Molecular Diagnostics for Infectious Disease By Syndrome, Plex, Place and by Country. With Analysis and Executive Guides. 2025 - 2029

Table of Contents

1. Market Guides

• 1.1. Strategic Situation Analysis
• 1.2. Guide for Executives and Business Development Staff
• 1.3. Guide for Management Consultants and Investment Advisors

2. Introduction and Market Definition

• 2.1. What are Molecular Diagnostics?
• 2.2. The Diagnostics Revolution
• 2.3. Market Definition
  • 2.3.1. Revenues
• 2.4. Methodology
  • 2.4.1. Methodology
  • 2.4.2. Sources
  • 2.4.3. Authors
• 2.5. Perspective: Healthcare and the IVD Industry
  • 2.5.1. Global Healthcare Spending
  • 2.5.2. Spending on Diagnostics
  • 2.5.3. Important Role of Insurance for Diagnostics

3. The Infectious Diseases - Market Analysis by Disease

• 3.1. HIV - Human Immunodeficiency Virus (AIDS)
  • 3.1.1. Virology
    • 3.1.1.1. Classification
    • 3.1.1.2. Structure and genome
    • 3.1.1.3. Tropism
    • 3.1.1.4. Replication cycle
    • 3.1.1.5. Genetic variability
  • 3.1.2. Diagnosis
  • 3.1.3. Testing
    • 3.1.3.1. Antibody tests
    • 3.1.3.2. Point of Care Tests (POCT)
    • 3.1.3.3. Antigen Tests
    • 3.1.3.4. Nucleic acid-based tests (NAT)
    • 3.1.3.5. Other tests used in HIV treatment
  • 3.1.4. Market Opportunity Analysis
• 3.2. HBV - Hepatitis B
  • 3.2.1. Virology
    • 3.2.1.1. Genome
    • 3.2.1.2. Pathogenesis
    • 3.2.1.3. Hepatitis B virus replication
    • 3.2.1.4. Serotypes and genotypes
  • 3.2.2. Mechanisms
  • 3.2.3. Diagnosis
  • 3.2.4. Market Opportunity Analysis
• 3.3. HCV - Hepatitis C
  • 3.3.1. Taxonomy
  • 3.3.2. Structure
    • 3.3.2.1. Genome
  • 3.3.3. Molecular biology
  • 3.3.4. Replication
  • 3.3.5. Genotypes
    • 3.3.5.1. Clinical importance
  • 3.3.6. Market Opportunity Analysis
• 3.4. HPV - Human papillomavirus
  • 3.4.1. Virology
    • 3.4.1.1. E6/E7 proteins
    • 3.4.1.2. Role in cancer
    • 3.4.1.3. E2 research
    • 3.4.1.4. Latency period
    • 3.4.1.5. Clearance
  • 3.4.2. Diagnosis
    • 3.4.2.1. Cervical testing
    • 3.4.2.2. Oral testing
    • 3.4.2.3. Testing men
    • 3.4.2.4. Other testing
  • 3.4.3. Market Opportunity Analysis
• 3.5. Influenza
  • 3.5.1. Virology
    • 3.5.1.1. Types of virus
    • 3.5.1.2. Influenzavirus A
    • 3.5.1.3. Influenzavirus B
    • 3.5.1.4. Influenzavirus C
    • 3.5.1.5. Structure, properties, and subtype nomenclature
    • 3.5.1.6. Replication
  • 3.5.2. Testing
    • 3.5.2.1. Advantages/Disadvantages of Molecular Assays
  • 3.5.3. Market Opportunity Analysis
• 3.6. CTGC - Chlamydia/Gonorhea
  • 3.6.1. Gonorrhea
    • 3.6.1.1. Diagnosis
    • 3.6.1.2. Screening
  • 3.6.2. Chlamydia
    • 3.6.2.1. Diagnosis
    • 3.6.2.2. Screening
  • 3.6.3. Testing
    • 3.6.3.1. Nucleic acid amplification tests (NAATs).
    • 3.6.3.2. Performance of NAAT Tests
  • 3.6.4. Market Opportunity Analysis
• 3.7. Tuberculosis
  • 3.7.1. Mycobacteria
  • 3.7.2. Diagnosis
    • 3.7.2.1. Active tuberculosis
    • 3.7.2.2. Latent tuberculosis
  • 3.7.3. Epidemiology
  • 3.7.4. Molecular Diagnostic Tests
  • 3.7.5. Market Opportunity Analysis
• 3.8. MRSA - Methicillin-resistant Staphylococcus aureus
  • 3.8.1. Diagnosis
  • 3.8.2. FDA Approved Molecular Tests
  • 3.8.3. Market Opportunity Analysis
• 3.9. VRE - Vancomycin-resistant Enterococcus
  • 3.9.1. FDA Approved MDx Tests for VRE
  • 3.9.2. Market Opportunity Analysis
• 3.10. Blood Screening
  • 3.10.1. Collection and Testing
  • 3.10.2. FDA Approved Multiplex Assays
  • 3.10.3. Market Opportunity Analysis
• 3.11. COVID-19
  • 3.11.1. Signs and symptoms
  • 3.11.2. Transmission
  • 3.11.3. Diagnosis
  • 3.11.4. Prevention
  • 3.11.5. Management
  • 3.11.6. Prognosis
• 3.12. Pandemic Diagnostics
  • 3.12.1. Risk Management - Spark and Spread
  • 3.12.2. Dx Technology - Nucleic Acid Based
  • 3.12.3. Dx Technology - Immunoassay & Serology
  • 3.12.4. Time to Market and Preparedness Issues
  • 3.12.5. Unrecognized Role of Multiplex in Pandemic Mangement

