分子診断の世界市場：第13版

世界の体外診断（IVD）産業の牽引役である分子診断市場は、パンデミック後数年経過した現在も成長を続けており、感染症、がん、移植診断に大きな成長機会をもたらしています。

分子診断は、抗菌薬耐性感染症の特定から個別化がん治療のサポートまで、正確な疾患検出と治療に重要な役割を果たしています。分子診断に対する需要は、北米と欧州を中心に先進国市場と新興国市場の両方で急増しています。分子感染症診断、がん診断、移植診断などの分野が技術革新と成長を牽引しています。先進的な分子技術の臨床現場への統合により、同市場は世界的にヘルスケア基準を再定義する態勢を整えています。

当レポートでは、世界の分子診断市場について調査し、市場の概要とともに、技術動向と注目すべき動向、および市場に参入する企業のプロファイルなどをまとめています。

目次

第1章 エグゼクティブサマリー

第2章 分子診断市場

• 最近の活発な活動
• 最近の製品導入と規制承認
• セグメント別の市場規模と予測
• 感染症
• HIV市場とCOVID-19の影響
• NAT血液スクリーニング
• COVID-19の影響
• 分子組織学および細胞診断
• HPV
• 製品開発
• 分子がん診断市場
• 分子移植診断
• 分子遺伝性疾患の診断
• 血栓形成と凝固マーカー
• 非侵襲的出生前検査（NIPT）
• 遺伝性疾患検査
• 分子診断市場の取引、コラボレーション、買収

第3章 注目すべき動向-シーケンシング、CRISPR、自動化

• シーケンシング
• NGSとコンパニオン診断
• 分子診断におけるNGSの展望
• 臨床シーケンスにおける進化するインフォマティクスソリューション
• サンプル調製と品質管理
• ラボオートメーションと分子診断
• 分子診断における遺伝子編集の応用
• CRISPRと診断用途

第4章 企業プロファイル

• Abbott Diagnostics
• Alinity s System
• Advanced Cell Diagnostics (Bio-Techne)
• Agena Bioscience
• Agendia BV
• Agilent Technologies (incl. Dako)
• Altona Diagnostics
• Amoy Diagnostics
• Applied Spectral Imaging
• ARUP Laboratories
• Asuragen Inc. (Bio-Techne)
• Becton, Dickinson & Co. (BD)
• TVA Medical, Inc.
• R. Bard, Inc.
• CareFusion Corporation
• Beijing Genomics Institute (BGI)
• MGI Tech Co., Ltd.
• Berry Genomics
• binx health
• Bio-Rad Laboratories, Inc.
• Biocartis
• Biodesix
• bioMerieux
• CareDx, Inc.
• Danaher
• Leica Biosystems
• DiaSorin
• Eiken Chemical
• Exact Sciences Corp.
• Greiner Bio-One GmbH
• Grifols, S. A
• Hologic, Inc.
• Illumina, Inc.
• Meridian Bioscience Inc
• Myriad Genetics, Inc.
• NanoString Technologies, Inc.
• Oxford Nanopore Technologies Ltd
• Promega Corporation
• Qiagen
• QuantuMDx Group
• QuidelOrtho
• Revvity
• Rheonix, Inc.
• Roche Diagnostics
• Seegene
• Sekisui Diagnostics LLC
• Sherlock Biosciences
• Standard BioTools
• T2 Biosystems
• Thermo Fisher Scientific Inc.
• Vela Diagnostics
• Veracyte, Inc.

The molecular diagnostics market, a driving force within the global in vitro diagnostics (IVD) industry, continues to thrive several years post-pandemic, offering significant growth opportunities across infectious diseases, cancer, and transplant diagnostics. Kalorama Information's latest report, "The World Market for Molecular Diagnostics, 13th Edition", provides an unparalleled deep dive into this dynamic sector, revealing key trends, applications, and innovations shaping the market from 2024 to 2029.

Why This Report is a Must-Have:

• Comprehensive Market Insights: Analyze global and regional molecular diagnostics markets, segmented by application areas such as infectious diseases, blood screening, cancer, and histology.
• Cutting-Edge Trends: Understand how technologies like Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), and ISH are transforming healthcare.
• Competitive Intelligence: Gain strategic insights into major players, including Roche Diagnostics, Thermo Fisher Scientific, and Illumina, along with emerging competitors.
• Strategic Guidance: Navigate complex markets with detailed forecasts and actionable data to identify high-growth areas and untapped opportunities.

Key Market Highlights:

• Molecular diagnostics plays a vital role in precise disease detection and treatment, from identifying antimicrobial-resistant infections to supporting personalized cancer therapies.
• The demand for molecular diagnostics is surging in both developed and emerging markets, with North America and Europe leading adoption.
• Segments like molecular infectious disease diagnostics, cancer diagnostics, and transplant diagnostics are driving innovation and growth.

With the integration of advanced molecular techniques into clinical settings, the market is poised to redefine healthcare standards globally.

Table of Contents

Chapter One: Executive Summary

• Size of Molecular Diagnostics Market
  • Table 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
  • Figure 1-1: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2023 vs 2024 ($ million)
  • Figure 1-2: Molecular Diagnostics Global Market (COVID-19 and without COVID-19), 2024 ($ million)
  • Figure 1-3: Overall Molecular Diagnostics Global Market, 2023, 2024, 2029 ($ million)
• Growth Areas in Molecular Diagnostics
  • Table 1-2: Growth Applications, by Segment Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])
  • Figure 1-4: Growth Applications, by Revenue Growth, 2024-2029 (%) (Cancer Assays, Circulating Tumor Cells, HAIs/Sepsis, Hepatitis, Histology [ISH, FISH], HIV, Inherited/Genetic, Molecular HPV, NIPT, Respiratory, STIs, Transplantation, Tuberculosis [TB])
• Recent Developments
• Emerging Trends
  • Avian Flu
  • Monkeypox
  • Automation
  • Molecular Point of Care
  • Table 1-3: Selected Molecular POC Diagnostic Platforms, 2024
  • Next-Generation Sequencing
• Other Developments in Molecular Diagnostics, 2023-2024

Chapter Two: Molecular Diagnostics Market

• Recent Brisk Activity
• Recent Product Introductions and Regulatory Approvals
  • Table 2-1: Recent Product Introductions, 2018-2024
  • Table 2-2: Regulatory Approvals and Announcements, 2019-2024
• Market Size and Forecast by Segments
  • Table 2-3: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells; Genetic [Inherited/Genetic, NIPT]; Infectious: [COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other]; NAT Blood Screening; Oncology [Cancer Assays, Histology [ISH/FISH], Molecular HPV]; Transplantation)
  • Figure 2-1: Molecular Diagnostic Market, by Segment, 2024 and 2029 ($ million) (Circulating Tumor Cells, Genetic; Infectious, NAT Blood Screening, Oncology, Transplantation)
  • Figure 2-2: Infectious Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
  • Figure 2-3: Infectious Molecular Diagnostic Market, by Segment Share, 2024 (%) (COVID, HAIs/Sepsis, Hepatitis, HIV, Respiratory, STIs, TB, Other)
  • Figure 2-4: Genetic Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Inherited/Genetic, NIPT)
  • Figure 2-5: Genetic Molecular Diagnostic Market, by Segment Share, 2024 (%) (Inherited/Genetic, NIPT)
  • Figure 2-6: Oncology Molecular Diagnostic Market, Sales by Segment, 2024 and 2029 ($ million) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
  • Figure 2-7: Oncology Molecular Diagnostic Market, by Segment Share, 2024 (%) (Cancer Assays, Histology [ISH/FISH], Molecular HPV)
  • Table 2-4: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
  • Figure 2-8: Molecular Diagnostic Market, by Region, 2024 ($ million) (APAC, Europe, North America, Rest of World)
  • Figure 2-9: Molecular Diagnostics Market Share, by Region, 2024 (%) (APAC, Europe, North America, Rest of World)
• Infectious Diseases
  • Table 2-5: Selected Molecular Hepatitis Tests
• HIV Market and COVID-19 Impact
  • Table 2-6: Selected Molecular Test Products for HIV
• NAT Blood Screening
• COVID-19 Impact
  • Other Trends
  • Declining Blood Transfusions in Developed Markets
• Molecular Histology and Cytology Diagnostics
• HPV
• Product Developments
• Markets for Molecular Cancer Diagnostics
  • Liquid Biopsy
• Molecular Transplant Diagnostics
  • Table 2-7: Selected Innovations in the Field of Molecular Transplant Diagnostics
• Molecular Inherited Diseases Diagnostics
• Thrombophilia and Coagulation Markers
• Non-Invasive Prenatal Testing (NIPT)
  • NIPT and Research Areas
• Inherited Disease Tests
• Molecular Diagnostics Market Deals, Collaborations, Acquisitions
  • Table 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions, 2018-2024

