing demand for minimally invasive procedures is escalating adoption of needle-based, image-guided, and vacuum-assisted biopsy techniques.

• Increasing technological advancements, including vacuum-assisted systems, image-guided techniques, robotic-assisted procedures, and liquid biopsy innovations, are enhancing diagnostic accuracy, speed, and patient safety.

• Needle-based biopsy instruments accounted for around 39% of the product type segment share in 2024, remaining the most widely adopted and trusted method for tissue sampling.

• Breast biopsy dominated the application segment with around 30% share in 2024, driven by the rising global incidence of breast cancer.

• North America is expected to dominate the overall market, accounting for approximately 41% of the total share in 2024, while Asia-Pacific is emerging as a key growth hub.

• Leading biopsy devices companies include Boston Scientific Corporation, Cardinal Health, Medtronic, BD, Cook, Devicor Medical Products Inc., Hologic Inc., and others.

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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. 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.

Factors Driving the Growth of the Biopsy Devices MarketIncreasing 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.

According to DelveInsight’s estimates (2024), in 2023, there were approximately 102,000 incident cases of triple-negative breast cancer (TNBC) in the 7MM. 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.

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. 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 and reduce the risk of tissue injury.

Biopsy Devices Market Segment AnalysisBy Product Type: Needle-based Biopsy Instruments Category Dominates the 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. These 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, and are often used with imaging modalities like ultrasound, MRI, and CT scans for guided procedures. In July 2025, Mendaera secured FDA clearance for its handheld robotic needle delivery system designed to enhance precision in fine-needle aspiration biopsies.

By Application: Breast Biopsy Category Dominates the Market

Breast biopsies are anticipated to dominate, accounting for around 30% of the market share in 2024, driven by the rising global incidence of breast cancer and the growing emphasis on early detection through mammography and ultrasound screening. 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 and integrating tissue acquisition, real-time imaging, and post-biopsy handling in a single workflow.

By End-User: Hospitals Dominate the 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, making them the dominant setting for biopsy device adoption.

Biopsy Devices Market Regional AnalysisNorth America is Expected to Dominate the Overall Biopsy Devices Market

North America is projected to dominate the global 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. According to DelveInsight estimates (2024), new incidence cases of breast cancer in North America were 306,308 in 2022, projected to increase to 384,262 by 2045. 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.

Europe Biopsy Devices Market Trends

Europe is playing a significant role in driving market growth due to the rising prevalence of cancer, with new incidence cases of breast cancer estimated at 557,533 in 2022, projected to increase to 600,705 by 2045. Strong healthcare infrastructure, supportive government initiatives, increased investment in cancer research, and widespread availability of minimally invasive biopsy techniques are further fueling demand.

Asia-Pacific Biopsy Devices Market Trends

Asia-Pacific is emerging as a major growth driver due to the rising prevalence of cancer, increasing awareness about early disease detection, and improving access to advanced healthcare technologies, supported by rapidly expanding healthcare infrastructure and rising healthcare spending in countries like China, India, and Japan.

Biopsy Devices Key Companies

Biopsy Devices Companies include:

• 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.

• and others.

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Latest Highlights from 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, an AI tool that analyzes digital pathology from biopsy slides to predict long-term outcomes and guide treatment strategies.

• 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, enabling real-time needle trajectory adjustments for prostate biopsy and ablation procedures.

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Biopsy Devices Market Outlook

The biopsy devices market is witnessing accelerated growth, primarily driven by the rising global burden of cancer, including breast, lung, and prostate cancers, alongside the global push toward early detection through screening programs and regular mammography. 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, often image-guided, which enable high-accuracy tissue sampling while minimizing trauma to surrounding tissues.

Despite strong growth drivers, the market faces restraints including the high cost of advanced devices such as image-guided and robot-assisted systems, risk of complications and patient anxiety, stringent and time-consuming regulatory processes, growing competition from alternative diagnostic methods such as liquid biopsies and advanced imaging, and a shortage of skilled professionals trained to use complex devices.

Looking ahead, 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.

Scope of the Biopsy Devices Market Report

Study Period: 2022–2032

Forecast Period: 2025–2032

Market Size (2032): USD 10,812.77 Million

CAGR (2025–2032): 8.09%

Major biopsy devices 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.

Market Segments Covered: Product Type, Application, End-User, and Geography.

Competitive Intelligence Analysis: Market trends, competitive landscape, strategic collaborations, acquisitions, investments, regulatory approvals, and emerging technologies.

Key Focus Areas: Needle-based Biopsy Instruments, Biopsy Guidance Systems, Robotic Biopsy Devices, Image-Guided Biopsy, Vacuum-Assisted Biopsy, and AI-Assisted Digital Pathology.

Table of Contents

1. Biopsy Devices Market Report Introduction

2. Biopsy Devices Market Executive Summary

3. Biopsy Devices Market Key Factors Analysis

4. Impact Analysis

5. Regulatory Analysis

6. Biopsy Devices Market Porter’s Five Forces Analysis

7. Biopsy Devices Market Assessment

8. Competitive Landscape

9. Startup Funding & Investment Trends

10. Biopsy Devices Market Company and Product Profiles

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer & Contact Us

How DelveInsight’s Biopsy Devices Market Report Helps CXOs and Business Leaders

• Evaluate the current and future market opportunity across key regions, including North America, Europe, Asia-Pacific, and Rest of the World, through detailed market forecasts, technology assessments, and growth trend analysis.

• Benchmark leading biopsy device technologies, products, and diagnostic platforms through comprehensive competitive intelligence, company profiling, product portfolio evaluation, and innovation tracking.

• Identify potential licensing, acquisition, co-development, and strategic partnership opportunities by monitoring emerging market participants, novel device technologies, and recent industry collaborations, mergers, and investments.

• Assess the impact of upcoming regulatory approvals, technological advancements, reimbursement developments, and product launches on market share, pricing strategies, adoption rates, and commercial success.

• Support strategic decision-making with insights into key opinion leader (KOL) perspectives, unmet diagnostic needs, clinical adoption trends, biomarker and biopsy technique utilization, patient stratification approaches, and evolving market dynamics within the Biopsy Devices landscape.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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