암 생검 시장 : 제품 유형, 용도, 기술, 최종사용자별 - 세계 예측(2025-2032년)

The Cancer Biopsy Market is projected to grow by USD 86.72 billion at a CAGR of 12.63% by 2032.

A strategic framing of how clinical needs, device innovation, and care delivery reconfiguration are jointly shaping modern cancer biopsy practice across care settings

The introduction positions contemporary cancer biopsy practice at the confluence of clinical imperative, technological innovation, and evolving care delivery models. Advances in imaging, instrumentation, and procedural guidance have reshaped diagnostic workflows, while heightened expectations for precision, patient comfort, and turnaround time have elevated the role of minimally invasive sampling techniques. Consequently, multidisciplinary teams are recalibrating protocols to integrate diagnostic accuracy with throughput and cost considerations, and administrators are prioritizing modalities that align with broader value-based care objectives.

As stakeholders confront workforce constraints, regulatory scrutiny, and shifting payer dynamics, the case for robust evidence on procedure choice, technology adoption, and site-of-care optimization grows stronger. Therefore, this executive summary frames the critical trends influencing practice patterns, supply chains, and vendor strategies, offering readers a clear orientation to the underlying forces redefining how tissue acquisition is selected, performed, and managed across diverse clinical settings.

Key transformative shifts revealing how imaging advances, care migration to ambulatory settings, and interdisciplinary workflows are redefining biopsy practice

The landscape of cancer biopsy is undergoing transformative shifts driven by technological maturation, workflow redesign, and a heightened emphasis on patient-centered outcomes. Imaging-guided approaches have become more sophisticated, enabling more precise targeting of lesions and reducing non-diagnostic sampling, while robotics and automation are beginning to emerge in select centers to improve reproducibility and safety. Meanwhile, procedural pathways are migrating from inpatient settings to ambulatory surgical centers and diagnostic imaging centers as clinicians and administrators seek to lower costs, improve throughput, and enhance patient experience.

In parallel, there is a convergence of diagnostic modalities, with pathologists, radiologists, and interventionalists collaborating more closely to ensure that tissue sampling is optimized for downstream molecular and genomic testing. This interdisciplinary integration is influencing device design, specimen handling protocols, and supply chain arrangements. As a result, manufacturers and providers must adapt their strategies to support seamless care coordination, regulatory compliance, and quality assurance, all while addressing patient preferences and institutional efficiency mandates.

How the 2025 tariff environment is reshaping sourcing strategies, procurement resilience, and cost-to-serve models for devices and consumables used in cancer biopsy

The cumulative impact of recent tariff actions in 2025 introduces a layer of complexity for procurement teams, manufacturers, and clinical providers that rely on cross-border supply chains for biopsy needles, imaging hardware, disposables, and accessory devices. Increased import duties on select medical devices and components amplify landed costs and create incentives for firms to reassess sourcing strategies. This environment encourages procurement leaders to prioritize supplier diversification, nearshoring where feasible, and contract structures that allocate risk across the supply chain.

Operationally, hospitals and diagnostic centers face tighter budgetary constraints and may extend inventory pooling and consignment arrangements to mitigate price volatility. In response, device makers are exploring redesigns that substitute tariff-exposed components, negotiating long-term supply agreements, and accelerating qualification of alternative suppliers. Regulatory compliance and quality assurance remain non-negotiable, so any sourcing pivot must preserve clinical performance and sterility standards. Ultimately, the tariff environment is prompting a re-evaluation of cost-to-serve models, while underscoring the need for transparent supplier relationships and scenario planning to maintain clinical continuity.

Segment-driven insights revealing how product, application, technology, and end-user differences drive clinical choice, procurement, and innovation priorities

A granular segmentation lens clarifies where clinical demand, technology fit, and end-user capabilities intersect to determine adoption patterns and operational priorities. Product Type distinctions illuminate performance trade-offs between alternatives such as Core Needle Biopsy versus Fine Needle Aspiration, and the relative roles of Surgical Biopsy and Vacuum-Assisted Biopsy in different clinical scenarios; these modalities differ in sample volume, diagnostic yield, and procedural setting requirements. Application-based segmentation highlights unique clinical pathways and specimen handling demands across tumor sites, including distinct workflows for Breast, Liver, Lung, Prostate, and Thyroid procedures that influence device selection and imaging needs.

Technology segmentation underscores the implications of Imaging Guided Biopsy compared with Manual Freehand Biopsy and the emerging role of Robotic Assisted Biopsy in enhancing precision and reproducibility, while end-user segmentation reveals how operational capabilities vary across Ambulatory Surgical Centers, Diagnostic Imaging Centers, Hospitals, and Physicians Offices. When combined, these perspectives support targeted product development, differentiated training programs, and tailored commercial approaches that align device features with the clinical and operational realities of each segment.

Regional dynamics and care delivery variations across major geographies that influence device adoption, regulatory strategy, and clinical workflow optimization

Regional dynamics play a decisive role in shaping clinical protocols, reimbursement frameworks, and device availability, which in turn influence adoption curves and vendor strategies. In the Americas, healthcare systems span complex private and public mixes with strong emphasis on cost containment and value-based outcomes, prompting providers to favor procedures that deliver robust diagnostic yield with efficient throughput. Regulatory pathways and reimbursement policies in this region also incentivize adoption of minimally invasive techniques that reduce length of stay and expedite diagnosis.

Europe, Middle East & Africa present a heterogeneous landscape where national health systems and varying levels of infrastructure affect technology diffusion. In higher-resource markets, there is rapid uptake of advanced imaging-guided and robotic-assisted solutions, whereas other markets prioritize durable, cost-effective devices and local training to expand access. In Asia-Pacific, rapid urbanization, investments in oncology infrastructure, and high procedural volumes drive demand for scalable solutions and integrated diagnostic pathways. Across all regions, local regulatory requirements, supply chain considerations, and workforce skills shape the practical rollout of new biopsy technologies and service models.

Competitive and strategic company insights highlighting innovation in device integration, evidence generation, and partnership-driven diagnostic pathways

Competitive dynamics in the biopsy ecosystem reflect a blend of technological differentiation, strategic partnerships, and focused clinical evidence development. Leading firms are prioritizing investments in imaging compatibility, specimen preservation technologies, and integrated procedural platforms that streamline clinician workflows and reduce non-diagnostic rates. Companies that demonstrate clinical outcomes improvements through peer-reviewed studies and real-world evidence gain credibility with key opinion leaders and hospital procurement committees, thereby accelerating institutional adoption.

At the same time, smaller, specialized entrants are carving niches by addressing unmet procedural needs, such as biopsy devices tailored for difficult-to-access lesions or tools optimized for molecular-grade specimen collection. Strategic collaborations between device makers and pathology or genomic testing providers are emerging to ensure that the entire diagnostic pathway, from tissue acquisition to molecular analysis, is optimized. Finally, commercial strategy is increasingly informed by service models-training, procedural support, and bundled offerings-that help providers adopt new technologies with lower operational friction.

Practical and prioritized strategic recommendations for manufacturers, providers, and procurement leaders to improve outcomes, mitigate supply risk, and accelerate adoption

Leaders in device manufacturing, hospital systems, and diagnostic services can take concrete steps to strengthen clinical outcomes, operational resilience, and commercial performance. First, invest in evidence generation that demonstrates improvements in diagnostic yield, downstream treatment decision-making, and patient-reported outcomes; such data supports procurement discussions and clinician acceptance. Second, develop flexible supply arrangements and supplier diversification plans that reduce exposure to single-source disruptions and respond to tariff-driven cost pressures by qualifying alternative components and nearshore suppliers.

Third, align product development with the nuanced needs of each clinical application and end user by incorporating feedback from interventional radiology, pathology, and oncology teams; tailoring training and onboarding reduces implementation risk. Fourth, pursue strategic partnerships that integrate tissue acquisition with downstream molecular testing to create end-to-end solutions valued by health systems. Finally, prioritize digital enablement-data capture, workflow integration, and remote proctoring-to improve quality assurance and facilitate scale across disparate sites of care.

A rigorous, multi-source research methodology combining clinician interviews, device technical review, and evidence triangulation to ensure credible and actionable insights

The study synthesizes qualitative and quantitative evidence using a triangulated research approach that emphasizes data integrity and reproducibility. Primary inputs include structured interviews with clinicians, procurement leaders, and device engineers to capture procedural preferences, device performance trade-offs, and implementation experience. Secondary research encompasses peer-reviewed literature, regulatory filings, procedural guidelines, and publicly available technical specifications to validate clinical claims and contextualize technological advances.

Analytical rigor is achieved through methodical cross-validation across data streams, sensitivity checks on key assumptions, and iterative review by clinical experts to ensure that interpretations reflect frontline practice. Where applicable, case studies and vendor-provided clinical data are assessed for methodology and bias, and limitations are transparently documented to guide appropriate application of findings. This methodology ensures that conclusions rest on a balanced synthesis of practitioner insight, device performance evidence, and regulatory context.

A concise synthesis of strategic imperatives and operational priorities that will determine which biopsy approaches gain broad adoption and clinical trust

The conclusion synthesizes the dominant themes that emerged from the analysis: that clinical imperatives, technological evolution, and operational constraints are jointly driving a shift toward more precise, less invasive, and more workflow-friendly biopsy solutions. Institutional decision-makers must weigh procedural efficacy against operational considerations such as throughput, training burden, and supply chain stability. As diagnostic pathways become increasingly integrated with molecular testing, the importance of specimen integrity and standardized handling protocols will grow.

Looking ahead, stakeholders who proactively adapt to regional regulatory requirements, engage in strategic partnerships, and invest in evidence generation will be best positioned to influence clinical practice and capture value. The interplay between innovation and practical implementation will determine which technologies achieve broad adoption and which remain niche solutions, underscoring the need for disciplined evaluation and adaptive strategies across commercial, clinical, and supply chain functions.

Table of Contents

1. Preface

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

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Integration of liquid biopsy assays for early cancer detection using ctDNA and exosomal biomarkers
• 5.2. Adoption of AI-driven image analysis in needle biopsy procedures to enhance diagnostic accuracy and reduce sample processing times
• 5.3. Development of minimally invasive robotic biopsy devices enabling precision sampling of deep-seated tumors
• 5.4. Expansion of next-generation sequencing panels in biopsy specimens to guide personalized oncology treatment decisions
• 5.5. Growth of point-of-care biopsy diagnostic platforms for rapid molecular profiling in outpatient oncology settings
• 5.6. Emergence of multianalyte liquid biopsy tests combining circulating tumor cells, DNA, and RNA for comprehensive tumor characterization
• 5.7. Regulatory approvals and reimbursement reforms driving commercialization of innovative biopsy technologies in major markets
• 5.8. Collaborations between diagnostic companies and academic centers to validate novel biopsy biomarkers and protocols
• 5.9. Rise of pan-cancer early detection assays leveraging cfDNA methylation profiling for multi-cancer screening
• 5.10. Integration of AI-driven decision support tools with biopsy genotyping data to predict patient outcomes and therapy response

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Cancer Biopsy Market, by Product Type

• 8.1. Core Needle Biopsy
• 8.2. Fine Needle Aspiration
• 8.3. Surgical Biopsy
• 8.4. Vacuum-Assisted Biopsy

9. Cancer Biopsy Market, by Application

• 9.1. Breast
• 9.2. Liver
• 9.3. Lung
• 9.4. Prostate
• 9.5. Thyroid

10. Cancer Biopsy Market, by Technology

• 10.1. Imaging Guided Biopsy
• 10.2. Manual Freehand Biopsy
• 10.3. Robotic Assisted Biopsy

11. Cancer Biopsy Market, by End User

• 11.1. Ambulatory Surgical Centers
• 11.2. Diagnostic Imaging Centers
• 11.3. Hospitals
• 11.4. Physicians Offices

12. Cancer Biopsy Market, by Region

• 12.1. Americas
  • 12.1.1. North America
  • 12.1.2. Latin America
• 12.2. Europe, Middle East & Africa
  • 12.2.1. Europe
  • 12.2.2. Middle East
  • 12.2.3. Africa
• 12.3. Asia-Pacific

13. Cancer Biopsy Market, by Group

• 13.1. ASEAN
• 13.2. GCC
• 13.3. European Union
• 13.4. BRICS
• 13.5. G7
• 13.6. NATO

14. Cancer Biopsy Market, by Country

• 14.1. United States
• 14.2. Canada
• 14.3. Mexico
• 14.4. Brazil
• 14.5. United Kingdom
• 14.6. Germany
• 14.7. France
• 14.8. Russia
• 14.9. Italy
• 14.10. Spain
• 14.11. China
• 14.12. India
• 14.13. Japan
• 14.14. Australia
• 14.15. South Korea

15. Competitive Landscape

• 15.1. Market Share Analysis, 2024
• 15.2. FPNV Positioning Matrix, 2024
• 15.3. Competitive Analysis
  • 15.3.1. Boston Scientific Corporation
  • 15.3.2. Hologic, Inc.
  • 15.3.3. Medtronic plc
  • 15.3.4. Cardinal Health, Inc.
  • 15.3.5. Cook Medical LLC
  • 15.3.6. Becton, Dickinson and Company
  • 15.3.7. Olympus Corporation
  • 15.3.8. Argon Medical Devices, Inc.
  • 15.3.9. Teleflex Incorporated
  • 15.3.10. B. Braun Melsungen AG