Plasma collection is still record breaking. The increase, marked for the second consecutive year, made it possible to exceed the threshold of 900 thousand kg of plasma sent for industrial fractionation, never reached before in the history of our country. This extraordinary result, achieved thanks to the generosity of Italian donors, allows us to take a further step in the complex path that leads Italy towards self-sufficiency in plasma-derived medicines.

In 2024, 906,938 kilos of plasma were sent to the industry for the production of plasma-derived medicines, a figure which represents an increase of 3% compared to the 880,000 delivered in 2023, to which must be added 15,141 kilos destined for the production of Solvent/Detergent virus inactivated plasma. In Italy, 15.4 kilos of plasma were sent to industrial fractionation for every 1,000 inhabitants (in 2023 this rate stood at 14.9). The objective of 18 kilos per 1,000 inhabitants indicated as the reference value for achieving strategic independence from the foreign market for immunoglobulins, the market driver product, is therefore approaching.

Plasma is the liquid part of the blood, which can be donated either through a simple donation of whole blood or through plasmapheresis. It is mainly used to produce the so-called plasma derivatives (i.e. Albumin and Immunoglobulins) which are the basis of numerous life saving therapies. However, the medicines produced with plasma donated by Italian donors are not sufficient to cover the needs of our patients and therefore, every year, the National Health Service must resort to the foreign market to procure the necessary medicines. This dependence exposes our country to the risk of shortages, as the COVID period also confirmed when the difficulties recorded globally translated into the difficulty of obtaining drugs as well as a general increase in prices.

Even though self-sufficiency is still a long way off, the path taken by the Italian blood system seems to be the right one. The quantity of plasma for fractionation delivered to the industry is well above pre-COVID levels (+5.6% compared to 2019) with a delivery rate per 1,000 inhabitants which at the time was 14.2 kilos.

Regarding the plasma sent to the industry for the production of medicines, the objective achieved was higher than the one set in the National Self-sufficiency Program by approximately 35 thousand kilos (+4%). Many territories have contributed to this increase compared to 2023, showing a significant effort, such as the Autonomous Provinces of Trento and Bolzano (respectively +9% and +8%), the Basilicata and Piedmont Regions (+8%) and Emilia-Romagna (+7%), while the commitment of Regions such as Marche and Friuli Venezia Giulia remains unchanged, confirming themselves as those that provide the most plasma in relation to the number of inhabitants, with a contribution rate equal to 23.9 kilos per 1,000 inhabitants for the Marche and 24.8 kilos per 1000 inhabitants for Friuli.

Orazio Schillaci, Minister of Health, states: “The trend of positive results, relating to plasma collection which follow those of blood donation in general, confirms the importance of the communication initiatives carried out in recent years. It also confirms the fundamental value of the network and the synergistic collaboration between institutions and the territory through a consolidated model which saw the active participation of various actors involved in the widespread diffusion of the donation message I thank all the donors, associations, operators and volunteers, aware that there is further room for improvement in the actions to be taken to raise awareness among the population of the importance of a gesture of great generosity that contributes to saving human lives.”

Vincenzo De Angelis, director of the National Blood Centre, comments: “These new results are sensational but represent, inevitably, only an intermediate step. The importance of plasma-derived medicines for the well-being and health of patients, both Italian and from all over the world, is increasingly predominant. The Italian blood system is well aware of this, as evidenced by the excellent work carried out both at an institutional level and at a hospital and association level, from the head doctors to the individual volunteer. A job that professionals in the sector carry out with dedication and resilience at the service of that great resource which is the generosity of donors, without which all this would be a vain effort. The objective has not yet been achieved but today more than ever it seems within reach and it is not a trivial thing, especially after the years of COVID and its variants which had made us take many steps backwards”.

Paolo Monorchio, blood donation manager of the Italian Red Cross and temporary coordinator of CIVIS, the acronym that brings together the main associations of blood donors, declares: “The extraordinary result obtained in terms of plasma donations, which we remember is based on totally voluntary and unpaid donation is based on the intense and fruitful collaboration between Donor Associations, Transfusion Centers and Health Institutions and is confirmed as an added value of the Italian transfusion system. The synergistic work between the world of Volunteering and the CNS represents the fundamental guarantee that in Italy the system remains ethical and supportive and that it protects donor and recipient. CIVIS and the entire world of volunteering with its associations confirm their constant and incessant commitment in raising awareness, in particular, of the new generations and in promoting not only periodic, voluntary, anonymous blood and plasma donation, but of a wider participation of active citizens, attentive to the needs and requirements of the community and in particular of the sick and the most vulnerable”.

Plasmapheresis
It is dedicated 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 production of drugs from national plasma
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 medicines are distributed free of charge to patients who need them and any batches exceeding national needs are donated to other countries through international collaboration programs.