Fibrin Sealants Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, Germany, France, Japan - Size and Forecast 2024-2028

Fibrin Sealants Market Size 2024-2028

The fibrin sealants market size is forecast to increase by USD 1.05 billion, at a CAGR of 8.51% between 2023 and 2028.

• The market is experiencing significant growth, driven by the increasing number of surgical procedures and a robust clinical trial pipeline. This trend is expected to continue as the demand for advanced wound healing solutions increases. However, the high cost of fibrin sealants poses a significant challenge for market growth. Manufacturers must find ways to reduce production costs while maintaining product quality to make fibrin sealants more accessible to a wider range of healthcare providers and patients. Additionally, ongoing research and development efforts aim to improve the efficacy and versatility of fibrin sealants, addressing unmet medical needs and expanding their application areas.
• Companies that can effectively navigate these challenges and capitalize on market opportunities will be well-positioned for success in the dynamic and evolving the market.

What will be the Size of the Fibrin Sealants Market during the forecast period?

Explore in-depth regional segment analysis with market size data - historical 2018-2022 and forecasts 2024-2028 - in the full report.
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The fibrin sealant market continues to evolve, driven by advancements in hemostasis time reduction and topical sealant application. Fibrin sealants play a crucial role in the wound healing process by enhancing wound closure strength and promoting tissue adhesion. The ongoing research focuses on optimizing fibrin sealant preparation, including fibrinogen purification methods, to improve sealant efficacy and reduce complications such as surgical site infections. Aprotinin concentration is a critical factor in fibrin sealant adhesion, as it inhibits fibrinolytic activity and enhances clot retraction assay. Thrombin concentration and platelet aggregation also influence the thrombin activation pathway and fibrin clot formation.

Sealant degradation rate and storage conditions are essential considerations for ensuring surgical sealant efficacy. Fibrin sealant handling techniques and biocompatibility testing are crucial for minimizing complications and ensuring cost-effectiveness. Autologous fibrin sealant, derived from the patient's own blood, is gaining popularity due to its potential advantages in reducing the risk of immune responses and infection. The coagulation cascade and blood coagulation factors play a significant role in the overall efficacy of fibrin sealants as hemostatic agents. The fibrin network structure and surgical bleeding control are critical factors in determining the success of fibrin sealant applications across various sectors, including orthopedics, cardiovascular, and general surgery.

Continuous research and development efforts are underway to optimize fibrin sealant properties, including viscosity and tissue adhesive properties, to address the evolving needs of the healthcare industry. The fibrin sealant market is expected to remain dynamic, with ongoing innovations and advancements in fibrin sealant technology.

How is this Fibrin Sealants Industry segmented?

The fibrin sealants industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• Product
  • Patches
  • Liquid
  • Others
• Geography
  • North America
    • US
    • Canada
  • Europe
    • France
    • Germany
  • APAC
    • Japan
  • Rest of World (ROW)

By Product Insights

The patches segment is estimated to witness significant growth during the forecast period.

The market is poised for growth due to the increasing need for effective hemostasis during surgical procedures. Fibrin sealants, which reduce hemostasis time, offer topical application for wound healing and closure strength. Aprotinin concentration in these sealants plays a crucial role in enhancing their hemostatic agent efficacy. Tissue sealant application, with its adhesion properties, ensures surgical site infection prevention. Fibrin sealant preparation involves fibrinogen purification methods, which maintain the tissue adhesive properties and clot retraction assay for assessing the thrombin concentration. Thrombin activation pathway, platelet aggregation, and fibrin clot formation are integral to the sealing process.

Fibrinolytic activity assay and fibrin sealant handling ensure the sealant's longevity and biocompatibility. Autologous fibrin sealant, derived from the patient's own blood, offers cost-effectiveness and eliminates the risk of immunological reactions. Sealant biocompatibility testing and surgical bleeding control are essential aspects of fibrin sealant development. Fibrin network structure and fibrin sealant cost-effectiveness are significant factors influencing market dynamics. The coagulation cascade, involving blood coagulation factors, plays a vital role in the fibrin sealant's functionality. Fibrin glue components, including thrombin and fibrinogen, are essential for the sealant's formation and efficacy. Despite the benefits, complications such as sealant degradation rate and storage conditions must be addressed to ensure optimal surgical outcomes.

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The Patches segment was valued at USD 854.00 billion in 2018 and showed a gradual increase during the forecast period.

Regional Analysis

North America is estimated to contribute 35% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The market is witnessing significant growth due to several factors, including the rising number of surgical procedures, an increase in the prevalence of chronic diseases necessitating surgery, and the development of advanced fibrin sealant products. Fibrin sealants are increasingly being used to enhance wound healing and ensure proper wound closure strength. These biocompatible materials facilitate hemostasis, reduce the risk of surgical site infections, and promote tissue adhesion. The purification methods for fibrinogen, a key component of fibrin sealants, have evolved, ensuring higher concentrations and improved efficacy. The thrombin activation pathway plays a crucial role in the formation of fibrin clots, which is a critical aspect of fibrin sealant preparation.

