The fibrinogen concentrate market size was USD 2.80 Billion in 2021 and is expected to register a revenue CAGR of 6.1% during the forecast period. Market revenue growth is primarily driven by factors such as increasing use of fibrinogen concentrates in patients for treatment of bleeding and Congenital Fibrinogen Deficiencies (CFD) and growth in number of approvals related to fibrinogen concentrate. Fibrinogen is a glycoprotein involved in the blood clotting process, which is transformed into fibrin using enzymes such as thrombin. This enzyme leads to blood clotting to prevent excess bleeding.and prevents bleeding through blood vessels. Fibrinogen concentrate is used in treating bleeding problems in patients who lack congenital fibrinogen. Individualized fibrinogen supplementation can be used to prevent bleeding, including during surgery and treat spontaneous or traumatic bleeding events in individuals with CFD. Fresh Frozen Plasma (FFP) or cryoprecipitate were once used to replace fibrinogen; however, Human Fibrinogen Concentrate (FCH) has mostly taken their place. When compared to FFP or cryoprecipitate, FCH offers benefit of offering a standardized dose of human plasma-derived fibrinogen that can be provided in a small volume, lowering the risk of volume overload. Moreover, when compared to FFP, it also lowers risk of transfusion-related acute lung injury. FCH passes through a viral inactivation phase, which reduces likelihood of viral transmission. Guidelines advise considering administering 50-100 mg/kg of FCH for significant bleeding/major surgery in CFD patients to maintain plasma levels of >1.0 g/L. Furthermore, those with a personal or family history of severe bleeding or with fibrinogen levels below 0.1 g/L should take into account long-term prophylaxis with FCH (with an aim to maintain plasma fibrinogen levels >0.5 g/L).
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A recent trend in the market is increasing use of fibrinogen concentrate to treat Acquired Fibrinogen Deficiency (AFD). For instance, a clinical development program for a highly rare disease began with 2011 launch of clinical study to examine usage of high-purity human fibrinogen concentrate in congenital fibrinogen deficiency. However, it also served as the first step in one of Octapharma’s most daring clinical programmes, which sought to treat Acquired Fibrinogen Insufficiency (AFD). For instance, high blood loss from things, such as major surgery or trauma, causes AFD. There is a significant medical need for a fibrinogen concentrate that has been licensed for this indication, since AFD is typically treated with cryoprecipitate, as there are no other options. In addition, ambitious objective of this program was to demonstrate that their high-purity human fibrinogen concentrate, is a more viable and dependable alternative to cryoprecipitate for AFD. After careful design, planning, and clinical trial execution by a Octapharma team over the course of eight years, their high-purity human fibrinogen concentrate has now received approval for treatment of AFD in 15 EU countries.
Driver: Rise in awareness and concerns pertaining to health is a key factor driving market growth
Rise in awareness and concerns pertaining to health is expected to drive revenue growth of the market. Despite the fact that health outcomes in Low- And Middle-Income Countries (LMICs) have improved recently, a new reality is now being witnessed. The bar is being raised for health systems to achieve better health outcomes and higher social value due to shifting health needs, rising public awareness, and ambitious new health goals. However, continuing on the current course will require high-quality health systems that consistently provide care that enhances or preserves health, which are respected and trusted by all individuals and adapt to changing demands of population. Furthermore, as health systems cannot enhance health without it, human right to health is useless without high-quality care. Hence, demand for high quality treatment is leading to a rise in demand for various treatment options, including fibrinogen concentrate, which is in turn, expected to drive market revenue growth.
