Plasma Fractionation Market Analysis

Global Plasma Fractionation Market Overview

The Plasma Fractionation Market is emerging due to the increasing demand for Plasma-Derived Medicinal Products (PDMPs), growing awareness and diagnosis of rare diseases, and the rising geriatric population across the globe. Additionally, the growing technological advancements and innovation will provide growth opportunities for the market in the future.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Plasma Fractionation Trends

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  Increasing demand for plasma-derived medicinal products (PDMPS) fuels market growth

  
  

The escalating demand for Plasma-Derived Medicinal Products (PDMPs) is a pivotal driver propelling the Plasma Fractionation Market. PDMPs, derived through the meticulous process of plasma fractionation, constitute a diverse array of therapeutic products essential for treating various medical conditions. Immunoglobulins, exemplified by Intravenous Immunoglobulin (IVIG), stand out as crucial components extracted from human plasma. IVIG plays a central role in treating primary immunodeficiency disorders and enhancing immune responses in affected individuals. Additionally, clotting factors, such as Factor VIII and Factor IX, form integral PDMPs for addressing hemophilia and preventing excessive bleeding. Albumin, another vital protein derived from plasma, finds application in PDMPs to restore proper fluid balance in conditions like hypovolemia or liver failure. Fibrinogen concentrates contribute to PDMPs aimed at managing fibrinogen deficiency and specific bleeding disorders. Furthermore, hyperimmune globulins, specialized PDMPs with elevated pathogen-specific antibodies, are instrumental in preventing and treating infectious diseases such as hepatitis B and rabies. As the awareness of these diverse PDMPs increases and advancements in plasma fractionation technologies persist, the demand for these specialized therapeutic products is expected to further burgeon, steering the Plasma Fractionation market towards continued growth and innovation.

Plasma Fractionation Segment Insights

Plasma Fractionation Product Insights

The Plasma Fractionation Market segmentation, based on product, includes immunoglobulin, coagulation factor concentrates, albumin, protease inhibitors, and others. The immunoglobulin segment held the majority share in the market in 2022. The immunoglobulin segment is further segmented into intravenous immunoglobulins, subcutaneous immunoglobulins, and others. Intravenous immunoglobulins (IVIg) offer several advantages, such as rapid delivery, high efficacy, versatility, and relatively low safety. This is being utilized in conditions such as immune thrombocytopenia (ITP), Kawasaki disease, and Guillain-Barre syndrome, among others. Moreover, subcutaneous immunoglobulins (SCIg) are commonly given in Variant Creutzfeldt-Jakob disease, Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV), and among others.     

Plasma Fractionation Method Insights

The Plasma Fractionation Market segmentation, based on method, includes cryoprecipitation, chromatography, ethanol precipitation, ultrafiltration, and others. The cryoprecipitation segment held the largest market share in 2022 and is the fastest-growing segment during the forecast period. Cryoprecipitate is the precipitated fraction formed after thawing FFP (fresh frozen plasma) at 4°C. This method of isolation involves pooling cryoprecipitate from FFP collected from numerous donors. Cryoprecipitate contains high levels of factor VIII, von Willebrand factor, factor XIII, and fibronectin.

Figure 2: Plasma Fractionation Market, by Method, 2022 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Plasma Fractionation Application Insights

The Plasma Fractionation Market segmentation, based on application, includes immunology, neurology, hematology, critical care, pulmonology, rheumatology, hemato-oncology, and others. The neurology segment held the largest market share in 2022, and hemato-oncology segment is the fastest-growing segment during the forecast period i.e., 2024-2032. Increasing incidences of diseases such as immune disorders, respiratory diseases, infectious diseases, cancer, and among others, rising awareness of the plasma fractionation products to treat above mentioned diseases, growing expansion of the plasma fractionated products in developing regions to fulfill the demand of patients and physicians are burgeoning the growth of the application segment.

The Plasma Fractionation Market segmentation, based on end user, includes hospitals & clinics, clinical research laboratories, academic institutes, and others. The hospitals & clinics segment held the largest market share in 2022, and academic institutes segment is the fastest-growing segment during the forecast period i.e., 2024-2032. Increasing number of surgical procedures and growing number of surgical procedures are the factors driving the end user segment.

Plasma Fractionation Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World. The North America plasma fractionation market is experiencing significant growth, driven by factors such as increasing demand for plasma-derived therapies, advancements in biopharmaceutical research, and the rising prevalence of chronic diseases. Plasma fractionation, a crucial process in the production of various therapeutic products, involves separating plasma into its component parts, such as proteins and antibodies, for the treatment of conditions like immunodeficiency disorders and hemophilia. The region's well-established healthcare infrastructure, technological innovations, and favorable regulatory environment contribute to the market's expansion.

