임상 시퀀싱 및 시퀀싱 기반 체외진단(IVD) 제품 시장(2026년)

Clinical sequencing has moved beyond its role as an emerging technology and is increasingly becoming a cornerstone of precision medicine. As applications expand across oncology, inherited disease testing, reproductive health, transplant medicine, molecular residual disease monitoring, and population screening programs, industry participants face a rapidly evolving landscape shaped by technological innovation, changing reimbursement models, regulatory developments, and shifting competitive dynamics.

Strategic Insights Beyond Market Size

The World Market for Clinical Sequencing and Sequencing-Based IVD Products, 2026 provides a comprehensive analysis of the global market for sequencing instruments, consumables, software, and diagnostic products used in clinical settings. The report examines how sequencing technologies are being commercialized across major healthcare markets and explores the growing interplay between regulated diagnostic products, laboratory-developed tests, and centralized testing services.

The study analyzes the competitive, regulatory, and commercial forces influencing market growth, including reimbursement trends, laboratory adoption patterns, decentralized testing models, evolving regulatory frameworks, and the emergence of new sequencing platforms. Particular attention is given to the changing balance between diagnostic products and testing services, one of the most important strategic developments affecting suppliers and investors alike.

Growth Opportunities Across Clinical Applications

The report evaluates opportunities across companion diagnostics, comprehensive genomic profiling, liquid biopsy, molecular residual disease testing, newborn screening, inherited disease applications, reproductive health, and transplant diagnostics. It also assesses the growing role of bioinformatics, software, and clinical interpretation platforms as sources of competitive differentiation.

Comprehensive market estimates and forecasts through 2030 provide insight into current market conditions, future growth opportunities, regional dynamics, application trends, and potential market scenarios under differing regulatory and commercial conditions.

Comprehensive Competitive Intelligence

In addition to quantitative market analysis, the report delivers extensive coverage of product introductions, regulatory approvals, partnerships, acquisitions, investments, and other developments shaping the competitive landscape. Detailed profiles of leading industry participants examine technologies, product portfolios, strategic initiatives, and market positioning.

Based on extensive primary and secondary research, this report provides executives, investors, business development professionals, marketers, and industry stakeholders with the strategic intelligence needed to understand the opportunities, risks, and competitive forces driving the future of clinical sequencing and sequencing-based diagnostics.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• ABOUT KALORAMA INFORMATION
• INTRODUCTION
• OVERVIEW
• TRENDS AFFECTING THE MARKET
• SIZE OF MARKET
  • Table 1-1: Clinical Sequencing Products Market Revenues, 2025-2030 (US$ millions)
  • Figure 1-1: Clinical Sequencing Products Market Revenues and Growth Rate, 2025-2030 (US$ millions) (%)
• SCOPE AND METHODOLOGY

CHAPTER TWO: TECHNOLOGIES AND PRODUCTS

• INTRODUCTION
• TECHNOLOGIES USED IN CLINICAL APPLICATIONS OF SEQUENCING
  • Sequencing by Synthesis (SBS)
  • Semiconductor and Ion-Based Sequencing
  • Nanopore Sequencing
  • Long-Read Single-Molecule Sequencing
  • Emerging Sequencing Chemistries
  • Target Enrichment: Amplicon versus Hybrid Capture
  • Nucleic Acid Extraction, Purification and Library Preparation
  • Bioinformatics, Variant Interpretation and the Regulated Software Layer
• PRODUCTS OFFERED IN CLINICAL SEQUENCING AREAS
  • Sequencing Platforms
    • Table 2-1: Selected Sequencing Platforms Used in Clinical Applications
  • FDA-Authorized NGS Kits
    • Table 2-2: Selected FDA-Authorized NGS IVD Kits Sold to Laboratories
  • CE-IVD and IVDR-Marked NGS Kits
    • Table 2-3: Selected CE-IVD / IVDR-Marked NGS Kits Not FDA Approved
  • Extraction, Library Preparation and Target Enrichment
    • Table 2-4: Selected Extraction, Library Preparation and Target Enrichment Products
  • NMPA-Registered Products in China
    • Table 2-5: Selected NMPA-Registered NGS Products in China
  • Bioinformatics and Variant Interpretation Software
    • Table 2-6: Selected Bioinformatics, Variant Interpretation and Regulated Software
  • Sequencing Test Services Holding Regulatory Authorization
    • Table 2-7: Selected Sequencing Test Services Holding Regulatory Authorization
  • Sequencing-Based Laboratory Services and CDx Networks
    • Table 2-8: Selected Sequencing-Based Laboratory Services and CDx Networks
    • Table 2-9: Regulatory Positions Held by Dx-Configured Sequencing Instruments

