분자진단 시장(제14판)

The molecular diagnostics market remains a powerful growth engine within the global in vitro diagnostics (IVD) industry. Several years after the pandemic, demand continues to expand across infectious disease testing, cancer diagnostics, and transplant applications. Kalorama Information's World Market for Molecular Diagnostics, 14th Edition delivers a comprehensive, data-driven analysis of this fast-evolving sector, examining the technologies, applications, and competitive dynamics shaping the market from 2025 to 2030.

As molecular techniques become increasingly integrated into routine clinical practice, this report provides essential insight into how innovations in diagnostics are enabling more precise disease detection, supporting personalized treatment strategies, and driving continued market expansion in both developed and emerging regions.

Report Features

Comprehensive Market Insights

Analyze global and regional molecular diagnostics markets at the manufacturer level, segmented by key application areas including infectious diseases, blood screening, cancer diagnostics, and histology. Market size estimates for 2025 and detailed forecasts through 2030 are provided, along with compound annual growth rates (CAGRs) for each segment.

Technology-Driven Market Evolution

Explore how core molecular technologies-including polymerase chain reaction (PCR), next-generation sequencing (NGS), and in situ hybridization (ISH)-are transforming diagnostic capabilities and expanding the role of molecular diagnostics in clinical settings worldwide.

Competitive Intelligence and Market Structure

Gain insight into the competitive landscape through profiles of major market participants such as Roche Diagnostics, Thermo Fisher Scientific, and Illumina, alongside emerging competitors. The report examines company performance, new product developments, partnerships, mergers and acquisitions, and evolving competitive strategies.

Research Parameters

World Market for Molecular Diagnostics, 14th Edition covers global and regional markets for molecular diagnostics IVD products, including systems, kits, and consumables. Market data reflect manufacturer revenues, with 2025 as the base year and forecasts extending through 2030.

The analysis is supported by extensive primary and secondary research, including interviews with IVD manufacturers, clinical laboratory professionals, and industry experts, in addition to information from government and trade publications, industry reports, company annual reports, and public filings.

Table of Contents

Chapter 1: Executive Summary

• Scope and Methodology
• Overview
• Size of Molecular Diagnostics Market
  • Table 1-1: Global Molecular Diagnostics Market, w/ and w/out COVID-19, 2025 ($ million)
  • Figure 1-1: Global Molecular Diagnostics Market, w/ and w/out COVID-19, 2025 ($ million)
• Growth Areas in Molecular Diagnostics
  • Table 1-2: Molecular Diagnostics Growth Applications, by Revenue Growth, 2025-2030 (%) [Cancer Assays, Circulating tumor cells, HAIs/sepsis, Hepatitis, Histology (ISH, FISH), HIV, Inherited/genetic, Molecular HPV, NIPT, Respiratory, STIs, TB, Transplantation]
  • Figure 1-2: Molecular Diagnostics Growth Applications, by Revenue Growth, 2025-2030 (%) [Cancer Assays, Circulating tumor cells, HAIs/sepsis, Hepatitis, Histology (ISH, FISH), HIV, Inherited/genetic, Molecular HPV, NIPT, Respiratory, STIs, TB, Transplantation]
• Recent Trends and Developments
  • Automation
  • Molecular Point of Care
    • Table 1-3: Selected Molecular POC Diagnostic Platforms
  • Next-Generation Sequencing
  • Avian Flu
  • Monkeypox
• Other Developments in Molecular Diagnostics, 2024-2025

Chapter 2: Molecular Diagnostics Market

• Recent Product Introductions and Regulatory Approvals
  • Table 2-1: Regulatory Approvals and Announcements, January 2020-December 2025
  • Table 2-2: Recent Product Introductions, January 2020-December 2024
• Market Size and Forecast by Segments
  • Table 2-3: Worldwide Molecular Diagnostic Market, by Segment, 2025 and 2030 ($ million) [Infectious (Respiratory, HAIs/Sepsis, Hepatitis, HIV, STIs, TB, Organism ID, Other); Oncology (Cancer Assays, Histology {SH, FISH}, Molecular HPV, Circulating Tumor Cells); NAT Blood Screening; Genetic (NIPT, Inherited/Genetic); Transplantation]
  • Table 2-4: Worldwide Molecular Diagnostic Market, by Region, 2025 ($ million) [APAC, Europe, North America, Rest of World]
  • Figure 2-1: Molecular Diagnostics Market, by Region, 2025 ($ million) [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, 2020-2025

