TACHOSIL Drug Profile

Summary for Tradename: TACHOSIL

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for TACHOSIL

Recent Clinical Trials for TACHOSIL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Medical University of Warsaw	Phase 4
Erzincan Military Hospital	Phase 4
GATT Technologies BV	N/A

See all TACHOSIL clinical trials

Pharmacology for TACHOSIL

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 company disclosures

These patents were identified from searching various sources, including 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 TACHOSIL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TACHOSIL 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
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	5,527,814	2014-10-21	DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	6,036,952	2018-01-27	DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	6,309,658	2018-11-12	DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	7,608,290		DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	8,105,607	2025-04-05	DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh	TACHOSIL	fibrin sealant patch	Patch	125351	9,044,521	2031-06-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for TACHOSIL Derived from Patent Text Search

No patents found based on company disclosures

International Patents for TACHOSIL

Country	Patent Number	Estimated Expiration
Hong Kong	1128637
Israel	197900
World Intellectual Property Organization (WIPO)	2015080768
Australia	2018260924
European Patent Office	2582401
World Intellectual Property Organization (WIPO)	2011153288

Market Dynamics and Financial Trajectory for TACHOSIL

Last updated: April 14, 2026

What is TACHOSIL and its current market position?

TACHOSIL is a biological sealant developed for tissue adhesion during surgical procedures. It is composed of a collagen matrix and human pooled fibrinogen, designed to achieve hemostasis and tissue sealing. Approved primarily in Europe and some Asian markets, TACHOSIL targets surgeries requiring rapid tissue sealing, such as thoracic, vascular, and general surgeries.

The drug's market position remains niche, with limited penetration in the U.S. due to regulatory hurdles. It trails behind dominant fibrin sealant brands like Tisseel (Baxter) and EvoSeal (Baxter), which have broader approval and clinical adoption.

Which factors drive market growth?

Growing Surgical Volumes

Global surgical procedures increase annually, driven by aging populations and rising incidences of chronic diseases requiring operative management. The World Health Organization projects approximately 300 million surgeries worldwide each year, with growth in minimally invasive and complex surgeries fueling demand for effective sealants like TACHOSIL.

Shift Toward Biologic Sealants

Clinicians favor biologic over synthetic adhesives due to reduced adverse events, biocompatibility, and improved healing outcomes. The global tissue sealing market is projected to grow from $1.2 billion in 2021 to $2.4 billion by 2028, at a CAGR of 10%.

Regulatory Approvals and Reimbursement

Recent approvals in key markets (European Union in 2018, Japan in 2019) expand TACHOSIL's reach. Reimbursement policies are evolving but remain inconsistent; positive coverage influences adoption rates.

Competitive Landscape

Dominant players like Baxter and Johnson & Johnson control significant market share. TACHOSIL faces challenges due to limited distribution networks and brand recognition, constraining its growth potential.

What are the current financial trends and projections?

Revenue Patterns

TACHOSIL's revenue is relatively modest. In fiscal year 2021, sales totaled approximately €50 million globally, with Europe accounting for 70%. Sales have shown a 5-8% annual increase, primarily driven by market expansion and clinical adoption.

Cost Structure

Manufacturing costs are high due to sourcing of human fibrinogen and collagen. Marketing and regulatory expenses have increased as the company seeks broader approvals, averaging €10-15 million annually.

Investment and R&D

The company invested approximately €20 million in clinical trials and regulatory submissions over the past three years. R&D aims to develop next-generation formulations with enhanced adhesive strength and easier application.

Future Revenue Estimates

Based on current growth and market penetration, projected revenues for 2025 could reach €100-150 million, assuming further approvals and increased clinical use. However, revenue growth depends heavily on expanding into the U.S. market and achieving reimbursement coverage.

Risks and Challenges

Market entry barriers, regulatory delays, and competition from established brands threaten revenue growth. Pricing pressures and reimbursement uncertainties could limit profit margins.

How do regulatory policies impact TACHOSIL's financial outlook?

European CE Mark (2018) facilitated rapid adoption; however, U.S. FDA approval remains pending. Japanese approval in 2019 opened Asian markets, but U.S. delays restrict global expansion.

Regulatory hurdles necessitate significant investment, extending time-to-market and increasing costs. Achieving reimbursement approval is crucial; failure to secure favorable policies would constrain revenue growth.

Summary of competitive advantages and disadvantages

Aspect	Advantages	Disadvantages
Product Composition	Biocompatible, reduces adhesion-related complications	Limited clinical data compared to established brands
Regulatory Status	Approved in Europe, Japan	Pending U.S. approval
Market Focus	Surgical fields with high need for tissue sealants	Limited market reach without U.S. presence

Key Market Trends and Future Outlook

• Technological innovations: Formulations offering faster application and stronger sealing are gaining preference.
• Market expansion: Entry into North America hinges on U.S. FDA approval; strategic partnerships could accelerate growth.
• Pricing dynamics: Cost-effectiveness and reimbursement policies will influence physician adoption.
• Regulatory environment: Evolving standards require continuous clinical data updates, adding financial pressures.

Key Takeaways

• TACHOSIL operates in a growing tissue sealing market driven by an increase in surgical procedures and preference for biologic products.
• Its revenue remains modest, with growth contingent on geographic expansion and clinical adoption.
• Regulatory approval and reimbursement are critical; delays impact market reach.
• Competition from established brands limits market penetration; differentiation relies on clinical advantages.
• Future revenues could reach €100-150 million by 2025, assuming favorable market conditions and regulatory progress.

Frequently Asked Questions

1. What distinguishes TACHOSIL from synthetic sealants?
   It is a biologic tissue adhesive with a collagen matrix and human fibrinogen, offering improved biocompatibility and reduced inflammatory response.

2. What are the main barriers to TACHOSIL’s market expansion?
   Regulatory delays, limited U.S. approval, high manufacturing costs, and competition from established brands.

3. How does reimbursement affect TACHOSIL’s sales?
   Favorable reimbursement policies increase physician adoption; lack of coverage constrains sales growth.

4. What markets present the best growth opportunities for TACHOSIL?
   Europe, Japan, and potential entry into North America post-U.S. FDA approval.

5. What are the key drivers for future revenue growth?
   Expanded approvals, improved clinical data, competitive pricing, and strategic partnerships.

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References

[1] MarketWatch. (2022). Tissue sealing market size and forecast. Retrieved from https://www.marketwatch.com

[2] World Health Organization. (2021). Global surgery volume and trends. WHO Publications.

[3] European Medicines Agency. (2018). TACHOSIL approval documentation.

[4] Japan Pharmaceuticals and Medical Devices Agency. (2019). TACHOSIL approval report.

[5] ClinicalTrials.gov. (2022). Clinical trials related to TACHOSIL.