Analytical Framework for Examining the Value of Antibacterial Products. 5.1.12 Expected Percentage Reduction in Revenues due to Increased Competition


The market for rapid POC diagnostics is competitive, especially for those infectious diseases that have the potential to impact sizeable populations, such as influenza and Group A Streptococcus. MRSA is one such market as there are many different strains of MRSA affecting a large number of individuals in many different healthcare settings at present (Collier, 2004).

Unlike antibacterial drugs, rapid POC diagnostics do not have marketing exclusivity protections that would prevent other device manufacturers from market entry for a specified time period.  Thus, we assume that other manufacturers of rapid POC diagnostics for MRSA will enter the market over time reducing revenues to the developer.  According to research by ECRI (2008), FDA provided GeneOhm Sciences with 510(k) marketing clearance for their IDI-MRSA Assay (also known as the BD GeneOhm MRSA Assay) in March 2004.  Approximately 3 years later, FDA provided Cepheid Inc. with 510(k) clearance for their Xpert MRSA Assay (ECRI Institute, 2008).  Thus, for the model, we estimate the average time for experiencing a reduction in market share for a rapid POC diagnostic manufacturer at 3 years.  Similar to antibacterial drugs, we further estimate reduction in revenues due to increased competition at 50 percent.

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