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Last Updated: December 31, 2025

TACHOSIL Drug Profile


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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

SponsorPhase
Medical University of WarsawPhase 4
Erzincan Military HospitalPhase 4
GATT Technologies BVN/A

See all TACHOSIL clinical trials

Pharmacology for TACHOSIL
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
  2. 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.

  3. DrugPatentWatch analysis and company disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ⤷  Get Started Free 2014-10-21 DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh TACHOSIL fibrin sealant patch Patch 125351 ⤷  Get Started Free 2018-01-27 DrugPatentWatch analysis and company disclosures
Corza Medical Gmbh TACHOSIL fibrin sealant patch Patch 125351 ⤷  Get Started Free 2018-11-12 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug TACHOSIL

Last updated: September 25, 2025

Introduction

TACHOSIL is a biologic adhesive tissue sealant developed by Tachosil, a collagen-based fibrin sealant primarily designed for surgical applications. It combines collagen matrices with human thrombin and fibrinogen, facilitating rapid hemostasis and tissue sealing during surgical procedures. As a leading product in the biologic hemostatic market, understanding its market dynamics and financial trajectory is critical for stakeholders, including healthcare providers, investors, and competitors.

Market Overview

Market Size and Growth

The global surgical sealants and tissue adhesives market, inclusive of biologics like TACHOSIL, is projected to grow substantially. As per industry reports, the market was valued at approximately $4.2 billion in 2021 and is expected to reach around $7.1 billion by 2028, exhibiting a compound annual growth rate (CAGR) of approximately 7% (Source: Grand View Research). The increasing prevalence of chronic diseases requiring surgical interventions, along with advancements in minimally invasive procedures, are key drivers.

Key Market Segments

  • Application Areas: Cardiovascular, neurological, general surgery, thoracic, orthopedic, and dental surgeries.
  • End-User: Hospitals, ambulatory surgical centers, and specialty clinics.
  • Region: North America leads, driven by high healthcare expenditure, but Asia-Pacific shows the fastest growth due to increasing healthcare accessibility.

Competitive Landscape

TACHOSIL competes with several biologic and synthetic tissue sealants, including products like Evicel (fibrin sealant), Coseal, and derivatives of fibrin-based glues. Major players include Johnson & Johnson, Baxter International, and Ethicon. Market differentiation hinges on efficacy, safety profile, ease of use, and regulatory approvals.

Market Drivers

Rising Surgical Procedures

Increasing numbers of complex surgeries, particularly in cardiothoracic and neuro surgeries, require reliable tissue adhesives. The minimally invasive surgery trend further amplifies demand for effective hemostatic agents like TACHOSIL.

Regulatory Approvals and Reimbursement Policies

Stringent approvals enhance product credibility. TACHOSIL’s clearance in multiple regions (e.g., FDA approval, CE mark) broadens its market access. Reimbursement policies that favor biologic sealants may lead to increased adoption.

Technological Advancements

Innovations in biomaterials, such as improved biocompatibility and faster coagulation times, make products like TACHOSIL more attractive. Combining fibrin with collagen enhances adhesion and reduces adverse effects, thus boosting market share.

Aging Population

Global demographic shifts toward older populations increase the need for surgeries related to cardiovascular diseases, degenerative conditions, and trauma, elevating demand for effective hemostatic agents.

Challenges in the Market

High Cost and Reimbursement Constraints

Biologic sealants tend to be expensive, which can limit their adoption in cost-sensitive markets. Reimbursement complexities vary across regions, impacting market penetration.

Competition from Synthetic Sealants

Synthetic alternatives, often less costly and with streamlined regulatory pathways, pose competitive threats. Demonstrating superior efficacy and safety remains essential for biologic sealants like TACHOSIL.

Safety and Regulatory Constraints

Concerns related to infection risk, immune reactions, and transmission of transmissible agents necessitate rigorous safety profiles, affecting market confidence and regulatory approval timelines.

