The World Market for Molecular Diagnostics Tests, 11th Edition

The 11th Edition report of the clinical molecular testing industry provides marketing sizing and forecasts for in vitro diagnostics (IVDs) over a five-year period. 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 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.

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)

Molecular diagnostics proved themselves during the COVID-19 pandemic, but the market in 2022 is a different place.

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.

Companies considered in this report include:

Roche
Abbot
Thermo Fisher
Meridian Bioscience
Myriad
Perkin Elmer
Cepheid
BioMérieux
Promega
QuantuMDX
QuidelOrtho
Hologic

CHAPTER 1: EXECUTIVE SUMMARY

MOLECULAR DIAGNOSTICS IN THE SPOTLIGHT
Figure 1-1: Molecular Diagnostics Market (w COVID-19 and w/out COVID-19, 2021 ($B)
Hundreds of PCR Tests on the Market, U.S. Labs Settle on a Few
Table 1-1: Table 1-1: COVID-19 Molecular Testing Market, First Half-Year 2020, Full Year 2020, and Q 2021 ($M)
Figure 1-2: Estimated COVID-19 Molecular Diagnostic Revenue, Q1 2020-Q1 2021 COVID-19 Market
EMERGING TRENDS
Automation
Table 1-2: Market-Available Molecular POC Diagnostic Platforms Molecular Point of Care
Next-Generation Sequencing on the Rise
LDT Regulation and COVID-19
Reimbursement Environment
Thermo and Qiagen Merger
Table 1-3: Complementary diagnostic products offered by Thermo Fisher, Qiagen
CRISPR, Sequencing and COVID-19
THE GLOBAL MOLECULAR DIAGNOSTICS MARKET IN THE ERA OF COVID-19
Table 1-4: Non-COVID-19 Molecular Diagnostics Market, 2020-2026 ($M)

CHAPTER 2: COVID-19 MOLECULAR DIAGNOSTIC MARKET ANALYSIS

MAJOR IVD PLAYERS SEE BRISK COVID-19 TEST SALES
Table 2-1: COVID-19 Molecular Detection Tests from Major Suppliers
Figure 2-1: COVID-19 Molecular Diagnostics Monthly Volume
Figure 2-2: COVID-19 Molecular Diagnostics Monthly Test Volume
Table 2-2a: COVID-19 Molecular Diagnostics Revenues by Region Estimated: North America, Europe, APAC, ROW, LATAM, World, Q1 2020-Q1 2021 (in $)
Table 2-2b: COVID-19 Molecular Diagnostics Shares by Region Estimated: North America, Europe, APAC, ROW, LATAM, World, 2020-Q1 2021 (%)
Figure 2-3: COVID-19 Molecular Diagnostics Estimated Revenue by Region
Figure 2-4: COVID-19 Revenue Shares by Region
NORTH AMERICA
Table 2-3: COVID-19 Tests, North America (early June 2021)
Figure 2-5: USA - New Cases per Day
Figure 2-6: USA Daily Testing Volume
Figure 2-7: Canada - New Cases per Day
Figure 2-8: Canada Daily Testing Volume
EUROPE
Table 2-4: COVID Tests, Europe (early June 2021)
Figure 2-9: Italy - New Cases per Day
Figure 2-10: Italy Daily Testing Volume
Figure 2-11: Russia - New Cases per Day
Figure 2-12: Russia Daily Testing Volume
APAC
Table 2-5: COVID Tests APAC Region (early June 2021)
Figure 2-13: India - New Cases per Day
Figure 2-14: India Daily Testing Volume
Figure 2-15: Australia - New Cases per Day
Figure 2-16: Australia Daily Testing Volume
LATIN AMERICA
Table 2-6: Latin America COVID Testing (early June 2021)
Figure 2-17: Colombia - New Cases per day
Figure 2-18: Colombia Daily Testing Volume
Figure 2-19: Chile - New Cases per Day
Figure 2-20: Chile Daily Testing Volume
REST-OF-WORLD
Table 2-7: Rest of World Testing (early June 2021)
Figure 2-21: Turkey - New Cases per Day
Figure 2-22: Turkey Daily Testing Volume
Figure 2-23: South Africa - New Cases per Day
Figure 2-24: South Africa Daily Testing Volume
COVID TESTING MARKET COMPUTATION METHODOLOGY
TEST VENDORS
Table 2-8: Other PCR Tests Products on the Market
TESTING TRENDS, RECOMMENDATIONS, AND CONSENSUS TAKING SHAPE
CHAPTER 3: MARKETS FOR OTHER MOLECULAR DIAGNOSTIC TESTS
Table 3-1a: Molecular Diagnostic Market, 2021 and 2026 by Category ($M)
Table 3-1b: Molecular Diagnostic (non-COVID) Market, by Region 2021 ($M)
Figure 3-1: Molecular Diagnostics (non-COVID) Market by Region 2021 ($M)
RECENT PRODUCT INTRODUCTIONS AND REGULATORY APPROVALS
Table 3-2: Recent Product Introduction
Table 3-3: Recent Regulatory Approvals and Related Announcements
INFECTIOUS DISEASES
Respiratory Diseases: COVID-19 Impact
Mycobacteria/Tuberculosis: Market and COVID-19 Impact
Product Developments
Hospital-Acquired Infections (HAIs): Market and COVID-19 Impact
COVID as a hospital infection?
Vendors
Sexually Transmitted Infections: Market and COVID-19 Impact
Increased Vendor Activity in Molecular Trichomoniasis vaginalis (TV)
Hepatitis: COVID-19 Impact
New HCV Screening Guidelines
Table 3-4: Selected Molecular Hepatitis Tests
HIV Market and COVID-19 Impact
Table 3-5: Selected Molecular Test Products for HIV
NAT BLOOD SCREENING
COVID-19 Impact
Other Trends
Declining Blood Transfusions in Developed Markets
MOLECULAR HISTOLOGY AND CYTOLOGY DIAGNOSTICS
COVID-19 Impact
HPV
Eliminating HPV Threat? Lancet Public Health Study
COVID-19 Impact
Product Developments
MARKETS FOR MOLECULAR CANCER DIAGNOSTICS
Cancer Molecular Blood Markers - COVID-19 Impact
Other Trends
Liquid Biopsy
MOLECULAR TRANSPLANT DIAGNOSTICS
COVID-19
Table 3-6: Selected Innovations in the Field of Molecular Transplant Diagnostics
MOLECULAR INHERITED DISEASES DIAGNOSTICS
Inherited Diseases - COVID-19 Impact
Thrombophilia and Coagulation Markers
Non-Invasive Prenatal Testing (NIPT)
Promising NIPT Studies
Inherited Disease Tests
MOLECULAR DIAGNOSTICS MARKET DEALS, COLLABORATIONS, ACQUISITIONS
Table 3-7: Selected Deals

