Introduction: The role of Plasma-Derived Medicinal Products (PDMPs) in managing life-threatening diseases is remarkable. Human plasma as a raw material for PDMPs is obtained from volunteers through apheresis or whole blood collection. The global PDMPs market in 2021 shows an average annual growth rate of 7.4% since 1996 which is higher than the average annual pharmaceutical market growth rate. In line with WHO policies, Iran has improved its national voluntary non-remunerated donors (VNRD) program to supply the local PDMPs market. This study shows the 10-year Iran PDMPs market evolution to assess its Self-sufficiency.
Method: We conducted a cross-sectional study from 2012 to 2021 to assess the Self-sufficiency rate of Iran’s plasma industry for PDMPs including Albumin, Immune globulins, and Antihemophilic Factors. In addition, we show the gap between market supply and demand to lighten the Self-sufficiency future.
Result: The annual growth rate of total collected plasma was 18.9% over 10 years in Iran from 2012 to 2021. Although the consumption rate of intravenous Immune globulins has increased from 777 kg to 2,108 Kg, due to a significant increase in local plasma production, its Self-sufficiency rate increased from 53% to 93%. Similarly, the demand rate for Albumin grew from 21% in 2012 to 90% in 2021.
Discussion: Although local plasma production in Iran significantly provided plasma Self-sufficiency as a raw material, local market demand for PDMPs is mainly supplied through contract fractionation with European fractionators. Access to complete Self-sufficiency in Iran needs increasing plasma production, as well as developing major local plasma fractionators.