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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. 2020 to 2024

  • ID: 5018692
  • Report
  • July 2021
  • Region: Global
  • 394 Pages
  • Howe Sound Research
COVID-19 Creates New Direct to Consumer Diagnostics Opportunities.

FEATURED COMPANIES

  • 1DropDiagnostics
  • Biocartis
  • Everlywell
  • Janssen Diagnostics
  • myLabBox
  • Quantumdx

Over the Counter and Direct to Consumer diagnostics set to help solve the pandemic problem. New technologies create rapid test solutions for the home market. Self-Sampling technology key.

Genetic DTC testing led the way. Now infectious disease testing is moving directly to the consumer. New sampling technology, rapid and multiplex tests have changed the picture on how and where testing is done. And the COVID-19 situation will lead the charge. This report explores the DTC outlook for different syndromes. Find out where the action is and the learn about the players.

Exciting technical developments especially in the seesaw between PCR and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication. Even CRISPR diagnostics are now coming into play.

The report has hundreds of pages of information including a complete list of Current 2019 United States Medicare Fee Payment Schedules to help sharpen your pricing.

The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 1DropDiagnostics
  • Biocartis
  • Everlywell
  • Janssen Diagnostics
  • myLabBox
  • Quantumdx

i. Market Guides
iA. Situation Analysis and COVID-19 Market Analysis
iB. Guide for Executives and Marketing Staff
iC. 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/Gonorrhoea
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 Segments
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 Physician’s 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 Development179
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
4.4.5 The Relationship to DTC Genetic
4.4.6 The Relationship to TeleHealth
4.4.7 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
  • 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
  • Miraca Holdings Inc. and Seventh Sense Biosystems, Inc. Announce Distribution Agreement
  • OraSure Technologies, Inc. Announces Two Acquisitions
  • Mylan signs HIV test commercialisation deal with Atomo Diagnostics
  • Nigerian Govt Approves Alere HIV Self-Test Kit
  • Rapid HIV tests vary in their accuracy
  • Montreal researchers develop HIV self-testing app
  • Boots launches UTI test and treat service across 37 branches
  • Scanwell Health moves beyond home UTI testing with 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
  • LabCorp to offer self-testing home kits.
  • 1Drop Diagnostics draws $4.25M for portable blood diagnostic panel
  • DBS Systems HEMAXIS receives CE/IVD mark 211 myLAB Box Announces $1.56M in Seed Funding
  • Abbott HbA1c point-of-care test reliably diagnoses diabetes

6. Profiles of Key Diagnostic Testing Companies
1DropDiagnostics
Abbott Diagnostics (Alere)
Atomo Diagnostics
Ador Diagnostics
Akkoni Biosystems
Alveo Technologies
Applied BioCode
Atlas Genetics
Aus Diagnostics
BD Diagnostics
Biocartis
BioFire Diagnostics
bioMérieux
Bio-Rad Laboratories
Bosch Healthcare Solutions GmbH
Cepheid
Curetis
DBS Systems
Diagenode Diagnostics
Diasorin
Everlywell
Fusion Genomics
GenePOC Diagnostics
GenMark Dx
Healthy.IO
Hologic
Inflammatix
Inui Health
Invetech
Janssen Diagnostics
Karius
Labcorp - Pixel
Letsgetchecked
Lexigene
Luminex
Mbio Diagnostics
Mesa Biotech
Mobidiag
myLabBox
Mylan
Nanomix
Orasure
Oxford Nanopore
Panagene
Primerdesign
Prominex
Qiagen (Statdx)
Quantumdx
Quest Diagnostics – Quest Direct
Roche Molecular Diagnostics
Scanwell Health
Seegene
Sensovation
Seventh Sense Biosystems.
Siemens Healthineers (Fast Track Diagnostics)
SkylineDx
T2 Biosystems
TestCard Diagnostics
Thermo Fisher
Thriva
Veramarx
XCR Diagnostics

7. Global Market Size
7.1 OTC/DTC ID Global Market Size by Country with Charts
7.2 OTC/DTC ID Global Market Size by Syndrome with Charts

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

9. Global Market by Channel
9.1 OTC/DTC Market by Channel
9.1.1 OTC/DTC Market by Channel with Chart
9.2 OTC Market
9.2.1 OTC Market by Country
9.3 DTC Market
9.3.1 DTC Market by Country with Chart
9.4 HSG Market
9.4.1 HSG Market by Country with Chart

Appendices
I. United States Medicare System: 2020 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
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 STD Testing market by country
Table 30 UTI Testing market by country.
Table 31 HxV Testing market by country
Table 32 Other Testing market by country
Table 33 DTC Testing market by country
Table 34 HSG Testing market by country
Table 35 2020 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 11 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 2019 vs 2014
Figure 16 Syndrome Share 2019.
Figure 17 Syndrome Share 2024.
Figure 18 Chart - Respiratory market 5 Year Growth
Figure 19 Chart – STD market 5 Year Growht
Figure 20 Chart – UTI 5 Year market Growth
Figure 21 Chart - HxV market 5 Year Growth
Figure 22 Chart – Other market 5 Year Growth
Figure 23 Channel Share by Year.
Figure 24 Chart - OTC Channel 5 Year Growth
Figure 25 Chart – DTC Channel 5 Year Growth
Figure 26 Chart – HSG Channel 5 Year Growth

Note: Product cover images may vary from those shown

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  • 1DropDiagnostics
  • Abbott Diagnostics (Alere)
  • Ador Diagnostics
  • Akkoni Biosystems
  • Alveo Technologies
  • Applied BioCode
  • Atlas Genetics
  • Atomo Diagnostics
  • Aus Diagnostics
  • BD Diagnostics
  • Bio-Rad Laboratories
  • Biocartis
  • BioFire Diagnostics
  • bioMérieux
  • Bosch Healthcare Solutions GmbH
  • Cepheid
  • Curetis
  • DBS Systems
  • Diagenode Diagnostics
  • Diasorin
  • Everlywell
  • Fusion Genomics
  • GenePOC Diagnostics
  • GenMark Dx
  • Healthy.IO
  • Hologic
  • Inflammatix
  • Inui Health
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Labcorp - Pixel
  • Letsgetchecked
  • Lexigene
  • Luminex
  • Mbio Diagnostics
  • Mesa Biotech
  • Mobidiag
  • myLabBox
  • Mylan
  • Nanomix
  • Orasure
  • Oxford Nanopore
  • Panagene
  • Primerdesign
  • Prominex
  • Qiagen (Statdx)
  • Quantumdx
  • Quest Diagnostics – Quest Direct
  • Roche Molecular Diagnostics
  • Scanwell Health
  • Seegene
  • Sensovation
  • Seventh Sense Biosystems.
  • Siemens Healthineers (Fast Track Diagnostics)
  • SkylineDx
  • T2 Biosystems
  • TestCard Diagnostics
  • Thermo Fisher
  • Thriva
  • Veramarx
  • XCR Diagnostics
Note: Product cover images may vary from those shown
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