생검 기기 시장 : 세계 시장 예측(2026-2032년)

The Biopsy Devices Market is projected to grow by USD 15.30 billion at a CAGR of 9.43% by 2032.

Biopsy Devices Executive Summary

Biopsy devices are central to modern diagnostic pathways, enabling clinicians to obtain tissue samples for cancer diagnosis, infectious disease evaluation, organ transplant monitoring, and molecular pathology. Demand for minimally invasive biopsy systems is being reinforced by the rising global cancer burden, the expansion of image-guided procedures, and the clinical shift toward earlier detection and precision medicine. Core product categories include needle-based biopsy devices, vacuum-assisted biopsy systems, forceps, localization devices, guidance accessories, and specimen management tools used across breast, lung, prostate, liver, kidney, gastrointestinal, and soft-tissue applications.

The industry is being shaped by the need for higher diagnostic yield, fewer repeat procedures, improved patient comfort, and compatibility with advanced imaging modalities such as ultrasound, computed tomography, magnetic resonance imaging, mammography, and endoscopic platforms. Healthcare providers are prioritizing devices that support accurate targeting, tissue integrity, workflow efficiency, and safe sample retrieval in outpatient and ambulatory settings. At the same time, pathology laboratories increasingly require high-quality tissue suitable for immunohistochemistry, genomic testing, next-generation sequencing, and companion diagnostics. These trends position biopsy devices as a critical link between clinical suspicion, definitive diagnosis, and personalized treatment selection.

Transformative Shifts in the Biopsy Devices Landscape

The biopsy devices landscape is undergoing a significant transformation as healthcare systems move from invasive surgical sampling toward minimally invasive, image-guided, and outpatient-based tissue acquisition. Core needle biopsy and vacuum-assisted biopsy have gained clinical relevance because they can provide larger or more representative samples than fine-needle aspiration in many indications, while reducing the need for open surgical biopsy. In breast care, stereotactic, ultrasound-guided, and MRI-guided biopsy techniques are widely used to investigate suspicious lesions identified through screening and diagnostic imaging. In lung and abdominal applications, CT-guided and ultrasound-guided biopsy procedures continue to improve access to deep-seated lesions.

Another major shift is the integration of biopsy workflows with precision oncology. As treatment decisions increasingly depend on receptor status, biomarker expression, mutational profiling, and molecular signatures, tissue acquisition must preserve sample quality and minimize contamination or fragmentation. This is encouraging the adoption of devices designed for consistent core retrieval, controlled penetration depth, and compatibility with downstream pathology. Single-use and sterile biopsy instruments are also gaining prominence due to infection prevention standards and operational convenience.

The market is also being influenced by procedural migration into ambulatory surgery centers, interventional radiology suites, and office-based specialty settings. This shift increases demand for ergonomic, easy-to-use biopsy systems that shorten procedure times and integrate with existing imaging infrastructure. Regulatory emphasis on safety, traceability, and performance validation is further elevating expectations for device design, documentation, and post-market surveillance.

Cumulative Impact of Artificial Intelligence on Biopsy Devices

Artificial intelligence is beginning to influence biopsy devices through its role in imaging, lesion detection, procedural planning, targeting support, and pathology interpretation. In radiology, AI-enabled image analysis can help identify suspicious lesions, segment anatomical structures, prioritize cases, and support decision-making for whether a biopsy is warranted. When combined with ultrasound, mammography, CT, MRI, or endoscopic imaging, AI has the potential to improve lesion localization and reduce variability in procedure planning.

During biopsy procedures, AI-assisted navigation and image fusion can support more precise needle trajectory planning, particularly for small, deep, or difficult-to-access lesions. This is relevant in lung, prostate, liver, and breast biopsy where targeting accuracy directly affects diagnostic yield and repeat biopsy rates. In prostate care, for example, MRI-ultrasound fusion biopsy has become an important approach for targeting clinically significant lesions identified on multiparametric MRI, and AI may further enhance segmentation, lesion scoring, and workflow consistency.

