Plasma Fractionation Market Size, Share & COVID-19 Impact Analysis, By Product (Albumin, Immunoglobulin (Intravenous Immunoglobulin (IVIG), Subcutaneous Immunoglobulin (SCIG)), Coagulation Factors (Factor IX, Factor VIII, Prothrombin Complex Concentrates, Fibrinogen Concentrates, Others), Protease Inhibitors, Others), By Application (Immunology & Neurology, Hematology, Critical Care, Pulmonology, Others), By End-user (Hospitals & Clinics, Clinical Research Laboratories, Others), and Regional Forecast, 2022-2029

The global plasma fractionation market size was valued at USD 28.69 billion in 2021. The market is projected to grow from USD 30.64 billion in 2022 to USD 49.61 billion by 2029, exhibiting a CAGR of 7.1% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with plasma fractionation experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a slower growth of 4.9% in 2020 as compared to 2019.

Plasma fractionation has always ignited curiosity among researchers and industrialists alike. The therapeutic efficacies of blood plasma to treat and manage immunodeficiency diseases have helped the growth of the market. Cryo precipitation and ethanol fractionation are the major processes to separate therapeutic protein components from whole blood in the plasma fractionation equipment. Protein components, such as prothrombin complex, thrombin, fibrinogen, and others, play a major role in managing diseases. These fractionation plasma products have therapeutic efficiencies in treating diseases such as congenital metabolic deficiencies, trauma, immunological disorders, and other life-threatening diseases.

In response to the high demand for plasma-derived products, major companies in the market have engaged in several R&D initiatives to launch new plasma-derived therapies in the market. Furthermore, these key market players also intensely focused on owning and acquiring new plasma collection centers to streamline the availability of plasma to develop new products.

For example, in December 2021, Grifols, S.A., through its Subsidiary company Grifols Canada Therapeutics Inc., acquired all the shares of Prometic Plasma Resources Inc. Similarly, in April 2021, CSL Plasma and Terumo Blood and Cell Technologies announced a collaboration to develop and deliver a new plasma collection platform at the U.S. CSL Plasma Collection Centers. Therefore, the major companies' strategic efforts are expected to drive the growth of the global market.

COVID-19 IMPACT

Disruption in Plasma Collection due to Stringent COVID-19 Guidelines Impacted the Global Market

The COVID-19 outbreak led to various organizations experimenting with plasma-based therapies for the treatment of infected individuals. Several companies launched various research & development initiatives to combat COVID-19. For instance, in 2020, Biotest AG entered into industry-wide cooperation within the COVID-19 Plasma Alliance along with companies such as LFB, CSL Behring, Takeda Pharmaceutical Company Limited, and Octapharma AG. The companies together worked on a new polyclonal hyperimmunoglobulin drug against SARS-CoV-2. 

However, the market experienced slow growth due to the disruption in the plasma collection process. Despite being called an “essential infrastructure”, plasma collection was impacted due to the growth in the number of cases and COVID-19 guidelines such as social distancing and stay-at-home orders. For example, according to the annual report published by CSL Limited for the year 2020/2021, due to COVID-19, the plasma collection volume decreased along with an increase in the cost of collection with respect to donor compensation. Furthermore, the revenues for major companies were also impacted. For example, Octapharma AG recorded a growth of 8.1% in its revenue in FY 2020 compared to 23.2% in 2019. Similarly, Grifols, S.A. also witnessed a slow growth of 4.8% in 2020 compared to 15.6% in 2019 in the segments of biosciences and bio supplies.

LATEST TRENDS

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Launch of New Technologies by Key Players to Augment Market Growth

This process involves breaking down plasma into various individual proteins, such as albumin, immunoglobulin and coagulation factor, and protease inhibitor, for clinical use. Major key players in this market have their own plasma fractionation centers where they can extract such proteins. The current demand for plasma-derived therapies led to the launch of various technologies which can make the process faster. For instance, in April 2021, GEA delivered a new separator technology to Biopharma S.A. in its new plant in Bila Tserkva, Ukraine.

In March 2022, the U.S. Food and Drug Administration also cleared Terumo Corporation’s BCT collection system to meet the increasing demand for plasma-derived therapies. Rika Plasma Donation System is said to be a next-generation automated technology designed to meet the growing demand for plasma-derived therapies. On average, the device can complete plasma collection within 35 minutes, ensuring that at one time, there is not more than 200 milliliters of blood outside the donor’s body. The continuous efforts by various players to introduce technologies for the plasma fractionation process will augment the growth opportunities for the market over the forecast period.

DRIVING FACTORS

Growing Incidences of Immunodeficiency Disorders Propel Growth of the Market

There has been a considerable surge in demand for plasma-derived therapies across the world. The demand for immunoglobulin increased strongly, leading to positive growth of the global market. The growing demand is due to the rise in cases of various immunodeficiency disorders worldwide.

Primary immunodeficiency is a group of 300 diseases characterized by recurrent chronic infections, autoimmunity, allergy, or inflammation. These infections are a consequence of genetic alteration, which affects the immune system. The treatment for such disorders can be done through immunoglobulin substitution or specific immunoglobulin therapies. Therefore, the growing requirement for such treatments leads to increased immunoglobulin production by these processes, thus driving the market. For instance, according to UNAIDS, in 2020, there were 37.7 million people globally suffering from Human Immunodeficiency Virus (HIV). The U.S. Food and Drug Administration (FDA) has approved IVIG for use in children with HIV to reduce the risk of bacterial infections. Therefore, the growing incidences of these immunodeficiency disorders along with various other diseases led to the increasing demand for plasma-derived therapies, thus boosting the growth of the global market.

Surge in Demand for Plasma Derived Medicinal Products Drives the Market Growth

Plasma-derived Medicinal Products (PDMPs) are prepared industrially with the help of human plasma. These products include albumin, immunoglobulins, and coagulation factors. The World Health Organization (WHO) included several PDMP products in the model list of essential medicines. This initiative highlighted these medications to be effective and safe for major needs in a health system. The strong requirement for plasma-derived products increases the demand for these procedures, leading to positive market growth. For instance, primary immunodeficiency diseases can be treated with immunoglobulin by replacing the missing IgG serotype antibodies. However, Von Willebrand (VWD) disease and hemophilia require the replacement of coagulation factors. Plasma therapies also play an important role in prenatal and intensive care, and thus are proven essential for serious deficiencies.

According to an article published by the National Center of Biotechnology Information (NCBI) in 2019, a worldwide shortage of IVIG and the COVID-19 pandemic also added to the ongoing shortage of plasma supply. During the same period, the demand for plasma-derived therapies also witnessed a surge as they proved to be a potential treatment for the new disease. With the surge in demand, major companies started various R&D initiatives to introduce products in the market and cater to the global demand.

For instance, the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application submitted by Octapharma AG for a phase three clinical trial on the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression. The rising adoption of PDMPs for rare immunodeficiency diseases and various other neurological and hematological disorders leads to an increase in the production of plasma-derived products, thus eventually contributing positively to market growth.

RESTRAINING FACTORS

Emergence of Recombinant Therapies as an Alternative to Plasma Derived Medicines Restraints the Market Growth

In recent years, many recombinant alternatives have been developed for various plasma-driven therapies. Recombinant products are used prophylactically and are comparatively less immunogenic than plasma-derived products. In addition to these, various other longer-acting replacement factors are in the development pipeline. The products provide significant benefits, like less frequent administration, and are more effective in prophylactic use. The growing use of recombinant factors and their increased use in prophylactic therapies is thus a major factor limiting the adoption of plasma products.

The recombinant product version of plasma-derived products is manufactured by the expression of equivalent proteins from genetically engineered cells and offers a safer option than plasma-derived products as they avoid potential blood-borne transmission of infectious diseases. Therefore, the advantages associated with such products make them more reliable than plasma-derived products, thus restraining the market growth.

SEGMENTATION

By Product Analysis

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Protease Inhibitor Segment to Witness Significant Growth during the Forecast Period of 2022-2029

Based on product, the market is categorized into albumin, immunoglobulin, coagulation factors, protease inhibitors, and others. The immunoglobulin segment can be sub-segmented into Intravenous Immunoglobulin (IVIG) and Subcutaneous Immunoglobulin (SCIG). The coagulation factors segment can be further sub-segmented into factor IX, factor VIII, prothrombin complex concentrates, fibrinogen concentrates, and others.

The immunoglobulin segment dominates the market, contributing to a higher market share. The dominance is attributable to the high demand for IVIG products for primary and secondary immunodeficiency diseases. Growing prevalence and improvement in treating such diseases has led to the surge in demand for intravenous immunoglobulin. Significant product launches by major market players also boost the growth of the segment dominated by coagulation factors.

The growth of the segment of coagulation factors, also known as coagulation factor concentrates in 2021, is due to the development of hemostasis technology has led to the introduction of a wide range of products that can help clinicians provide adequate assistance to hemophilic patients. Growing accidents and trauma cases also drive the segment's growth. According to the PubMed Central published article, the mortality rate in some severely injured trauma patients is 3 to 4 times higher than those without coagulation complications.

