OTC/DTC Infectious Disease Diagnostics Strategies and Trends, COVID-19 Adjusted Forecasts: by Application, by Channel, by Country. With Market Analysis, Executive Guides, Customization and COVID-19 Market Opportunity Analysis.

Table of Contents

i. Market Guides
A. Situation Analysis and COVID-19 Market Analysis 
B. Guide for Executives and Marketing Staff 
C. Guide for Investment Analysts and Management Consultants 

1. Introduction and Market Definition 
1.1 What is OTC and DTC Testing? 
1.2 OTC/DTC Testing - the quiet revolution in diagnostics 
1.3 Self vs. Send - who knew? 
1.4 Market Definition 
1.4.1 Retail vs. Wholesale 
1.42 OTC, DTC, HxV and HSG  
1.4.3 Currency  
1.4.4 Years 
1.5 Methodology 
1.5.1 Authors  
1.5.2 Sources  
1.6 U.S. Medical Market and Clinical Laboratory Testing - Perspective
1.6.1 U.S. Medicare Expenditures for Clinical Testing 

2. The Infectious Diseases - Guide to the Pathogens 
2.1 HIV - Human Immunodeficiency Virus (AIDS) 
2.1.1 Virology 
2.1.1.1 Classification
2.1.1.2 Structure and genome 
2.1.1.3 Tropism 
2.1.1.4 Replication cycle 
2.1.1.5 Genetic variability 
2.1.2 Diagnosis  
2.1.3 Testing
2.1.3.1 Antibody tests 
2.1.3.2 Point of Care Tests (POCT)  
2.1.3.4 Antigen Tests 
2.1.3.5 Nucleic acid-based tests (NAT)
2.1.3.6 Other tests used in HIV treatment  
2.2 HBV - Hepatitis B  
2.2.1 Virology 
2.2.1.1 Genome
2.2.1.2 Pathogenesis  
2.2.1.3 Hepatitis B virus replication 
2.2.1.4 Serotypes and genotypes  
2.2.2 Mechanisms 
2.2.3 Diagnosis  
2.2.4 Market Opportunity Analysis
2.3 HCV - Hepatitis C 
2.3.1 Taxonomy
2.3.2.1 Structure 
2.3.2.2 Genome
2.3.3 Molecular biology  
2.3.4 Replication  
2.3.5 Genotypes  
2.3.5.1 Clinical importance 
2.3.6 Market Opportunity Analysis
2.4 HPV - Human papillomavirus 
2.4.1 Virology 
2.4.1.1 E6/E7 proteins 
2.4.1.2 Role in cancer 
2.4.1.3 E2 research  
2.4.1.4 Latency period  
2.4.1.5 Clearance
2.4.2 Diagnosis  
2.4.2.1 Cervical testing 
2.4.2.2 Oral testing
2.4.2.3 Testing men 
2.4.2.4 Other testing 
2.4.3 Market Opportunity Analysis
2.5 Coronavirus 
2.5.1 Severe acute respiratory syndrome (SARS) 
2.5.2 Middle East respiratory syndrome (MERS) 
2.5.3 COVID-19. The SARS CoV 2 Virus
2.5.3.1 Signs and symptoms
2.5.3.2 Transmission 
2.5.3.3 Diagnosis 
2.5.3.4 Prevention  
2.5.3.5 Management  
2.5.3.6 Prognosis 
2.5.4 Pandemic Diagnostics 
2.5.4.1 Risk Management - Spark and Spread 
2.5.4.2 Dx Technology - Nucleic Acid Based
2.5.4.3 Dx Technology - Immunoassay 
2.5.4.4 Time to Market and Preparedness Issues 
2.5.5 COVID-19 Market Opportunity Analysis - A Special Case 
2.5.6 Current COVID-19 DTC Tests 
2.6 Influenza 
2.6.1 Flu
2.6.1.1 Types of virus 
2.6.1.2 Influenzavirus A 
2.6.1.3 Influenzavirus B
2.6.1.4 Influenzavirus C
2.6.1.5 Structure, properties, and subtype nomenclature 
2.6.1.6 Replication
2.6.2 Testing 
2.6.2.1 Advantages/Disadvantages of Molecular Assays 
2.6.3 Market Opportunity Analysis 
2.7 CT/NG - Chlamydia/Gonorhea  
2.7.1 Gonorrhea 
2.7.1.1 Diagnosis 
2.7.1.2 Screening 
2.7.2 Chlamydia 
2.7.2.1 Diagnosis 
2.7.2.2 Screening 
2.7.3 Testing 
2.7.3.1 Nucleic acid amplification tests (NAATs)
2.7.3.2 Performance of NAAT Tests 
2.7.4 Market Opportunity Analysis 
2.8 UTI
2.8.1 Diagnosis 
2.8.2 Testing 
2.8.2.1 Nitrites test  
2.8.2.2 Leukocytes test 
2.8.3 Market Opportunity Analysis 
2.9 GAS
2.9.1 Infectious Agents  
2.9.2 Market Opportunity Analysis 
2.10 RESP 
2.10.1 Diagnosis 
2.10.2 Market Opportunity Analysis

