- 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
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 significant driver for the U.S. plasma-derived therapy market is the expansion of treatment options for infectious diseases, particularly for individuals at high risk of exposure or complications from certain pathogens. Plasma-derived biologics, such as Nabi-HB (Hepatitis B Immune Globulin, Human), plays a crucial role in the prevention and treatment of infectious diseases by providing passive immunity against specific pathogens.
Infectious diseases continue to pose significant public health challenges globally, contributing to morbidity and mortality rates. Hepatitis B, for example, affects over 257 million people worldwide, leading to approximately 887,000 deaths annually, according to the World Health Organization. Plasma-derived biologics, such as Hepatitis B Immune Globulin, are used as preventive measures for individuals at high risk of exposure to Hepatitis B virus, such as those with acute exposure to blood containing HBsAg. These products provide passive immunity and help reduce the risk of developing Hepatitis B infection following exposure. With the emergence of new infectious pathogens and the potential for pandemics, there is an increased need for effective treatment options to mitigate the spread of these diseases. Plasma-derived biologics, with their ability to provide passive immunity, offer a valuable tool in the arsenal against infectious diseases. Plasma-derived biologics are also being explored for expanded indications beyond their traditional uses. For example, ADMA Biologics, the manufacturer of Nabi-HB, is developing a pipeline of plasma-derived therapeutics, including products aimed at preventing and treating infections caused by Streptococcus pneumoniae.
In addition to expanding the range of available plasma-derived therapies, there is an opportunity to broaden the indications for existing products to address unmet medical needs across diverse patient populations. This involves conducting clinical trials and gathering real-world evidence to demonstrate the efficacy and safety of plasma-derived therapies in treating new disease indications or patient subgroups. By expanding the indications for existing therapies, manufacturers can increase market penetration and provide valuable treatment options for patients with previously underserved medical conditions. This expansion of treatment options and indications represents a significant opportunity for the U.S. plasma-derived therapies market to enhance its competitive position and contribute to advancements in patient care.
U.S. Plasma-Derived Therapies Market Key Developments:
In December 2023, Kedrion Biopharma has announced a significant development aimed at strengthening its presence in the U.S. plasma-derived therapy market. The company has executed a binding memorandum of understanding with Kamada Ltd., a global biopharmaceutical leader specializing in specialty plasma-derived products, to amend and extend the distribution agreement for KEDRAB® Human Rabies Immune Globulin (HRIG) in the United States.
U.S. Plasma-Derived Therapies Market Dynamics
The U.S. plasma-derived therapies market is expected to grow over the forecasted period due to the advancements to improve the efficiency of plasma fractionation processes and the development of novel plasma-derived therapies with enhanced safety profiles. The key areas of advancement in plasma fractionation technology is the development of improved fractionation techniques. These techniques have led to higher yields of plasma proteins, resulting in increased supply of plasma-derived therapies to meet the growing demand. Advanced fractionation methods such as chromatography and ion exchange have enabled more efficient separation and purification of plasma proteins, leading to higher product purity and potency. Furthermore, technological innovations have facilitated the development of novel plasma-derived therapies with improved efficacy and safety profiles. For example, the introduction of subcutaneous immunoglobulin (SCIG) formulations has provided patients with more convenient treatment options compared to traditional intravenous administration. SCIG formulations allow for self-administration at home, reducing the need for frequent hospital visits and improving patient adherence to treatment regimens.
U.S. Plasma Derived Therapies Market Segmentation
By Product Type
By Disease/ Medical Condition
- 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
Frequently Asked Questions
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 expansion of evidence-based uses for IVIG and expansion of treatment options for infectious diseases & other indications is expected to provide opportunities to the market players in the market growth over the forecast period.
The leading players in the U.S. plasma-derived therapies market are Takeda Pharmaceutical Company, Grifols, CSL Behring, Octapharma, Bio Products Laboratory (BPL), Kedrion Biopharma Inc., ADMA Biologics, Inc., Kamada and LFB S.A.
The U.S. plasma-derived therapies market is segmented based on product and disease/ medical condition.
