by Plasma Protein Plasma Protein Therapeutic Industry
Plasma proteins are proteins that are naturally present in human blood plasma. They are isolated from donated human plasma through a process known as fractionation. Some key plasma proteins that are used to manufacture life-saving therapies include immunoglobulins, coagulation factors, albumin and alpha-1 proteinase inhibitor. These plasma protein therapies are used to treat a variety of rare and complex diseases.
Immunoglobulin Plasma Protein Therapeutic Industry
Immunoglobulins or antibodies are gamma globulin proteins that help the body fight infections and disease. There are several immunoglobulin therapies used to treat primary immunodeficiencies, neurological conditions and other rare diseases. Intravenous immunoglobulin (IVIG) therapy involves administering concentrated immunoglobulins via intravenous injection to replace missing or non-functioning antibodies. Subcutaneous immunoglobulin (SCIG) therapy delivers concentrated immunoglobulins beneath the skin through an infusion pump. These therapies help prevent life-threatening infections in patients with antibody deficiencies.
Coagulation Factor Therapies
Coagulation factor therapies contain clotting factors that are deficient or missing in patients with specific bleeding disorders. Examples include factor VIII therapy for hemophilia A, factor IX therapy for hemophilia B and factor XIII therapy. Regular prophylactic infusions of these therapies can help reduce bleeding episodes, joint damage and disability in patients. Advanced therapies now include longer-acting recombinant and fusion Plasma protein therapeutics factors that only need to be dosed weekly or bi-weekly.
Albumin Therapy
Albumin is the most abundant protein in blood plasma and helps maintain proper fluid balance throughout the body. Albumin therapy involves intravenous infusion of concentrated human albumin to expand blood volume in critically ill patients or those experiencing blood loss from surgery or trauma. It is also used occasionally as a resuscitation fluid in the emergency department setting.
Alpha-1 Proteinase Inhibitor Therapy
Alpha-1 proteinase inhibitor (A1-PI) therapy contains the enzyme A1-PI, which is deficient or non-functional in patients with Alpha-1 Antitrypsin Deficiency (AATD). AATD is a genetic condition associated with liver disease in children and early-onset emphysema in adults. A1-PI therapy helps slow the progression of lung disease by replacing the missing enzyme through weekly intravenous infusion. Inhaled A1-PI therapies are also being studied.
Regulatory Standards and Global Supply
The plasma protein therapy industry is highly regulated to ensure the safety, purity and potency of products. In the United States, the Food and Drug Administration (FDA) regulates the entire chain from plasma collection to fractionation and manufacturing under strict current Good Manufacturing Practice (cGMP) standards. Similar stringent regulations exist in the European Union under the oversight of respective national agencies and the European Medicines Agency (EMA).
While these life-saving therapies are manufactured by only a handful of companies globally, the demand continues to rise due to aging populations and improved diagnostics identifying more patients. Meeting this growing demand requires a reliable and large source of donated human plasma. The US and some European countries have a system of compensated plasma donation to encourage regular plasma donations and ensure adequate supply of plasma proteins. Other regions rely primarily on volunteer unpaid donations. Ensuring global plasma supply security remains an ongoing priority and focus area.
Market Growth and Innovation Trends
The global plasma protein therapeutics market was valued at over $26 billion in 2020 and is projected to reach $35 billion by 2027, growing at a CAGR of 4-5% annually during this period according to various market reports and analysts. Key growth regions include the US, major EU markets and China. The US accounts for the largest market share currently due to its leadership in plasma fractionation infrastructure, while China is expected to see rapid growth in the coming years as access to plasma therapies expands.
Significant market drivers include the rising prevalence of genetic bleeding and immune disorders due to better diagnostic tools, an aging global population with greater healthcare needs, and the entry of extended half-life recombinant versions of coagulation factor therapies that improve patient convenience and compliance. Pipeline innovations also include gene therapy and nucleic acid-based approaches that hold promise to provide functional cures for certain genetic conditions like hemophilia in the future. Overall, improving access globally and sustaining supply remain ongoing areas of focus for future growth.
Regulatory Harmonization and Global Access
While plasma protein therapies have expanded treatment access significantly in developed markets, ensuring their availability worldwide remains a challenge. Harmonizing regulatory standards and increasing manufacturing capacity in developing regions will be crucial to improve global access over time. Initiatives like the “Roadmap for Harmonization” developed by the Plasma Protein Therapeutics Association aim to streamline regulatory pathways and manufacturing practices through cooperation between national regulatory agencies.
In emerging markets like China, India and Latin America, access has been growing steadily through a combination of local production, imports and increased health insurance coverage. However, self-sufficiency remains limited and import dependency continues for many essential therapies. Future trends point towards expanding local fractionation capacity, regional cooperation on quality standards and clinical research to develop homegrown manufacturing capabilities and expertise over the long term. Overall, regulatory harmonization and cooperative capacity building hold promise to make lifesaving plasma therapies truly accessible for patients worldwide.
the global plasma protein therapeutics industry is projected to continue growing steadily to meet the rising need for treating complex genetic disorders. Robust regulations, reliable supply sources and technological innovation will be key enablers for the industry. Meanwhile, expanding equitable access globally through regulatory harmonization and local manufacturing capacity
*Note:
1. Source: Coherent Market Insights, Public Source, Desk Research
2. We have leveraged AI tools to mine information and compile it
About Author - Vaagisha Singh
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
