Plasma Fractionation Market

The global plasma fractionation market in terms of revenue was estimated to be worth $29.0 billion in 2023 and is poised to reach $40.4 billion by 2028, growing at a CAGR of 6.9% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is driven mainly by factors such as the growing use of immunoglobulins in various therapeutic areas, strategic expansion of plasma collection centers/inventories by market players, and the growing prevalence of respiratory diseases and AATD. However, high costs, limited reimbursements for plasma products, and market disruption caused by recombinant alternatives are expected to restrain the growth of this market to a certain extent during the forecast period.

Plasma Fractionation Market - Global Forecast to 2028

To know about the assumptions considered for the study, Request for Free Sample Report

Attractive Opportunities in the Plasma Fractionation Market

Global Plasma Fractionation Market Dynamics

DRIVER: Growing prevalence of respiratory diseases and AATD

In recent years, the use of protease inhibitors such as alpha-1-antitrypsin has increased significantly for the treatment of lung diseases (such as emphysema) and hepatic diseases (such as hepatic inflammation, fibrosis, and cirrhosis). Alpha-1-antitrypsin deficiency (AATD) is a chronic, unrecognized metabolic genetic disorder. It is responsible for 2–3% of emphysema cases in the US. The deficiency of alpha-1-antitrypsin leads to the early onset of pan-lobular emphysema in both smokers and non-smokers, and the abnormal accumulation of alpha-1-antitrypsin in the liver leads to liver diseases. AATD occurs worldwide, but its prevalence varies by geography. Emphysema, along with chronic bronchitis, is collectively known as chronic obstructive pulmonary disease (COPD). Severe AATD is associated with a significant number of cases of COPD. According to a publication by Elsevier B.V. in July 2023, an estimated worldwide prevalence of the PI*ZZ Alpha-1 Antitrypsin genotype in subjects with COPD was around 50% in Europe, 37% in America, 9% in Asia, 3% in Australasia, and 1% in Africa. The estimated crude prevalence of COPD in adults older than 40 years was 13.51% in America, 12.45% in Europe, 13.22% in Africa, 11.70% in Asia, and 11.86% in Australasia. Prevalence was significantly higher, especially in Europe, the USA, Canada, New Zealand, and Australia, while it was found to be lower, especially in regions of Asia and Africa.

The growing prevalence of AATD and emphysema and improvements in diagnostic techniques such as CT scanning are expected to increase the number of people undergoing therapies for these diseases. This, in turn, will lead to a greater demand for protease inhibitors such as alpha-1-antitrypsin and contribute to the overall growth of the plasma fractionation market.

RESTRAINT: Market disruption caused by recombinant alternatives

Recent approvals for recombinant factors such as AFSTYLA (CSL), VONVENDI (Takeda/Shire), and Kovaltry (Bayer) are expected to offer lucrative opportunities for companies operating in this market space. At present, two different classes of recombinant factor products are available—standard half-life products and extended half-life products. The former class of recombinant factors last in the body for the same amount of time as the natural factor VIII or factor IX. Whereas extended half-life products are modified to last longer in the body than standard half-life products.

In developed countries, recombinant factors VIII and IX have already gained traction as alternatives to plasma-derived factors VIII and IX in bleeding disorders, as reported by the Annual Global Survey conducted by the World Federation of Hemophilia (WFH) in 2020. On the other hand, the use of recombinant factors has also increased in countries such as Brazil, India, and Russia. This trend is expected to impose certain limitations on the expansion of plasma-derived coagulation factors, thereby affecting the overall market growth.

OPPORTUNITY: Government strategies increasing regional self-sufficiency

The implementation of government strategies aimed at increasing regional self-sufficiency in plasma fractionation acts as a significant driver for the plasma fractionation market. These strategies are designed to strengthen the domestic production and availability of plasma-derived products within a specific region.

The United States is the world's leading provider of plasma and plasma-derived medicinal products, with plasma received entirely from US donors. The majority of other nations that produce therapies using plasma rely on importing US plasma, plasma fractions, and plasma pharmacological products. The nations have long aimed to stop depending on US plasma by reviewing outdated policies that restrict plasma collection. The UK removed the ban on domestic blood plasma for clinical use in 2021, which was imposed two decades ago in reaction to mad cow disease (BSE, or bovine spongiform encephalopathy). The UK's annual plasma collection rate increased as a result of the policy change, which increased the potential for manufacturing plasma-derived products to meet local patient demands. For the rest of Europe, 40% of plasma is collected in Germany, Austria, Hungary, and the Czech Republic. The EU Blood, Tissues, and Cells (BTC) regulation is currently being revised, which may lead to other countries increasing plasma collection and fractionation.

CHALLENGE: Stringent government regulations for maintaining the safety and quality of plasma-derived products

Plasma fractionation is one of the most heavily regulated sectors in the pharmaceutical industry. The risk of transmission of blood-borne pathogens and other diseases associated with transfusion has compelled regulatory authorities to focus on the safety and quality of fractionated plasma products. According to WHO guidelines, national regulatory authorities should inspect the quality of sourced plasma and plasma-derived products regularly. The WHO has also mentioned the characteristics of plasma for the fractionation process. The stringent regulations in the market act as a barrier to the entrance of new players, besides posing as a restraint for small local players to expand in the international market. Multinational companies also face challenges while investing in local/regional markets such as China. The import of plasma products, except albumin, has been banned in China since 1986. These factors are hampering the growth of the market in China, which is the second-largest market for plasma fractionation products.