Financial Trajectory of TACHOSIL

Revenue Generation

TACHOSIL generates revenue through sales to hospitals and surgical centers worldwide. Its revenue trajectory depends on factors such as:

  • Market Penetration: Adoption rates in developed markets are relatively higher; expanding into emerging markets is crucial for growth.
  • Product Lifecycle: Patent expiries could lead to increased competition, impacting market share.
  • Pricing Strategy: Premium pricing is justified by clinical benefits but may face resistance in price-sensitive markets.

Investment and R&D Outlook

Continued investment in research enhances TACHOSIL’s formulation, safety, and application spectrum. Potential future innovations include bioengineered sealants, rapid-application formulations, or combination products for comprehensive surgical hemostasis.

Partnership and Licensing

Strategic alliances with regional distributors or co-development agreements can accelerate market access, especially in Asia-Pacific and Latin America, directly impacting sales volume and revenue growth.

Regulatory and Reimbursement Impact

Successful navigation of regulatory approvals and favorable reimbursement policies significantly influence TACHOSIL’s financial trajectory. Accelerating approval processes or inclusion in reimbursement schemes would boost revenue trajectories.

Future Outlook and Opportunities

Expansion into New Indications

Exploring applications beyond traditional surgery, such as in trauma management and minimally invasive procedures, could diversify revenue streams.

Technological Integration

Integrating TACHOSIL into surgical robotics and digital health platforms can enhance utility and adoption, translating to higher sales.

Geographic Expansion

Targeting emerging markets with tailored pricing and local regulatory strategies may unlock significant revenue potential.

Focus on Safety and Outcomes

Emphasizing clinical efficacy and safety in marketing can solidify market position and justify premium pricing.

Conclusion

The market for biologic tissue sealants like TACHOSIL is poised for sustained growth driven by demographic trends, technological innovations, and expanding surgical procedures. Its financial trajectory will depend on effective market penetration, regulatory strategies, and competitive positioning. Strategic focus on innovation, global expansion, and stakeholder engagement will be vital to capturing value in this expanding segment.


Key Takeaways

  • The global biologic tissue sealant market is expanding at a CAGR of approximately 7%, with TACHOSIL positioned as a key contender.
  • Market growth is driven by rising surgical volumes, demographic shifts, and technological improvements.
  • Challenges include high costs, competition from synthetic alternatives, and regulatory hurdles.
  • TACHOSIL’s revenue prospects depend on regional adoption, pricing, and strategic partnerships.
  • Innovation and geographic expansion are pivotal for maximizing financial growth and market share.

Frequently Asked Questions (FAQs)

1. What factors influence TACHOSIL’s market share in the global tissue sealant industry?
Market share is influenced by product efficacy and safety, regulatory approvals, pricing strategies, clinical adoption, and regional presence. Demonstrating superior outcomes and establishing strong distribution channels are crucial.

2. How does regulatory approval impact the financial trajectory of TACHOSIL?
Regulatory approvals facilitate market entry and reimbursement eligibility, directly impacting sales volumes and revenue. Delays or restrictions can hamper growth, while approvals in major markets accelerate financial gains.

3. What are the main growth opportunities for TACHOSIL in emerging markets?
Expanding into countries with increasing surgical volume, improving healthcare infrastructure, and offering tailored pricing strategies present significant growth opportunities.

4. How does competition from synthetic sealants affect TACHOSIL’s revenues?
Synthetic sealants often have lower costs and easier regulatory pathways, which can limit TACHOSIL’s adoption unless it demonstrates clear clinical advantages such as better safety or efficacy profiles.

5. What role does ongoing research and development play in TACHOSIL’s future?
R&D enhances product features, safety, and new indications, helping TACHOSIL stay competitive, enter new markets, and justify premium pricing, ultimately boosting long-term revenues.


Sources:

[1] Grand View Research. “Surgical Sealants Market Size, Share & Trends Analysis Report.” 2022.

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