According to a research report “Plasma Fractionation Market projected to reach USD 40.4 billion by 2028 from USD 29.0 billion in 2023, at a CAGR of 6.9% during the forecast period. The growing popularity of immunoglobulins for the treatment of various therapeutic areas such as hematology, neurology, and pulmonology, as well as the use of protease inhibitors for the treatment of lung and hepatic disorders with rising incidence rates, are driving the growth of the market. However, the rising cost of plasma-derived products, limited reimbursements, and the rise of recombinant alternatives are projected to hamper the market’s growth during the forecast period.

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Key Market Player:

The global plasma fractionation market is highly consolidated. The prominent players operating in this 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), Haualan 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). Geographic expansions and collaborations are the key growth strategies undertaken by these companies to maintain their positions in the market.

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.

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The immunoglobins segment accounted for the largest share by-product in the plasma fractionation market in 2022.

Based on product, the plasma fractionation market is segmented into protease inhibitors, coagulation factor concentrates, immunoglobulins, albumins, and other products. Immunoglobulins accounted for the largest share of the global plasma fractionation market in 2022. The dominance of this segment is mainly attributed to the rise in the cases of neurological and immunological diseases, the increase in off-label utilization of immunoglobulins, especially IVIg, and the increased usage of these immunoglobulins in the treatment of a variety of diseases and conditions that are linked to humoral immune deficiency or immune system dysfunction, including immune thrombocytopenic purpura, Kawasaki syndrome, Guillain-Barré syndrome, and graft-versus-host diseases after bone marrow transplantation.

The pulmonology segment is expected to grow at the highest CAGR during the forecast period.

Based on application, the plasma fractionation market is segmented into pulmonology, hemato-oncology neurology, immunology, hematology, critical care, rheumatology, and other applications. In 2022, the pulmonology segment is expected to register the highest CAGR during the forecast period. The increasing demand for immunoglobulins to prevent and treat upper and lower respiratory tract infections due to their efficiency is a major factor driving growth in this market segment. Additionally, the use of protease inhibitors such as alpha-1-antitrypsin has also increased substantially over the past few years.

North America was the largest regional market for plasma fractionation market in 2022

The global plasma fractionation market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. In 2022, North America accounted for the largest share of the plasma fractionation market, followed by Europe and the Asia Pacific. The significant market share held by North America is supported by the region’s rising hemophilic population as well as the rising demand for immunoglobulins for conditions like PID, idiopathic thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy (CIDP), allogenic bone marrow transplantation, pediatric HIV, and B-cell chronic lymphocytic leukemia. The market in Asia Pacific, on the other hand, is projected to grow at the greatest CAGR throughout the forecast period. This can be attributed to the expansion of the healthcare sector, the increasing incidence of hemophilia, the increase in the number of organ transplants, the increased emphasis on early diagnosis and prophylactic care, the increased awareness of technologically advanced products, and the rising standards of living in many countries in APAC.

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Recent Development:

• 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.

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