According to Vision Research Reports, the global recombinant plasma protein therapeutics market size is expected to reach US$ 21.7 bn by 2030 and anticipated expand at a CAGR of 9.2% from 2022 to 2030.
According to Vision Research Reports, the global recombinant plasma protein therapeutics market size is expected to reach US$ 21.7 bn by 2030 and anticipated expand at a CAGR of 9.2% from 2022 to 2030.
Replacement of plasma derived proteins by recombinant plasma products, increase in the number of products launched, and rise in the demand for novel therapies of hemophilia treatment are anticipated to drive the market.
Report Highlights
- In 2021, immunoglobulin captured the leading position with more than 47.07% market share.
- The albumin segment is expected to gain significant share over the forecast period.
- The PID segment captured the largest market share in 2021 and is expected to exhibit substantial growth through the forecast period.
- Approximately 74.11% of the market is concentrated in North America and Europe.
- The U.S. spearheaded the market with more than 44.5% share in 2021.
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Rising Number of Regulatory Approvals to Drive Market
There has been an increase in the number of regulatory approvals in the last three years that have increased the availability of various options for patients with rare diseases such as hemophilia and other bleeding disorders. These approvals enabled companies to expand their product portfolios and gain competitive advantage. For instance, in September 2017, Ministry of Health, Labour and Welfare, Japan, approved CSL Behrings AFSTYLA, a recombinant factor VIII indicated for the treatment of hemophilia A. AFSTYLA has been also approved in the U.S., Canada, and Switzerland. In April 2018, Shire received Food and Drug Administration (FDA) approval for VONVENDI recombinant von Willebrand factor, indicated for perioperative management of bleeding in patients with von Willebrand disease (VWD). In July 2018, Bayer AG announced the approval for Kovaltry, recombinant factor VIII from the regulatory authorities in China, indicated for the treatment of hemophilia A.
Product Insights
Based on product, the plasma protein therapeutics market is segmented into albumin, Immunoglobulins (IG), plasma-derived factor VIII, and others. In 2021, immunoglobulin captured the leading position with more than 47.07% market share. The large share can be attributed to the approval of biologics across multiple indications, ease of administration, and treatment cost.
The albumin segment is expected to gain significant share over the forecast period driven by improved diagnosis of hypoalbuminemia caused by liver cirrhosis and hepatitis B. High demand and usage in China, which is the largest market for albumin, is anticipated to further fuel the growth. Patients suffering from moderate to severe hemophilia A require clotting factor VIII as a preventive or on-demand therapy. However, approximately 70.0% of hemophilia patients receive none or inadequate treatment. The factor VIII market is expected to witness a decline in sales due to increasing competition from recombinant and other long-term therapies.
The others segment includes alpha-1 antitrypsin, hyperimmune immunoglobulins, coagulation factors, fibrogammin, and c1 esterase inhibitors. Alpha-1 Antitrypsin (AAT) is used as a replacement therapy to treat a rare form of hereditary emphysema. The deficiency causes conditions such as Chronic Obstructive Pulmonary Disease (COPD), bronchitis, and neonatal hepatitis. Currently, only about 10.0% to 15.0% of AAT deficient patients receive treatment in the U.S. and Europe, thus creating room for market growth. The overall segment is anticipated to exhibit lucrative growth driven by improvement in diagnosis rate and product launches.
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Application Insights
On basis of application, the market for plasma protein therapeutics is segmented into Hemophilia, Primary Immunodeficiency Diseases (PID), Idiopathic Thrombocytopenic Purpura (ITP), and others. Primary immunodeficiency diseases include more than 200 rare, chronic diseases that result from a defect in the immune system.
Globally, more than 6.0 million individuals are living with a PID, of which less than 60,000 cases are reported annually. The PID segment captured the largest market share in 2021 and is expected to exhibit substantial growth through the forecast period. Increasing expansion of clinical applications for immunoglobulins, approval of SCIGs, and high treatment costs are contributing to the segment growth.
Regional Insights
Geographically, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. Approximately 74.11% of the market is concentrated in North America and Europe. The U.S. spearheaded the market with more than 44.5% share in 2021. Presence of large patient base, growing geriatric population, availability of well-developed infrastructure for storing, and maintaining high-quality source plasma are some of the key regional drivers. Increased adoption of novel therapeutics and rising disease prevalence are some of the other key factors contributing to the regional growth.
Companies Mentioned in Report
The report also profiles major players operating in the global recombinant plasma protein therapeutics market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments. Key players profiled in the market report include CSL Limited, Shire (Takeda Pharmaceutical Company Limited), Octapharma, Novo Nordisk A/S, Bayer AG, Bioverativ Therapeutics, Inc. (Sanofi), Aptevo Therapeutics, Pharming Group NV, and Pfizer Inc.
The global recombinant plasma protein therapeutics market has been segmented as below:
- By Drug Class
- Recombinant Coagulation Factors
- Recombinant Coagulation Factor VIII
- Recombinant Coagulation Factor IX
- Recombinant Coagulation Factor VIIa
- Others
- Human C1 Esterase Inhibitor
- Recombinant Coagulation Factors
- By Cell Line
- Chinese Hamster Ovary (CHO) Cell Line
- Baby Hamster Kidney (BHK) Cell Line
- Human Embryonic Kidney (HEK) Cell Line
- Others
- By Indication
- Hemophilia A
- Hemophilia B
- Von Willebrand Disease
- Others
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