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COVID-19 Update: Impact on Molecular Diagnostics, Serology, Critical Care Tests, Vaccines and Telehealth Markets

  • Report

  • 125 Pages
  • May 2020
  • Region: Global
  • Kalorama Information
  • ID: 5026937
The current COVID-19 crisis affecting the United States and the world has caused hundreds of thousands of deaths and countless economic costs. This has brought forth an array of solutions that could contribute to detecting, containing, and possibly treating the disease. The analyst has covered the fields of molecular diagnostics, vaccines, and telehealth for decades. These important industries, already growing in revenues and number of competitors, now find themselves part of the current crisis. This COVID-19 Update provides trending developments, company announcements, and analysis from the analysis team on fast-breaking events in the COVID-19 pandemic.

Early COVID-19 IVD Market Estimates - Moderate Case, Best Case, Worst Case


In preparing market analysis, the analyst normally consults detailed financial information from the major in vitro diagnostics firms to obtain accurate results. In the throes of this crisis, such data are lacking. However, using the many statements that have been issued plus knowledge gleaned from the analyst's databases on flu and other molecular testing.

The analyst has assembled the following market cases for COVID-19 testing:


  • COVID-19 Tests Moderate IVD Market Case (Molecular, Antibody, US/Global)
  • COVID-19 Tests Best IVD Market Case (Molecular, Antibody, US/Global)
  • COVID-19 Tests Worst IVD Market Case (Molecular, Antibody, US/Global)

In addition, the report features an Appendix that presents the COVID-19 moderate market case analysis in detail (note that the best and worst market cases were built from this moderate case analysis).

Molecular Diagnostics


Testing for viruses is normally conducted using RT-PCR, a form of molecular testing. To a lesser degree, antibody tests are used. Both types of testing have been present in the COVID-19 crisis. The report takes a particular interest in molecular diagnostics, the segment in vitro diagnostics directly affected by COVID-19.

Topics explored include the following:


  • Early COVD-19 Related Financial Results at Molecular Test Companies
  • Smaller, Mid-Size MDx Companies See Double-Digit Boosts
  • Life Science Company Revenues Down
  • Molecular Testing: A Learning Curve
  • EUA Authorizations
  • Survey of Clinical Diagnostic Labs
  • Reopening Plans
  • Supply Issues
  • Marketed Molecular Tests (EUA, CE Other)
  • Potential Market Impacts

Serology Tests


Serology tests are serum-based immunoassays that are inexpensive and run on high-volume analyzers that are very common in hospital and reference labs, in contrast to PCR tests, which tend to be more complex and expensive. These tests look for the presence of host antibodies that a patient may have developed in reaction to the disease, rather than detecting the disease itself. In so doing, serology tests at some point could ascertain whether patients have immunity, though mechanisms of immunity have not been fully explored with COVID-19.

COVID-19 Update provides information about serology testing:


  • FDA Actions Related to Serology Tests
  • Serum/Whole Blood Tests
  • Serology Tests on The Market
  • Fingerstick Tests

Other IVD Tests


The results of a survey on the US Impact on Hospital and Reference Test Volume have pointed toward other in vitro diagnostic testing that may provide useful COVID-19 insights, as well as non-COVID testing issues:


  • Critical Care Chemistries
  • Blood Gas Testing
  • d-Dimer
  • Cardiac Troponin
  • PCT
  • CRP
  • AKI Testing
  • Ferritin
  • HAIs
  • Other Non-COVID Testing Declines

Vaccines, Remote Patient Monitoring, and Other Impacted Markets


COVID-19’s influence is being felt across the healthcare spectrum.

