임상 종양 NGS : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the clinical oncology NGS market size is expected to grow from USD 345.91 million in 2025 to USD 400.37 million in 2026 and is forecast to reach USD 831.17 million by 2031 at 15.74% CAGR over 2026-2031.

This report is Segmented by Technology (Whole Genome Sequencing, and More), Workflow (Pre-Analytical Sample Preparation, and More), Sample Type (Tissue-Based, and More), Application (Screening, and More), End User (Hospitals & Cancer Centers, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Clinical Oncology NGS Market Trends and Insights

Advancing Precision-Oncology Adoption & CGP Standard-Of-Care

Clinical guidelines in lung, breast, colorectal, prostate, and ovarian cancers now recommend NGS-based comprehensive genomic profiling as first-line testing. FoundationOne CDx alone underpins 60% of U.S. companion-diagnostic approvals, spanning 300+ cancer-related genes. Consolidating multiple single-gene assays into one panel trims overall turnaround from 30 days to 2-3 days, lowering inpatient costs and accelerating targeted therapy start-dates. Health-system savings and survival gains sustain widespread CGP uptake.

Rising Global Cancer Incidence & Aging Population

An older population profile and lifestyle shifts increase worldwide cancer prevalence, spurring demand for high-throughput NGS. In India, 80% of 1,000 profiled patients carried actionable alterations, prompting a national cancer budget of INR 99,858 crore (USD 12.3 billion) in 2025. Similar demographic pressure in China, Japan, and the United States drives annual test volumes, particularly for less invasive repeat draws favored by geriatric cohorts.

Bioinformatics Talent & Data-Management Bottlenecks

The supply of clinical bioinformaticians lags behind explosive test demand. Hospitals pay premium salaries while investing in cloud pipelines, yet variant-annotation complexity still slows reporting. Outsourcing to specialty providers and embedding AI interpretation engines partly offsets workforce constraints but does not fully resolve the training gap.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Decline in Sequencing Cost Per Sample
2. Expanded Reimbursement For NGS-Based Oncology Tests
3. Uncertain Regulatory Pathways for Pan-Cancer Panels

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

Segment Analysis

Targeted panels held 52.05% of the clinical oncology NGS market share in 2025 by aligning actionable genes with payer preferences for concise reporting. Integrated DNA-plus-RNA kits enhance fusion detection while keeping file sizes manageable for hospital IT teams. Whole exome profiling is catching up on cost grounds, propelling a 16.98% CAGR that will narrow the gap by 2031. Clinicians increasingly order exomes for tumor types with heterogeneous driver mutations, leveraging the broader mutational canvas to guide immunotherapy combinations. The clinical oncology NGS market size for whole exome sequencing is set to climb sharply from 2026 as compelling evidence in solid tumors accumulates.

Growth prospects favor platforms that let laboratories toggle between 50-gene hotspot panels and 20,000-gene exomes within a single run. FoundationOne RNA adds splice-variant insight across 318 genes, signaling an era in which multi-omic panels become standard kit. Meanwhile, whole-genome assays remain a niche option for structural-variant-heavy malignancies or research cohorts but still benefit from falling reagents cost. As hospital molecular boards mature, demand shifts from "one-gene, one-drug" to pan-tumor biomarker signatures, sustaining the clinical oncology NGS market momentum across both targeted and exome modalities.

Sequencing instruments accounted for 43.41% revenue in 2025, reflecting their capital cost and consumables footprint. Yet the data-analysis tier is the fastest climber at 18.9% CAGR, because converting FASTQ files into therapy recommendations remains labor-intensive. Cloud-native interpretation suites now bundle automated QC, annotation, and report drafting, relieving clinical labs of scarce computational expertise. The emerging standard attaches tumor-only and paired-normal pipelines plus germline filtering to prevent incidental findings confusion.

Tempus, SOPHiA GENETICS, and Microsoft illustrate the shift toward hybrid SaaS plus bench-top models that bundle software seats with sequencing service credits. Long-read assemblers and graph-based aligners further stress compute infrastructure, fueling demand for GPU farms and FPGA accelerators. Consequently, the clinical oncology NGS market size expansion in data analytics is outpacing instrument sales, flipping the revenue mix toward interpretation subscriptions by early 2031. Vendors that integrate LIS connectivity, billing automation, and clinical-trial matching win contracts with both academic centers and community oncology chains.

Complete Report Scope:

• By Technology
  • Whole Genome Sequencing
  • Whole Exome Sequencing
  • Targeted Sequencing & Resequencing Centrifuges
• By Workflow
  • Pre-analytical Sample Preparation
  • Sequencing
  • Data Analysis & Interpretation
• By Sample Type
  • Tissue-based
  • Liquid Biopsy
  • Other Biofluids
• By Application
  • Screening
    • Sporadic Cancer
    • Inherited Cancer
  • Companion Diagnostics
  • Minimal Residual-Disease Monitoring
  • Tumor Mutation-Burden Profiling
  • Other Diagnostics
• By End User
  • Hospitals & Cancer Centers
  • Clinical Reference Laboratories
  • Academic & Research Institutes
  • Contract Research Organizations
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
      • GCC
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America retained 45.20% of global revenue in 2025 because CMS Local Coverage Determinations reimburse both tissue and plasma CGP without case-by-case pre-authorization. FDA's breakthrough-device pathway hastens liquid-biopsy approvals, and U.S. oncology networks such as US Oncology and Mayo Clinic institutionalize NGS in treatment guidelines. Canada's publicly funded provinces follow with pan-Canadian Oncology Drug Review alignment, while Mexico's private insurers gradually adopt U.S. CPT codes.

