The World Market for Clinical Sequencing and Sequencing-Based IVD Products, 2026

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