Blood Products and the Advent of Recombinants
Clotting factors were unavailable before the 1960s. From then, until the early 1980’s, they were supplied only from processed human blood plasma (fractionation). The infection of 75% of the world’s haemophiliac population with HIV through tainted blood products, however, caused a significant review of blood product production processes, and aided the introduction of the recombinant products. More recently, concerns over the transmission of variant Creutsfeld Jacob Disease (vCJD) and Hepatitis C virus have further led to a greater demand for the recombinant versions.
Fractionation, the process of extracting the various components of human plasma, including the clotting factors, was already an expensive process. The added requirement of monoclonal antibody purification simply served to increase the cost and support the high prices charged for the recombinant products. Despite these premium prices, recombinant products have ~80% of the market in the industrialised nations. Plasma derived product is still used; though supply in Europe is now sourced principally from the USA where there is a perceived reduced risk from vCJD. Fractionation from human plasma, however, continues to be limited due to limited blood and plasma donations.
Blood products were always subject to significant government control, particularly in Europe where fractionation plants were often operated as government agencies. The introduction of recombinant products served to fill the gap left by the reduction in supply caused by the increased purity demands on blood-derived product. With patient pressure on the FDA to approve, and patent protection, the recombinant products rapidly gained market share and the markets remain remarkably free of competing manufacturers.
Nevertheless, the market, previously dominated for more than 25 years by Baxter, Bayer, CSL-Behring and Pfizer, has seen new entrants in Biogen-Idec, Novo Nordisk and Octapharma adding to the volume of product available to treat more patients. The market value of recombinant Factor VIII exceeds $6BN per year.