The World Market for Molecular Diagnostics Tests, 11th Edition
There is a market in excess of $21 billion for molecular testing technologies. For comparison purposes, this is nearly the size of the IVD market two decades ago. The majority of the market is COVID-19, but there remains a sizable market for other molecular IVD applications, from cancer to transplant typing to infectious diseases. This Kalorama Information report assess the business opportunity in each of these areas. Molecular diagnostics proved themselves during the COVID-19 pandemic, but the market in 2022 is a different place. Kalorama Information's 11th Edition report of the clinical molecular testing industry provides marketing sizing and forecasts for IVDs over a five-year period.
Overall Market
- Infectious Disease Molecular Diagnostics (COVID-19, Hepatitis, HIV, Respiratory, STI, HAIs, Others)
- Cancer Molecular Diagnostic Markets (Blood-based and Tissue-based)
- Genetic Molecular Diagnostic Markets (SNPs, Inherited, NIPT, Other)
- Blood Banking Molecular Diagnostics Markets
- Transplantation Molecular Diagnostic Markets
- Regional Molecular Diagnostics Markets (North America, Europe, Asia, Global)
This report is published as the industry experienced accelerated installed bases and new product introductions. Molecular diagnostics has always been a fast-evolving and dynamic field. Taken together, it is the fastest growing segment within the in vitro diagnostics (IVD) market. It has become an indispensable tool in clinical medicine that touches all aspects of healthcare including treatment decisions in terms of identifying antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions.
This market is heavily competitive. Companies considered include:
- Roche
- Abbott
- Thermo Fisher
- Meridian Bioscience
- Myriad
- Perkin Elmer
- Cepheid
- BioMérieux
- Promega
- QuantuMDX
- QuidelOrtho
- Hologic
- Qiagen
- ARUP
- Asuragen
- CareDX
- Vela Diagnostics
- Becton, Dickinson &Co.
- BGI
- Bio-Rad
- Leica Biosystems
- Greiner Bio-One
- Biocartis
- Credo
- Eiken
- CTK
- Leica Biosystems
- Grifols
- Illumina
- T2
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Chapter One: Executive Summary
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Size of Molecular Diagnostics Market
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Growth Areas in Molecular Diagnostics
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Recent Developments
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Emerging Trends
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Monkeypox
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Automation
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Molecular Point of Care
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Next-Generation Sequencing
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CRISPR
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Other 2022 Developments in Molecular Diagnostics
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Chapter Two: 2022 COVID-19 Molecular Diagnostic Market Analysis
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Major IVD Players See Decline in COVID-19 Sales
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North America
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Europe
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APAC
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Latin America
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Rest-of-World
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COVID Testing Market Computation Methodology
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Test Vendors
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Chapter Three: Molecular Diagnostics Market
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Brisk Recent Activity
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Recent Product Introductions and Regulatory Approvals
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Market Size and Forecast by Segments
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Infectious Diseases
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HIV Market and COVID-19 Impact
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NAT Blood Screening
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Molecular Histology and Cytology Diagnostics
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HPV
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Markets for Molecular Cancer Diagnostics
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Molecular Transplant Diagnostics
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Molecular Inherited Diseases Diagnostics
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Thrombophilia and Coagulation Markers
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Non-Invasive Prenatal Testing (NIPT)
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Inherited Disease Tests
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Molecular Diagnostics Market Deals, Collaborations, Acquisitions
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Chapter Four: Trends to Watch - Sequencing, CRISPR, Automation
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Sequencing
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NGS and Companion Diagnostics
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Outlook For NGS in Molecular Diagnostics
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Evolving Informatics Solutions in Clinical Sequencing
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Sample Preparation and Quality Control
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Lab Automation and Molecular Diagnostics
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CRISPR and Molecular Diagnostics
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Chapter Five: Company Profiles
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Abbott Diagnostics
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Company Overview
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Financial Review
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FDA approval of Alinity m STI assay
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FDA approval of ALK Break Apart FISH Probe Kit
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Alinity s System
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WHO prequalification (PQ) approval of viral load test
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Advanced Cell Diagnostics (Bio-Techne)
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Agena Bioscience
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Agendia BV
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Agilent Technologies (incl. Dako)
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Company Overview
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Financial Review
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Aidian Oy
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Altona Diagnostics
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Amoy Diagnostics
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Applied Spectral Imaging
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ARUP Laboratories
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Asuragen Inc. (Bio-Techne)
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Becton, Dickinson & Co. (BD)
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Business Segments
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Recent Acquisitions
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Recent Divestitures
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Leading Position in the Flow Cytometry Market
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Revenue and Growth
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Molecular Diagnostics Focus
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Beijing Genomics Institute (BGI)
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Berry Genomics
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binx health
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Bio-Rad Laboratories, Inc.
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Key Comment
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Recent Revenue History
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Biocartis
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Company Overview
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Financial Review
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Products and Technologies
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Biodesix
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Biomeme, Inc
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bioMérieux
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Bioneer
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AccuPower COVID-19 Real-Time RT-PCR Kit
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CareDx, Inc.
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AlloMap Tests
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Products Offered by CareDx
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Credo Bioscience
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CTK Biotech
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Danaher (Cepheid and Leica Biosystems)
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Life Sciences Business
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Diagnostics Business
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Cepheid
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Leica Biosystems
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Danaher’s 2019 Performance and 2020 Expectations
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DiaSorin
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Eiken Chemical
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Exact Sciences Corp.
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GenMark Diagnostics (Roche)
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Genotypic Technology Pvt. Ltd.
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Greiner Bio-One GmbH
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Grifols, S. A
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Molecular Immunohematology and Specialty Testing Products
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NAT Blood Screening
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Hologic, Inc.
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Illumina, Inc.
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Immucor, Inc.
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Meridian Bioscience Inc
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Molbio Diagnostics Pvt. Ltd.
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Myriad Genetics, Inc.
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Company Overview
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Financial Review
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NanoString Technologies, Inc.
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NeuroMoDX
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Oxford Nanopore Technologies Ltd
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PerkinElmer Inc.
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Promega Corporation
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Qiagen
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Company Overview
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Thermo Fisher Purchase
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QuantuMDx Group
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QuidelOrtho
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Rheonix, Inc.
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Roche Diagnostics
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Company Overview
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Financial Review
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Recent Regulatory and Product Developments
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Cobas Liat System - POC
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Acquisition of GenMark Diagnostics
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Sysmex Agreement
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Non-Exclusive 15-Year Collaboration With Illumina
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Approval for cobas EZH2 Mutation Test
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June 2020 – partnership with SpeeDX
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Stratos Genomics
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HPV
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PLUS Cytoogy
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ASPiRATION study
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Cobas Zika test for blood screening
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FDA approval of Babesia test
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Release of NAVIFY Guidelines app
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EBV and BKV Tests on the cobas 6800/8800 Systems
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Expanded use of VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC)
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FDA 510(k) clearance for cobas TV/MG test
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Seegene
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Sekisui Diagnostics LLC
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Sherlock Biosciences
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SOLVD Health (AutoGenomics)
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Standard BioTools
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T2 Biosystems
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Thermo Fisher Scientific Inc.
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Company Overview
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Transplant Diagnostics
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qPCR
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Sequencing
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Qiagen Acquisition Scrapped
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Vela Diagnostics
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Veracyte, Inc.
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Molecular Diagnostics - 22-053.pdf