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市場調查報告書

COVID-19的影響:分子診斷、血清學的檢驗、急救醫療檢驗、疫苗、遠程醫療

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

出版商 Kalorama Information 商品編碼 936346
出版日期 內容資訊 英文 125 Pages
商品交期: 最快1-2個工作天內
價格
COVID-19的影響:分子診斷、血清學的檢驗、急救醫療檢驗、疫苗、遠程醫療 Kalorama COVID-19 Update: Impact on Molecular Diagnostics, Serology, Critical Care Tests, Vaccines and Telehealth Markets
出版日期: 2020年05月14日內容資訊: 英文 125 Pages
簡介

新型冠狀病毒感染疾病(COVID-19)給美國及世界帶來甚大的影響,造成幾十萬名死亡的莫大經濟成本。

本報告提供新型冠狀病毒感染疾病(COVID-19)的分子診斷調查,血清學的檢驗,救命相關檢驗,疫苗,遠程醫療對市場的影響,SARS-COV-2及COVID-19最新趨勢,FDA的核准趨勢,已上市產品與開發趨勢,主要企業的業績,各種配合措施等資料彙整。

第1章 SARS-COV-2:最新趨勢

  • 分子診斷企業的第一季的成果
  • 中小規模的MDX:2位數成長
  • 分子生命科學企業的收益減少
  • 分子檢驗:學習曲線
  • FDA已批准檢驗
  • 抗體檢驗成長預測
  • 分子診斷檢驗及整體診斷檢查數量的增加:新調查中發現
  • 再開始計劃
  • 供給的問題
  • 手術、相關診斷檢驗的再開始
  • CARES:追加250億美元的資金
  • 背景
  • COVID-19以外的檢驗企業的發表增加
  • IVD的根本性變化預測
  • COVID-19 IVD的初期估計:中等案例、最佳案例、最壞案例

第2章 COVID-19分子化驗

  • 最高等級IVD企業的已通過核准檢驗
  • Roche
  • Abbott
  • bioMerieux-R -GENE
  • Bio-Rad
  • Seegene,SD Biosensor
  • Rheonix,Inc.
  • Becton Dickinson
  • Thermo Fisher Scientific
  • Qiagen QIAstat-Dx
  • 分子POC
  • 市場全部的RT-PCR檢驗

第3章 COVID-19血清學的檢驗

  • 主要供應商的抗體檢驗
  • 中和抗體相關的好新聞
  • FDA與血清學的檢驗相關措施
  • 血清/全血檢驗
  • 指棒檢驗

第4章 關注的檢驗:血氣、PCT、肌鈣蛋白、D-二聚體、其他

  • 調查結果:醫院及 索引檢查數量的影響
  • 緊急醫療化學
  • D-二聚體
  • 心臟肌鈣蛋白
  • PCT
  • CRP
  • AKI檢驗
  • 含鐵蛋白
  • 院內感染

第5章 實驗室的自動化和COVID-19

第6章 非COVID檢驗的減少

第7章 疫苗和SARS-COV-2

  • 分析師的見解:技術的重要性
  • 製造相關考察
  • 3D原子比例圖的疫苗支援

第8章 遠端患者監護和COVID-19危機

  • 關注的企業
    • 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)

附錄

目錄
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