Syndromic Multiplex Diagnostic Markets with COVID-19 Impacts. Strategies and Trends, Forecasts by Syndrome (Respiratory, Sepsis, GI Etc.), by Country, with Market Analysis, Executive Guides and Customization

Table of Contents

1 Market Guides 
1.1 Situation Analysis & COVID Impact Overview 
1.2 Guide for Executives and Marketing Staff 
1.3 Guide for Investment Analysts and Management Consultants 
1.4 Market Shares of Leading Companies - Table and Chart 

2 Introduction and Market Definition 
2.1 What are Syndromic Multiplex Tests? 
2.2 Syndromic Testing - the quiet revolution in diagnostics 
2.2.1 Syndromic Testing - more than Panels. 
2.3 Market Definition 
2.3.1 Multiplex Market Size. 
2.3.2 Currency. 
2.3.3 Years. 
2.4 Methodology 
2.4.1 Authors 
2.4.2 Sources 
2.5 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic 
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 - Guide to the Pathogens 
3.1 The Coronavirus 
3.1.1 Severe acute respiratory syndrome (SARS) 
3.1.2 Middle East respiratory syndrome (MERS) 
3.1.3 COVID-19. The SARS CoV 2 Virus. 
3.1.3.1 Signs and symptoms 
3.1.3.2 Transmission 
3.1.3.3 Diagnosis 
3.1.3.4 Prevention 
3.1.3.5 Management 
3.1.3.6 Prognosis 
3.1.3.7 New Strains and Subsequent Mutations 
3.3 HIV - Human Immunodeficiency Virus (AIDS) 
3.3.1 Virology 
3.3.1.1 Classification 
3.3.1.2 Structure and genome 
3.3.1.3 Tropism 
3.3.1.4 Replication cycle 
3.3.1.5 Genetic variability 
3.3.2 Diagnosis 
3.3.3 Testing 
3.3.3.1 Antibody tests 
3.3.3.2 Point of Care Tests (POCT) 
3.3.3.3 Antigen Tests 
3.3.3.4 Nucleic acid-based tests (NAT) 
3.3.3.5 Other tests used in HIV treatment 
3.4 HBV - Hepatitis B
3.4.1 Virology 
3.4.1.1 Genome 
3.4.1.2 Pathogenesis 
3.4.1.3 Hepatitis B virus replication 
3.4.1.4 Serotypes and genotypes 
3.4.2 Mechanisms 
3.4.3 Diagnosis 
3.4.4 Market Opportunity Analysis 
3.5 HCV - Hepatitis C 
3.5.1 Taxonomy 
3.5.1.1 Structure 
3.5.1.2 Genome 
3.5.2 Molecular biology 
3.5.3 Replication 
3.5.4 Genotypes 
3.5.4.1 Clinical importance 
3.5.5 Market Opportunity Analysis 
3.6 2.4 HPV - Human papillomavirus 
3.6.1 Virology 
3.6.1.1 E6/E7 proteins 
3.6.1.2 Role in cancer 
3.6.1.3 E2 research 
3.6.1.4 Latency period 
3.6.1.5 Clearance 
3.6.2 Diagnosis 
3.6.2.1 Cervical testing 
3.6.2.2 Oral testing 
3.6.2.3 Testing men 
3.6.2.4 Other testing 
3.6.3 Market Opportunity Analysis 
3.7 Influenza 
3.7.1 Virology 
3.7.1.1 Types of virus 
3.7.1.2 Influenzavirus A 
3.7.1.3 Influenzavirus B 
3.7.1.4 Influenzavirus C 
3.7.1.5 Structure, properties, and subtype nomenclature 
3.7.1.6 Replication 
3.7.2 Testing 
3.7.2.1 Advantages/Disadvantages of Molecular Assays 
3.7.3 Market Opportunity Analysis 
3.8 CTGC - Chlamydia/Gonorhea 
3.8.1 Gonorrhea 
3.8.1.1 Diagnosis 
3.8.1.2 Screening 
3.8.2 Chlamydia 
3.8.2.1 Diagnosis 
3.8.2.2 Screening 
3.8.3 Testing 
3.8.3.1 Nucleic acid amplification tests (NAATs). 
3.8.3.2 Performance of NAAT Tests 
3.8.4 Market Opportunity Analysis 
3.9 Tuberculosis 
3.9.1 Mycobacteria 
3.9.2 Diagnosis 
3.9.2.1 Active tuberculosis 
3.9.2.2 Latent tuberculosis 
3.9.3 Epidemiology 
3.9.4 Molecular Diagnostic Tests 
3.9.5 Market Opportunity Analysis 
3.10 MRSA - Methicillin-resistant Staphylococcus aureus 
3.10.1 Diagnosis 
3.10.2 FDA Approved Molecular Tests 
3.10.3 Market Opportunity Analysis 
3.11 VRE - Vancomycin-resistant Enterococcus 
3.11.1 FDA Approved MDx Tests for VRE 
3.11.2 Market Opportunity Analysis 

