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Molecular Diagnostics Markets in the COVID-19 Era (Markets for Molecular COVID-19 IVD Tests, Respiratory Tests, Blood Screening, Cancer Markers and Other IVD Tests)

  • ID: 5129036
  • Report
  • July 2020
  • Region: Global
  • Kalorama Information

FEATURED COMPANIES

  • Abbott Diagnostics
  • Becton, Dickinson & Co.
  • Coyote Bioscience
  • GenMark
  • MobiDiag
  • Qiagen
  • MORE

Now more than ever, molecular diagnostics are the most important part of in vitro diagnostics.  The analyst has, for many years, estimated the size of and forecasted the growth of the worldwide market for molecular diagnostics in all major segments, and does so in this edition as a pandemic has reached developed markets including the United States.

2020 was set to be a year of growth and innovations in molecular diagnostics under any circumstances. New products, higher growth than other in vitro diagnostic categories, continued acceptance of next-generation sequencing methods were driving. Liquid biopsy technologies and the increased use of predictive genetic tests were and still are areas of anticipated revenue growth. The sudden onset of SARS-CoV-2 and the resulting disease COVID-19 put the world’s focus on molecular diagnostics in an unexpected way.

This will not be universally the case. In non-COVID-19 testing areas, such as cancer and inherited diseases, molecular diagnostics vendors need to continue to persuade.   Here volumes may be reduced by social distancing measures.  But they are expected to continue to make progress converting laboratory customers. New technologies such as molecular near-patient and next-generation sequencing are increasingly part of the mix.  The report details these trends.

This report provides 2020 market sizing and expected growth to 2025 for the following segments:

  • COVID-19 Molecular IVD Test Market (Full Year 2020 Projected and Market 2H 2020)
    • COVID-19 Molecular IVD Test Market North America
    • COVID-19 Molecular IVD Test Market Europe
    • COVID-19 Molecular IVD Test Market Asia Pacific
    • COVID-19 Molecular IVD Test Market Rest of World
  • Infectious Disease Markets, including:
    • Hepatitis
    • HIV
    • Respiratory
    • HAIs and Sepsis Tests
    • TB
    • Sexually Transmitted Diseases
  • NAT Blood Testing
  • Molecular Histology
  • Molecular Cancer Testing
  • Molecular Transplantation Testing
  • Inherited Disease Testing
    • NIPT
    • Inherited
    • Thrombophilia
    • Pharmacogenomics

There has also been a huge influx of product introductions from small, obscure companies. These have mostly targeted the low end of the price range and often had poor performance, while a small number of high-end automated systems are mostly limited to certain segments of the market, such as independent reference laboratories and centralized hospital laboratories. Low-quality products from fly-by-night companies are the predictable result of the shortages and the relatively basic resources needed to produce mediocre antibody test kits with a low level of quality control. A few major companies are seeing the most test runs, particularly in the United States.

COVID-19 testing has also been a bit of a double-edged sword for labs generally, for in vitro diagnostics and for molecular tests. Boosting volumes in infectious disease have been notably paired with drops due to social distancing measures and hospital surgical postponements. What is the result? The report helps to sort out the array of news and reports about the current state of molecular diagnostics, reasonable global estimates for COVID, and the impact of COVID-19 on the rest of molecular testing.

The report covers the global markets. For All Markets, the analyst provides the following:

  • Impacts of COVID-19 on Market Segments
  • Regional Market Distribution
  • Profiles of Top Companies
  • Major Companies with COVID-19 Tests
  • Other Companies with COVID-19 Tests
  • HIV Products on the Market
  • Transplantation Products on the Market
  • The Increasing Role of Next-Generation Sequencing
  • Trends - Lab Automation and Molecular Diagnostics
  • Trends - CRISPR
  • Trends - Artificial Intelligence
  • Company Profiles

The analyst has monitored 2020 secondary sources, trade publications, medical journals, government websites and policy documents, as well as financial statements from vendors to assess the market impact of COVID-19. In addition, the analyst has been tracking lab volumes with a survey since mid-April, and the analyst U.S. MasterFile product was used to keep track of instrument trends.

