In the modern medicine landscape, therapeutic drivers and innovative biotech products are crossing the milestones to treat chronic diseases such as Hepatitis B and cancer. Plasma-derived products such as protein albumin, antibodies, and fibrinogen are used for delivering therapies. Similar to other therapies, plasma-protein therapies that are obtained by fractionation of human blood play an essential role in treating bacterial infections, immunological disorders, deficiency of coagulation factors, and trauma.
Furthermore, plasma-derived protein exhibits a pathogen safety profile, due to this it is in high demand for treatments. Although the concept of plasma fractionation has been here for ages, in recent years, it has witnessed huge success, creating a new era of transformative therapies. Over time, the use of plasma fractionation has been expanded, and now the key marketing players have shown keen interest in designing plasma-derived medicinal products. With ongoing advancements and potential benefits of blood components in the treatment of diseases, the plasma fractionation market is expected to grow at a CAGR of ~10% during the forecast period.
What is Plasma Fractionation?
It refers to the process of separation of plasma components to use for life-saving therapies. The palms fractionation process is carried out using separation techniques such as centrifugation, precipitation, filtration, and separation. Dr. Edwin Cohn, an American Biochemist with his associates, developed the human plasma fractionation method during World War II. The components separated from the plasma were used to treat soldiers suffering from burns and shock during wartime. Cohn separated the protein albumin that represents around 55-60% of the total proteins available in plasma.
In modern times, fractionations are used in plasma therapies to treat immune deficiency disorder inactivation of viral contaminants such as Human Immunodeficiency Virus and Hepatitis Viruses. The plasma fractionation can be done in two ways.
- Whole Blood Plasma
This is known as recovered plasma, which is separated by a centrifugal machine from the cellular debris and cells of the whole blood.
This procedure involves the removal of blood from the donor and fractionated it into different components to obtain a particular protein. The remaining blood is then transferred back into the bloodstream of the donor. The process is done to remove disease-provoking components.
Types of Plasma Proteins Used in Therapies
Different types of plasma protein fractions that are used in the treatment of numerous diseases include:
- Albumin- 55.2%
- Globulins- 38.3%: α1-Globulin – 5.3% (α1-Antitrypsin, TBG, Transcortin, etc.), α2-Globulin – 8.6% (Haptoglobulin, ceruloplasmin, α2- macroglobulin, etc.), β-Globulin – 13.4% (β1-transferrin, β-lipoprotein, etc), ¥-Globulin – 11.0% (Antibodies, etc.)
- Fibrinogen- 6.5%
Currently, plasma manufacturing companies are focused on the fractionation of the following components.
It accounts for a major part of plasma protein (2.8-4.5gm/100ml). Albumin can be precipitated by using saturated ammonium sulfate. The serum albumin contains essential amino acids such as leucine, lysine, phenylalanine, arginine, threonine, and histidine. It helps in maintaining osmotic pressure and fluid balance in the body. This is usually used in the immediate treatment during trauma to recover fluid loss.
Immunoglobulins are the main component of globulins, and they are classified as IgA, IgG, and IgM. These immunoglobulins generate immunological reactions to fight against infection in the body. In some cases, these globulins are used for the treatment of diseases such as primary immunodeficiency.
It acts as a blood-coagulating factor and is used in the treatment of blood-clotting diseases such as Von Willebrand’s disease and hemophilia. When an injury occurs, fibrinogen, which is a plasma protein, is converted into fibrin that forms a clot to prevent bleeding and promote wound healing. It also helps to prevent the formation of blood clots that are formed in the blood vessels.
Types of Rare and Chronic Conditions That Can Be Treated With Plasma Therapy
In most cases, an antibiotic is the first choice to treat patients with rare diseases and chronic conditions. However, the constant use of antibiotics leads to drug resistance, due to which the patient’s body does not respond to the medicine. Plasma-derived therapies are alternatives for patients to treat rare diseases and chronic conditions listed below.
⬝ Primary Immunodeficiency Disease (PID): It is a genetic condition that affects the functioning of the immune system. Immune globulins are used to treat patients who are suffering from PIDs.
⬝ Hemophilia A: It is a hereditary bleeding disorder that results due to a lack of blood clotting factor VIII. The individual suffering from this rare disease experiences continuous bleeding after an injury and bleeding into the joints. The coagulating factors that are derived from plasma are used in the treatment of Hemophilia A.
⬝ Alpha-1 Antitrypsin Deficiency: The deficiency of Alpha-1 antitrypsin deficiency can cause liver and lung diseases in adults and children. Alpha-1 antitrypsin is used to treat patients with this hereditary disorder.
In addition, several chronic diseases are treated by using plasma-derived medicinal products.
How does Plasma Therapy Play An Integrated Role in the Healthcare Sector?
There is a rapid increase in the number of patients who are affected by rare diseases within the past few decades due to sedentary lifestyle and weak immunity. During pandemic outbreaks across the globe, researchers are looking to develop antidotes against Coronavirus. Plasma therapy, often known as convalescent plasma therapy, comes up as a lifesaver for healthcare sectors.
The therapy has been used worldwide for the treatment of patients having COVID-19 and suffering from liver dysfunction. Plasma fractionation serves as a strategic source for plasma-derived medicinal products.—PDMPs are listed as essential medicines by the World Health Organization for managing autoimmune disorders, bleeding emergencies, acquired immunodeficiencies, and protein-inherited disorders.
These plasma-derived products have the potential to treat such disorders; due to this, it becomes imperative for plasma fractionation companies to supply components uninterrupted. Driven by the rising interest in using blood components for treatment, the global plasma fractionation market is estimated to be worth $4.4 billion in 2023. It is expected to grow at a CAGR of ~10% in future, according to Roots Analysis
List of Plasma-Derived Medicinal Products (PDMPs) That Have Received Biologics License Application Approval
Human blood plasma is rich in different kinds of proteins that have therapeutic value and help to fight against infectious diseases. Out of all the plasma proteins, some of the PDMPs that have received Biologics License Applications approval are
⬝ Antihemophilic factor
⬝ Alpha-1 proteinase inhibitor
⬝ Antithrombin, coagulation factors
⬝ C1 esterase inhibitor
⬝ Immune globulins
In addition to the above-listed plasma products, the USFDA has approved the following blood components for the treatment of patients having chronic diseases including liver infection, shock, burns, pediatric hepatitis and infection:
⬝ Alpha antitrypsin
⬝ Antihemophilic factor/von Willebrand factor complex
⬝ Antihemophilic factor (recombinant)
⬝ Antithrombin (recombinant)
⬝ Anti-inhibitor coagulant complex
⬝ Profiling SD – factor IX complex
⬝ Kcentra (prothrombin complex concentrate, human) and protein C concentrate.
Currently, some of the leading plasma fractionation companies that are actively involved in the development of plasma fractionation include Grifols, Baxter, Octapharma, Kedrion, and Takeda Pharmaceutical.
Where will the Plasma Fractionation Market Reach in the Future?
With the ongoing improvement in fractionation techniques, plasma protein manufacturers are able to design advanced proteins for therapies. Moreover, the introduction of automated filter presses allows easy harvesting of protein, altering the speed of the fractionation press. In the future, the manufacturers will begin to use advanced techniques to design more plasma therapies that help to treat a wide range of diseases.
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