Fibrin sealant (human) - Biologic Drug Details

Summary for fibrin sealant (human)

Tradenames:	4
High Confidence Patents:	0
Applicants:	4
BLAs:	4
Suppliers: see list	2

Pharmacology for fibrin sealant (human)

Physiological Effect	Increased Coagulation Activity Increased Coagulation Factor Activity
Established Pharmacologic Class	Human Blood Coagulation Factor
Chemical Structure	Blood Coagulation Factors

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for fibrin sealant (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fibrin sealant (human) Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,634,473	2040-03-10	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,857,564	2037-12-13	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,957,324	2041-05-12	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,957,798	2042-07-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,993,797	2041-12-09	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	12,082,796	2041-05-06	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	12,357,722	2040-07-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for fibrin sealant (human) Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Instituto Grifols, S.a.	VISTASEAL	fibrin sealant (human)	Frozen	125640	11,071,786	2039-11-05	Patent claims search
Instituto Grifols, S.a.	VISTASEAL	fibrin sealant (human)	Frozen	125640	8,697,193	2033-02-25	Patent claims search

International Patents for fibrin sealant (human)

Country	Patent Number	Estimated Expiration
South Korea	102519771
Australia	2004311543
Japan	5608741
Spain	2625092
Japan	2015525641
China	116133701
Brazil	112016022175

Market Dynamics and Financial Trajectory for Human Fibrin Sealant

Last updated: March 1, 2026

What Is the Current Market Size and Growth Rate?

The global fibrin sealant market was valued at approximately USD 880 million in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2022 to 2028. This growth is driven by increasing demand for surgical hemostats, tissue sealing, and wound management products across various medical specialties.

What Are Key Drivers Influencing Market Expansion?

Regulatory Approvals and Label Expansion: Several regions have approved fibrin sealants for multiple indications, broadening their usage. Notably, the U.S. FDA approved human fibrin sealants for various surgical procedures, including cardiovascular, general, and neurological procedures.

Rising Surgical Procedures: An increasing volume of surgical interventions, notably in cardiovascular, orthopedic, and neurosurgery segments, fuels demand. The World Health Organization estimates over 300 million surgeries annually worldwide, with a growing share necessitating effective tissue sealing agents.

Growth in Wound Care and Trauma Management: The rising burden of trauma and chronic wounds enhances the need for advanced sealing agents, including human-derived fibrin sealants.

Technological Advancements: Innovations in purified human fibrin components improve safety profiles, boosting clinician confidence and market adoption.

Aging Population: The global demographic shift toward older populations increases surgeries and chronic conditions requiring surgical intervention, further expanding the market.

How Do Competitive Players and Product Approaches Compare?

Major players include Becton Dickinson, Takeda Pharmaceutical, and CSL Limited, offering both pooled human plasma and recombinant versions. Key distinctions:

• Source: Human fibrin sealants derived from pooled plasma versus recombinant versions with synthetic or recombinant thrombin.
• Safety Profiles: Human plasma-based sealants have minimal antigenicity but carry risks of pathogen transmission unless extensively processed.
• Pricing: Pooled human fibrin sealants tend to be more cost-effective compared to recombinant variants, affecting market penetration.

What Are Regulatory and Policy Factors Affecting Financial Trajectory?

FDA and EMA Approvals: Clear guidelines and approval pathways for human fibrin sealants in surgical applications bolster market confidence. The FDA's approval processes in 2010s enable expanded indications.

Safety and Liability Concerns: Stringent manufacturing standards and pathogen reduction techniques mitigate safety risks, supporting market sustainability.

Reimbursement Policies: Reimbursement rates for surgical sealants impact adoption. In the U.S., coverage by Medicare and private insurers for fibrin sealants varies but generally supports procedural billing.

Customs and Import Restrictions: Regulations in emerging markets influence supply chain logistics and pricing strategies.

What Is the Revenue and Cost Structure Overview?

Revenue Streams:

• Direct sales to hospitals and surgery centers.
• Licensing agreements with regional distributors.
• Bulk procurement for governmental health agencies.

Cost Components:

• Raw materials (plasma, recombinant proteins).
• Manufacturing and purification.
• Quality control, validation, and regulatory compliance.
• Marketing, education, and training initiatives.

Profitability Margins: Gross margins for fibrin sealant products range between 45% and 55%, influenced by sourcing methods and regulatory compliance costs.

What Are Future Market Opportunities and Challenges?

Opportunities:

• Developing recombinant fibrin sealants to eliminate pathogen transmission risks.
• Expanding indications into aesthetic and dental procedures.
• Customizing formulations for minimally invasive and robotic surgeries.

Challenges:

• Entry barriers due to costly manufacturing and regulatory requirements.
• Competition from synthetic and other biological sealants.
• Managing safety concerns related to pathogen transmission and immunogenicity.

How Might Market Dynamics Evolve?

A gradual shift toward recombinant fibrin products may occur, driven by safety and consistency benefits. While human plasma-based sealants maintain a cost advantage, regulatory developments and technological improvements could reduce this gap.

Emerging markets with growing surgical volumes and limited current use of biological products present expansion prospects but face infrastructure and regulatory hurdles.

Key Takeaways

• The fibrin sealant market is growing, driven by surgical volume increases and technological advancements.
• Human-derived fibrin sealants have safety, efficacy, and cost considerations influencing their adoption.
• Regulatory frameworks support expansion but require substantial compliance investments.
• Cost structures are sensitive to sourcing methods and manufacturing efficiency.
• Future growth hinges on innovation, safety improvements, and market penetration strategies in emerging regions.

FAQs

Q1: How does the safety profile of human fibrin sealants compare to recombinant versions?
Human fibrin sealants processed with current pathogen reduction techniques have a low risk of pathogen transmission. Recombinant versions eliminate this risk entirely but may carry different immunogenicity profiles.

Q2: Which surgical procedures primarily utilize fibrin sealants?
Cardiovascular, neurological, general, and orthopedic surgeries are primary applications. Usage also extends to wound management and trauma care.

Q3: What factors could impede market growth?
Regulatory hurdles, safety concerns, high manufacturing costs, and competition from synthetic sealants or newer biological products.

Q4: What regions are key markets for fibrin sealant?
North America and Europe are mature markets with high adoption rates. Emerging markets like Asia-Pacific are growing rapidly due to increased surgical procedures and healthcare access.

Q5: How does pricing influence market penetration?
Lower-cost plasma-derived products facilitate broader adoption in cost-sensitive regions. Premium recombinant products target high-end procedures and specialized centers.

References

1. MarketsandMarkets. (2022). Fibrin Sealant Market Size, Share & Trends Analysis Report.
2. World Health Organization. (2019). Global Surgery Volume Estimates.
3. FDA. (2021). Approval Summary for Human Fibrin Sealants.
4. Takeda Pharmaceuticals. (2020). Product Portfolio and Market Strategy.
5. Becton Dickinson. (2021). Surgical Hemostats and Sealants Overview.