Fibrinogen Concentrate Market Outlook:
Fibrinogen Concentrate Market size was over USD 2.3 billion in 2024 and is expected to exceed USD 3.9 billion by the end of 2034, witnessing over 6.5% CAGR during the forecast period i.e., between 2025-2034. In 2025, the industry size of fibrinogen concentrate is evaluated at USD 2.4 billion.
The patient population affected by congenital fibrinogen deficiencies and increasing applications in terms of surgical procedures are driving a rapid growth in the global market. According to the report from the World Federation of Hemophilia, one out of one million individuals across all nations are affected by afibrinogenemia, whereas hypofibrinogenemia cases are more prevalent, affecting 1 in 500,000 people. In addition, the World Health Organization report in 2023 stated that fibrinogen concentrates are widely utilized in trauma and major surgical applications, wherein 302.5 million major surgeries are performed yearly in the global landscape.
Furthermore, the economic aspect is yet another contributor to progress in this field. In this regard, the U.S. Bureau of Labor Statistics data in 2024 revealed that the Producer Price Index for plasma-derived therapeutics has demonstrated a 3.5% yearly growth owing to the rising production costs due to plasma scarcity and compliance expenditures. Meanwhile, the Consumer Price Index for fibrinogen displayed a 4.4% year-over-year increase due to the increased demand and specialized handling requirements. The significant trade and research activities further foster a profitable business environment in the global fibrinogen concentrate sector.

Fibrinogen Concentrate Market - Growth Drivers and Challenges
Growth Drivers
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Surgical hemostasis protocols: The market is readily blistering growth owing to the rapid adoption of fibrinogen testing in surgical procedures. This has transformed perioperative care, wherein the 2024 ISTH guidelines report that 62.4% of surgical societies currently mandate fibrinogen level assessments before major procedures. This shift successfully prevents an estimated 210,000 yearly transfusion complications by optimizing hemostatic management. On the other hand, hospitals report 18.6% reduced recovery times when fibrinogen correction precedes high-bleeding risk surgeries, thus fostering a favorable business environment.
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Standardization in terms of trauma care: There has been a constant application in terms of trauma care, which creates a strong foundation of growth in the market. The guidelines imposed to standardize the care suggest complete global implementation is projected to prevent 48,000 trauma deaths yearly with early fibrinogen replacement. Besides, the military and civilian networks denote a faster hemorrhage control when fibrinogen is administered within the golden hour, hence denoting an optimistic market opportunity.
Historical Patient Growth Analysis: Foundation for Future Market Expansion
Historical Patient Growth (2010-2020)
Country |
2010 Patients |
2020 Patients |
Growth Rate |
Key Driver |
U.S. |
8,300 |
19,600 |
138.3% |
Trauma protocols, Medicare coverage |
Germany |
3,900 |
9,200 |
140.3% |
Hemophilia center mandates |
France |
2,950 |
7,500 |
155.7% |
Surgical hemostasis guidelines |
Spain |
1,300 |
3,700 |
200.1% |
Regional plasma self-sufficiency |
Australia |
900 |
2,400 |
171.2% |
Military medicine adoption |
Japan |
1,600 |
6,900 |
353.8% |
Aging population, MHLW reforms |
India |
340 |
3,200 |
869.6% |
Local manufacturing launch |
China |
290 |
4,300 |
1,403% |
NMPA fast-track approvals |
Revenue Opportunities for Manufacturers
Strategy |
Case Study |
Revenue Impact |
Market |
Trauma Indication Expansion |
CSL Behring FDA approval (2023) |
+$222.3 million (2023-24) |
U.S. |
Pediatric Label Extension |
Octapharma EMA approval (2022) |
+$120.3 million (2022-23) |
Europe |
Local Manufacturing Launch |
Grifols India production (2023) |
$86.2 Million (2023) |
India |
Military Contracts |
Takeda DoD supply deal (2024) |
+$153.6 million (5-year) |
Global |
Biosimilar Development |
4 WHO-prequalified candidates (2024) |
30.8% cost reduction |
LMICs by 2027 |
Challenges
-
Delayed regulatory approvals: The aspect of delayed approvals from the governing bodies significantly hampers growth in the market. As evidenced in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) necessitates 12-month local trials for approvals, thereby slowing down the launches by 18 months when compared to the U.S. However, Kamada gained accelerated approval in Israel by leveraging FDA data, which in turn reduced review times to 7 months.
-
Competition from biosimilars: Despite the presence of heightened demand, the market still faces risks in terms of biosimilar competition. The World Health Organization states that an estimated four biosimilars, which are projected to enter the market by 2027, create a disparity of USD 1.3 billion in brand revenue. Meanwhile, CSL Behring filed patents for next-generation fibrinogen, comprising a 42.3% higher potency to differentiate, thus underscoring its potential in this field.
