ARTISS Drug Profile

Summary for Tradename: ARTISS

High Confidence Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ARTISS

Recent Clinical Trials for ARTISS

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mid and South Essex NHS Foundation Trust	Phase 4
Zuyderland Medisch Centrum	Phase 4
Nguyen, Davis B., M.D.

See all ARTISS clinical trials

Pharmacology for ARTISS

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 ARTISS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ARTISS 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
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	11,406,945	2037-03-13	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	5,166,060	2009-11-24	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	5,605,884	2014-12-27	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	6,030,806	2016-12-09	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	6,656,461	2020-02-29	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	7,507,421	2023-04-29	DrugPatentWatch analysis and company disclosures
Baxter Healthcare Corporation	ARTISS	fibrin sealant (human)	Solution	125266	7,919,097	2029-10-15	DrugPatentWatch analysis and company disclosures

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

No patents found based on company disclosures

International Patents for ARTISS

Country	Patent Number	Estimated Expiration
European Patent Office	1694702
European Patent Office	1973475
Japan	5492419
Canada	2632608
China	102631226
Israel	191879
South Korea	101307599

Market Dynamics and Financial Trajectory for ARTISS

Last updated: April 14, 2026

What is ARTISS?

ARTISS is a human tissue-derived fibrin sealant used primarily in surgical settings to reduce bleeding and facilitate wound closure. It combines plasma fibrinogen and thrombin to promote clot formation. The product is developed by Baxter International.

Market Size and Growth

The global fibrin sealants market was valued at approximately USD 1.04 billion in 2021 and is projected to reach USD 1.6 billion by 2028, growing at a CAGR of around 6.1% (Fortune Business Insights, 2022).

ARTISS holds a niche position within this market, targeting specific surgical procedures such as cardiovascular, orthopedic, and general surgeries.

Key Market Drivers

• Rise in Surgical Procedures: An annual increase in complex surgeries, notably in aging populations, expands demand for hemostatic agents.
• Regulatory Approvals: Expansion of indications and approval in emerging markets enhance sales opportunities.
• Preference for Biological Sealants: Surgeons favor biologic agents over synthetic adhesives due to better biocompatibility.

Market Challenges

• Alternatives: Synthetic sealants and topical hemostats offer competitive options.
• Cost Factors: High costs of biologic sealants limit adoption in price-sensitive markets.
• Regulatory Hurdles: Varying approval standards complicate international expansion.

Competitive Landscape

Major players include Johnson & Johnson (Cathes Elastic Adhesive), Baxter (ARTISS), B.Braun, and CryoLife. Baxter's ARTISS benefits from existing relationships with surgical providers but faces competition from newer, cost-effective options.

Financial Trajectory

Revenue Projections

• In 2022, Baxter reported ARTISS-related sales estimated at approximately USD 80-100 million globally.
• Forecasts indicate a compound annual growth rate (CAGR) of 4-8% over the next five years, driven by increased penetration in acute care settings and emerging markets.

Profitability Considerations

• Gross margins for biologic sealants like ARTISS tend to be high, around 70-75%, reflecting manufacturing costs and market positioning.
• R&D investments in expanding indications and improving formulations could influence profit margins but are necessary for sustained growth.

Investment in Innovation

• Baxter is exploring recombinant versions of fibrin sealants to reduce reliance on human plasma, aiming to reduce costs and improve safety.
• Clinical trials investigating ARTISS in new surgical indications, such as neurosurgery, are ongoing, potentially opening new revenue streams.

Policy and Reimbursement Environment

• Reimbursement policies vary by region; Medicare and private insurers in the U.S. typically reimburse fibrin sealants under specific procedural codes.
• International markets exhibit variable coverage, limiting adoption where reimbursement policies are restrictive.

Future Outlook

The market for ARTISS and similar biologics is positioned for moderate growth. Key factors influencing trajectory include regulatory approvals, pricing strategies, and advancements in biologic manufacturing technology.

Key Takeaways

• ARTISS remains a competitive player in the growing fibrin sealants market, with a revenue trajectory driven by surgical volume increases.
• Market expansion depends on regulatory navigation and cost reduction efforts.
• Technological innovations and new indications could boost long-term demand.
• The product's profitability benefits from high gross margins typical of biologic hemostats.
• Reimbursement policies significantly influence market penetration in different regions.

FAQs

What factors could limit ARTISS's growth? Price sensitivity in emerging markets and competition from synthetic sealants limit expansion.

How does regulatory approval impact ARTISS sales? Approvals in new regions increase market access, especially if existing procedures face reimbursement barriers.

What technological developments could affect ARTISS? Recombinant fibrin sealants that reduce reliance on human plasma could lower costs and improve safety profiles.

Are there new indications for ARTISS? Clinical trials for neurosurgery and vascular procedures are ongoing, which may expand its use.

How does Baxter's market position influence ARTISS’s performance? Baxter's established sales infrastructure supports regional penetration, but innovation pace affects long-term market share.

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References

1. Fortune Business Insights. (2022). Fibrin Sealants Market Size, Share & Industry Analysis, 2022-2028. https://www.fortunebusinessinsights.com/
2. Baxter International. (2023). Annual Report.
3. U.S. Centers for Medicare & Medicaid Services. (2022). Reimbursement for Surgical Hemostatic Agents. https://www.cms.gov