The World Market for Molecular Diagnostics Tests, 11th Edition

The World Market for Molecular Diagnostics Tests, 11th Edition

Overall Market

• Infectious Disease Molecular Diagnostics (COVID-19, Hepatitis, HIV, Respiratory, STI, HAIs, Others)
• Cancer Molecular Diagnostic Markets (Blood-based and Tissue-based)
• Genetic Molecular Diagnostic Markets (SNPs, Inherited, NIPT, Other)
• Blood Banking Molecular Diagnostics Markets
• Transplantation Molecular Diagnostic Markets
• Regional Molecular Diagnostics Markets (North America, Europe, Asia, Global)

This report is published as the industry experienced accelerated installed bases and new product introductions. Molecular diagnostics has always been a fast-evolving and dynamic field. Taken together, it 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.

This market is heavily competitive. Companies considered include:

• Roche
• Abbott
• Thermo Fisher
• Meridian Bioscience
• Myriad
• Perkin Elmer
• Cepheid
• BioMérieux
• Promega
• QuantuMDX
• QuidelOrtho
• Hologic
• Qiagen
• ARUP
• Asuragen
• CareDX
• Vela Diagnostics
• Becton, Dickinson &Co.
• BGI
• Bio-Rad
• Leica Biosystems
• Greiner Bio-One
• Biocartis
• Credo
• Eiken
• CTK
• Leica Biosystems  
• Grifols
• Illumina
• T2

These are among the competitors in this field; there are others and there are expected to be more given the growth rates in this area of testing. Indeed, detection of active and latent patient infections by targeting genetic sequences specific to pathogens is the approach used in molecular infectious disease tests. Clinical molecular tests available for infectious disease testing offer a combination of high sensitivity, specificity and low turnaround time advantages.

This has powered this segment for high market growth over other major diagnostic platforms commonly used for infectious disease testing such as immunoassay and ID/AST. Molecular detection platforms are increasingly being recognized for the improved sensitivity and specificity they can offer, even though they are more expensive. The report offers global analysis of the molecular infectious disease diagnostics segment, as well as analysis of subsegments that include CT/NG, HPV, hepatitis, HIV, HAIs, respiratory diseases, and tuberculosis:

It is notable that the first category where molecular diagnostics earned their place was infectious disease. In this category, specific results were needed for treatment decisions. The pioneers in the molecular diagnostics field include Roche Diagnostics, Gen-Probe, and Becton Dickinson. The main focus of the initial molecular diagnostics products was infectious disease including HIV, Chlamydia Trachomatis/Neisseria Gonorrhoea (CT/NG), and TB. These diseases are still critical components of the market. Recently growth in molecular diagnostics methods has also been coming from inherited diseases, cancer, coagulation, and other areas.

• Global Molecular Infectious Disease Diagnostics Markets (2022-2027), By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($, Million)
• Global Molecular Infectious Disease Diagnostics Markets, by Region (2022-2027)
• Global Molecular HPV Testing Markets, By Region (2022-2027)
• Global Molecular CT/NG Testing Markets, By Region (2022-2027)
• Global Molecular Hepatitis Testing Markets, By Region (2022-2027)
• Global Molecular HIV Testing Markets,
• Global Molecular HAIs/Sepsis Testing Markets,
• Global Molecular Respiratory Diseases Testing Markets
• Global Molecular Mycobacteria/TB Testing Markets

As a result of concerted efforts to make blood product transfusions safer, there is an increase in antigen testing by nucleic acid test (NAT) screening to test for common pathogens. Developing countries are replacing immunoassays by molecular tests, especially for HIV, hepatitis, etc. World Molecular Diagnostics Market covers the markets for molecular blood screening diagnostics, outlining the blood testing market by geography:

• Global Molecular Blood Screening Diagnostics Markets, By Region (2022-2027) ($, Million)

Molecular histology, which predominantly consists of ISH tests, captures several different areas of testing including molecular cytogenetics or study of chromosomes, related techniques for the detection of pre- and post-natal genetic disorders, cancer testing, and the detection of pathogens or pathogenic activity from tissues and blood cultures. Various sub-segments within the ISH segment of molecular histology market include FISH, CISH, Rapid ISH (RISH), etc. CISH for RNA markers is increasingly used in drug development and companion diagnostics. The report analyzes key molecular histology segments:

• Global Molecular Histology and Cytology Diagnostics Markets by Application (2022-2027) (Cancer, Inherited diseases, Infectious/Other, Total) ($, Million)
• Global Molecular Histology and Cytology Diagnostics Markets, by Region (2022-2027) ($, Million)
• Global Molecular Histology Diagnostics Markets, by Region (2022-2027) l) ($, Million)

This report reviews the current makeup of the molecular diagnostics market in cancer, including its notable products and geographical segmentation. The report also reviews expected developments, such as technology and product introduction. The current market is largely composed of tissue-based tests, companion assays, and tests for the prognosis and diagnosis of specific cancer types. Some of the most significant developments in this field may have an impact in shaping cancer diagnostics and treatment management. The report examines the markets for molecular cancer diagnostics, outlining the global market by geography:

• Global Molecular Cancer Diagnostics Markets, By Region (2022-2027) (North America, Europe, APAC, RoW, Total) ($, Million)
The molecular transplant diagnostics space is a competitive market with many companies offering PCR-based and bead-array-based test kits based on the HLA genes that have been characterized. The demand for NGS has been growing in the segment. An HLA test requires that some six genes are screened in parallel, with each displaying about 100 important (known) local variants. This requirement lends itself to technologies such as microarrays and sequencing that can screen for many targets. The report outlines the markets for molecular transplant diagnostics by geography:
• Global Molecular Transplant Diagnostics Markets, By Region (2022-2027) ($, Million)

The detection of single nucleotide polymorphisms (SNPs) or gene variants from tissue, blood, urine and saliva samples can be used to diagnose inherited diseases and genetic disorders as well as determine the risk of disease manifestation or progression. One of the major challenges facing molecular tests for gene based inherited diseases is getting stakeholders including payers, physicians, researchers and regulators to work together to close the gap between research and clinical applicability. World Molecular Diagnostics Market analyzes the developments in most significant markets within molecular inherited disease diagnostics and provides the following market data:

• Global Molecular Genetic Diagnostics Markets, By Disease Segments (2022-2027) (Inherited, Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total) ($, Million)