The World Market for Molecular Diagnostics Tests, 11th Edition

Table of Contents

Chapter One: Executive Summary

Size of Molecular Diagnostics Market

• Figure 1-1: Molecular Diagnostics Market (w COVID-19 and w/out COVID-19, $B)

Growth Areas in Molecular Diagnostics

• Figure 1-2: Non-COVID-19 Growth Applications by Revenue Growth %
• Figure 1-3: COVID-19 Molecular Testing Market, 2020- Q2 2022 ($M)

Recent Developments

Emerging Trends

Monkeypox

Automation

Molecular Point of Care

• Table 1-1: Market-Available Molecular POC Diagnostic Platforms

Next-Generation Sequencing

CRISPR

Other 2022 Developments in Molecular Diagnostics

Chapter Two: 2022 COVID-19 Molecular Diagnostic Market Analysis

Major IVD Players See Decline in COVID-19 Sales

• Table 2-1: Selected COVID-19 Molecular Tests from Major Suppliers
• Figure 2-1: Estimated COVID-19 Molecular Diagnostics Global Monthly Volume (# tests)
• Figure 2-2: Estimated Monthly COVID-19 Molecular Diagnostic Test Volume, 2020- Q2 ’22 by Region ($M)
• Table 2-2: COVID-19 Molecular Diagnostic Revenues by Region Estimated: North America, Europe, APAC, ROW, LATAM (#M)
• Figure 2-3: COVID-19 Molecular Diagnostic Estimated Quarterly Rev. 2020- Q2’22 by Region
• Figure 2-4: Estimated Molecular Diagnostic COVID-19 Revenue Shares, 2020-Q2’22 by Region

North America

• Figure 2-5: USA – New Cases per Day
• Figure 2-6: USA – Testing Volume per Day
• Figure 2-7: Canada – New Cases per Day
• Figure 2-8: Canada – Testing Volume per Day

Europe

• 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 – Testing Volume per Day

APAC

• 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

• 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

• 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 2-3: Other PCR Tests Products on the Market

Chapter Three: Molecular Diagnostics Market

Brisk Recent Activity

Recent Product Introductions and Regulatory Approvals

• Table 3-1: Recent Product Introductions
• Table 3-2: Regulatory Approvals and Announcements

Market Size and Forecast by Segments

• Table 3-3: Molecular Diagnostic Market, 2022 and 2027 by Segment, $M (HAI/Sepsis, Hepatitis, HIV, STIs, Respiratory, TB, Cancer Assays, Histology (ISH, FISH) Molecular HPV, NAT Blood Screening,  NIPT, Thrombophilia/SNPs, Pharmacogenomics, Inherited/ genetic, Transplantation, COVID-19)
• Table 3-4: Molecular Diagnostics Market w/ and w/o COVID
• Table 3-5: Molecular Diagnostic (non-COVID) Market, 2022 by Region ($M)
• Figure 3-1: Molecular Diagnostics (non-COVID) Market by Region 2022 ($M)

Infectious Diseases

• Table 3-6: Selected Molecular Hepatitis Tests

HIV Market and COVID-19 Impact

• Table 3-7: 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

HPV

Product Developments

Markets for Molecular Cancer Diagnostics

Liquid Biopsy

Molecular Transplant Diagnostics

• Table 3-8: Selected Innovations in the Field of Molecular Transplant Diagnostics

Molecular Inherited Diseases Diagnostics

Thrombophilia and Coagulation Markers

Non-Invasive Prenatal Testing (NIPT)

Promising NIPT Studies

Inherited Disease Tests

Molecular Diagnostics Market Deals, Collaborations, Acquisitions

• Table 3-9: Molecular Diagnostics Market Deals, Collaborations, Acquisitions

Chapter Four: Trends to Watch – Sequencing, CRISPR, Automation

Sequencing

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 by Test Technique 2022

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

CRISPR and Molecular Diagnostics

CRISPR and COVID-19

• Table 4-3: CRISPR Innovations

Chapter Five: Company Profiles

Abbott Diagnostics

Company Overview

Financial Review

• Table 5-1: Abbott Diagnostics’ Recent Revenue History ($M), 2015-2021
• Figure 5-1: Abbott Diagnostics’ Molecular Diagnostic Revenue History ($M), 2016- Q2 2022
• Figure 5-2: Abbott Rapid Diagnostics Revenue

FDA approval of Alinity m STI assay

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)

Agena Bioscience

Agendia BV

Agilent Technologies (incl. Dako)

Company Overview

Financial Review

• Table 5-3: Agilent Technologies’ Recent Revenue History ($ millions)
• Figure 5-3: Agilent Diagnostics and Genomics Revenues, 2016- Q3 2022 ($M)

Aidian Oy

Altona Diagnostics

Amoy Diagnostics

Applied Spectral Imaging

ARUP Laboratories

Asuragen Inc. (Bio-Techne)

Becton, Dickinson & Co. (BD)

Business Segments

BD Medical

BD Life Sciences

BD Interventional

Recent Acquisitions

TVA Medical, Inc.

1. 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 5-4: BD Life Sciences Unit Quarterly Revenues, 2020- Q2’22 ($M)

Molecular Diagnostics Focus

Beijing Genomics Institute (BGI)

Sequencing Technologies

Berry Genomics

binx health

Bio-Rad Laboratories, Inc.

Key Comment

Recent Revenue History

Table 5-4: Bio-Rad Revenue History ($M)

Biocartis

Company Overview

Financial Review

• Table 5-5: Biocartis’ Recent Revenue History ($ millions)

Products and Technologies

Biodesix

Biomeme, Inc

bioMérieux

• Figure 5-6: bioMérieux’s Molecular Biology and Microbiology Segments, 2016-2022

Molecular

Bioneer

AccuPower COVID-19 Real-Time RT-PCR Kit

CareDx, Inc.

• Figure 5-6: CareDx Revenue, 2017-2022

AlloMap Tests

AlloSure Tests

Products Offered by CareDx

Credo Bioscience

CTK Biotech

Danaher (Cepheid and Leica Biosystems)

Life Sciences Business

Diagnostics Business

Cepheid

Leica Biosystems

Danaher’s 2019 Performance and 2020 Expectations

• Figure 5-7: Danaher Major Segment Revenues by Quarter, Q1 2018 – Q2 2022 ($M)

DiaSorin

Eiken Chemical

Exact Sciences Corp.

GenMark Diagnostics (Roche)

• Figure 5-8: Gen Mark Revenues, Pre Acquisition

Genotypic Technology Pvt. Ltd.

Greiner Bio-One GmbH

Grifols, S. A

Molecular Immunohematology and Specialty Testing Products

NAT Blood Screening

Hologic, Inc.

• Figure 5-9: Hologic Diagnostics Revenues, Calendar Q4 2017 – Q2 2022 ($M)
• Table 5-6: Hologic’s Recent Revenue History ($ millions)

Illumina, Inc.

Company Overview

• Table 5-7: Illumina’s Recent Revenue History ($ millions)
• Figure 5-9: Illumina’s Recent Revenue History ($ millions)

Immucor, Inc.

Transfusion Diagnostics

Meridian Bioscience Inc

• Figure 5-10: Meridian Bioscience Quarterly Revenues, Calendar Q1 2015 – Q2 2022 ($M)

Molbio Diagnostics Pvt. Ltd.

Myriad Genetics, Inc.

Company Overview

Financial Review

• Table 5-8: Myriad Genetics’ Recent Revenue History ($ millions)

NanoString Technologies, Inc.

NeuroMoDX

Oxford Nanopore Technologies Ltd

PerkinElmer Inc.

Promega Corporation

Qiagen

Company Overview

Thermo Fisher Purchase

• Table 5-9: QIAGEN’s Recent Revenue History ($ millions)

QuantuMDx Group

QuidelOrtho

Rheonix, Inc.

Products

Roche Diagnostics

Company Overview

Financial Review

• Figure 5-11: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016 – Q2 2022 ($M)
• Table 5-10: Roche Diagnostics’ Recent Revenue History ($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

Sekisui Diagnostics LLC

Sherlock Biosciences

SOLVD Health (AutoGenomics)

Standard BioTools

T2 Biosystems

Thermo Fisher Scientific Inc.

Company Overview

• Table 5-11: Thermo Fisher’s Recent Revenue History ($ millions)

Transplant Diagnostics

qPCR

Sequencing

Qiagen Acquisition Scrapped

Vela Diagnostics

Veracyte, Inc.