4 Industry Overview 
4.1 Industry Participants 
4.1.1 IVD Supplier 
4.1.2 Independent lab specialized/esoteric 
4.1.3 Independent lab national/regional
4.1.4 Independent lab analytical 
4.1.5 Public National/regional lab 
4.1.6 Hospital lab 
4.1.7 Physician lab 
4.1.8 Audit body 
4.2 The Clinical Laboratory Market Segments 
4.2.1 Traditional Market Segmentation
4.2.2 Laboratory Focus and Segmentation 
4.2.3 Segmenting the Syndromic Testing Market 
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 Market Trends 
5.1 Factors Driving Growth 
5.1.1 Speed of Diagnosis. 
5.1.2 Effect of Syndromic Testing on Costs. 
5.1.3 Point of Care Advantage. 
5.1.4 Syndrome Testing, Accuracy and Diagnostic Risk
5.1.5 Single Visits. 
5.1.6 Improvement in Outcomes. 
5.1.7 Impact of the COVID-19 Pandemic. 
5.2 Factors Limiting Growth 
5.2.1 Lower Prices. 
5.2.2 Administration/reimbursement. 
5.2.3 Infectious Disease is Declining But…. 
5.2.4 Wellness Hurts. 
5.2.5 Economic Growth improves Living Standards. 
5.2.6 Impact of the Pandemic Recession 
5.3 Instrumentation and Automation 
5.3.1 Instruments Key to Market Share 
5.3.2 The Shrinking Machine. 
5.3.3 Syndrome Testing Moving to Big Instruments? 
5.4 Diagnostic Technology Development 
5.4.1 Syndromictrends.com 
5.4.2 Comparing Syndrome and Targeted Testing 
5.4.3 The Multiplex Paradigm Shift
5.4.4 The Sepsis Testing Market - Bellwether for Syndromics 
5.4.5 The Single Visit and AntiMicrobial Resistance 
5.4.6 Syndromics drives POCT adoption. 
5.4.7 A Big Future for PCR? 

6 Syndromic Testing Recent Developments
6.1 Recent Developments - Importance and How to Use This Section 
6.1.1 Importance of These Developments 
6.1.2 How to Use This Section 
6.2 QuantuMDx Developing Syndromic Panels for European Launch 
6.3 Quidel Gains CE Mark for Savanna Analyzer, Respiratory Panel 
6.4 QuantumDx Gets CE Mark for Rapid PoC PCR System 
6.5 Bio-Rad Laboratories, Seegene Partner for MDx Development 
6.6 Baebies to Expand Finder Platform 
6.7 With Luminex Acquisition, DiaSorin to Broaden MDx Portfolio 
6.8 Binx Health Targeting Clinics, DTC & OTC With STI Tests 
6.9 Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV 
6.10 Molzym, Fraunhofer Developing Rapid Sepsis Diagnostic 
6.11 MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test 
6.12 New Approach Involves Silicon-Based Test for Infectious Disease Screening 
6.13 Scanogen's Portable Battery Operated Instrument for 90 Minute Multiplex Test 
6.14 Qiagen sees NeuMoDx as Growth Vehicle 
6.15 Torus Biosystems Developing Syndromic Test with 30-Minute Turnaround 
6.16 Roche, SpeeDx Partner to Expand Access to Antibiotic Resistance Tests 
6.17 BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA EAU 
6.18 Infectious Disease Testing Firm Curative Acquires KorvaLabs 
6.19 ChromaCode Raises Additional $10M 
6.20 COVID-19 Patients Need Syndromic Testing 
6.21 GenMark Diagnostics - New Respiratory Panel due in June 
6.22 Qiagen Respiratory Panel with Coronavirus Targets Receives CE Mark 
6.23 Exact Diagnostics launches respiratory panel control 
6.24 bioMérieux submits enhanced BIOFIRE® BCID2 Panel to FDA 
6.25 Nanomix Receives CE Mark for Diagnostic 
6.26 Applied BioCode Applies to FDA for Syndromic Respiratory Panel 
6.27 Expedeon AG and Sona Nanotech to Collaborate on Multiplex POC 
6.28 QIAGEN's New GI Panel Performance Assessed 
6.29 McKesson to Distribute QIAstat-Dx Syndromic Testing Solution in USA 
6.30 Applied BioCode Obtains FDA Clearance 
6.31 Meridian Bioscience to Acquire GenePOC Inc. 
6.32 Curetis Introduces Rapid DNA Testing for Antibiotic Resistance 
6.33 Qiagen gets FDA clearance for syndromic testing system 
6.34 Entasis Therapeutics Signs Rapid Diagnostic Agreement with bioMérieux 
6.35 Akonni Biosystems Submits Multiplex Diagnostics System to FDA 
6.36 Ador Diagnostic to receive $30M in Funding for 100-Plex PoC 
6.37 SAW Diagnostics Receives Funding for Commercialisation of PoC Platform 
6.38 QuantuMDx and Molbio announce MoU 
6.39 Immunexpress Wins $745K Contract for Rapid Sepsis Assay 
6.40 Mobidiag Inks European, Middle Eastern Distribution Deals 
6.41 BIOFIRE® FILMARRAY® System chosen for Phase 3 clinical trial 

7 Profiles of Key Syndromic Testing Companies 
7.1 Abacus Diagnostica 
7.2 Abbott Diagnostics 
7.3 Accelerate Diagnostics 
7.4 Ador Diagnostics 
7.5 Akonni Biosystems 
7.6 Alveo Technologies 
7.7 Antelope Dx 
7.8 Applied BioCode 
7.9 Aus Diagnostics 
7.10 Baebies 
7.11 Beckman Coulter Diagnostics 
7.12 Becton, Dickinson and Company 
7.13 Binx Health 
7.14 Biocartis 
7.15 BioFire Diagnostics (bioMérieux) 
7.16 bioMérieux Diagnostics 
7.17 Bio-Rad Laboratories, Inc
7.18 Bosch Healthcare Solutions GmbH 
7.19 Cepheid (Danaher) 
7.20 Credo Diagnostics Biomedical 
7.21 Cue Health 
7.22 Curetis N.V. / Curetis GmbH 
7.23 Diagenode Diagnostics 
7.24 Diasorin S.p.A. 
7.25 Enzo Life Sciences, Inc. 
7.26 Eurofins Scientific 
7.27 Fluxergy 
7.28 Fusion Genomics. 
7.29 Genetic Signatures 
7.30 GenMark Dx (Roche) 
7.31 Hibergene Diagnostics
7.32 Hologic 
7.33 Immunexpress 
7.34 Inflammatix 
7.35 Invetech 
7.36 Janssen Diagnostics 
7.37 Karius 
7.38 Lexagene 
7.39 LightDeck Diagnostics 
7.40 Lucira Health 
7.41 Luminex Corp 
7.42 Maxim Biomedical 
7.43 Meridian Bioscience 
7.44 Mesa Biotech (Thermo Fisher) 
7.45 Millipore Sigma 
7.46 Mobidiag (Hologic) 
7.47 Molbio Diagnostics 
7.48 Nanomix 
7.49 Novel Microdevices 
7.50 Operon 
7.51 Oxford Nanopore Technologies 
7.52 Panagene 
7.53 Perkin Elmer 
7.54 Primerdesign (Novacyt) 
7.55 Prominex 
7.56 Qiagen Gmbh 
7.57 Quantumdx 
7.58 Quidel 
7.59 Roche Molecular Diagnostics 
7.60 Saw Diagnostics 
7.61 Seegene
7.62 Siemens Healthineers 
7.63 Sona Nanotech 
7.64 SpeeDx 
7.65 T2 Biosystems 
7.66 Talis Biomedical 
7.67 Thermo Fisher Scientific Inc. 
7.68 Veramarx 
7.69 Visby Medical 
7.70 XCR Diagnostics 