Key Features of the Reports
The restraint for the U.S. plasma-derived therapies market is the occurrence of shortages and instability in the supply of Intravenous/Subcutaneous Immunoglobulin (IV/SC-IgG) products. IV/SC-IgG plays a crucial role in the treatment of various medical conditions, including primary and secondary immunodeficiencies, autoimmune diseases, and inflammatory disorders. However, the market has experienced challenges related to the availability and stability of IV/SC-IgG supply, leading to disruptions in patient care and treatment outcomes.
The production of IV/SC-IgG products relies on a steady and reliable supply of source plasma collected from healthy donors. However, fluctuations in donor availability, production capacity, and manufacturing processes can lead to supply shortages and instability. Factors such as increased demand, production issues, and regulatory challenges can exacerbate supply chain disruptions.
| 1.Executive Summary |
| 2.U.S. Plasma-Derived Therapies Market Introduction |
| 2.1.U.S. Plasma-Derived Therapies Market - Taxonomy |
| 2.2.U.S. Plasma-Derived Therapies Market - Definitions |
| 2.2.1.By Product |
| 2.2.2.By Disease / Medical Condition |
| 3.U.S. Plasma-Derived Therapies Market Dynamics |
| 3.1. U.S. Plasma-Derived Therapies Market - Macro-Economics Factors |
| 3.2. U.S. Plasma-Derived Therapies Market Dynamic Factors - Impact Analysis |
| 3.3. U.S. Plasma-Derived Therapies Market Dynamic Factors – Market Background |
| 3.3.1. Drivers and Restraints |
| 3.3.2. Opportunities/Unmet Needs of the Market & Trends |
| 3.4. Value Added Insights (USPs) |
| 4.U.S. Plasma-Derived Therapies Market Analysis, 2019-2023 and Forecast 2024-2030 |
| 4.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) |
| 4.3. Market Opportunity Analysis |
| 5.U.S. Plasma-Derived Therapies Market By Product, 2019-2023 and Forecast 2024-2030 (Sales Value USD Million) |
| 5.1. Intravenous Immunoglobulin (IVIG) &Subcutaneous IG (SCIG) |
| 5.1.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.1.3. Market Opportunity Analysis |
| 5.2. Clotting Factors Concentrates |
| 5.2.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.2.3. Market Opportunity Analysis |
| 5.3. Protein C Concentrates |
| 5.3.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.3.3. Market Opportunity Analysis |
| 5.4. Albumin |
| 5.4.1.Albumin Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.4.3. Market Opportunity Analysis |
| 5.5. Factor VIII and IX |
| 5.5.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.5.3. Market Opportunity Analysis |
| 5.6. Alpha-1 Antitrypsin (AAT) |
| 5.6.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.6.3. Market Opportunity Analysis |
| 5.7. Hyperimmune Globulins |
| 5.7.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.7.3. Market Opportunity Analysis |
| 5.8. Fibrinogen Concentrate |
| 5.8.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.8.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.8.3. Market Opportunity Analysis |
| 5.9. Pooled Plasma Products |
| 5.9.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.9.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.9.3. Market Opportunity Analysis |
| 5.10. Anti-Thymocyte Globulin (ATG) |
| 5.10.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.10.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.10.3. Market Opportunity Analysis |
| 5.11. Rho(D) Immune Globulin (RhIg) |
| 5.11.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.11.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.11.3. Market Opportunity Analysis |
| 5.12. Varicella-Zoster Immune Globulin (VZIG) |
| 5.12.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.12.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.12.3. Market Opportunity Analysis |
| 5.7. Tetanus Immune Globulin (TIG) |
| 5.7.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.7.3. Market Opportunity Analysis |
| 5.14. Others |
