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 and Executive Guides. 2024 to 2028

Genetic 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. Find out where the action is and the learn about the players.

Exciting technical developments 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 newer diagnostics are now coming into play.

The report has hundreds of pages of information including a complete list and analysis 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.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

ABOUT THE LEAD AUTHOR:

Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:

B.Sc. (Chemistry) University of BC
M.B.A. (Finance and Policy) University of BC
Market Research Seminar - Burke Institute
Finance for Senior Executives - Harvard Business School

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 Infections - The Big Picture
3.2 The Pathogens
- 3.2.1 Bacteria
- 3.2.2 Fungi and Protozoa
- 3.2.3 Viruses
- 3.2.4 Prions
- 3.2.5 Symptoms and Syndromes
- 3.2.6 Bacterial or viral
- 3.2.7 Typical Viral Symptoms
- 3.2.8 Typical Bacterial Symptoms
3.3 Disease
3.4 Transmission
3.5 Infectious Disease Diagnostics
- 3.5.1 Microbial culture
- 3.5.2 Microscopy
- 3.5.3 Biochemical tests
- 3.5.4 PCR-based diagnostics
- 3.5.5 Metagenomic sequencing
3.6 Defining Infections
3.7 Syndromic Infection

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
  - 4.3.4.1 The Problem with POLS
- 4.3.5 Physician's and OCT/DTC
- 4.3.6 Pharmacies and OCT/DTC
  - 4.3.6.1 The Diagnostic Plight of Pharmacies - Trying to do good
  - 4.3.6.2 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 Silicon Valley Building Online Wellness Market
6.3 Simple HealthKit partners with Amazon
6.4 The future of at-home molecular testing
6.5 OTC Self-Tests, Tempered by Lack of Reimbursement
6.6 LetsGetChecked Gets FDA STD Test Approval
6.7 DiagMetrics Developing Breath Assays
6.8 Co-Diagnostics Awarded $2.3M for TB, HPV Tests
6.9 POC Developers Nuclein and Minute Molecular Dx Merge
6.10 ReadyGo Dx to Make MDx Testing a 'Snap'
6.11 Altratech Enters POC Space Supplanting PCR
6.12 FDA Authorizes First OTC Home Test for both Influenza and COVID-19
6.13 Pharmacies Poised to Capture At-Home Diagnostics Category
6.14 How Labcorp, Abbott, BD, Siemens plan to expand home testing market
6.15 Morgan Health Invests in LetsGetChecked
6.16 New US$ 1 price for HIV self-tests
6.17 Startup Detect to Roll Out Next-Gen Molecular Instrument
6.18 Diagnostics for the Real World Third-Generation POC Platform
6.19 Labcorp Partnering With Getlabs for Home Collection
6.20 Salignostics Closes Funding Round
6.21 Cue Health Targets DTC Market in 2022
6.22 Grip Molecular Developing Home Respiratory Panel
6.23 Mainz Biomed Developing Home ColoAlert Assay
6.24 MFB Fertility Closes Series A Financing Round
6.25 Continued Demand for SARS-CoV-2 Rapid Tests
6.26 Rapid Covid-19 Test Results Risk Going Uncounted
6.27 FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit
6.28 Researchers Develop 15-Minute PCR System
6.29 Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test
6.30 Lucira Health Files for $115M IPO
6.31 Spectrum Solutions Gets CE Mark for Saliva Collection Devices
6.32 Sherlock Biosciences Receives Gates Foundation Grant for COVID-19 Self-Test
6.33 LabCorp Receives EUA for OTC COVID-19 Test Home Collection Kit
6.34 FemtoDx Launches Rapid At-Home Test Development for COVID-19
6.35 FDA approves first at-home coronavirus test
6.36 Free Home HIV Tests Detect More Infections
6.37 Biohacking trend supports self testing.
6.38 PerkinElmer and EverlyWell to Expand U.S. At-Home Health Test Market
6.39 Mylan, Atomo Diagnostics Get WHO Prequalification Approval for HIV Self-Test
6.40 OraSure Technologies, Inc. Announces Two Acquisitions
6.41 Nigerian Govt Approves Alere HIV Self-Test Kit
6.42 Boots launches UTI test and treat service across 37 branches
6.43 Scanwell Health moves beyond home UTI testing
6.44 Healthy.io raises $18 million for at-home urinalysis tests
6.45 LetsGetChecked collects $30M more for at-home health testing
6.46 TestCard, a $4 Urine Test Read by Smartphone
6.47 Digital Health Startup EverlyWell Raises $50M
6.48 Thriva adds test-at-home kits for female hormone and cortisol stress
6.49 Tasso scores $6.1M for patch-based home blood testing
6.50 DBS Systems HEMAXIS receives CE/IVD mark
6.51 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 Accel Diagnostics
7.4 Ador Diagnostics
7.5 ADT Biotech
7.6 Akonni Biosystems
7.7 AlphaBiolabs
7.8 Alveo Technologies
7.9 Applied BioCode
7.10 Atomo Diagnostics
7.11 Aureum Diagnostics
7.12 Aus Diagnostics
7.13 Becton, Dickinson and Company
7.14 Binx Health
7.15 Biocartis
7.16 BioFire Diagnostics (bioMerieux)
7.17 bioMerieux Diagnostics
7.18 Bio-Rad Laboratories, Inc
7.19 Bosch Healthcare Solutions GmbH
7.20 Cepheid (Danaher)
7.21 Cue Health
7.22 Curetis (OpGen)
7.23 DBS Systems
7.24 Detect
7.25 Diagenode Diagnostics (Hologic)
7.26 Diasorin S.p.A.
7.27 Domus Diagnostics
7.28 Ellume
7.29 Everywell
7.30 Getlabs
7.31 Grip Molecular Technologies
7.32 Healthy.io
7.33 Hologic
7.34 Inflammatix
7.35 Invetech
7.36 J&J Innovative Medicine
7.37 Karius
7.38 Laboratory Corporation of America
7.39 Letsgetchecked
7.40 LightDeck Diagnostics
7.41 Lucira Health (Pfizer)
7.42 LumiraDx
7.43 Meep
7.44 MFB Fertility
7.45 myLabBox
7.46 Nanomix
7.47 OraSure Technologies
7.48 Oxford Nanopore Technologies
7.49 Panagene
7.50 Prenetics
7.51 Primerdesign (Novacyt)
7.52 Prominex
7.53 Qiagen
7.54 QuantuMDx
7.55 Quest Diagnostics
7.56 QuidelOrtho
7.57 Randox Toxicology
7.58 R-Biopharm AG
7.59 Response Biomedical
7.60 Roche Diagnostics
7.61 Salignostics
7.62 SD Biosensor
7.63 Seegene
7.64 Sekisui Diagnostics
7.65 Siemens Healthineers
7.66 T2 Biosystems
7.67 TestCard
7.68 Thermo Fisher Scientific
7.69 Thriva
7.70 Visby Medical
7.71 XCR Diagnostics
7.72 YourBio Health

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 Growth of Approved IVD Test Menu
11.2 Growth of Approved Average IVD Test Fee
11.3 The Most Used IVD Assays
11.4 The Highest Grossing Assays
11.5 Laboratory Fees Schedule

Table of Tables

Table 1 Market Players by Type
Table 2 Clinical Laboratory Departments and Segments
Table 3 Laboratory Management Focus - Different Approaches
Table 4 Key Segmentation Variables Going Forward
Table 5 Possible Market Segments of OTC/DTC Market
Table 6 Five Factors Driving Growth
Table 7 Four Factors Limiting Growth
Table 8 Self vs. Send TAT
Table 9 OTC/DTC ID Global Market by Country/Region
Table 10 OTC/DTC ID Global Market by Syndrome
Table 11 OTC/DTC ID Global Market by Channel
Table 12 Respiratory Syndrome by Country
Table 13 STD Testing market by country
Table 14 UTI Testing market by country
Table 15 HxV Testing market by country
Table 16 Other Testing market by country
Table 17 OTC Market by Country
Table 18 DTC market by country
Table 19 HSG market by country
Table 20 The Most Common Assays
Table 21 Largest Revenue Assays
Table 22 Clinical Lab Fee Schedule

Table of Figures

Figure 1 Global Healthcare Spending Map
Figure 2 Chart Death Rates and Infectious Disease Decline
Figure 3 The Multiplex Paradigm Shift
Figure 4 Market Size by Country-Key Countries
Figure 5 Chart of Global Market by Syndrome by Year
Figure 6 Syndrome Segment Shares Base vs Final
Figure 7 Syndrome Share Base Year
Figure 8 Syndrome Share Final Year
Figure 9 Syndrome Segment Growth Rates
Figure 10 Chart of Global Market by Channel by Year
Figure 11 Channel Segment Shares Base vs Final
Figure 12 Channel Share Base Year
Figure 13 Channel Share Final Year
Figure 14 Channel Segment Growth Rates
Figure 15 Chart-Respiratory market Growth
Figure 16 Chart - STD market Growht
Figure 17 Chart - UTI market Growth
Figure 18 Chart-HxV market Growth
Figure 19 Chart - Other market Growth
Figure 20 Chart-OTC market Growth
Figure 21 Chart - DTC market Growht
Figure 22 Chart - HSG market Growth
Figure 23 IVD Test Menu Growth
Figure 24 IVD Test Average Fees - A Ten Year View