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COVID-19の影響:分子診断・血清学的検査・救急医療検査・ワクチン・遠隔医療

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

出版日: | 発行: Kalorama Information | ページ情報: 英文 125 Pages | 納期: 即日から翌営業日

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COVID-19の影響:分子診断・血清学的検査・救急医療検査・ワクチン・遠隔医療
出版日: 2020年05月14日
発行: Kalorama Information
ページ情報: 英文 125 Pages
納期: 即日から翌営業日
担当者のコメント
体外診断におけるグローバル市場、参入企業分析の動向調査において定評のある、米国のKalorama Information社より、COVID-19 診断に着目した分析レポートが新たにリリースされました。5月中旬時点におけるDiagnosticsメーカー様の取り組みをPCRなど技術タイプ別にまとめております。
  • 全表示
  • 概要
  • 目次
概要

新型コロナウイルス感染症(COVID-19)は米国および世界に甚大な影響を及ぼし、何十万人もの死者と莫大な経済コストをもたらしています。

当レポートでは、新型コロナウイルス感染症(COVID-19)の分子診断、血清学的検査、救命関連検査、ワクチン、遠隔医療の市場への影響を調査し、SARS-COV-2およびCOVID-19の最新動向、FDAによる承認の動向、上市済み製品と開発の動向、主要企業の業績、各種取り組みなどをまとめています。

第1章 SARS-COV-2:最新の動向

  • 分子診断企業による第1四半期の成果
  • 中小規模のMDX:2桁成長
  • 分子生命科学企業の収益は減少
  • 分子検査:学習曲線
  • FDAに承認された検査
  • 抗体検査が成長の見通し
  • 分子診断検査および全体的な診断検査件数の増加:新たな調査で判明
  • 再開計画
  • 供給の問題
  • 手術・関連診断検査の再開
  • CARES:250億米ドルの資金を追加
  • 背景
  • COVID-19以外の検査企業による発表の増加
  • IVDの根本的変化の見通し
  • COVID-19 IVDの初期推計:モデレートケース・ベストケース・ワーストケース

第2章 COVID-19分子アッセイ

  • トップティアIVD企業の承認済み検査
  • Roche
  • Abbott
  • bioMerieux-R -GENE
  • Bio-Rad
  • Seegene、SD Biosensor
  • Rheonix、Inc.
  • Becton Dickinson
  • Thermo Fisher Scientific
  • Qiagen QIAstat-Dx
  • 分子POC
  • 市場のすべてのRT-PCR検査

第3章 COVID-19血清学的検査

  • 主要ベンダーによる抗体検査
  • 中和抗体に関する良いニュース
  • 血清学的検査に関連するFDAの対応
  • 血清/全血検査
  • フィンガースティック検査

第4章 注目の検査:血液ガス・PCT・トロポニン・Dダイマー・その他

  • 調査結果:病院およびリファレンス検査件数に対する影響
  • 救命医療化学
  • Dダイマー
  • 心臓トロポニン
  • PCT
  • CRP
  • AKI検査
  • フェリチン
  • 院内感染

第5章 ラボの自動化とCOVID-19

第6章 非COVID検査の減少

第7章 ワクチンとSARS-COV-2

  • アナリストの見解:技術の重要性
  • 製造に関する考察
  • 3次元原子スケールマップによるワクチン支援

第8章 遠隔患者モニタリングとCOVID-19クライシス

  • 注目の企業
    • 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 NV(Royal Philips)
    • Athena GTX
    • Bright.md
    • Eko Devices
    • GD(General Devices)

付録

目次
Product Code: 20-056

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. Kalorama Information 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. ‘Kalorama COVID-19 Update’ provides trending developments, company announcements and analysis from the Kalorama 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, Kalorama Information normally consults detailed financial information from major in vitro diagnostics firms to obtain accurate results. In the throes of this crisis such data is lacking. However, using the many statements that have been issued plus knowledge gleaned from our databases on flu and other molecular testing, Kalorama 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 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
  • Kalorama 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 me 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. ‘Kalorama 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 Kalorama 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 ‘Kalorama 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

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-19 (n = 191)
    • Quest Reports Change in Volume
  • REOPENING PLANS
    • Taiwan Case Study
    • Advice on Reopening for 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)

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

FOUR: TESTS TO WATCH: BLOOD GAS, PCT, TROPONIN, D-DIMER, OTHERS

  • RESULTS OF KALORAMA 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

FIVE: LAB AUTOMATION AND COVID-19

  • Table 5-1: Selected Automated Molecular Test Instrument Platforms

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

SEVEN: VACCINES AND SARS-COV-2

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

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
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