Human Blood Plasma is a unique material, where we are just scratching the surface of its potential therapeutic use. As this industry continues to grow, so too does the complexity of managing its supply chain.

To provide a simplified overview of the different actors, the pictures below depict the three main ones in this tightly interconnected supply chain.

• Donors & Donor Centres
• Plasma Logistics
• Manufacturing

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In order to gain an understanding of the current macro supply chain complexities, we try to explain them through the most influencing factors, being economic, ethical, quality and complex global supply & demand.

‍Economic

Economic factors exert a significant influence on the blood plasma supply chain. In the United States, a notable aspect is the practice of providing donor compensation for their time and commitment to donating plasma ⁶. This practice has made the US a major contributor to the global plasma supply. Various donor compensation models are employed, including direct payments per donation, loyalty programs that reward frequent donors, and referral bonuses ⁷. The costs associated with plasma collection, including donor compensation, and the complex manufacturing processes involved in fractionation significantly impact the overall pricing of plasma-derived products ⁸. The market for plasma protein therapeutics is substantial and continues to experience significant growth, which in turn influences investment decisions and fosters innovation within the sector ⁹. The economic incentives provided to donors in certain regions play a crucial role in securing the necessary plasma supply, particularly in the US, which has a considerable impact on the global market dynamics. The overall economics of the supply chain, encompassing donor compensation, manufacturing costs, and market demand, ultimately shape both donor behaviour and the accessibility of these essential therapies for patients.

Ethics

Beyond the operational and economic considerations, the blood plasma supply chain also raises important ethical considerations. A significant debate revolves around the ethics of paying individuals for their plasma donations, with concerns raised about the potential for exploiting vulnerable populations who may be motivated by financial need ¹⁰. Organizations like the WHO strongly advocate for a system based on voluntary, non-remunerated donations ¹¹. Another critical ethical consideration is ensuring equitable access to plasma-derived therapies for all patients who require them, regardless of their socioeconomic status or geographical location, particularly given that these therapies can often be expensive ¹². The observed trend of commercial plasma centres being located in lower-income urban areas also raises questions about social equity and the potential for these centres to disproportionately impact certain communities ¹⁰. These ethical dimensions, particularly the ongoing discussion surrounding paid versus voluntary donation and the challenges of achieving global access to these life-saving medicines, represent critical considerations for ensuring the long-term sustainability and social responsibility of the blood plasma supply chain. Balancing the imperative of securing a sufficient plasma supply with fundamental ethical principles related to donor well-being and equitable patient access requires ongoing careful consideration and the development of thoughtful policies.

Quality

The blood plasma supply chain, while delivering life-saving therapies, faces a unique set of complexities and challenges. One significant aspect is the inherent nature of blood plasma as a biological raw material with a limited shelf life ¹. Like other blood components, plasma is perishable and requires specific storage conditions, primarily in a frozen state, to maintain its integrity and therapeutic properties. This necessitates a robust and meticulously managed cold chain throughout the entire supply chain, from the point of collection to its eventual use in manufacturing or transfusion ². Maintaining the correct frozen temperatures is crucial to prevent the degradation of essential proteins and ensure the efficacy of the final products. Furthermore, once thawed, plasma components have a limited time frame within which they must be used. This perishability adds a layer of complexity to inventory management and logistics, requiring careful forecasting of demand and efficient processing to minimize waste and ensure timely availability for patients with urgent needs. The inherent variability in blood and plasma donations, coupled with the often unpredictable and stochastic nature of patient needs for blood products, further complicates the task of effectively matching supply and demand ³.

Supply & Demand

These complex global supply and demand dynamics, lead to the potential for shortages. The global demand for plasma-derived therapies has been steadily increasing, placing considerable pressure on the existing supply chain infrastructure ⁴. Notably, Europe exhibits a significant dependence on plasma imports from the United States due to an existing imbalance in the global collection of plasma needed for the production of plasma-derived medicinal products (PDMPs) ⁵. Unforeseen events, such as the COVID-19 pandemic, can also have a substantial impact on plasma donation rates, leading to significant shortages of critical plasma-derived therapies ⁵. Ensuring a sufficient and consistent supply of plasma necessitates ongoing and proactive efforts in donor recruitment, along with the implementation of efficient and streamlined collection processes ⁶. The global nature of this supply chain means that regional imbalances in plasma collection and unforeseen disruptions in one part of the world can have far-reaching consequences for patients globally.

In the next blog we will share insights in how Aegis can support navigating the complexity of the plasma supply chain.

Citations

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