Restraint: Certain adverse reactions, such as arterial thrombosis, chills, dyspnea, nausea, vomiting, and pulmonary embolism, is restraining market growth
Symptoms, such as chills, fever, nausea, and vomiting, are examples of generalized reactions, which can occur when being administered with fibrinogen concentrate. Negative consequences of using fibrinogen concentration include allergic-anaphylactic reactions, which could be an allergy symptom or first indications of hypersensitivity reactions (hives, urticaria, wheezing, hypotension, and anaphylaxis). If this occurs, one should stop administering medication right away. The next course of action will depend on how severe reaction was. Moreover, in patients with congenital fibrinogen insufficiency, thrombosis has been seen both with and without fibrinogen replacement therapy. Furthermore, patients receiving treatment with fibrinogen concentrate can also exhibit pulmonary embolism, myocardial infarction, deep vein thrombosis, and arterial thrombosis signs and symptoms.
Based on type, the global fibrinogen concentrate market is segmented into human fibrinogen concentrates and animal fibrinogen concentrates.
The human fibrinogen concentrates segment is expected to register a rapid revenue growth rate during the forecast period. Afibrinogenemia and hypofibrinogenemia individuals with congenital fibrinogen deficiency can be treated for acute bleeding episodes with fibrinogen human, a hemostatic medication. Human fibrinogen concentrate is a hematological agent, which functions by substituting a specific blood protein that aids in blood coagulation. A soluble plasma glycoprotein with a molecular weight of about 340 kDa is fibrinogen (factor I). Plasmin, factor XIIIa, and thrombin are three enzymes that use it as a physiological substrate. It is also prescribed to patients with congenital fibrinogen deficiency to treat acute bleeding episodes, including afibrinogenemia and hypofibrinogenemia.
The animal fibrinogen concentrates segment is expected to register a rapid revenue growth rate during the forecast period owing to increasing use of bovine fibrinogen. Bovine fibrinogen has been used for research on hemostatic therapy for surgical and severe trauma patients. According to these investigations, fibrinogen can prove to be more effective at halting blood loss than using Fresh Frozen Plasma (FFP). It can be used to prepare fibrin plates for examination of fibrinolytic enzymes, serve as a substrate for clotting tests, and investigate breakdown products of fibrinogen.
Based on application, the global fibrinogen concentrate market is segmented into congenital fibrinogen deficiency and surgical procedures.
The congenital fibrinogen deficiency segment is expected to account for a rapid revenue growth rate during the forecast period. Fibrinogen supplementation is the predominant treatment for Congenital Fibrinogen Deficiency (CFD), a rare bleeding condition characterized by decreased levels of (afibrinogenemia, hypofibrinogenemia) or malfunctioning fibrinogen (dysfibrinogenemia). In individuals with congenital afibrinogenemia, human fibrinogen concentrate proved effective for on-demand therapy of bleeding and as surgical prophylaxis, with an acceptable safety profile. Fibrinogen replacement, with a goal of achieving a plasma fibrinogen level of 100–150 mg/dL, is the standard treatment for bleeding patients with congenital fibrinogen insufficiency. In addition, therapies include Human Fibrinogen Concentrate (HFC), cryoprecipitate, and Fresh-Frozen Plasma (FFP). FFP has a low and variable fibrinogen content (as well as variable amounts of other coagulation factors), which inhibits exact dosing, which also requires freezing and donor-recipient ABO compatibility blood matching prior to delivery. Large transfusion volumes are required for FFP to replace fibrinogen, which carries a risk of volume overload. These factors make HFC a better treatment option.
The surgical procedures segment is expected to account for a rapid revenue growth rate during the forecast period. In patients undergoing major surgeries, such as abdominal PMP surgery, human fibrinogen concentrate is hemostatically effective and has a good safety profile. As a result of total blood loss, hemodilution (from intravenous fluid support), and consumption after extensive surgical excision, fibrinogen concentration falls, necessitating ongoing fibrin production at the wound site. Exogenous fibrinogen must be administered to treat this acquired fibrinogen shortage as there are no endothelial or hepatic stores of this coagulation factor.
