Challenges for Plasma-Derived Medicinal Products

Area of Science:

• Biotechnology and Pharmaceutical Sciences
• Public Health and Healthcare Policy

Background:

• Plasma-derived medicinal products (PDMPs) are essential medicines derived from human plasma.
• PDMPs are critical for treating immune deficiencies, autoimmune diseases, bleeding disorders, and congenital conditions.
• The primary source of plasma for PDMP manufacturing is currently the USA.

Purpose of the Study:

• To highlight the critical dependence of PDMP treatments on plasma supply.
• To address the challenges leading to regional and global shortages of essential PDMPs.
• To advocate for strategic resource management of plasma and explore market limitations for PDMPs.

Main Methods:

• Review of current plasma collection and PDMP manufacturing practices.
• Analysis of global plasma supply chain dynamics and identified shortages.
• Examination of policy implications for plasma as a strategic resource.

Main Results:

• Global plasma collection imbalances are causing shortages of essential PDMPs.
• The reliance on a single region (USA) for plasma poses a risk to supply chain stability.
• Increased plasma collection outside the USA, including in LMICs, is necessary.

Conclusions:

• Plasma should be recognized as a strategic resource, similar to energy or rare materials.
• The free market model for PDMPs may have limitations, necessitating protective measures.
• Diversifying plasma collection sources is essential to safeguard patient access to life-saving PDMPs.