Fibrin Sealants Market

Fibrin Sealants Market Outlook (2023-2033)

Evolving at a CAGR of 7%, the global fibrin sealants market is currently valued at US$ 976.5 million and is projected to reach US$ 1.92 billion by the year 2033.

A fibrin sealant patch is a two-component hemostatic patch consisting of collagen or cellulose that is flexible and implanted with fibrinogen and thrombin from human plasma. These fibrin sealant patches do not rely on the patient’s blood having sufficient amounts of fibrinogen to accomplish hemostasis because they deliver both human fibrinogen and thrombin to the bleeding site.

Fibrin sealants are bifurcated into liquid fibrin sealants and patch fibrin sealants. Global demand for fibrin liquid sealants and fibrin patches is expected to increase at CAGRs of 7.5% and 6.5%, respectively, during the next 10 years.

In 1998, fibrin sealants were the first substance from the contemporary age to receive American approval as a hemostat. It is the only substance that the Food and Drug Administration has officially approved for use as a hemostat, adhesive, and sealant. In addition to initial liquid formulations, the solution is now available in patch form too. Liquid fibrin sealants are currently dominating the market in terms of revenue due to their superior procedural outcomes compared to fibrin patches. Additionally, the characteristics of liquid fibrin glue such as quick action and greater rational stability are boosting sales growth.

Although surgical bleeding is a typical complication seen during operations, excessive bleeding can raise the risk of morbidity and fatality. One of the main developments in the fibrin sealants market is the use of fibrin sealant in hemostasis procedures to reduce bleeding during and after surgical procedures.

When there is significant bleeding, fibrin sealant, which is made up of fibrinogen and thrombin, is crucial to the process of hemostasis. As per the National Institutes of Health's classification, there are various types of fibrin sealants, including individual human plasma liquid, human pooled plasma and equine collagen patch, bovine collagen and bovine thrombin, human pooled plasma liquid, and human pooled plasma, as well as oxidised regenerated cellulose patch.

During the projection period (2022-2033), it is predicted that the market would develop faster because of the increasing use of hemostatic devices in surgical procedures due to improved procedural efficiency and a decrease in mortality risk. The adoption of tissue sealant devices is expected to increase by 2033 as a result of an enormous rise in the frequency of cardiovascular diseases worldwide and an increasing demand for enhanced hemostatic devices.

• Cardiovascular disease is currently the leading cause of mortality worldwide and is predicted to reach 23.6 million fatalities by 2030, according to the Centers for Disease Control and Prevention, the American Heart Association, and the National Institutes of Health.

Report Attributes	Details
Market Size (2023E)	US$ 976.5 Million
Forecasted Market Value (2033F)	US$ 1.92 Billion
Global Market Growth Rate (2023-2033)	7% CAGR
China Market Growth Rate (2023-2033)	10.5% CAGR
Japan Market Growth Rate (2023-2033)	4.5% CAGR
Germany Market Growth Rate (2023-2033)	5% CAGR
Key Companies Profiled	Adhesys Medical GmbH Baxter Covidien Inc. CSL Behring Ethicon Johnson & Johnson Services, Inc. Mallinckrodt Pharmaceuticals Stryker Takeda Pharmaceutical Vivostat A/S

Which Key Factors are Driving the Sales of Fibrin Sealants?

“Need for Advanced Efficiency in Various Types of Surgeries”

Escalating demand for effective tissue sealing and hemostasis during operations has had a significant influence on the advancement of contemporary surgical techniques. To aid in hemostasis and tissue sealing during surgeries, a class of substances known as surgical tissue adhesives, which includes both natural and synthetic substances, has been developed.

The most effective tissue adhesives now on the market are fibrin sealants. They are both biodegradable and biocompatible. Human thrombin, refined, virus-inactivated human fibrinogen, and occasionally other substances such as virus-inactivated human factor XIII and bovine aprotinin make up the fibrin sealants.

To form a fibrin clot, these substances mimic the concluding stages of the normal clotting cascade. Thus, the increasing use of fibrin sealants in the healthcare industry is boosting sales growth.

“Rising Cases of Blood-related Disorders”

Currently, fibrin sealants are utilised in a variety of surgical procedures, including dental surgeries, plastic and reconstructive surgeries, thoracic surgeries, and cardiovascular surgeries. The application of fibrin sealants vastly enhances the duration of hemostasis, reduces blood loss, and reduces the complexity of surgical procedures.

Numerous electrosurgical tools can be used to examine and seal vascular systems. Topical hemostatic medications, including fibrin sealants, are used to stop bleeding from surfaces or cavities that are resistant to suturing, electrosurgeries, or other useful tools such as the argon plasma coagulator.

• According to the National Center for Biotechnology Information analysis, 1 in 1000 men and women worldwide suffer from bleeding-related issues.

Demand for fibrin sealants is increasing due to the rising surgical operations and patients with blood-related diseases such as haemophilia.

“Increasing Need of Surgeries to Treat Chronic Disorders”

Elderly patients require intensive care since they are more likely to experience wounds and traumas which need a long time to heal. The demand for fibrin sealants is anticipated to rise quickly due to rising cases of common wounds and injuries across the globe.

The majority of chronic illnesses eventually require surgical operations, which then spur sales growth. Hernia fixation, diabetes, spine injuries, ocular injuries and replacements, urological diseases, and burns are a few chronic conditions that require fibrin sealants.

Alternative wound closure procedures were rejected in favour of these solutions, which led to a growth of their applications, notably in endoscopic procedures. Peptic ulcers can be effectively treated with endoscopic hemostatic therapy. Patients undergoing treatment for everything from simple wounds to burns and neurosurgery procedures benefit from the use of fibrin-sealing solutions.

Cardiovascular surgeries experience the highest demand after general operations. Due to sealants' greater clinical results when compared to alternative wound closure techniques, their usefulness in cardiovascular diseases is higher.

What are the Challenges Faced by Manufacturers of Fibrin Sealants?

“Limitations on Usage of Fibrin Sealants in Some Surgeries”

Limitations on the use of fibrin sealants in laparoscopic and minimally-invasive surgeries are anticipated to slow their uptake, which may hinder the growth of the fibrin sealants market over the forecast period. Also, the strict regulations for product approvals and high costs associated with treatment procedures may slower sales growth.

Country-wise Analysis

Why is Demand for Fibrin Sealants Rising Rapidly in the United States?

“Increasing Cases of Cardiovascular Disorders & Blood Clotting Issues”

The U.S. currently holds a dominant position in the North American fibrin sealants market as a result of advanced healthcare infrastructure, widespread usage of cutting-edge automated analyzers, and a big target patient base.

• The Automated Blood Coagulation Analyzers CN-6000 and CN-3000, which are next-generation analyzers in the hemostasis field, were revealed by Sysmex Corporation in 2018.

Additionally, technological advancements have increased accessibility to healthcare services, and in the coming years, the entry of new manufacturers is likely to fuel sales growth in the country. Blood clot-related disorders are becoming more common, which is also pushing up demand for fibrin sealants.

• According to the US Centers for Disease Control and Prevention (CDC), haemophilia affects one in every 5,617 live male births. Between 30,000 and 33,000 males in the US are hemophilic.
• Every 34 seconds, a person in the United States dies from cardiovascular disease, according to the same source.

Thus, all the above-mentioned aspects are increasing the demand for fibrin sealants in the U.S.

What is Driving the Sales of Fibrin Sealants in Asia Pacific?

“Huge Presence of Pharma & Biotech Companies & Advancing Healthcare Infrastructure”

China, Japan, and South Korea are considered to be the most profitable markets in the Asia Pacific region and are expected to have greater market values. These countries are anticipated to dominate the Asia Pacific market in terms of revenue share and expand at a much quicker rate than other nations due to their technologically advanced healthcare systems, novel treatment procedures, and sizable patient population.

Growth of the fibrin sealants market in the region is attributed to the presence of top pharmaceutical and biotech companies working on therapeutic development. The rapidly developing healthcare industry also supports the sales of fibrin sealants.

Furthermore, there are potential opportunities for market growth as a result of increased fibrin sealant demand and rising cardiovascular disorder prevalence in the region. Demand for fibrin sealants in China and Japan is expected to increase at CAGRs of 10.5% and 4.5%, during the forecast period, respectively.

How are Fibrin Sealant Sales Faring in the European Market?

“Increasing Cases of Various Dental Conditions”

The market for fibrin sealants in Europe is currently dominated by nations including the United Kingdom, Germany, Italy, and France. According to a survey conducted in the U.K., most people with dentures struggle with confidence because they feel uncomfortable wearing loose-fitting dentures in their mouths. As a result, they might avoid social situations.

Rapidly rising prevalence of dental and oral conditions such as tooth decay, and periodontal flap closure, as well as increasing demand for cosmetics and conditions, is expected to boost the demand for dental sealants in the U.K. profitably over the projected period. This is due to the rising adoption of several innovative and cutting-edge sealant products.

Germany is currently commanding a substantial sales share in the Europe market as more people are undergoing orthodontic and cardiovascular treatment procedures. Sales of fibrin sealants in Germany are predicted to rise at a CAGR of 5% during the next 10 years.

Category-wise Analysis

Who is the Leading End User of Fibrin Sealants?

“High Demand for Fibrin Glues from Hospitals”

Throughout the projected period, the hospitals are anticipated to hold a significant share of the market. Demand for fibrin sealants from hospitals is anticipated to be driven by an increasing number of coronary artery bypass grafting and other cardiovascular surgeries performed in hospitals due to the presence of advanced healthcare facilities and improved technologies.

• According to a Yale Medicine article, about 900,000 percutaneous coronary interventions (PCIs) are carried out annually in the U.S.

Along with this, there is a steady movement in patient choice from inpatient to outpatient visits, which is predicted to provide specialty clinics with significant development prospects during the forecast period.

Competitive Landscape

Since a few significant competitors control the majority of the market share, the fibrin sealants market is highly concentrated. The majority of the market share in this sector is currently held by Baxter and Ethicon (a division of Johnson & Johnson Services, Inc.), with Baxter dominating in terms of revenue.

Strong brand recognition, a stable client base, a presence across all regions, and a reliable distribution system all contribute to this. Due to ongoing product introductions, strategic partnerships, and a concentration on market penetration in emerging regions, it is predicted that Ethicon's market share will rise over the forecast period.

• Baxter recently presented Tisseel fibrin sealant hemostatic agents with design improvements at the AORN symposium.
• For US$ 400 million, J&J's Ethicon purchased Takeda's TachoSil Surgical Patch in May 2019.

Key Segments of Fibrin Sealants Industry Research

• By Type :

  • Liquid
  • Patches

• By Application :

  • Cardiovascular Surgeries
  • Orthopedic Surgeries
  • General Surgeries
  • Transplant Surgeries
  • Wound Management
  • Thoracic Surgeries
  • Neurosurgeries
  • Dental Surgeries
  • Urological Surgeries
  • Ophthalmic Surgeries

• By Technology :

  • Viral Inactivation
  • Autologous Donation
  • Recombinant Production

• By End User :

  • Hospitals
  • Specialty Clinics
  • Ambulatory Surgical Centres

• By Region :

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Oceania
  • MEA