Blood banking has been the most dynamic testing segment to adopt molecular diagnostics approaches since their introduction. Screening for HIV, HCV and HBV in donated blood, plasma and organs has largely been done by immunoassay procedures. In conjunction with background screening, this has become a very effective approach toward guaranteeing the safety of the blood/organ supply. However, there is a lag time between infection with these viruses and the production of antibodies against them. In some cases, such as HBV, it has been possible to provide viral surface antigen assays, but even these do not indicate the earliest infections. The use of molecular diagnostics has the power to pick up early infections, before antibodies or surface antigens are in high enough quantities in the blood to be assayed.
This summary report, extracted from Kalorama Information’s U.S. Market for Molecular Diagnostics, (2nd Edition, May 2004), focuses on the technologies and application of molecular diagnostics in the field of blood banking. It is designed to give an overview of the market environment for these types of tests in the blood banking and plasmapheresis area. The essential data sets include number of tests, estimated cost per test, and market potential (in U.S. dollars) for the years 2003 to 2013 for molecular tests in the following areas:
- Human immunodeficiency virus (HIV)
- Hepatitis A virus (HAV)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Human T-cell leukemia virus (HTLV)
- West Nile virus (WNV)
The report outlines issues and barriers such as costs and regulation, and profiles three key industry participants.