Diagnostics companies sell instruments and tests for the diagnosis and analysis of a disease or condition. The results of testing cause roughly 75% of health care decisions. It is therefore a high value-added activity.
Diagnostics (Dx) is a roughly $50 billion annual industry growing in the mid-single digits annually. Dx has numerous sub-segments with differing rates of growth. In vitro diagnostics (IVD), a roughly $33 billion sub-market of Dx, are tests performed outside of the body.
Within the IVD market, immunoassay diagnostics (IADx) is growing, at a roughly 7% compound annual growth rate (CAGR), and it is estimated that it will have reached more than $9.3 billion by 2012. Rapid IADx testing has potential for significantly improved clinical sensitivity and specificity by detecting microorganisms, bacteria, viruses and cancer cells, based on identification of protein biomarkers.
Key sub-markets within IADx include infectious disease and cardiac testing. IBI is currently developing new assays using its BioFlash-Dx™ technology to address market needs in infectious disease and has an interest in cardiac testing.
Detection and screening for infectious diseases is the largest and one of the most established sub-markets within IADx, growing at 8.1% CAGR and expected to reach $12.4 billion in 2013. There is broad interest and increasing desire to use IADx methods to screen and detect infectious diseases, like drug resistant Tuberculosis, MRSA, C. difficile, Influenza and Encephalitis. Also, there is a desire to perform rapid drug susceptibility testing.
Screening and early diagnosis for cardiovascular diseases is becoming increasingly important in managing patients and health care costs. Through biosensor testing, there is potential for significantly improved clinical sensitivity and specificity in the early detection of such diseases based on identification of protein markers.