4. Industry Overview

• 4.1. Players in a Dynamic Market
  • 4.1.1. Academic Research Lab
  • 4.1.2. Diagnostic Test Developer
  • 4.1.3. Instrumentation Supplier
  • 4.1.4. Chemical/Reagent Supplier
  • 4.1.5. Pathology Supplier
  • 4.1.6. Independent Clinical Laboratory
  • 4.1.7. Public National/regional Laboratory
  • 4.1.8. Hospital Laboratory
  • 4.1.9. Physicians Office Lab (POLS)
  • 4.1.10. Audit Body
  • 4.1.11. Certification Body
• 4.2. The Clinical Laboratory Market Segments
  • 4.2.1. Traditional Market Segmentation
  • 4.2.2. Laboratory Focus and Segmentation
• 4.3. Industry Structure
  • 4.3.1. Hospital Testing Share
  • 4.3.2. Economies of Scale
    • 4.3.2.1. Hospital vs. Central Lab
  • 4.3.3. Physician Office Lab's
  • 4.3.4. Physician's and POCT

5. Profiles of Key MDx Companies

• 5.1 1928 Diagnostics
• 5.2. Abacus Diagnostica
• 5.3. Abbott Laboratories
• 5.4. Accelerate Diagnostics
• 5.5. Access Bio
• 5.6. Ador Diagnostics
• 5.7. ADT Biotech
• 5.8. Akonni Biosystems
• 5.9. Altona Diagnostics
• 5.10. Alveo Technologies
• 5.11. Anatolia Geneworks
• 5.12. Anitoa
• 5.13. Antelope Dx
• 5.14. Applied BioCode
• 5.15. Assurance Scientific Laboratories
• 5.16. Aureum Diagnostics
• 5.17. Aus Diagnostics
• 5.18. Beckman Coulter Diagnostics
• 5.19. Becton, Dickinson and Company
• 5.20. Binx Health
• 5.21. Biocartis
• 5.22. BioFire Diagnostics (bioMerieux)
• 5.23. bioMerieux Diagnostics
• 5.24. Bio-Rad Laboratories, Inc
• 5.25. Bosch Healthcare Solutions GmbH
• 5.26. Celemics
• 5.27. Cepheid (Danaher)
• 5.28. Chembio
• 5.29. Co Diagnostics
• 5.30. Credo Diagnostics Biomedical
• 5.31. Cue Health
• 5.32. Curetis N.V. / Curetis GmbH
• 5.33. Detect
• 5.34. Diagenode Diagnostics
• 5.35. Diascopic
• 5.36. Diasorin S.p.A.
• 5.37. Domus Diagnostics
• 5.38. Eiken Chemical
• 5.39. Element Biosciences
• 5.40. Enzo Biochem
• 5.41. Eurofins Scientific
• 5.42. Fluxergy
• 5.43. Fulgent Genetics
• 5.44. Fusion Genomics.
• 5.45. Genedrive
• 5.46. Genetic Signatures
• 5.47. GenMark Dx (Roche)
• 5.48. Genomadix
• 5.49. Grifols
• 5.50. Grip Molecular Technologies
• 5.51. Hibergene Diagnostics
• 5.52. Hologic
• 5.53. Illumina
• 5.54. Immunexpress
• 5.55. Inflammatix
• 5.56. Invetech
• 5.57. Janssen Diagnostics
• 5.58. Karius
• 5.59. Lexagene