CHAPTER 4: TRENDS TO WATCH - SEQUENCING, CRISPR, AUTOMATION SEQUENCING

Avoiding New Waves of Infection
COVID and NGS
NGS and Inherited Disease
NGS and Companion Diagnostics
Table 4-1: Selected Clinical NGS Platforms in the Market
Outlook For NGS in Molecular Diagnostics
Figure 4-1: Percent of the MDX Market Revenues for Tests Using NGS 2020 and 2025
Evolving Informatics Solutions in Clinical Sequencing
Sample Preparation and Quality Control
LAB AUTOMATION AND MOLECULAR DIAGNOSTICS
Table 4-2: Selected Automated Molecular Test Instrument Platforms
Table 4-3: Selected FDA Declared EUA Tests
CRISPR AND MOLECULAR DIAGNOSTICS
Table 4-4: CRISPR Innovations CRISPR and COVID-19

CHAPTER 5: COMPANY PROFILES

ABBOTT DIAGNOSTICS
Company Overview
Table 5-1: Abbott Diagnostics' Recent Revenue History ($M), 2015-2020
Figure 5-1a: Abbott Diagnostics' Molecular Diagnostics Revenue History ($M), 2016- Q1 2021
Figure 5-1b: Abbott Diagnostics' Molecular Diagnostics Revenue History ($M), 2016- Q1 2021 Financial Review
COVID-19
FDA approval of ALK Break Apart FISH Probe Kit
Alinity s System
WHO prequalification (PQ) approval of viral load test
ADVANCED CELL DIAGNOSTICS (BIO-TECHNE)
Company Overview
AGENA BIOSCIENCE
Company Overview
AGENDIA BV
Company Overview
AGILENT TECHNOLOGIES (INCL. DAKO)
Company Overview
Table 5-2: Agilent Technologies' Recent Revenue History ($ millions)
Figure 5-2: Diagnostics and Genomics Revenue ($M), 2016- Q1 2021 Financial Review
AIDIAN OY
Company Overview
ALTONA DIAGNOSTICS
Company Overview
AMOY DIAGNOSTICS
Company Overview
APPLIED SPECTRAL IMAGING
Company Overview
ARUP LABORATORIES
Company Overview
Table 5-3: ARUP Labs' Recent Revenue History ($ millions)
ASURAGEN INC. (BIO-TECHNE)
Company Overview
BECTON, DICKINSON & CO. (BD)
Company Overview
Business Segments
BD Medical.
BD Life Sciences
BD Interventional
Recent Acquisitions
TVA Medical, Inc.
C. R. Bard, Inc.
CareFusion Corporation
Recent Divestitures
Advanced Bio-processing
Respiratory Solutions and Vyaire Medical
Leading Position in the Flow Cytometry Market
Revenue and Growth
Figure 5-3: BD Quarterly Revenues ($M)
Molecular Diagnostics Focus
BEIJING GENOMICS INSTITUTE (BGI)
Company Overview
Complete Genomics
Sanger Sequencing
BERRY GENOMICS
Company Overview
BINX HEALTH
Company Overview
BIO-RAD LABORATORIES, INC.
Company Overview
Recent Revenue History
Table 5-4: Bio-Rad Revenue History ($M)
BIOCARTIS
Company Overview
Financial Review
Table 5-5: Biocartis' Recent Revenue History ($ millions)
BIODESIX
Company Overview
BIOMEME, INC
Company Overview
Company Overview
Table 5-6: bioMérieux Revenue History
Figure 5-4: bioMérieux’s Molecular Biology and Microbiology Segments
Molecular
BIONEER
Company Overview
AccuPower COVID-19 Real-Time RT-PCR Kit
CAREDX, INC.
Company Overview
Figure 5-5: CareDx Recent Revenues
AlloMap Tests
AlloSure Tests
Products Offered by CareDx
CREDO BIOSCIENCE
Company Overview
CTK BIOTECH
Company Overview
DANAHER (CEPHEID AND LEICA BIOSYSTEMS)
Company Overview
Life Sciences Business
Diagnostics Business
Cepheid
Leica Biosystems
Danaher’s 2019 Performance and 2020 Expectations
Figure 5-6: Danaher Recent Revenues
DIASORIN
Company Overview
EIKEN CHEMICAL