Chapter 3: Trends to Watch - Sequencing, CRISPR, Automation

• Sequencing
  • NGS and Companion Diagnostics
    • Table 3-1: Selected Clinical NGS Platforms
  • Outlook For NGS in Molecular Diagnostics
    • Figure 3-1: Share of the Molecular Diagnostics Market Revenues, by Test Technique, 2025 (%) [ISH, Microarrays, NGS, PCR]
  • Evolving Informatics Solutions in Clinical Sequencing
  • Sample Preparation and Quality Control
• Lab Automation and Molecular Diagnostics
  • Table 3-2: Selected Automated/ Integrated Molecular Test Instrument Platforms
• Gene Editing Applications in Molecular Diagnostics
  • CRISPR and Diagnostic Applications
    • Table 3-3: Selected Gene Editing / CRISPR Innovations

Chapter 4: Company Profiles

• Abbott Diagnostics
  • Company Overview
  • Financial Review
    • Table 4-1: Abbott Diagnostics Revenue History, by Segment, 2022-2024 ($ million)
    • Figure 4-1: Abbott Diagnostics Molecular Diagnostic Revenue History, 2016-Q3 2025 ($ million)
    • Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2025 ($ million)
  • Corporate Background
  • FDA Approval of Alinity m STI Assay and High-Risk HPV Assay
  • FDA Approval of ALK Break Apart FISH Probe Kit
  • WHO Prequalification for Viral Load Test
  • Products in Molecular Diagnostics
• Advanced Cell Diagnostics (Bio-Techne)
  • Company Overview
  • Products and Technologies
  • Expansion Into Clinical Diagnostics
  • Industry Collaborations and Automation Partnerships
  • Product Enhancements and Automation Advances
• Agena Bioscience
  • Company Overview
• Agendia BV
  • Company Overview
  • Partnerships and Business Expansion
  • Recent Developments
  • Regulatory Recognition and Clinical Validation
  • Details on MammaPrint and BluePrint
  • ColoPrint
  • Digital Pathology and AI Collaborations
  • Agilent Technologies (incl. Dako)
  • Company Overview
  • Financial Review
  • Company Overview
    • Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, Fiscal 2016-Q3 2025 ($ million)
  • Genomics
  • Cytogenetic Analysis
  • Sequencing
• Altona Diagnostics
  • Company Overview
  • Selected EUA and IVD Launches
• Amoy Diagnostics
  • Company Overview
  • Product Portfolio and Regulatory Status
  • Key Partnerships and Collaborations
  • Ongoing Expansion and Newer Collaborations
• Applied Spectral Imaging
  • Company Overview
  • Molecular Clinical Diagnostics Applications
  • Karyotyping
  • ISH and FISH Applications
  • Digital Pathology (HiPath)
  • Key Partnerships and Technology Developments
• ARUP Laboratories
  • Company Overview
  • COVID-19 Response
  • Key Collaborations and Innovation Initiatives
  • Oncology and Genetic Testing Developments
  • Additional Partnerships and Assay Launches
  • Recent Launches
• Asuragen Inc. (Bio-Techne)
  • Company Overview
  • Quantidex and NGS-Related Technologies
  • RNA Stabilization and Sample-Handling Technology
  • NGS Panel Development and Collaborations
  • Additional Test and Technology Releases
  • Acquisition
• Becton, Dickinson & Co. (BD)
  • Company Overview
  • Business Segments
  • BD Medical
  • BD Life Sciences
  • BD Interventional
  • Acquisitions
  • Divestitures
  • Leading Position in Flow Cytometry
  • Cytology
  • Revenue and Growth
    • Figure 4-4: BD Diagnostic Solutions Quarterly Revenues, Fiscal 2024- 2025 ($ million)
  • Molecular Diagnostics Focus
  • BD MAX System
  • BD Affirm and ProbeTec Platforms
  • BD Viper System
  • COVID-19, Respiratory Panels, and Other Recent Developments
• Beijing Genomics Institute (BGI)
  • Company Overview
  • PCR and Fluorescent Diagnostics
  • MGI Tech Co., Ltd.
  • Prenatal Testing
  • Test Services
  • Notable Research and Partnerships
  • Whole Genome Sequencing (WGS) Initiatives
  • Regulatory Approvals
  • NGS Sequencing and Metagenomics
  • Collaborations
• Berry Genomics
  • Company Overview
  • NIPT and Genetic Disease Testing