Europe's adoption trajectory is shaped by IVDR and the January 2025 HTA regulation that synchronizes clinical-and-economic reviews across 27 countries. Germany, France, and the United Kingdom extend nationwide genomic medicine initiatives, funding centralized sequencing hubs that feed real-world evidence datasets. Southern and Eastern members ramp capacity through Horizon Europe grants, yet certification bottlenecks slow small lab offerings. ESG scrutiny nudges EU buyers toward instruments with documented lower carbon footprints, modestly inflating capital expense but aligning with Green Deal procurement criteria.

Asia-Pacific is the growth locomotive at 20.7% CAGR. China blends domestic NGS champions with strict data-localization mandates yet funds rural cancer screening pilots. Japan covers CGP under national insurance and features a rapidly aging demographic with high gastric-cancer prevalence, boosting panel demand. India's large patient pool and government budget increases funnel volume to Bengaluru and Hyderabad reference labs equipped with NovaSeq X. Australia, Singapore, and South Korea act as technology testbeds, trialing AI-enabled same-day oncology reporting that feeds back into vendor R&D pipelines. Overall, expanding reimbursement, relaxed import duties, and high cancer incidence cement Asia-Pacific as the fastest mover in the clinical oncology NGS market.

1. Illumina
2. Thermo Fisher Scientific
3. Roche
4. Agilent Technologies
5. Foundation Medicine, Inc.
6. Guardant Health, Inc.
7. BGI Genomics Co. Ltd.
8. Pacific Bioscience
9. Oxford Nanopore Technologies plc
10. QIAGEN
11. Exact Sciences
12. Caris Life Sciences
13. Myriad Genetics
14. Adaptive Biotechnologies Corp.
15. Personalis, Inc.
16. ArcherDX (Invitae)
17. Eurofins
18. PerkinElmer
19. SOPHiA GENETICS SA
20. Tempus Labs, Inc.

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 Advancing Precision-Oncology Adoption & CGP Standard-of-Care
  • 4.2.2 Rising Global Cancer Incidence & Ageing Population
  • 4.2.3 Rapid Decline in Sequencing Cost Per Sample
  • 4.2.4 Expanded Reimbursement For NGS-Based Oncology Tests
  • 4.2.5 Liquid-Biopsy-Based MRD Monitoring Boosting Repeat Testing
  • 4.2.6 AI-Enabled Ultra-Rapid Sequencing for Point-Of-Care Decisions
• 4.3 Market Restraints
  • 4.3.1 Bioinformatics Talent & Data-Management Bottlenecks
  • 4.3.2 Uncertain Regulatory Pathways for Pan-Cancer Panels
  • 4.3.3 ESG Scrutiny of Sequencer Carbon Footprint Elevates Costs
  • 4.3.4 Cross-Border Genomic-Data Privacy Legislation
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers/Consumers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Technology
  • 5.1.1 Whole Genome Sequencing
  • 5.1.2 Whole Exome Sequencing
  • 5.1.3 Targeted Sequencing & Resequencing Centrifuges
• 5.2 By Workflow
  • 5.2.1 Pre-analytical Sample Preparation
  • 5.2.2 Sequencing
  • 5.2.3 Data Analysis & Interpretation
• 5.3 By Sample Type
  • 5.3.1 Tissue-based
  • 5.3.2 Liquid Biopsy
  • 5.3.3 Other Biofluids
• 5.4 By Application
  • 5.4.1 Screening
    • 5.4.1.1 Sporadic Cancer
    • 5.4.1.2 Inherited Cancer
  • 5.4.2 Companion Diagnostics
  • 5.4.3 Minimal Residual-Disease Monitoring
  • 5.4.4 Tumor Mutation-Burden Profiling
  • 5.4.5 Other Diagnostics
• 5.5 By End User
  • 5.5.1 Hospitals & Cancer Centers
  • 5.5.2 Clinical Reference Laboratories
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Contract Research Organizations
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
      • 5.6.4.2.1 GCC
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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 Thermo Fisher Scientific Inc.
  • 6.3.3 F. Hoffmann-La Roche Ltd.
  • 6.3.4 Agilent Technologies, Inc.
  • 6.3.5 Foundation Medicine, Inc.
  • 6.3.6 Guardant Health, Inc.
  • 6.3.7 BGI Genomics Co. Ltd.
  • 6.3.8 Pacific Biosciences of California, Inc.
  • 6.3.9 Oxford Nanopore Technologies plc
  • 6.3.10 QIAGEN N.V.
  • 6.3.11 Exact Sciences Corporation
  • 6.3.12 Caris Life Sciences
  • 6.3.13 Myriad Genetics, Inc.
  • 6.3.14 Adaptive Biotechnologies Corp.
  • 6.3.15 Personalis, Inc.
  • 6.3.16 ArcherDX (Invitae)
  • 6.3.17 Eurofins Scientific S.E.
  • 6.3.18 PerkinElmer, Inc.
  • 6.3.19 SOPHiA GENETICS SA
  • 6.3.20 Tempus Labs, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment