A new research report from G2 Intelligence estimates the U.S. molecular diagnostics market will total about $7.8 billion in 2013. While demand for molecular testing is expected to increase, driven by declining costs and growing acceptance of the tests in clinical practice, this growth will likely be offset by the implementation of the new molecular pathology Current Procedural Terminology codes, which will impede growth both through lower reimbursement rates as well as decreases in positive coverage decisions by payers. G2 Intelligence used a proprietary market-sizing methodology that integrates different estimation approaches through a “triangulation” of data from diverse sources, including surveys of laboratories, modeling of disease incidence and testing guidelines, secondary market research, and top-down estimates from Medicare resources. Market size estimates, growth rates, and MDx market subsegments were all calculated using this methodology. The seven market subsegments include hematology, women’s health, general infectious disease, inherited genetic diseases, pharmacogenomics, transplant, and blood screening. MDx is defined in the report as including nucleic acid assays utilizing polymerase chain reaction, in situ hybridization, sequencing, microarrays, cytogenetics, electrophoresis, and genomic immunohistochemistry techniques. Though molecular diagnostics represents a small share of the total clinical laboratory testing market, it is the fastest-growing segment. While hospital or academic university laboratories made up the majority of the laboratories offering clinical MDx testing in 2012 (70 percent), independent laboratories (including reference or specialty laboratories) had the majority of the MDx test volume in 2013 (62 percent). G2 Intelligence’s new report, “U.S. Molecular Diagnostic and Genomic Testing,” provides detailed analysis of the entire molecular market, major molecular diagnostic sectors, the dynamics of molecular reimbursement, and lab-developed tests. The report also includes overall market size and projections for each sector through 2015, analysis of key market drivers and inhibitors, and platform usage analysis by test type. The report is available for purchase for $1,195 at www.G2Intelligence.com. For multiuser or multilocation pricing, contact Customer Service customerservice@g2intelligence.com.

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