• 5.60. LightDeck Diagnostics
• 5.61. Lucira Health
• 5.62. Luminex Corp (DiaSorin)
• 5.63. LumiraDx
• 5.64. Lumos Diagnostics
• 5.65. Mammoth Biosciences
• 5.66. Maxim Biomedical
• 5.67. Meridian Bioscience
• 5.68. Mesa Biotech (Thermo Fisher)
• 5.69. MicroGem
• 5.70. Millipore Sigma
• 5.71. Mindray
• 5.72. Minute Molecular
• 5.73. Mobidiag (Hologic)
• 5.74. Molbio Diagnostics
• 5.75. NanoDx
• 5.76. Nanomix
• 5.77. Novacyt
• 5.78. Novel Microdevices
• 5.79. OnsiteGene
• 5.80. Operon
• 5.81. Oxford Nanopore Technologies
• 5.82. Panagene
• 5.83. Pathogenomix
• 5.84. Perkin Elmer
• 5.85. Prenetics
• 5.86. Primerdesign (Novacyt)
• 5.87. Prominex
• 5.88. Proof Diagnostics
• 5.89. Qiagen
• 5.90. QuantuMDx
• 5.91. Quest Diagnostics
• 5.92. QuidelOrtho
• 5.93. Randox Toxicology
• 5.94. Roche Molecular Diagnostics
• 5.95. Saw Diagnostics
• 5.96. Scope Fluidics
• 5.97. SD Biosensor
• 5.98. Seegene
• 5.99. Siemens Healthineers
• 5.100. Singular Genomics
• 5.101. SomaLogic
• 5.102. Sona Nanotech
• 5.103. SpeeDx
• 5.104. T2 Biosystems
• 5.105. Talis Biomedical
• 5.106. Thermo Fisher Scientific Inc.
• 5.107. Ultima Genomics
• 5.108. Vela Diagnostics
• 5.109. Veramarx
• 5.110. Veredus Laboratories
• 5.111. Vir
• 5.112. Vircell
• 5.113. Visby Medical
• 5.114. XCR Diagnostics
• 5.115. YD Diagnostics
• 5.116. Zhejiang Orient Gene Biotech

6. Market Trends

• 6.1. Factors Driving Growth
  • 6.1.1. New Genotypes Creating New Markets
  • 6.1.2. The Aging Effect
  • 6.1.3. Developing World Driving ID Dx Growth
  • 6.1.4. Point of Care - Why Centralization is Losing Steam
  • 6.1.5. Self Testing
  • 6.1.6. The Need for Speed
  • 6.1.7. The COVID Pandemic
• 6.2. Factors Limiting Growth
  • 6.2.1. Lower Costs
  • 6.2.2. Infectious Disease is Declining
  • 6.2.3. Wellness Hurts
  • 6.2.4. Economic Growth improves Living Standards
• 6.3. Instrumentation and Automation
  • 6.3.1. Instruments Key to Market Share
  • 6.3.2. The Shrinking Machine
  • 6.3.3. Multiplex, Point of Care and The Speed Factor
• 6.4. Diagnostic Technology Development
  • 6.4.1. The Sepsis Testing Market - A New Direction?
  • 6.4.2. POCT/Self Testing as a Disruptive Force
  • 6.4.3. The Genetics Play - One Test for All Known Infections
  • 6.4.4. Antibiotic Resistance Genes - Simplifying Diagnostics