  • Strategic Partnerships and Technology Development
  • Expansion of Sequencing Capabilities
• binx health
  • Company Overview
  • The io Platform
  • Pipeline and Additional Tests
  • Regulatory and Commercial Milestones
  • Partnerships
• Bio-Rad Laboratories, Inc.
  • Key Comment
  • Company Overview
  • Recent Revenue History
    • Table 4-2: Bio-Rad Diagnostics Revenue History, 2020-2024 ($ million)
  • Acquisitions and Partnerships
  • Key Product Launches and Regulatory Approvals
  • QX One ddPCR System
  • Liquid Biopsy and Oncology Diagnostics
  • QC and Control Products
  • Liquid Biopsy and CTC Technologies
  • Digital PCR Leadership
  • Sequencing Collaboration with Illumina
• Biocartis
  • Company Overview
  • Strategic Partnerships and Collaborations
  • Immuno-Oncology and CDx Partnerships
  • Assay Development and Commercialization Agreements
  • Financial Review
    • Table 4-3: Biocartis' Revenue History, 2017-2023 ($ million)
  • Products and Technologies
  • Menu Expansion and Assay Development
  • Additional Commercial and Regulatory Milestones
• Biodesix
  • Company Overview
  • VeriStrat-R Proteomic Test
  • GeneStrat-R Liquid Biopsy Test
  • Research Partnerships and Collaborations
  • Technology Platforms
• bioMerieux
  • Company Overview
    • Figure 4-5: bioMerieux's Revenue History by Quarter, Molecular Biology and Microbiology Segments, 2016-Q3 2025 (Euro million)
  • BIOFIRE Business
  • Molecular Diagnostics
  • Centralized Lab Molecular Portfolio
  • Isothermal Testing (NASBA)
  • FilmArray - Impact on Molecular Diagnostics
  • NGS-Based Epidemiology
• CareDx, Inc.
  • Company Overview
    • Figure 4-6: CareDx Revenue, 2017-Q3 2025 ($ million)
  • 2022-2025 Developments
  • Testing Services Offered by CareDx
  • AlloMap-R
  • AlloSure-R
  • Products Gained Through Allenex Acquisition
  • Regulatory and Legal Updates
• Danaher
  • Company Overview
  • Revenue Performance
  • Revenue by Segment
    • Figure 4-7: Danaher Major Segment Revenues, by Quarter, Q1 2018-Q3 2025 ($ million)
  • Life Sciences Business
  • Diagnostics Business
  • Cepheid
  • GeneXpert / Xpress Line
  • Tuberculosis
  • Microbiology
  • Point-of-Care STI Testing
  • Cancer
  • Leica Biosystems
  • Digital Pathology (Aperio)
  • Strategic Partnerships and Collaborations
  • Recent Organizational and Technology Milestones
• DiaSorin
  • Company Overview
  • Expansion into Molecular Diagnostics
  • Regulatory Milestones and Product Approvals
  • Growth Strategy
  • LIAISON IAM and LIAISON IXT Platforms
  • Corporate Transactions
  • Molecular Diagnostics Portfolio
  • Key Regulatory Milestones
  • Molecular Oncology
  • Expansion Activities
• Eiken Chemical
  • Company Overview
  • LAMP Technology and Molecular Platform
  • Global Impact and Licensing
  • Product News
  • Fecal Occult Blood and Microbiology Products
  • Strategic Partnerships and NGS Development
• Greiner Bio-One GmbH
  • Company Overview
  • Genspeed R2 Analyzer and Molecular Diagnostics
  • System Features
  • Available CE-IVD Assays
  • oCheck Diagnostic Product Line
  • PapilloCheck-R
  • Corporate Updates and Strategic Moves
• Grifols, S. A
  • Company Overview
  • Expansion Through Acquisitions and Investments
  • Molecular Immunohematology and Specialty Testing (Progenika)
  • Procleix NAT Blood Screening
  • Platforms
  • Procleix Assays
  • Recent Approvals
  • Additional Corporate Developments
• Hologic, Inc.
  • Company Overview
    • Figure 4-8: Hologic Diagnostics Revenues, Calendar Q4 2019 -Q3 2025 ($ million)
    • Table 4-4: Hologic's Diagnostics Revenue History, Fiscal 2019-2025 ($ million)
  • Acquisitions
  • Panther Molecular System
  • Panther Assay Menu (U.S.)
  • Panther Assay Menu (Europe)
  • Panther Trax (2021)
  • Panther Fusion
  • Open Access (LDT Capability)
  • HIV Testing
  • Sexually Transmitted Infections
  • Infectious Diseases
