03/26/2024
As the supplier of 70% of the world's plasma, plasma donors in the United States continue to be critical to the health and well-being of millions of people around the world. The plasma ecosystem has been growing for a variety of reasons, and the need for plasma-derived products is projected to continue to increase into the future.
Plasma is one of the most critical components of blood. It makes up 55% of blood, and though it is 90% water, it carries cells, enzymes, and proteins throughout the body. More patients requiring more regular treatment with plasma-based products is the main driver for the continued increase in the need for plasma. But where are these patients coming from?
Currently, approximately 15-20 of the 2000 proteins in plasma are fractionated for medical use. As the industry continues innovation to separate out more crucial elements of plasma, more rare conditions will be able to be treated. For example, a study published in Communications Biology, showed that an ultra-rare adult-onset neurological disease caused by iron accumulation, which might be able to be treated with ceruloplasmin. The protein can be purified from a portion of a plasma fractionation that is currently discarded. The study showed this treatment could prevent neurological, liver, and blood symptoms in mice with the condition.
New rare conditions also continue to be discovered, growing the overall number of patients who require plasma-based medications to treat them. For example, in 2003 there were 250 known primary immunodeficiencies (PI). However, research identifying disease-causing gene variants has been very active in recent years and has uncovered over 400 distinct variants that cause PI, according to the International Union of Immunological Societies (IUIS) 2019 classification.
Even for the hundreds of rare conditions that are already known, it sometimes takes decades for individuals to receive a diagnosis because they are so rare. It is estimated that 70-90% of those affected by PI alone remain undiagnosed. This is true for rare bleeding disorders as well. Prior to a study released in 2019, it was estimated that 400,000 men around the world had hemophilia, a rare bleeding disorder that can be treated with plasma-derived clotting factors. After that study, the number jumped to 1,125,000. As healthcare providers become more familiar with these diseases, the length of time to diagnosis will shorten. This, too, will increase the need for plasma medicines to treat these additional individuals.
Not only are newly discovered conditions growing the need for plasma around the world, but regulatory agencies continue to approve new indications for the use of plasma and new plasma-derived products. For example, in March 2023, Grifols collaborated with Selagine for the development of immunoglobulin eye drops to treat dry eye disease. Also, in February 2023, Octapharma received the European medical authorities' approval for the lyophilized presentation of their product octaplasLG to be used in pre-hospital emergency settings for trauma. CSL Plasma also received manufacturing and marketing authorization from the Ministry of Health, Labor and Welfare in Japan in September 2022 for its plasma-derived, human C1-esterase inhibitor concentrate to prevent acute hereditary angioedema attacks.
Other potential new indications for plasma therapy include Alzheimer's disease, liver cirrhosis, secondary immunodeficiencies, myasthenia gravis (MG), and multiple sclerosis. For example, MG patients use plasma exchange to offer a quick improvement in muscle strength through intravenously withdrawing their own blood, eliminating the antibodies in their plasma that are causing the autoimmune attack, and then returning the remaining blood components as well as additional fresh plasma back into the body. These plasma exchange treatments last for only a few months before symptoms return. While PI still makes up a large portion of the conditions being treated through manufactured plasma products, these newly identified indications for plasma therapy in the fields of neurology, oncology, and rheumatology, are responsible for a significant amount of increased demand year over year.
Plasma is a biologic, which means there is no artificial substitute that can be manufactured to provide the lifesaving medicines that so many people require. The healing properties in plasma that individuals rely on can only be supplied through the generosity of donors like you!
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