3. Industry Overview 
3.1 Industry Participants 
3.1.1 IVD Supplier 
3.1.2 Independent lab specialized/esoteric 
3.1.3 Independent lab national/regional 
3.1.4 Independent lab analytical  
3.1.5 Public National/regional lab 
3.1.6 Hospital lab  
3.1.7 Physician lab 
3.1.8 Pharmacies  
3.1.9 Audit body 
3.2 The Clinical Laboratory Market Segments1
3.2.1 Traditional Market Segmentation
3.2.2 Laboratory Focus and Segmentation 
3.2.3 Segmenting the OTC/DTC Market 
3.3 Industry Structure  
3.3.1 Hospital Testing Share 
3.3.2 Economies of Scale
3.3.2.1 Hospital vs. Central Lab 
3.3.3 Physician Office Lab’s 
3.3.3.1 The Problem with POLS
3.3.4 Physicians and OCT/DTC 
3.3.5 Pharmacies and OCT/DTC 
3.3.5.1 The Diagnostic Plight of Pharmacies - Trying to do good 
3.3.5.2 The Theranos Legacy  

4. Market Trends
4.1 Factors Driving Growth 
4.1.1 Privacy and Anonymity
4.1.2 The Internet Effect.  
4.1.3 Rapid Result. 
4.1.4 The Wellness Movement  
4.1.5 The COVID-19 Impact.  
4.2 Factors Limiting Growth
4.2.1 Trust Factor 
4.2.2 Infectious Disease is Declining But…. 
4.2.3 Wellness Hurts 
4.2.4 Economic Growth improves Living Standards 
4.3 Diagnostic Technology Development1
4.3.1 The Multiplex Paradigm Shift 
4.3.2 NAT vs. Lateral Flow 
4.3.3 The Unusual Role of GPS  
4.3.4 Self and Send Competition 
4.3.5 The Relationship to DTC Genetic 
4.3.6 The Relationship to TeleHealth 
4.3.7 Sample Collection - Who Knew?

5. OTC/DTC Infectious Disease Testing Recent Developments 

• Recent Developments - Importance and How to Use This Section 
• Importance of These Developments 
• How to Use This Section 
• FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit
• Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test
• Lucira Health Files for $115M IPO
• Spectrum Solutions Gets CE Mark for Saliva Collection Devices
• Sherlock Biosciences Receives Gates Foundation Grant for COVID-19 Self-Test 
• LabCorp Receives EUA for OTC COVID-19 Test Home Collection Kit  
• FemtoDx Launches Rapid At-Home Test Development for COVID-19 
• FDA approves first at-home coronavirus test  
• Free Home HIV Tests Detect More Infections  
• Biohacking trend supports self testing
• PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market  
• Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test 
• OraSure Technologies, Inc. Announces Two Acquisitions 
• Nigerian Govt Approves Alere HIV Self-Test Kit  
• Boots launches UTI test and treat service across 37 branches 
• Scanwell Health moves beyond home UTI testing with a nationwide kidney disease study partnership
• Healthy.io raises $18 million for at-home urinalysis tests 
• LetsGetChecked collects $30M more for at-home health testing
• TestCard, a $4 Urine Test Read by Smartphone 
• Digital Health Startup EverlyWell Raises $50M 
• Thriva adds test-at-home kits for female hormone and cortisol stress 
• Tasso scores $6.1M for patch-based home blood testing  
• DBS Systems HEMAXIS receives CE/IVD mark  
• Abbott HbA1c point-of-care test reliably diagnoses diabetes 

