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OTC/DTC Infectious Disease Diagnostics Industry Assessment w/ COVID-19 Adjusted Analysis 2020-2024 - New Technologies Create Rapid Test Solutions for the Home Market

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News provided by

Research and Markets

Apr 28, 2020, 10:45 ET

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DUBLIN, April 28, 2020 /PRNewswire/ -- The "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" report has been added to ResearchAndMarkets.com's offering.

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 is 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.

Key Topics Covered

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 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
  • 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
  • bioMrieux
  • 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
8.3 UTI Market
8.4 HxV Market
8.5 Other Market

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
9.3 DTC Market
9.4 HSG Market

Appendices
I. United States Medicare System: 2020 Clinical Laboratory Fees Schedule
II. FDA Approved Microbial Tests

For more information about this report visit https://www.researchandmarkets.com/r/55urs0

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.


Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]   

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