Thrombin, topical (human) - Biologic Drug Details

Summary for thrombin, topical (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for thrombin, topical (human)

Physiological Effect	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 thrombin, topical (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for thrombin, topical (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	EVITHROM	thrombin, topical (human)	Solution	125247		2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2033-03-04	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	For Injection	125247		2033-03-04	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for thrombin, topical (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
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2034-07-29	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2035-07-20	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2037-02-27	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2038-03-15	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2002-05-05	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247		2007-05-06	Patent claims search

International Patents for thrombin, topical (human)

Country	Patent Number	Estimated Expiration
Japan	2016505543
Russian Federation	2015126540
Israel	239043
Japan	2018162254
South Korea	20200039831
Russian Federation	2670956

Market Dynamics and Financial Trajectory for Topical Human Thrombin: A Strategic Outlook

Last updated: August 7, 2025

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Introduction

Topical human thrombin, a biologic hemostatic agent used to control bleeding in surgical and wound management settings, is embedded within a competitive landscape driven by technological advancements, regulatory pathways, and evolving healthcare needs. As a recombinant or purified human plasma product, thrombin’s market trajectory hinges upon clinical efficacy, safety profiles, and manufacturing scalability. This analysis underscores recent market trends, competitive forces, regulatory considerations, and the financial outlook for this biologic.

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Market Overview and Key Drivers

Market Size and Growth

The global surgical hemostats market, which includes topical human thrombin, was valued at approximately USD 3.4 billion in 2022, with an estimated compound annual growth rate (CAGR) of around 6% projected through 2030 [1]. Topical thrombin’s share is influenced by its widespread use in neurosurgery, cardiovascular, and general surgical procedures where bleeding control is critical.

Key Market Drivers

1. Rising Surgical Volumes: An aging population and increasing prevalence of chronic diseases generate a higher volume of surgeries requiring effective hemostasis.
2. Advances in Biologics Manufacturing: Improvements in purification and recombinant technology enhance safety and supply stability, making human thrombin a preferred option over bovine-derived alternatives.
3. Regulatory Approvals and Indications Expansion: Approval of new formulations and expanded indications bolster market penetration.
4. Cost-Effectiveness and Safety: Human-derived thrombin exhibits low immunogenicity relative to animal sources, aligning with safety guidelines which influence clinician preference.

Market Challenges

• Pricing Pressures: Payers and healthcare providers seek cost-effective alternatives, including synthetic or recombinant agents.
• Competitor Products: Recombinant thrombin and adjunct hemostatic agents, such as fibrin sealants, pose substitution risks.
• Regulatory Hurdles: Stringent approval processes can delay market entry, particularly in emerging markets.

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Competitive Landscape

Major Players

• Pfizer (Thrombin-JMI): The leading biologic thrombin supplier with a significant market share, leveraging established manufacturing and broad distribution networks.
• Baxter International: Offers a range of hemostatic agents, including bovine and human thrombin formulations, with ongoing R&D in recombinant technologies.
• Ethicon (Johnson & Johnson): Focuses on fibrin sealants but indirectly competes through integrated hemostatic solutions.
• New entrants and biosimilar developers: Emerging biotech firms focus on recombinant or synthetic thrombin, seeking FDA and EMA approval pathways.

Product Differentiation

• Human thrombin’s key advantages include lower immunogenicity, higher purity, and compatibility with sensitive surgical procedures.
• Novel formulations aim to improve stability, ease of application, and shelf-life, providing competitive differentiation.

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Regulatory and Reimbursement Landscape

Regulatory Pathways

• FDA (U.S.): Human thrombin products typically qualify as biologics under the Public Health Service Act, requiring Biosimilarity or Biosimilar pathways for recombinant formulations.
• EMA (Europe): Regulatory approval involves demonstrating biosimilarity or non-inferiority to existing products, with rigorous safety and efficacy data requirements.
• Emerging Markets: Often less stringent but challenging due to infrastructure limitations and reimbursement frameworks.