• Illumina, Inc.
  • Company Overview
    • Table 4-5: Illumina's Revenue History, 2016-2024 ($ million)
    • Figure 4-9: Illumina's Revenue History, 2017-Q3 2024 ($ million)
  • Sequencing Systems and Clinical Expansion
  • Systems and Products
  • MiSeq
  • MiSeqDx
  • iSeq 100
  • NovaSeq Series
  • Long-Read Technology
  • Recent International Approvals
  • COVIDSeq
  • Companion Diagnostics, cfDNA, and Liquid Biopsy
  • TruSight Oncology 500 (TSO 500)
  • VeriSeq NIPT Solution v2
  • TruSight Oncology 500 ctDNA
  • TruSight Tumor 170
  • Pan-Cancer CDx (2022)
  • Strategic Collaborations and Deals
  • Roche Partnership (January 2020)
  • PierianDx Collaboration (January 2019)
  • Frederick National Lab / NCI Studies (2019)
  • QIAGEN Partnership (October 2019)
  • Imagia AI Collaboration (June 2020)
  • BlueBee Acquisition (June 2020)
  • Pacific Biosciences Merger Termination (January 2020)
  • GRAIL Acquisition and Divestiture (2020-2024)
  • Precision Oncology Partnerships (2021-2023)
  • Pillar Biosciences Partnership (August 2023)
  • Single-Cell Sequencing Partnership with Bio-Rad
  • CareDx Licensing Agreement
  • Illumina in China
  • Key Developments
• Meridian Bioscience Inc
  • Company Overview
    • Figure 4-10: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015-Q4 2022 ($ million)
  • Life Science Business
  • Clinical Diagnostics Portfolio
  • Diagnostic Platforms
  • FDA-Cleared Alethia Assays
  • Gastrointestinal and Pediatric Strength
  • Regulatory and Product Milestones (2018-2025)
  • Merger
• NanoString Technologies, Inc.
  • Company Overview
  • Technology and Core Platforms
  • nCounter System Features
  • Specialized Assays
  • Spatial Biology Portfolio
  • GeoMx Digital Spatial Profiler (DSP) - Launched March 2019
  • CosMx SMI Platform
  • Additional Product and Research Milestones
  • Corporate Partnerships and Licensing
  • Transplant Diagnostics (2020)
  • Cloud and Data Analysis
  • High-Throughput SARS-CoV-2 Testing
  • Diagnostic Platform Licensing
  • Illumina Accelerator Partnership (March 2021)
  • New Oncology and Immune Panels
  • New Platforms and Data-Integration Tools
  • Acquisition by Bruker
  • Oxford Nanopore Technologies Ltd
  • Company Overview
  • Promega Corporation
  • Company Overview
  • Companion Diagnostics and MSI Portfolio
  • Strategic Partnerships and Technology Licensing
  • Research Tools and Product Portfolio
  • Molecular Diagnostics and Infectious Disease
  • OncoMate MSI Dx System
• Qiagen
  • Company Overview
    • Table 4-6: QIAGEN's Revenue History, 2018-2024 ($ million)
  • Molecular Expansion Strategy
  • QIAstat-Dx System Features
  • Regulatory and Portfolio Expansion
  • Next-Generation Syndromic Testing Systems
  • NeuMoDx System Discontinuation
  • Precision Medicine / Companion Diagnostics
  • Key Regulatory and Partnership Milestones (2019-2023)
  • Molecular Microbiology
  • New artus and Molecular Assays
  • QIAstat-Dx Menu Expansion
  • Prenatal Testing
  • PartoSure
  • Next-Generation Sequencing Portfolio
  • NGS Product Development Timeline
  • Sample Prep and Informatics
  • Digital PCR
  • Liquid Biopsy
  • Cervical Cancer Portfolio
  • Expansion and Additional Developments
  • Antimicrobial Resistance (AMR) Informatics
  • Apis Assay Technologies Partnership
  • China Market Strategy
  • Immuno-Oncology Assets
  • Key Regulatory Events
  • Digital PCR Clinical Expansion
  • Recent Product Introductions
  • IVDR Milestone
  • Thermo Fisher Acquisition Attempt (2020)
  • Other Industry Partnerships
• QuidelOrtho
  • Company Overview
  • Lyra Platform
  • Solana Molecular Platform
  • Key Solana Features
  • Solana Assay Menu
  • Regulatory Milestones
• Revvity
  • Company Overview
  • Prenatal and Maternal Health Solutions
  • Key Acquisitions Supporting Screening and Genomics
  • Diagnostics Division
  • Sequencing and Genomics