6. Profiles of Key Diagnostic Testing Companies 

• 1DropDiagnostics 
• Abbott Diagnostics 
• Ador Diagnostics  
• Akonni Biosystems
• Alveo Technologies 
• Applied BioCode 
• Atomo Diagnostics  
• Aus Diagnostics 
• Becton, Dickinson and Company 
• Binx Health 
• Biocartis  
• bioMérieux Diagnostics 
• Bio-Rad Laboratories, Inc
• Bosch Healthcare Solutions GmbH 
• Cepheid (now Danaher) 
• Curetis N.V. / Curetis GmbH  
• DBS Systems 
• Diagenode Diagnostics 
• Diasorin S.p.A
• Ellume  
• Everywell 
• Healthy.io  
• Hologic 
• Inflammatix  
• Invetech 
• Janssen Diagnostics 
• Karius 
• Laboratory Corporation of America
• Letsgetchecked 
• Lexagene  
• Luminex Corp 
• Mbio Diagnostics  
• Mesa Biotech  
• Mobidiag
• myLabBox 
• Mylan
• Nanomix 
• Orasure
• Oxford Nanopore Technologies 
• Panagene 
• Primerdesign 
• Prominex
• Qiagen Gmbh 
• Lucira Health
• Quantumdx 
• Quest Diagnostics
• Quidel 
• Roche Molecular Diagnostics  
• Scanwell Health
• Seegene
• Seventh Sense Biosystems
• Siemens Healthineers 
• T2 Biosystems 
• TestCard 
• Thermo Fisher Scientific Inc. 
• Thriva 
• XCR Diagnostics

7. Global Market Size
7.1 OTC/DTC ID Global Market Size by Country 
7.1.1 OTC/DTC ID Global Market Size by Country Table  
7.1.2 OTC/DTC ID Global Market Size by Country Chart 
7.2 OTC/DTC ID Global Market Size by Syndrome
7.2.1 OTC/DTC ID Global Market Size by Syndrome Table 
7.2.2 OTC/DTC ID Global Market Size by Syndrome Share by Year  
7.2.3 OTC/DTC ID Global Market Size by Syndrome Base vs Final 
7.2.4 OTC/DTC ID Global Market Size by Syndrome Base Year
7.2.5 OTC/DTC ID Global Market Size by Syndrome Final Year 
7.2.6 OTC/DTC ID Global Market Size by Syndrome Segment Growth
7.3 OTC/DTC ID Global Market Size by Channel  
7.3.1 OTC/DTC ID Global Market Size by Channel Table 
7.3.2 OTC/DTC ID Global Market Size by Channel Share by Year 
7.3.3 OTC/DTC ID Global Market Size by Channel Base vs Final 
7.3.4 OTC/DTC ID Global Market Size by Channel Base Year  
7.3.5 OTC/DTC ID Global Market Size by Channel Final Year
7.3.6 OTC/DTC ID Global Market Size by Channel Segment Growth  

8. Global Market by Syndrome 
8.1 Respiratory Market (including COVID-19) 
8.1.1 Respiratory Market by Country Table  
8.1.2 Respiratory Market Chart
8.2 STD Market 
8.2.1 STD Market by Country Table 
8.2.2 STD Market Chart 
8.3 UTI Market 
8.3.1 UTI Market by Country Table 
8.3.2 UTI Market Chart 
8.4 HxV Market
8.4.1 HxV Market by Country Table  
8.4.2 HxV Market by Chart 
8.5 Other Market
8.5.1 Other Market by Country Table  
8.5.2 Other Market Chart

9. Global Market by Channel 
9.1 OTC Market 
9.1.1 OTC Market by Country Table 
9.1.2 OTC Market Chart 
9.2 DTC Market  
9.2.1 DTC Market by Country Table  
9.2.2 DTC Market Chart
9.3 HSG Market  
9.3.1 HSG Market by Country Table  
9.3.2 HSG Market Chart 

Appendices 
I. United States Medicare System: 2021 Clinical Laboratory Fees Schedule 
II. FDA Approved Microbial Tests

