Report Overview:
In a Post Pandemic world molecular diagnostics sees technologies boom. Nucleic acids become key.
The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for new growth. Find out what the numbers are in this informative report. And find out about the exciting technology developments which threaten to change diagnosis and treatment while limiting the threat of anti microbial drug resistance.
Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this new report from Howe Sound Research. A range of dynamic trends are pushing market growth and company valuations.
Exciting technical developments especially in the seesaw between nucleic acid testing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication.
All report data is available in Excel format on request.
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
- 2.4. 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
- 3.3.3. 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