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OTC/DTC Infectious Disease Diagnostics Strategies and Trends for Over the Counter and Direct To Consumer. Forecasts by Application by Channel by Country. With Market Analysis, Executive Guides, Customization and Market Opportunity Analysis 2022 to 2026

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  • 467 Pages
  • August 2022
  • Region: Global
  • Howe Sound Research
  • ID: 5590086

The sleeping giant of Over the Counter and Direct to Consumer diagnostics is set to create a broad new diagnostic industry.  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, and rapid and multiplex tests have changed the picture on how and where testing is done.  And the pandemic has proven the need for self-testing.  This report explores the DTC outlook for different syndromes.  Find out where the action is and 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 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.

Table of Contents

1. Market Guides
1.1 Situation Analysis
1.2 Guide for Executives and Marketing Staff
1.3 Guide for Investment Analysts and Management Consultants
2 Introduction and Market Definition
2.1 What is OTC and DTC Testing?
2.2 OTC/DTC Testing - the quiet revolution in diagnostics
2.3 Self vs. Send - who knew?
2.4 Market Definition
2.4.1 Retail vs. Wholesale
2.4.2 OTC, DTC, HxV and HSG
2.4.3 Currency
2.4.4 Years
2.5 Methodology
2.5.1 Methodology
2.5.2 Sources
2.5.3 Authors
2.6 Perspective: Healthcare and the IVD Industry
2.6.1 Global Healthcare Spending
2.6.2 Spending on Diagnostics
2.6.3 Important Role of Insurance for Diagnostics
3 The Infectious Diseases - Guide to the Pathogens
3.1 HIV - Human Immunodeficiency Virus (AIDS)
3.1.1 Virology Classification Structure and genome Tropism Replication cycle Genetic variability
3.1.2 Diagnosis
3.1.3 Testing Antibody tests Point of Care Tests (POCT) Antigen Tests Nucleic acid-based tests (NAT) Other tests used in HIV treatment
3.2 HBV - Hepatitis B.
3.2.1 Virology Genome Pathogenesis Hepatitis B virus replication 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 Structure Genome
3.3.2 Molecular biology
3.3.3 Replication
3.3.4 Genotypes Clinical importance
3.3.5 Market Opportunity Analysis
3.4 HPV - Human papillomavirus
3.4.1 Virology E6/E7 proteins Role in cancer Research Latency period Clearance
3.4.2 Diagnosis Cervical testing Oral testing Testing men Other testing
3.4.3 Market Opportunity Analysis
3.5 Coronavirus
3.5.1 Severe acute respiratory syndrome (SARS)
3.5.2 Middle East respiratory syndrome (MERS)
3.5.2 COVID-19. The SARS CoV 2 Virus Signs and symptoms Transmission Diagnosis Prevention 103 Management Prognosis
3.5.3 Pandemic Diagnostics Risk Management - Spark and Spread Dx Technology - Nucleic Acid Based Dx Technology - Immunoassay Time to Market and Preparedness Issues
3.6 Influenza
3.6.1 Flu Types of virus Influenzavirus A Influenzavirus B Influenzavirus C Structure, properties, and subtype nomenclature Replication
3.6.2 Testing Advantages/Disadvantages of Molecular Assays
3.6.3 Market Opportunity Analysis
3.7 CT/NG - Chlamydia/Gonorhea
3.7.1 Gonorrhea Diagnosis Screening
3.7.2 Chlamydia Diagnosis Screening
3.7.3 Testing 132 Nucleic acid amplification tests (NAATs). Performance of NAAT Tests
3.7.4 Market Opportunity Analysis
