Report Overview:
COVID-19 has broken open the market for point of care testing of respiratory infections. Now the competition for market share begins in earnest. Large new markets are opening up. And lets not forget the screening market, not just for COVID, but for the rest of the 20 something respiratory pathogens as well. Multiplex vs single plex? Explore the rapidly changing market as competitors jockey for position in new markets that are not yet well understood.
New technology is forever changing the diagnosis of respiratory infections. Shrinking time to result is opening up markets multiple times the size of current microbiology based practice. The Laboratory has already moved into the Emergency Room.
The widespread nature of respiratory infections, (young people can get 8 colds a year) means that potential market sizes are enormous. Respiratory, already the largest infectious disease category could multiply in size. This is a growth opportunity for all diagnostic companies. Understand the opportunity and the risk with this in depth report.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
Table of Contents
1. Market Guides
- 1.1. 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 Respiratory Infections?
- 2.2. The Role of Diagnosis & Treatment
- 2.3. Market Definition
- 2.3.1. Revenue Market Size
- 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. Market Overview
- 3.1. Players in a Dynamic Market
- 3.1.1. Academic Research Lab
- 3.1.2. Diagnostic Test Developer
- 3.1.3. Instrumentation Supplier
- 3.1.4. Chemical/Reagent Supplier
- 3.1.5. Pathology Supplier
- 3.1.6. Independent Clinical Laboratory
- 3.1.7. Public National/regional Laboratory
- 3.1.8. Hospital Laboratory
- 3.1.9. Physicians Office Lab (POLS)
- 3.1.10. Audit Body
- 3.1.11. Certification Body
- 3.2. Respiratory Infections
- 3.2.1. Upper vs. Lower - Marketing Implications
- 3.2.2. Understanding the Role of Pneumonia
- 3.2.3. Bacterial Infections
- 3.2.3.1. Streptococcal Infections
- 3.2.3.2. Acute Otitis Media
- 3.2.3.3. Bacterial Rhinosinusitis
- 3.2.3.4. Diphtheria
- 3.2.3.5. Pneumococcal Pneumonia
- 3.2.3.6. Haemophilus Pneumonia
- 3.2.3.7. Mycoplasma Pneumonia (Walking Pneumonia)
- 3.2.3.8. Chlamydial Pneumonias and Psittacosis
- 3.2.3.9. Health Care-Associated Pneumonia
- 3.2.3.10. Pseudomonas Pneumonia
- 3.2.3.11. Legionnaires Disease
- 3.2.4. Tuberculosis - A Special Case
- 3.2.5. Viral Infections
- 3.2.5.1. The Common Cold
- 3.2.5.2. Influenza
- 3.2.5.3. Viral Pneumonia
- 3.2.5.4. SARS and MERS
- 3.2.5.5. Measles (Rubeola)
- 3.2.5.6. Rubella (German Measles)
- 3.2.5.7. Chickenpox and Shingles
- 3.2.6. Fungal and Other Pathogens
- 3.2.6.1. Histoplasmosis
- 3.2.6.2. Coccidioidomycosis
- 3.2.6.3. Blastomycosis
- 3.2.6.4. Mucormycosis
- 3.2.6.5. Aspergillosis
- 3.2.6.6. Pneumocystis Pneumonia
- 3.2.6.7. Cryptococcosis
- 3.3. Diagnostics - A Changing Role
- 3.3.1. Historical Practice
- 3.3.2. Current Diagnostics
- 3.3.3. The Multiplex Vector
- 3.3.4. Future Diagnostics - The Question of When and Where
- 3.3.5. Respiratory Infection Diagnostics - The Destination
- 3.3.6. Diagnostics as Defensive Weapons
- 3.4. COVID-19
- 3.4.1. Signs and symptoms
- 3.4.2. Transmission
- 3.4.3. Diagnosis
- 3.4.4. Prevention
- 3.4.5. Management
- 3.4.6. Prognosis
- 3.5. Pandemic Diagnostics
- 3.5.1. Risk Management - Spark and Spread
- 3.5.2. Dx Technology - Nucleic Acid Based
- 3.5.3. Dx Technology - Immunoassay & Serology
- 3.5.4. Time to Market and Preparedness Issues
- 3.5.5. Unrecognized Role of Multiplex in Pandemic Mangement
4. Market Trends
- 4.1. Factors Driving Growth
- 4.1.1. Syndromic Multiplexing
- 4.1.2. T.A.T.