7. Molecular Dx - Infectious Disease Recent Developments

• 7.1. Recent Developments - Importance and How to Use This Section
  • 7.1.1. Importance of These Developments
  • 7.1.2. How to Use This Section
• 7.2. Hologic Revenues Rise 5 Percent on MDx Strength
• 7.3. Genetic Signatures Halts U.S. Molecular Respiratory Panel
• 7.4. Molecular Testing Growth Creates Reimbursement Problems
• 7.5. Binx Health Refocuses on POC STD Testing
• 7.6. LetsGetChecked Authorized for STD Test
• 7.7. Genetic Signatures Applies for GI Parasite Detection Kit
• 7.8. Sensible Diagnostics Nabs Award for Respiratory Panel
• 7.9. Post-Pandemic Changes Landscape of ID Dx
• 7.10. Multiplex Meningitis/Encephalitis Panel Market Expanding
• 7.11. Sensible Diagnostics to Launch 10-Minute POC PCR System
• 7.12. ReadyGo Dx Emerges From Stealth With MDx Plan
• 7.13. BioMerieux, Oxford Nanopore Form ID Dx Pact
• 7.14. SD Biosensor Eyes Global Expansion for Rapid MDx System
• 7.15. Compact POCT Platform Unlocks Multiplexing Potential of Real-Time PCR
• 7.16. Takara Bio and BioExcel Partner on ID Panels
• 7.17. BioGX introduces pixl real-time PCR platform
• 7.18. Sherlock Biosciences Improves ID Dx Toolkit
• 7.19. Climate change is making hundreds of diseases much worse
• 7.20. BioMerieux Invests in Sepsis Dx Startup Weezion
• 7.21. Domus Diagnostics to Launch POC MDx Test System
• 7.22. Proof Dx Plans Infectious Disease, Oncology Tests for CRISPR-Based POC
• 7.23. Oxford Nanopore Diagnostics to Develop Clinical Tools
• 7.24. Pathogenomix Developing Infectious Disease Platform Using NGS
• 7.25. COVID-19 Accelerating Trend Toward Pharmacy-Based Testing
• 7.26. Co-Diagnostics Seeks FDA EUA for At-Home PCR Diagnostic
• 7.27. Sense Biodetection to Debut Instrument-Free Point-of-Care MDx
• 7.28. Home Test Company Prenetics to go Public
• 7.29. Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
• 7.30. Lucira Health Posts Revenue Growth on OTC C19 Test
• 7.31. BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
• 7.32. Talis Biomedical Discusses Point-of-Care
• 7.33. Roche to Acquire GenMark Diagnostics for $1.8B
• 7.34. Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
• 7.35. Hologic to Acquire Mobidiag
• 7.36. Lucira Health Focuses on User Friendly Approach to Home Testing
• 7.37. Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
• 7.38. Fluidigm Plans 'Durable' Diagnostics, Clinical Business
• 7.39. Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
• 7.40. Mammoth Biosciences Developing Pathogen Detection Tech
• 7.41. Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
• 7.42. Scanogen Developing 90 Minute Infection Test
• 7.43. Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
• 7.44. FDA Provides Self Testing SARS-CoV-2 EAU Guidance
• 7.45. Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic

8. The Global Market for Molecular Diagnostics Infectious Disease

• 8.1. Global Market Overview by Country
  • 8.1.1. Table - Global Market by Country
  • 8.1.2. Chart - Global Market by Country
• 8.2. Global Market by Syndrome - Overview
  • 8.2.1. Table - Global Market by Syndrome
  • 8.2.2. Chart - Global Market by Syndrome - Base/Final Year Comparison
  • 8.2.3. Chart - Global Market by Syndrome - Base Year
  • 8.2.4. Chart - Global Market by Syndrome - End Year
  • 8.2.5. Chart - Global Market by Syndrome - Share by Year
  • 8.2.6. Chart - Global Market by Syndrome - Segments Growth
• 8.3. Global Market by Plex - Overview
  • 8.3.1. Table - Global Market by Plex
  • 8.3.2. Chart - Global Market by Plex - Base/Final Year Comparison
  • 8.3.3. Chart - Global Market by Plex - Base Year
  • 8.3.4. Chart - Global Market by Plex - End Year
  • 8.3.5. Chart - Global Market by Plex - Share by Year
  • 8.3.6. Chart - Global Market by Plex - Segments Growth
• 8.4. Global Market by Place - Overview
  • 8.4.1. Table - Global Market by Place
  • 8.4.2. Chart - Global Market by Place - Base/Final Year Comparison
  • 8.4.3. Chart - Global Market by Place - Base Year
  • 8.4.4. Chart - Global Market by Place - End Year
  • 8.4.5. Chart - Global Market by Place - Share by Year
  • 8.4.6. Chart - Global Market by Place - Segments Growth

9. Global MDx Infectious Disease Markets - By Syndrome

• 9.1. Respiratory
  • 9.1.1. Table Respiratory - by Country
  • 9.1.2. Chart - Respiratory Growth
• 9.2. Gastrointestinal
  • 9.2.1. Table Gastrointestinal - by Country
  • 9.2.2. Chart - Gastrointestinal Growth
• 9.3. Blood
  • 9.3.1. Table Blood - by Country
  • 9.3.2. Chart - Blood Growth
• 9.4. Meningitis/Encephalitis
  • 9.4.1. Table Meningitis/Encephalitis - by Country
  • 9.4.2. Chart - Meningitis/Encephalitis Growth
• 9.5. Sexually Transmitted Disease
  • 9.5.1. Table Sexually Transmitted Disease - by Country
  • 9.5.2. Chart - Sexually Transmitted Disease Growth
• 9.6. Other
  • 9.6.1. Table Other - by Country
  • 9.6.2. Chart - Other Growth

10. Global MDx Markets for Infectious Disease - by Plex

• 10.1. Single Plex
  • 10.1.1. Table Single Plex - by Country
  • 10.1.2. Chart - Single Plex Growth
• 10.2. Duplex
  • 10.2.1. Table Duplex - by Country
  • 10.2.2. Chart - Duplex Growth
• 10.3. Triplex
  • 10.3.1. Table Triplex - by Country
  • 10.3.2. Chart - Triplex Growth
• 10.4. Multiplex Technology
  • 10.4.1. Table Multiplex - by Country
  • 10.4.2. Chart - Multiplex Growth

11. Global MDx Infectious Disease Markets - by Place

• 11.1. Hospital Lab
  • 11.1.1. Table Hospital Lab - by Country
  • 11.1.2. Chart - Hospital Lab Growth
• 11.2. Outpatient Lab
  • 11.2.1. Table Outpatient Lab - by Country
  • 11.2.2. Chart - Outpatient Lab Growth
• 11.3. POC
  • 11.3.1. Table POC - by Country
  • 11.3.2. Chart - POC Growth
• 11.4. Other Place
  • 11.4.1. Table Other Place- by Country
  • 11.4.2. Chart - Other Place Growth

12. Appendices

• 12.1. United States Medicare System: Clinical Laboratory Fees Schedule
• 12.2. The Most Used IVD Assays
• 12.3. The Highest Grossing Assays