Companies Profiled in the Report Include

  • Abbott Diagnostics
  • Agena Bioscience
  • Agendia BV
  • ARUP Laboratories
  • Asuragen
  • Advanced Cell Diagnostics
  • Agilent
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co.
  • Biocartis
  • BGI
  • Berry Genomics
  • BioMerieux
  • Bio-Rad
  • Care DX
  • Danaher
    • Cepheid
    • Beckman Coulter
    • Leica Biosystems
  • Eiken Chemical
  • Fluidigm
  • GenMark
  • Genotypic Technology PVT
  • Greiner Bio-One GMBH
  • Grifols
  • Hologic
  • Illumina
  • Immucor
  • Meridian
  • Molbio
  • Myriad Genetics
  • Nanostring
  • Neogenomics
  • NeuromoDX
  • Perkin Elmer
  • Oxford Nanopore
  • Promega
  • Prescient Medicine
  • Qiagen
  • Quidel
  • Roche
  • Thermo
  • Vela
  • Veracyte
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Abbott Diagnostics
  • Becton, Dickinson & Co.
  • Coyote Bioscience
  • GenMark
  • MobiDiag
  • Qiagen
  • MORE

Chapter One: Executive Summary

  • COVID-19 Testing
  • Hundreds of Tests on The Market, U.S. Labs Settle on a Few
  • Emerging Trends Influencing the Market Landscape
  • Reimbursement Environment
  • Regulatory Status of Laboratory Developed Tests (LDTs)
  • The Global Molecular Diagnostics Market in the Era of COVID-19
  • Table 1-1: Global Markets for Molecular Diagnostics by Application Segments (2019-2024) ($, Million)
  • Next-Generation Sequencing on the Rise
  • Molecular Diagnostics Markets

Chapter Two: COVID-19

  • Hundreds of Tests on The Market, U.S. Labs Settle on a Few
  • Table 2-1: COVD-19 Molecular Detection Tests from Major Suppliers
  • Regional Variance in Cases and Testing
  • Other COVID-19 RT-PCR Tests
  • Table 2-2: Other PCR Tests Products on the Market
  • Testing trends, recommendations, consensus taking shape

Chapter Three: Sequencing, CRISPR, Automation, and Other Trends

  • Sequencing
  • COVID and NGS
  • Inherited Disease
  • Companion Diagnostics
  • Table 3-1: Selected Clinical NGS Platforms in the Market
  • Outlook For NGS
  • Evolving Informatics Solutions in Clinical Sequencing
  • Sample Preparation and Quality Control
  • Lab Automation and Molecular Diagnostics
  • Table 3-2: Selected Automated Molecular Test Instrument Platforms
  • Table 3-3: Selected FDA Declared EUA Tests
  • CRISPR and Molecular Diagnostics
  • CRISPR and COVID-19
  • Table 3-4: CRISPR Innovations
  • Microbiome and Molecular Diagnostics
  • Artificial Intelligence

Chapter Four: Markets for Molecular Infectious Disease Diagnostics

  • Global Market Overview
  • Table 4-1: Global Molecular Infectious Disease Diagnostics Markets (2019-2024), By Infection ($, Million)
  • Repiratory Diseases
  • COVID-19 Impact
  • Mycobacteria/Tuberculosis
  • COVID-19 Impact
  • Product Developments
  • Table 4-2: Global Molecular Mycobacteria/TB Testing Markets (2019-2024) ($, Million)
  • Hospital-Acquired Infections (HAIs)
  • COVID-19 Impact
  • COVID as a hospital infection?
  • Product Developments
  • Size and Growth of the Market
  • Table 4-3: Global Molecular HAIs/Sepsis Testing Markets,  (2019-2024)
  • Sexualty Transmitted Infections: CT/NG, Others
  • COVID-19 Impact
  • Table 4-4: Global Molecular STI Testing Markets (2019-2024) ($, Million)
  • HPV
  • Eliminating HPV Threat: Lancet Public Health Study
  • COVID-19 Impact
  • HPV Vaccine and Market Effects
  • Product Developments
  • Size and Growth of Market
  • Table 4-5: Global Molecular HPV Testing Markets  (2019-2024) ($, Million)
  • Hepatitis
  • Hepatitis Types
  • New HCV Screening Guidelines
  • COVID-19 Impact
  • Product Developments
  • Table 4-6: Selected Molecular Hepatitis Tests
  • Tranisition to Molecular POC
  • Size and Growth of the Market
  • Table 4-7: Global Molecular Hepatitis Testing Markets (2019-2024) ($, Million)
  • HIV
  • New Guidelines
  • COVID-19 Impact
  • Product Developments
  • Table 4-8: Selected Molecular Test Products for HIV
  • Size and Growth of the Market
  • Table 4-9: Global Molecular HIV Testing Markets (2019-2024)

