The World Market for Molecular Diagnostics Tests, 10th Edition

The World Market for Molecular Diagnostics Tests, 10th Edition

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)


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:

Global Molecular Infectious Disease Diagnostics Markets (2021-2026),
By Infection (Hepatitis, HIV, HAIs/Sepsis, HPV, CT/NG, Respiratory diseases, Mycobacteria/TB, Other, Total) ($, Million)

Global Molecular Infectious Disease Diagnostics Markets, by Region
(2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular HPV Testing Markets, By Region (2021-2026) (North
America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular CT/NG Testing Markets, By Region (2021-2026) (North
America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular Hepatitis Testing Markets, By Region (2021-2026)
(North America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular HIV Testing Markets, By Region (North America,
Europe, APAC, RoW, Total) (2021-2026) ($, Million)

Global Molecular HAIs/Sepsis Testing Markets, By Region (2021-2026)
(North America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular Respiratory Diseases Testing Markets, By Region
(2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular Mycobacteria/TB Testing Markets, By Region (2021-2026)
(North America, Europe, APAC, RoW, Total) ($, Million)

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
(2021-2026) (North America, Europe, APAC, RoW, Total) ($, 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
(2021-2026) (Cancer, Inherited diseases, Infectious/Other, Total) ($, Million)

Global Molecular Histology and Cytology Diagnostics Markets, by
Region (2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

Global Molecular Histology Diagnostics Markets, by Region (2021-2026)
(North America, Europe, APAC, RoW, Total) ($, 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 (2021-2026)
(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 (2021-2026)
(North America, Europe, APAC, RoW, Total) ($, 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 Inherited Diseases Diagnostics Markets, By Disease
Segments (2021-2026) (Thrombophilia [SNP tests] & Coagulation Markers, NIPT, Others, Total) ($, Million)

Global Molecular Inherited Diseases Diagnostics Markets, By Region
(2021-2026) (North America, Europe, APAC, RoW, Total) ($, Million)

In addition to reviewing recent industry and market developments, as well as examining key market trends that are influencing the market landscape, the report looks at the molecular diagnostics industry players. The following companies are profiled:

Abbott Diagnostics

Advanced Cell Diagnostics (Biotechne)

Agilent Technologies

Amoy Diagnostics

Applied Spectral Imaging

Becton, Dickinson & Co. (BD)

Beijing Genomics Institute (BGI)

Berry Genomics

bioMérieux

Bio-Rad Laboratories

CareDx, Inc.

Danaher (Cepheid and Leica Biosystems)

Eiken Chemical

GenMark Diagnostics

Genotypic Technology Pvt. Ltd.

Grifols, S. A

Illumina

Immucor, Inc.

Meridian Bioscience Inc

Molbio Diagnostics Pvt. Ltd.

PerkinElmer Inc.

QIAGEN N.V.

Quidel Corporation

Roche Diagnostics

Thermo Fisher Scientific Inc.

Vela Diagnostics