Rise of Plasma Protein Therapeutic Industry
Over the past few decades, plasma protein therapeutics have emerged as an important class of treatments for several rare and chronic diseases. Plasma proteins derived from human blood are utilized to treat conditions where the healthy human body is either lacking or not producing enough of a specific protein. Some key factors that have driven the rise of Plasma protein therapeutics protein therapeutics globally include growing disease burden, advancement in purification technologies, and establishment of plasma collection infrastructure across many countries.
Plasma Collection and Plasma Protein Therapeutic Industry
The production of plasma protein therapeutics starts with the collection of human plasma from voluntary donors at FDA approved plasma donation centers. On an average, a donor can donate plasma up to twice a week and each donation collects around 650ml of plasma. The collected fresh-frozen plasma undergoes the process of fractionation where it is separated into its individual protein components using techniques like ethanol fractionation and chromatography. This process yields final purified plasma protein therapeutics like immunoglobulins, clotting factors, albumin and alpha-1 proteinase inhibitor which find applications in treating different rare conditions.
Ensuring Supply Chain Reliability and Quality Standards
Due to the human origin of these therapies, reliable sourcing of safe plasma in sufficient quantities is critical to meet global treatment needs. Leading manufacturers have established plasma collection networks across various geographies to diversify supply sources and ensure treatment continuity for patients. They are also investing in new plasma collection and processing technologies to maximize yields. Strict adherence to Good Manufacturing Practices and quality processes during production is essential to deliver consistent and high-purity final drug products. Regulatory agencies like FDA and EMA conduct frequent audits of plasma collection centers and manufacturing facilities to verify compliance with safety and cGMP guidelines.
Immunoglobulins - Largest Product Category
Within plasma protein therapeutics, immunoglobulins constitute the largest product category by volume and find application in treating a wide range of primary and secondary immunodeficiencies as well as neurological disorders. Some major immunoglobulin products include intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) used for antibody replacement therapy. Annual IVIG sales globally exceed $10 billion, demonstrating the sizable market demand. Ongoing clinical research is also exploring new potential uses of immunoglobulins in autoimmune conditions like ITP, GBS and Kawasaki disease.
Coagulation Factors for Hemophilia Care
Coagulation factors derived from human plasma serve as standard-of-care replacement therapies for patients afflicted by hemophilia A and B. Products like factor VIII, factor IX, von Willebrand factor and activated prothrombin complex concentrates help treat and prevent bleeding episodes in these genetic bleeding disorders. Developments like extended half-life factor therapies that need to be administered less frequently, have provided major improvements in hemophilia management and patient quality of life. Multiple biopharmaceutical companies commercialize a wide portfolio of recombinant and plasma-derived coagulation factors globally.
Albumin - Diverse Medical Applications
Human albumin, the most abundantly available plasma protein, has diverse applications as a volume expander for hypovolemia treatment, stabilizing agent for drugs and vaccines, and hepatic therapy for decompensated cirrhosis and other conditions. It finds usage in areas like surgery, traumatology, burn care and intensive care units. Leading producers supply both 5% and 25% albumin products meeting current Good Manufacturing Practice standards. Post pandemic demand spikes have highlighted the critical role of albumin supplies during emergencies and stresses on production capacities.
Emerging Plasma Therapies
In the coming years, newer technologies leveraging human plasma are expected to expand therapeutic options further. Areas like gene therapy utilizing recombinant adeno-associated virus vectors and nanotechnology enabled drug delivery systems hold promise. Clinical research is also evaluating plasma-derived exosomes and microvesicles for tissue regeneration applications. Growing understanding of the molecular basis of various inherited and acquired diseases will allow identification of new potential plasma protein therapies. Meanwhile, alternative production platforms like transgenic animal systems and plant cell culture are being developed to enhance yields and supplement traditional plasma fractionation methods.
Global Supply Dynamics
While the United States remains the largest producer and consumer of plasma protein medicines historically, other regions have strengthened their infrastructure and self-sufficiency over time. The European Union collectively processes around 25% of the global plasma supply currently through countries like Germany, Austria, Czech Republic, Hungary and Italy. Asia Pacific markets like China, South Korea and Taiwan are also emerging as significant global players through capacity expansions. Across all major markets, meeting treatment needs through increased plasma collections, new product introductions and regional manufacturing continues to be an area of focus for industry and regulatory stakeholders. Ongoing trade negotiations also aim to ensure smooth cross-border plasma exchanges between importer and exporter nations.
plasma protein therapeutics derived from human blood have transformed the treatment landscape for rare bleeding disorders, immunodeficiencies and other conditions demanding replacement therapies. Robust supply chains and adherence to global quality standards enables these life-saving medicines to benefit patients worldwide. Going forward, innovation in purification technologies, emerging applications, expanded access and plasma sufficiency will help realize the full potential of plasma protein therapeutics in improving human health outcomes globally.
Get More Insights On Plasma Protein Therapeutics
About Author
Vaagisha brings over three years of expertise as a content editor in the market research domain. Originally a creative writer, she discovered her passion for editing, combining her flair for writing with a meticulous eye for detail. Her ability to craft and refine compelling content makes her an invaluable asset in delivering polished and engaging write-ups.
(LinkedIn: https://www.linkedin.com/in/vaagisha-singh-8080b91)
