| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2019-2022 |
| Base Year |
2023 |
| Forecast Period |
2024-2032 |
| Plasma Protein Therapeutics Market Size 2024 |
USD 30,479.5 million |
| Plasma Protein Therapeutics Market, CAGR |
5.00% |
| Plasma Protein Therapeutics Market Size 2032 |
USD 45,032.1 million |
Market Overview
The Global Plasma Protein Therapeutics Market is projected to grow from USD 30,479.5 million in 2023 to an estimated USD 45,032.1 million by 2032, with a compound annual growth rate (CAGR) of 5.00% from 2024 to 2032. This growth reflects the rising demand for plasma-derived therapies used to treat a variety of life-threatening conditions such as immune deficiencies, hemophilia, and other blood-related disorders.
Several key drivers fuel this market growth, including a surge in the prevalence of rare diseases and a greater awareness of the benefits of plasma-derived treatments. Additionally, the trend of personalized medicine and innovations in drug delivery methods are reshaping the industry, leading to enhanced efficacy and safety of plasma protein therapies. Improvements in healthcare infrastructure in emerging economies are further supporting market penetration and adoption of these therapies.
Geographically, North America holds the largest share of the Plasma Protein Therapeutics Market, driven by a well-established healthcare infrastructure and a high demand for advanced treatments. However, Asia-Pacific is anticipated to witness the fastest growth due to an increasing patient population and rising investments in healthcare. Key players in the market include CSL Behring, Grifols S.A., Takeda Pharmaceutical Company, Octapharma AG, and Kedrion Biopharma, which are actively involved in expanding their product portfolios and geographic presence to cater to a growing patient base worldwide.
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Market Drivers
Increasing Prevalence of Rare and Chronic Diseases
The growing incidence of rare and chronic diseases, such as hemophilia, primary immunodeficiency disorders, and chronic inflammatory demyelinating polyneuropathy (CIDP), is a primary driver of the Global Plasma Protein Therapeutics Market. Plasma-derived therapies are crucial for treating these conditions, providing patients with essential proteins that their bodies cannot produce. For instance, a study indicated that the overall prevalence of chronic diseases among adults in India is approximately 41.73%, with hypertension and diabetes accounting for about 68% of these cases. This highlights the urgent need for effective treatments, including plasma-derived therapies, to manage these conditions effectively. As the population ages, chronic illnesses are becoming more prevalent, resulting in a higher demand for plasma protein-based therapies. In the context of specific rare diseases, the incidence of CIDP has been reported at 0.68 per 100,000 person-years, with a prevalence of 7.00 per 100,000 individuals. Such statistics underscore the necessity for targeted therapies derived from plasma to address these rare conditions. Organizations such as the World Federation of Hemophilia and national hemophilia associations are also raising awareness of these conditions, helping to identify more patients and driving demand for effective treatments. Additionally, the rise in autoimmune diseases is further expanding the scope of plasma protein therapeutics, as immunoglobulins derived from plasma are vital in managing these immune system disorders
Advancements in Plasma Fractionation and Purification Technologies
Technological advancements in plasma fractionation and purification have significantly contributed to the growth of the plasma protein therapeutics market. Modern fractionation techniques enable manufacturers to extract a wider range of plasma proteins with greater efficiency and higher purity. Innovations such as chromatography-based purification, nanofiltration, and other virus inactivation methods have improved product safety, making plasma-derived therapies safer and more reliable for patients. Furthermore, these advancements allow for the optimization of manufacturing processes, which in turn reduces costs and facilitates large-scale production. Companies in the sector are investing heavily in research and development to enhance existing plasma fractionation techniques and to explore novel methods for deriving protein therapies from plasma. These improvements not only enable increased production capacity but also enhance product consistency, quality, and effectiveness, thereby driving market growth.
Growing Awareness and Acceptance of Plasma-Derived Therapies
Increased awareness of plasma protein therapies among both healthcare providers and patients has led to a higher adoption rate of these treatments. Initiatives by healthcare organizations, industry groups, and non-profit foundations are educating the public and the medical community about the benefits of plasma-derived therapies, particularly in treating rare and chronic diseases. For example, awareness campaigns by organizations like the Plasma Protein Therapeutics Association (PPTA) have underscored the vital role of plasma donations in treating conditions that would otherwise have limited therapeutic options. Improved awareness has helped reduce stigmas associated with plasma donations and has motivated more individuals to donate plasma, which is essential for ensuring a steady supply of raw material.Additionally, as plasma-derived therapies gain regulatory approvals worldwide and demonstrate proven efficacy—such as those used to treat hemophilia affecting approximately 1 in every 5,000 male births globally—they are increasingly integrated into treatment protocols. This further supports market expansion by ensuring that effective treatments are available for managing both chronic illnesses and rare diseases effectively.