Global Plasma Fractionation Market Ecosystem Analysis

The plasma fractionation market ecosystem comprises raw material suppliers such as blood donation & plasma donation centers, plasma fractionation product manufacturers, and end users such as hospitals & clinics, biopharmaceutical manufacturers, R&D institutes, CROs, CDMOs, and academic institutes. Plasma fractionation manufacturers provide various types of plasma products, such as immunoglobulins, albumin, protease inhibitors, coagulation factor concentrates, and other plasma products.

The immunoglobins segment of the plasma fractionation industry will witness the highest growth during the forecast period.

Based on product, the plasma fractionation market is segmented into albumins, protease inhibitors, immunoglobulins, coagulation factor concentrates, and other products. The immunoglobulins segment has accounted for the largest share of the plasma fractionation market in 2022. The large share of the segment is due to several off-label immunoglobulin indications and applications of these medicines. Additionally, Immunoglobulins are also used as a defense against immunosenescence and other aging-related immune system problems. In coming years, it is anticipated that the use of immunoglobulins will expand due to the rising prevalence of infectious diseases. Furthermore, this segment is also expected to register the highest CAGR during the forecast period, based on volume, owing to the high demand for intravenous immunoglobulin (IVIg) for a wide range of indications including primary immunodeficiency disorders, autoimmune diseases, neurological disorders, among others.

The neurology segment dominated the plasma fractionation industry in 2022.

Based on application, the plasma fractionation market is segmented into hemato-oncology, rheumatology, neurology, immunology, hematology, critical care, pulmonology, and other applications. In 2022, the neurology segment accounted for the largest share of the plasma fractionation market. This is primarily due to the fact that IVIg produces a faster response than steroids or oral immunosuppressants. IVIg is effective for a range of disorders with the peripheral and central nervous systems. Additionally, IVIg is being investigated for additional neurological indications like Alzheimer's disease. If these indications demonstrated encouraging results, there would be a surge in the demand for IVIg in neurological applications.

To know about the assumptions considered for the study, download the pdf brochure

Asia Pacific was the fastest-growing regional market for plasma fractionation industry during the forecast period.

Geographically, the plasma fractionation market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. In the forecast period 2023-2028, the Asia Pacific accounted for the highest CAGR of the plasma fractionation market. This is attributed to the growing use of albumin and immunoglobulins. The increasing focus on better diagnosis, prophylactic treatments, and medical research will increase the adoption of plasma-derived products, which, in turn, will drive the market for plasma fractionation in Asia Pacific.

Key players in the global plasma fractionation market include CSL (Australia), Takeda Pharmaceutical company limited (Japan), Grifols, S.A. (Spain), Octapharma AG (Switzerland), Kedrion S.P.A (Italy), LFB (France), ADMA Biologics (US), Sanquin (Netherlands), China Biologic Products Holdings Inc. (China), GC Pharma (Korea), Hualan Bioengineering Co., Ltd. (China), Japan Blood Products Organization (Japan), Emergent BioSolutions (US), Shanghai Raas Blood Products Co., Ltd. (China), Intas Pharmaceuticals Ltd. (India), Bharat Serum Vaccines Limited (India), SK Plasma (Korea), Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (China), Kamada (Israel), Centurion Pharma (Istanbul), Prothya Biosolutions (Netherlands), PlasmaGen BioSciences Pvt. Ltd. (India), Virchow Biotech Private Limited (India), Fusion Healthcare (India), and Hemarus Therapeutics Limited (India).

Scope of the Plasma Fractionation Industry:

This report categorizes the plasma fractionation market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Immunoglobulins
  • Intravenous Immunoglobulins
  • Subcutaneous Immunoglobulins
  • Other Immunoglobulins
• Coagulation Factor Concentrates
  • Factor VIII
  • Factor IX
  • Von Willebrand Factor
  • Prothrombin Complex Concentrate
  • Fibrinogen Concentrates
  • Factor XIII
  • Other Coagulation Factor Concentrates
• Albumin
• Protease Inhibitors
• Other Plasma Products

By Application

• Neurology
• Immunology
• Hematology
• Critical care
• Pulmonology
• Hemato-Oncology
• Rheumatology
• Other Applications

By End User

• Hospitals and Clinics
• Clinical Research Laboratories
• Academic institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • Australia
  • India
  • Vietnam
  • Indonesia
  • Malaysia
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • RoLATAM
• Middle East and Africa (MEA)
  • Turkey
  • Saudi Arabia
  • Egypt
  • UAE
  • Rest of Middle East and Africa

Recent Developments of Plasma Fractionation Industry

• In April 2023, CSL (Australia) received Food and Drug Administration (FDA) approval for the 50mL/10gm prefilled syringe for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid for patients suffering from PI and CIPD.
• In March 2022, Grifols (Spain) received European approvals for XEMBIFY, a 20% subcutaneous immunoglobulin (SCIG)
• In January 2022, Permira, a global investment firm, announced that it would be acquiring Kedrion and merging the company with BPL.

Frequently Asked Questions (FAQ):

To speak to our analyst for a discussion on the above findings, click Speak to Analyst