- 4.1.3. Antimicrobial Resistance Movement
- 4.1.4. Pandemic Mitigation
- 4.1.5. An Aging at Risk Population
- 4.2. Factors Limiting Growth
- 4.2.1. The Cost Curve
- 4.2.2. Regulation and coverage
- 4.2.3. Laissez Faire
- 4.3. Instrumentation and Automation
- 4.3.1. The Shrinking Multiplexing Machine
- 4.3.2. Bioinformatics Networking and Anonymous Reporting
- 4.4. Diagnostic Technology Development
- 4.4.1. The Key Role of Time to Result
- 4.4.2. Single Cell Genomics Changes the Picture
- 4.4.3. Pharmacogenomics Blurs Diagnosis and Treatment
5. Respiratory Infection Diagnostics Recent Developments
- 5.1. Recent Developments - Importance and How to Use This Section
- 5.1.1. Importance of These Developments
- 5.1.2. How to Use This Section
- 5.2. Qiagen Respiratory Mini Panel Approved
- 5.3. Co-Diagnostics Submits At-Home PCR System to FDA
- 5.4. AMDI scores $5.3m NIH grant for Rapid POC Panel
- 5.5. Roche Gets Multiplex Emergency Use Authorization
- 5.6. ReadyGo Diagnostics, Gemina Labs Pursue Respiratory Market
- 5.7 3EO Health to Launch Molecular Point-of-Care Device
- 5.8. Delve Bio to Commercialize Metagenomic Pathogen Test
- 5.9. Sensible Diagnostics Nabs Award for Respiratory Panel
- 5.10. BD - FDA Clearance for Combo Respiratory Test
- 5.11. Co-Diagnostics Awarded for Upper Respiratory Panel
- 5.12. FDA Authorizes Cue Health C19 At-Home MDx
- 5.13. BioMerieux Waiver for Respiratory Mini Panel
- 5.14. Aptitude Medical Systems Aiming for At-Home Market
- 5.15. SD Biosensor Eyes Global Expansion For Rapid MDx System
- 5.16. New bioMerieux Respiratory Diagnostic System
- 5.17. Visby Medical Nabs FDA EUA for POC Respiratory Panel Test
- 5.18. SENZO SECURES FUNDING FOR PCR-ACCURATE LATERAL FLOW TEST
- 5.19. Takara Bio USA, BioExcel Diagnostics Partner for Dx Panels
- 5.20. ProtonDx's Dragonfly Dx System successfully deployed
- 5.21. Genomtec Gets CE-IVD Mark for POC Respiratory Disease Test
- 5.22. FDA Issues First EUA for Non-Prescription COVID-19/Flu/RSV Test
- 5.23. "Diagnostics for the Real World" Plans Third-Generation POC Platform
- 5.24. Cue Health Targets DTC Market
- 5.25. Investors Skeptical of Ortho Clinical Diagnostics Acquisition by Quidel
- 5.26. Sense Biodetection to Debut Instrument-Free POC MDx
- 5.27. LGC Develops 'Ultra-High-Throughput' COVID Workflow
- 5.28. Cue Health Files for IPO for up to $100M
- 5.29. QuantuMDx Developing Multiplex System, Syndromic Panels
- 5.30. Bio-Rad Laboratories Gets CE Mark for Respiratory RT-PCR Assay Kit
- 5.31. BforCure Preparing Multiple Panels for PoC qPCR Platform
- 5.32. Angstrom Bio Raises $3M in Private Financing
- 5.33. Test for Them All
- 5.34. Hologic Banking on MDx Acquisitions
- 5.35. Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
- 5.36. Talis Biomedical 2020 Revenues Rise Sharply
- 5.37. Luminex to Develop Covid/Flu/RSV Test
- 5.38. Becton Dickinson Charts Transition of COVID Diagnostics
