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.

中文翻译：

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意大利血浆衍生医药产品自给自足的血浆收费分馏趋势

背景和目标：在意大利，直到 2014 年仅由一家公司进行的国内血浆收费分馏，获得不同技术和产品以及价格竞争的机会有限。2017 年，四家公司充当了 827,720 公斤血浆的竞争性收费分馏厂。在这里，我们评估了收费制造的贡献和竞争对国家自给自足的影响。结果：新的分馏器增加了免疫球蛋白的产量（11-41%，在一些地区足以自给自足），尽管需求的增加仍需要市场贡献。白蛋白使用量的下降（2015 年相比 2014 年减少了 2.6%）可能是由于更好地控制了令人印象深刻的高需求（2015 年为 35.4 吨）。VIII因子的需求仍高于产量，但国内血浆不能作为其唯一来源。新的招标扩大了产品组合，因子 IX、凝血酶原复合物浓缩物、抗凝血酶、纤维蛋白原和 α-1-抗胰蛋白酶的理论自给自足。结血浆衍生医药产品自给自足计划。