Plasma Fractionation Market is projected to reach USD 36.7 billion by 2027 from USD 26.5 billion in 2022, at a CAGR of 6.7% during the forecast period. Market growth is driven mainly by factors such as increased application of immunoglobulins for treatment of various therapeutic areas such as hematology, neurology and pulmonology, and the use of protease inhibitors for the treatment of lung diseases and hepatic diseases that have growing incidence rate. However, the increased cost of plasma products, limited reimbursements, and the growth of recombinant alternatives are expected to restrain the growth of this market during the forecast period.
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Key Market Players
The global plasma fractionation market is highly consolidated. The prominent players operating in this market include CSL (Australia), Grifols, S.A. (Spain), Shire (US), Octapharma AG (Switzerland), Kedrion S.P.A (Italy), LFB (France), Biotest AG (Germany), Sanquin (Netherlands), China Biologic Products Holdings Inc. (China), GC Pharma (Korea), Bio Products Ltd. (UK), 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), KabaFusion (US), Centurion Pharma (Istanbul), ADMA Biologics, Inc. (US), PlasmaGen BioSciences Pvt. Ltd. (India), Virchow Biotech Private Limited (India), Fusion Healthcare (India), and Hemarus Therapeutics Limited (India). Geographic expansions and collaborations are the key growth strategies undertaken by these companies to maintain their positions in the market.
Drivers: Growing use of immunoglobulins for various therapeutic area
The increasing use of immunoglobulins for various therapeutic areas, such as autoimmune diseases, immune deficiencies, and infectious diseases, is driving the growth of the plasma fractionation market. Immunoglobulins are proteins produced by the immune system to fight against infections, allergies, and other diseases. Plasma fractionation processes are used to extract immunoglobulins from the plasma of healthy donors. These immunoglobulins are then used to treat various diseases, such as primary immunodeficiencies, autoimmune diseases, and infectious diseases. In addition, the increasing demand for immunoglobulins in the research sector is also driving the growth of the plasma fractionation market.
Restraints: Use of recombinant alternatives for certain plasma products
The use of recombinant alternatives for certain plasma products such as factor VIII, IX and von Willebrand factor is a key restraint for the growth of the plasma fractionation market. The advent of recombinant alternative products has enabled more efficient and cost-effective treatment of hemophilia, while also eliminating the risk of infections associated with the use of plasma-derived products. Numerous companies, such as Novo Nordisk, have launched recombinant alternative products in the market, which has significantly impacted the market of plasma-derived products.
Opportunities: Increased risk of communicable disease
The increasing risk of communicable diseases such as influenza, coronavirus, and HIV is expected to drive demand for plasma fractionation products. According to the World Health Organization (WHO), the number of reported cases of communicable diseases such as HIV, malaria, and tuberculosis has been increasing consistently over the past few decades. This has necessitated the need for more efficient and effective treatments and therapies for these diseases, which is expected to drive the demand for plasma fractionation products in the coming years.
Challenges: Stringent Government Regulations
The plasma fractionation market is highly regulated by government regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These organizations have stringent regulations for the approval and sale of plasma products. For instance, the FDA requires that manufacturers must comply with the Current Good Manufacturing Practice (cGMP) requirements as well as provide documentation such as product specifications, manufacturing and testing protocols, and safety data for plasma products before approval. Additionally, strict regulations on the collection and distribution of plasma also limit the market growth.
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Recent Developments
- Baxter International Inc. acquired ChemoSera S.A. in 2022. The acquisition will expand Baxter’s portfolio of plasma fractionation products and enable the company to expand its presence in the European markets.
- Biovian Oy acquired ViroClinics Biosciences B.V. in 2022. The acquisition will expand Biovian’s plasma fractionation capabilities, increase its global presence, and enable the company to enhance its offerings in the field of plasma-derived biopharmaceuticals.
- Takeda Pharmaceutical Company Limited acquired Shire Plc in 2022. This acquisition will broaden Takeda’s product portfolio, enabling the company to expand its presence in the plasma fractionation market.
- Grifols S.A. acquired Hologic Inc. in 2022. The acquisition of Hologic & business will enable Grifols to expand its offering of plasma fractionation products and services, as well as its global presence.
- CSL Limited acquired Terumo BCT in 2023. This acquisition will enable CSL to expand its product portfolio and strengthen its position in the global plasma fractionation market.
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