U.S. Plasma-derived Therapies Market Dynamics, Growth Drivers, Market Constraints and Challenges 2024

According to Precision Business Insights (PBI), the latest report, the U.S. plasma-derived therapies market was valued at USD 11,299.7 million in 2023 and is expected to grow at a 5.4% CAGR from 2024 to 2029. The U.S. plasma-derived therapies market is expected to continue its upward trajectory, driven by ongoing advancements in biotechnology and an increasing focus on personalized medicine. Strategic collaborations and investments in research and development are anticipated to further fuel market expansion, leading to the development of novel therapies targeting specific disease mechanisms and patient populations.

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THE U.S. PLASMA-DERIVED THERAPIES MARKET DETAILED SEGMENTATION:
Based on the product, the market is segmented into the following:
• Intravenous Immunoglobulin (IVIG)
• Subcutaneous IG (SCIG)
• Clotting Factors Concentrates
• Protein C Concentrates
• Albumin
• Factor VIII and IX
• Alpha-1 Antitrypsin (AAT)
• Hyperimmune Globulins
• Fibrinogen Concentrate
• Pooled Plasma Products
• Anti-Thymocyte Globulin (ATG)
• Rho(D) Immune Globulin (RhIg)
• Varicella-Zoster Immune Globulin (VZIG)
• Tetanus Immune Globulin (TIG)
• Others

Based on the product, the U.S. plasma-derived therapies market is segmented into intravenous immunoglobulin (IVIG), subcutaneous IG (SCIG), clotting factors concentrates, protein C concentrates, albumin, factor VIII and IX, alpha-1 antitrypsin (AAT), hyperimmune globulins, fibrinogen concentrate, pooled plasma products, anti-thymocyte globulin (ATG), Rho(D) immune globulin (RhIg), varicella-zoster immune globulin (VZIG), tetanus immune globulin (TIG), others. The intravenous immunoglobulin (IVIG) segment is expected to account for a larger revenue share of 40.8% in the U.S. plasma-derived therapies market in 2022. The U.S. plasma-derived therapy market lies in the expansion of evidence-based uses for IVIG (Intravenous Immune Globulin). While there are currently only 14 labeled indications approved by the FDA for IVIG products, medical literature identifies at least 150 evidence-based uses for IVIG, with approximately 60 included on lists of reimbursable uses by Medicare and other healthcare plans are expected to drive the growth of plasma-derived therapies market in this segment.

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Based on the Disease/ Medical Condition, the market is segmented into the following:
• Immune Deficiencies
• Hemophilia and Bleeding Disorders
• Autoimmune Disorders
• Alpha-1 Antitrypsin (AAT) Deficiency
• Rabies Post-Exposure Prophylaxis
• Tetanus Prevention
• Cytomegalovirus Prevention in Transplant Recipients
• Varicella-Zoster Virus Prevention
• Hepatitis B Prevention
• Others

Based on the disease/ medical condition segment, the U.S. plasma-derived therapies market is segmented into immune deficiencies, hemophilia and bleeding disorders, autoimmune disorders, alpha-1 antitrypsin (AAT) deficiency, rabies post-exposure prophylaxis, tetanus prevention, cytomegalovirus prevention in transplant recipients, varicella-zoster virus prevention, hepatitis b prevention, others. The immune deficiencies segment in U.S. plasma-derived therapies market accounted for 37.6% in 2022 and it is expected to increase over the forecast period because immunodeficiency disorders, such as primary humoral immunodeficiency (PIDD), result in a weakened or absent immune system, making individuals more susceptible to infections and other diseases. As the incidence and awareness of these disorders continue to rise, there is a growing demand for plasma-derived biologics that can help bolster the immune response and improve the quality of life for affected individuals. Primary humoral immunodeficiency (PIDD) is one of the most common types of immunodeficiency disorders, affecting an estimated 1 in 500 to 1 in 5,000 individuals worldwide, according to the Immune Deficiency Foundation. In the United States alone, it is estimated that there are over 250,000 people living with PIDD. The increasing immunodeficiency disorders will drive the overall U.S. plasma-derived therapies market.

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STRATEGIC FDA APPROVALS, MERGERS, AND AGREEMENTS ARE THE KEY STRATEGIES ADOPTED BY MARKET PLAYERS:
Companies often seek to expand their market presence and leverage complementary expertise through partnerships and collaborations with other industry players. This involve distribution agreements, joint ventures, or strategic alliances aimed at enhancing product portfolios and market reach. Obtaining regulatory approvals from agencies like the FDA is crucial for market players to launch and commercialize plasma-derived therapies to improve market revenue share and gain significant geographic presence across the region.

• In December 2023, Kamada Ltd. has announced a groundbreaking development aimed at strengthening its presence in the U.S. plasma-derived therapy market. The company has executed a binding memorandum of understanding with Kedrion, a leading player in the plasma-derived therapy market, for the amendment and extension of the KEDRAB® U.S. distribution agreement between the parties.

• In December 2023, the approval of ADMA Biologics' tenth ADMA BioCenters plasma collection facility in Laurel, Maryland, by the U.S. Food and Drug Administration (FDA) represents a significant milestone and key development for the company. This approval signifies the culmination of ADMA's efforts to expand its plasma collection capabilities and further strengthen its position as an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics.

Key players profiles in the U.S. Plasma-Derived Therapies Market report are ADMA Biologics, Inc., Takeda Pharmaceutical Company, Grifols, CSL Behring, Octapharma, Bio Products Laboratory (BPL), Kedrion Biopharma Inc.

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