Chapter Five: Markets for Molecular Blood Screening Diagnostics

  • COVID-19 Impact
  • Other Trends
  • Declining Blood Transfusions in Developed Markets
  • Growing Demand in Developing Nations
  • New Infectious Disease Threats and Assay Introductions
  • Nucleic Acid Testing Markets for Blood Screening
  • Size and Growth of the Market
  • Table 5-1: Global Molecular Blood Screening Diagnostics Markets (2019-2024)

Chapter Six: Markets for Molecular Histology and Cytology Diagnostics

  • In Situ Hybridization (ISH)
  • Table 6-1: Examples of Commercially Available ISH Companion Diagnostics
  • Histology Automation
  • Prenatal Testing Moving from FISH to NIPT
  • Size and Growth of the Market
  • Table 6-2: Global Molecular Histology and Cytology Diagnostics Markets by Application (2019-2024) ($, Million)
  • Table 6-3: Global Molecular Histology Diagnostics Markets (2019-2024)($, Million)

Chapter Seven: Markets for Molecular Cancer Diagnostics

  • COVID-19 Impact
  • Other Trends
  • Predictive Biomarker Tests for Identifying Drug-Gene Match
  • Liquid Biopsy
  • Table 7-3: Companies Offering Liquid Biopsy-based Molecular Cancer Assays
  • Relevant DNA/RNA Variants
  • Table 7-4: Human Genome and Cancer Gene Identification
  • Lung Cancer Study Provides Justification for MDx
  • Cancer Rates
  • Product Developments
  • Size and Growth of the Market
  • Table 7-6: Global Molecular Cancer Diagnostics Markets (2019-2024) ($, Million)
  • U.S. Reimbursement Structure
  • Cancer Molecular Diagnostics Markets, Europe
  • Reimbursement Structure, Challenges and Recent Activity
  • Cancer Molecular Diagnostics Markets, APAC
  • Japan
  • China
  • Table 7-7: Recent Partnerships Established between Illumina and Diagnostics Companies in China
  • Table 7-8: China – Top 10 Cancer Incidences, 2018
  • Figure 7-1: China – Leading Cancer Incidence Distribution, 2018 (%)
  • Reimbursement Environment in India
  • ASEAN

Chapter Eight: Markets for Molecular Transplant Diagnostics

  • COVID-19 Impact
  • Other Trends
  • Role of NGS Increasing
  • Competitive Situation in Transplantation Diagnostics
  • Immucor
  • Qiagen
  • CareDX
  • ThermoFisher
  • GeneDX
  • Omixon
  • Biofortuna
  • Table 8-1: Selected Innovations in the Field of Molecular Transplant Diagnostics
  • Size and Growth of the Molecular Transplant Diagnostics Market
  • Table 8-2: Global Molecular Transplant Diagnostics Markets (2019-2024) ($, Million)

Chapter Nine: Markets for Molecular Inherited Diseases Diagnostics

  • COVID-19 Impact
  • Trends in the Market
  • Pilot Program “Baby Bear” in the United States
  • China
  • India
  • Thrombophilia and Coagulation Markers
  • Non-Invasive Prenatal Testing (NIPT)
  • Product Developments
  • Promising NIPT Studies
  • Other Tests
  • Autism
  • Seizures
  • Alzheimer’s Disease
  • Cardiovascular Disease
  • Psychiatric Disorders
  • Size and Growth of the Market
  • Table 9-1: Global Molecular Inherited Diseases Diagnostics Markets, By Disease Segments (2019-2024) ($, Million)
  • Table 9-2: Global Molecular Inherited Diseases Diagnostics Markets (2019-2024) ($, Million)