The cumulative impact of artificial intelligence extends beyond tissue collection into digital pathology and molecular diagnostics. AI-based pathology tools can assist with tumor detection, grading support, biomarker quantification, and quality control of tissue sections. These capabilities increase the importance of collecting adequate, well-preserved tissue samples at the point of biopsy. However, adoption depends on clinical validation, interoperability with hospital systems, data governance, cybersecurity, regulatory clearance, and clinician trust. Industry participants that align biopsy devices with AI-enabled imaging and pathology ecosystems are better positioned to support precision diagnostics.

Key Regional Insights for Biopsy Devices

Asia-Pacific is experiencing strong demand drivers for biopsy devices due to rising cancer incidence, expanding diagnostic imaging infrastructure, growing use of screening programs, and increasing access to specialty care in urban centers. China, India, Japan, South Korea, and Australia are important contributors to regional adoption, with demand influenced by oncology capacity, reimbursement structures, hospital modernization, and investment in interventional radiology and pathology services. The region also shows growing interest in cost-efficient, high-throughput biopsy solutions that can serve large patient populations.

North America remains a highly advanced region for biopsy technologies because of established cancer screening programs, widespread availability of imaging-guided procedures, strong use of molecular diagnostics, and mature hospital and ambulatory care infrastructure. The United States and Canada have well-developed pathways for breast, prostate, lung, and gastrointestinal biopsy, supported by radiology, oncology, pathology, and surgical specialty networks. Adoption is further influenced by quality standards, clinical guidelines, reimbursement policies, and demand for devices that support precision medicine workflows.

Latin America is advancing gradually as public and private healthcare systems expand oncology diagnosis and imaging access. Brazil and Mexico are key markets where demand is shaped by cancer awareness initiatives, growing private hospital networks, and the need to improve early diagnosis. However, uneven access to advanced imaging, pathology capacity constraints, and affordability considerations continue to affect device selection and procedural availability across the region.

Europe demonstrates broad adoption of biopsy devices, supported by national cancer screening programs, strong regulatory oversight, and established diagnostic pathways. Western European countries typically show higher penetration of image-guided and vacuum-assisted biopsy procedures, while Central and Eastern European systems continue to invest in modernization of oncology and imaging infrastructure. European demand is closely tied to compliance with medical device regulations, evidence-based procurement, and integration with molecular testing.

The Middle East is expanding biopsy device utilization through investments in tertiary hospitals, oncology centers, and medical imaging infrastructure. Gulf countries are particularly focused on specialized care, cancer screening, and advanced diagnostics, while other parts of the region face greater variability in access. Africa presents substantial unmet need for biopsy devices, especially where cancer diagnosis is delayed by limited imaging availability, pathology workforce shortages, and infrastructure gaps. Across Africa, sustainable adoption depends on affordable devices, workforce training, referral networks, and specimen transport systems that preserve tissue quality.

Key Group Insights Across ASEAN, GCC, EU, BRICS, G7, and NATO

ASEAN countries are strengthening biopsy device adoption as cancer screening, private healthcare investment, and diagnostic imaging access expand across major urban centers. The group is characterized by diverse healthcare maturity levels, making affordability, training, and device versatility important procurement considerations. Hospitals in more developed ASEAN systems are increasingly integrating image-guided biopsy into oncology workflows, while emerging systems require scalable technologies and capacity-building support.

The GCC is distinguished by rapid investment in advanced hospital infrastructure, oncology centers, and diagnostic technologies. Biopsy device demand across the group is supported by public health modernization, medical tourism ambitions, and increasing emphasis on early cancer detection. Procurement priorities often include premium imaging-compatible systems, sterile single-use devices, and solutions that align with international clinical standards.

The European Union has a highly regulated and quality-driven biopsy device environment, shaped by harmonized medical device oversight, clinical evidence expectations, and established cancer screening frameworks. Demand is influenced by hospital procurement criteria, reimbursement rules, sustainability considerations, and the need for compliance with strict safety and performance requirements. The EU also places strong emphasis on traceability, post-market surveillance, and integration with precision diagnostics.

