The World Market for Molecular Diagnostics, 12 th Edition

The World Market for Molecular Diagnostics, 12 th 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 market 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:

Abbott Diagnostics
Advanced Cell Diagnostics (Bio-Techne)
Agena Bioscience
Agendia BV
Agilent Technologies (incl. Dako)
Aidian Oy
Altona Diagnostics
Amoy Diagnostics
Applied Spectral Imaging
ARUP Laboratories
Asuragen Inc. (Bio-Techne)
Becton, Dickinson & Co. (BD)
Beijing Genomics Institute (BGI)
Berry Genomics
binx health
Bio-Rad Laboratories, Inc.
Biocartis
Biodesix
bioMérieux
Bioneer
CareDx, Inc.
Danaher
DiaSorin
Eiken Chemical
Exact Sciences Corp.
GenMark Diagnostics (Roche)
Genotypic Technology Pvt. Ltd.
Greiner Bio-One GmbH
Grifols, S. A
Hologic, Inc.
Illumina, Inc.
Meridian Bioscience Inc
Myriad Genetics, Inc.
NanoString Technologies, Inc.
NeuroMoDX
Oxford Nanopore Technologies Ltd
Promega Corporation
Qiagen
QuantuMDx Group
QuidelOrtho
Revvity
Rheonix, Inc.
Roche Diagnostics
Seegene
Sekisui Diagnostics LLC
Sherlock Biosciences
Standard BioTools
T2 Biosystems
Thermo Fisher Scientific Inc.
Vela Diagnostics
Veracyte, Inc.

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.