PUBLISHER: Kalorama Information | PRODUCT CODE: 1399406
PUBLISHER: Kalorama Information | PRODUCT CODE: 1399406
The World Market for Molecular Diagnostics, 12th Edition
Recent years saw molecular diagnostics emerge as the fastest growing segment within the global in vitro diagnostics (IVD) market. The market was both boosted and challenged in unexpected ways by COVID-19. But where does the multi-billion-dollar molecular diagnostic market stand post pandemic? This new report by Kalorama Information, “The World Market for Molecular Diagnostics, 12th Edition ”, reveals that post-pandemic the market remains ripe with opportunity, notably in the areas of infectious diseases, cancer, and transplant diagnostics. Global demand persists, with North America and Europe leading other regions worldwide.
Molecular diagnostics has evolved into an essential instrument in clinical medicine, influencing various facets of healthcare. It plays a pivotal role in treatment decisions by swiftly identifying antimicrobial-resistant (AMR) infections. Additionally, it contributes to companion diagnostics, aiding in the assessment of the appropriateness of diverse cancer treatment options. Molecular diagnostics is integral to understanding pharmacokinetics or patient metabolism of drugs for conditions like HIV, psychiatric disorders, or blood thinners. Its impact extends to cancer prognosis and therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions.
“The World Market for Molecular Diagnostics, 12th Edition ” delves into global and regional markets, exploring the widespread applications of molecular diagnostics across healthcare. This includes:
- Global Markets for Molecular Diagnostics by Application Segments (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
- North American Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
- European Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
- Asia Pacific Markets for Molecular Diagnostics (2023-2028) (Infectious Diseases, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases, Total) ($ Million)
The market is highly competitive, with several companies vying for prominence. Among those considered are:
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The competitive landscape in this field includes the aforementioned companies, and it's worth noting that there are additional competitors, with the expectation of more entering the market due to the rapid growth in this testing sector. The molecular infectious disease tests utilize an approach that involves detecting active and latent patient infections by targeting specific genetic sequences of pathogens. Clinical molecular tests designed for infectious disease testing provide a compelling combination of high sensitivity, specificity, and rapid turnaround time.
This has propelled the molecular infectious disease diagnostics segment to achieve substantial market growth compared to other major diagnostic platforms like immunoassay and ID/AST commonly employed in infectious disease testing. Despite being relatively more expensive, molecular detection platforms are gaining recognition for their enhanced sensitivity and specificity. The report offers a global analysis of the molecular infectious disease diagnostics segment, with detailed subsegment analyses covering areas such as CT/NG, HPV, hepatitis, HIV, HAIs (Healthcare-Associated Infections), respiratory diseases, and tuberculosis.
It's noteworthy that infectious diseases were the first category where molecular diagnostics made a significant impact, providing specific results crucial for treatment decisions. Pioneering companies in the molecular diagnostics field, such as Roche Diagnostics, Gen-Probe, and Becton Dickinson, initially focused on infectious diseases like HIV, Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG), and Tuberculosis (TB). These diseases remain pivotal in the market, although recent growth in molecular diagnostics methods has also been driven by applications in inherited diseases, cancer, coagulation, and other medical areas.
- Global Molecular Infectious Disease Diagnostics Markets (2023-2028), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($ Million)
- Global Molecular Infectious Disease Diagnostics Markets, by Region (2023-2028)
- Global Molecular HIV Testing Markets,
- Global Molecular HAIs/Sepsis Testing Markets,
- Global Molecular Respiratory Diseases Testing Markets
- Global Molecular Mycobacteria/TB Testing Markets
Due to dedicated initiatives aimed at enhancing the safety of blood product transfusions, there has been a notable rise in antigen testing through nucleic acid test (NAT) screening for common pathogens. In this context, developing countries are increasingly transitioning from immunoassays to molecular tests, particularly for diseases such as HIV and hepatitis. The report comprehensively explores the markets for molecular blood screening diagnostics, providing an overview of the blood testing market based on geographical considerations.
Molecular histology, primarily centered around in situ hybridization (ISH) tests, encompasses diverse testing domains. This includes molecular cytogenetics for the study of chromosomes, associated techniques for detecting pre- and post-natal genetic disorders, cancer testing, and identifying pathogens or pathogenic activities in tissues and blood cultures. The ISH segment of the molecular histology market is further divided into various sub-segments such as Fluorescence In Situ Hybridization (FISH), Chromogenic In Situ Hybridization (CISH), Rapid In Situ Hybridization (RISH), among others. Notably, CISH for RNA markers is gaining increased utilization in drug development and companion diagnostics. The report provides a comprehensive analysis of key segments within the molecular histology landscape.
This report evaluates the present configuration of the molecular diagnostics market in cancer, providing insights into prominent products and geographical segmentation. Additionally, the report assesses anticipated advancements, including technological innovations and product introductions. The existing market is predominantly comprised of tissue-based tests, companion assays, and diagnostic tests for the prognosis of specific cancer types. Noteworthy developments in this domain have the potential to significantly influence the landscape of cancer diagnostics and treatment management. The report delves into the markets for molecular cancer diagnostics, offering a comprehensive overview of the global market categorized by geography.
The molecular transplant diagnostics sector is marked by intense competition, with numerous companies providing test kits based on Polymerase Chain Reaction (PCR) and bead-array technologies, focusing on the characterization of Human Leukocyte Antigen (HLA) genes. The market has witnessed an increasing demand for Next-Generation Sequencing (NGS) in this segment. HLA tests necessitate the screening of approximately six genes in parallel, each presenting around 100 significant local variants. This complexity makes technologies like microarrays and sequencing well-suited for simultaneously screening multiple targets. The report provides an overview of the markets for molecular transplant diagnostics, offering insights into geographical segmentation.
The identification of single nucleotide polymorphisms (SNPs) or gene variants in tissue, blood, urine, and saliva samples serves as a diagnostic tool for inherited diseases and genetic disorders. It also aids in assessing the risk of disease development or progression. A key obstacle in implementing molecular tests for gene-based inherited diseases is the necessity for collaboration among stakeholders, including payers, physicians, researchers, and regulators, to bridge the divide between research findings and clinical applicability.
The report scrutinizes advancements in the most significant markets within molecular inherited disease diagnostics, offering comprehensive market data on key developments and trends in this domain.
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