BRICS countries collectively represent a diverse set of biopsy device opportunities driven by large patient populations, rising cancer burden, and expanding healthcare infrastructure. China and India are particularly significant because of large diagnostic volumes and growing investment in oncology capacity, while Brazil, Russia, and South Africa show demand linked to public health modernization and private sector expansion. Across BRICS, cost-effectiveness, local distribution strength, and compatibility with variable imaging infrastructure are critical.

G7 countries are mature adopters of advanced biopsy devices due to established healthcare systems, robust imaging networks, and high utilization of pathology and molecular diagnostics. Clinical guideline adherence, reimbursement structures, and patient safety expectations shape product selection. NATO member countries overlap substantially with advanced European and North American healthcare systems, but the group also includes countries at different stages of healthcare modernization. In these markets, resilient supply chains, regulatory compliance, and hospital readiness are important for sustained adoption.

Key Country Insights for Biopsy Devices

The United States is one of the most advanced environments for biopsy devices, supported by broad access to image-guided procedures, strong use of cancer screening, advanced pathology infrastructure, and high adoption of molecular diagnostics. Canada shows similar clinical standards, with demand influenced by provincial healthcare systems, cancer care networks, and access to diagnostic imaging. Mexico is expanding biopsy utilization through private healthcare growth and public efforts to improve cancer diagnosis, although regional disparities in imaging and pathology capacity remain important.

Brazil is the leading Latin American country for biopsy device demand, supported by large hospital networks, oncology centers, and increasing diagnostic awareness. In Europe, the United Kingdom, Germany, France, Italy, and Spain have established biopsy pathways supported by screening programs, radiology capacity, and specialist oncology services. Germany and France demonstrate strong emphasis on high-quality diagnostic workflows and regulatory compliance, while the United Kingdom continues to prioritize cancer pathway efficiency and early diagnosis. Italy and Spain benefit from developed healthcare infrastructure and widespread use of image-guided biopsy in breast, prostate, and other cancer indications. Russia has substantial diagnostic needs and hospital infrastructure in major cities, but access can vary widely by region.

China is advancing rapidly through hospital modernization, cancer screening expansion, and increasing availability of imaging-guided biopsy in large medical centers. India is driven by a high disease burden, expanding private hospital networks, and growing cancer awareness, while affordability and access disparities influence product choice. Japan has a mature diagnostic environment with strong imaging capabilities, high clinical quality standards, and demand for precise, minimally invasive biopsy systems. Australia benefits from organized cancer care, advanced imaging infrastructure, and strong adoption of guideline-based diagnostic pathways. South Korea has a technologically advanced healthcare system with extensive imaging access, strong screening participation, and increasing integration of precision oncology, supporting demand for high-performance biopsy devices.

Actionable Recommendations for Biopsy Device Industry Leaders

Industry leaders should prioritize biopsy device innovation that improves diagnostic yield, tissue preservation, procedural efficiency, and patient safety. Product strategies should focus on minimally invasive systems, image-guided compatibility, ergonomic design, controlled sampling, and reliable specimen capture. Devices that support breast, prostate, lung, liver, and gastrointestinal biopsy procedures can benefit from alignment with high-volume diagnostic pathways and precision oncology requirements.

Manufacturers and suppliers should strengthen clinical evidence generation, including usability studies, diagnostic adequacy assessments, safety outcomes, and workflow efficiency data. Regulatory readiness is essential, particularly in regions with stringent medical device oversight and post-market surveillance requirements. Partnerships with hospitals, radiology departments, pathology laboratories, and training centers can support adoption by improving procedural confidence and standardization.

Commercial strategies should be region-specific. Mature markets require differentiation through quality, integration with imaging platforms, and support for molecular diagnostics, while emerging markets need affordability, durable design, training, and reliable distribution. Supply chain resilience, sterile device availability, and service responsiveness are increasingly important procurement factors. Companies should also prepare for AI-enabled workflows by ensuring interoperability, digital documentation, and compatibility with image-guided navigation and pathology ecosystems.