Company Overview
EXACT SCIENCES CORP.
Company Overview
FLUIDIGM CORPORATION
Company Overview
GENMARK DIAGNOSTICS (ROCHE)
Company Overview
Figure 5-7: GenMark Recent Revenues
GENOTYPIC TECHNOLOGY PVT. LTD.
Company Overview
GREINER BIO-ONE GMBH
Company Overview
GRIFOLS, S. A
Company Overview
Molecular Immunohematology and Specialty Testing Products
NAT Blood Screening
HOLOGIC, INC.
Company Overview
Figure 5-8: Hologic Recent Revenues
Table 5-7: Hologic's Recent Revenue History ($ millions)
ILLUMINA, INC.
Company Overview
Table 5-8: Illumina's Recent Revenue History ($ millions)
Figure 5-8: Illumina Recent Revenues
Table 5-9: Illumina’s Technology Platforms and Targeted Applications
IMMUCOR, INC.
Company Overview
Transfusion Diagnostics
MERIDIAN BIOSCIENCE INC
Company Overview
Figure 5-8: Meridian Recent Revenues
MESA BIOTECH, INC. (THERMO)
Company Overview
MOLBIO DIAGNOSTICS PVT. LTD.
Company Overview
MYRIAD GENETICS, INC.
Company Overview
Financial Review
Table 5-10: Myriad Genetics' Recent Revenue History ($ millions)
NANOSTRING TECHNOLOGIES, INC.
Company Overview
NEUROMODX
Company Overview
OXFORD NANOPORE TECHNOLOGIES LTD
Company Overview
PERKINELMER INC.
Company Overview
PRESCIENT MEDICINE HOLDINGS (AUTOGENOMICS)
Company Overview
PROMEGA CORPORATION
Company Overview
QIAGEN
Company Overview
Thermo Fisher Purchase
Table 5-11: Complementary diagnostic products offered by Thermo Fisher, Qiagen
Table 5-12: QIAGEN's Recent Revenue History ($ millions)
QUANTUMDX GROUP.
Company Overview
QUIDEL CORPORATION
Company Overview
RHEONIX, INC.
Company Overview
Products
ROCHE DIAGNOSTICS
Company Overview
COVID-19 Early Actions
Financial Review
Figure 5-8: Roche Recent Revenue
Table 5-13: Roche Diagnostics' Recent Revenue History ($M)
Recent Regulatory and Product Developments
Cobas Liat System - POC
Acquisition of GenMark Diagnostics
Sysmex Agreement
Non-Exclusive 15-Year Collaboration With Illumina
Approval for cobas EZH2 Mutation Test
June 2020 - partnership with SpeeDX
Stratos Genomics
HPV
PLUS Cytoogy
ASPiRATION study
Cobas Zika test for blood screening
FDA approval of Babesia test
Release of NAVIFY Guidelines app
EBV and BKV Tests on the cobas 6800/8800 Systems
Expanded use of VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC)
FDA 510(k) clearance for cobas TV/MG test
SEEGENE
Company Overview
SEKISUI DIAGNOSTICS LLC
Company Overview
SHERLOCK BIOSCIENCES
Company Overview
T2 BIOSYSTEMS
Company Overview
THERMO FISHER SCIENTIFIC INC.
Company Overview
Table 5-14: Thermo Fisher's Recent Revenue History ($ millions)
Transplant Diagnostics
qPCR
Sequencing
Qiagen Acquisition Scrapped
VELA DIAGNOSTICS
Company Overview
VERACYTE, INC.
Company Overview

Companies Mentioned

ARUP
Abbott
Asuragen
BGI
Becton, Dickinson &Co.
Bio-Rad
BioMérieux
Biocartis
CTK
CareDX
Cepheid
Credo
Eiken
Greiner Bio-One
Grifols
Hologic
Illumina
Leica Biosystems
Leica Biosystems
Meridian Bioscience
Myriad
Perkin Elmer
Promega
Qiagen
QuantuMDX
QuidelOrtho
Roche
T2
Thermo Fisher
Vela Diagnostics

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Companies considered in this report include:

Table of Contents

Companies Mentioned

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