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Kalorama: Molecular Diagnostics Market Reaches 6.1 Billion Dollars

NEW YORK, Oct. 21, 2015 /PRNewswire/ -- The 2014 market for molecular assays worldwide was estimated at $6.1 billion by Kalorama Information.   Employing molecular biology techniques, these novel diagnostics are now nearly two decades old, and are used in just about every facet of laboratory medicine: infectious diseases, inherited diseases and cancer among others. The healthcare market researcher said that molecular diagnostics account for about 10% of the total market for IVDs and is also one of the fastest growth segments in clinical diagnostics. The projection was made in Kalorama Information's report, The World Market for Molecular Diagnostics, 6th Edition authored by the company's lead IVD analyst Shara Rosen, R.T., MBA. 

The report can be found at

"For the past 5 years the number of assays introduced has been growing," Rosen said.  "Moreover, growth of this segment is fueled by rising incidence of chronic disorders, and an increasing geriatric population and adoption of personalized medicines.

The report said that technical innovations and their clinical applications have transformed the practice of clinical diagnostics with new technologies and applications being continually added.  The technologies that are part of molecular diagnostics go far beyond first-generation amplification and include (in no particular order): DNA/RNA/miRNA probes, fluorescent in-situ hybridization (FISH), biochips, microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays, microfluidics, circulating tumor cells, cell-free nucleic acid, exosomes, nanoprobes, DNA methylation, sequencing of DNA from formalin-fixed tissues, and quantitative nucleic acid amplification methods for viral infections, and MALDI-TOF mass spectrometry.

"Molecular diagnostics test is rapidly being developed for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing and others," Rosen said.

The report expects continued growth, and that in the next few years a constant stream of commercially available test kits for the newest molecular targets will be coming to market. Yet for the next generation of molecular tests for infectious diseases, emerging pathogens, chronic diseases and oncology, it appears that test services from large hospital and private and company sponsored laboratories prevail. This limits the growth potential of the market for commercial products. The report discusses these challenges and the strategies some companies may use to overcome them.

In 2015 the technologies that were used for the Human Genome Project have become tools that molecular pathologists routinely use to diagnose diseases in patients that had remained a mystery for a long time.  This is good for patient care but the evolution of sequencing and next generation sequencing-based tests have gone so quickly that government agencies and payers are scurrying to cope with the regulatory, reimbursement and ethical issues that accompany this new generation of tests.

"Only five years ago it would have been almost inconceivable that hospital and government funded programs would provide whole genome and whole exome sequencing for thousands and even millions of people," Rosen said.

The report, The World Market for Molecular Diagnostics, 6th Edition, includes market sizing and forecasts for eight categories of molecular tests as well as several segments.  In addition the report contains trend analysis, strategic recommendations, analyst conclusions and company profiles of over 190 companies.  The report can be found at:

About Kalorama Information
Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on and

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at  

Bruce Carlson
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