Chapter Ten: Company Profiles

  • Abbott Diagnostics
  • Company Overview
  • Financial Review
  • Table 10-1: Abbott Diagnostics’ Recent Revenue History ($ millions)
  • Agena Bioscience
  • Agendia BV
  • ARUP Laboratories
  • Table 10-2: ARUP Labs’ Recent Revenue History ($ millions)
  • Asuragen Inc.
  • Advanced Cell Diagnostics (Biotechne)
  • Agilent Technologies Inc./Dako
  • Company Overview
  • Financial Review
  • Table 10-3: Agilent Technologies’ Recent Revenue History ($ millions)
  • Amoy Diagnostics
  • Applied Spectral Imaging
  • Becton, Dickinson & Co. (BD)
  • Business Segments
  • Recent Acquisitions
  • Recent Divestitures
  • Leading Position in the Flow Cytometry Market
  • Revenue and Growth
  • Molecular Diagnostics Focus
  • Biocartis
  • Company Overview
  • Financial Review
  • Table 10-4: Biocartis’ Recent Revenue History ($ millions)
  • Biodesix
  • Beijing Genomics Institute (BGI)
  • Complete Genomics
  • Sanger Sequencing
  • Berry Genomics
  • bioMérieux
  • Molecular
  • Sequencing
  • Bio-Rad Laboratories, Inc.
  • Key Comment
  • Recent Revenue History
  • CareDx, Inc.
  • Testing Services Offered by CareDx
  • Products Offered by CareDx
  • Danaher (Cepheid and Leica Biosystems)
  • Life Sciences Business
  • Diagnostics Business
  • Cepheid
  • Leica Biosystems
  • Danaher’s 2018 Performance and 2019 Expectations
  • Acquisitions and Divestments in 2018 / 2019
  • Eiken Chemical
  • Fluidigm Corporation
  • GenMark Diagnostics
  • Genotypic Technology Pvt. Ltd.
  • Greiner Bio-One GmbH
  • Greiner Bio-One GmbH
  • Grifols, S. A
  • Molecular Immunohematology and Specialty Testing Products
  • NAT Blood Screening
  • Hologic, Inc.
  • Table 10-5: Hologic’s Recent Revenue History ($ millions)
  • Illumina, Inc.
  • Company Overview
  • Table 10-6: Illumina’s Recent Revenue History ($ millions)
  • Table 10-7: Illumina’s Technology Platforms and Targeted Applications
  • Immucor, Inc.
  • Transfusion Diagnostics
  • Meridian Bioscience Inc
  • Molbio Diagnostics Pvt. Ltd.
  • Myriad Genetics, Inc.
  • Company Overview
  • Financial Review
  • Table 10-8: Myriad Genetics’ Recent Revenue History ($ millions)
  • NanoString Technologies, Inc.
  • NeoGenomics
  • Company Overview
  • Financial Review
  • Table 10-9: NeoGenomics Recent Revenue History ($ millions)
  • Product Overview: Companion Dx
  • NeuroMoDX
  • PerkinElmer Inc.
  • Oxford Nanopore Technologies Ltd
  • Promega Coproration
  • Prescient Medicine Holdings (AutoGenomics)
  • QIAGEN N.V.
  • Company Overview
  • Financial Review
  • Table 10-10: QIAGEN’s Recent Revenue History ($ millions)
  • Product Overview: Companion Dx
  • Quidel Corporation
  • Roche Diagnostics
  • Company Overview
  • Financial Review
  • Table 10-11: Roche Diagnostics’ Recent Revenue History ($ millions)
  • Cobas Liat System – POC
  • Blood Bank
  • Transplant Medicine
  • Cancer Companion Testing
  • Prenatal
  • Liquid Biopsy
  • Partnering with Information Technology
  • Product Launches in 2018
  • Thermo Fisher Scientific Inc.
  • Company Overview
  • Table 10-12: Thermo Fisher’s Recent Revenue History ($ millions)
  • Transplant Diagnostics
  • qPCR
  • Transplant Diagnostics
  • qPCR
  • Sequencing
  • Vela Diagnostics
  • Veracyte, Inc.
  • Other Companies Mentioned in the Report
  • 3B BlackBio Biotech India Ltd
  • altona Diagnostics GmbH
  • Amoy Dx
  • Anitoa
  • AnyGenes
  • Applied DNA Sci
  • BGI Genomics Co. Ltd
  • BioCore Co., Ltd.
  • BioGX
  • Biomeme
  • bioMérieux
  • Bioneer
  • Bioperfectus Technologies Co. Ltd
  • Bruker
  • Chroma Code
  • Coyote Bioscience
  • Credo Dx BioMed
  • CTK Biotech
  • DiaCarta, Inc.
  • Diagnostics for the Real World Ltd,
  • Dian Biotechnology Co., Ltd
  • DiaSorin Molecular LLC
  • DNA XPERTS
  • EasyDiagnosis Biomedicine Co., Ltd,
  • Enzo Biochem
  • Eurobio
  • Euroimmun US Inc.
  • Gencurix, Inc.
  • GeneMatrix, Inc.
  • Genesystems (Pall sub)
  • Genetic PCR Signatures Limited,
  • Genomictree, Inc.,
  • GenScript,
  • gerbion GmbH & Co.,
  • Gnomegen LLC
  • Haitai Biological Pharmaceutical Co., LTD,
  • Maccura Biotechnology
  • Medical & Biological Laboratories Co., Ltd
  • Meridian Biosciences
  • Mesa Biotech Inc.
  • MobiDiag
  • Molbio Dx
  • Osang Healthcare
  • PlexBio Co., Ltd.
  • PreciGenome LLC
  • Primerdesign Ltd
  • Primerdesign Ltd.
  • Promis
  • QuantuMDx
  • Rheonix
  • Rheonix, Inc.
  • Roche Molecular Systems, Inc. (RMS)
  • Sansure Biotech, Inc.,
  • Seasun
  • Seegene
  • Seegene, Inc.
  • Shahai GeneoDx Biotechnology Co., Ltd
  • SolGent Co., Ltd
  • Thermo Fisher Scientific, Inc.
  • Veredus Labs
  • Vircell, S.L.
  • Vircell, S.L.,
  • Wuxi Shenrui Bio-pharmaceuticals Co. Ltd
  • Zymo Research
Note: Product cover images may vary from those shown