3.8 UTI
3.8.1 Diagnosis
3.8.2 Testing Nitrites test Leukocytes test
3.8.3 Market Opportunity Analysis
3.9 GAS
3.9.1 Infectious Agents
3.9.2 Market Opportunity Analysis
3.10 RESP
3.10.1 Diagnosis
3.10.2 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 Pharmacies
4.1.9 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 OTC/DTC Market
4.3 Industry Structure
4.3.1 Hospital Testing Share
4.3.2 Economies of Scale
4.3.3 Hospital vs. Central Lab
4.3.4 Physician Office Lab’s The Problem with POLS
4.3.5 Physician’s and OCT/DTC
4.3.6 Pharmacies and OCT/DTC The Diagnostic Plight of Pharmacies - Trying to do good The Theranos Legacy
5 Market Trends
5.1 Factors Driving Growth
5.1.1 Privacy and Anonymity
5.1.2 The Internet Effect
5.1.3 Rapid Result
5.1.4 The Wellness Movement
5.1.5 The COVID-19 Impact
5.2 Factors Limiting Growth
5.2.1 Trust Factor
5.2.2 Infectious Disease is Declining But….
5.2.3 Wellness Hurts
5.2.4 Economic Growth improves Living Standards
5.3 Diagnostic Technology Development
5.3.1 The Multiplex Paradigm Shift
5.3.2 NAT vs. Lateral Flow
5.3.3 The Unusual Role of GPS
5.3.4 Self and Send Competition
5.3.5 The Relationship to DTC Genetic
5.3.6 The Relationship to TeleHealth
5.3.7 Sample Collection - Who Knew?
6 OTC/DTC Infectious Disease 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 Startup Detect to Roll Out Next-Gen Molecular Instrument
6.3 Diagnostics for the Real World Third-Generation POC Platform
6.4 Labcorp Partnering With Getlabs for Home Collection
6.5 Salignostics Closes Funding Round
6.6 Cue Health Targets DTC Market in 2022
6.7 Grip Molecular Developing Home Respiratory Panel
6.8 Mainz Biomed Developing Home ColoAlert Assay
6.9 MFB Fertility Closes Series A Financing Round
6.10 Continued Demand for SARS-CoV-2 Rapid Tests
6.11 Rapid Covid-19 Test Results Risk Going Uncounted
6.12 FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit
6.13 Researchers Develop 15-Minute PCR System
6.14 Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test
6.15 Lucira Health Files for $115M IPO
6.16 Spectrum Solutions Gets CE Mark for Saliva Collection Devices
6.17 Sherlock Biosciences Receives Gates Foundation Grant for COVID-19 Self-Test
6.18 LabCorp Receives EUA for OTC COVID-19 Test Home Collection Kit
6.19 FemtoDx Launches Rapid At-Home Test Development for COVID-19
6.20 FDA approves first at-home coronavirus test
6.21 Free Home HIV Tests Detect More Infections
6.22 Biohacking trend supports self testing
6.23 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market
6.24 Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test
6.25 OraSure Technologies, Inc. Announces Two Acquisitions
6.26 Nigerian Govt Approves Alere HIV Self-Test Kit
6.27 Boots launches UTI test and treat service across 37 branches
6.28 Scanwell Health moves beyond home UTI testing
6.29 Healthy.io raises $18 million for at-home urinalysis tests
6.30 LetsGetChecked collects $30M more for at-home health testing
6.31 TestCard, a $4 Urine Test Read by Smartphone
6.32 Digital Health Startup EverlyWell Raises $50M
6.33 Thriva adds test-at-home kits for female hormone and cortisol stress
6.34 Tasso scores $6.1M for patch-based home blood testing
6.35 DBS Systems HEMAXIS receives CE/IVD mark
6.36 Abbott HbA1c point-of-care test reliably diagnoses diabetes
7 Profiles of Key Diagnostic Testing Companies
7.1 1DropDiagnostics
7.2 Abbott Laboratories
7.3 Ador Diagnostics
7.4 ADT Biotech
7.5 Akonni Biosystems
7.6 Alveo Technologies
7.7 Antelope Dx
7.8 Applied BioCode
7.9 Atomo Diagnostics
7.10 Aus Diagnostics
7.11 Becton, Dickinson and Company
7.12 Binx Health
7.13 Biocartis
7.14 BioFire Diagnostics (bioMérieux)
7.15 bioMérieux Diagnostics
7.16 Bio-Rad Laboratories, Inc
7.17 Bosch Healthcare Solutions GmbH
7.18 Cepheid (Danaher)
7.19 Cue Health
7.20 Curetis N.V./Curetis GmbH
7.21 DBS Systems
7.22 Detect
7.23 Diagenode Diagnostics
7.24 Diasorin S.p.A.
7.25 Ellume
7.26 Everywell
7.27 Getlabs.
7.28 Grip Molecular Technologies
7.29 Healthy.io
7.30 Hologic
7.31 Inflammatix
7.32 Invetech
7.33 Janssen Diagnostics
7.34 Karius
7.35 Laboratory Corporation of America
7.36 Letsgetchecked
7.37 Lexagene
7.38 Lucira Health
7.39 Luminex Corp
7.40 Mbio Diagnostics
7.41 Mesa Biotech (Thermo Fisher)
7.42 MFB Fertility
7.43 Mobidiag (Hologic)
7.44 myLabBox
7.45 Mylan
7.46 Nanomix
7.47 OraSure Technologies
7.48 Oxford Nanopore Technologies
7.49 Panagene
7.50 Primerdesign (Novacyt)
7.51 Prominex
7.52 Qiagen
7.53 QuantuMDx
7.54 Quest Diagnostics
7.55 Quidel
7.56 Randox Toxicology
7.57 Roche Molecular Diagnostics
7.58 Salignostics
7.59 Scanwell Health
7.60 SD Biosensor
7. 61 Seegene
7.62 Seventh Sense Biosystems.
7.63 Siemens Healthineers
7.64 T2 Biosystems
7.65 TestCard
7.66 Thermo Fisher Scientific Inc.
7.67 Thriva
7.68 Visby Medical
7.69 XCR Diagnostics
8 Global Market Size
8.1 OTC/DTC ID Global Market Size by Country
8.1.1 OTC/DTC ID Global Market Size by Country Table
8.1.2 OTC/DTC ID Global Market Size by Country Chart
8.2 OTC/DTC ID Global Market Size by Syndrome
8.2.1 OTC/DTC ID Global Market Size by Syndrome Table
8.2.2 OTC/DTC ID Global Market Size by Syndrome Share by Year
8.2.3 OTC/DTC ID Global Market Size by Syndrome Base vs Final
8.2.4 OTC/DTC ID Global Market Size by Syndrome Base Year
8.2.5 OTC/DTC ID Global Market Size by Syndrome Final Year
8.2.6 OTC/DTC ID Global Market Size by Syndrome Segment Growth
8.3 OTC/DTC ID Global Market Size by Channel
8.3.1 OTC/DTC ID Global Market Size by Channel Table
8.3.2 OTC/DTC ID Global Market Size by Channel Share by Year
8.3.3 OTC/DTC ID Global Market Size by Channel Base vs Final
8.3.4 OTC/DTC ID Global Market Size by Channel Base Year
8.3.5 OTC/DTC ID Global Market Size by Channel Final Year
8.3.6 OTC/DTC ID Global Market Size by Channel Segment Growth
9 Global Market by Syndrome
9.1 Respiratory Market
9.1.1 Respiratory Market by Country Table
9.1.2 Respiratory Market Chart
9.2 STD Market
9.2.1 STD Market by Country Table
9.2.2 STD Market Chart
9.3 UTI Market
9.3.1 UTI Market by Country Table
9.3.2 UTI Market Chart
9.4 HxV Market
9.4.1 HxV Market by Country Table
9.4.2 HxV Market by Chart
9.5 Other Market
9.5.1 Other Market by Country Table
9.5.2 Other Market Chart
10 Global Market by Channel
10.1 OTC Market
10.1.1 OTC Market by Country Table
10.1.2 OTC Market Chart
10.2 DTC Market 359
10.2.1 DTC Market by Country Table
10.2.2 DTC Market Chart
10.3 HSG Market
10.3.1 HSG Market by Country Table
10.3.2 HSG Market Chart
11 Appendices
11.1 United States Medicare System: 2022 Clinical Laboratory Fees Schedule
11.2 FDA Approved Microbial Tests

Companies Mentioned

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