血液バンクにおける分子診断の活用

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?fs 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 follwing 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)
• Others

The report outlines issues and barriers such as costs and regulation, and profiles three key industry participants.

OVERVIEW

SCOPE AND METHODOLOGY

MARKET CONTEXT

• Exhibit 1: Distribution of Molecular Diagnostics Testing in the United States, 2004

BLOOD BANKING PRACTICES, TRENDS, REGULATION

COST AND OTHER BARRIERS

PRODUCTS OF NOTE

• Exhibit 5: Commercially Available Molecular (Nucleic Acid) Tests for Blood, Plasma and Organ Donor Screening in the United States: 2004

NUMBER OF TESTS

• Exhibit 2: Projected Blood Banking and Plasmapheresis Testing by Molecular Diagnostics in the United States: 2003-2013
• Exhibit 3: Trending in the Projected Number of Blood Banking and Plasmapheresis Tests by Molecular Diagnostics in the United States: 2003-2013
• Exhibit 4: Trending in the Percentage Distribution of Blood Banking and Plasma-pheresis Tests by Molecular Diagnostics in the United States 2003-2013

MARKET AND COST PER TEST PROJECTIONS, 2003-2013

• Exhibit 5: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the United States: 2003-2013
• Exhibit 6: Trending in the Projected Test Volume for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
• Exhibit 7: Trending in the Projected Test Volume Composition for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
• Exhibit 8: Trending in the Projected Market Potential for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
• Exhibit 9: Trending in the Projected Market Potential Composition for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013
• Exhibit 10: Trending in the Projected Average Cost Per Test for Molecular Diagnostics in Blood Banking Applications in the United States: 2003-2013

MAJOR COMPETITORS

• Abbott Diagnostics (Division of Abbott Laboratories)
• Chiron Corp.
• Gen-Probe Inc.