Science and Medicine Group

The World Market for Molecular Diagnostics Tests, 10th Edition (NGS, PCR, NAAT, ISH, TMA, Other) 18 Jun 2021

Report details
40 Figures
39 Tables

Chapter 1: Executive Summary
- Molecular Diagnostics in the Spotlight
  - Hundreds of PCR Tests on the Market, U.S. Labs Settle on a Few
  - COVID-19 Market
- Emerging Trends
  - Automation
  - Molecular Point of Care
  - Next-Generation Sequencing on the Rise
  - LDT Regulation and COVID-19
  - Reimbursement Environment
  - Thermo and Qiagen Merger
  - CRISPR, Sequencing and COVID-19
- The Global Molecular Diagnostics Market in the Era of COVID-19
Chapter 2: COVID-19 Molecular Diagnostic Market Analysis
- Major IVD Players See Brisk COVID-19 Test Sales
- North America
- Europe
- APAC
- Latin America
- Rest-of-World
- COVID Testing Market Computation Methodology
- Test Vendors
- Testing Trends, Recommendations, Consensus Taking Shape
Chapter 3: Markets for Other Molecular Diagnostic Tests
- Recent Product Introductions and Regulatory Approvals
- Infectious Diseases
  - Respiratory Diseases: COVID-19 Impact
  - Mycobacteria/Tuberculosis: Market and COVID-19 Impact
  - Hospital-Acquired Infections (HAIs) : Market and COVID-19 Impact
  - Sexually Transmitted Infections: Market and COVID-19 Impact
  - Hepatitis: COVID-19 Impact
  - HIV Market and COVID-19 Impact
- NAT Blood Screening
  - COVID-19 Impact
- 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
- Molecular Transplant Diagnostics
  - COVID-19
- Molecular Inherited Diseases Diagnostics
  - Inherited Diseases - COVID-19 Impact
  - Thrombophilia and Coagulation Markers
  - Non-Invasive Prenatal Testing (NIPT)
  - Inherited Disease Tests
- Molecular Diagnostics Market Deals, Collaborations, Acquisitions
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
  - Outlook For NGS in Molecular Diagnostics
  - Evolving Informatics Solutions in Clinical Sequencing
  - Sample Preparation and Quality Control
- Lab Automation and Molecular Diagnostics
- CRISPR and Molecular Diagnostics
  - CRISPR and COVID-19
Chapter 5: Company Profiles
- Abbott Diagnostics
  - Company Overview
  - 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
  - Financial Review
- Aidian Oy
  - Company Overview
- Altona Diagnostics
  - Company Overview
- Amoy Diagnostics
  - Company Overview
- Applied Spectral Imaging
  - Company Overview
- ARUP Laboratories
  - Company Overview
- Asuragen Inc. (Bio-Techne)
  - Company Overview
- Becton, Dickinson & Co. (BD)
  - Company Overview
  - Business Segments
  - Recent Acquisitions
  - Recent Divestitures
  - Leading Position in the Flow Cytometry Market
  - Revenue and Growth
  - 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
- Biocartis
  - Company Overview
  - Financial Review
- Biodesix
  - Company Overview
- Biomeme, Inc
  - Company Overview
  - Company Overview
  - Molecular
- Bioneer
  - Company Overview
  - AccuPower COVID-19 Real-Time RT-PCR Kit
- CareDx, Inc.
  - Company Overview
  - AlloMap 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
- DiaSorin
  - Company Overview
- Eiken Chemical
  - Company Overview
- Exact Sciences Corp.
  - Company Overview
- Fluidigm Corporation
  - Company Overview
- GenMark Diagnostics (Roche)
  - Company Overview
- 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
- Illumina, Inc.
  - Company Overview
- Immucor, Inc.
  - Company Overview
  - Transfusion Diagnostics
- Meridian Bioscience Inc
  - Company Overview
- Mesa Biotech, Inc. (Thermo)
  - Company Overview
- Molbio Diagnostics Pvt. Ltd.
  - Company Overview
- Myriad Genetics, Inc.
  - Company Overview
  - Financial Review
- 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
- QuantuMDx Group
  - Company Overview
- Quidel Corporation
  - Company Overview
- Rheonix, Inc.
  - Company Overview
  - Products
- Roche Diagnostics
  - Company Overview
  - COVID-19 Early Actions
  - Financial Review
  - 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…
  - 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
  - Transplant Diagnostics
  - qPCR
  - Sequencing
  - Qiagen Acquisition Scrapped
- Vela Diagnostics
  - Company Overview
- Veracyte, Inc.
  - Company Overview

Attachments

21-028 - Molecular Diagnostics Markets.pdf

The World Market for Molecular Diagnostics Tests, 10th Edition (NGS, PCR, NAAT, ISH, TMA, Other)

