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

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SKU: 20-033 Categories: Diagnostics Market Research, Molecular & Nucleic Acid Testing Pages: 300
  • Description
  • Table of Contents
  • Latest reports

Description

Molecular Diagnostics could be said to be the most important part of in vitro diagnostics.  This is especially true in the wake of COVID-19.  Kalorama Information has, for many years, estimated the size of and forecasted the growth of the worldwide market for these important in vitro diagnostic tests 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 DNA-based testing in an unexpected way.

 

The Size of the Molecular Diagnostic Test Market

As it was MDx segment has been fastest growing segment within the global IVD market. The global market was estimated to be $8,760 million in 2019. Including  COVID-19 tests, Kalorama Information now projects that market to be $13.4 billion dollars. A multi-year forecast including COVID-19 cannot be made with accuracy given the unknowns of the virus threat, outside of COVID-19, other  test segments are expected to grow to 9,025 in 2025. Major segments that are expected to drive the growth are infectious diseases, cancer, and transplant diagnostics. A detailed analysis of each of these application segments is presented in the respective segment.

Infectious Disease Assays Drive Growth

Infectious disease testing segments are driven by the COVID-19 crisis (not only detection tests but related rule-out respiratory tests and HAIs). The demand will come from advanced markets such as North America and Europe, while blood screening, histology and inherited diseases testing are driven by additions to blood test protocols and emerging markets.

COVID-19 Impact

Kalorama estimates a 4.4 billion dollar market for COVID-19 testing by year’s end. Unique near-patient tests, sample collection methods such as saliva or self-test, NGS and mass spectrometry testing, multiple PCR test targets, improved antibody tests, high throughputs, extraction kit workarounds – these are all examples of areas that innovators can improve. The worldwide demand for COVID tests has materialized rapidly from zero and is on course to become a multi-billion dollar market in 2020.

Will this market continue into future years? Assuming, as estimated in our analysis, cancer tests are able to be completed in a surge of ‘make-up’ healthcare visits and procedures later in the year and into 2021 it presages a strong momentum for growth. It’s worthwhile noting that DNA-based testing technologies already represent nearly a 10 billion-dollar market without COVID-19. While it’s possible COVID-19 tests will be panelized and added to larger menus and may not have the emergency system sales of 2020, its influence should last in other ways. It already has boosted the respiratory and healthcare infection testing market segments.

For More Information: Kalorama Information’s Latest Market Research Study

For more information, Kalorama Information’s report on the worldwide  MDx market, Molecular Diagnostics Markets in the COVID-19 Era is available:

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? Kalorama Information’s 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.

Kalorama covers the global markets. For All Markets, Kalorama Information 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

Kalorama Information 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, Kalorama has been tracking lab volumes with a survey since mid-April, and Kalorama’s 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

Table of Contents

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
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