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The World Market for Molecular Diagnostics, 12th Edition
Publication Date: December 19, 2023
Tags: COVID-19, Genetic Diseases, Hematology, Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Point-of-Care (POC) Testing
Pages: 300
SKU: 23-053
In recent years, molecular diagnostics has become the fastest-growing segment within the global in vitro diagnostics (IVD) market, significantly influenced by the COVID-19 pandemic. This report examines the current state of the multi-billion-dollar molecular diagnostic market, highlighting key areas of opportunity in infectious diseases, cancer, and transplant diagnostics. North America and Europe continue to lead the global demand, with the market poised for further growth.
Molecular diagnostics is now a critical tool in clinical medicine, impacting various aspects of healthcare. It plays a vital role in treatment decisions by quickly identifying antimicrobial-resistant (AMR) infections. It also supports companion diagnostics, helping assess the suitability of different cancer treatments. Moreover, molecular diagnostics is essential for understanding patient metabolism of drugs for conditions like HIV, psychiatric disorders, or blood thinners, and its applications extend to cancer prognosis, organ matching, blood safety, and the diagnosis of latent and neonatal conditions.
Exploring the Dynamic Landscape of Post-Pandemic Molecular Diagnostics:
Kalorama Information’s comprehensive market research report, The World Market for Molecular Diagnostics, 12th Edition, delves into the evolving molecular diagnostics sector, uncovering the opportunities and challenges that have emerged in the post-pandemic era.
Key Insights and Market Segments:
This report provides an in-depth analysis of global and regional markets for molecular diagnostics, covering:
- Global Markets for Molecular Diagnostics by Application Segments (2023-2028): Including Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, and Inherited Diseases.
- North American Markets for Molecular Diagnostics (2023-2028): Detailed analysis by application segments.
- European Markets for Molecular Diagnostics (2023-2028): Comprehensive insights by application segments.
- Asia Pacific Markets for Molecular Diagnostics (2023-2028): Regional analysis by application segments.
Table: Growth Applications, by Revenue Growth, 2023 (%)
| Application | Revenue Growth (%) |
| Cancer Assays | XX% |
| TB | XX% |
| Histology (ISH, FISH) | XX% |
| NIPT | XX% |
| Respiratory | XX% |
| Molecular HPV | XX% |
| Hepatitis | XX% |
| Transplantation | XX% |
| HAIs/ sepsis | XX% |
| Inherited/ genetic | XX% |
| STIs | XX% |
| HIV | XX% |
| Circulating tumor cells | XX% |
Source: Kalorama Information
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Table of Contents
Chapter 1: Executive Summary
Size of Molecular Diagnostics Market
- Table 1-1: Molecular Diagnostics Market, w COVID-19 and w/out COVID-19, 2023 ($B)
- Figure 1-1: Molecular Diagnostics Market, w COVID-19 and w/out COVID-19 ($B)
Growth Areas in Molecular Diagnostics
- Table 1-2: Growth Applications, by Revenue Growth, 2023 (%)
- Figure 1-2: Growth Applications by Revenue Growth, 2023 (%)
Recent Developments
Emerging Trends
Monkeypox
Automation
Molecular Point of Care
- Table 1-3: Selected Molecular POC Diagnostic Platforms
Next-Generation Sequencing
Other 2023 Developments in Molecular Diagnostics
Chapter 2: Molecular Diagnostics Market
Brisk Recent Activity
Recent Product Introductions and Regulatory Approvals
- Table 2-1: Recent Product Introductions
- Table 2-2: Regulatory Approvals and Announcements
Market Size and Forecast by Segments