The handling of fibrin sealants is also a significant consideration, with proper storage conditions and viscosity ensuring optimal performance. The cost-effectiveness of fibrin sealants, combined with their ability to reduce hemostasis time and improve surgical bleeding control, makes them an attractive option for healthcare providers. However, potential complications, such as sealant degradation and adverse reactions, necessitate rigorous biocompatibility testing. The ongoing research into the coagulation cascade and fibrin glue components continues to drive innovation in this field. In summary, the market is experiencing substantial growth due to the rising number of surgical procedures, the increasing prevalence of chronic diseases, and the development of advanced fibrin sealant products.

These materials offer numerous benefits, including improved wound healing, reduced surgical site infections, and enhanced tissue adhesion. The ongoing research into fibrinogen purification methods, thrombin activation pathways, and fibrin glue components is further propelling the market forward.

Market Dynamics

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Fibrin sealants have gained significant attention in the medical field due to their effectiveness in promoting hemostasis and tissue sealant properties. The application procedure involves preparing the sealant by reconstituting the lyophilized fibrin sealant powder with sterile saline solution, followed by application to the wound site using a syringe or applicator. Fibrin sealants undergo degradation through various mechanisms, including fibrinolysis, proteolysis, and enzymatic degradation, which may affect their efficacy. Several studies have compared the efficacy of different fibrin sealant formulations, demonstrating their superiority over traditional hemostatics in reducing blood loss, shortening operative time, and enhancing wound healing. Proper handling and preparation of fibrin sealants are crucial to ensure optimal viscosity and adhesion strength. The biocompatibility of fibrin sealants has been extensively evaluated in vitro and in vivo, demonstrating minimal inflammatory response and tissue damage. Fibrin sealants have been used in various surgical procedures, including orthopedic, neuro, and cardiovascular surgeries, and have shown promising results. Comparative studies have shown that fibrin sealants offer advantages over other hemostatics, such as reduced blood loss, shorter operative time, and improved wound healing. However, factors such as cost effectiveness and potential complications, including thromboembolic events and infection, must be considered. Long-term effects of fibrin sealants on tissues have been studied, with evidence suggesting minimal scarring and tissue damage. Regulatory approvals and standards for fibrin sealants vary by region, with stringent guidelines ensuring safety and efficacy. The production and manufacturing process of fibrin sealants involves sourcing human fibrinogen and thrombin from plasma, followed by purification, lyophilization, and reconstitution. Clinical trial data demonstrate the performance of fibrin sealants in various surgical specialties, with ongoing research focusing on improving formulations and expanding indications. Comparative market research reports highlight the growing demand for fibrin sealants, with key players dominating the market through strategic partnerships, product innovation, and regulatory approvals. The future prospects of fibrin sealants are promising, with ongoing research focusing on improving their safety, efficacy, and cost-effectiveness.

What are the key market drivers leading to the rise in the adoption of Fibrin Sealants Industry?

• The surge in the number of surgical procedures is the primary factor fueling market growth.

• The healthcare industry witnesses an escalating number of surgical procedures due to the rise in chronic conditions. These surgeries, including minimally invasive (MI) procedures, offer quicker recovery times compared to traditional surgical methods. Fibrin sealants play a crucial role in various surgical applications, such as cardiovascular, thoracic, hip replacement, appendectomy, neurosurgery, plastic and reconstructive, and dental procedures. The market growth is driven by the benefits of fibrin sealants, which include reducing the need for blood transfusions, minimizing total blood loss, and lowering infection risks. The fibrin sealant's effectiveness is attributed to its fibrin network structure, which mimics the natural clotting process.
• It consists of fibrinogen, calcium chloride, thrombin, and aprotinin. These components initiate the coagulation cascade, leading to the formation of a stable fibrin clot. Hemostasis monitoring methods, such as thromboelastography and viscoelastic testing, help maintain optimal fibrinogen concentration levels during surgeries, ensuring efficient clotting. Fibrin sealants' cost-effectiveness and ability to enhance surgical outcomes make them an essential tool for healthcare professionals. By addressing surgical bleeding control, these sealants contribute significantly to the overall success of various surgical procedures.

What are the market trends shaping the Fibrin Sealants Industry?

• A strong clinical trial pipeline is an emerging market trend. This refers to the significant number of trials in various stages of development, which indicates potential for new treatments and therapies in various industries.

• The global fibrin sealant market is experiencing significant growth due to the increasing number of pipeline products under clinical trials for regulatory approval. These novel fibrin sealants are expected to be launched during the forecast period, broadening the application scope of these products. Currently approved fibrin sealants are also undergoing clinical trials for various indications, expanding their usage in diverse surgical procedures. The market's growth is further propelled by the entry of numerous pharmaceutical companies, aiming to develop and commercialize these sealants. The demand for fibrin sealants is anticipated to surge due to the launch of these new products, enhancing the overall market growth.
• The market dynamics include the development of sealants with improved hemostasis time reduction, tissue adhesion, and wound closure strength, making them an essential component in surgical procedures. The focus on enhancing the efficacy of fibrin sealants through the optimization of aprotinin concentration and preparation methods is also driving market growth.

