Trends in Plasma Toll Fractionation for Self Sufficiency of Plasma-Derived Medicinal Products in Italy

Background and Aims: In Italy, domestic plasma toll fractionation, performed until 2014 by only one company, had limited access to different technologies and products and to price competition. In 2017, four companies acted as competitive toll fractionators for 827,720 kg of plasma. Here, we evaluate the contribution of toll manufacturing and the effects of competition on national self-sufficiency. Results: An increase in immunoglobulin production is granted by new fractionators (11-41%, in some regions adequate for self-sufficiency), although the rise in demand will still require market contribution. The decrease in albumin use (-2.6% in 2015 vs. 2014) is probably due to a better control of an impressively high demand (35.4 t in 2015). Factor VIII demand is still higher than production, but domestic plasma cannot serve as its unique source. New tenders enlarged the portfolio of products and a theoretical self-sufficiency is granted for Factor IX, prothrombin complex concentrates, antithrombin, fibrinogen, and alpha-1-antithrypsin. Conclusions: Competition among companies resulted in higher yields of albumin and immunoglobulin, decreasing their level of market dependence, an increase in the portfolio of medicines, and a decrease in price due to fractionation (20-30%), thus improving perspectives of the national program for self-sufficiency in plasma-derived medicinal products.