Table of Tables

• Table 1: Classification of HIV Species
• Table 2: HIV Tests - CMS Codes & Prices
• Table 3: Current HIV Molecular Tests and Instruments Used
• Table 4: HBV Tests - CMS Codes & Prices
• Table 5: HCV Tests - CMS Codes & Prices
• Table 6: HPV Clearance Rates
• Table 7: HPV Tests - CMS Codes & Prices
• Table 8: HPV Tests, Technology, Types
• Table 9: Types of Influenza Tests
• Table 10: Influenza Tests - CMS Codes & Prices
• Table 11: FDA Cleared Molecular Assays for Influenza
• Table 12: FDA Cleared NAAT CTGC Tests
• Table 13: CTGC NAAT Target Sequences and Possible False Reactions
• Table 14: CTGC Tests - CMS Codes & Prices
• Table 15: FDA Approved MDx Tests for Tuberculosis
• Table 16: Tuberculosis Tests - CMS Codes & Prices
• Table 17: FDA Approved Tests for MRSA
• Table 18: MRSA Tests - CMS Codes & Prices
• Table 19: FDA Approved Tests for VRE
• Table 20: VRE Tests - CMS Codes & Prices
• Table 21: FDA Approved Multiplex Assays
• Table 22: Characteristics of Coronavirus Pandemic Infections
• Table 23: COVID-19 Symptoms
• Table 24: Market Players by Type
• Table 25: Clinical Laboratory Departments and Segments
• Table 26: Laboratory Management Focus - Different Approaches
• Table 27: Key Segmentation Variables Going Forward
• Table 28: Five Factors Driving Growth
• Table 29: Four Factors Limiting Growth
• Table 30: Key Diagnostic Laboratory Technology Trends
• Table 31: Global Market by Region
• Table 32: Global Market by Syndrome
• Table 33: Global Market by Plex
• Table 34: Global Market by Place
• Table 35: Respiratory by Country
• Table 36: Gastrointestinal by Country
• Table 37: Blood by Country
• Table 38: Meningitis/Encephalitis by Country
• Table 39: Sexually Transmitted Disease by Country
• Table 40: Other by Country
• Table 41: Single Plex by Country
• Table 42: Duplex by Country
• Table 43: Triplex by Country
• Table 44: Multiplex by Country
• Table 45: Hospital Lab by Country
• Table 46: Outpatient Lab by Country
• Table 47: POC by Country
• Table 48: Other Place by Country
• Table 49: Clinical Lab Fee Schedule
• Table 50: The Most Common Assays
• Table 51: Largest Revenue Assays

Table of Figures

• Figure 1: Global Healthcare Spending
• Figure 2: The Lab Test Pie
• Figure 3: HIV Virion
• Figure 4: Diagram of the HIV Replication Cycle
• Figure 5: The Structure of the HBV Virus
• Figure 6: Hepatitis B Replication
• Figure 7: Structure of the HCV Virus
• Figure 8: HCV Replication Cycle
• Figure 9: Structure of the Influenza Virion
• Figure 10: Influenza Replication
• Figure 11: Scanning Electronmicrograph of Tuberculosis
• Figure 12: The Road to Diagnostics
• Figure 13: The Changing Age of The World's Population
• Figure 14: Health Care Consumption by Age
• Figure 15: Cancer Incidence by Age
• Figure 16: Chart Infectious Disease Decline
• Figure 17: Global Market Shares Chart
• Figure 18: Global Market by Syndrome - Base vs. Final
• Figure 19: Global Market by Syndrome Base Year
• Figure 20: Global Market by Syndrome End Year
• Figure 21: Syndrome Share by Year
• Figure 22: Syndrome Segments Growth
• Figure 23: Global Market by Plex - Base vs. Final
• Figure 24: Global Market by Plex Base Year
• Figure 25: Global Market by Plex End Year
• Figure 26: Plex Share by Year
• Figure 27: Plex Segments Growth
• Figure 28: Global Market by Place - Base vs. Final
• Figure 29: Global Market by Place Base Year
• Figure 30: Global Market by Place End Year
• Figure 31: Place Share by Year
• Figure 32: Place Segments Growth
• Figure 33: Respiratory Growth
• Figure 34: Gastrointestinal Diagnostics Growth
• Figure 35: Blood Growth
• Figure 36: Meningitis/Encephalitis Growth
• Figure 37: Sexually Transmitted Disease Growth
• Figure 38: Other Growth
• Figure 39: Single Plex Growth
• Figure 40: Duplex Growth
• Figure 41: Triplex Growth
• Figure 42: Multiplex Growth
• Figure 43: Hospital Lab Growth
• Figure 44: Outpatient Lab Growth
• Figure 45: POC Growth
• Figure 46: Other Place Growth