Understanding supply sustainability of plasma-derived medicinal products: Drivers and consequences of shortages

Plasma-derived medicinal products (PDMPs), particularly immunoglobulins (Igs), are essential treatments for numerous diseases, often serving as the primary therapeutic option and playing a critical role in patient care. The human origin of these products, however, can lead to supply constraints due to a lack of plasma collection, market dynamics, regulatory challenges and manufacturing complexities. Many nations lack plasma self-sufficiency and often rely on the United States, which supplies approximately 70% of the world's plasma. This supply chain is vulnerable to disruptions, such as those caused by COVID-19. Additionally, plasma processing timelines are lengthy-Ig manufacturing takes 7-12 months compared with 2-3 months for biologics. Despite the global Ig market's projected growth from $13.36 billion to $24.98 billion between 2023 and 2032, plasma shortages persist. The European Medicines Agency anticipated shortages to affect 14 European countries in 2024. These factors can have significant implications for patients, with growing demand likely leading to supply challenges and forcing countries to prioritize certain indications in the face of shortages. Policy interventions may be needed to ensure the sustainable use of these products in treating immune-mediated disorders and related conditions. Exploring alternative treatments where possible could also mitigate the risk of shortages and maintain access to these life-saving therapies. This review examines the sustainability of PDMPs, focusing on drivers and consequences of shortages, insufficient plasma collection, vulnerability of the plasma supply chain and impacts on patients. A scoping literature research was conducted in PubMed, supplemented by internal knowledge and targeted web searches.