  • GenePrism: Actionable Insights
  • Key Genomics Collaborations
  • Liquid Biopsy
  • Histology and Spatial Pathology
  • Prenatal Screening and NIPT Portfolio
  • Key Products and Milestones
  • Laboratory Services
  • U.S. Operations
  • WGS Expansion via ViaCord
• Roche Diagnostics
  • Company Overview
  • Financial Review
    • Figure 4-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016-Q3 2025 (CHF M)
    • Table 4-7: Roche Diagnostics' Revenue History, 2022-2024 ($ million)
  • Roche Tissue Diagnostics
  • Molecular Expansion
  • Core Molecular Systems
  • December 2025 - cobas 6800/8800 Version 2.0
  • Respiratory Flex Panel and TAGS Technology
  • Assay Menu
  • Regulatory Highlights
  • Digital PCR
  • HPV
  • Additional Milestones
  • HIV
  • Coagulation
  • cobas Liat - Point-of-Care PCR
  • Key Regulatory Milestones
  • Blood Bank / Donor Screening
  • Key NAT and Donor-Screening Tests
  • Transplant Medicine
  • Cancer Companion Testing
  • Foundation Medicine Partnership
  • Key Timeline of CDx Approvals
  • IT in Anatomical Pathology
  • Key Roche Digital Pathology Milestones
  • Information Technology
  • Other Recent Developments
• Seegene
  • Company Overview
  • Syndromic Panels and Global Expansion
  • Seegene's Proprietary Diagnostic Systems
  • CE-Marked Assays
  • qTOCE Quantitative Multiplex Assays
  • Additional CE-Marked Solutions
  • Automation and New Product Development
• Sekisui Diagnostics LLC
  • Company Overview
  • Coagulation Business Transitions
  • POC and Molecular Testing Portfolio
  • Silaris Molecular POC System
  • Acucy Influenza A&B
  • OSOM Ultra Plus Flu A&B
  • Recent Partnerships and Product Launches
  • Aptitude Metrix Platform
  • Acucy Influenza A&B System Update
  • Metrix COVID/Flu Test
• Sherlock Biosciences
  • Company Overview
  • Product Development and Technology
  • Corporate Growth, Investments, and Acquisitions
  • Partnerships and Collaborations
  • CRISPR-Based COVID-19 and STI Testing
  • Licensing and Technology Exchange
  • Global Health Collaborations
• Standard BioTools
  • Company Overview
  • Microfluidics and PCR Systems
  • Key Technology Platforms
  • C1 and REAP-Seq
  • Imaging Mass Cytometry (IMC)
  • Maxpar Direct Immune Profiling System
  • Advanta Solid Tumor NGS Assay
  • IMC Expansion
  • Acquisitions
  • Pathology and Sample-Prep Advances
  • Global Partnerships
  • New Microfluidics and PCR Systems
  • Biomark X
  • Company Rebranding
  • X9 Real-Time PCR System
  • Imaging Mass Cytometry - Hyperion XTi
• Thermo Fisher Scientific Inc.
  • Company Overview
    • Table 4-8: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2018-2024 ($ million)
  • Geographic Profile and Strategic Expansion
  • Attempted Acquisition of QIAGEN (2020)
  • Microbiology
  • Molecular Test Business
  • Siemens Partnership (2016-2024)
  • QuantStudio 5 Dx (2021)
  • Recent Diagnostic Product Launches
  • Next Generation Sequencing
  • Key NGS Collaborations & Milestones
  • qPCR
  • Oncology Companion Diagnostics
  • CDx Timeline
  • Transplant Medicine
  • Microbiome
  • Other Collaborations and Acquisitions
  • Mesa Biotech Overview (Accula Platform)
  • Gene Editing and Cell Therapy
  • China
• Vela Diagnostics
  • Company Overview
  • Product and Panel Launches
  • Regulatory Milestones
  • Technology Licensing and Development
  • Acquisitions and Global Expansion
  • Great Basin Scientific Acquisition (June 2018)
  • Middle East Expansion (November 2018)
  • Corporate History and Investment
• Veracyte, Inc.
  • Company Overview
  • Strategic Partnerships, Collaborations & Product Expansions
  • Lung Cancer Diagnostics
  • Transplant Diagnostics & nCounter Platform
  • COVID-19 and High-Throughput Sequencing
  • Regulatory Milestones
  • Acquisitions and Portfolio Growth
  • International Reimbursement and Market Expansion
  • Additional Collaborations