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
Cambium Bio Limited	PHASE3
Imam Abdulrahman Bin Faisal University	PHASE3

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		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		2034-07-29	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		2034-12-26	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		2036-03-21	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		2039-11-05	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		1993-06-19	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		1995-11-26	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612		1997-04-11	Patent claims search

International Patents for fibrinogen (human)

Country	Patent Number	Estimated Expiration
China	106046147
China	103328503
European Patent Office	2619225
Canada	2809471
Brazil	112013006384
Russian Federation	2013118323
Mexico	347190

Market Dynamics and Financial Trajectory for the Biologic Drug: Fibrinogen (Human)

Last updated: July 29, 2025

Introduction

Fibrinogen (human), a vital plasma glycoprotein involved in coagulation, has garnered significant attention in the pharmaceutical and medical sectors due to its therapeutic applications in bleeding disorders, trauma, and surgical procedures. As a biologic, it offers targeted treatment options that standard therapies often cannot match. The evolving landscape of coagulation management, combined with advancements in biologic production technologies, shapes its market dynamics and financial prospects.

Overview of Fibrinogen (Human): Therapeutic Indications and Market Relevance

Fibrinogen (human) plays a central role in hemostasis, acting as a precursor for fibrin clot formation. It is primarily indicated for:

• Congenital Fibrinogen Deficiency: Rare hereditary disorders, such as afibrinogenemia and hypofibrinogenemia.
• Acquired Deficiencies: Due to trauma, surgical hemorrhage, disseminated intravascular coagulation (DIC), or liver failure.
• Bleeding Management: Especially in patients unresponsive to traditional blood transfusions.
• Potential Use in Trauma and Surgical Settings: As an adjunct to control bleeding in high-risk procedures.

The increasing prevalence of bleeding disorders and trauma cases worldwide, especially in aging populations, sustains a steady demand for fibrinogen therapies.

Market Dynamics

1. Growth Drivers

• Rising Incidence of Bleeding Disorders: Congenital fibrinogen deficiency is rare; however, acquired deficiencies are more prevalent, fueled by trauma, surgeries, and liver diseases ([2]). The global burden of traumatic injuries is rising, especially in low- and middle-income countries (LMICs), increasing demand.
• Advances in Biologic Manufacturing: Innovations in plasma-derived and recombinant production techniques reduce immunogenicity and enhance safety, boosting clinician confidence and market adoption.
• Regulatory Approvals and Reimbursement Policies: Streamlining approval pathways and coverage for fibrinogen products encourage development and commercialization.
• Growing Awareness and Diagnostics: Improved diagnostic tools allow early detection of fibrinogen deficiencies, leading to timely treatment interventions.

2. Challenges and Constraints

• Limited Patient Pool: The rarity of congenital fibrinogen deficiency restricts large-scale commercialization efforts.
• High Cost of Biologics: Elevated manufacturing costs translate into premium pricing, which may limit accessibility in certain regions.
• Risks of Pathogen Transmission: Despite rigorous screening, concerns persist about plasma-derived products transmitting infections, though recombinant options mitigate this.
• Competition and Market Fragmentation: Multiple manufacturers with different formulations (plasma-derived vs. recombinant) operate in a fragmented landscape, affecting pricing and market share dynamics.

3. Competitive Landscape

The market features several mature players predominantly offering plasma-derived fibrinogen concentrates, including CSL Behring, Grifols, and BPL ([3]). Innovators are increasingly investing in recombinant fibrinogen, which offers advantages in safety and supply consistency. Notable developments include:

• Recombinant Fibrinogen: Clinical trial programs are advancing, promising a pathogen-free alternative.
• Biosimilar Development: As patents expire, biosimilars may enter the market, intensifying price competition.