Research Methodology for Biopsy Devices Analysis

This executive summary is developed using a structured secondary research approach supported by verification across credible public and industry-relevant sources. The methodology emphasizes clinically validated, data-backed insights from regulatory agencies, public health organizations, cancer registries, peer-reviewed medical literature, clinical guidelines, hospital practice patterns, and healthcare infrastructure indicators. The analysis focuses on technology adoption, clinical workflow relevance, regional healthcare dynamics, regulatory considerations, and diagnostic pathway evolution.

Research inputs are reviewed for consistency, recency, and applicability to biopsy devices across product categories, procedure types, imaging modalities, and end-use settings. The methodology excludes market sizing, market estimation, market share, and forecasting in accordance with the scope. Qualitative assessment is used to identify structural drivers such as cancer burden, screening access, imaging availability, pathology capacity, minimally invasive procedure adoption, and precision medicine integration.

Regional, group, and country insights are synthesized through comparative evaluation of healthcare infrastructure, clinical adoption maturity, reimbursement environment, public health priorities, and access to diagnostic technologies. The result is a decision-oriented view of the biopsy devices landscape designed to support strategic planning, product positioning, and market entry assessment without relying on speculative projections.

Conclusion

Biopsy devices are becoming increasingly important as healthcare systems prioritize early diagnosis, minimally invasive care, and precision oncology. The industry is moving toward image-guided, outpatient-compatible, and tissue-quality-focused solutions that support accurate diagnosis and downstream molecular testing. Artificial intelligence, digital pathology, and advanced imaging are expected to deepen the connection between biopsy procedures and personalized treatment decisions.

Regional opportunities vary significantly by healthcare maturity, diagnostic imaging availability, cancer screening coverage, pathology infrastructure, and reimbursement frameworks. Mature markets emphasize evidence, safety, workflow integration, and advanced biopsy performance, while emerging markets require scalable, affordable, and training-supported solutions. Industry leaders that combine clinical reliability, regulatory compliance, supply resilience, and digital interoperability will be best positioned to address evolving diagnostic needs across global healthcare systems.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Definition
• 1.3. Market Segmentation & Coverage
• 1.4. Years Considered for the Study
• 1.5. Currency Considered for the Study
• 1.6. Language Considered for the Study
• 1.7. Key Stakeholders

2. Research Methodology

• 2.1. Introduction
• 2.2. Research Design
  • 2.2.1. Primary Research
  • 2.2.2. Secondary Research
• 2.3. Research Framework
  • 2.3.1. Qualitative Analysis
  • 2.3.2. Quantitative Analysis
• 2.4. Market Size Estimation
  • 2.4.1. Top-Down Approach
  • 2.4.2. Bottom-Up Approach
• 2.5. Data Triangulation
• 2.6. Research Outcomes
• 2.7. Research Assumptions
• 2.8. Research Limitations

3. Executive Summary

• 3.1. Introduction
• 3.2. CXO Perspective
• 3.3. Market Size & Growth Trends
• 3.4. New Revenue Opportunities
• 3.5. Next-Generation Business Models
• 3.6. Industry Roadmap

4. Market Overview

• 4.1. Introduction
• 4.2. Industry Ecosystem & Value Chain Analysis
  • 4.2.1. Supply-Side Analysis
  • 4.2.2. Demand-Side Analysis
  • 4.2.3. Stakeholder Analysis
• 4.3. Market Dynamics
  • 4.3.1. Key Drivers
  • 4.3.2. Key Restraints
  • 4.3.3. Key Opportunities
  • 4.3.4. Key Challenges
• 4.4. Porter's Five Forces Analysis
• 4.5. PESTLE Analysis
• 4.6. Market Outlook
  • 4.6.1. Near-Term Market Outlook (0-2 Years)
  • 4.6.2. Medium-Term Market Outlook (3-5 Years)
  • 4.6.3. Long-Term Market Outlook (5-10 Years)
• 4.7. Go-to-Market Strategy