- 5.39. MiRxes Receives Approval for Multiplex Covid/Flu Test
- 5.40. New Silicon-Based Test for Infectious Disease Screening
- 5.41. GenMark to Meet Demand for Respiratory Panel
- 5.42. Tempus Announces COVID-19 Testing, Data Initiative
- 5.43. Abacus Diagnostica Readying Multiplex Respiratory Test
- 5.44. Qiagen Acquires NeuMoDx Molecular
- 5.45. Companies Shift to Multiplex Tests for SARS-CoV-2, Influenza
- 5.46. Novacyt Gets CE Mark for Coronavirus, Flu, RSV Combo Panel
- 5.47. Cepheid Debuts 10-Color Technology With New Tuberculosis Test
- 5.48. BioMerieux's Pneumonia Panel Could Improve Care
- 5.49. Mammoth Biosciences Announces CRISPR-Based C19 Diagnostic
- 5.50. Genetic Signatures Gets CE Mark for C19 Molecular Test
- 5.51. Qiagen Respiratory Panel with C19 Receives CE Mark
- 5.52. Lumos Diagnostics Closes $15M Series A Funding
- 5.53. Fusion Genomics to Assess NGS Respiratory Tract Assay
6. Profiles of Key Players
- 6.1. Abacus Diagnostica
- 6.2. Abbott Laboratories
- 6.3. Accelerate Diagnostics
- 6.4. Access Bio
- 6.5. Ador Diagnostics
- 6.6. ADT Biotech
- 6.7. Akonni Biosystems
- 6.8. Altona Diagnostics
- 6.9. Alveo Technologies
- 6.10. Anatolia Geneworks
- 6.11. Antelope Dx
- 6.12. Applied BioCode
- 6.13. Assurance Scientific Laboratories
- 6.14. Aureum Diagnostics
- 6.15. Aus Diagnostics
- 6.16. Beckman Coulter Diagnostics
- 6.17. Becton, Dickinson and Company
- 6.18. Binx Health
- 6.19. Biocartis
- 6.20. BioFire Diagnostics (bioMerieux)
- 6.21. bioMerieux Diagnostics
- 6.22. Bio-Rad Laboratories, Inc.
- 6.23. Bosch Healthcare Solutions GmbH
- 6.24. Celemics
- 6.25. Cepheid (Danaher)
- 6.26. Chembio
- 6.27. Co Diagnostics
- 6.28. Credo Diagnostics Biomedical
- 6.29. Cue Health
- 6.30. Curetis N.V. / Curetis GmbH
- 6.31. Detect
- 6.32. Diagenode Diagnostics
- 6.33. Diascopic
- 6.34. Diasorin S.p.A.
- 6.35. Enzo Biochem
- 6.36. Eurofins Scientific
- 6.37. Fluxergy
- 6.38. Fulgent Genetics
- 6.39. Fusion Genomics.
- 6.40. Genetic Signatures
- 6.41. GenMark Dx (Roche)
- 6.42. Hibergene Diagnostics
- 6.43. Hologic
- 6.44. Immunexpress
- 6.45. Inflammatix
- 6.46. Invetech
- 6.47. Janssen Diagnostics
- 6.48. Karius
- 6.49. Lexagene
- 6.50. LightDeck Diagnostics
- 6.51. Luminex Corp
- 6.52. Lumos Diagnostics
- 6.53. Mammoth Biosciences
- 6.54. Maxim Biomedical
- 6.55. Meridian Bioscience
- 6.56. Mesa Biotech (Thermo Fisher)
- 6.57. Millipore Sigma
- 6.58. Mindray
- 6.59. Mobidiag (Hologic)
- 6.60. Mologic
- 6.61. Nanomix
- 6.62. Operon
- 6.63. Oxford Nanopore Technologies
- 6.64. Panagene
- 6.65. Perkin Elmer
- 6.66. Prenetics
- 6.67. Primerdesign (Novacyt)
- 6.68. Prominex
- 6.69. Qiagen
- 6.70. QuantuMDx
- 6.71. QuidelOrtho
- 6.72. Roche Molecular Diagnostics
- 6.73. Seegene
- 6.74. Siemens Healthineers
- 6.75. Sona Nanotech
- 6.76. SpeeDx
- 6.77. T2 Biosystems
- 6.78. Talis Biomedical
- 6.79. Thermo Fisher Scientific Inc.