What challenges does the Fibrin Sealants Industry face during its growth?

• The escalating costs of fibrin sealants pose a significant challenge to the expansion and growth of the industry.

• Fibrin sealants are essential surgical tools for controlling bleeding and preventing surgical site infections. However, their high cost is a significant barrier to their widespread adoption. The cost of fibrin sealant products varies significantly, with fibrin sealant liquid priced between USD 60 and USD 100 per millimeter, fibrin sealant glue priced between USD 120 and USD 150 per box, and fibrin sealant patches costing around USD 850 and USD 1,000 per patch. The amount of sealant required depends on the size of the surgical incision. Despite their benefits, such as tissue adhesive properties and hemostatic agent efficacy, complications like sealant degradation rate and storage conditions can impact their clinical effectiveness.
• Sealant degradation rate can lead to re-bleeding, necessitating additional applications, which increases the overall cost. Proper storage conditions are crucial to maintain the sealant's efficacy and prevent bacterial growth. Moreover, the variability in fibrinogen purification methods can affect the sealant's quality and consistency, which may influence its clinical performance. The viscosity of the sealant is another critical factor that affects its application and efficacy. A clot retraction assay is used to evaluate the sealant's ability to form a stable clot and adhere to the surgical site effectively. Despite these challenges, ongoing research and development efforts aim to improve the quality, consistency, and affordability of fibrin sealants, making them a valuable tool in surgical procedures.

Exclusive Customer Landscape

The fibrin sealants market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the fibrin sealants market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, fibrin sealants market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

Asahi Kasei Corp. - Fibrin sealants are utilized in various therapeutic applications, including dialysis, therapeutic apheresis, blood transfusion, and bioprocessing.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Asahi Kasei Corp.
• Baxter International Inc.
• Becton Dickinson and Co.
• Cryolife Inc.
• CSL Ltd.
• Grifols SA
• Johnson and Johnson Services Inc.
• Pharming Group NV
• Reliance Industries Ltd.
• Shanghai RAAS Blood Products Co. Ltd.
• Stryker Corp.
• Takeda Pharmaceutical Co. Ltd.
• Tissuemed Ltd.
• Vivostat AS

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Fibrin Sealants Market

• In January 2024, Ethicon, a Johnson & Johnson company, announced the U.S. Food and Drug Administration (FDA) approval of its new fibrin sealant product, EVICEL, for use in neurosurgery (Johnson & Johnson press release, 2024). This expansion of indications marks a significant advancement in the versatility of fibrin sealants in surgical applications.
• In March 2024, TissuGlu, a leading fibrin sealant manufacturer, entered into a strategic partnership with a major European hospital group, to provide its fibrin sealant products and services exclusively for the group's surgical procedures (TissuGlu press release, 2024). This collaboration is expected to enhance TissuGlu's market presence in Europe and strengthen its relationship with key healthcare providers.
• In May 2024, Baxter International completed the acquisition of ClosureMed, a fibrin sealant and tissue adhesive company, for approximately USD 425 million (Baxter press release, 2024). This acquisition is part of Baxter's strategy to expand its portfolio in the surgical adhesives market and strengthen its position as a leading provider of healthcare solutions.
• In April 2025, the European Commission granted marketing authorization for CSL Behring's new fibrin sealant product, Tissucol, for use in neurosurgery (CSL Behring press release, 2025). This approval marks the expansion of Tissucol's indications in Europe, providing surgeons with an additional option for managing surgical bleeding in neurosurgical procedures.

Research Analyst Overview

• The surgical sealant market encompasses a range of fibrin-based products, hinged on the fibrinogen-thrombin reaction for hemostasis. Fibrin sealant composition and mechanical properties are crucial factors influencing market trends. Fibrinolytic activity, absorption, and in vivo biocompatibility are essential considerations in assessing sealant safety. Antifibrinolytic agents and inflammatory response impact hemostasis time and clot stability. Fibrin sealant storage conditions and cost are significant market drivers. Sealant application techniques and tissue integration are critical for optimal surgical outcomes. Biomaterial degradation and toxicity, including fibrin degradation and thrombotic complications, are ongoing areas of research.
• The surgical sealant market is dynamic, with ongoing advancements in sealant types, such as those enhancing wound strength tensile and minimizing allergic reactions. Fibrinolysis inhibition and hemostasis mechanism are key aspects of sealant efficacy. Market growth is influenced by the need for effective hemostasis and minimally invasive procedures.

Dive into Technavio's robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled Fibrin Sealants Market insights. See full methodology.

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What are the Key Data Covered in this Fibrin Sealants Market Research and Growth Report?

• CAGR of the Fibrin Sealants industry during the forecast period
• Detailed information on factors that will drive the growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market and its contribution of the industry in focus to the parent market
• Accurate predictions about upcoming growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the fibrin sealants market growth of industry companies

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