The growth in using albumin in various applications, such as cardiovascular diseases, sepsis, and cirrhosis, led to the segment's growth in 2021. For instance, according to an article published by BioSupply Trends Quarterly in 2019, albumin is used as a leading treatment for advanced liver disease in China. It is estimated that 28 million patients require treatment, along with 7 million people who require urgent, intensive treatment for advanced liver disease. Furthermore, almost 2.5 million people live with cirrhosis or liver cancer requiring urgent treatment, sometimes including albumin administration. The protease inhibitor segment is expected to grow at a comparatively higher CAGR than other segments.

By Application Analysis

Adoption of Plasma Proteins in Immunology & Neurology Procedures Drives the Segment Growth

Based on application, the market is segmented into hematology, critical care, pulmonology, immunology & neurology, and others.

The immunology & neurology segment is projected to grow at a higher growth rate during the forecast period and has a comparatively higher market share in 2021. The increasing burden of immunodeficiency and autoimmune diseases led to strong global demand for these products. The growing prevalence of immunological & neurological diseases led to extensive use of plasma proteins such as coagulation factors and immunoglobulins in various treatment procedures. Combined with this, numerous plasma-based proteins are under development or undergoing clinical trials for neurology and immunology applications, leading to the segment's growth in the forecast period.

The hematology segment held a substantial plasma fractionation market share in 2021 due to advancements in several hemostasis technologies, leading to its global adoption and the growth of the hematology segment. Furthermore, the prevalence of congenital bleeding disorders positively drives the market growth. The growing number of trauma cases and accidents across the globe led to the surge in demand for plasma-derived products such as coagulation factors in the critical care segment, thus driving the growth in the segment’s revenue.

The pulmonology segment has the second-highest CAGR and is expected to have substantial growth in the global plasma fractionation market forecast period. The development of the segment can be due to the use of IVIG in various pulmonary diseases. For example, as per an article published in ScienceDirect in 2019, intravenous immunoglobulin treatment has been proven as a salvage therapy for patients with active and progressive Interstitial Lung Disease who do not respond to the combination of steroids and first-line immunosuppressant drugs.

By End-user Analysis

Strong Demand for Plasma Products in Hospitals & Clinics Enable Them to Be at a Leading Position

In terms of end-user, the market is categorized into hospitals & clinics, clinical research laboratories, and others (academic institutes). The hospitals & clinics segment is projected to generate the highest revenue in the global market during the forecast period. The segment's growth is attributed to the increasing number of people opting for plasma-derived therapies across the globe. Various private hospitals with improved infrastructure and technology have adopted plasma-derived therapies and are prescribing their patients suffering from rare immunodeficiency diseases. For example, the Brazilian Rare Disease Network (BRDN) is under development, comprising 40 institutions, including 18 university hospitals, 17 Rare Diseases Reference Services, and five Newborn Screening Reference Services.

The clinical research laboratories segment is in the second position in terms of market share. The growth is due to the increasing demand for plasma therapy for various rare diseases and growing R&D initiatives to develop more PDMP products for clinical applications. The others segment constitutes organizations such as academic institutes and is expected to grow at a significant CAGR in the forecast period.

REGIONAL INSIGHTS

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North America stood at USD 16.10 billion in 2021 and is estimated to dominate the global market during the forecast period. The highest market share of this region is attributed to several factors. Some factors include major companies that develop and market technologically advanced plasma-derived therapies and products, contributing positively to the region’s growth. Furthermore, the presence of a maximum number of plasma fractionation centers in the U.S. significantly contributes to the market growth.

Europe, on the other hand, secured the second position in terms of market share. This is due to the rising prevalence of immunodeficiency and bleeding disorders in the region, and increasing investments in these systems are augmenting the market growth in the region. For example, according to a 2021 article published by the NCBI, Common Variable Immunodeficiency (CVID) affects approximately 1 of 25,000 individuals, with a higher prevalence in northern Europe.

Increased expenditure on pharmaceutical products and evolving healthcare research infrastructure in India and China led to increasing demand for plasma-derived products, thus driving the market growth. Furthermore, the growing prevalence of hemophilia in Asian countries is expected to positively affect the market growth in Asia Pacific. For instance, according to a study published by the Annals of Blood in 2018, the factor VIII IU’s per capita consumption in Japan and China is 4.0 and 0.1, respectively. Moreover, albumin and IVIG consumption in India is 1.3 kg/million population.