Further, the major countries will be study are US, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: Plasma Fractionation Market by Region 2022 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe plasma fractionation market accounted for the second-largest market share due to sophisticated healthcare infrastructure, coupled with a rising incidence of chronic diseases, drives the need for innovative treatment options. Furthermore, the Germany plasma fractionation provider attributed to hold the largest market share, and the France plasma fractionation providers is projected be the fastest growing market in the Europe region.

The Asia-Pacific plasma fractionation market is expected to be the fastest growing from 2024 to 2032 due to increasing demand for plasma-derived therapies, robust economic development, expanding healthcare infrastructure, and a growing awareness of advanced medical treatments. Moreover, China plasma fractionation accounted to hold the largest market share, and the India plasma fractionation is projected to be the fastest growing market in the Asia-Pacific region.

Plasma Fractionation Key Market Players & Competitive Insights

The Plasma Fractionation Market is distinguished by the presence of many global, regional, and local players. The increasing demand for plasma-derived medicinal products (PDMPS), growing awareness and diagnosis of rare diseases, and rising geriatric population across the globe are further expected to drive the growth of the Plasma Fractionation Market during the forecast period. However, emergence of recombinant therapies as an alternative to plasma-derived medicines may hamper the growth of the Plasma Fractionation Market. The major players have adopted a strategy of obtaining regulatory approval from government agencies for their products and signing contracts and agreements to broaden their reach and reduce operational costs.

Pfizer Inc. (Pfizer) manufactures and develops vaccines and medicines for a wide range of medical disciplines that include oncology, cardiology, immunology, diabetology/endocrinology, and neurology. Pfizer also collaborates with healthcare providers, governments, and local communities to support and broaden access to high-quality, reasonably priced healthcare globally. Pfizer distributes its goods through distributors, retailers, hospitals, clinics, public institutions, and pharmacies. The company has R&D platforms in the field of biosimilars, gene therapy, precision medicines, and medicinal sciences. Pfizer operates in countries such as Germany, France, Greece, Korea, Mexico, Russia, the Netherlands, India, Poland, Turkey, Israel, China, and others. Furthermore, the company supplies its products across all regions namely, Americas, Europe, Asia-Pacific, and the Middle East & Africa.

Moreover, In February 2021, The U.S. Food and Drug Administration (FDA) approved Pfizer’s supplemental biologics license application (sBLA) for PANZYGA (immune globulin intravenous [human] ifas 10% Liquid Preparation) to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disease of the peripheral nerves.

Key Companies in the Plasma Fractionation market includes.

• CSL (Australia)


• Grifols S.A. (Spain)


• Takeda Pharmaceutical Company Limited (Japan)


• Octapharma AG (Switzerland)


• Pfizer, Inc (US)


• Bio Products Laboratory Ltd (UK)


• Kedrion S.p.A (Italy)


• ADMA Biologics, Inc (US)


• Japan Blood Products Organization (Japan)


• KM Biologics (Japan)

Plasma Fractionation Industry Developments

• In September 2023, Takeda (Japan) announced that the Japanese Ministry of Health, Labour, and Welfare has approved the use of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in patients aged 2 years and older with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent antibody levels and an increased risk of serious recurring infection caused by PID or SID2.


• In July 2023, Octapharma (Switzerland) announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed as octaplex in Europe and Canada) has received FDA approval for the urgent reversal of acquired coagulation factor deficiency caused by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients requiring urgent surgery or invasive procedures.


• In July 2023, Kedrion S.p.A (Italy) expanded its product portfolio to China to supply human plasma-derived products (Albumin). As part of a product line expansion, the company wants to offer plasma-derived products to patients in China.

Plasma Fractionation Segmentation

Plasma Fractionation Product Outlook

• Immunoglobulin
  
  
  
  • Intravenous Immunoglobulins
  
  
  • Subcutaneous Immunoglobulins
  
  
  • Others
  
  
  
  


• Coagulation Factor Concentrates
  
  
  
  • Factor VII
  
  
  • Factor VIII (Von Willebrand Factor)
  
  
  • Factor IX
  
  
  • Prothrombin Complex Concentrate
  
  
  • Fibrinogen Concentrates
  
  
  • Factor XIII
  
  
  
  


• Albumin


• Protease Inhibitors


• Others

Plasma Fractionation Method Outlook

• Cryoprecipitation


• Chromatography


• Ethanol Precipitation


• Ultrafiltration


• Others

Plasma Fractionation Application Outlook

• Immunology


• Neurology


• Hematology


• Critical Care


• Pulmonology


• Rheumatology


• Hemato-Oncology


• Others

Plasma Fractionation End User Outlook

• Hospitals & Clinics


• Clinical Research Laboratories


• Academic Institutes


• Others

Plasma Fractionation Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Belgium
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America