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

According to Mordor Intelligence, the next-generation sequencing market size is projected to be USD 10.49 billion in 2025, USD 11.81 billion in 2026, and reach USD 22.43 billion by 2031, growing at a CAGR of 13.69% from 2026 to 2031.

This report is Segmented by Type of Sequencing (Whole Genome, and More), Product Type (Instruments, Reagents and Consumables, and Services), Application (Drug Discovery and Personalized Medicine, and More), End User (Hospitals and Healthcare Institutions, and More), and Geography (North America, Europe, and More). Market Forecasts are Provided in Terms of Value (USD).

Global Next-generation Sequencing (NGS) Market Trends and Insights

Accelerating Adoption of Precision Medicine and Companion Diagnostics

Companion diagnostics linked to targeted therapies are embedding next-generation sequencing into oncology workflows, converting the technology from a research tool to a reimbursable clinical service. The U.S. FDA granted breakthrough designation to 14 NGS-based companion tests during 2024-2025, covering solid tumors such as lung, breast, and melanoma. Medicare's 2025 coverage expansion for comprehensive genomic profiling eliminated prior-authorization hurdles, boosting test volumes in hospital laboratories. Liquid-biopsy assays that detect circulating tumor DNA are being integrated into earlier treatment lines, with Guardant Health and Foundation Medicine reporting double-digit growth in requisitions in 2025. Although European approvals proceed more slowly, the European Commission's 2024 proposal to streamline in-vitro diagnostic regulation signals faster clearance pathways after 2027. Collectively, these regulatory trends establish NGS as a clinical mainstay rather than an experimental option.

Continuous Decline in Cost Per Genome and Throughput Gains

Whole-genome sequencing costs fell below USD 500 in 2025 on high-throughput instruments, making population screening economically feasible for public health systems. Ultima Genomics validated a USD 100 genome in peer-reviewed studies during 2024, forcing incumbents to unbundle reagent pricing and rethink revenue models. Illumina's NovaSeq X delivers 16 terabases per run, enabling laboratories to process thousands of samples weekly. Element Biosciences' semiconductor-based AVITI platform reduces reagent consumption by 30%, translating cost savings directly to users. These efficiencies are accelerating adoption in middle-income countries that previously considered whole-genome sequencing too expensive for routine diagnostics.

Fragmented Global Regulatory Landscape for Clinical NGS

Divergent approval pathways across the FDA, EU IVDR, and APAC agencies necessitate region-specific validations, which increase time-to-market and costs. The FDA's 2024 draft on laboratory-developed tests adds oversight that academic medical centers argue may curb innovation. Europe's IVDR extensions to 2027 leave hundreds of assays in limbo, while China's regulators demand domestic clinical trials, lengthening launches by up to 24 months. Japan's conditional approval pathway introduced in 2025 still lacks precise post-market requirements, discouraging smaller firms. Maintaining multiple assay versions dilutes economies of scale and favors companies with deep regulatory resources.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Population-Scale Genomics Programs
2. On-Cartridge Sequencing Workflows for Point-of-Care Testing
3. High Capital Outlay for Long-Read & Spatial Platforms

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

Segment Analysis

Whole-exome sequencing is projected to grow at a 14.23% CAGR to 2031 as insurers adopt it for rare-disease diagnostics, redirecting budgets from single-gene tests to comprehensive panels. Targeted resequencing held 38.09% of the next-generation sequencing market share in 2025, driven by oncology panels, yet falling exome costs below USD 200 per sample erode its price advantage. Whole-genome sequencing remains the benchmark for structural variants, although the 30-fold increase in data volume strains hospital IT resources. RNA sequencing is gaining traction in immuno-oncology, and spatial transcriptomics reached USD 180 million in sales in 2025.

The next-generation sequencing market is witnessing rare-disease pathways transition from research to reimbursed care, validating exome tests as first-tier diagnostics. The FDA's approval of the first exome-based neurodevelopmental test in 2025 solidified this transition. Vendors offering turnkey analysis pipelines are gaining favor over those selling raw capacity alone, as community hospitals seek simplicity in bioinformatics.

Reagents and consumables captured 69.88% of the next-generation sequencing market size in 2025, but instruments will outpace at 14.39% CAGR through 2031. Benchtop systems that integrate sample prep cut hands-on time and lower point-of-care adoption barriers. Element Biosciences and Singular Genomics employ open-reagent designs that undercut proprietary razor-and-blade models. Illumina's 2025 reagent-neutral mode acknowledges growing demand for interoperability.

Services, although the smallest segment, are expanding as pharmaceutical sponsors outsource large-scale sequencing to high-throughput centers. Automation platforms from Tecan and Hamilton reduce reagent waste, compressing consumable revenue growth. The shift toward open chemistry compresses margins while broadening the user base, especially among resource-constrained academic institutions.

Complete Report Scope:

• By Type of Sequencing
  • Whole Genome Sequencing
  • Targeted Resequencing
  • Whole Exome Sequencing
  • RNA Sequencing
  • ChIP Sequencing
  • De Novo Sequencing
  • Methyl Sequencing
• By Product Type
  • Instruments
  • Reagents And Consumables
  • Services
• By Application
  • Drug Discovery And Personalized Medicine
  • Genetic Screening
  • Diagnostics
  • Agriculture And Animal Research
  • Other Applications (Epigenomics, Metagenomics, Transcriptomics)
• By End User
  • Hospitals And Healthcare Institutions
  • Academics
  • Pharmaceuticals And Biotechnology Companies
• 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 contributed 41.90% of 2025 revenue, supported by Medicare coverage for comprehensive genomic profiling and the FDA's expedited approval pathway for companion diagnostics. Canada invested CAD 45 million (approximately USD 33 million) in pediatric rare-disease sequencing in 2025, while Mexico expanded its pharmacogenomic capacity. However, reimbursement remains a challenge to addressing research-oriented workforce shortages in genetic counseling and bioinformatics, tempering growth.

