암 생검 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the cancer biopsy market size was valued at USD 33.36 billion in 2025 and estimated to grow from USD 37.12 billion in 2026 to reach USD 63.17 billion by 2031, at a CAGR of 11.27% during the forecast period (2026-2031).

This report is Segmented by Product (Instruments, Kits and Consumables, and More), Procedure (Tissue Biopsy [Core Needle, and More], and Liquid Biopsy [Blood, Urine and More]), Cancer Type (Breast, Colorectal, Cervical, Lung, and More), End User (Hospitals, Diagnostic Laboratories, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Cancer Biopsy Market Trends and Insights

Rising Global Oncology Burden & Ageing Population

Cancer incidence is expected to rise 47% by 2040, a shift that is enlarging the long-run addressable base for diagnostic providers. In markets such as China, a national lung-cancer protocol built on three-dimensional CT reconstruction has already improved early-stage detection rates and driven screening volumes higher. The combination of older patient cohorts living longer with cancer and expanding chronic-disease infrastructure in emerging economies keeps the demand curve steep for both tissue and liquid tests. Growing survivor populations also sustain repeated molecular residual-disease monitoring, bolstering test utilisation after initial diagnosis. As population-scale screening becomes standard, payors are increasingly viewing early detection as a cost-containment strategy rather than an incremental expense.

Technological Advances in NGS-Enabled Liquid Biopsy

The convergence of next-generation sequencing with blood-based assays now allows comprehensive genomic profiling from a single tube of plasma. FDA endorsement of FoundationOne Liquid CDx for non-small-cell lung cancer companion uses in November 2024 underscored the platform's clinical validity. Oxford Nanopore's real-time sequencing can detect structural variants and methylation signatures in under two hours, narrowing the feedback loop between sampling and treatment decisions. Academic demonstrators such as the MRD-EDGE workflow have pushed analytic sensitivity to parts-per-million ranges, enabling earlier relapse detection. These innovations are repositioning the cancer biopsy market from a confirmatory tool into a longitudinal disease-management platform.

High Test Costs & Patchy Reimbursement Coverage

Comprehensive liquid biopsy panels often exceed USD 3,000 per sample, a price still out of reach for many payors outside North America and Western Europe. In emerging economies where out-of-pocket spending remains common, limited insurance penetration suppresses test utilisation despite high disease burden. Even in the United States, commercial insurers frequently trail Medicare by up to two years before granting coverage, creating revenue gaps for laboratories. Laboratories also face heavy upfront capital expenditures for automated extraction and sequencing instruments, costs that discourage market entry by smaller regional players. Until supply-chain scale and competition compress kit pricing, economic barriers will slow uniform adoption.

Other drivers and restraints analyzed in the detailed report include:

1. Patient Demand for Minimally-Invasive Diagnostics
2. Reimbursement Wins & Regulatory Green-Lights for ctDNA Tests
3. Procedural & Sampling-Error Risks (False Negatives)

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Needle-based devices captured 38.02% of 2025 revenue, reflecting their entrenched role in hospital-based tissue collection. The cancer biopsy market size for kits and consumables, however, is projected to grow at a 12.05% CAGR between 2026 and 2031 as laboratories pivot toward automated, cartridge-driven protocols that reduce human error and turn fixed costs into variable costs. QIAGEN's QIAsymphony Connect, announced for 2026 launch, can run 192 samples in a single shift, driving per-test reagent demand and anchoring a recurring revenue model.

Instruments remain essential but face price compression as buyers allocate budgets toward high-margin consumable streams. Software and bioinformatics suites such as Ingenuity Pathway Analysis, now expanded with an AI engine, improve variant annotation turnaround and reinforce vendor lock-in. Guidance systems and vacuum-assisted devices occupy niche procedure types where tactile feedback or tissue volume is critical; growth here is steady but not spectacular. Over the forecast window, consumable line-extensions-from cfDNA collection tubes to sequencing cartridges-will account for a rising share of overall cancer biopsy market revenue as providers favor predictable cost-per-test economics.

Tissue biopsies still accounted for 65.12% of cancer biopsy market share in 2025, yet liquid procedures will capture a growing slice of spending as technology matures. Core needle extraction remains preferred for many solid tumours because it balances diagnostic yield against patient discomfort. Fine-needle aspiration supports anatomically challenging sites but delivers limited material for multi-omic profiling.

Surgical excisions continue for complex lesions but are declining in frequency as blood-based assays gain confidence among multidisciplinary tumour boards. On the liquid side, blood tests dominate given the ease of serial sampling and recent regulatory wins. Urine-based workflows are scaling in urological cancers, and research into saliva and cerebrospinal fluid profiling extends test menus to other hard-to-biopsy indications. Throughout the next five years, hybrid pathways-initial non-invasive screen followed by tissue confirmation-will become common, gradually reducing the volume of first-line surgical biopsies and redirecting capital budgets to high-throughput plasma labs.

