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市場調查報告書
商品編碼
2133295

全球臨床定序和基於定序的體外診斷（IVD）產品市場（2026 年）

The World Market for Clinical Sequencing and Sequencing-Based IVD Products, 2026
出版日期: | 出版商: Kalorama Information | 英文 129 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

臨床定序已不再侷限於新興技術，而是日益成為精準醫療的基石。隨著其應用範圍擴展至腫瘤學、遺傳疾病檢測、生殖醫學、移植醫學、分子殘留病灶監測和人群篩檢等領域，行業相關人員面臨著由技術創新、報銷模式轉變、監管發展和競爭環境變化共同塑造的快速變化格局。

超越市場規模的策略洞察

《全球臨床定序及基於定序的體外診斷（IVD）產品市場（2026）》報告全面分析了全球用於臨床環境的定序設備、耗材、軟體和診斷產品的市場。該報告檢驗了定序技術在關鍵醫療保健市場的商業化進程，並分析了受監管的診斷產品、檢查室自建檢測（LDT）和集中檢測服務之間日益密切的互動關係。

本研究分析了影響市場成長的競爭、監管和商業性，包括報銷趨勢、檢查室採用模式、分散式檢查模式、不斷演變的法律規範以及新型定序平台的出現。尤其關注診斷產品與檢測服務之間不斷變化的平衡，這是影響供應商和投資者的最重要的策略趨勢之一。

臨床應用領域的發展機遇

本報告評估了伴隨診斷、綜合基因組分析、液態生物檢體、分子殘留疾病檢測、新生兒篩檢、遺傳疾病應用、生殖醫學和移植診斷等領域的機會。報告還評估了生物資訊學、軟體和臨床解讀平台作為競爭優勢的日益重要的作用。

到 2030 年的全面市場估算和預測提供了對當前市場狀況、未來成長機會、區域趨勢、應用領域趨勢以及不同監管和商業性條件下的潛在市場情景的深入見解。

全面的競爭訊息

除了定量市場分析外，本報告還廣泛涵蓋了新產品發布、監管批准、合作關係、收購、投資以及其他影響競爭格局的發展動態。報告還對行業領導者進行了詳細介紹，檢驗了它們的技術、產品系列、策略舉措和市場定位。

本報告基於廣泛的一手和二手研究，為高階主管、投資者、業務負責人、負責人和產業相關人員提供必要的策略見解，以了解塑造臨床定序和基於定序的診斷未來的機會、風險和競爭力量。

目錄

第1章執行摘要

第2章 技術與產品

  • 介紹
  • 定序在臨床應用中所使用的技術
  • 臨床定序領域提供的產品
    • 定序平台
    • FDA已通過核准的NGS試劑盒
    • 帶有 CE-IVD 和 IVDR 標誌的 NGS 試劑盒
    • 萃取、文庫製備與目標濃度
    • 中國國家藥品監督管理局（NMPA）註冊產品
    • 生物資訊學和變異解讀軟體
    • 經監管機構批准的定序檢驗服務
    • 基於序列分析的檢測服務和CDx網路

    第3章 趨勢

    • 介紹
    • 套件和服務之間的區別是什麼意思？
      • 監管分類的重新調整可能成為變革的主要來源。
      • 服務和產品之間的選擇取決於報銷額度，而不是核准結果。
      • 雖然歐洲的 NGS 伴隨診斷市場停滯不前，但 NGS 試劑盒市場卻並非如此。
      • 亞洲是試劑盒的銷售地區，但主要是PCR試劑盒的銷售地區。
      • 製藥業對分散式伴隨診斷試劑的需求依然持續存在且尚未滿足。
      • 網路型實驗室正成為一種替代途徑。
      • 平台競爭日益激烈，基因組分析成本持續下降。
      • MRD是成長最快的應用。
      • 此次整合將重點放在已擁有該平台的收購公司。
      • 將解釋層視為需要監管的因素。
    • 近期產品發布及法規核准
    • 市場發布記錄顯示
    • 監管記錄揭示了什麼
  • 交易、合作、收購
  • 交易結構發生了哪些變化？
  • 交易記錄內容

第4章 市場預測與展望

  • 介紹
  • 按細分市場分類的市場規模和預測
  • 區域分佈
  • 按應用領域分類的市場規模

第5章：公司簡介

  • 介紹
  • 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
簡介目錄
Product Code: 26-043KA

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