Chapter Three: Trends to Watch - Sequencing, CRISPR, Automation

• Sequencing
• NGS and Companion Diagnostics
  • Table 3-1: Selected Clinical NGS Platforms
• Outlook for NGS in Molecular Diagnostics
  • Table 3-2: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)
  • Figure 3-1: Percent of the MDX Market Revenues, by Test Technique, 2024 (%) (ISH, Microarrays, NGS, PCR)
• Evolving Informatics Solutions in Clinical Sequencing
• Sample Preparation and Quality Control
• Lab Automation and Molecular Diagnostics
  • Table 3-3: Selected Automated/ Integrated Molecular Test Instrument Platforms
• Gene Editing Applications in Molecular Diagnostics
• CRISPR and Diagnostic Applications
  • Table 3-4: Selected Gene Editing / CRISPR Innovations

Chapter Four: Company Profiles

• Abbott Diagnostics
• Company Overview
• Financial Review
  • Table 4-1: Abbott Diagnostics' Revenue History, 2017-2023 ($ billion)
  • Figure 4-1: Abbott Diagnostics' Molecular Diagnostic Revenue History, 2016-Q3 2024 ($ million)
  • Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2024 ($ million)
• FDA approval of Alinity m STI assay and High Risk HPV Assay
• FDA approval of ALK Break Apart FISH Probe Kit
• Alinity s System
• WHO prequalification (PQ) approval of viral load test
• Advanced Cell Diagnostics (Bio-Techne)
• Company Overview
• Agena Bioscience
• Company Overview
• Agendia BV
• Company Overview
• Agilent Technologies (incl. Dako)
• Company Overview
• Financial Review
  • Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, Fiscal 2016- Q3 2024 ($ million)
• Genomics
• Cytogenetic Analysis
• Sequencing
• Altona Diagnostics
• Company Overview
• Amoy Diagnostics
• Company Overview
• Applied Spectral Imaging
• Company Overview
• ARUP Laboratories
• Company Overview
• Asuragen Inc. (Bio-Techne)
• Company Overview
• Becton, Dickinson & Co. (BD)
• Company Overview
• Business Segments
  • BD Medical
  • BD Life Sciences
  • BD Interventional
• Acquisitions
  • TVA Medical, Inc.
  • R. Bard, Inc.
  • CareFusion Corporation
• Divestitures
  • Advanced Bio-processing
  • Respiratory Solutions and Vyaire Medical
• Leading Position in the Flow Cytometry Market
• Cytology
• Revenue and Growth
  • Figure 4-4: BD Life Sciences Unit Quarterly Revenues, Fiscal 2018-Q4 2024 ($ million)
• Molecular Diagnostics Focus
• Beijing Genomics Institute (BGI)
• Company Overview
• PCR and Fluorescence
• MGI Tech Co., Ltd.
• Prenatal Testing
• Test Services
• Whole Genome Sequencing (WGS)
• NGS Sequencing
• Collaborations
• Berry Genomics
• Company Overview
• binx health
• Company Overview
• Bio-Rad Laboratories, Inc.
• Company Overview
• Recent Revenue History
  • Table 4-2: Bio-Rad Diagnostics Revenue History, 2017-2023 ($ million)
• Liquid Biopsy
• Droplet Digital PCR
• Sequencing
• Biocartis
• Company Overview
• Financial Review
  • Table 4-3: Biocartis' Revenue History, 2017-2023 ($ million)
• Products and Technologies
• Biodesix
• Company Overview
• bioMerieux
• Company Overview
  • Figure 4-5: bioMerieux's Revenue History, Molecular Biology and Microbiology Segments, 2016-Q1 2024 (Euro million)
• BIOFIRE Business
• Molecular Diagnostics
• CareDx, Inc.
• Company Overview
  • Figure 4-6: CareDx Revenue, 2017-Q3 2024 ($ million)
• Testing Services Offered by CareDx
  • AlloMap Tests
  • AlloSure Tests
  • Products Offered by CareDx
• Danaher
• Company Overview