Expansion of Healthcare Infrastructure and Accessibility in Emerging Markets
The expansion of healthcare infrastructure, particularly in emerging markets, is another crucial factor driving the Global Plasma Protein Therapeutics Market. Countries in Asia-Pacific, Latin America, and parts of the Middle East are investing significantly in healthcare systems, improving access to advanced treatments, and expanding diagnostic services. These developments facilitate the identification and diagnosis of patients who can benefit from plasma-derived therapies. As disposable incomes rise and healthcare expenditures increase in these regions, there is a growing willingness and ability among patients and healthcare providers to adopt these specialized therapies. Furthermore, governments in emerging economies are prioritizing healthcare improvements and implementing policies to support advanced medical treatments, including plasma protein therapies. Pharmaceutical companies are increasingly establishing partnerships, collaborations, and local production facilities in these regions, contributing to the greater availability and affordability of plasma-derived therapies.
Market Trends
Shift Towards Personalized Plasma Protein Therapies
The Global Plasma Protein Therapeutics Market is witnessing a significant shift towards personalized and targeted plasma protein therapies. Advances in biotechnology and pharmacology are enabling more precise customization of treatments, allowing therapies to be tailored to individual patients based on their unique genetic and physiological characteristics. By leveraging genomics, proteomics, and advanced diagnostic tools, healthcare providers can identify specific plasma protein deficiencies or abnormalities and create therapies that address these specific needs. For instance, it has been reported that personalized treatments can lead to a reduction in adverse reactions by up to 30%, enhancing overall therapeutic effectiveness. This trend is also supported by the ongoing development of innovative drug delivery systems, such as intravenous infusions and subcutaneous injections, which are designed to increase patient comfort, adherence, and therapeutic efficacy. As a result, pharmaceutical companies are investing heavily in R&D to expand their portfolios with targeted plasma protein therapies, positioning themselves competitively in the market.
Expansion of Plasma Collection and Processing Facilities
The rapid expansion of plasma collection centers and processing facilities worldwide is another prominent trend in the plasma protein therapeutics market. Data indicates that the number of plasma donation centers in the U.S. has surged from fewer than 300 in 2005 to over 1,100 by early 2023, representing a growth rate of more than 270% over this period. To meet the rising demand for plasma-derived products, key industry players are establishing new plasma collection sites, especially in regions with robust healthcare infrastructure and high donation rates, such as North America and Europe. At the same time, emerging markets in Asia-Pacific and Latin America are becoming focal points for expansion due to increasing awareness of plasma donation and improving healthcare frameworks. Advanced plasma collection technologies, including automated plasmapheresis and efficient donor management systems, are also contributing to higher collection volumes. In 2019 alone, these centers facilitated a record 53.5 million paid plasma donations, which is roughly three times the volume during the Great Recession. Additionally, pharmaceutical companies are focusing on establishing local processing plants to reduce logistical costs, enhance production scalability, and ensure compliance with local regulatory standards. This expansion not only boosts the supply of raw plasma but also increases the capacity to develop a wider range of plasma protein therapies, enabling more consistent and accessible treatments for patients globally.
Market Restraints and Challenges
High Cost and Limited Availability of Plasma-Derived Products
The high cost of plasma protein therapeutics remains a significant restraint for the Global Plasma Protein Therapeutics Market. The process of collecting and fractionating plasma is complex, labor-intensive, and costly, requiring advanced technologies and stringent regulatory compliance. Furthermore, a single treatment often necessitates large volumes of plasma, adding to the expense and limiting accessibility for many patients, particularly in regions with less-developed healthcare infrastructures. These costs are frequently passed down to end-users, leading to affordability challenges for patients and healthcare systems. Additionally, due to the time and resources needed to process and produce plasma-derived therapies, there can be supply shortages. These shortages, combined with the growing global demand, exacerbate availability issues, making it challenging to ensure consistent access to plasma protein treatments across all regions.
