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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 and by Country with Market Analysis, Executive Guides, and Market Opportunity Analysis 2023 to 2027

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  • 492 Pages
  • April 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5745051

The End of the Pandemic Opens Up a New Market for Diagnostic Technology

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, 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 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 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 Spending on Diagnostics
2.6.2 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)
2.5.2 Middle East Respiratory Syndrome (MERS)
3.5.2 COVID-19. The SARS CoV 2 Virus Signs and Symptoms Transmission Diagnosis Prevention 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 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 DiagMetrics Developing Breath Assays
6.3 Co-Diagnostics Awarded $2.3M for TB, HPV Tests
6.4 POC Developers Nuclein and Minute Molecular Dx Merge
6.5 ReadyGo Dx to Make MDx Testing a 'Snap'
6.6 Altratech Enters POC Space Supplanting PCR
6.7 FDA Authorizes First OTC Home Test for both Influenza and COVID-19
6.8 Pharmacies Poised to Capture At-Home Diagnostics Category
6.9 How Labcorp, Abbott, BD, Siemens plan to expand home testing market
6.10 Morgan Health Invests in LetsGetChecked
6.11 New US$ 1 price for HIV self-tests
6.12 Startup Detect to Roll Out Next-Gen Molecular Instrument
6.13 Diagnostics for the Real World Third-Generation POC Platform
6.14 Labcorp Partnering With Getlabs for Home Collection
6.15 Salignostics Closes Funding Round
6.16 Cue Health Targets DTC Market in 2022
6.17 Grip Molecular Developing Home Respiratory Panel
6.18 Mainz Biomed Developing Home ColoAlert Assay
6.19 MFB Fertility Closes Series A Financing Round
6.20 Continued Demand for SARS-CoV-2 Rapid Tests
6.21 Rapid Covid-19 Test Results Risk Going Uncounted
6.22 FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit
6.23 Researchers Develop 15-Minute PCR System
6.24 Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test
6.25 Lucira Health Files for $115M IPO
6.26 Spectrum Solutions Gets CE Mark for Saliva Collection Devices
6.27 Sherlock Biosciences Receives Gates Foundation Grant for COVID-19 Self-Test
6.28 LabCorp Receives EUA for OTC COVID-19 Test Home Collection Kit
6.29 FemtoDx Launches Rapid At-Home Test Development for COVID-19
6.30 FDA approves first at-home coronavirus test
6.31 Free Home HIV Tests Detect More Infections
6.32 Biohacking trend supports self-testing.
6.33 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market
6.34 Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test
6.35 OraSure Technologies, Inc. Announces Two Acquisitions
6.36 Nigerian Govt Approves Alere HIV Self-Test Kit
6.37 Boots launches UTI test and treatment service across 37 branches
6.38 Scanwell Health moves beyond home UTI testing
6.39 Healthy.io raises $18 million for at-home urinalysis tests
6.40 LetsGetChecked collects $30M more for at-home health testing
6.41 TestCard, a $4 Urine Test Read by Smartphone
6.42 Digital Health Startup EverlyWell Raises $50M
6.43 Thriva adds test-at-home kits for female hormone and cortisol stress
6.44 Tasso scores $6.1M for patch-based home blood testing
6.45 DBS Systems HEMAXIS receives CE/IVD mark
6.46 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
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: Clinical Laboratory Fees Schedule
11.2 FDA Approved Microbial Tests

List of Tables
Table 1 Classification of HIV Species
Table 2 HBV Tests - CMS Codes & Prices
Table 3 HCV Tests - CMS Codes & Prices
Table 4 HPV Clearance Rates
Table 5 HPV Tests - CMS Codes & Prices
Table 6 HPV Tests, Technology, Types
Table 7 Characteristics of Coronavirus Pandemic Infections
Table 8 COVID-19 Symptoms
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 CT/NG Tests - CMS Codes & Prices
Table 15 GAS Panel BioFire
Table 16 BioFire RESP Panel
Table 17 Market Players by Type
Table 18 Clinical Laboratory Departments and Segments
Table 19 Laboratory Management Focus - Different Approaches
Table 20 Key Segmentation Variables Going Forward
Table 21 Possible Market Segments of the OTC/DTC Market
Table 22 Five Factors Driving Growth
Table 23 Four Factors Limiting Growth
Table 24 Self vs. Send TAT
Table 25 OTC/DTC ID Global Market by Country/Region
Table 26 OTC/DTC ID Global Market by Syndrome
Table 27 OTC/DTC ID Global Market by Channel
Table 28 Respiratory Syndrome by Country
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 OTC Market by Country
Table 34 DTC market by country
Table 35 HSG market by country
Table 36 Clinical Lab Fee Schedule

List of Figures
Figure 1 Global Healthcare Spending Map
Figure 2 The Lab Test Pie
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 Coronaviruses
Figure 10 Structure of the Influenza Virion
Figure 11 Influenza Replication
Figure 12 Chart Death Rates and Infectious Disease Decline
Figure 13 The Multiplex Paradigm Shift
Figure 14 Market Size by Country - Key Countries
Figure 15 Chart of Global Market by Syndrome by Year
Figure 16 Syndrome Segment Shares Base vs Final
Figure 17 Syndrome Share Base Year
Figure 18 Syndrome Share Final Year
Figure 19 Syndrome Segment Growth Rates
Figure 20 Chart of Global Market by Channel by Year
Figure 21 Channel Segment Shares Base vs Final
Figure 22 Channel Share Base Year
Figure 23 Channel Share Final Year
Figure 24 Channel Segment Growth Rates
Figure 25 Chart - Respiratory Market Growth
Figure 26 Chart - STD market growth
Figure 27 Chart - UTI market Growth
Figure 28 Chart - HxV Market Growth
Figure 29 Chart - Other Market Growth
Figure 30 Chart - OTC market Growth
Figure 31 Chart - DTC market growth
Figure 32 Chart - HSG Market Growth

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
  • Bio-Rad Laboratories, Inc
  • Biocartis
  • BioFire Diagnostics (bioMérieux)
  • bioMérieux Diagnostics
  • Bosch Healthcare Solutions GmbH
  • Cepheid (Danaher)
  • Cue Health
  • 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