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According to a new report series on the U.S. market for in vitro diagnostics by iData Research, molecular diagnostics (MDx) is the fastest-growing in vitro diagnostic (IVD) segment, accounting for nearly 30% of the total U.S. IVD market revenues in 2015. Infectious disease testing accounted for more than half of the total MDx revenues, while molecular testing for different cancers is expected to witness the highest growth rates in the coming years. MDx is at the heart of personalized medicine for cancer care. The companion diagnostic (CDx) tests, associated with new therapeutic drugs developed for cancer patients, monitor the efficacy of the drugs on individual patients by identifying the presence of biomarkers or disease-specific therapeutic targets.
Growth in the molecular diagnostics market will be driven by increases in the number of Food and Drug Administration (FDA) approved tests and higher penetration of molecular testing in medium and small volume labs due to the decreasing costs. In addition, testing is expected to shift from other methods, such as microbiology and immunoassay, to molecular techniques due to their higher sensitivity and specificity. With FDA guidelines requiring new drugs to have CDx tests before being available in the market coupled with the rising incidence of different cancers among the U.S. population, the volume of CDx tests is expected to see a sharp increase in the future. Thus, this will empower the clinical labs to be key partners in the decision making process by providing patient-specific and actionable information to the health care providers.
In 2015, the U.S. oncology assay market is set to exceed $800 million. This market includes molecular assays used for breast, colorectal and prostate cancer. The high prevalence of sexually transmitted infections (STIs) and hospital acquired infections (HAIs) among the U.S. population coupled with the high costs associated with their treatment will be a major driving factor for the sustained growth of infectious disease assay market. With the steep rise of cancer among the U.S. population, predictive testing products for screening the predisposition of at-risk individuals will expand the molecular oncology market.
“The highest volume of testing was performed for breast cancer, followed by testing for prostate cancer and colorectal cancer”, explains Dr. Kamran Zamanian, CEO of iData. “Growth is expected in all market segments as testing converts from microbiology, immunoassay or biopsy methods to molecular diagnostics. High specificity and accuracy of molecular methods will drive this conversion.”
Myriad Genetics has been competing exclusively in the oncology assay market, where they held nearly 40% market share. They offered products for all the three oncology markets: breast, colorectal and prostate cancer with a focus on predictive, diagnostic and prognostic testing. Genomic Health, the second leading competitor, focuses on tests for patients suffering from invasive breast cancer in order to determine the need for chemotherapy. Genomic Health’s 2014 revenues grew by more than 80% from the previous year. Other leading competitors in the molecular diagnostics market include Roche Diagnostics, Hologic, Cephied, Quigen, Becton Dickinson, Abbott Diagnostics, Siemens Healthcare Diagnostics, bioMérieux, Luminex, and AutoGenomics Inc. among others.
For Further Information
More on the molecular diagnostics market in the US can be found in a series of reports published by iData Research encompassing the US Market for In Vitro Diagnostics. The reports covered in this suite include immunochemistry, molecular diagnostics, molecular blood donor screenings, hemostasis market, hematology market, and point of care diagnostic devices.
Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
To find out more about molecular diagnostics market data or procedure data, register online or email us at [email protected] for a US Market for In Vitro Diagnostic report series brochure and synopsis.
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