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  • 3B BlackBio Biotech India Ltd
  • ARUP Laboratories
  • Abbott Diagnostics
  • Advanced Cell Diagnostics
  • Agena Bioscience
  • Agendia BV
  • Agilent
  • altona Diagnostics GmbH
  • Amoy Diagnostics
  • Amoy Dx
  • Anitoa
  • AnyGenes
  • Applied DNA Sci
  • Applied Spectral Imaging
  • Asuragen
  • BGI
  • BGI Genomics Co. Ltd
  • Beckman Coulter
  • Becton, Dickinson & Co.
  • Berry Genomics
  • Bio-Rad
  • BioCore Co., Ltd.
  • BioGX
  • BioMerieux
  • Biocartis
  • Biomeme
  • Bioneer
  • Bioperfectus Technologies Co. Ltd
  • Bruker
  • CTK Biotech
  • Care DX
  • Cepheid
  • Chroma Code
  • Coyote Bioscience
  • Credo Dx BioMed
  • DNA XPERTS
  • Danaher
  • DiaCarta, Inc.
  • DiaSorin Molecular LLC
  • Diagnostics for the Real World Ltd
  • Dian Biotechnology Co., Ltd
  • EasyDiagnosis Biomedicine Co., Ltd
  • Eiken Chemical
  • Enzo Biochem
  • Eurobio
  • Euroimmun US Inc.
  • Fluidigm
  • GenMark
  • GenScript,
  • Gencurix, Inc.
  • GeneMatrix, Inc.
  • Genesystems (Pall sub)
  • Genetic PCR Signatures Limited
  • Genomictree, Inc.,
  • Genotypic Technology PVT
  • gerbion GmbH & Co.,
  • Gnomegen LLC
  • Greiner Bio-One GMBH
  • Grifols
  • Haitai Biological Pharmaceutical Co., LTD
  • Hologic
  • Illumina
  • Immucor
  • Leica Biosystems
  • Maccura Biotechnology
  • Medical & Biological Laboratories Co., Ltd
  • Meridian Biosciences
  • Mesa Biotech Inc.
  • MobiDiag
  • Molbio Dx
  • Myriad Genetics
  • Nanostring
  • Neogenomics
  • NeuromoDX
  • Osang Healthcare
  • Oxford Nanopore
  • Perkin Elmer
  • PlexBio Co., Ltd.
  • PreciGenome LLC
  • Prescient Medicine
  • Primerdesign Ltd.
  • Promega
  • Promis
  • Qiagen
  • QuantuMDx
  • Quidel
  • Rheonix
  • Rheonix, Inc.
  • Roche
  • Roche Molecular Systems, Inc. (RMS)
  • Sansure Biotech, Inc.,
  • Seasun
  • Seegene
  • Seegene, Inc.
  • Shahai GeneoDx Biotechnology Co., Ltd
  • SolGent Co., Ltd
  • Thermo
  • Thermo Fisher Scientific, Inc.
  • Vela
  • Veracyte
  • Veredus Labs
  • Vircell, S.L.,
  • Wuxi Shenrui Bio-pharmaceuticals Co. Ltd
  • Zymo Research
Note: Product cover images may vary from those shown
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