This market includes revenues for select segments of immunochemistry, molecular diagnostics, blood donor screening, hemostasis, hematology and point-of-care (POC) testing. Sales of analyzer systems predominantly involve some form of reagent rental contracts, where a large percentage of the cost of the analyzer is recovered through the sales of reagents. Due to the wide variability associated with these contracts from one customer to another, only units and growth rates are reported for the analyzer systems, while units (number of tests), ASPs and market values are reported for the reagents. The only exception to this practice is found in the point of care (POC) testing, where analyzers are mostly purchased due to their relatively low cost.

The U.S. in vitro diagnostics market includes devices and reagents used for performing assays in vitro, Latin for “in glass,” which can be interpreted as in a controlled environment outside of the living organism. In the context of medicine, in vitro diagnostics involves testing of bodily fluids for diseases, conditions or infections. Test results are then used for monitoring disease progress and effects of treatment, or aiding in the diagnosis of disease. In vitro diagnostic testing can be performed in a variety of different environments, ranging from hospital laboratories and commercial reference laboratories care to physician offices and imaging centers.