Fibrin Sealants Market Trends, Regulations and Competitive Landscape Outlook to 2017-2025
Hemostasis and tissue sealing agents are medical devices utilized to control bleeding during surgical procedures. Fibrin was the first modern hemostatic agent approved for use in the U.S. in 1998. Fibrin sealant is the only commercially available FDA-approved material for clinical use as a hemostat, sealant, and adhesive. Fibrin sealants are referred as most adopted hemostats worldwide. Flowable hemostatic agents are thick fibrin sealants, flowable, consistency products, which comprise two chief components, one active and the other passive, that convert fibrinogen to fibrin at the site of bleeding. The passive component is either bovine or porcine gelatin, while the active component is thrombin. Thrombin addition to gelatin may not be required in certain cases. Advancements in hemostasis technology has led to development of wide range of products that have enabled clinicians to provide proper emergency assistance to patients. Hemostatic products include thrombin sealants, fibrin glue, bovine serum/albumin/glutaraldehyde, gelatin matrix, microfibrillar collagen matrix, and oxidized regenerated cellulose. Each of these agents differ in mechanism, application, and cost. Fibrin sealant can be applied in liquid form or as a patch. However, liquid fibrin presents a challenge of being cumbersome to use due to its preparatory steps of thawing, mixing, etc. Hence, patches have become far convenient for use as hemostatic agents. Baxter Healthcare’s Tisseel and TachoSil, Orthovita, Inc.’s Vitagel, and Ethicon US, LLC’s Evicel and Evarrest are the prominent fibrin sealant based hemostatic products in the market. Tisseel has been used in Europe for more than 25 years and has been used for over 9.5 million surgical procedures including cardiac, splenic trauma, and colon anastomosis surgery. Evicel has been approved by the U.S. FDA for hemostasis in liver surgery.
The patient pool with different chronic diseases is also growing rapidly across the world. This is likely to increase the number of surgical procedures, consequently propelling the fibrin sealants market in the near future. Strict but inconsistent regulatory policies across the world are creating an apprehensive environment among the market players, thereby restraining the fibrin sealants market. According to the National Hemophilia Foundation, over 400,000 people suffer from hemophilia globally. However, only about 176,000 are accurately identified. Factor VIII forms an indispensable treatment option for such patients. Large unmet needs of the undiagnosed population is likely to propel the fibrin sealants market. Increase in number of trauma cases, rise in geriatric population, surge in surgical procedures, high number of patients with blood-related disorders such as hemophilia, and expanding product portfolios are the major drivers of the fibrin sealants market.
The global fibrin sealants market can be segmented based on type of product, end-user, and region. In terms of type of product, the market can be classified into liquid form, patch, and others. New product launch of sealants across the world is projected to boost the growth of the global fibrin sealants market. Based on end-user, the global fibrin sealants market can be categorized into hospitals, specialty clinics, and ambulatory surgical centers. The hospitals segment is expected to account for the largest share of the market.
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The global fibrin sealants market can be segmented into five key regions: Asia Pacific, North America, Europe, Latin America, and Middle East & Africa. North America and Europe are expected to dominate the market due to high number of surgeries carried out in these regions. According to data released by the Centers for Disease Control and Prevention (CDC), the prevalence rate of hemophilia in the U.S. is 1 in every 5000 male births. Von Willebrand disease (VWD), another bleeding disorder, is the most commonly occurring blood disorder that affects 1% of the population of the U.S. The hemostasis products market in Asia Pacific offers significant opportunities in the next few years. Growth of the market is attributed to large patient pool with underserved requirements along with rapidly growing population, and rise in investments by market players in this region.
The global fibrin sealants market is fragmented, with presence of small number of key players. These include Baxter International, CSL Behring, and Johnson & Johnson Services, Inc.
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