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
Japan	2016505543
Japan	2020502241
World Intellectual Property Organization (WIPO)	2014016819
Israel	277033
Mexico	2015006986
Israel	275269
India	5901DEN2014

Market Dynamics and Financial Trajectory for the Biologic Drug: Fibrin Sealant (Human)

Last updated: August 3, 2025

Introduction

Fibrin sealant (human), a biologic hemostatic agent derived from human plasma, has established a niche within surgical hemostasis, wound healing, and tissue sealing. Its unique properties—biocompatibility, biodegradability, and efficacy—have driven its adoption across various medical disciplines. The current market trajectory is shaped by advances in biotechnological manufacturing, expanding surgical indications, and evolving healthcare regulations. This report assesses the core market dynamics and forecasts the financial trajectory for fibrin sealant (human), equipping industry stakeholders with strategic insights.

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Market Overview

Fibrin sealants, predominantly based on human-derived components, facilitate rapid clot formation by mimicking the final stages of the coagulation cascade. The global fibrin sealant market was valued at approximately USD 1.2 billion in 2022 and is projected to attain a compound annual growth rate (CAGR) of roughly 8-10% over the next five years (2023-2028) [1]. The positioning of human-derived fibrin sealants, as opposed to animal-based or recombinant formulations, aligns with increasing preferences for biologics with high biocompatibility and lower immunogenicity.

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Market Drivers

1. Expansion into New Surgical Indications:
The scope of fibrin sealants now encompasses cardiovascular surgeries, neurosurgeries, orthopedic procedures, and dental surgeries. Clinical evidence supports their efficacy in reducing operative time, minimizing blood loss, and improving postoperative healing. The approval of fibrin sealants in minimally invasive surgeries further broadens their application, fueling demand.

2. Rising Surgical Volumes:
An aging global population, coupled with increases in complex surgical interventions, bolsters the need for effective hemostasis agents. The World Health Organization (WHO) estimates an annual 4% increase in surgical procedures globally, significantly impacting demand for fibrin sealants [2].

3. Product Innovations and Competitive Differentiation:
Advancements in formulation—such as enhanced adhesiveness, multi-component systems, and reduced transmission risk—improve therapeutic efficacy and safety profiles. Companies investing in R&D are gaining competitive advantages, fostering market expansion.

4. Regulatory Environment and Reimbursement Policies:
Stringent safety regulations, particularly concerning plasma-derived products, initially constrained market growth. However, recent approvals and favorable reimbursement policies in North America, Europe, and select Asian markets incentivize adoption.

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Market Challenges

1. Supply Chain Constraints and Cost Issues:
Reliance on pooled human plasma elevates production costs and introduces supply chain vulnerabilities. Shortages of plasma donors and rigorous screening for blood-borne pathogens impact product availability and pricing.

2. Safety and Ethical Concerns:
Potential transmission of infections, despite rigorous screening, remains a concern. Ethical debates surrounding pooled human plasma sourcing may influence regulatory and consumer acceptance.

3. Competition from Alternative Hemostatic Agents:
Recombinant fibrin sealants, synthetic adhesives, and topical hemostats—including collagen-based agents—pose alternatives that can be more cost-effective or have enhanced safety profiles.

4. Market Penetration in Emerging Economies:
Limited access, affordability, and regulatory hurdles hamper market growth in low- and middle-income countries (LMICs). Overcoming these barriers requires strategic partnerships and localized manufacturing.

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Technological and Regulatory Trends

1. Bioengineering and Manufacturing Advances:
Innovations such as pathogen reduction technologies and recombinant techniques decrease transmission risk and improve purity, making human fibrin sealants more competitive. Continuous improvements in lyophilization processes enable extended shelf-life and ease of storage.

2. Regulatory Approvals and Reimbursements:
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to approve new fibrin sealant formulations, emphasizing safety and efficacy. Positive reimbursement policies, especially in North America, support market adoption.

3. Shift Towards Personalized Medicine:
Tailoring fibrin sealant formulations based on patient-specific factors and surgical procedures fosters differentiation but may increase manufacturing complexity.

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Financial Trajectory Analysis

Revenue Growth Prospects:
The market is expected to grow at a CAGR of 8-10%, reaching an estimated USD 2.0–2.3 billion by 2028. This growth is primarily driven by increased adoption in emerging indications, technological innovations, and expanding geographical penetration.

Market Segmentation and Revenue Distribution:

• By Application: Cardiovascular (30%), Neurosurgery (20%), Orthopedics (15%), General Surgery (25%), Others (10%).
• By Region: North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%). The North American market maintains dominance due to early adoption, high healthcare expenditure, and advanced regulatory frameworks.