Asia-Pacific is forecast to expand at a 14.21% CAGR, the highest globally. China's 14th Five-Year Plan earmarked USD 1.2 billion for genomic infrastructure through 2027, and the Shenzhen National Gene Bank surpassed 800,000 genomes by mid-2025. Japan mandates domestic data residency, channeling instrument sales to local facilities, while India plans to reach 100,000 sequenced genomes by 2028. Australia and South Korea advanced reimbursement policies for hereditary disease sequencing in 2024-2025, further fueling regional demand.

Europe's growth is moderated by IVDR transition delays, which have placed hundreds of lab-developed tests in regulatory limbo through 2025. Germany expanded statutory insurance coverage for tumor profiling in 2024, adding 80,000 tests annually, yet reimbursement rates remain below cost recovery. The U.K. Genomic Medicine Service completed 100,000 whole genomes in 2025 and plans to double by 2027. France's national plan committed EUR 670 million (USD 730 million) to 12 regional platforms, though procurement delays pushed installations into late 2025.

The Middle East and Latin America trail in absolute volumes but register rapid project-based uptake. Saudi Arabia's Genome Program and the UAE's data-sovereignty rules incentivize local capacity. Brazil piloted NGS-based TB drug-resistance testing in 2024, demonstrating potential public health applications if funding remains stable.

1. 10x Genomics Inc.
2. Agilent Technologies
3. BGI Genomics Co. Ltd.
4. Bio-Rad Laboratories
5. Element Biosciences Inc.
6. Eurofins
7. Roche
8. Fulgent Genetics Inc.
9. Guardant Health
10. Illumina
11. Macrogen
12. Oxford Nanopore Technologies Plc
13. Pacific Biosciences Of California Inc.
14. PerkinElmer
15. QIAGEN
16. Singular Genomics Systems Inc.
17. SOPHiA GENETICS SA
18. Thermo Fisher Scientific
19. Twist Bioscience Corp.
20. Ultima Genomics 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 Accelerating Adoption of Precision Medicine & Companion Diagnostics
  • 4.2.2 Continuous Decline in Cost Per Genome & Throughput Gains
  • 4.2.3 Expansion of Population-Scale Genomics Programs
  • 4.2.4 On-Cartridge Sequencing Workflows for Point-of-Care Testing
  • 4.2.5 Sovereign Genomic Data Centers Demanding Localized NGS Capacity
  • 4.2.6 Carbon-Neutral Sequencing Initiatives Influencing Procurement
• 4.3 Market Restraints
  • 4.3.1 Fragmented Global Regulatory Landscape for Clinical NGS
  • 4.3.2 High Capital Outlay for Long-Read & Spatial Platforms
  • 4.3.3 Consumable Supply-Chain Vulnerabilities Post-Export Controls
  • 4.3.4 Algorithmic Bias in AI-Based Variant Calling & Liability Risks
• 4.4 Regulatory Outlook
• 4.5 Technological Landscape
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Bargaining Power of Buyers
  • 4.6.2 Bargaining Power of Suppliers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type of Sequencing
  • 5.1.1 Whole Genome Sequencing
  • 5.1.2 Targeted Resequencing
  • 5.1.3 Whole Exome Sequencing
  • 5.1.4 RNA Sequencing
  • 5.1.5 ChIP Sequencing
  • 5.1.6 De Novo Sequencing
  • 5.1.7 Methyl Sequencing
• 5.2 By Product Type
  • 5.2.1 Instruments
  • 5.2.2 Reagents And Consumables
  • 5.2.3 Services
• 5.3 By Application
  • 5.3.1 Drug Discovery And Personalized Medicine
  • 5.3.2 Genetic Screening
  • 5.3.3 Diagnostics
  • 5.3.4 Agriculture And Animal Research
  • 5.3.5 Other Applications (Epigenomics, Metagenomics, Transcriptomics)
• 5.4 By End User
  • 5.4.1 Hospitals And Healthcare Institutions
  • 5.4.2 Academics
  • 5.4.3 Pharmaceuticals And Biotechnology Companies
• 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 10x Genomics Inc.
  • 6.3.2 Agilent Technologies Inc.
  • 6.3.3 BGI Genomics Co. Ltd.
  • 6.3.4 Bio-Rad Laboratories Inc.
  • 6.3.5 Element Biosciences Inc.
  • 6.3.6 Eurofins Scientific SE
  • 6.3.7 F. Hoffmann-La Roche Ltd.
  • 6.3.8 Fulgent Genetics Inc.
  • 6.3.9 Guardant Health Inc.
  • 6.3.10 Illumina Inc.
  • 6.3.11 Macrogen Inc.
  • 6.3.12 Oxford Nanopore Technologies Plc
  • 6.3.13 Pacific Biosciences Of California Inc.
  • 6.3.14 PerkinElmer Inc.
  • 6.3.15 Qiagen N.V.
  • 6.3.16 Singular Genomics Systems Inc.
  • 6.3.17 SOPHiA GENETICS SA
  • 6.3.18 Thermo Fisher Scientific Inc.
  • 6.3.19 Twist Bioscience Corp.
  • 6.3.20 Ultima Genomics Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment