Table of Content

1 Market Guides 
1.1 Strategic Situation Analysis and Impact of COVID-19. 
1.2 Guide for Executives, Marketing, Sales 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 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 - 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 Distributor and Reagent Supplier 
4.1.5 Independent Testing Lab 
4.1.6 Public National/regional lab 
4.1.7 Hospital lab 
4.1.8 Physician Office Labs 
4.1.9 Audit Body 
4.1.10 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 Abacus Diagnostica 
5.2 Abbott Diagnostics 
5.3 Accelerate Diagnostics 
5.4 Ador Diagnostics 
5.5 Akonni Biosystems 
5.6 Alveo Technologies 
5.7 Applied BioCode 
5.8 Aus Diagnostics 
5.9 Beckman Coulter Diagnostics 
5.10 Becton, Dickinson and Company 
5.11 Binx Health 
5.12 Biocartis 
5.13 bioMérieux Diagnostics 
5.14 Bio-Rad Laboratories, Inc
5.15 Bosch Healthcare Solutions GmbH 
5.16 Cepheid (now Danaher) 
5.17 Chembio 
5.18 Co Diagnostics 
5.19 Credo Diagnostics Biomedical 
5.20 Cue Health 
5.21 Curetis N.V. / Curetis GmbH 
5.22 Diagenode Diagnostics 
5.23 Diascopic 
5.24 Diasorin S.p.A. 
5.25 Eiken Chemical 
5.26 Enzo Life Sciences, Inc. 
5.27 Eurofins Scientific 
5.28 Fluxergy 
5.29 Fulgent Genetics 
5.30 Fusion Genomics. 
5.31 Genedrive 
5.32 Genetic Signatures 
5.33 GenMark Dx 
5.34 Grifols 
5.35 Hibergene Diagnostics
5.36 Hologic 
5.37 Illumina 
5.38 Immunexpress 
5.39 Inflammatix 
5.40 Invetech 
5.41 Janssen Diagnostics 
5.42 Karius 
5.43 Lexagene 
5.44 LightDeck Diagnostics 
5.45 Luminex Corp 
5.46 Lumos Diagnostics 
5.47 Mammoth Biosciences 
5.48 Maxim Biomedical 
5.49 Meridian Bioscience 
5.50 Mesa Biotech 
5.51 Millipore Sigma 
5.52 Mindray 
5.53 Mobidiag 
5.54 Nanomix 
5.55 Operon 
5.56 Oxford Nanopore Technologies 
5.57 Panagene 
5.58 Perkin Elmer 
5.59 Primerdesign 
5.60 Prominex 
5.61 Qiagen Gmbh 
5.62 Quantumdx 
5.63 Quidel 
5.64 Roche Molecular Diagnostics 
5.65 Saw Diagnostics 
5.66 Seegene
5.67 Siemens Healthineers 
5.68 Sona Nanotech 
5.69 SpeeDx 
5.70 T2 Biosystems 
5.71 Thermo Fisher Scientific Inc. 
5.72 Veramarx 
5.73 Veredus Laboratories 
5.74 Vir 
5.75 XCR Diagnostics 

6 Market Trends 
6.1 Factors Driving Growth 
6.1.1 New Genotypes Creating New Markets 
6.1.2 Aging Population a Boon for All Diagnostics 
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 Home Test Company Prenetics to go Public 
7.3 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
7.4 Lucira Health Posts Revenue Growth on OTC C19 Test 
7.5 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform 
7.6 Talis Biomedical Discusses Point-of-Care 
7.7 Roche to Acquire GenMark Diagnostics for $1.8B 
7.8 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization 
7.9 Hologic to Acquire Mobidiag 
7.10 Lucira Health Focuses on User Friendly Approach to Home Testing 
7.11 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO 
7.12 Fluidigm Plans 'Durable' Diagnostics, Clinical Business 
7.13 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M 
7.14 Mammoth Biosciences Developing Pathogen Detection Tech 
7.15 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests 
7.16 Scanogen Developing 90 Minute Infection Test 
7.17 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection 
7.18 FDA Provides Self Testing SARS-CoV-2 EAU Guidance 
7.19 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic 
7.20 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test 
7.21 Qiagen Respiratory Panel with Coronavirus Receives CE Mark 
7.22 Lumos Diagnostics Closes $15M Series A Funding 
7.23 Fusion Genomics to Assess NGS-Based Respiratory Tract Infection Assay 
7.24 New Genomic Tests Diagnose Deadly Infections Faster 
7.25 Biotia Raises $2.4M Seed Round 
7.26 STDs resurge in US 
7.27 Ares Genetics signs R&D agreement with leading global IVD corporation 
7.28 Cell-Free DNA Used for Infectious Disease Testing 
7.29 One BioMed Raises $5M 

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: 2021 Clinical Laboratory Fees Schedule 



List of Figures


 Figure 1 Map - Global Healthcare Spending Per Capita 
Figure 2 The Lab Test Pie - Wholesale and Retail 
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 Percentage of World Population Over 65 
Figure 13 Chart Infectious Disease Decline 
Figure 14 Global Market Shares Chart 
Figure 15 Global Market by Syndrome - Base vs. Final 
Figure 16 Global Market by Syndrome Base Year 
Figure 17 Global Market by Syndrome End Year 
Figure 18 Syndrome Share by Year 
Figure 19 Syndrome Segments Growth 
Figure 20 Global Market by Plex - Base vs. Final
Figure 21 Global Market by Plex Base Year 
Figure 22 Global Market by Plex End Year 
Figure 23 Plex Share by Year 
Figure 24 Plex Segments Growth 
Figure 25 Global Market by Place - Base vs. Final
Figure 26 Global Market by Place Base Year 
Figure 27 Global Market by Place End Year 
Figure 28 Place Share by Year 
Figure 29 Place Segments Growth 
Figure 30 Respiratory Growth 
Figure 31 Gastrointestinal Diagnostics Growth 
Figure 32 Blood Growth 
Figure 33 Meningitis/Encephalitis Growth 
Figure 34 Sexually Transmitted Disease Growth 
Figure 35 Other Growth 
Figure 36 Single Plex Growth 
Figure 37 Duplex Growth 
Figure 38 Triplex Growth 
Figure 39 Multiplex Growth 
Figure 40 Hospital Lab Growth 
Figure 41 Outpatient Lab Growth 
Figure 42 POC Growth
Figure 43 Other Place Growth 

List 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 2021 Clinical Lab Fee Schedule