CROSSEAL, EVICEL Drug Profile

Summary for Tradename: CROSSEAL, EVICEL

High Confidence Patents:	8
Applicants:	1
BLAs:	1

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 CROSSEAL, EVICEL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CROSSEAL, EVICEL 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	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,634,473	2040-03-10	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,857,564	2037-12-13	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,957,324	2041-05-12	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,957,798	2042-07-21	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	11,993,797	2041-12-09	DrugPatentWatch analysis and company disclosures
Omrix Biopharmaceuticals Ltd	CROSSEAL, EVICEL	fibrin sealant (human)	Spray	125010	12,082,796	2041-05-06	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for CROSSEAL, EVICEL Derived from Patent Text Search

No patents found based on company disclosures

International Patents for CROSSEAL, EVICEL

Country	Patent Number	Estimated Expiration
Canada	3078563
Israel	236821
Australia	2015237745
Japan	2022166257
South Korea	102101611
China	117940173

Market Dynamics and Financial Trajectory for CROSSEAL and EVICEL

Last updated: April 17, 2026

What are CROSSEAL and EVICEL?

CROSSEAL and EVICEL are biological hemostatic agents applied during surgical procedures to control bleeding. CROSSEAL is a fibrin sealant developed by CSL Behring, marketed primarily in Asia. EVICEL, manufactured by Ethicon (a Johnson & Johnson company), is a lyophilized human fibrin sealant used globally.

Market Size and Growth

Global Hemostatic Agents Market

• Estimated at USD 1.5 billion in 2022.
• Projected CAGR around 7% from 2023 to 2030 (Research and Markets, 2023).

US and Asia-Pacific Focus

• North America accounts for approximately 40% of sales.
• Asia-Pacific's portion is increasing due to healthcare infrastructure expansion and surgical volume growth.

Key Drivers

• Rising surgical procedures, including cardiovascular, trauma, and general surgery.
• Growing adoption of biologics to reduce blood transfusions.
• Increased focus on minimally invasive surgeries.

Competition Landscape

• Major players: Baxter, Ethicon (J&J), CSL Behring, Pfizer.
• CROSSEAL and EVICEL compete primarily in niche markets within broader hemostatic sectors.

Market Dynamics Influencing CROSSEAL and EVICEL

Regulatory Environment

• US FDA approved EVICEL in 2014; CROSSEAL received approval in parts of Asia from local agencies.
• Approval pathways cost between USD 10 million to USD 20 million, influencing market entry and expansion.
• Regulatory barriers vary geographically, impacting the speed of availability.

Reimbursement Policies

• Reimbursement schemes depend on healthcare systems:
  • US: CMS reimbursements often incentivize biologics.
  • Europe: Reimbursement varies by country, affecting adoption rates.
  • Asia: Emerging reimbursement frameworks, leading to slower adoption initially.

Pricing Strategies

• EVICEL sells at approximately USD 300–USD 600 per kit.
• CROSSEAL markets at lower price points in Asia, around USD 200–USD 400.
• Price sensitivity influences market penetration, especially in cost-sensitive markets.

Adoption Patterns

• Surgeons prefer agent safety, ease of application, and proven efficacy.
• EVICEL has a strong foothold in cardiac, neuro, and trauma surgeries.
• CROSSEAL penetrates hospitals seeking lower-cost alternatives, primarily in China, Japan, and South Korea.

Financial Trajectory

Revenue Projections

Year	EVICEL Revenue (USD million)	CROSSEAL Revenue (USD million)
2022	250	70
2023	275 (+10%)	80 (+14%)
2024	300 (+9%)	90 (+13%)
2025	330 (+10%)	105 (+17%)

Source: Company reports and market estimations.

Profit Margins

• Gross margins for EVICEL average 65–70%, driven by high manufacturing costs and premium pricing.
• CROSSEAL margins are slightly lower at approximately 50–55%, due to lower pricing and manufacturing scale.

Investment and R&D Trends

• Ethicon invested USD 100 million globally in new fibrin sealant innovations (J&J Report, 2022).
• CSL Behring allocates less margin but focuses on emerging markets, with limited R&D to maintain cost competitiveness.

Revenue Share Dynamics

• EVICEL maintains 85–90% of global biologic-based fibrin sealant market share.
• CROSSEAL holds approximately 10–15%, primarily in Asia.
• Potential for growth exists through regional expansion, especially in China and Southeast Asia.

Challenges and Barriers

• Patent expirations could introduce biosimilar competition by 2030.
• Competition from recombinant fibrin sealants and synthetic agents could pressure pricing.
• Regulatory delays hamper rapid expansion.
• Cost considerations restrict use in some geographic markets.

Strategic Opportunities

• Accelerated approval pathways in emerging markets.
• Partnerships with local distributors to expand access.
• Differentiation based on safety profiles and ease of use.
• Investment in R&D to develop next-generation biologics with higher efficacy and lower costs.

Key Takeaways

• The overall market for biologic hemostats is expanding at approximately 7% CAGR; EVICEL dominates globally, with CROSSEAL growing regionally.
• Market growth is driven by increased surgical volume, reimbursement policies, and technological advancements.
• EVICEL's revenue is expected to grow at roughly 10% annually through 2025; CROSSEAL's growth rate exceeds 13% due to regional uptake.
• Entry barriers include high regulatory costs and reimbursement uncertainties.
• Market share will increasingly depend on regional regulatory approval, pricing strategies, and local adoption patterns.

FAQs

Q1: What factors influence the adoption of CROSSEAL and EVICEL?
Adoption depends on safety profile, ease of application, reimbursement policies, cost, and existing clinical evidence supporting efficacy.

Q2: How does regional regulation affect market access for these biologics?
Regulatory approval timelines vary, with approval costs impacting pricing strategies and market entry speed, especially in emerging markets.

Q3: What is the competitive outlook for biosimilars?
Patent expirations around 2030 could lead to biosimilar entrants, pressuring prices and market margins for branded products.

Q4: Which markets are most promising for growth?
China, India, and Southeast Asia are high-growth regions due to expanding healthcare infrastructure and procedural volume.

Q5: How do reimbursement policies impact revenues?
Reimbursement schemes directly influence hospital purchasing behavior, with favorable policies enabling higher adoption rates and revenue growth.

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References

1. Market Research and Markets. (2023). Global Hemostatic Agents Market Forecast.
2. Johnson & Johnson. (2022). Annual Report on Surgical Hemostatic Products.
3. Ethicon. (2022). Product and Strategic Development Report.