8 The Global Market for Syndromic Multiplex Diagnostics 
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 Place - Overview 
8.3.1 Table - Global Market by Place 
8.3.2 Chart - Global Market by Place - Base/Final Year Comparison 
8.3.3 Chart - Global Market by Place - Base Year
8.3.4 Chart - Global Market by Place - End Year 
8.3.5 Chart - Global Market by Place - Share by Year 
8.3.6 Chart - Global Market by Place - Segments Growth 
8.4 Global Market by Product - Overview 
8.4.1 Table - Global Market by Product 
8.4.2 Chart - Global Market by Product - Base/Final Year Comparison 
8.4.3 Chart - Global Market by Product - Base Year 
8.4.4 Chart - Global Market by Product - End Year 
8.4.5 Chart - Global Market by Product - Share by Year 
8.4.6 Chart - Global Market by Product - Segments Growth 

9 Global Syndromic Multiplex 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 Syndrome 
9.6.1 Table Other - by Country 
9.6.2 Chart - Other Growth 

10 Global MDx Infectious Disease 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 Point of Care 
10.3.1 Table Point of Care - by Country 
10.3.2 Chart - Point of Care Growth 
10.4 Other Place 
10.4.1 Table Other - by Country 
10.4.2 Chart - Other Place Growth 

11 Global MDx Infectious Disease Markets - by Product 
11.1 Instruments 
11.1.1 Table Instruments - by Country 
11.1.2 Chart - Instruments Growth 
11.2 Cartridges 
11.2.1 Table Cartridges - by Country 
11.2.2 Chart - Cartridges Growth 
11.3 Reagents 
11.3.1 Table Reagents - by Country 
11.3.2 Chart - Reagents Growth 
11.4 Other Product 
11.4.1 Table Other Product - by Country 
11.4.2 Chart - Other Product Growth 

12 Appendices 
12.1 United States Medicare System: 2021 Clinical Laboratory Fees Schedule 

List of Tables
Table 1 Market Share of Leading Companies 
Table 2 Characteristics of Coronavirus Pandemic Infections 
Table 3 COVID-19 Symptoms 
Table 4 Classification of HIV Species 
Table 5 HBV Tests - CMS Codes & Prices 
Table 6 HCV Tests - CMS Codes & Prices 
Table 7 HPV Clearance Rates 
Table 8 HPV Tests - CMS Codes & Prices 
Table 9 HPV Tests, Technology, Types 
Table 10 Types of Influenza Tests 
Table 11 Influenza Tests - CMS Codes & Prices 
Table 12 FDA Cleared Molecular Assays for Influenza 
Table 13 FDA Cleared NAAT CTGC Tests 
Table 14 CTGC NAAT Target Sequences and Possible False Reactions 
Table 15 Influenza Tests - CMS Codes & Prices 
Table 16 FDA Approved MDx Tests for Tuberculosis 
Table 17 Tuberculosis Tests - CMS Codes & Prices 
Table 18 FDA Approved Tests for MRSA 
Table 19 MRSA Tests - CMS Codes & Prices 
Table 20 FDA Approved Tests for VRE 
Table 21 VRE Tests - CMS Codes & Prices 
Table 22 Market Players by Type 
Table 23 Clinical Laboratory Departments and Segments 
Table 24 Laboratory Management Focus - Different Approaches 
Table 25 Key Segmentation Variables Going Forward 
Table 26 Possible Market Segments of Syndromic Multiplex Market 
Table 27 Five Factors Driving Growth 
Table 28 How SMT Improves Outcomes 
Table 29 Four Factors Limiting Growth 
Table 30 - Global Market by Region 
Table 31 Global Market by Syndrome 
Table 32 Global Market by Place 
Table 33 Global Market by Product 
Table 34 Respiratory by Country
Table 35 Gastrointestinal by Country 
Table 36 Blood by Country 
Table 37 Meningitis/Encephalitis by Country 
Table 38 Sexually Transmitted Disease by Country 
Table 39 Other by Country 
Table 40 Hospital Lab by Country 
Table 41 Outpatient Lab by Country 
Table 42 Point of Care by Country 
Table 43 Other by Country 
Table 44 Instruments by Country 
Table 45 Cartridges by Country 
Table 46 Reagents by Country 
Table 47 Other Product by Country 
Table 48 2021 Clinical Lab Fee Schedule 

