OBJECTIVES: Plasma-Derived Medicinal Products (PDMPs), especially Immunoglobulins (Igs), are essential treatment options for numerous conditions. At the same time, these products can face supply constraints due to regulatory challenges and market dynamics, which can impact patient access. This research aims to understand the factors impacting supply and availability of PDMPs/Igs to support optimization of patient care.

METHODS: A scoping literature review was conducted in April 2024 using PubMed and targeted literature searches. Two authors screened titles and abstracts. Studies were excluded if they:

• Focused on clinical/biological aspects
• Were outside date (2008-2024) or geographic (Europe, US, Canada, Australia) scope
• Were not in English

RESULTS: Of 6,842 articles, 101 were included. Findings highlight that while global Ig use is increasing (market size expected to increase from $13.36 - $24.98 billion between 2023-2032), there have been instances of plasma shortages worldwide, an issue the European Medicines Agency expects to continue in 2024 for 14 European countries. There is a lack of self-sufficiency in many countries due to factors like donor scarcity and reliance on the US, which supplies ~70% of global plasma. This supply and demand structure is susceptible to unexpected external disruptions (e.g., COVID-19), and plasma processing timelines (e.g. Ig manufacturing process is 7-12 months vs. 2-3 months for traditional pharmaceuticals). These factors have implications for patients: PDMP/Ig supply is expected to be increasingly challenging in the context of growing demand, which can lead to countries prioritizing indications, especially during shortages.

CONCLUSIONS: PDMPs/Igs are and will continue to be essential treatments for several conditions. Their sustainable and effective use can be facilitated through supportive policies for supply sustainability, and exploring alternative treatment options where possible to help reduce dependency, minimise risk of shortages and better ensure continued patient access to life-saving therapies.