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	12,311,015	2044-01-22	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	9,028,851	2031-12-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	9,212,357	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	10,046,081	2034-07-29	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	10,245,348	2035-07-20	Patent claims search
Omrix Biopharmaceuticals Ltd	EVITHROM	thrombin, topical (human)	Solution	125247	10,493,094	2037-02-27	Patent claims search

International Patents for thrombin, topical (human)

Country	Patent Number	Estimated Expiration
Israel	280625
Brazil	112015013071
Hong Kong	1214958

Market Dynamics and Financial Trajectory for Topical Human Thrombin

Last updated: March 8, 2026

What Is the Current Market Size and Growth Rate for Topical Human Thrombin?

The market for topical human thrombin, used primarily for hemostasis in surgical procedures, has experienced steady growth. In 2022, the global biologic hemostat market reached approximately $2.5 billion, with topical thrombin accounting for roughly 20% ($500 million). The compound annual growth rate (CAGR) for this segment is estimated at 6.2% over the next five years, driven by increasing surgical procedures, rising adoption in wound management, and an expanding pipeline of biologic hemostats.

Key drivers include:

• Growth in cardiovascular, orthopedic, and neurosurgical procedures.
• Efforts to reduce surgical bleeding complications.
• Adoption of biologic products over traditional hemostats, due to their efficacy and safety profile.

The market segmentation shows North America as the largest region, with more than 45% market share, followed by Europe (25%) and Asia-Pacific (20%). The remaining 10% is distributed across Latin America, Middle East, and Africa.

Who Are the Major Players and Competitive Landscape?

Leading companies in topical human thrombin include:

• Johnson & Johnson (Ethicon): Has marketed Thrombin-JMI, a commercially available topical human thrombin product, since 1998.
• Baxter International: Offers products under its hemostatic portfolio, including biologic thrombin preparations.
• Fresenius Medical Care: Engages in biologic hemostats for surgical applications.
• Haemonetics Corporation: Focuses on blood management and related biologic products.

The competitive landscape is characterized by:

• Proprietary manufacturing processes, especially recombinant human thrombin production.
• Patent protection for specific formulations and delivery systems.
• Entry barriers related to bioprocessing complexity, regulatory approval, and clinical validation.

What Are the Regulatory Considerations and Pipeline Opportunities?

Topical human thrombin products are regulated as biologic drugs by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national agencies. The regulatory pathway requires demonstrating safety, efficacy, and manufacturing consistency.

• FDA approval status: Several products have received full approval or are marketed under the biologic license application (BLA) pathway.
• Pipeline developments: Multiple biotechs are developing recombinant human thrombin with enhanced hemostatic properties and reduced immunogenicity. For example, biotech firms explore modified recombinant versions with longer shelf life and ease of application.

Emerging trends focus on:

• Recombinant DNA technology to minimize immunogenic reactions and transmission risks.
• Combination products with other hemostatic agents.
• Injectable or topical forms with improved adhesion.

What Are the Key Market Risks and Challenges?

• Immunogenicity: Despite its human origin, thrombin can trigger immune responses, especially if derived from animal sources or contaminated.
• Manufacturing complexity: Producing recombinant human thrombin involves complex bioprocessing, high costs, and strict quality control.
• Regulatory hurdles: Use of recombinant products requires extensive clinical data, which prolongs development timelines.
• Competitive pressure: Established products like Thrombin-JMI face generic competition and price erosion.
• Safety concerns: Risk of transmission of infectious agents if coming from pooled human plasma; recombinant methods mitigate this but introduce new challenges.

What Is the Financial Trajectory for Investors and R&D?

Financial prospects depend on several factors:

• Product pipeline success: Therapies advancing through clinical trials could expand market share.
• Patent expiration: Loss of exclusivity for existing products is imminent; companies need innovative formulations or new indications.
• Market penetration: Adoption rates are influenced by healthcare infrastructure, surgeon preferences, and reimbursement policies.

Investment in recombinant formulations is a notable trend, with biotech firms raising capital to fund development. For example, a biotech company reported that production costs for recombinant thrombin are approximately 30-50% higher than pooled plasma-derived products, affecting pricing strategies.

Future revenue projections, based on conservative adoption estimates, suggest that recombinant thrombin could capture up to 25% of the current market within a decade, translating to potential revenues of $1.2 billion globally by 2032.

What Are the Policy and Reimbursement Influences?

• Reimbursement policies favor products demonstrated to reduce surgical time and complications.
• Hospitals prioritize cost-effective solutions; cheaper animal-derived thrombin products are often preferred unless safety concerns arise.
• Regulatory encouragement for recombinant biologics supports innovation and adoption.

Summary and Strategic Insights

The topical human thrombin market is mature but evolving amid technological advances. Growth will center on recombinant development and novel delivery systems. Companies with patents on recombinant processes, or integrated biologic manufacturing capabilities, are best positioned for market share gains.

Key Takeaways

• The global market for topical human thrombin was valued at approximately $500 million in 2022, with a CAGR of 6.2%.
• Major competitors include Johnson & Johnson, Baxter, and emerging biotech firms developing recombinant versions.
• Regulatory pathways favor recombinant thrombin, but high manufacturing costs and safety concerns influence commercial success.
• Pipeline products aim to improve safety, stability, and ease of use.
• Revenue potential hinges on successful clinical development, regulatory approval, and market penetration, with revenues possibly reaching $1.2 billion globally by 2032.

FAQs

1. What are the main advantages of recombinant human thrombin over plasma-derived products?

Recombinant thrombin reduces risks of pathogen transmission, offers consistent production quality, and allows for improved stability and formulation options.

2. How does immunogenicity impact product adoption?

While human origin reduces immunogenic potential, recombinant products are designed to further minimize immune responses, making them safer over long-term and repeated use.

3. What factors influence reimbursement rates for topical thrombin?

Efficacy in reducing surgical time and bleeding complications, safety profiles, and overall cost-effectiveness determine reimbursement decisions.

4. When are new recombinant thrombin products expected to reach market?

Clinical trials for several recombinant thrombin candidates are underway, with commercialization anticipated within the next 3-5 years, pending successful trial outcomes and regulatory review.

5. How does patent expiration impact the market?

Patent expirations for key products often lead to increased generic competition, pressure on prices, and the need for innovation or new delivery platforms to sustain revenues.

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References

[1] Markets and Markets. (2022). Biologic Hemostat Market. https://www.marketsandmarkets.com/

[2] U.S. Food and Drug Administration. (2022). Biologic License Applications (BLA). https://www.fda.gov/

[3] Grand View Research. (2023). Hemostats Market Size, Share & Trends. https://www.grandviewresearch.com/