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. For instance, National Hemophilia Foundation (NHF), in the U.S., has updated its treatment guidelines to include fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for intravenous use, in the management of congenital fibrinogen (Factor 1) insufficiency. Octapharma makes Fibryga, a highly pure, virus-inactivated, fibrinogen concentrate generated from human plasma. NHF Medical and Scientific Advisory Council (MASAC) suggested changing the treatment recommendations for Factor 1 deficiency, an uncommon, genetic blood condition where the blood does not clot normally. Afibrinogenemia, hypofibrinogenemia, and dysfibrinogenemia are all symptoms of factor 1 deficiency, while dysfibrinogenemia is not an indication for Fibryga.
The Asia Pacific market is expected to register a rapid revenue growth rate during the forecast period. This is due to increasing R&D activities in this region. For instance, researchers from China and California have created a method to extract human fibrinogen from blood plasma to improve manufacturing procedures. Researchers were able to create functional monomers from five different L-amino acids, L-lysine (Lys), L-arginine (Arg), L-glutamic acid (Glu), L-phenylalanine (Phe), and L-leucine (Leu), all of which include hydrophobic side chains. After being incubated, nanoparticles that included N-acryloyl-Arg monomers ([email protected]) demonstrated greatest and most focused binding affinity to fibrinogen. The team’s findings can encourage more investigation into and development of [email protected] as a fibrinogen-specific affinity reagent for pharmaceutical production.
The Europe market is expected to register a steady revenue growth rate during the forecast period due to increasing activities by key market players in this region. For instance, according to a recent announcement from Biotest AG, which is a German company, phase III Adjusted Fibrinogen Replacement Strategy(AdFIrst) experiment with Fibrinogen in patients with acquired fibrinogen insufficiency was successfully completed. A prospective, randomized, active-controlled, multicenter phase III trial examining efficacy and safety of fibrinogen in management of severe blood loss in patients undergoing scheduled spinal or abdominal surgery is called AdFIrst study. In the AdFIrst research, fibrinogen’s efficacy and tolerability are being compared to those of standard therapy, which consists of two blood products: fresh frozen plasma or cryoprecipitate.
Competitive landscape of the global fibrinogen concentrate market is fragmented with many key players operating on global and regional levels. Key players are engaged in product development and strategic alliances to expand their respective product portfolio and gain a robust footing in the global market. Major players in the market include 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.
Initiatives taken by market players are driving growth of the market, for instance:
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 updated product labels. The results of two post-marketing studies (LAS-212, LAS-213) assessing product’s effectiveness, safety, and tolerability for infants through age 20 are now included in Octaplas labelling. 91 pediatric patients up to age 20 had Octaplas, a fresh frozen plasma substitute, tested. Investigators did not find any hyperfibrinolytic or treatment-related thromboembolic events. These trials’ findings support the use of Octaplas in pediatric patients who are seriously unwell.
On 11 August 2022, CSL, a leader in global biotech, announced that all of its business divisions would become one big family under CSL global brand. The company’s plasma collection division, CSL Plasma, as well as CSL Behring, which provides treatments for uncommon and dangerous diseases, will continue to operate under their current names. One of the top suppliers of influenza vaccines in the world, Seqirus, will change its name to CSL Seqirus. Newly purchased Vifor Pharma will now operate under the name CSL Vifor. Seqirus’ name is currently being changed formally by CSL and at a later date, names of Vifor Pharma entities are also expected to change.
Segments Covered in the Report
This report offers historical data and forecasts revenue growth at a global, regional, and country level and provides analysis of the market trends in each of the sub-segments from 2022 to 2030. For this study, Reports and Data have segmented the fibrinogen concentrate markets based on type, application, and region:
Type Outlook (Revenue, USD Million; 2022–2030)
- Human Fibrinogen Concentrates
- Animal Fibrinogen Concentrates
Application Outlook (Revenue, USD Million; 2022–2030)
- Congenital Fibrinogen Deficiency
- Surgical Procedures
Regional Outlook (Revenue, USD Million; 2022–2030)
- North America
- Rest of Europe
- South Korea
- Rest of APAC
- Latin America
- Rest of LATAM
- Middle East & Africa
- Saudi Arabia
- South Africa
- Rest of MEA
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