Complete Report Scope:

• By Product
  • Instruments
  • Kits & Consumables
  • Software & Bioinformatics
  • Needle-based Devices
  • Vacuum-assisted Devices
  • Guidance Systems
• By Procedure
  • Tissue Biopsy
    • Core Needle
    • Fine-Needle Aspiration
    • Surgical Excisional
  • Liquid Biopsy
    • Blood
    • Urine
    • Saliva
    • Cerebrospinal Fluid
• By Cancer Type
  • Breast
  • Lung
  • Colorectal
  • Prostate
  • Cervical
  • Pancreatic
  • Melanoma
  • Others
• By End User
  • Hospitals
  • Diagnostic Laboratories
  • Ambulatory Surgical Centres
  • Cancer Research Institutes
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America generated 38.35% of global revenue in 2025, buoyed by Medicare coverage, biomarker mandates in 15 states and a constant stream of FDA device approvals. Canada benefits from unified reimbursement across provinces and a growing roster of precision-medicine pilot projects, while Mexico's medical-device export corridor supplies disposable biopsy kits at competitive prices. Asia-Pacific is the fastest-expanding theatre, logging a 14.03% CAGR through 2031. China's three-dimensional CT reconstruction pathway for lung-cancer screening and AI-assisted nodule triage has already scaled to provincial centres, lifting test volumes and creating bulk-procurement tenders. India's AIIMS-led deployment of deep-learning diagnostics into district hospitals showcases leap-frog adoption in resource-limited settings, while Japan's approval of Guardant360 CDx as a companion assay aligns domestic oncology care with global standards.

Europe advances at a steadier pace, aided by cross-border research programs and harmonised CE-IVD regulation. Uptake of AI-enabled histopathology, along with national genomics initiatives in the United Kingdom and France, supports broader adoption of molecular biopsy approaches. Nevertheless, reimbursement disparities among member states mean private laboratories often face multi-year approval cycles before liquid tests are fully funded. The Middle East and Africa region is experiencing moderate expansion, driven by GCC investments in comprehensive cancer centres and targeted tourism from neighbouring countries. South Africa leads sub-Saharan diagnostics capacity, whereas many other African markets lack sequencing infrastructure, extending the time to widespread liquid biopsy availability.

South America's outlook is positive yet volatile. Brazil is directing public funds toward national cancer-control plans that include molecular screening components, and Argentina's biomedical cluster is piloting local reagent manufacturing to lower costs. Currency fluctuations and regulatory heterogeneity, however, can stall cross-border expansion for multinational vendors.

Collectively, geographic trends signal a gradual rebalancing of the cancer biopsy market toward emerging economies, although North American and European payor systems will continue to anchor premium test revenue through 2030.

1. Illumina
2. QIAGEN
3. Thermo Fisher Scientific
4. Guardant Health
5. Roche
6. Hologic
7. Danaher
8. Beckton Dickinson
9. Agilent Technologies
10. Sysmex
11. Myriad Genetics
12. Exact Sciences
13. Natera
14. Bio-Rad Laboratories
15. LabCorp
16. Quest Diagnostics
17. ANGLE
18. Biocept
19. Lucence Diagnostics
20. GRAIL LLC

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Oncology Burden & Ageing Population
  • 4.2.2 Technological Advances In NGS-Enabled Liquid Biopsy
  • 4.2.3 Patient Demand For Minimally-Invasive Diagnostics
  • 4.2.4 Reimbursement Wins & Regulatory Green-Lights For Ctdna Tests
  • 4.2.5 Real-Time Nanopore Sequencing & AI-Augmented Analytics
  • 4.2.6 Point-Of-Care Biopsy Kits For Low-Resource Settings
• 4.3 Market Restraints
  • 4.3.1 High Test Costs & Patchy Reimbursement Coverage
  • 4.3.2 Procedural & Sampling-Error Risks (False Negatives)
  • 4.3.3 Genomic-Data Privacy / Ownership Concerns
  • 4.3.4 Liquid-Biopsy Sensitivity Gaps In Early-Stage Solid Tumours
• 4.4 Technological Outlook
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Instruments
  • 5.1.2 Kits & Consumables
  • 5.1.3 Software & Bioinformatics
  • 5.1.4 Needle-based Devices
  • 5.1.5 Vacuum-assisted Devices
  • 5.1.6 Guidance Systems
• 5.2 By Procedure
  • 5.2.1 Tissue Biopsy
    • 5.2.1.1 Core Needle
    • 5.2.1.2 Fine-Needle Aspiration
    • 5.2.1.3 Surgical Excisional
  • 5.2.2 Liquid Biopsy
    • 5.2.2.1 Blood
    • 5.2.2.2 Urine
    • 5.2.2.3 Saliva
    • 5.2.2.4 Cerebrospinal Fluid
• 5.3 By Cancer Type
  • 5.3.1 Breast
  • 5.3.2 Lung
  • 5.3.3 Colorectal
  • 5.3.4 Prostate
  • 5.3.5 Cervical
  • 5.3.6 Pancreatic
  • 5.3.7 Melanoma
  • 5.3.8 Others
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Diagnostic Laboratories
  • 5.4.3 Ambulatory Surgical Centres
  • 5.4.4 Cancer Research Institutes
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Illumina Inc.
  • 6.3.2 QIAGEN NV
  • 6.3.3 Thermo Fisher Scientific
  • 6.3.4 Guardant Health
  • 6.3.5 F. Hoffmann-La Roche AG
  • 6.3.6 Hologic Inc.
  • 6.3.7 Danaher Corporation
  • 6.3.8 Becton, Dickinson & Company
  • 6.3.9 Agilent Technologies
  • 6.3.10 Sysmex Corporation
  • 6.3.11 Myriad Genetics
  • 6.3.12 Exact Sciences
  • 6.3.13 Natera Inc.
  • 6.3.14 Bio-Rad Laboratories
  • 6.3.15 Labcorp
  • 6.3.16 Quest Diagnostics
  • 6.3.17 ANGLE PLC
  • 6.3.18 Biocept Inc.
  • 6.3.19 Lucence Diagnostics
  • 6.3.20 GRAIL LLC

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment