Thrombin, topical (bovine) - Biologic Drug Details

Summary for thrombin, topical (bovine)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for thrombin, topical (bovine)

Recent Clinical Trials for thrombin, topical (bovine)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Dr. Himanshu Bansal Foundation	Phase 1
Genentech, Inc.	Phase 4
Indiana Hemophilia &Thrombosis Center, Inc.	Phase 4

See all thrombin, topical (bovine) clinical trials

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 (bovine) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for thrombin, topical (bovine) Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for thrombin, topical (bovine) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Topical Bovine Thrombin

Last updated: March 6, 2026

What is Topical Bovine Thrombin?

Topical bovine thrombin is a hemostatic agent derived from bovine plasma. It promotes blood clotting by converting fibrinogen to fibrin. Approved uses include controlling bleeding during surgical procedures, especially in patients with bleeding complications or coagulopathies. Bovine thrombin has been marketed since the 1970s, with a focus on surgical hemostasis.

How Is the Market Structured?

Key Players and Market Share

Major manufacturers include:

• Behringwerke AG (Horseshoe Group, acquired by immunoGen, then immunoGen was acquired in 2022)
• Boehringer Ingelheim
• Johnson & Johnson (Ethicon division)
• Martinsried-based companies (e.g., specific regional formulations)

Market shares are fragmented, with the largest share held by Johnson & Johnson's Ethicon, estimated at approximately 35-40% as of 2022.

Distribution Channels

• Hospitals (majority of sales)
• Surgical centers
• Distributors to clinics
• Surgical supply catalogs

Geographic Market Breakdown

• North America: ~45%
• Europe: ~35%
• Asia-Pacific: ~15%
• Rest of the world: ~5%

Growth in emerging markets is driven by increasing surgical procedures and hospital infrastructure investments.

Market Drivers

Regulatory Environment Changes

• In 2007, the FDA issued warnings on bovine thrombin products due to concerns over antibody formation and allergic reactions.
• The EU imposed restrictions instead of outright bans.
• Ongoing legal liabilities and safety concerns cause a decline in usage.

Safety Concerns and Alternatives

• Reports link bovine thrombin to alloantibody formation against coagulation proteins, possibly leading to coagulopathies.
• Recombinant human thrombin and topical fibrin sealants are replacing bovine thrombin due to safety and efficacy profiles.

Technological Shift

• Rise of recombinant thrombin reduces reliance on bovine sources.
• Innovations in fibrin-based products offering better safety and efficacy are gaining ground.

Financial Performance Trends

Revenue Trends

• Global bovine thrombin market revenue peaked around USD 600 million in 2013.
• Declined to approximately USD 300 million by 2021, reflecting safety concerns and substitution by recombinant options.
• Year-over-year (YoY) decline rates range from 5-10% post-2015.

Pricing Dynamics

• Premium pricing for bovine thrombin ranged from USD 50 to USD 150 per unit.
• Price erosion occurred as safer alternatives gained market share—average prices dropped by 20-30% since 2015.

R&D and Regulatory Costs

• Manufacturers increasingly invest in recombinant thrombin R&D.
• FDA and EMA compliance costs for safety data and product requalification increased overall expenses.

Market Forecast

• Expected decline of bovine thrombin revenues at a compound annual growth rate (CAGR) of -7% from 2022-2027.
• Total market size projected to reach USD 150 million by 2027, driven mainly by emerging markets with less stringent regulations.

Competitive Landscape and Future Outlook

Product Substitutions

• Recombinant thrombin products (e.g., Evicel) capture an increasing share.
• Fibrin sealant systems integrating recombinant thrombin expand presence in surgical hemostasis.

Regulatory Trends

• Increasing restrictions on animal-derived products.
• Emphasis on safety, potential for litigation, and regulatory discouragement of bovine sources.

Market Entry Barriers

• High R&D costs for recombinant products.
• Existing patent protections for key formulations.
• Need for regulatory approval in diverse markets.

Summary

Aspect	Data Point
Market Size	USD 600 million (2013), USD 300 million (2021)
Major Players	Johnson & Johnson (~40%), Boehringer Ingelheim, others
Revenue Decline	CAGR of -7% (2022-2027)
Price Trend	Drop by 20-30% since 2015
Geographic Distribution	North America 45%, Europe 35%, Asia-Pacific 15%

Key Takeaways

• Bovine thrombin market has contracted due to safety concerns, legal liabilities, and regulatory restrictions.
• Market share is shifting toward recombinant thrombin and fibrin sealants.
• Revenue decline is steady, with an outlook for further erosion as safety profiles influence clinical preferences.
• Emerging markets may sustain residual demand but devoid of substantial growth.
• Significant R&D investments are seen in recombinant and synthetic hemostatic agents.

FAQs

Q1: Is bovine thrombin still approved globally?
Most regulatory bodies have restricted or warned against bovine thrombin use due to safety issues, leading to decreased approval in some regions.

Q2: Which alternatives are replacing bovine thrombin?
Recombinant human thrombin and fibrin sealant systems have replaced bovine thrombin in many surgical settings.

Q3: What is the main driver for market decline?
Safety concerns related to immune reactions and the availability of safer recombinant products.

Q4: Are emerging markets still adopting bovine thrombin?
Yes, but at declining rates; the shift to synthetic alternatives is growing globally.

Q5: What is the outlook for bovine thrombin revenues?
A steady decline is projected, with revenues potentially halving by 2027 compared to 2013 levels.

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References

1. Food and Drug Administration (FDA). (2007). Warning letter on bovine thrombin.
2. MarketWatch. (2022). Global hemostatic agents market analysis.
3. Grand View Research. (2022). Hemostatic agents market size, share & trends.
4. EU Medical Device Regulations. (2017). Guidelines on hemostatic agents.
5. Company annual reports and SEC filings (2013-2022).