18 Jun 2021

GSL

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SKU 21-028

Molecular diagnostics is a fast evolving and dynamic field and 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. Kalorama’s The World Molecular Diagnostics Market, 10th Edition, examines the global market as well as markets by region, including:

Global Markets for Molecular Diagnostics by Application Segments (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
Global Markets for Molecular Diagnostics by Technology Segments (2021-2026) (PCR, iNAAT, Microarrays, ISH, NGS, Other, Total) ($, Million)
North American Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
European Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($, Million)
Asia Pacific Markets for Molecular Diagnostics (2021-2026) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant , Inherited Diseases, Total) ($, Million)

Page Count: 337

Table of Contents

Chapter 1: Executive Summary
- Molecular Diagnostics in the Spotlight
  - Hundreds of PCR Tests on the Market, U.S. Labs Settle on a Few
  - COVID-19 Market
- Emerging Trends
  - Automation
  - Molecular Point of Care
  - Next-Generation Sequencing on the Rise
  - LDT Regulation and COVID-19
  - Reimbursement Environment
  - Thermo and Qiagen Merger
  - CRISPR, Sequencing and COVID-19
- The Global Molecular Diagnostics Market in the Era of COVID-19
Chapter 2: COVID-19 Molecular Diagnostic Market Analysis
- Major IVD Players See Brisk COVID-19 Test Sales
- North America
- Europe
- APAC
- Latin America
- Rest-of-World
- COVID Testing Market Computation Methodology
- Test Vendors
- Testing Trends, Recommendations, Consensus Taking Shape
Chapter 3: Markets for Other Molecular Diagnostic Tests
- Recent Product Introductions and Regulatory Approvals
- Infectious Diseases
  - Respiratory Diseases: COVID-19 Impact
  - Mycobacteria/Tuberculosis: Market and COVID-19 Impact
  - Hospital-Acquired Infections (HAIs) : Market and COVID-19 Impact
  - Sexually Transmitted Infections: Market and COVID-19 Impact
  - Hepatitis: COVID-19 Impact
  - HIV Market and COVID-19 Impact
- NAT Blood Screening
  - COVID-19 Impact
- 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
- Molecular Transplant Diagnostics
  - COVID-19
- Molecular Inherited Diseases Diagnostics
  - Inherited Diseases - COVID-19 Impact
  - Thrombophilia and Coagulation Markers
  - Non-Invasive Prenatal Testing (NIPT)
  - Inherited Disease Tests
- Molecular Diagnostics Market Deals, Collaborations, Acquisitions
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
  - Outlook For NGS in Molecular Diagnostics
  - Evolving Informatics Solutions in Clinical Sequencing
  - Sample Preparation and Quality Control
- Lab Automation and Molecular Diagnostics
- CRISPR and Molecular Diagnostics
  - CRISPR and COVID-19
Chapter 5: Company Profiles
- Abbott Diagnostics
  - Company Overview
  - 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
  - Financial Review
- Aidian Oy
  - Company Overview
- Altona Diagnostics
  - Company Overview
- Amoy Diagnostics
  - Company Overview
- Applied Spectral Imaging
  - Company Overview
- ARUP Laboratories
  - Company Overview
- Asuragen Inc. (Bio-Techne)
  - Company Overview
- Becton, Dickinson & Co. (BD)
  - Company Overview
  - Business Segments
  - Recent Acquisitions
  - Recent Divestitures
  - Leading Position in the Flow Cytometry Market
  - Revenue and Growth
  - 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
- Biocartis
  - Company Overview
  - Financial Review
- Biodesix
  - Company Overview
- Biomeme, Inc
  - Company Overview
  - Company Overview
  - Molecular
- Bioneer
  - Company Overview
  - AccuPower COVID-19 Real-Time RT-PCR Kit
- CareDx, Inc.
  - Company Overview
  - AlloMap 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
- DiaSorin
  - Company Overview
- Eiken Chemical
  - Company Overview
- Exact Sciences Corp.
  - Company Overview
- Fluidigm Corporation
  - Company Overview
- GenMark Diagnostics (Roche)
  - Company Overview
- 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
- Illumina, Inc.
  - Company Overview
- Immucor, Inc.
  - Company Overview
  - Transfusion Diagnostics
- Meridian Bioscience Inc
  - Company Overview
- Mesa Biotech, Inc. (Thermo)
  - Company Overview
- Molbio Diagnostics Pvt. Ltd.
  - Company Overview
- Myriad Genetics, Inc.
  - Company Overview
  - Financial Review
- 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
- QuantuMDx Group
  - Company Overview
- Quidel Corporation
  - Company Overview
- Rheonix, Inc.
  - Company Overview
  - Products
- Roche Diagnostics
  - Company Overview
  - COVID-19 Early Actions
  - Financial Review
  - 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
  - Transplant Diagnostics
  - qPCR
  - Sequencing
  - Qiagen Acquisition Scrapped
- Vela Diagnostics
  - Company Overview
- Veracyte, Inc.
  - Company Overview