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Market Research Report

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. 2021 to 2025

Published by Howe Sound Research Product code 990691
Published Content info 428 Pages
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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. 2021 to 2025
Published: February 22, 2021 Content info: 428 Pages
Description

OVERVIEW:

Covid-19 Awakens the sleeping giant of at home diagnostics. Over the Counter and Direct to Consumer diagnostics are 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 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
Table of Contents

Table of Contents

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/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 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 Development
    • 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
  • 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 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

Table 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 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

Table 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 Growht
  • 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 Growht
  • Figure 31 Chart - HSG market Growth
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