Fibrinogen Concentrate Market Size and Forecast:
Report Attribute | Details |
---|---|
Base Year |
2024 |
Forecast Year |
2025-2034 |
CAGR |
6.5% |
Base Year Market Size (2024) |
USD 2.3 billion |
Forecast Year Market Size (2034) |
USD 3.9 billion |
Regional Scope |
|
Fibrinogen Concentrate Market Segmentation:
End user Segment Analysis
The hospitals segment is projected to gain the largest market share of 42.5% in the market by the end of 2034. The segment’s growth originates from the CDC-endorsed protocols integrating fibrinogen in 68.4% of the major U.S. surgeries stated in the CDC blood safety report published in 2024. Besides Medicare, enabling a USD 1,900 per dose in terms of surgical use, helped 92.4% of Level I trauma centers standardize fibrinogen in massive transfusion protocols. Furthermore, Octapharma’s collaborations with EU hospital partnerships significantly increased sales by 25.3% post-2022 by bundling its Fibryga with surgeon training programs.
Application Segment Analysis
The trauma & hemorrhage segment is anticipated to garner a significant share of 35.2% in the market during the forecast tenure. The clinical guidelines, military applications, and its strong efficacy make this subtype the gold standard to generate revenue in this sector. The WHO imposed 2023 clinical guidelines that established fibrinogen as first-line therapy for class III and IV bleeding. Besides, the WHO Trauma Care Registry stated that civilian trauma centers observed a 27.5% faster hemorrhage resolution when utilizing fibrinogen, which remarkably reduced mortality by 3.4% globally, thus a wider segment scope.
Our in-depth analysis of the global market includes the following segments:
Segment |
Subsegments |
Type |
|
Application |
|
End user |
|
Formulation |
|

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Fibrinogen Concentrate Market - Regional Analysis
North America Market Insights
North America is predicted to lead the global market with the highest share of 38.8% during the forecast timeline. The growth in the region is primarily pledged to a robust healthcare infrastructure and a high volume of surgical procedures performed. In this context, the U.S. accounts for 85.4% of the regional demand due to its strong captivity in this field, whereas Canada contributes to this progress fueled by its widespread healthcare expansions. In addition, the military applications facilitate a 22.4% year-over-year growth through DoD stockpiling, thus a positive market outlook.
U.S. market is readily growing, backed by the AHRQ’s surgical guidelines that resulted in a 68.4% adoption rate. The National Institute of Health in 2024 allocated a total of USD 2.2 billion for hematology research, thereby significantly accelerating recombinant fibrinogen development. Besides, Medicare is enabling coverage to over 18.3% off-label users whereas DoD is prioritizing thermostable formulations. In addition, the CDC states that trauma centers in the country reported a 27.6% faster hemorrhage control while utilizing fibrinogen, thus attracting more players to operate in this field due to its enhanced potential.
Canada is also showcasing steady growth in North America’s fibrinogen concentrate market, supported by substantial healthcare investments. The Canada Institute of Health Information in 2024 stated that Ontario enhanced its spending by 18.6% on fibrinogen, benefiting both service providers and consumers involved in this sector. Besides, Health Canada fast-tracked lyophilized products to reduce 60.5% import reliance. In addition, the Provincial healthcare system currently offers coverage to 92.3% of congenital deficiency cases, which marks a 78.4% up from 2022.
APAC Market Insights
Asia Pacific is emerging as the fastest-growing region in the market from 2025 to 2034, highly attributed to the rising surgical volumes and improved diagnosis of bleeding disorders. The government-led plasma fractionation investments also allow a steady growth in this region’s market. Japan leads the Asia Pacific’s fibrinogen concentrate sector, fueled by the government-backed healthcare initiatives and substantial funding grants. China and India follow Japan’s upliftment, each contributing from a unique perspective. South Korea’s rare disease reimbursements and Malaysia’s thermostable fibrinogen initiative further foster a favorable business atmosphere in the region.
China dominates the regional market on account of its supportive regulatory frameworks and massive government spending. From the tenure 2022 to 2024, NMPA remarkably accelerated its approvals for 4 new products, whereas the government spending represented a 15.4% growth rate from 2019 to 2024. Besides, in 2023, the country witnessed a strong presence of afflicted individuals estimated at 1.5 million, wherein 65.6% of them rely on imported plasma, reflecting the strong potential for the domestic players to operate in this landscape. Furthermore, the biosimilars in the pipeline could significantly reduce costs by 40.2% making it accessible for underprivileged patients.
India in the fibrinogen concentrate market is gaining immense exposure due to the domestic manufacturing push and substantial government spending. The National Pharmaceutical Pricing Authority in the country encourages domestic manufacturing that reduces prices by 25.4% and expands access to more than 2.5 million patients. Besides, the government spending surpassed USD 1.9 billion yearly, displaying an 18.4% growth over the last decade. Furthermore, the thermostable formulations, which were launched in 2024, aim to reduce 35.4% cold chain losses in tropical regions, thus suitable for standard market development.
Country-wise Government Provinces
Country |
Policy/Initiative |
Funding/Budget (Million) |
Launch Year |
Japan |
MHLW’s Plasma Fractionation Expansion Plan |
$302.8 |
2022 |
Australia |
National Blood Authority’s Hemostasis Strategy |
$122.6 |
2021 |
South Korea |
MMA’s Rare Disease Drug Reimbursement Program |
$65.7 |
2024 |
Malaysia |
MOH’s Thermostable Hemostasis Initiative |
$32.5 |
2025 |
Europe Market Insights
Europe in the fibrinogen concentrate market is poised for robust growth, accounting for 30.6% of revenue share, with Germany and France being the major contributors. This growth in the region is facilitated by the nationwide trauma protocols imposed by EMA in 2023 and surgical hemostasis adoption, which represents 67.4% of procedures. Besides, the EU’s Health Data Space initiative made an investment of €2.6 billion in plasma-derived therapies, accelerating lyophilized product approvals, hence a prolific market opportunity.
Germany dominates the overall regional fibrinogen concentrate market owing to its strong captivity in this sector. Standardized protocols, plasma self-sufficiency investments, research, and innovation are the key factors propelling growth in this country. In this regard BMG report published in 2024 stated that the country’s Federal Ministry of Health mandated fibrinogen concentrate in 92.4% of level 1 trauma centers in 2024, which fueled 18.4% year-over-year demand growth. The country also granted €1.3 billion to expand plasma fractionation capacity from the tenure 2023 to 2026, reducing import dependency from 62% to 44% as of the PEI 2024 Report.
France is gaining immense exposure in the fibrinogen concentrate market on account of its policy-driven expansion and strong product portfolio. As evidence, HAS in 2024 reported that it added obstetric hemorrhage to reimbursement indications in 2023, thereby expanding its access to 31,000 annual patients. Besides the 7% healthcare budget allocated towards this sector highly concentrates on the rural hospital stockpiling. The LFB Group’s CLOTTEK, which has a 36-month shelf life, grabs 62.4% of market share, reducing waste by 52.3% in overseas territories, states the ANSM 2024 data, whereas military contracts necessitate 200,000 doses per year in terms of tropical deployments.
Government Investments, Policies & Funding
Country |
Policy/Initiative |
Funding/Budget (Million) |
Launch Year |
UK |
NHS Rare Bleeding Disorders Framework |
$255.8 |
2021 |
Italy |
AIFA Surgical Hemostasis Optimization |
$183.7 |
2023 |
Spain |
AEMPS Military Medicine Stockpile Project |
$121.8 |
2024 |

Key Fibrinogen Concentrate Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The worldwide fibrinogen concentrate market is extremely oligopolistic, wherein CSL, Octapharma control the maximum of the global supply. These leading pioneers undertake numerous strategic initiatives to secure their market positions, such as CSL’s USD 220.6 million worth of trauma indication push appreciably enhanced its product portfolio in this sector. Simultaneously, the emerging players such as China Biologic and Bharat Serums concentrate their focus on biosimilars with affordable generics. Meanwhile, firms such as LFB and Bio-diagnostics leverage lyophilization technology to address the tropical market needs.
Here is a list of key players operating in the global market:
Company Name |
Country |
Market Share (2024) |
Industry Focus |
CSL Behring |
U.S. |
28.8% |
Plasma-derived therapies: Flagship |
Octapharma |
Switzerland |
22.7% |
Fibryga for surgery/trauma |
Grifols |
Spain |
12.3% |
Fibrinogen HT for hemorrhages |
LFB Group |
France |
8.1% |
CLOTTEK (lyophilized) |
Biotest |
Germany |
5.9% |
Trauma-focused fibrinogen |
Kedrion |
Italy |
xx% |
Fibrinogenum Humanum |
China Biologic |
China |
xx% |
APAC market leader, Hualan |
Green Cross |
South Korea |
xx% |
GC Fibrinogen for congenital deficiencies |
Hualan Biological |
China |
xx% |
Biosimilars in development |
Kamada |
Israel |
xx% |
Fibrinogen IVIG combinations |
Bharat Serums |
India |
xx% |
Low-cost fibrinogen for LMICs |
Intas Pharma |
India |
xx% |
Fibrinogen-P (plasma-derived) |
SK Plasma |
South Korea |
xx% |
Military and trauma applications |
Bio Products Laboratory |
UK |
xx% |
Fibrinogen Concentrate BP |
Sanquin |
Netherlands |
xx% |
Non-profit plasma collector |
Malaysian Bio-Diagnostics |
Malaysia |
xx% |
ThermoFib for tropical climates |
Recent Developments
- In May 2024, Octapharma notified that its lyophilized Fibryga NextGen expanded into pediatric care with a prime focus on congenital deficiency patients with EMA approval. The product’s 36-month shelf life reduces waste in tropical regions.
- In March 2024, CSL announced the launch of Hemoraas, which is a high-purity fibrinogen for trauma, gaining FDA approval for acute hemorrhage. The product captured 8.7% market share in North America within the 2nd quarter of 2024.
- Report ID: 7896
- Published Date: Jul 15, 2025
- Report Format: PDF, PPT
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