Plasma: record harvest in Italy but self-sufficiency is far away

The demand for immunoglobulins is growing: preliminary data presented at the conference organized by the National Blood Center

Record growth for plasma collection but self-sufficiency is even further away. It is the paradox that emerges from the second edition of “The Supply of Plasma-derived Medicinal Products in the Future of Europe“, The international conference dedicated to plasmasponsored by Ministry of Health and organized by National Blood Center, which represented an opportunity for debate and discussion between experts and policy makers, donor and patient associations and Italian, European and international institutions.

According to the still preliminary data, shared during the conference by the CNS experts, regarding the immunoglobulinsa driver product in the plasma-derived medicines market, Italy has reached a self-sufficiency level of 62% in 2023two percentage points lower than the previous year, when the self-sufficiency rate was 64. The paradoxical aspect is represented by the data of 2023 collection who, with his 880 thousand kilos of plasmathe result of the generous donations of approximately 1.5 million donors, has reached the highest levels ever for Italy.

What distanced our Parse from the strategic goal of autonomy in the field of plasma derivatives was a marked increase in the demand for immunoglobulins, increased from approximately 104 grams per thousand inhabitants in 2022 to 108 in 2023. The preliminary data is partly mitigated by the increase in the level of self-sufficiency in albumin, another market driver, which went from 72% in 2022 to 78% in 2023, also thanks to a decline in demand.

Italy, which is self-sufficient in terms of the collection of red blood cells, must therefore resort to the international market to meet the demand for plasma derivatives and integrate medicines, also used in life-saving therapyproduced from plasma collected from voluntary, anonymous and unpaid donations.

“The lack of self-sufficiency of plasma-derived medicines remains a strategic problem for the national health system”, is the comment of the director of the CNS, Vincenzo de Angelis, at the conclusion of the conference work and the comparison of experiences and perspectives on the future of plasma collection. “The data, although still preliminary – continues De Angelis – confirm the need to increase collection through awareness-raising actions aimed at possible new donors, but this is not enough. It will also be necessary to rationalize demand, especially for a product like immunoglobulins which is finding more and more applications at a therapeutic level. It is an objective on which we are already working with many Italian and European partners, because COVID has shown that, in particular and often unpredictable situations, the international market cannot always respond to the demand of our patients”.

Plasma donation is a collection carried out using a device (cell separator) which immediately separates the corpuscular part, i.e. red and white blood cells and platelets, from the liquid component which is collected in a bag of approximately 600-700 ml. The corpuscular part is reinfused into the donor. The volume of liquid that is removed with the donation is reconstituted thanks to natural recovery mechanisms, the infusion of physiological solution and the intake of liquids.

The plasma is delivered to the pharmaceutical industry where it will be used to produce life-saving medicines, the so-called plasma derivatives, such as immunoglobulins, albumin or coagulation factors. Medicines produced with donated plasma are not used for commercial purposes; once the manufacturing process is finished, they are returned to the Healthcare Facilities of the Italian Regions and Autonomous Provinces. Plasma-derived drugs are distributed free of charge to patients who need them and any batches exceeding national needs are donated to countries in difficulty through international collaboration programs.

 
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