The global fibrinogen concentrate market size is expected to reach USD 4.81 Billion at a steady revenue CAGR of 6.1% in 2030, according to latest analysis by Emergen Research. Increasing use of fibrinogen concentrates in patients for treatment of bleeding and CFD is a major factor driving market revenue growth. Congenital afibrinogenaemia and hypofibrinogenaemia are uncommon hereditary illnesses with an estimated frequency of 1 in 106 in homozygotic patients. Since birth or early childhood, patients have experienced numerous severe bleeding episodes. Following a minor injury or minor surgery, skin, mucosa, muscles, gastrointestinal system, or brain can bleed. In patients with certain fibrinogen deficiencies, therapeutic substitution with human fibrinogen concentrate can cure haemostatic deficiency and stop bleeding. For example, octafibrin, is a highly purified, albumin-free concentration of human plasma fibrinogen.
In addition, octafibrin is double virus inactivated utilizing two separate virus inactivation/removal procedures, solvent/detergent treatment, and nanofiltration. A strategy for global development of Octafibrin has been developed after negotiations with FDA and European regulators. Discussions about this approach were also held with European Pediatric Committee (PDCO), which is in charge of ensuring that children are taken into account during drug development in accordance with new EMA regulations.
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A recent trend in the market is increasing use of fibrinogen concentrate during cardiac surgery. Replacement of depleted plasma fibrinogen with fibrinogen concentrate reduces intraoperative bleeding by reversing coagulopathic bleeding and improving speed and strength of blood clot formation. Moreover, only 2 randomized clinical trials have looked at the use of fibrinogen concentrate infusion in cardiac surgery, which is used to control bleeding during heart surgery. The other study looked at fibrinogen concentrate infusion administered in doses based on thromboelastometry assessment but unrelated to continuous blood loss. One of these investigations included a total of 60 participants. Furthermore, effectiveness of fibrinogen concentrate infusion to stop continuous bleeding during heart surgery was not proven in any of these studies.
Some Key Highlights in the Report
- The human fibrinogen concentrates segment is expected to register a rapid revenue growth rate during the forecast period. Fibrinogen human, a hemostatic drug, is used to treat acute bleeding episodes in individuals with afibrinogenemia and hypofibrinogenemia who have congenital fibrinogen deficiency. Hematological agents include concentrated human fibrinogen, which works by replacing a particular blood protein that promotes blood coagulation. Fibrinogen is a soluble plasma glycoprotein with a molecular weight of approximately 340 kDa (factor I), which serves as a physiological substrate for three enzymes, thrombin, factor XIIIa, and plasmin. To treat acute bleeding episodes, including afibrinogenemia and hypofibrinogenemia, it is prescribed to patients with congenital fibrinogen deficiency.
- The congenital fibrinogen deficiency segment is expected to account for a rapid revenue growth rate during the forecast period. Congenital Fibrinogen Deficiency (CFD), a rare bleeding disorder marked by low levels of (afibrinogenemia, hypofibrinogenemia) or dysfunctional fibrinogen, is typically treated with fibrinogen supplementation (dysfibrinogenemia). Human fibrinogen concentrate demonstrated a satisfactory safety profile while being useful for on-demand treatment of bleeding and as surgical prophylaxis in patients with congenital afibrinogenemia. In addition, recommended course of treatment for bleeding patients with congenital fibrinogen insufficiency is fibrinogen replacement with the aim of obtaining a plasma fibrinogen level of 100-150 mg/dL. Cryoprecipitate, Fresh-Frozen Plasma (FFP), and Human Fibrinogen Concentrate (HFC) are examples of treatments. Exact dosage is hindered by low and fluctuating fibrinogen level of FFP (as well as varying amounts of other coagulation components). Prior to birth, freezing and blood matching for donor-recipient ABO compatibility are also necessary.
- The North America market is expected to account for largest revenue share during the forecast period. This is due to increasing activities to include fibrinogen concentrate for treatments in this region. To manage congenital fibrinogen (Factor 1) insufficiency, National Hemophilia Foundation (NHF) in the U.S. modified its treatment recommendations to include fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for intravenous use. Fibryga, a very pure, virus-inactivated fibrinogen concentrate made from human plasma, is produced by Octapharma. Changes to the treatment guidelines for Factor 1 deficiency, a rare genetic blood disorder where blood does not clot normally, were suggested by NHF Medical and Scientific Advisory Council (MASAC). Symptoms of factor 1 deficiency include afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia, while dysfibrinogenemia is not a Fibryga indication.
- On 29 March, 2021, The U.S. Food and Drug Administration (FDA) approved two Octapharma amendments to biological license applications, expanding the company's line of pediatric critical care products. As a result of supplement approval, octaplas, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution have their updated product labels. Results of two post-marketing studies (LAS-212, LAS-213) assessing product's effectiveness, safety, and tolerability for infants through age of 20 are now included in Octaplas labelling. 91 pediatric patients up to age of 20 had Octaplas, a fresh frozen plasma substitute, tested. Investigators did not find any hyperfibrinolytic or treatment-related thromboembolic events. These trials' findings support use of Octaplas in pediatric patients who are seriously unwell.
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Key Players covered in this report are:
CSI, Baxter, LFB Group, ProFibrix BV, Shanghai RAAS, Jiangxi Boya Bio Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical Co., Ltd., Green Cross, and Shanghai Xinxing Medicine Co. Ltd.
Type Outlook (Revenue, USD Million; 2019–2030)
- Human Fibrinogen Concentrates
- Animal Fibrinogen Concentrates
Application Outlook (Revenue, USD Million; 2019–2030)
- Congenital Fibrinogen Deficiency
- Surgical Procedures
Based on Region market is segmented into:
- North America
- Europe
- Asia-Pacific
- South America
- Middle East & Africa
Major Points covered in this report are as below:
- The Fibrinogen Concentrate industry development trends and marketing channels are analyzed. The feasibility of new investment projects are assessed and overall research conclusions offered.
- Fibrinogen Concentrate industry development trends, marketing channels, feasibility of new investment projects, and overall conclusions of research are presented.
With the tables and figures, the report provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.
As a valuable source of guidance and direction for companies and individuals interested in the market, the report provides key statistics on the state of the industry through tables and figures. - Development policies and plans, manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand figures, cost, price, revenue and gross margins.
- This report also analyzes production processes, production costs and import/export figures, as well as cost, price, revenue and gross margins, as well as development policies
- The Fibrinogen Concentrate Market report provides key statistics on the market status of the Fibrinogen Concentrate manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry.
As well as providing key statistics on the market status of the Fibrinogen Concentrate manufacturers, the Fibrinogen Concentrate Market report provides valuable guidance and direction for companies and individuals interested in the industry.
We can also provide the customized data for separate regions like North America, United States, Canada, Mexico, Asia-Pacific, China, India, Japan, South Korea, Australia, Indonesia, Singapore, Rest of Asia-Pacific, Europe, Germany, France, UK, Italy, Spain, Russia, Rest of Europe, Central & South America, Brazil, Argentina, Rest of South America, Middle East & Africa, Saudi Arabia, Turkey, Rest of Middle East & Africa
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This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth.
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