| 5.14.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 5.14.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 5.14.3. Market Opportunity Analysis |
| 6.U.S. Plasma-Derived Therapies Market By Disease / Medical Condition, 2019-2023 and Forecast 2024-2030 (Sales Value USD Million) |
| 6.1. Immune Deficiencies |
| 6.1.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.1.3. Market Opportunity Analysis |
| 6.2. Hemophilia and Bleeding Disorders |
| 6.2.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.2.3. Market Opportunity Analysis |
| 6.3. Autoimmune Disorders |
| 6.3.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.3.3. Market Opportunity Analysis |
| 6.4. Alpha-1 Antitrypsin (AAT) Deficiency |
| 6.4.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.4.3. Market Opportunity Analysis |
| 6.5. Rabies Post-Exposure Prophylaxis |
| 6.5.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.5.3. Market Opportunity Analysis |
| 6.6. Tetanus Prevention |
| 6.6.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.6.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.6.3. Market Opportunity Analysis |
| 6.7. Cytomegalovirus Prevention in Transplant Recipients |
| 6.7.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.7.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.7.3. Market Opportunity Analysis |
| 6.8. Varicella-Zoster Virus Prevention |
| 6.8.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.8.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.8.3. Market Opportunity Analysis |
| 6.9. Hepatitis B Prevention |
| 6.9.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.9.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.9.3. Market Opportunity Analysis |
| 6.10. Others |
| 6.10.1. Market Analysis, 2019-2023 and Forecast, 2024-2030, (Sales Value USD Million) |
| 6.10.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) |
| 6.10.3. Market Opportunity Analysis |
| 7. Competition Landscape |
| 7.1. Market Player Profiles (Introduction, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) |
| 7.2.1.Takeda Pharmaceutical Company |
| 7.2.2.Grifols |
| 7.2.3.CSL Behring |
| 7.2.4.Octapharma |
| 7.2.5.Bio Products Laboratory (BPL) |
| 7.2.6.Kedrion Biopharma |
| 7.2.7.ADMA Biologics Inc. |
| 7.2.8.Kamada Pharmaceuticals |
| 7.2.9.LFB S.A. |
| 8. Research Methodology |
| 9. Key Assumptions and Acronyms |
| LOF: U.S. Plasma Derived Therapies Market |
| Figure 1: Overview of the U.S. Plasma-Derived Therapies Market Share (%), By Product, 2022 (A) |
| Figure 2: Overview of the U.S. Plasma-Derived Therapies Market Value (Share %), By Disease / Medical Condition, 2022 (A), 2029 (F) |
| Figure 3: U.S. Plasma-Derived Therapies Market Value (USD Million), 2019 - 2030 |
| Figure 4: U.S. Plasma-Derived Therapies Market - Market Opportunity (US$ Mn), 2018, 2022, & 2029 |
| Figure 5: U.S. Plasma-Derived Therapies Market Share by Product, 2019 - 2030 |
| Figure 6: U.S. Plasma-Derived Therapies Market Y-o-Y Growth (%), by Product, 2019 - 2030 |
| Figure 7: U.S. Plasma-Derived Therapies Market, Historical, Forecast Market Sizes (US$ Mn) and Market Opportunity (US$ Mn), by Product, 2018, 2023, & 2029 |
| Figure 8: U.S. Plasma-Derived Therapies Market - Opportunity Analysis, By Product Type, 2023 - 2029 |
| Figure 9: U.S. Plasma-Derived Therapies Market Share by Disease / Medical Condition, 2022(A) & 2029(F) |
| Figure 10: U.S. Plasma-Derived Therapies Market Y-o-Y Growth (%), by Disease / Medical Condition, 2019 - 2030 |
| Figure 11: U.S. Plasma-Derived Therapies Market, Historical, Forecast Market Sizes (US$ Mn) and Market Opportunity (US$ Mn), by Disease / Medical Condition, 2018, 2023, & 2029 |
| Figure 12: U.S. Plasma-Derived Therapies Market - Opportunity Analysis, By Disease / Medical Condition, 2023 - 2029 |
- Takeda Pharmaceutical Company
- Grifols
- CSL Behring
- Octapharma
- Bio Products Laboratory (BPL)
- Kedrion Biopharma Inc.
- ADMA Biologics, Inc.
- Kamada
- LFB S.A.