Reimbursement Dynamics

• Reimbursement levels directly impact market adoption; positive coverage for human thrombin encourages hospital procurement.
• Value-based care models favor products with proven safety and cost efficiencies, which may limit high-cost biologic agents from gaining predominant market share.

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Financial Trajectory and Investment Outlook

Revenue Projections

Based on current growth trends and market penetration, revenues for topical human thrombin are projected to grow from approximately USD 400 million in 2022 to over USD 600 million by 2030, representing a CAGR of around 5.5–6%. The principal growth drivers include increased surgical procedures and continued adoption of human-derived products over animal sources.

Research and Development Investment

Clinical innovation remains critical; investments in recombinant thrombin and improved formulations directly influence future revenue streams. Biotech firms exploring biosimilar pathways aim to capitalize on patent expirations and market expansion in emerging economies.

Cost Dynamics

Developments in manufacturing—such as plasma fractionation efficiency and recombinant expression—aim to reduce production costs. These savings bolster profit margins and enable competitive pricing, broadening market access.

Market Risks and Opportunities

• Risks: Bioequivalence regulation delays, pricing pressures, and competition from synthetic agents could restrain growth.
• Opportunities: Reimbursement expansion in developing countries and technological advances facilitating more effective delivery systems create growth avenues.

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Emerging Trends and Future Outlook

1. Recombinant Thrombin Development: Multiple biotech companies are developing recombinant thrombin formulations to meet safety and supply chain needs.
2. Combination Products: Integration with fibrin sealants or adhesive matrices presents opportunities for bundled solutions.
3. Personalized Hemostasis: Advancements in diagnostics and targeted delivery may enhance the efficacy of topical thrombin applications.
4. Global Expansion: Markets like Asia-Pacific are expected to exhibit the fastest growth rates due to increasing surgical procedures and healthcare investments.

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Regulatory and Ethical Considerations

Enhanced safety profiles of recombinant thrombin mitigate concerns over infectious disease transmission linked to plasma-derived products. Regulatory agencies prioritize biosafety and manufacturing transparency, influencing market entry timelines and product acceptance.

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Key Takeaways

• The topical human thrombin market is on a steady growth trajectory driven by surgical volume increases and a shift toward safer biologics.
• Competitive differentiation hinges on safety profiles, manufacturing scalability, and regulatory agility.
• Price sensitivity and reimbursement policies, especially in emerging markets, substantially influence market expansion.
• Technological innovation in recombinant production and combination products will shape future market dynamics.
• Companies investing in R&D and navigating regulatory pathways efficiently can capitalize on the increasing demand for safe, effective hemostatic biologics.

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Conclusion

The market landscape for topical human thrombin is characterized by gradual expansion, with significant opportunities driven by technological innovation, geographic growth, and evolving clinical preferences. Strategic investments in recombinant technologies, coupled with proactive regulatory engagement, are essential for industry players seeking sustainable financial growth in this segment.

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FAQs

Q1: What are the main advantages of recombinant human thrombin over plasma-derived products?
A1: Recombinant thrombin offers higher safety by eliminating risks of viral transmission, has consistent purity, and ensures supply stability, making it preferable over plasma-derived versions.

Q2: How will regulatory developments affect the market for topical human thrombin?
A2: Streamlined approval pathways for biosimilars and recombinant products can lower entry barriers, increase competition, and drive prices downward, but stricter safety requirements may extend development timelines.

Q3: Which regions are expected to drive the fastest growth in this market?
A3: Asia-Pacific and Latin America are projected to experience rapid growth due to increasing healthcare infrastructure, surgical procedures, and rising healthcare expenditure.

Q4: How does competition from fibrin sealants impact the thrombin market?
A4: Fibrin sealants often serve as alternatives with comparable efficacy, pressuring thrombin products to emphasize safety, ease of use, and cost-effectiveness to maintain market share.

Q5: What are the key factors influencing the profitability of biologic thrombin manufacturers?
A5: Critical factors include manufacturing costs, regulatory approval efficiency, patent strategies, market access, reimbursement policies, and innovation pace.

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References

[1] MarketWatch. “Global Surgical Hemostats Market Size, Share & Trends Analysis Report.” 2022.