5. Market Insights

• 5.1. Consumer Insights & End-User Perspective
• 5.2. Consumer Experience Benchmarking
• 5.3. Opportunity Mapping
• 5.4. Distribution Channel Analysis
• 5.5. Pricing Trend Analysis
• 5.6. Regulatory Compliance & Standards Framework
• 5.7. ESG & Sustainability Analysis
• 5.8. Disruption & Risk Scenarios
• 5.9. Return on Investment & Cost-Benefit Analysis

6. Cumulative Impact of Artificial Intelligence 2026

7. Biopsy Devices Market, by Product Type

• 7.1. Introduction
• 7.2. Core Needle
  • 7.2.1. Automatic
  • 7.2.2. Semi Automatic
• 7.3. Endoscopic
  • 7.3.1. Flexible
  • 7.3.2. Rigid
• 7.4. Fine Needle Aspiration
  • 7.4.1. Aspiration
  • 7.4.2. Manual
• 7.5. Vacuum Assisted
  • 7.5.1. Console Based
  • 7.5.2. Handheld

8. Biopsy Devices Market, by Guidance Technique

• 8.1. Introduction
• 8.2. Image-Guided Biopsy
• 8.3. Non-Image-Guided Biopsy

9. Biopsy Devices Market, by Application

• 9.1. Introduction
• 9.2. Breast
• 9.3. Kidney
• 9.4. Liver
• 9.5. Lung
• 9.6. Prostate

10. Biopsy Devices Market, by End User

• 10.1. Introduction
• 10.2. Ambulatory Surgical Centers
• 10.3. Clinics
• 10.4. Diagnostic Laboratories
• 10.5. Hospitals

11. Biopsy Devices Market, by Region

• 11.1. Asia-Pacific
• 11.2. North America
• 11.3. Latin America
• 11.4. Europe
• 11.5. Middle East
• 11.6. Africa

12. Biopsy Devices Market, by Group

• 12.1. ASEAN
• 12.2. GCC
• 12.3. European Union
• 12.4. BRICS
• 12.5. G7
• 12.6. NATO

13. Biopsy Devices Market, by Country

• 13.1. United States
• 13.2. Canada
• 13.3. Mexico
• 13.4. Brazil
• 13.5. United Kingdom
• 13.6. Germany
• 13.7. France
• 13.8. Russia
• 13.9. Italy
• 13.10. Spain
• 13.11. China
• 13.12. India
• 13.13. Japan
• 13.14. Australia
• 13.15. South Korea

14. Competitive Landscape

• 14.1. Market Share Analysis, 2025
• 14.2. FPNV Positioning Matrix, 2025
• 14.3. Market Concentration Analysis, 2025
  • 14.3.1. Concentration Ratio (CR)
  • 14.3.2. Herfindahl Hirschman Index (HHI)
• 14.4. Recent Developments & Impact Analysis, 2025
• 14.5. Product Portfolio Analysis, 2025
• 14.6. Benchmarking Analysis, 2025

15. Company Profiles

• 15.1. Angiotech Pharmaceuticals, Inc.
• 15.2. Argon Medical Devices, Inc.
• 15.3. B. Braun Melsungen AG
• 15.4. Becton, Dickinson and Company
• 15.5. Boston Scientific Corporation
• 15.6. Cardinal Health, Inc.
• 15.7. CONMED Corporation
• 15.8. Cook Group Incorporated
• 15.9. Danaher Corporation
• 15.10. DTR Medical Ltd. by Innovia Medical
• 15.11. Fujifilm Holdings Corporation
• 15.12. Gallini Srl
• 15.13. Hologic, Inc.
• 15.14. INRAD, Inc.
• 15.15. Intact Medical Corporation
• 15.16. Integra LifeSciences Corporation
• 15.17. Leica Biosystems Nussloch GmbH
• 15.18. Medtronic PLC
• 15.19. Merit Medical Systems
• 15.20. Olympus Corporation
• 15.21. Precision Biopsy, LLC
• 15.22. Scion Medical Technologies, LLC
• 15.23. Stryker Corporation
• 15.24. TransMed7, LLC
• 15.25. TSK Laboratory Europe BV