Molecular Diagnostics Sector Reaches New Peak

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

Employing molecular biology techniques, these novel diagnostics are now nearly two decades old. Innovations have transformed diagnostics with new technologies and clinical applications being continually added. 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, as well as quantitative nucleic acid amplification methods for viral infections, and MALDI-TOF mass spectrometry.

“Molecular diagnostics is rapidly being developed for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing, and others," said Rosen. Continued growth is expected and in the next few years a constant stream of test kits for the newest molecular targets will become commercially available. For the next generation of tests for infectious diseases, emerging pathogens, chronic diseases, and oncology, it appears that services from large hospital and private company-sponsored laboratories will prevail, which limits growth potential for commercial products.

Technologies that were used for the Human Genome Project have now become tools that molecular pathologists routinely use to diagnose diseases that had long remained a mystery. This is good for patient care, but sequencing and next generation sequencing-based tests have evolved so quickly that government agencies and payers are scurrying to cope with accompanying regulatory, reimbursement, and ethical issues.

“Only 5 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,” said Rosen.

The report includes market sizing and forecasts for 8 categories of molecular tests as well as several segments. It also contains trend analysis, strategic recommendations, analyst conclusions, and company profiles of over 190 companies.

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Kalorama Information
The World Market for Molecular Diagnostics, 6th Edition