Latin America and the Middle East & Africa are estimated to register comparatively slower growth during the forecast period. However, the prevalence of autoimmune diseases in the regions contributes positively to the plasma fractionation market growth. For example, as per a study published by the National Library of Medicine in 2019, the prevalence of autoimmune diseases in regions of Brazil was 673.6 cases per 100,000 inhabitants, with the highest prevalence for Hashimoto’s thyroiditis at 140.6 cases per 100,000, followed by Vitiligo 132.4 cases per 100,000, and rheumatoid arthritis 105.9 cases per 100,000. Furthermore, there have been continuous government initiatives for improving healthcare infrastructure and facilities by focusing on a strategic partnership to fulfill the unmet needs of plasma-derived medicines in patients suffering from immunodeficiency disease and autoimmune disorders. For instance, in November 2020, Grifols and the National Service Projects Organization (NSPO) entered into a strategic alliance to develop the local plasma-derived therapies market by opening 20 plasma centers and constructing production facilities in Egypt, including a plasma fractionation plant and a protein purification plant.

KEY INDUSTRY PLAYERS

Significant Efforts by CSL and Grifols, S.A. to Launch New Products to Strengthen its Global Market Position

In terms of competitive landscape, companies, such as CSL and Grifols, S.A., hold the major shares of the market. Higher expenditure for R&D initiatives and increased focus on opening new plasma collection centers in various countries have increased their dominance in the global market. For instance, in March 2021, Biomat USA, Inc., a subsidiary of Grifols, S.A. acquired 7 plasma donation centers in the U.S. from Kedplasma, LLC. Another factor contributing to the company's dominance is the approvals from regulatory authorities to launch new plasma products for the treatment of chronic diseases. For instance, in February 2020, CSL Behring announced the U.S. FDA approval for Privigen (Immune Globulin Intravenous (Human), 10% Liquid), an orphan drug designation for an investigational therapy for the treatment of systemic sclerosis (SSc).

Other major players in the global market are Baxter, Kedrion S.p.A, and Takeda Pharmaceutical Company Limited, among others. Continuous efforts in launching advanced products and investments in RD are attributable to the increased market presence of these companies in the global market. In June 2021, Kedrion Biopharma and Kamada Ltd. announced that they received approval from the U.S. FDA to update the label for KEDRAB (Rabies Immune Globulin [Human]). The updates are based on KEDRAB U.S. post-marketing pediatric study.

LIST OF KEY COMPANIES PROFILED:

• CSL (U.S.)


• Grifols, S.A (Spain)


• Takeda Pharmaceutical Company Limited (Japan)


• Kedrion S.p.A (Italy)


• Octapharma (Switzerland)


• Bio Products Laboratory Ltd. (U.K.)


• Biotest AG (Germany)


• LFB (France)    

KEY INDUSTRY DEVELOPMENTS:

• January 2022 – Octapharma AG announced that the European Union (EU) expanded the indication for cutaquig, a human immunoglobulin, administered subcutaneously. The expansion would provide more flexible treatment options to patients with acquired immune deficiencies.


• January 2022 – Permira announced a partnership with the Marucci family and FSI, the existing shareholders of Kedrion S.p.A., to jointly acquire and combine Kedrion and Bio Products Laboratory (BPL). The two companies' partnership would create a global player for medicines derived from human plasma to treat life-threatening and rare conditions.


• January 2022- Kedrion S.p.A. and LFB formed an industrial cooperation agreement to increase the availability of immunoglobulins for patients in France. Following the agreement, immunoglobulins manufactured by Kedrion S.p.A will be imported by LFB in France and distributed among hospitals in this region along with their own immunoglobulins.


• January 2022- Bio Products Laboratory Ltd. announced that the National Medical Products Administration (NMPA) for China granted the company a license to market ALBUMINEX 25% in China.


• June 2021- LFB Plasma announced the acquisition of ImmunoTek Bio Center. The acquisition of the plasma collection center will ensure a steady and reliable supply of plasma in the U.S.

REPORT COVERAGE

An Infographic Representation of Plasma Fractionation Market

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The report provides detailed market analysis and focuses on key aspects such as the overview of the types of plasma fractionation products, regulatory scenario by key countries, reimbursement scenario by key countries, pipeline analysis, number of plasma collection centers for key countries, prevalence of chronic diseases by key countries, pricing analysis of plasma products, regional distribution of plasma fractionation throughput, and distribution of the product (volume) by region. Additionally, it includes an overview of new product launches/approvals and the impact of COVID-19 on the global market. Besides these, the report offers insights into market trends and highlights key strategies by market players. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation