US demand for in vitro diagnostic (IVD) products will rise more than six percent annually to nearly $25 billion in 2016. Aging demographic patterns, expanding levels of health insurance coverages, and new product introductions will underlie gains. Growth in the middle aged and elderly population segments will boost overall health care needs, leading to a rising volume of IVD tests. The extension of health insurance coverage attributable to the Affordable Health Care Act of 2010 will make basic and specialized IVD procedures available to a greater number of individuals. Advances in cellular analysis, molecular diagnostic and other advanced technologies will expand applications for IVD products in disease detection, forensic medical, and identity testing.
Clinical chemistry and immunoassay will remain the top two IVD methodologies, the former based on sales of personal blood glucose monitors and test strips and the latter due to the penetration of high value-added chemiluminescent products into infectious disease and drug testing markets. Molecular diagnostic products will post the fastest growth in demand among all IVD products based on throughput, accuracy, and speed advantages, especially in the detection of infectious diseases and cancer markers. Diabetes testing will remain the largest IVD application through 2016 and beyond due to increasing blood glucose monitoring among afflicted patients.
Based on their ability to quantify heart attack and embolism risk prior to occurrence, hemostasis tests for D-dimer and other cardiac parameters will command the best growth among IVD blood testing products. Demand for molecular diagnostic products will expand at a strong pace as next-generation PCR (polymerase chain reaction) and FISH (fluorescence in situ hybridization) penetrate applications involving the analysis, characterization, and therapeutic monitoring of complex infections and tumors. DNA-based forensic, genetic, and identity testing will comprise one of the fastest growing IVD applications through 2016 as the vast potential of law enforcement and genetic screening markets begins to translate into significant revenues. Among other IVD products, cellular analysis and anatomical pathology reagents and instruments will post the best sales gains. Cellular analysis techniques will continue to dominate cervical cancer testing and penetrate additional cancer diagnostic applications. Anatomical pathology will remain the leading IVD technique for biopsy-based cancer and infectious disease detection.
Evolving epidemiological trends and patient care approaches will impact favorably on growth opportunities for most types of IVD products. The market for clinical chemistry reagents and instruments will benefit from an increasing number of diabetic patients engaging in self-blood glucose monitoring and the expanding use of general health screening in routine patient examinations. The widening availability of chemiluminescent tests with inherent sensitivity and selectivity advantages will broaden applications for immunoassays in therapeutic drug monitoring, drugs of abuse detection, and infectious disease testing.
Details on these and other findings are contained in Freedonia industry study, “In Vitro Diagnostics”, which presents historical demand data for 2001, 2006 and 2011, as well as forecasts for 2016 and 2021 by product, application, and market. This study also considers key market environment factors, evaluates company market share, and profiles 27 competitors in the US IVD industry.
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