인간 피브리노겐 농축 제제 시장 규모, 점유율, 성장 및 세계 산업 분석 : 용도별, 최종사용자별, 지역별 인사이트 및 예측(2026-2034년)

Growth Factors of human fibrinogen concentrates Market

The global human fibrinogen concentrates market size was valued at USD 853.4 million in 2025 and is projected to grow from USD 949.68 million in 2026 to USD 2,195.60 million by 2034, registering a robust CAGR of 11.04% during the forecast period (2026-2034). Europe dominated the market with a 23.96% share in 2025, supported by strong presence of leading plasma product manufacturers and increasing surgical volumes.

Human fibrinogen concentrates are plasma-derived therapies used to restore fibrinogen levels in patients experiencing significant bleeding due to trauma, major surgeries, or congenital and acquired fibrinogen deficiencies. Fibrinogen plays a critical role in blood clot formation; its deficiency prolongs clotting time and increases bleeding risk, necessitating external supplementation. Growing awareness of advanced hemostatic therapies and technological advancements in plasma fractionation are key contributors to market expansion.

For instance, in September 2022, AIIMS reported over 250,000 total knee replacement surgeries in India, reflecting rising surgical demand and supporting product adoption globally. Additionally, positive Phase 3 trial results for BT524 fibrinogen concentrate by Grifols (February 2024) further strengthened industry momentum.

Market Dynamics

Market Drivers

Rising Surgical Volumes and Trauma Cases

Increasing global surgical procedures across cardiovascular, orthopedic, neurological, and gynecological specialties significantly drive demand for fibrinogen concentrates. According to the National Institutes of Health (June 2024), high-income countries perform an average of 123.2 cardiac surgeries per 100,000 population annually. Moreover, the WHO estimated in September 2023 that over 300 million surgical procedures are conducted worldwide each year.

The need to reduce operative and postoperative bleeding complications has accelerated adoption of fibrinogen concentrates over conventional cryoprecipitate and fresh frozen plasma (FFP), thereby fueling global market growth.

Market Restraints

High Product Costs and Limited Reimbursement

Despite strong clinical benefits, high costs remain a significant barrier. For example, FIBRINOREL 1g dried fibrinogen (10 ml) costs around USD 185.4, limiting accessibility in low-income regions. The complex plasma fractionation process, stringent safety standards, and regulatory approvals increase production costs. Limited reimbursement policies in emerging economies further restrict product penetration.

Market Opportunities

Strategic Collaborations and Market Expansion

Collaborations among plasma product manufacturers and regional players are creating lucrative growth avenues. In June 2024, Plasmagen Biosciences partnered with CSL Behring to manufacture and commercialize Haemocomplettan P in India, expanding access to therapy for congenital afibrinogenemia and acquired hypofibrinogenemia.

Such partnerships enhance distribution networks, improve product accessibility in untapped markets, and strengthen global footprint. Increasing chronic disease prevalence in developing nations also offers long-term expansion opportunities.

Market Challenges

Supply Chain and Manufacturing Complexities

Production of fibrinogen concentrates requires extensive plasma donor networks, advanced fractionation facilities, cold chain logistics, and skilled personnel. Strict regulatory compliance and batch-release protocols create high entry barriers, limiting new market entrants and potentially impacting supply stability.

Market Trends

Emerging Pipeline Products Replacing Cryoprecipitate

Traditionally, cryoprecipitate has been used to treat fibrinogen deficiency; however, it requires thawing and lacks standardized dosing. New-generation fibrinogen concentrates offer faster administration, improved safety, and precise dosing.

In June 2025, Grifols announced positive Phase 3 results for BT524, demonstrating non-inferiority to cryoprecipitate and FFP in managing acquired fibrinogen deficiency during major surgeries. The product enables rapid, predictable dosing without thawing delays, improving patient outcomes in emergency settings. Such pipeline advancements are shaping future market trends.