Financial Trajectory

1. Revenue Forecasts

The global fibrinogen (human) market was valued at approximately USD 300-350 million in 2022, with projections estimating a compound annual growth rate (CAGR) of 4-6% through 2030 ([4]). Factors influencing this trajectory include:

• Market Penetration: Adoption of recombinant products could disrupt traditional plasma-based products, potentially leading to higher margins due to improved safety profiles.
• New Indications and Off-Label Uses: Expanding clinical applications may unlock additional revenue streams.
• Geographic Expansion: Emerging markets, especially in Asia-Pacific, are witnessing increased healthcare investments, contributing to market growth.

2. Investment and R&D Outlook

Investment in R&D is pivotal, especially for recombinant fibrinogen. Major pharmaceutical companies are channeling funds into:

• Clinical trials for recombinant formulations.
• Manufacturing process improvements.
• Post-market surveillance and safety enhancements.

These investments underpin future revenue streams and market competitiveness.

3. Pricing and Reimbursement Dynamics

Pricing remains a critical factor, with plasma-derived products priced at premium levels due to production costs and limited competition. Reimbursement policies vary globally but generally favor high-cost biologics in developed markets. Pricing strategies, coupled with healthcare system policies, influence sales volume and profitability.

Regulatory and Market Entry Considerations

Regulatory pathways, such as the U.S. FDA’s biologics license application (BLA) and the European EMA’s centralized procedures, dictate market access timelines and compliance costs. Market entry for recombinant fibrinogen faces regulatory scrutiny but offers competitive advantages once approved.

Future Outlook and Market Opportunities

• Technological Innovation: Advancements in bioprocessing will further reduce costs and improve supply stability.
• Personalized Medicine: Tailoring dosing based on patient-specific factors may optimize outcomes.
• Digital Healthcare Integration: Data-driven approaches can enhance patient monitoring and adherence, broadening application scope.

Key Market Drivers Summary

Driver	Impact
Rising trauma and bleeding cases	Enhances demand for fibrinogen products
Technological advancements	Improve safety, reduce costs, expand use
Regulatory support	Streamlines approval, accelerates market entry
Global healthcare expenditure growth	Expands access in emerging markets

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Key Takeaways

• The fibrinogen (human) market is shaped by an aging population, increasing trauma, and surgical procedures, fueling steady growth.
• Technological innovations, particularly recombinant products, offer significant potential to transform market dynamics through improved safety and supply reasons.
• High production costs and regulatory challenges limit market expansion but are balanced by increasing healthcare investments and supportive policies.
• Future revenue streams depend heavily on clinical trial success, regulatory approvals, and strategic pricing.
• Market fragmentation creates both challenges and opportunities for entrants and incumbents alike, emphasizing the importance of R&D investments and geographic expansion.

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FAQs

1. What factors are influencing the demand for human fibrinogen biologics?
Demand is driven by rising trauma incidence, surgical procedures, and coagulation disorder diagnoses, especially as populations age and healthcare access improves globally.

2. How are recombinant fibrinogen products changing the market landscape?
Recombinant fibrinogen offers pathogen-free, consistent supply benefits, potentially replacing plasma-derived versions and prompting manufacturers to innovate, though regulatory approval remains a hurdle.

3. What are the main challenges faced by fibrinogen manufacturers?
Limited patient populations, high production costs, regulatory complexities, and competition from biosimilars constrain profitability and market growth.

4. How do pricing and reimbursement policies impact fibrinogen market dynamics?
Premium pricing in developed markets is justified by manufacturing costs and safety advantages, but reimbursement decisions influence accessibility and sales volume.

5. What is the future outlook for investments in fibrinogen R&D?
Investments are expected to focus on recombinant development, safety enhancement, and expanding indications, positioning companies for growth amidst technological and regulatory shifts.

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References

[1] Market Research Future, 2022 report on plasma-derived coagulation products.
[2] World Health Organization, Data on bleeding disorders prevalence.
[3] GlobalData, 2022 competitive landscape analysis for fibrinogen products.
[4] Mordor Intelligence, 2023 market forecast for coagulation factor therapies.