List of Tables
Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2014 to 2024 ($Billion)  
Table 2 Classification of HIV Species
Table 3 HBV Tests - CMS Codes & Prices 
Table 4 HCV Tests - CMS Codes & Prices  
Table 5 HPV Clearance Rates 
Table 6 HPV Tests - CMS Codes & Prices 
Table 7 HPV Tests, Technology, Types 
Table 8 Characteristics of Coronavirus Pandemic Infections  
Table 9 COVID-19 Symptoms 
Table 10 DTC COVID-19 Tests and Current Status  
Table 11 Types of Influenza Tests 
Table 12 Influenza Tests - CMS Codes & Prices
Table 13 FDA Cleared Molecular Assays for Influenza  
Table 14 FDA Cleared NAAT CTGC Tests 
Table 15 CTGC NAAT Target Sequences and Possible False Reactions 
Table 16 CT/NG Tests - CMS Codes & Prices 
Table 17 GAS Panel BioFire 
Table 18 BioFire RESP Panel 
Table 19 Market Players by Type 
Table 20 Clinical Laboratory Departments and Segments 
Table 21 Laboratory Management Focus - Different Approaches  
Table 22 Key Segmentation Variables Going Forward 
Table 23 Possible Market Segments of OTC/DTC Market 1
Table 24 Five Factors Driving Growth 
Table 25 Four Factors Limiting Growth 
Table 26 Self vs. Send TAT 
Table 27 OTC/DTC ID Global Market by Country/Region 
Table 28 OTC/DTC ID Global Market by Syndrome 
Table 29 OTC/DTC ID Global Market by Channel 
Table 30 Respiratory Syndrome by Country 
Table 31 STD Testing market by country 
Table 32 UTI Testing market by country
Table 33 HxV Testing market by country
Table 34 Other Testing market by country
Table 35 OTC Market by Country 
Table 36 DTC market by country 
Table 37 HSG market by country
Table 38 2021 Clinical Lab Fee Schedule 

List of Figures
Figure 1 Medicare Clinical Lab Expenditures 2014 to 2024 ($Million)  
Figure 2 HIV Virion 
Figure 3 Diagram of the HIV Replication Cycle 
Figure 4 The Structure of the HBV Virus
Figure 5 Hepatitis B Replication  
Figure 6 Structure of the HCV Virus
Figure 7 HCV Replication Cycle 
Figure 8 Structure of Coronaviruses 
Figure 9 Structure of the Influenza Virion 
Figure 10 Influenza Replication
Figure 11 Chart Death Rates and Infectious Disease Decline  
Figure 12 The Multiplex Paradigm Shift
Figure 13 Market Size by Country - Key Countries
Figure 14 Chart of Global Market by Syndrome by Year 
Figure 15 Syndrome Segment Shares Base vs Final 
Figure 16 Syndrome Share Base Year
Figure 17 Syndrome Share Final Year 
Figure 18 Syndrome Segment Growth Rates
Figure 19 Chart of Global Market by Channel by Year
Figure 20 Channel Segment Shares Base vs Final 
Figure 21 Channel Share Base Year  
Figure 22 Channel Share Final Year 
Figure 23 Channel Segment Growth Rates  
Figure 24 Chart - Respiratory market Growth  
Figure 25 Chart - STD market Growth  
Figure 26 Chart - UTI market Growth
Figure 27 Chart - HxV market Growth  
Figure 28 Chart - Other market Growth 
Figure 29 Chart - OTC market Growth 
Figure 30 Chart - DTC market Growth 
Figure 31 Chart - HSG market Growth 

Companies Mentioned

• 1DropDiagnostics 
• Abbott Diagnostics 
• Ador Diagnostics  
• Akonni Biosystems
• Alveo Technologies 
• Applied BioCode 
• Atomo Diagnostics  
• Aus Diagnostics 
• Becton, Dickinson and Company 
• Binx Health 
• Biocartis  
• bioMérieux Diagnostics 
• Bio-Rad Laboratories, Inc
• Bosch Healthcare Solutions GmbH 
• Cepheid (now Danaher) 
• Curetis N.V. / Curetis GmbH  
• DBS Systems 
• Diagenode Diagnostics 
• Diasorin S.p.A
• Ellume  
• Everywell 
• Healthy.io  
• Hologic 
• Inflammatix  
• Invetech 
• Janssen Diagnostics 
• Karius 
• Laboratory Corporation of America
• Letsgetchecked 
• Lexagene  
• Luminex Corp 
• Mbio Diagnostics  
• Mesa Biotech  
• Mobidiag
• myLabBox 
• Mylan
• Nanomix 
• Orasure
• Oxford Nanopore Technologies 
• Panagene 
• Primerdesign 
• Prominex
• Qiagen Gmbh 
• Lucira Health
• Quantumdx 
• Quest Diagnostics
• Quidel 
• Roche Molecular Diagnostics  
• Scanwell Health
• Seegene
• Seventh Sense Biosystems
• Siemens Healthineers 
• T2 Biosystems 
• TestCard 
• Thermo Fisher Scientific Inc. 
• Thriva 
• XCR Diagnostics