List of Figures
Figure 1 Market Share of Leading Companies Chart 
Figure 2 The Global Healthcare Spending Picture
Figure 3 The Lab Test Pie 
Figure 4 Structure Of Coronaviruses 
Figure 5 HIV Virion 
Figure 6 Diagram of the HIV Replication Cycle 
Figure 7 The Structure of the HBV Virus
Figure 8 Hepatitis B Replication 
Figure 9 Structure of the HCV Virus 
Figure 10 HCV Replication Cycle 
Figure 11 Structure of the Influenza Virion 
Figure 12 Influenza Replication 
Figure 13 Scanning Electronmicrograph of Tuberculosis 
Figure 14 Chart Death Rates and Infectious Disease Decline 
Figure 15 Comparing Syndromic and Targeted Testing 
Figure 16 The Multiplex Paradigm Shift 
Figure 17 Global Market Share 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 Place - Base vs. Final
Figure 24 Global Market by Place Base Year
Figure 25 Global Market by Place End Year 
Figure 26 Place Share by Year 
Figure 27 Place Segments Growth 
Figure 28 Global Market by Product - Base vs. Final 
Figure 29 Global Market by Product Base Year 
Figure 30 Global Market by Product End Year 
Figure 31 Product Share by Year 
Figure 32 Product 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 Hospital Lab Growth 
Figure 40 Outpatient Lab Growth 
Figure 41 Point of Care Growth 
Figure 42 Other Growth 
Figure 43 Instruments Growth 
Figure 44 Cartridges Growth 
Figure 45 Reagents Growth 
Figure 46 Other Product Growth 

Samples

Companies Mentioned

• Abacus Diagnostica 
• Abbott Diagnostics 
• Accelerate Diagnostics 
• Ador Diagnostics 
• Akonni Biosystems 
• Alveo Technologies 
• Antelope Dx 
• Applied BioCode 
• Aus Diagnostics 
• Baebies 
• Beckman Coulter Diagnostics 
• Becton, Dickinson and Company 
• Binx Health 
• Bio-Rad Laboratories, Inc
• Biocartis 
• BioFire Diagnostics (bioMérieux) 
• bioMérieux Diagnostics 
• Bosch Healthcare Solutions GmbH 
• Cepheid (Danaher) 
• Credo Diagnostics Biomedical 
• Cue Health 
• Curetis N.V./Curetis GmbH 
• Diagenode Diagnostics 
• Diasorin S.p.A. 
• Enzo Life Sciences, Inc. 
• Eurofins Scientific 
• Fluxergy 
• Fusion Genomics. 
• Genetic Signatures 
• GenMark Dx (Roche) 
• Hibergene Diagnostics
• Hologic 
• Immunexpress 
• Inflammatix 
• Invetech 
• Janssen Diagnostics 
• Karius 
• Lexagene 
• LightDeck Diagnostics 
• Lucira Health 
• Luminex Corp 
• Maxim Biomedical 
• Meridian Bioscience 
• Mesa Biotech (Thermo Fisher) 
• Millipore Sigma 
• Mobidiag (Hologic) 
• Molbio Diagnostics 
• Nanomix 
• Novel Microdevices 
• Operon 
• Oxford Nanopore Technologies 
• Panagene 
• Perkin Elmer 
• Primerdesign (Novacyt) 
• Prominex 
• Qiagen Gmbh 
• Quantumdx 
• Quidel 
• Roche Molecular Diagnostics 
• Saw Diagnostics 
• Seegene
• Siemens Healthineers 
• Sona Nanotech 
• SpeeDx 
• T2 Biosystems 
• Talis Biomedical 
• Thermo Fisher Scientific Inc. 
• Veramarx 
• Visby Medical 
• XCR Diagnostics 

Methodology