Plasma Fractionation Market Size, Share, Competitive Landscape and Trend Analysis Report 2030

 Plasma fractionation is a highly sophisticated biotechnological process that separates human blood plasma into its individual components, enabling the production of life-saving therapies. This process is crucial in modern medicine and contributes to the treatment of a wide range of diseases, including immunodeficiencies, hemophilia, burns, liver disease, and more. In this blog post, we’ll explore what plasma fractionation is, how it works, and the vital role it plays in global healthcare.

The global plasma fractionation market was valued at $18,222 million in 2019, and is expected to reach $23,006 million by 2027, registering a CAGR of 6.2% from 2020 to 2027.

What is Plasma Fractionation?

Plasma fractionation refers to the method of separating plasma into its constituent proteins, including albumin, immunoglobulins, clotting factors, and other essential proteins. These proteins are then purified and processed into specific therapeutic products.

Plasma is the liquid portion of blood and makes up about 55% of its total volume. It is primarily composed of water, electrolytes, proteins, hormones, and waste products. The key proteins extracted from plasma during fractionation serve a variety of therapeutic functions. They can help replace missing proteins in patients who have conditions that affect their blood’s ability to function properly.

The Importance of Plasma Fractionation in Medicine

Plasma-derived therapies have made a profound impact on the treatment of many medical conditions. Some of the most notable examples include:

• Immunoglobulins (IVIG): These are antibodies that are extracted from plasma and used to treat immune deficiencies and autoimmune diseases. IVIG therapies help patients by boosting their immune response, offering protection against infections, and modulating immune system activity.
• Albumin: A protein that helps maintain blood volume and pressure. It is used in treating conditions such as burns, shock, liver cirrhosis, and nephrotic syndrome, where albumin levels are dangerously low.
• Coagulation Factors: Plasma fractionation produces clotting factors like Factor VIII and Factor IX, which are used to treat hemophilia, a genetic disorder that prevents blood from clotting properly. These treatments are often life-saving for individuals with bleeding disorders.
• Alpha-1 Antitrypsin (AAT): A protein extracted from plasma that is used in treating genetic conditions like Alpha-1 antitrypsin deficiency, which leads to lung damage and emphysema.

These products are indispensable in managing a variety of chronic diseases, emergency situations, and even rare genetic disorders.

The Plasma Fractionation Process

Plasma fractionation involves several key stages, each of which is designed to ensure the purity and safety of the final therapeutic products:

1. Collection of Plasma: Blood donors provide the plasma, which is then collected and transported to specialized facilities for processing. Donors undergo a rigorous screening process to ensure that their plasma is safe and suitable for therapeutic use.
2. Separation: The first step in the fractionation process is to separate the plasma proteins from the other components of the blood (such as red blood cells, white blood cells, and platelets). This is typically done through a process called centrifugation, where the plasma is spun at high speeds to separate its components based on density.
3. Precipitation: The separated plasma is then treated with chemical agents (often solvents or salts) that precipitate out specific proteins. This allows for the separation of distinct fractions, including albumin, clotting factors, and immunoglobulins.
4. Purification: After precipitation, the proteins are purified using techniques like chromatography, filtration, and viral inactivation to ensure that the final products are free from contaminants, including viruses and bacteria.
5. Formulation and Packaging: The purified proteins are then concentrated, formulated into therapeutic solutions, and packaged into vials, ready for distribution to healthcare providers.
6. Quality Control: Throughout the entire fractionation process, rigorous testing is conducted to ensure the purity, potency, and safety of the final products. This includes checking for microbial contamination, ensuring correct protein levels, and verifying the absence of any harmful substances.

Safety and Ethical Considerations

Given that plasma fractionation involves human biological material, it is crucial to maintain the highest standards of safety, quality, and ethics. Plasma donation is voluntary, and donors are thoroughly screened for potential infections and diseases, such as HIV, hepatitis, and other transmissible diseases. Modern fractionation techniques also include rigorous viral inactivation steps to further reduce the risk of contamination.

Additionally, plasma products are strictly regulated by global health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These organizations oversee the entire process, from donor screening to product distribution, to ensure public safety.

The Global Demand for Plasma

The global demand for plasma-derived therapies has been steadily rising due to an aging population, increasing incidences of chronic diseases, and improvements in medical technology. Plasma donation is a critical component of the healthcare system in many countries, as the process is labor-intensive, time-consuming, and requires highly specialized facilities.

For example, in the United States, approximately 130 million liters of human blood plasma are collected annually, and the majority of this plasma is used in fractionation to produce therapeutic products. Countries like Germany and China are also major contributors to the global plasma supply.

Despite the growing demand, there is often a shortage of plasma donations, making it essential for health authorities and organizations to continue educating the public on the importance of voluntary blood and plasma donation.

Conclusion

Plasma fractionation plays an essential role in producing life-saving treatments for individuals around the world. By separating plasma into its individual components and purifying the proteins, we can provide targeted therapies for conditions such as immune deficiencies, hemophilia, burns, and many other chronic and acute diseases. As the need for these therapies continues to rise, ensuring a steady supply of safe and high-quality plasma will remain a priority for the healthcare industry.