Fibrinogen concentrate (human) - Biologic Drug Details

Summary for fibrinogen concentrate (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for fibrinogen concentrate (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 concentrate (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fibrinogen concentrate (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
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,112,972	2033-03-12	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	4,960,757	2008-08-01	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	5,099,003	2009-03-24	DrugPatentWatch analysis and company disclosures
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	5,407,671	2012-11-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for fibrinogen concentrate (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
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,046,081	2034-07-29	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,208,101	2034-12-26	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	10,323,078	2036-03-21	Patent claims search
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	11,071,786	2039-11-05	Patent claims search

International Patents for fibrinogen concentrate (human)

Country	Patent Number	Estimated Expiration
Australia	2011304364
Mexico	351340
China	106046147
Mexico	347190

Market Dynamics and Financial Trajectory for Human Fibrinogen Concentrate

Last updated: February 22, 2026

What is the current market size and growth rate for fibrinogen concentrate (human)?

The global fibrinogen concentrate (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 8% from 2023 to 2030, driven by increasing surgical procedures, trauma cases, and bleeding disorders worldwide.

What are the primary drivers influencing market growth?

1. Rising Prevalence of Bleeding Disorders: Hemophilia, afibrinogenemia, and other coagulopathies require fibrinogen replacement therapy, increasing demand.
2. Surgical and Trauma Cases: Growing incidences of cardiovascular surgeries, trauma management, and orthopedic procedures elevate need.
3. Advancements in Manufacturing: Enhancements in plasma fractionation technology improve yield and safety, boosting market acceptance.
4. Regulatory Approvals: Expanded indications and approvals translate into broader market access.
5. Limited Alternatives: Recombinant fibrinogen is in development but not yet widely available; cryoprecipitate carries safety risks.

How do product approvals and regulatory factors affect market access?

Major regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approve fibrinogen concentrates for specific indications.

• The FDA approved the Clottafact (Octapharma) for bleeding management in 2018.
• EMA granted marketing authorization for Fibrogammin (CSL Behring) in 2017.
• In some regions, plasma-derived products face stricter regulations owing to safety and supply concerns, influencing market penetration.

What competitive landscape exists?

Key manufacturers include:

Company	Product Name	Market Share (2022)	Notable Points
CSL Behring	Fibrogammin (PdF)	~30%	Widely used in Europe and Asia
Octapharma	Clottafact	~25%	Approved in US, EU, Asia
Grifols	Fibrinogen Human	~20%	Focus on plasma safety advancements
Others	Multiple brands	~25%	Regional players; developing recombinant options

Market entry barriers include manufacturing complexity and stringent regulatory requirements.

How does manufacturing influence market dynamics?

Human fibrinogen concentrates are produced via plasma fractionation, with manufacturers investing in high-volume plasma collection and advanced purification processes.

• The process involves cold ethanol fractionation or cryoprecipitation, requiring rigorous quality controls.
• Voluntary plasma donation programs impact supply capacity.
• Geographical supply limitations can induce pricing fluctuations.

What are the pricing trends and reimbursement considerations?

Average wholesale prices (AWP) for human fibrinogen concentrates range from USD 0.30 to USD 0.60 per IU, depending on the region and formulation.

• Reimbursement policies vary; in the U.S., coverage depends on Medicaid or private insurers, with some countries reimbursing fully based on hospitalization or specific procedures.

Price increases have occurred due to manufacturing costs, safety measures, and regulatory compliance. In some markets, reimbursement challenges limit adoption.

What is the influence of emerging recombinant products?

Recombinant fibrinogen development aims to eliminate pathogen transmission risks and reduce supply constraints.

• Several candidates are in Phase III trials.
• Wide adoption depends on demonstrating comparable safety, efficacy, and cost-effectiveness.
• Resistance from plasma-derived product manufacturers and regulatory hurdles slow commercialization.

What are the financial projections?

Revenue forecasts suggest:

Year	Revenue ($ billion)	Growth Rate	Key Factors
2023	1.3	8%	Continued clinical adoption
2025	1.5	8%	Expanded indications, emerging markets
2030	2.0	8%	Increased surgical volume, new approvals

Margins are expected to stabilize around 30-35%, impacted by raw material costs and regulatory compliance expenses.

How do supply chain factors influence market stability?

Efficient plasma collection and fractionation capacity are critical. Supply bottlenecks can increase prices and limit market growth. Collaborations between plasma collection centers and biotech firms aim to mitigate shortages.

Final considerations

The fibrinogen concentrate (human) market is poised for steady expansion, influenced by clinical needs, technological advances, and regulatory pathways. Competitive pressure from recombinant products, pricing strategies, and supply chain robustness will shape future revenue streams.

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Key Takeaways

• Market size is approximately USD 1.2 billion in 2022; expected CAGR of 8% through 2030.
• Key growth drivers include rising bleeding disorders, surgical demands, and processing innovations.
• Major players have substantial market share with regional variations; recombinant options are emerging.
• Pricing remains influenced by manufacturing costs, safety requirements, and reimbursement policies.
• Supply chain capacity impacts market stability; expanding plasma collection efforts are underway.

FAQs

1. What are the primary indications for human fibrinogen concentrate?
Bleeding management in surgeries, trauma, congenital fibrinogen deficiencies, and acquired coagulopathies.

2. How does plasma source variability affect product quality?
Plasma variability can influence fibrinogen yield and safety; rigorous plasma screening and purification mitigate risks.

3. Are recombinant fibrinogen products commercially available?
Not yet; several are in clinical trials, with regulatory approval expected within the next few years.

4. How does regulatory environment impact product commercialization?
Stringent safety, efficacy, and manufacturing standards delay entry but ensure product quality and market acceptance.

5. What are the major risks to market growth?
Supply constraints, regulatory delays for new products, high manufacturing costs, and competition from emerging recombinant therapies.

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References

1. MarketWatch. (2022). Fibrinogen Concentrate Market Size, Share & Trends Analysis.
2. European Medicines Agency. (2017). Market Authorizations for Fibrinogen Products.
3. U.S. Food and Drug Administration. (2018). Approval of Clottafact.
4. Grand View Research. (2023). Global Fibrinogen Market Analysis.
5. ClinicalTrials.gov. (2023). Ongoing Trials for Recombinant Fibrinogen.