- Table 2-3: Molecular Diagnostic Market, by Segment (HAI/Sepsis, Respiratory, Hepatitis, HIV, STIs, TB, Cancer Assays, Histology [ISH, FISH] Molecular HPV, NAT Blood Screening, NIPT, Inherited/Genetic, Transplantation, COVID-19), 2023 and 2028, ($M)
- Table 2-4: Molecular Diagnostic (non-COVID) Market, by Region (APAC, Europe, North America, Rest of World), 2023 ($M)
- Figure 2-1: Molecular Diagnostics (non-COVID) Market, by Region (APAC, Europe, North America, Rest of World), 2023 ($M)
Infectious Diseases
- Table 2-5: Selected Molecular Hepatitis Tests
HIV Market and COVID-19 Impact
- Table 2-6: Selected Molecular Test Products for HIV
NAT Blood Screening
COVID-19 Impact
Other Trends
Declining Blood Transfusions in Developed Markets
Molecular Histology and Cytology Diagnostics
HPV
Product Developments
Markets for Molecular Cancer Diagnostics
Liquid Biopsy
Molecular Transplant Diagnostics
- Table 2-7: Selected Innovations in the Field of Molecular Transplant Diagnostics
Molecular Inherited Diseases Diagnostics
Thrombophilia and Coagulation Markers
Non-Invasive Prenatal Testing (NIPT)
Promising NIPT Studies
Inherited Disease Tests
Molecular Diagnostics Market Deals, Collaborations, Acquisitions
- Table 2-8: Molecular Diagnostics Market Deals, Collaborations, Acquisitions
Chapter 3: Trends to Watch – Sequencing, CRISPR, Automation
Sequencing
NGS and Companion Diagnostics
- Table 3-1: Selected Clinical NGS Platforms in the Market
Outlook For NGS in Molecular Diagnostics
- Figure 3-1: Percent of the MDX Market Revenues, by Test Technique, 2023
Evolving Informatics Solutions in Clinical Sequencing
Sample Preparation and Quality Control
Lab Automation and Molecular Diagnostics
- Table 3-2: Selected Automated Molecular Test Instrument Platforms
CRISPR and Molecular Diagnostics
CRISPR and Applications
- Table 3-3: CRISPR Innovations
Chapter 4: Company Profiles
Abbott Diagnostics
Company Overview
Financial Review
- Table 4-1: Abbott Diagnostics’ Revenue History ($M), 2015-2022
- Figure 4-1: Abbott Diagnostics’ Molecular Diagnostic Revenue History ($M), 2016- Q3 2023
- Figure 4-2: Abbott Rapid Diagnostics Revenue History, Q4 2017-Q3 2023 ($M)
FDA approval of Alinity m STI assay and High Risk HPV 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)
Company Overview
Agena Bioscience
Company Overview
Agendia BV
Company Overview
Agilent Technologies (incl. Dako)
Company Overview
Financial Review
- Table 4-2: Agilent Technologies’ Recent Revenue History by Segment ($M), 2020-2022
- Figure 4-3: Agilent Diagnostics and Genomics Segment Revenues, 2016- Q3 2023 ($M)
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
BD Medical
BD Life Sciences
BD Interventional
Recent Acquisitions
TVA Medical, Inc.
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 4-4: BD Life Sciences Unit Quarterly Revenues, Fiscal 2018- Q4’2023 ($M)
Molecular Diagnostics Focus
Beijing Genomics Institute (BGI)
Company Overview
PCR and Fluorescence
MGI Tech Co., Ltd.
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
NGS Sequencing
Collaborations
Berry Genomics
Company Overview
binx health
Company Overview
Bio-Rad Laboratories, Inc.
Company Overview
Recent Revenue History
- Table 4-3: Bio-Rad Diagnostics Revenue History, 2015-2022 ($M)
Liquid Biopsy
Droplet Digital PCR
Sequencing
Biocartis
Company Overview
Financial Review
- Table 4-4: Biocartis’ Revenue History, 2015-2022 ($M)
Products and Technologies
Biodesix
Company Overview
bioMérieux
Company Overview
- Figure 4-5: bioMérieux’s Revenue History, Molecular Biology and Microbiology Segments, 2016-Q3 2023 (€M)
BIOFIRE Business
Molecular Diagnostics
Bioneer
Company Overview
CareDx, Inc.
Company Overview
- Figure 4-5: CareDx Revenue, 2017-Q3 2023 ($M)
Testing Services Offered by CareDx
AlloMap Tests
AlloSure Tests
Products Offered by CareDx
Danaher
Company Overview
Danaher’s 2022 Performance
- Figure 4-7: Danaher Major Segment Revenues by Quarter, Q1 2018 – Q3 2023 ($M)
Life Sciences Business
Diagnostics Business
Cepheid
GeneXpert/ Xpress Line
Tuberculosis
Microbiology
POC STI Testing
Cancer
Leica Biosystems
DiaSorin
Company Overview
Molecular Diagnostics
Molecular Oncology
Development Plan
Expansion
Eiken Chemical
Company Overview
Product News
Exact Sciences Corp.
Company Overview
Recent Revenues and Developments
GenMark Diagnostics (Roche)
Company Overview
- Figure 4-8: GenMark Revenues History, Pre-Acquisition ($M)
Genotypic Technology Pvt. Ltd.
Company Overview
Greiner Bio-One GmbH
Company Overview
Grifols, S. A
Company Overview
NAT Blood Screening
Hologic, Inc.
Company Overview
- Figure 4-9: Hologic Diagnostics Revenues, Calendar Q4 2019 – Q3 2022 ($M)
- Table 4-5: Hologic’s Diagnostics Revenue History, Fiscal 2017-2023 ($M)
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Panther Fusion
Illumina, Inc.
Company Overview
- Table 4-6: Illumina’s Revenue History, 2015-2022 ($M)
- Figure 4-10: Illumina’s Revenue History, 2017-Q3 2023 ($M)
China
Meridian Bioscience Inc
Company Overview
- Figure 4-11: Meridian Bioscience Pre-Merger Revenues, Calendar Q1 2015 – Q2 2022 ($M)
Myriad Genetics, Inc.
Company Overview
Financial Review
- Table 4-7: Myriad Genetics Revenue History, 2015-2022 ($M)
NanoString Technologies, Inc.
Company Overview
NeuroMoDX
Company Overview
Oxford Nanopore Technologies Ltd
Company Overview
Promega Corporation
Company Overview
Qiagen
Company Overview
- Table 4-8: QIAGEN’s Revenue History, 2015-2022 ($M)
Tuberculosis
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Sample Prep, Informatics
Digital PCR
Liquid Biopsy
Cervical Cancer
Expansion and Other Developments
QuantuMDx Group
Company Overview
QuidelOrtho
Company Overview
The Solana Business
Molecular – Savanna
Revvity
Company Overview
Diagnostics
Sequencing /Genomics
Liquid Biopsy
Histology
Prenatal Business
Lab Services
Rheonix, Inc.
Company Overview
Roche Diagnostics
Company Overview
Financial Review
- Figure 4-12: Roche Quarterly Molecular Diagnostics Revenues, Q1 2016 – Q3 2023 ($M)
- Table 4-9: Roche Diagnostics’ Revenue History, 2016-2022 ($M)
Molecular Expansion
Core Molecular
Digital PCR
Hematology
HPV
HIV
Coagulation
cobas Liat System – POC
Blood Bank
Transplant Medicine
Cancer Companion Testing
IT in Anatomical Pathology
Other Recent Developments
Seegene
Company Overview
Sekisui Diagnostics LLC
Company Overview
Sherlock Biosciences
Company Overview
Standard BioTools
Company Overview
T2 Biosystems
Company Overview
Thermo Fisher Scientific Inc.
Company Overview
- Table 4-10: Thermo Fisher Scientific Estimated Clinical Diag. and NGS Revenues, 2017-2022 ($M)
- Table 4-11: Thermo Fisher Scientific Estimated Revenues by IVD Test Segment, 2017-2022 ($M)
Microbiology
Molecular Test Business
Next Generation Sequencing
qPCR
Oncology Companion Diagnostics
Transplant Medicine
Microbiome
Other Collaborations and Acquisitions
Gene Editing and Cell Therapy
China
Vela Diagnostics
Company Overview
Veracyte, Inc.
Company Overview
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