  CHAPTER THREE: TRENDS

  • INTRODUCTION
  • WHAT THE KIT-VERSUS-SERVICE DIVIDE SIGNIFIES
    • Regulatory Reclassification Is Large Potential Swing Factor
    • Reimbursement, Not Clearance, Influences Services vs. Products Choice
    • Europe Stalling in NGS Companion Diagnostic Market, Not the NGS Kit Market
    • Asia Is a Kit Geography, but Predominantly a PCR Kit Geography
    • Pharmaceutical Demand for Decentralized CDx Is Sustained and Unmet
      • Table 3-1: Main Reasons for Gaps in CDx Usage, and Numbers of Patients Affected
    • Networked Laboratory Emerging as Alternative Route
    • Platform Competition Intensifies and Cost of a Genome Keeps Dropping
    • MRD Is the Fastest-Moving Application
    • Consolidation Is Concentrated Among Acquirers Who Already Own a Platform
    • The Interpretation Layer as Regulated Object
  • RECENT PRODUCT INTRODUCTIONS AND REGULATORY APPROVALS
    • Table 3-2: Recent Product/ Service Announcements
  • What the Launch Record Shows
    • Table 3-3: Regulatory Approvals and Related Announcements
  • What the Regulatory Record Shows
• DEALS, COLLABORATIONS, ACQUISITIONS
  • Table 3-4: Deals, Collaborations, Acquisitions in Clinical Sequencing
• How the Deal Mix Rotated
• What the Deal Record Contains
  • Table 3-5: Sequencing Deals by Category, January 2024 to August 2026
  • Figure 3-1: Clinical Sequencing Events per Month, 2024-2026

CHAPTER FOUR: MARKET ESTIMATE AND FORECAST

• INTRODUCTION
• MARKET SIZE AND FORECAST BY SEGMENTS
  • Table 4-1: Clinical Sequencing Products Market Revenues, 2025-2030 (US$ millions)
  • Figure 4-1: Clinical Sequencing Products Market Revenues, 2025-2030 (US$ millions)
  • Table 4-2: Clinical Sequencing Products Market by Region, Revenue and Market Share, 2025 (US$ Millions)
• REGIONAL DISTRIBUTION
  • Figure 4-2: Clinical Sequencing Products Market by Region, Revenue and Market Share, 2025 (US$ Millions)
• MARKET SIZE BY APPLICATION
  • Table 4-3: Clinical Sequencing Products Market, by Application, 2025 (US$ millions) [Carrier Screening, Companion Diagnostics, Inherited and Rare Disease Diagnosis, Population and Newborn Screening, Reproductive - NIPT and PGT, Transplant - HLA and Post-Transplant Monitoring, Tumor Profiling (no CDx claim), Other]
  • Figure 4-3: Clinical Sequencing Products Market by Application, Revenue and Market Share, 2025 (US$ Millions) [Carrier Screening, Companion Diagnostics, Inherited and Rare Disease Diagnosis, Population and Newborn Screening, Reproductive - NIPT and PGT, Transplant - HLA and Post-Transplant Monitoring, Tumor Profiling (no CDx claim), Other]
  • Figure 4-4: Registered IVD Sequencing Kits Against the Rest of the In-Scope Market, 2025 (US$ millions)

CHAPTER FIVE: COMPANY PROFILES

• INTRODUCTION
• AGILENT TECHNOLOGIES
• AMOY DIAGNOSTICS
• BGI GENOMICS; MGI TECH
• BURNING ROCK BIOTECH
• CAREDX
• DEVYSER
• ELEMENT BIOSCIENCES
• FOUNDATION MEDICINE (ROCHE)
• GENESEEQ TECHNOLOGY
• GUARDANT HEALTH
• ILLUMINA
• LABCORP
• NATERA
• OXFORD NANOPORE TECHNOLOGIES
• PACIFIC BIOSCIENCES
• QIAGEN
• ROCHE
• SOPHIA GENETICS
• THERMO FISHER SCIENTIFIC
• ULTIMA GENOMICS