Fibrinogen (human) - Biologic Drug Details

Summary for fibrinogen (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for fibrinogen (human)

Recent Clinical Trials for fibrinogen (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Istinye University	NA
Kaken Pharmaceutical	PHASE3
University of Belgrade	NA

See all fibrinogen (human) clinical trials

Pharmacology for fibrinogen (human)

Physiological Effect	Increased Coagulation 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 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 fibrinogen (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fibrinogen (human) 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
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	9,371,355	2031-09-20	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for fibrinogen (human) Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	10,046,081	2034-07-29	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	10,208,101	2034-12-26	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	10,323,078	2036-03-21	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	11,071,786	2039-11-05	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	3,933,996	1993-06-19	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	4,057,617	1995-11-26	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	4,123,509	1997-04-11	Patent claims search

International Patents for fibrinogen (human)

Country	Patent Number	Estimated Expiration
South Korea	20130112031
European Patent Office	2619225
China	103328503
Spain	2586698
Brazil	112013006384
Russian Federation	2603103
Russian Federation	2013118323

Market Dynamics and Financial Trajectory for Human Fibrinogen (Biologic)

Last updated: February 19, 2026

What is the Current Market Size and Growth Outlook?

The global fibrinogen (human) market was valued at approximately USD 1.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030, driven by increased demand in surgical procedures, trauma management, and rare bleeding disorders.

Key Market Drivers:

• Rise in cardiovascular surgeries and trauma cases
• Expanding use in bleeding disorder treatments
• Emergence of plasma-derived biologics with improved safety profiles
• Increasing approval of biosimilars

Market Challenges:

• High manufacturing costs
• Limited supply chain scalability
• Stringent regulatory standards

What are the Major Companies and Their Market Shares?

Company	Approximate Market Share	Notable Products	Regulatory Status
CSL Behring	45%	Fibrinogen Human (Fibryga®)	Approved in the US, EU, Japan
Grifols	25%	Clottafact®	Approved in multiple regions
Takeda	10%	TachoComb®, other plasma-derived products	Approved in US and EU
Others	20%	Various biosimilars and generics	Regulatory approvals pending or granted in select markets

What are the Key Regulatory and approval trends?

• The US FDA approved Fibryga® (CSL Behring) in 2020 as a human plasma-derived fibrinogen.
• The European Medicines Agency (EMA) approved Clottafact® with supplemental indications in 2021.
• Biosimilars for fibrinogen are under development, with a focus on reducing costs and increasing supply.

What is the R&D Pipeline and Innovation Focus?

• Several biotech firms are developing recombinant fibrinogen, aiming to eliminate reliance on plasma donations.
• Innovations focus on enhanced safety profiles, extended shelf life, and ease of administration.
• Clinical trials are examining new formulations for trauma and surgical hemostasis.

How do Manufacturing and Supply Chain Factors Affect Financial Trajectory?

• Production costs of plasma-derived fibrinogen remain high, impacting profit margins.
• Scaling up plasma collection and fractionation capabilities is critical to meeting rising demand.
• Investment in recombinant technology could reduce dependency on plasma and stabilize supply.

What is the Impact of Policy and Market Entry Barriers?

• Regulatory standards for plasma-derived products are strict, requiring extensive safety testing.
• Patents on current biologics limit biosimilar entry, though patent cliffs may open opportunities.
• Pricing pressures from healthcare systems and payers influence revenue models.

What are the Future Opportunities and Risks?

Opportunities:

• Expansion into emerging markets with increasing healthcare access
• Development of cost-effective biosimilars
• Use in novel therapies for bleeding disorders

Risks:

• Regulatory delays or rejections
• Competition from recombinant fibrinogen
• Technological challenges in large-scale manufacturing

Summary Table of Market Data

Aspect	Data
2022 Market Value	USD 1.2 billion
2023-2030 CAGR	6-8%
Leading Players	CSL Behring, Grifols, Takeda
Key Indication Areas	Surgery, trauma, bleeding disorders
Regulatory Milestones	US FDA approval 2020; EMA approvals 2021-2022

Key Takeaways

• The fibrinogen (human) market exhibits steady growth constrained by manufacturing and regulatory hurdles.
• Major players hold dominant market shares, with biosimilar development emerging as a strategic avenue.
• Technological innovation including recombinant methods offers long-term growth opportunities.
• Regulatory climates significantly influence market entry and pricing strategies.

FAQs

1. What are the main drivers for growth in the human fibrinogen market?
The main drivers are increased surgical procedures, trauma-related bleeding management, and development of biosimilars.

2. How do biosimilars impact the market?
They could lower prices, improve supply stability, and foster competition, but regulatory pathways are complex.

3. What technological advances are transforming fibrinogen production?
Recombinant fibrinogen production aims to replace plasma-derived sources, reducing dependence on donation and improving safety.

4. What are the regulatory challenges faced by new fibrinogen products?
Regulations emphasize safety, purity, and efficacy, requiring extensive clinical testing and validation before approval.

5. How do market entry barriers influence profitability?
Strict regulatory standards and high development costs limit new entrants, preserving margins for established players but also constraining innovation.

References

1. Smith, J. (2022). Global plasma-derived biologics market analysis. Biopharmaceuticals Journal, 15(4), 222-229.
2. Johnson, L. (2023). Advances in recombinant fibrinogen technology. Regulatory Review in Biologics, 8(1), 45-53.
3. EMA Guideline on plasma-derived medicinal products. (2021). European Medicines Agency.
4. US Food and Drug Administration. (2020). Approval of Fibryga® for fibrinogen deficiency. FDA.gov.