Year: 2009
Type: article
Abstract: From albumin to IVIG through factor VIII: The three phases of the plasma industry historical developmentOver the past fifty years, the plasma industry has gone through three phases, each one characterized by a different market driver: AlbuminFrom the 1950's through the late 1960's, the demand for human albumin determined the industry's plasma processing levels: the quantity of plasma processed by the fractionation plants was calculated to generate just enough albumin as was necessary to meet the market demand.Immunoglobulins were considered as by-products, and were available in large quantities that far exceeded their demand.Some of them could not be used commercially because of their low quality, and some was destroyed after sitting on the shelves for several years.Back then, the clinical potential of immunoglobulins for treating immune deficiencies had not yet been recognized.Furthermore, the purity, quality and safety of these products were much lower than the immunoglobulins available today and their administration through the intramuscular route was cumbersome and hampered their clinical efficacy. Factor VIIIIn the late 1960's, factor VIII concentrates began to be commercially available, and factor IX a few years later.These products not only changed the lives of hemophilia A and B patients but altered the industry's focus as well: from that point in time, the plasma fractionators strived to meet the growing demand for antihemophilic factor VIII concentrate.This product soon became the market driver, replacing human albumin in this role, as the volume of plasma processed was determined by the demand for plasma-derived factor VIII.In 1992, the volume of plasma available (recovered and source) for fractionation in the US was about 8 million liters.In 1982, polyvalent intravenous immune globulin (IVIG) was launched in the United States (it was already available in Germany and Japan) by Sandoz and Cutter.
Source: Pharmaceuticals Policy and Law
Author: Patrick Robert
Language: English
Subfield: Management of Technology and Innovation
Domain: Social Sciences
Open Access status: bronze
OpenAlex ID: W1572509751