The Role of Blood Plasma in Modern Medicine: An Overview of Plasma-Derived Medicinal Products

Introduction

Modern medicine has witnessed revolutionary advancements over the past century, many of which rely heavily on biological components extracted from the human body. Among these components, blood plasma plays a critical yet often overlooked role. Often referred to as the "liquid gold" of healthcare, plasma is the straw-colored liquid that makes up about 55% of human blood, serving as the carrier for cells, proteins, hormones, and waste products. What sets plasma apart is its unique therapeutic potential. Plasma contains life-saving proteins that cannot be synthetically replicated at scale, making it a vital resource for producing plasma-derived medicinal products (PDMPs). These products are essential in treating a variety of rare, chronic, and life-threatening conditions.

Definition

Blood plasma is the pale yellow, liquid component of blood that holds blood cells in suspension and contains water, proteins, electrolytes, hormones, and waste products. Plasma-derived medicinal products (PDMPs) are therapeutic substances manufactured from human plasma, including clotting factors, immunoglobulins, and albumin, used to treat a variety of serious health conditions such as bleeding disorders, immune deficiencies, and liver diseases.

Understanding Blood Plasma

Water makes up 90–92% of blood plasma, with the remaining 8–10% consisting of a complex mixture of essential proteins, electrolytes, enzymes, antibodies, and clotting factors. These components perform crucial roles such as maintaining blood pressure, pH balance, and immune defense.

The following are the proteins in plasma that are most clinically significant:

• Albumin: Maintains oncotic pressure and serves as a carrier for hormones, vitamins, and drugs.

• Immunoglobulins (Ig): Also known as antibodies, they are key to fighting infections.

• Clotting factors: Including Factor VIII and Factor IX, which are essential for blood coagulation.

Plasma is collected from healthy donors through two primary methods: whole blood donation and plasmapheresis, a process that separates plasma and returns the rest of the blood components to the donor. The collected plasma is then pooled, processed, and fractionated to produce PDMPs.

The Science Behind Plasma-Derived Medicinal Products

Plasma-derived medicinal products are therapeutic formulations created from plasma proteins through a process known as fractionation. This involves separating the plasma proteins based on their solubility and other properties, followed by purification and viral inactivation steps to ensure safety and efficacy.

PDMPs are used to treat a range of serious health conditions, particularly those that cannot be managed effectively with conventional synthetic drugs. Below are the most commonly used categories of PDMPs:

1. Immunoglobulins

Immunoglobulin therapy is indispensable for patients with primary immunodeficiency disorders (PIDs), where the body cannot produce sufficient antibodies. It is also used in autoimmune conditions like Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy (CIDP), and Kawasaki disease.

Intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) are the two main delivery formats, each chosen based on the patient’s condition and treatment needs.

2. Coagulation Factors

Patients with inherited bleeding disorders like hemophilia A (Factor VIII deficiency) and hemophilia B (Factor IX deficiency) rely on regular infusions of clotting factors to prevent or control bleeding episodes. Prior to the availability of PDMPs, these patients faced severe disability or early death. Today, thanks to plasma-derived factor concentrates and recombinant versions, their life expectancy has dramatically improved.

3. Albumin

Albumin is used to restore blood volume in patients undergoing major surgery, trauma, burns, or shock. It helps maintain blood pressure and transports various substances through the blood. Albumin’s use in critical care settings is well-established, particularly for treating hypoalbuminemia and acute liver failure.

4. Alpha-1 Antitrypsin

Alpha-1 antitrypsin (AAT) deficiency is a genetic disorder that can lead to severe lung disease (emphysema) or liver dysfunction. PDMPs containing AAT help manage this rare condition by replacing the deficient protein, thereby reducing the progression of lung damage.

5. Hyperimmune Globulins

These are specialized immunoglobulins derived from plasma of donors with high titers of specific antibodies, used for post-exposure prophylaxis. Examples include:

• Rabies immune globulin

• Hepatitis B immune globulin

• Tetanus immune globulin

• Varicella-zoster immune globulin

These products are critical in emergency situations where immediate immunity is needed.

The Global Importance of Plasma Donations

The only source of PDMP synthesis is voluntary plasma donations. Because red blood cells are returned to the donor, plasma can be donated more frequently than whole blood, usually twice a week. Global demand, however, is still higher than supply.

The United States currently supplies the majority of the world’s plasma, accounting for over 60% of global donations. This reliance on a single region poses a strategic risk to global health security. Many countries are now investing in domestic plasma collection programs to ensure self-sufficiency and resilience in their healthcare systems.

Regulatory Oversight and Safety

The process of creating PDMPs is intricate and heavily regulated. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce rigorous standards for donor screening, viral testing, and manufacturing practices. These safeguards have made plasma-derived therapies among the safest biologics available today.

Modern viral inactivation methods—such as solvent/detergent treatment, pasteurization, and nanofiltration—have virtually eliminated the risk of transmitting blood-borne pathogens like HIV and hepatitis C through PDMPs.

Innovations and Future Directions

The field of plasma medicine is constantly evolving. Research is ongoing into:

• Recombinant alternatives to plasma proteins to reduce dependency on human donations.

• Personalized medicine approaches, such as gene therapy for hemophilia, which may one day reduce the need for lifelong PDMP treatment.

• Expanded use of immunoglobulins in treating emerging viral diseases and neuroinflammatory conditions.

While recombinant products offer promising alternatives, they cannot yet replace the broad spectrum of benefits provided by plasma-derived products, especially in rare and complex cases.

Expansion Rate of Blood Plasma and Plasma Derived Medicinal Products Market

According to Data Bridge Market Research, the size of the global blood plasma & plasma derived medicinal products market was estimated at USD 34.88 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 7.65% to reach USD 62.66 billion by 2032.

Read More: https://www.databridgemarketresearch.com/reports/global-blood-plasma-and-plasma-derived-medicinal-products-market

Conclusion

Blood plasma is a cornerstone of modern medicine, offering a lifeline to millions of patients worldwide. Plasma-derived medicinal products have transformed the prognosis of conditions once considered incurable or fatal. From immunodeficiencies to bleeding disorders and emergency prophylaxis, PDMPs provide targeted, life-saving treatments that are unmatched by synthetic drugs.