Profitability Outlook:
While established players benefit from brand recognition and economies of scale, new entrants face high R&D and manufacturing costs. Profit margins are projected to stabilize around 25-30%, considering competitive pricing and premium formulations.

Investment and M&A Trends:
Venture capital inflows into biologics and biologic-devoted M&A activity are increasing, indicating investor confidence in the market’s growth potential. Notably, collaborations between plasma-derived biologics companies and biotech startups seek to accelerate product pipeline expansion.

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Competitive Landscape

Major industry players include Baxter International, Johnson & Johnson (Ethicon), CSL Behring, Takeda Pharmaceutical, and Becton Dickinson. Innovation focus areas encompass recombinant formulations, enhanced safety profiles, and broadened indications. Emerging companies leverage proprietary plasma processing technologies to challenge incumbents.

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Impact of COVID-19

The pandemic temporarily disrupted supply chains and delayed elective surgeries, constraining short-term demand. However, as healthcare systems adapt, elective procedures resume, and the focus on blood management intensifies, the market is rebounding. Additionally, heightened awareness of biological safety has accelerated acceptance of plasma-derived biologics.

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Key Market Opportunities

• Development of Recombinant Fibrin Sealants: Reduced transmission risk and improved consistency appeal to safety-conscious clinicians and regulators.
• Expanding Indications: Tissue engineering, regenerative medicine, and minimally invasive procedures foster new product applications.
• Emerging Market Penetration: Affordability improvements, localized manufacturing, and strategic partnerships can unlock substantial growth potential in LMICs.
• Personalized and Combination Therapies: Customized formulations and combination devices with other biologics or synthetic agents can differentiate offerings.

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Regulatory and Strategic Considerations

Companies must navigate complex international regulatory environments, emphasizing safety, potency, and manufacturing standards. Evidence generation through clinical trials remains critical to securing approvals and reimbursement. Strategic alliances, licensing agreements, and licensing-in of innovative technologies will be instrumental in maintaining competitive advantage.

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Conclusion

The biologic fibrin sealant (human) market presents a resilient, growth-oriented landscape driven by technological innovation and expanding surgical needs. While safety, supply chain, and cost challenges persist, strategic investments in R&D, regulatory compliance, and market expansion are poised to deliver robust financial returns. Stakeholders who adopt a long-term, innovation-driven approach will capitalize on the evolving dynamics and emerging opportunities within this vital segment of biologic therapeutics.

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Key Takeaways

• Market poised for steady growth: Projected CAGR of around 8-10% through 2028, driven by broader surgical applications and technological advancements.
• Innovation is essential: Recombinant and enhanced formulations will address safety concerns and differentiate market offerings.
• Emerging markets represent significant upside: Lower income regions, if approached strategically, can substantially expand the market base.
• Regulatory landscape is evolving: Stringent safety standards and approval pathways influence time-to-market and competitive dynamics.
• Supply chain resilience and cost-efficiency are critical: Managing plasma supply risks and controlling costs will be decisive in maintaining profitability.

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FAQs

1. What factors primarily influence the growth of fibrin sealant (human) in surgical applications?
The expansion into new indications, technological innovations enhancing safety and efficacy, rising global surgical volumes, and supportive regulatory policies are the main growth drivers.

2. How does the safety profile of human-derived fibrin sealants compare with recombinant alternatives?
Human-derived products inherently carry risks of blood-borne pathogen transmission; however, modern pathogen reduction technologies and rigorous screening mitigate this. Recombinant formulations eliminate these risks but may have different efficacy profiles.

3. What challenges hinder the widespread adoption of fibrin sealants in emerging economies?
High costs, limited infrastructure for plasma collection and processing, regulatory hurdles, and lack of reimbursement mechanisms restrict market penetration.

4. How could technological advances impact the financial success of fibrin sealant manufacturers?
Innovations such as recombinant formulations, improved shelf stability, and combination therapies can command premium pricing, expand indications, and improve safety, thereby enhancing profitability.

5. What role do regulatory agencies play in shaping the market trajectory?
Regulatory approvals determine market entry and acceptance; strict safety standards necessitate rigorous clinical and manufacturing compliance, impacting development timelines and costs.

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References

[1] MarketsandMarkets. "Fibrin Sealants Market by Product, Application, End-User – Global Forecast to 2028."
[2] WHO. "Global Surgery 2030: Evidence and Solutions for Achieving Surgical Equity," 2015.