• Danaher's 2023 Performance
  • Figure 4-7: Danaher Major Segment Revenues by Quarter, Q1 2018-Q3 2024 ($ million)
• Life Sciences Business
• Diagnostics Business
• Cepheid
• GeneXpert / Xpress Line
• Tuberculosis
• Microbiology
• POC STI Testing
• Cancer
• Leica Biosystems
• DiaSorin
• Company Overview
• Molecular Diagnostics
• Molecular Oncology
• Expansion
• Eiken Chemical
• Company Overview
• Product News
• Exact Sciences Corp.
• Company Overview
• Recent Revenues and Developments
• Greiner Bio-One GmbH
• Company Overview
• Grifols, S. A
• Company Overview
• Molecular Immunohematology and Specialty Testing Products
• NAT Blood Screening
• Hologic, Inc.
• Company Overview
  • Figure 4-8: Hologic Diagnostics Revenues, Calendar Q4 2019-Q3 2024 ($ million)
  • Table 4-4: Hologic's Diagnostics Revenue History, by Segment, Fiscal 2017-2023 ($ million)
• Acquisitions
• PANTHER Molecular System
• HIV Testing
• Sexually Transmitted Infections
• Infectious Diseases
• Panther Fusion
• Illumina, Inc.
  • Table 4-5: Illumina's Revenue History, 2015-2023 ($ million)
  • Figure 4-9: Illumina's Revenue History, 2017-Q3 2024 ($ million)
• China
• Meridian Bioscience Inc
• Company Overview
  • Figure 4-10: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015-Q4 2022 ($ million)
• Myriad Genetics, Inc.
• Company Overview
  • Table 4-6: Myriad Genetics Revenue History, 2017-2023 ($ million)
• NanoString Technologies, Inc.
• Company Overview
• Oxford Nanopore Technologies Ltd
• Company Overview
• Promega Corporation
• Company Overview
• Qiagen
• Company Overview
  • Table 4-7: QIAGEN's Revenue History, 2017-2023 ($ million)
• Molecular Expansion
• Precision Medicine / Companion Diagnostics
• Molecular Microbiology
• Prenatal Testing
• Next Generation Sequencing
• Sample Prep, Informatics
• Digital PCR
• Liquid Biopsy
• Cervical Cancer
• Expansion and Other Developments
• QuantuMDx Group
• Company Overview
• QuidelOrtho
• Company Overview
• The Solana Business
• Molecular - Savanna
• Revvity
• Company Overview
• Diagnostics
• Sequencing /Genomics
• Liquid Biopsy
• Histology
• Prenatal Business
• Lab Services
• Rheonix, Inc.
• Company Overview
• Roche Diagnostics
• Company Overview
• Financial Review
  • Figure 4-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016-Q2 2024 ($ million)
  • Table 4-8: Roche Diagnostics' Revenue History, 2016-2023 ($ million)
• Molecular Expansion
• Core Molecular
• Digital PCR
• HPV
• HIV
• Coagulation
• cobas Liat System - POC
• Blood Bank
• Transplant Medicine
• Cancer Companion Testing
• IT in Anatomical Pathology
• Information Technology
• Other Recent Developments
• Seegene
• Company Overview
• Sekisui Diagnostics LLC
• Company Overview
• Sherlock Biosciences
• Company Overview
• Standard BioTools
• Company Overview
• T2 Biosystems
• Company Overview
• Thermo Fisher Scientific Inc.
• Company Overview
  • Table 4-9: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2017-2023 ($ million)
  • Table 4-10: Thermo Fisher Scientific Estimated Revenues by IVD Test Segment, 2017-2023 ($ million)
• Microbiology
• Molecular Test Business
• Next Generation Sequencing
• qPCR
• Oncology Companion Diagnostics
• Transplant Medicine
• Microbiome
• Other Collaborations and Acquisitions
• Gene Editing and Cell Therapy
• China
• Vela Diagnostics
• Company Overview
• Veracyte, Inc.
• Company Overview