Recombinant Coagulation Factors Market Size & Forecast
The Recombinant Coagulation Factors Market is projected to reach $24.21 billion by 2030, at a CAGR of 8.6% from 2023 to 2030. Recombinant coagulation factors differ from plasma-derived factors due to their production technology, which involves recombinant DNA technology. These recombinant factors have a very low risk for blood-borne transmission of infectious diseases, and their use should eradicate the threat of infection from viruses such as hepatitis C and the human immunodeficiency virus. Thus, coagulation factors are majorly applicable to bleeding disorders like hemophilia.
The increasing prevalence of hemophilia and other bleeding disorders, growing R&D for coagulation factors, growing awareness about the benefits of the recombinant coagulation factors, and increasing prophylactic treatment for hemophilia across the globe are driving the growth of the recombinant coagulation factors market. Furthermore, the potential emerging economies and rising healthcare expenditure are expected to offer significant growth opportunities for the recombinant coagulation factors market.
However, the high cost of recombinant factors compared to plasma-derived ones and the limited accessibility and availability of recombinant clotting factors in developing & underdeveloped countries are expected to restrain the growth of this market. Additionally, manufacturing challenges in the production of recombinant coagulation factors, stringent regulatory requirements, lack of reimbursement in some countries, and lack of awareness among patients are some of the challenges to the growth of this market.
Rising Prevalence of Hemophilia to Drive the Demand for Recombinant Clotting Factors
Hemophilia A and B are the most common severe hereditary hemorrhagic disorders. These disorders are caused due to coagulation factor VIII and factor IX protein deficiency. Such deficient patients have prolonged bleeding with or without trauma, depending on the factor activity. According to National Center for Biotechnology Information (NCBI) data, in September 2022, the estimated frequency of hemophilia was about 1 in 10,000 live births, and the number of people worldwide living with hemophilia was about 4,00,000. Hemophilia A is more prevalent, about 80-85% of the total hemophilia population. It is present in 1 in 5,000 live male births, whereas hemophilia B is present in 1 in 30,000 live male births.
Thus, to tackle this disorder, coagulation factors, also known as clotting factors, are gaining popularity. The wide availability of recombinant factor VIII, viral inactivation, and better screening technology make the product and treatment safer. Thus, despite the availability of plasma-derived factor concentrates, about 75% of patients with hemophilia worldwide receive recombinant factor VIII products since they are much safer. Thus, the effectiveness of recombinant clotting factors products supports better treatment for hemophilic patients, driving the growth of this market.
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Preference for Recombinant Coagulation Factors over Plasma-derived Factors Provide Opportunity for the Players in this Market
Plasma-derived concentrates are made from human blood donated by healthy volunteers and screened for safety. Recombinant factor products are made in a laboratory using recombinant technology. These products are not made from human blood. Since recombinant factor products are manufactured in the laboratory, it avoids the risk of transmission of blood-borne viruses.
Previously, patients with bleeding disorders like hemophilia were treated with plasma concentrates. However, hemophilia patients treated with plasma concentrates prepared from pooled plasma were found to be at an enormously high risk of HIV infection because there was no way to screen plasma or plasma donors for HIV. Thus, traditionally, about 70-75% of patients with severe hemophilia are found to have HIV. Manufacturers provide virus inactivation methods that improve plasma concentrations. However, the perception of patients of the potential risk of blood-borne virus transmission remains high. This led to the emergence of recombinant coagulation factors. This offers a safer option than plasma-derived products because they avoid potential blood-borne transmission of infectious diseases. Thus, avoid secondary infection risk; hence, the use of recombinant factors over plasma-derived ones provides growth opportunities for the players in this market.
Key Findings in the Market Study:
In 2023, the Recombinant Factor VIII Segment is Expected to Dominate this Market
Based on type, the recombinant coagulation factors market is segmented into recombinant factor VIII, recombinant factor IX, and other types. In 2023, the recombinant factor VIII segment is expected to account for the largest share of this market. The large market share of this segment is attributed to advancements in recombinant technology, high demand for recombinant factor VIII due to a large patient pool of hemophilia A patients, and growing awareness about the benefits of recombinant coagulation factors.
In 2023, the Hemophilia A Segment is Expected to Dominate this Market
Based on application, the recombinant coagulation factors market is segmented into hemophilia A, hemophilia B, and other applications. In 2023, the hemophilia A segment is expected to account for the largest share of the recombinant coagulation factors market. The large market share of this segment is attributed to factors such as a higher number of hemophilia A patients compared to hemophilia B, favorable government initiatives to support the treatment of hemophilia A, and the rising global prevalence of hemophilia.
In 2023, the Hospitals & Clinics Segment is Expected to Dominate this Market
Based on end user, the recombinant coagulation factors market is segmented into hospitals & clinics, and clinical research laboratories. In 2023, the hospitals & clinics segment is expected to account for the largest share of the recombinant coagulation factors market. The large market share of this segment is attributed to the increased adoption of recombinant coagulation factors in hospitals for the treatment of coagulation disorders, rising healthcare expenditure, and rising awareness among healthcare professionals.
Asia-Pacific: Fastest-growing Regional Market
The growth of this market is driven by the increasing hereditary disorders, the increasing investments in healthcare in developing countries such as China and India, and the growing preference for recombinant technology owing to advantages compared to traditional are driving the growth of the recombinant coagulation factors market in Asia-Pacific.
Recombinant Coagulation Factors Market: Competitive Analysis
The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market players in the past few years. The key players profiled in the recombinant coagulation factors market report are Baxter International Inc. (U.S.), Grifols, S.A. (Spain), CSL Limited (Australia), Octapharma AG (Switzerland), Novo Nordisk A/S (Denmark), Biogen Inc. (U.S.), Bayer AG (Germany), Kedrion S.p.A. (Italy), Emergent BioSolutions (U.S.), and Pfizer Inc. (U.S.).
Recombinant Coagulation Factors Market Report Summary:
Particulars
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Details
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Number of Pages
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~180
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Format
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PDF
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Forecast Period
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2023-2030
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Base Year
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2022
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CAGR
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8.6%
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Estimated Market Size (Value)
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$24.21 billion by 2030
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Segments Covered
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By Type
- Recombinant Factor VIII
- Recombinant Factor IX
- Other Types
(Note: Other types include recombinant factor XIII, VIIa, and X)
By Source
- Chinese Hamster Ovary (CHO) Cell Line
- Human Embryonic Kidney (HEK) Cell Line
- Other Sources
(Note: Other sources include the Baby hamster kidney (BHK) cell line and COS cell line)
By Application
- Hemophilia A
- Hemophilia B
- Other Applications
By End User
- Hospitals & Clinics
- Clinical Research Laboratories
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Countries Covered
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North America (U.S. and Canada), Europe (Germany, France, U.K., Italy, Spain, Netherlands, Sweden, and Rest of Europe), Asia-Pacific (China, Japan, India, Australia, and Rest of Asia-Pacific), Latin America (Brazil, Mexico, Rest of Latin America), and Middle East & Africa
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Key Companies
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Baxter International Inc. (U.S.), Grifols, S.A. (Spain), CSL Limited (Australia), Octapharma AG (Switzerland), Novo Nordisk A/S (Denmark), Biogen Inc. (U.S.), Bayer AG (Germany), Kedrion S.p.A. (Italy), Emergent BioSolutions (U.S.), and Pfizer Inc. (U.S.).
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Key questions answered in the report: