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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Human Fibrinogen Concentrate (HFC)

Last updated: August 5, 2025

Introduction

Human fibrinogen concentrate (HFC) has emerged as a critical therapeutic in the management of bleeding disorders, notably in coagulopathies such as congenital fibrinogen deficiency and acquired fibrinogen deficits experienced during massive trauma, surgery, or obstetric hemorrhages. Its market trajectory reflects evolving clinical practices, regulatory standards, and technological innovations. This analysis delineates current market drivers, competitive landscape, regulatory influences, and future financial projections for HFC within the broader hemostasis and clotting factor therapeutics segment.

Market Overview and Key Drivers

The global fibrinogen concentrate market has experienced substantial growth driven by increasing awareness of bleeding management, advancements in plasma-derived therapies, and the rising prevalence of bleeding disorders.

Burden of Bleeding Disorders

Congenital fibrinogen deficiency, though rare—estimated at approximately 1–2 per million population—is diagnosed earlier due to advances in diagnostic techniques. Acquired deficiencies are more common, especially in trauma and surgical settings. The rising incidence of these conditions due to an aging population and increased surgical interventions propels demand for effective hemostatic agents like HFC [1].

Clinical Efficacy and Safety Profile

HFC’s advantages—rapid onset of action, standardized dosing, and lower risk of pathogen transmission compared to cryoprecipitate—are critical factors influencing its adoption. Regulatory approval journeys, such as the FDA’s approval of Fibryga by CSL Behring (2018) and FIBRYGA in the EU, bolster clinician confidence and expand market acceptance [2].

Regulatory Landscape

Regulatory endorsement shapes market potential significantly. The pathway for plasma-derived fibrinogen concentrates includes rigorous safety and efficacy standards to mitigate transmission risks. Increasingly, authorities favor pathogen-reduction technologies that improve product safety, further driving innovation and market growth.

Technological Innovations

Advances in manufacturing processes, such as lyophilization for improved stability and ease of use, are broadening application scope, especially in emergency care and military medicine. Customization of dosing regimens based on patient-specific needs enhances therapeutic outcomes and fosters market expansion.

Reimbursement and Market Accessibility

Reimbursement policies critically influence adoption. Favorable health insurance coverage, especially in developed markets, supports commercialization efforts. However, high cost and limited healthcare budgets in emerging economies pose market access challenges.

Competitive Landscape

The human fibrinogen concentrate market includes key players such as CSL Behring, grifols, and Kedrion, each investing in R&D to enhance product efficacy and safety.

Product Differentiation

• CSL Behring’s Fibryga® and FIBRYGA®: Marked by extensive safety profiles and pathogen reduction technology.
• Grifols: Developing next-generation formulations with improved pharmacokinetics.
• Kedrion: Engaging in collaborations to expand geographic reach.

The emergence of biosimilar products and generics, pending regulatory approvals, adds competitive pressure but also expands market options and affordability.

Market Challenges

• Price Sensitivity: The high cost of plasma-derived therapies limits uptake in resource-constrained regions.
• Limited Patient Pool: Rarity of congenital fibrinogen deficiency translates into limited demand, necessitating targeted marketing strategies.
• Supply Chain Complexity: Plasma collection and processing entail logistical challenges, affecting product availability and pricing.

Financial Projections

Based on current trends, the global fibrinogen concentrate market was valued at approximately $250 million in 2022 and is projected to reach $400–$450 million by 2030, with a compounded annual growth rate (CAGR) of ~6–8% over the forecast period [3].

Regional Growth Dynamics

• North America: Dominates due to technological infrastructure, regulatory support, and high awareness.
• Europe: Steady growth, with expanding markets in Germany, France, and the UK, supported by robust healthcare systems.
• Asia-Pacific: Exhibits the highest CAGR, driven by rising surgical volumes, improving healthcare infrastructure, and increasing recognition of bleeding disorders.

Key Revenue Streams

• Hospital-based administration remains the primary revenue channel.
• Emergency use and trauma hospitals present significant growth opportunities owing to product portability and rapid action.
• Military and disaster preparedness programs increasingly adopt fibrinogen concentrates, diversifying revenue sources.

Pricing Trends

Market prices for HFC currently range from $10–$30 per unit, influenced by manufacturing costs, regulatory compliance, and regional pricing policies. The push toward biosimilars may lead to price reductions, expanding access but potentially impacting revenues for innovative manufacturers.

Future Outlook

Emerging therapies, including recombinant fibrinogen products and gene therapies, may eventually contest the market, but currently, plasma-derived HFC remains the standard of care. Continuous improvements in manufacturing and supply chain logistics, coupled with expanding indications and indications, sustain a positive financial trajectory.

Enhanced global health initiatives, strategic partnerships, and innovations in plasma fractionation are expected to propel revenues. The increasing recognition of fibrinogen’s role in managing coagulopathies supports sustained market growth through 2030.

Key Takeaways

• The global human fibrinogen concentrate market is experiencing steady growth, projected to reach nearly $450 million by 2030.
• Key drivers include rising bleeding disorder management needs, regulatory approvals, and technological enhancements presenting opportunities for market expansion.
• Regional markets differ significantly, with North America leading, Europe maintaining steady growth, and Asia-Pacific offering high CAGR potential.
• Cost and supply chain complexities pose challenges; strategic partnerships and technological innovations can mitigate these.
• The entry of biosimilars and novel therapies will influence long-term market competitive dynamics and pricing strategies.

FAQs

1. What are the primary clinical applications of human fibrinogen concentrate?
HFC is primarily used for the treatment and prevention of bleeding episodes in patients with congenital fibrinogen deficiency, acquired fibrinogen deficits during surgeries or trauma, and obstetric hemorrhages.

2. How does regulatory approval impact the market for human fibrinogen concentrate?
Regulatory approvals from agencies like the FDA and EMA enhance product credibility, facilitate reimbursement, and expand geographic access, significantly influencing market growth.

3. What manufacturing advancements are influencing the human fibrinogen concentrate market?
Innovations such as pathogen reduction technologies, lyophilization, and purification processes improve safety, stability, and ease of administration, expanding the market’s scope.

4. Which regions are expected to experience the highest growth in the fibrinogen concentrate market?
Asia-Pacific is projected to have the highest CAGR, driven by increasing healthcare infrastructure, rising surgical procedures, and growing awareness of bleeding disorders.

5. How will biosimilars affect the future of the human fibrinogen concentrate market?
Biosimilar entrants could reduce prices and improve access, challenging traditional manufacturers’ market share but also fostering innovation and cost-effective alternatives.

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Sources

[1] Global Hemostasis & Coagulation market analysis, MarketsandMarkets, 2022.
[2] CSL Behring – Product approval announcements, Official Regulatory Agencies, 2018.
[3] Fibrinogen Concentrate Market Forecasts, Research and Markets, 2022.