The global plasma fractionation market size was estimated at US$ 32.75 billion in 2023 and is projected to grow to US$ 72.86 billion by 2034, rising at a compound annual growth rate (CAGR) of 7.54% from 2024 to 2034. The rising therapeutic demand for plasma is boosting the plasma fractionation market.
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Plasma fractionation is a complex process to separate blood plasma into individual components, predominantly protein which includes clotting factors, albumin, immunoglobulins and fibrinogens, other components are enzymes and antibodies with phenomenal therapeutical values. Plasma fractionation is widely used in pharmaceutical research to treat chronic diseases. The worldwide rising demand for plasma derivatives due to increased immune disease, coagulation disorders and genetic defects is fuelling the market growth.
In September 2024, Epsilogen, a leading biotechnology company based in London, raised $16.4 million in a financing round to advance its development of immunoglobulin E (IgE) antibodies for cancer treatment. The funds were secured from major investors including British Patient Capital, the Novartis Venture Fund, Epidarex Capital, the 3B Future Health Fund, and ALSA Ventures. This investment highlights the growing interest in plasma-based therapies for cancer treatment.
In June 2024, Biotest, a global supplier of plasma protein products and biotherapeutic drugs, which is now controlled by Grifols, a global healthcare leader, received FDA approval for its Yimmugo product. Yimmugo is a treatment for primary humoral immunodeficiency (PI) in patients aged two years and older, marking an important development in the plasma fractionation sector.
In July 2024, the Independent Health and Aged Care Pricing Authority introduced Activity Based Funding (ABF) for home-delivered subcutaneous immunoglobulin (SCIg) infusion therapy. This new service enables patients to administer their therapy at home without the need for healthcare providers, further emphasizing the trend toward decentralized treatments in plasma fractionation.
Chromatography-based methods for plasma separation are rapidly gaining traction in the plasma fractionation market. These techniques offer several advantages, including improved purity and the ability to create novel therapeutic products. Plasma contains over 120 different proteins, and when these proteins are carefully separated and concentrated, they can be used to produce life-saving treatments for various conditions like immune deficiencies and bleeding disorders.
Currently, the majority of plasma fractionation technology still relies on the original ethanol-based protocols, primarily used to isolate albumin. However, for the development of new plasma-derived therapeutics, chromatographic techniques are crucial. These techniques can isolate even trace proteins, preserving the integrity of sensitive proteins like coagulation factors, anticoagulants, and protease inhibitors. Ion-exchange chromatography (IEC), in particular, allows proteins to be preserved in their original pH and ionic conditions, ensuring that even fragile proteins remain intact during the fractionation process.
One of the significant challenges in plasma fractionation is the potential risk of sepsis, a life-threatening condition that can arise from certain plasma protein imbalances. A study published in Science Translational Medicine identified a pattern in the plasma profiles of ICU patients who developed sepsis. Sepsis occurs when the body’s response to infection becomes dysregulated, leading to multiple organ failure. It is a major cause of death, with approximately 50,000 deaths occurring annually in the United Kingdom due to sepsis.
The study involved analyzing plasma samples from 16,000 patients, measuring protein levels through tandem mass spectrometry and liquid chromatography. The results provided a general plasma protein profile, which can help identify patients who are at risk of developing sepsis. This discovery underscores the importance of monitoring plasma protein levels during fractionation processes to minimize the risk of sepsis and other complications in patients receiving plasma-derived therapies.
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