- 6.80. Veramarx
- 6.81. Veredus Laboratories
- 6.82. Visby Medical
- 6.84. XCR Diagnostics
- 6.85. Zhejiang Orient Gene Biotech
7. The Global Market for Respiratory Infection Diagnostics
- 7.1. Global Market by Country
- 7.1.1. Table - Global Market by Country
- 7.1.2. Chart - Global Market by Country
- 7.2. Global Market by Technology - Overview
- 7.2.1. Table - Global Market by Technology
- 7.2.2. Chart - Global Market by Technology - Base/End Year Comparison
- 7.2.3. Chart - Global Market by Technology - Base Year
- 7.2.4. Chart - Global Market by Technology - End Year
- 7.2.5. Chart - Global Market by Technology - Share by Year
- 7.2.6. Chart - Global Market by Technology - Segment Growth
- 7.3. Global Market by Plex - Overview
- 7.3.1. Table - Global Market by Plex
- 7.3.2. Chart - Global Market by Plex - Base/End Year Comparison
- 7.3.3. Chart - Global Market by Plex - Base Year
- 7.3.4. Chart - Global Market by Plex - End Year
- 7.3.5. Chart - Global Market by Plex - Share by Year
- 7.3.6. Chart - Global Market by Plex - Segment Growth
- 7.4. Global Market by Place - Overview
- 7.4.1. Table - Global Market by Place
- 7.4.2. Chart - Global Market by Place - Base/End Year Comparison
- 7.4.3. Chart - Global Market by Place - Base Year
- 7.4.4. Chart - Global Market by Place - End Year
- 7.4.5. Chart - Global Market by Place - Share by Year
- 7.4.6. Chart - Global Market by Place - Segments Growth
- 7.5. Global Market by Product - Overview
- 7.5.1. Table - Global Market by Product
- 7.5.2. Chart - Global Market by Product - Base/End Year Comparison
- 7.5.3. Chart - Global Market by Product - Base Year
- 7.5.4. Chart - Global Market by Product - End Year
- 7.5.5. Chart - Global Market by Product - Share by Year
- 7.5.6. Chart - Global Market by Product - Segments Growth
8. Global Respiratory Infection Diagnostic Markets - By Technology
- 8.1. Microbiology
- 8.1.1. Table Microbiology - by Country
- 8.1.2. Chart - Microbiology Growth
- 8.2. PCR
- 8.2.1. Table PCR - by Country
- 8.2.2. Chart - PCR Growth
- 8.3. NGS
- 8.3.1. Table NGS - by Country
- 8.3.2. Chart - NGS Growth
- 8.4. Immunoassay/Other
- 8.4.1. Table Immunoassay - by Country
- 8.4.2. Chart - Immunoassay/Other Growth
- 8.5. C19 Singleplex
- 8.5.1. Table C19splex - by Country
- 8.5.2. Chart - C19splex Growth
9. Global Respiratory Infection Diagnostic Markets - by Plex
- 9.1. C19 Single Plex
- 9.1.1. Chart - C19 Single Plex Growth
- 9.2. Singleplex
- 9.2.1. Table Singleplex - by Country
- 9.2.2. Chart - Singleplex Growth
- 9.3. Duplex/Triplex
- 9.3.1. Table Duplex/Triplex - by Country
- 9.3.2. Chart - Duplex/Triplex Growth
- 9.4. Multiplex Technology
- 9.4.1. Table Multiplex - by Country
- 9.4.2. Chart - Multiplex Growth
10. Global Respiratory Infection Diagnostic Markets - by Place
- 10.1. Hospital Lab
- 10.1.1. Table Hospital Lab - by Country
- 10.1.2. Chart - Hospital Lab Growth
- 10.2. Outpatient Lab
- 10.2.1. Table Outpatient Lab - by Country
- 10.2.2. Chart - Outpatient Lab Growth
- 10.3. POC
- 10.3.1. Table POC - by Country
- 10.3.2. Chart - POC Growth
- 10.4. Other Technology
- 10.4.1. Chart - Other Growth
11. Global Respiratory Infection Diagnostic Markets - by Product
- 11.1. Instruments
- 11.1.1. Table Instruments - by Country
- 11.1.2. Chart - Instruments Growth
- 11.2. Consumables
- 11.2.1. Table Consumables - by Country
- 11.2.2. Chart - Consumables Growth
- 11.3. Software & Service
- 11.3.1. Table Software & Service - by Country
- 11.3.2. Chart - Software & Service 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