Regulatory and Ethical Challenges in Plasma Collection
Plasma collection is heavily regulated due to the need to maintain high standards for donor safety and product purity. While necessary, these regulations can slow the process of establishing new collection centers and expanding capacity. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines for plasma collection, handling, and processing, which can increase operational costs and limit scalability for companies in this sector. Moreover, ethical concerns about plasma collection practices, including donor compensation and the potential for exploitation in certain regions, have raised scrutiny from advocacy groups and regulatory bodies. Addressing these ethical concerns while complying with varying international regulatory frameworks can present substantial operational challenges, potentially hindering the market’s growth. Companies are thus required to navigate complex regulatory landscapes and implement rigorous compliance measures, which can limit expansion efforts, delay product rollouts, and increase production costs.
Market Segmentation Analysis
By Product
The plasma protein therapeutics market is segmented by product types, with Albumin playing a key role due to its broad applications in treating liver diseases, shock, trauma, burns, and its utility in surgeries to maintain blood volume and patient stability. Rising cases of chronic liver diseases have driven sustained demand for albumin. Immunoglobulin (IG), the largest segment, is critical for treating immune deficiencies, autoimmune disorders, and neurological conditions, particularly for primary immunodeficiency disorder (PIDD) patients, with demand boosted by the prevalence of autoimmune diseases and advances in immunotherapy. Plasma-derived Factor VIII is vital for managing hemophilia A, as it prevents excessive bleeding and remains essential due to its cost-effectiveness, even with the emergence of recombinant alternatives; the segment’s growth is supported by increased awareness and diagnosis of hemophilia. Lastly, Other plasma-derived proteins, such as fibrinogen and alpha-1 antitrypsin, cater to specific disorders and represent a growing segment as research continues to uncover new therapeutic uses, indicating a rising demand for these specialized treatments.
By Application
The application of plasma protein therapeutics spans several key medical conditions, including hemophilia, primary immunodeficiency disorder (PIDD), idiopathic thrombocytopenic purpura (ITP), and others. Hemophilia remains a major application, as treatments like Factor VIII help replace missing clotting factors, preventing severe bleeding complications, and demand is driven by rising awareness and a focus on prophylactic treatments. PIDD, a significant driver for immunoglobulin therapies, is experiencing growth due to improved diagnosis, increased awareness, and advancements in treatment methods that support immune function in compromised patients. Similarly, immunoglobulin therapy plays a crucial role in managing ITP by elevating platelet counts and alleviating symptoms, and this segment continues to expand as accessibility and acceptance of these treatments grow. The “Others” category, which includes liver diseases, neurological disorders, and burns, presents additional growth opportunities as ongoing research uncovers new clinical uses for plasma protein therapies, paving the way for more specialized and diverse treatment options.
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Segments
Based on Product
- Albumin
- Immunoglobulin
- Plasmaderived Factor VIII
- Others
Based on Application
- Hemophilia
- Primary Immunodeficiency Disorder (PIDD)
- Idiopathic Thrombocytopenic Purpura (ITP)
- Others
Based on End User
Based on Regional
- North America
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- Japan
- China
- India
- Australia
- Thailand
- South Korea
- Latin America
- Middle East and Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Regional Analysis
North America (42%):
North America holds the largest share of the plasma protein therapeutics market, accounting for approximately 42% of the global market. This dominance is primarily driven by the United States, which has a well-established healthcare system and a high prevalence of chronic diseases and immune deficiencies. In addition, North America benefits from a robust network of plasma collection centers, advanced fractionation facilities, and substantial investments in research and development. Favorable reimbursement policies and strong regulatory support further stimulate market growth in this region. Companies such as CSL Behring, Grifols, and Takeda Pharmaceutical Company have significant operations in North America, where they focus on expanding their plasma collection and manufacturing capabilities to meet the growing demand for plasma protein therapies.
Europe (27%):
Europe is the second-largest market, holding around 27% of the global market share. Countries such as Germany, France, and the United Kingdom lead the demand for plasma protein therapeutics due to the high prevalence of hemophilia and immune deficiency disorders. The region’s advanced healthcare infrastructure and substantial investments in biotechnology and plasma research also support the market. Furthermore, European regulatory agencies, such as the European Medicines Agency (EMA), play an active role in monitoring the quality and safety of plasma-derived products, ensuring a high level of product safety and patient trust. However, the market in Europe is slightly constrained by stringent regulatory requirements and the relatively slower adoption of new technologies compared to North America.
Key players
- CSL
- Grifols, S.A.
- Takeda
- Octapharma AG
- Biotest AG
- Kedrion S.p.A.