The report examines the virus’ impact on the vaccines market, non-COVID testing, remote patient monitoring/telehealth and lab automation, including:


  • Select Vaccines in Development for COVID-19
  • Selected Automated Molecular Test Instrument Platforms
  • Non-COVID Testing: Magnitude of Pandemic Impact
  • Remote Patient Monitoring: Companies to Watch

Companies discussed in COVID-19 Update: Impact on Molecular Diagnostics, Serology, Critical Care Tests, Vaccines and Telehealth Markets include:


  • Abbott
  • AMD Global Telemedicine
  • American Well (Amwell)
  • Becton Dickinson (BD)
  • bioMérieux
  • Bio-Rad
  • BioTelemetry, Inc.
  • Bruker
  • CanSino Biologics
  • Cepheid
  • Doctor on Demand
  • Eko Devices
  • Fluidigm
  • GD (General Devices)
  • GlobalMed
  • Glooko
  • Inovio Pharmaceuticals
  • Masimo
  • MediOrbis
  • Medtronic
  • Meridian Bioscience
  • Moderna
  • Myriad Genetics
  • Natera
  • Qiagen
  • Quidel
  • Rheonix, Inc.
  • Roche
  • SD Biosensor
  • Seegene
  • Teladoc Health
  • Thermo Fisher Scientific
  • Thinklabs
  • Twist Bioscience
  • TytoCare

Table of Contents

CHAPTER ONE: SARS-COV-2 RECENT DEVELOPMENTS
  • BRISK FIRST QUARTER RESULTS AT MOLECULAR DIAGNOSTICS COMPANIES
  • Table 1-1: Early COVID-19 Related Financial Results at Molecular Test Companies
  • SMALLER, MID-SIZE MDX SEE DOUBLE-DIGIT BOOSTS
  • MOLECULAR LIFE SCIENCE COMPANY REVENUES DOWN
  • MOLECULAR TESTING: A LEARNING CURVE
  • Large Number of Approvals
  • TEST APPROVED BY FDA
  • Figure 1-1: Tests Authorized by FDA by Type (%; Molecular, LDT, Serology, Antigen)
  • ANTIBODY TESTING POISED TO GROW
  • Current Serology Tests
  • Creative Solutions for Lab Shortages
  • MOLECULAR DIAGNOSTIC TESTING UP, OVERALL DIAGNOSTICS TESTING TAKING A HIT IN NEW SURVEY
  • Overall US Lab Test Volume
  • Budget and New Purchases
  • Figure 1-2: Impact of Clinical Diagnostics Facilities' Non-Coronavirus Test Volume Due to COVID (n = 191)
  • Quest Reports Change in Volume
  • REOPENING PLANS
  • Taiwan Case Study
  • Advice on Reopening for the U.S. from CDC
  • SUPPLY ISSUES
  • WHEN WILL SURGERIES - AND RELATED DIAGNOSTIC TESTING - RESUME?
  • CARES ADDS $25 BILLION IN FUNDING
  • BACKGROUND
  • UPTICK IN NON-COVID-19 TEST COMPANY ANNOUNCEMENTS
  • WILL WE SEE FUNDAMENTAL CHANGE IN IVD?
  • EARLY COVID-19 IVD ESTIMATES – MODERATE CASE, BEST CASE, WORST CASE
  • Best Case IVD Market Assumptions
  • Moderate Case IVD Market Assumptions
  • Worst Case IVD Market Assumptions
  • Table 1-2: COVID-19 Tests Moderate IVD Market Case (Molecular, Antibody, US/Global)
  • Table 1-3: COVID-19 Tests Best IVD Market Case (Molecular, Antibody, US/Global)
  • Table 1-4: COVID-19 Tests Worst IVD Market Case (Molecular, Antibody, US/Global)


CHAPTER TWO: COVID-19 MOLECULAR ASSAYS
  • AUTHORIZED TEST FROM TOP-TIER IVD COMPANIES
  • Table 2-1: Molecular Tests on the Market with EUA Approval, COVID-19.
  • Roche
  • Abbott
  • bioMérieux - R -GENE
  • Bio-Rad
  • Seegene, SD Biosensor
  • Rheonix, Inc.
  • Becton Dickinson
  • Thermo Fisher Scientific
  • Qiagen QIAstat-Dx
  • MOLECULAR POINT OF CARE
  • Abbott - ID NOW
  • Cepheid - Gene Expert
  • bioMérieux - BioFire
  • ALL RT-PCR TESTS ON THE MARKET
  • Table 2-2: All RT-PCR Tests on the Market
  • THREE: COVID-19 SEROLOGY TESTS
  • MAJOR VENDORS LAUNCH ANTIBODY TESTS
  • Table 3-1: COVID-19 Antibody Tests from Major IVD Vendors
  • GOOD NEWS ABOUT NEUTRALIZING ANTIBODIES
  • Investigating Cellular Immune Responses
  • FDA ACTIONS RELATED TO SEROLOGY TESTS
  • Review Focused on Commercial Companies
  • SERUM/WHOLE BLOOD TESTS
  • Table 3-2: Serology Tests on the Market
  • FINGERSTICK TESTS
  • Table 3-3: Fingerstick Tests


CHAPTER FOUR: TESTS TO WATCH: BLOOD GAS, PCT, TROPONIN, D-DIMER, OTHERS
  • RESULTS OF SURVEY – US IMPACT ON HOSPITAL AND REFERENCE TEST VOLUME
  • Table 4-1: Tests to Watch and Expected Impact (Test Category, COVID-19, Market Impact [Positive, Negative, Neutral)
  • CRITICAL CARE CHEMISTRIES
  • Blood Gas Testing
  • D-DIMER
  • CARDIAC TROPONIN
  • PCT
  • CRP
  • AKI TESTING
  • FERRITIN
  • HOSPITAL INFECTIONS
  • Cytokine Storms and COVID-19 Weaken Patient Immune System


CHAPTER FIVE: LAB AUTOMATION AND COVID-19
  • Table 5-1: Selected Automated Molecular Test Instrument Platforms


CHAPTER SIX: NON-COVID TESTING DOWN
  • Table 6-1: Survey Respondents and Magnitude of Pandemic Impact
  • STAFFING TOPS LIST OF CONCERNS
  • RAMPING UP TESTING AS STATES REOPEN


CHAPTER SEVEN: VACCINES AND SARS-COV-2
  • Table 7-1: Select Vaccines in Development for COVID-19
  • ANALYSTS: TECHNOLOGY, NOT DEMAND CHALLENGE
  • PRODUCTION CONSIDERATION
  • 3D ATOMIC SCALE MAP COULD AID VACCINES


CHAPTER EIGHT: REMOTE PATIENT MONITORING AND THE COVID-19 CRISIS
  • COMPANIES TO WATCH
  • Abbott
  • Glooko
  • Doctor on Demand
  • eDevice
  • Masimo
  • American Well (Amwell)
  • BioTelemetry, Inc.
  • AMD Global Telemedicine
  • swyMed
  • Teladoc Health
  • Thinklabs
  • GlobalMed
  • MediOrbis
  • Medtronic
  • TytoCare
  • VSee Lab
  • OSI Systems
  • Philips - Koninklijke Philips N.V. (Royal Philips)
  • Athena GTX
  • Bright.md
  • Eko Devices
  • GD (General Devices)


APPENDIX: COVID-19 MARKET CASE TABLE DETAIL
  • MODERATE CASE ANALYSIS DETAIL
  • Table A-1: Moderate Case Analysis Detail

Samples

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Companies Mentioned

  • Abbott        
  • AMD Global Telemedicine        
  • American Well (Amwell)        
  • Becton Dickinson (BD)        
  • bioMérieux        
  • Bio-Rad        
  • BioTelemetry, Inc.        
  • Bruker        
  • CanSino Biologics        
  • Cepheid        
  • Doctor on Demand        
  • Eko Devices        
  • Fluidigm        
  • GD (General Devices)        
  • GlobalMed        
  • Glooko        
  • Inovio Pharmaceuticals        
  • Masimo        
  • MediOrbis        
  • Medtronic        
  • Meridian Bioscience        
  • Moderna        
  • Myriad Genetics        
  • Natera        
  • Qiagen        
  • Quidel        
  • Rheonix, Inc.        
  • Roche        
  • SD Biosensor        
  • Seegene        
  • Teladoc Health        
  • Thermo Fisher Scientific        
  • Thinklabs        
  • Twist Bioscience        
  • TytoCare