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Respiratory Infection Diagnostic Markets by Technology, Plex, Place, Product and by Region With Executive and Consultant Guides 2024-2028

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    Report

  • 602 Pages
  • April 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5441825

Technologies Compete for Respiratory Gold Rush as New Market Segments Open Up

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 let's 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 positions in new markets that are not yet well understood.

New technology is forever changing the diagnosis of respiratory infections. Shrinking time to results opens up markets multiple times the size of the 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.

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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
4.4.4 Pathogen Identification - A Projected Timetable of the Future

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 Roche Gets Multiplex Emergency Use Authorization
5.3 ReadyGo Diagnostics, Gemina Labs Pursue Respiratory Market
5.4 3EO Health to Launch Molecular Point-of-Care Device
5.5 Delve Bio to Commercialize Metagenomic Pathogen Test
5.6 Sensible Diagnostics Nabs Award for Respiratory Panel
5.7 BD - FDA Clearance for Combo Respiratory Test
5.8 Co-Diagnostics Awarded for Upper Respiratory Panel
5.9 FDA Authorizes Cue Health C19 At-Home MDx
5.10 BioMérieux Waiver for Respiratory Mini Panel
5.11 Aptitude Medical Systems Aiming for At-Home Market
5.12 SD Biosensor Eyes Global Expansion For Rapid MDx System
5.13 New bioMérieux Respiratory Diagnostic System
5.14 Visby Medical Nabs FDA EUA for POC Respiratory Panel Test
5.15 SENZO SECURES FUNDING FOR PCR-ACCURATE LATERAL FLOW TEST
5.16 Takara Bio USA, BioExcel Diagnostics Partner for Dx Panels
5.17 ProtonDx’s Dragonfly Dx System successfully deployed
5.18 Genomtec Gets CE-IVD Mark for POC Respiratory Disease Test
5.19 FDA Issues First EUA for Non-Prescription COVID-19/Flu/RSV Test
5.20 “Diagnostics for the Real World” Plans Third-Generation POC Platform
5.21 Cue Health Targets DTC Market
5.22 Investors Skeptical of Ortho Clinical Diagnostics Acquisition by Quidel
5.23 Sense Biodetection to Debut Instrument-Free POC MDx
5.24 LGC Develops 'Ultra-High-Throughput' COVID Workflow
5.25 Cue Health Files for IPO for up to $100M
5.26 QuantuMDx Developing Multiplex System, Syndromic Panels
5.27 Bio-Rad Laboratories Gets CE Mark for Respiratory RT-PCR Assay Kit
5.28 BforCure Preparing Multiple Panels for PoC qPCR Platform
5.29 Angstrom Bio Raises $3M in Private Financing
5.30 Test for Them All
5.31 Hologic Banking on MDx Acquisitions
5.32 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
5.33 Talis Biomedical 2020 Revenues Rise Sharply
5.34 Luminex to Develop Covid/Flu/RSV Test
5.35 Becton Dickinson Charts Transition of COVID Diagnostics
5.36 MiRxes Receives Approval for Multiplex Covid/Flu Test
5.37 New Silicon-Based Test for Infectious Disease Screening
5.38 GenMark to Meet Demand for Respiratory Panel
5.39 Tempus Announces COVID-19 Testing, Data Initiative
5.40 Abacus Diagnostica Readying Multiplex Respiratory Test
5.41 Qiagen Acquires NeuMoDx Molecular
5.42 Companies Shift to Multiplex Tests for SARS-CoV-2, Influenza
5.43 Novacyt Gets CE Mark for Coronavirus, Flu, RSV Combo Panel
5.44 Cepheid Debuts 10-Color Technology With New Tuberculosis Test
5.45 BioMérieux's Pneumonia Panel Could Improve Care
5.46 Mammoth Biosciences Announces CRISPR-Based C19 Diagnostic
5.47 Genetic Signatures Gets CE Mark for C19 Molecular Test
5.48 Qiagen Respiratory Panel with C19 Receives CE Mark
5.49 Lumos Diagnostics Closes $15M Series A Funding
5.50 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 (bioMérieux)
6.21 bioMérieux 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

List of Tables
Table 1 Market Players by Type
Table 2 Bacterial Causes of Pneumonia
Table 3 List of Influenza Pandemics
Table 4 Viral Infections of the Respiratory Tract
Table 5 Fungal Infections of the Respiratory Tract
Table 6 Characteristics of Coronavirus Pandemic Infections
Table 7 COVID-19 Symptoms
Table 8 Five Factors Driving Growth
Table 9 Three Factors Limiting Growth
Table 10 Key Diagnostic Laboratory Technology Trends
Table 11 Long Term Pathoghen Identification Timetable
Table 12 - Global Market by Region
Table 13 Global Market by Technology
Table 14 Global Market by Plex
Table 15 Global Market by Place
Table 16 Global Market by Product
Table 17 Microbiology by Country
Table 18 PCR by Country
Table 19 NGS by Country
Table 20 Immunoassay/Other by Country
Table 21 C19splex by Country
Table 22 C19 Single Plex by Country
Table 23 Singleplex by Country
Table 24 Duplex/Triplex by Country
Table 25 Multiplex by Country
Table 26 Hospital Lab by Country
Table 27 Outpatient Lab by Country
Table 28 POC by Country
Table 29 Other by Country
Table 30 Instruments by Country
Table 31 Consumables by Country
Table 32 Software & Service by Country
Table 33 Laboratory Fee Schedule
Table 34 The Most Common Assays
Table 35 Largest Revenue Assays

List of Figures
Figure 1 Respiratory Tract Infections
Figure 2 The LRI Mortality Rate Globally
Figure 3 Global Pandemic Pathogen Status
Figure 4 Global Healthcare Spending
Figure 5 The Lab Test Pie
Figure 6 The Road to Diagnostics
Figure 7 The BioFire Respiratory Panel
Figure 8 Pneumonia
Figure 9 Bacterial Infections of the Respiratory Tract
Figure 10 The Development Cycle of Tuberculosis
Figure 11 A Flu Epidemic in Europe - Historical Pattern
Figure 12 The Single Multiplex Shift
Figure 13 Percentage of World Population Over 65
Figure 14 Global Market Share Chart
Figure 15 Global Market by Technology - Base vs. End Year
Figure 16 Global Market by Technology Base Year
Figure 17 Global Market by Technology End Year
Figure 18 Technology Share by Year
Figure 19 Technology Segments Growth
Figure 20 Plex - Base vs. End Year Segment Shift
Figure 21 Plex Market Base Year
Figure 22 Plex Market End Year
Figure 23 Plex Share by Year
Figure 24 Plex Segments Growth
Figure 25 Place - Base vs. End Year
Figure 26 Place Market Base Year
Figure 27 Place Market End Year
Figure 28 Place Share by Year
Figure 29 Place Segments Growth
Figure 30 Product - Base vs. End Year
Figure 31 Product Market Base Year
Figure 32 Product Market End Year
Figure 33 Product Share by Year
Figure 34 Product Segments Growth
Figure 35 Microbiology Growth
Figure 36 PCR Diagnostics Growth
Figure 37 NGS Growth
Figure 38 Immunoassay/Other Growth
Figure 39 C19splex Growth
Figure 40 C19 Single Plex Growth
Figure 41 Singleplex Growth
Figure 42 Duplex/Triplex Growth
Figure 43 Multiplex Growth
Figure 44 Hospital Lab Growth
Figure 45 Outpatient Lab Growth
Figure 46 POC Growth
Figure 47 Other Growth
Figure 48 Instruments Growth
Figure 49 Consumables Growth
Figure 50 Software & Service Growth

Companies Mentioned

  • Abacus Diagnostica
  • Abbott Laboratories
  • Accelerate Diagnostics
  • Access Bio
  • Ador Diagnostics
  • ADT Biotech
  • Akonni Biosystems
  • Altona Diagnostics
  • Alveo Technologies
  • Anatolia Geneworks
  • Antelope Dx
  • Applied BioCode
  • Assurance Scientific Laboratories
  • Aureum Diagnostics
  • Aus Diagnostics
  • Beckman Coulter Diagnostics
  • Becton, Dickinson and Company
  • Binx Health
  • Bio-Rad Laboratories, Inc.
  • Biocartis
  • BioFire Diagnostics (bioMérieux)
  • bioMérieux Diagnostics
  • Bosch Healthcare Solutions GmbH
  • Celemics
  • Cepheid (Danaher)
  • Chembio
  • Co Diagnostics
  • Credo Diagnostics Biomedical
  • Cue Health
  • Curetis N.V. / Curetis GmbH
  • Detect
  • Diagenode Diagnostics
  • Diascopic
  • Diasorin S.p.A.
  • Enzo Biochem
  • Eurofins Scientific
  • Fluxergy
  • Fulgent Genetics
  • Fusion Genomics.
  • Genetic Signatures
  • GenMark Dx (Roche)
  • Hibergene Diagnostics
  • Hologic
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexagene
  • LightDeck Diagnostics
  • Luminex Corp
  • Lumos Diagnostics
  • Mammoth Biosciences
  • Maxim Biomedical
  • Meridian Bioscience
  • Mesa Biotech (Thermo Fisher)
  • Millipore Sigma
  • Mindray
  • Mobidiag (Hologic)
  • Mologic
  • Nanomix
  • Operon
  • Oxford Nanopore Technologies
  • Panagene
  • Perkin Elmer
  • Prenetics
  • Primerdesign (Novacyt)
  • Prominex
  • Qiagen
  • QuantuMDx
  • QuidelOrtho
  • Roche Molecular Diagnostics
  • Seegene
  • Siemens Healthineers
  • Sona Nanotech
  • SpeeDx
  • T2 Biosystems
  • Talis Biomedical
  • Thermo Fisher Scientific Inc.
  • Veramarx
  • Veredus Laboratories
  • Visby Medical
  • XCR Diagnostics
  • Zhejiang Orient Gene Biotech