Competitive Analysis
The Global Plasma Protein Therapeutics Market is highly competitive, with key players focusing on expanding their product portfolios and enhancing their production capabilities. CSL and Grifols, S.A. lead the market due to their extensive plasma collection networks and robust R&D investments. Takeda, following its acquisition of Shire, has also solidified its position by broadening its range of immunoglobulin and albumin products. Octapharma AG and Biotest AG focus on niche therapeutic areas, particularly in immune disorders and hematology, allowing them to cater to specialized market needs. Kedrion S.p.A. emphasizes expansion in emerging markets, contributing to greater accessibility to plasma-derived therapies. These companies are actively investing in strategic partnerships, acquisitions, and new technologies to maintain a competitive edge. In addition, they prioritize adherence to regulatory requirements to ensure product safety and quality, enhancing their market positions and driving growth within the plasma protein therapeutics sector.
Recent Developments
- In January 2024, CSL Behring announced the successful completion of a Phase 3 trial for its new immunoglobulin product, aimed at treating primary immunodeficiency. The company plans to submit regulatory applications in the U.S. and Europe later this year.
- In March 2024, Grifols plans to release Phase III results for its longInterm albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites, as part of its ongoing clinical trials.
- In October 2023, Takeda announced the launch of a new subcutaneous immunoglobulin product, expanding its portfolio in the plasmaInderived therapies market. This product aims to enhance patient convenience and adherence.
- In November 2023, Octapharma launched a new formulation of its human albumin product in several European countries, aimed at improving treatment options for patients with liver diseases.
- In January 2024, Following its acquisition by Grifols, Biotest announced plans to accelerate R&D efforts on immunoglobulin therapies, with new clinical trials expected to begin later in the year.
- In December 2023, Kedrion S.p.A. received FDA approval for its new hyperimmune globulin product, which is intended for use in patients with specific viral infections. This marks a significant expansion of their product line in the U.S. market.
Market Concentration and Characteristics
The Global Plasma Protein Therapeutics Market is moderately concentrated, with a few key players such as CSL, Grifols, S.A., Takeda, Octapharma AG, and Biotest AG holding a significant share of the market. These companies dominate due to their extensive plasma collection networks, advanced production facilities, and strong research and development capabilities, allowing them to maintain a competitive edge. The market is characterized by high barriers to entry due to stringent regulatory requirements, the need for sophisticated technologies in plasma fractionation and purification, and substantial initial capital investments. Additionally, the market is driven by continuous innovation, with companies focusing on expanding their product portfolios and enhancing therapy safety and efficacy to meet the growing demand for plasma-derived treatments globally. As a result, market participants tend to prioritize strategic partnerships, acquisitions, and compliance with regional and global regulatory standards to maintain their positions and drive sustainable growth in this sector.
Report Coverage
The research report offers an in-depth analysis based on Product, Application, End User and Region. It details leading market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven market expansion in recent years. The report also explores market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the market.
Future Outlook
- The demand for plasma protein therapies is projected to increase steadily due to the rising prevalence of chronic diseases and rare blood disorders worldwide, necessitating effective treatment options.
- Innovations in plasma collection methods, such as automated plasmapheresis, will enhance collection efficiency, reduce donor time, and increase the availability of plasma for therapeutic use.
- The market is expected to expand significantly in emerging regions like Asia-Pacific and Latin America, driven by improved healthcare infrastructure and rising awareness of plasma donation and therapies.
- The trend towards personalized and precision medicine will encourage the development of targeted plasma protein therapies, improving treatment efficacy and patient outcomes.
- Companies will continue to invest heavily in research and development to enhance existing therapies, discover new plasma proteins, and broaden the therapeutic applications of plasma-derived products.
- Market leaders are anticipated to pursue strategic partnerships, mergers, and acquisitions to expand their geographic presence, streamline operations, and access new technologies.
- Regulatory agencies are likely to enhance approval pathways and support innovation, which will accelerate the development and availability of plasma-derived therapies globally.
- Advances in fractionation and purification technologies will improve product safety and quality, enabling companies to meet growing demand while maintaining high standards.
- Awareness campaigns and donor incentive programs are expected to grow, encouraging more plasma donations and ensuring a stable supply of raw plasma for therapeutic needs.
- Digital health tools, such as data analytics and remote monitoring, will support plasma protein therapy management, enhancing patient adherence, monitoring efficacy, and optimizing healthcare provider support.