Segmentation Analysis

By Application

The market is segmented into congenital fibrinogen deficiency, acquired fibrinogen deficiency & surgical procedures, and others.

The acquired fibrinogen deficiency & surgical procedures segment dominated with a 92.61% share in 2025, driven by rising trauma and surgical cases. For example, Australia recorded 12,700 coronary artery bypass graft surgeries during 2020-2021, boosting demand for hemostatic agents.

Congenital fibrinogen deficiency held the second-largest share and is projected to grow moderately. According to Orphanet, afibrinogenemia prevalence ranges from 1 to 30 cases per 1 million individuals, supporting steady demand for replacement therapies.

By End-user

Based on end-user, the market includes hospitals, specialty clinics, and others.

The hospitals segment accounted for 83.34% share in 2026, owing to high surgical volumes and advanced infrastructure. Hospitals are primary users of fibrinogen concentrates for managing intraoperative bleeding.

Specialty clinics represent the second-largest segment, particularly in developing countries with expanding specialty care networks. Research institutes and healthcare organizations contribute a smaller share, focusing on product development initiatives.

Regional Outlook

Europe

The Europe human fibrinogen concentrates market was valued at USD 409.91 million in 2025, leading globally. Dominance is attributed to established plasma manufacturers such as Octapharma AG and LFB, high surgical volumes, and regulatory approvals. In November 2019, Octapharma expanded Fibryga approval across 15 European countries.

North America

North America held a significant share in 2025 due to well-developed healthcare infrastructure and rising bleeding disorder cases. According to CDC data (May 2024), approximately 33,000 males in the U.S. have hemophilia, increasing demand for advanced hemostatic agents.

Asia Pacific

Asia Pacific accounted for the second-largest share and is projected to grow at a notable CAGR through 2034. Aging populations, increasing chronic diseases, and healthcare investments are driving growth. The December 2024 "100-4-100 Project" initiative to upgrade 100 hospitals in India is expected to further stimulate surgical product demand.

Latin America & Middle East & Africa

These regions hold comparatively smaller shares but are expected to grow steadily due to rising awareness programs and improving healthcare expenditure.

Competitive Landscape

The market is consolidated, led by Octapharma AG, CSL, and LFB, along with key players such as Grifols, Shanghai RAAS, Reliance Life Sciences, and China Resources Boya Biopharmaceutical Group.

Key developments include:

• July 2025: Octapharma supported a USD 29.0 million trauma-focused clinical trial in the U.S.
• October 2024: LFB expanded bioproduction capacity at its Arras facility.
• December 2022: CSL opened a new plasma fractionation facility in Australia.

Conclusion

The global human fibrinogen concentrates market is projected to expand significantly from USD 853.4 million in 2025 to USD 949.68 million in 2026, reaching USD 2,195.60 million by 2034 at a CAGR of 11.04%. Growth is driven by increasing surgical volumes, trauma cases, rising bleeding disorder prevalence, and advancements in plasma-derived therapies. While high costs and supply chain complexities pose challenges, strategic collaborations, expanding healthcare infrastructure, and innovative pipeline products are expected to sustain long-term market growth.

Segmentation By Application

• Congenital Fibrinogen Deficiency
• Acquired Fibrinogen Deficiency & Surgical Procedures
• Others

By End-user

• Hospitals
• Specialty Clinics
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Table of Content

1. Introduction

• 1.1. Market Scope
• 1.2. Market Segmentation
• 1.3. Market Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Challenges
• 3.5. Market Trends

4. Key Insights

• 4.1. Human Fibrinogen Industry Technology Status and Trends
• 4.2. Industry Entry Barriers (Financial, Technical, Talent, Brand)
• 4.3. Consumer Preference Analysis
• 4.4. The Impact of Regional Situation on Human Fibrinogen Industries
• 4.5. The Impact of Inflation on Human Fibrinogen Industries
• 4.6. The Transformative Power of AI on Human Fibrinogen Industries
• 4.7. The Impact of Global Reciprocal Tariffs on the Industry
• 4.8. Industry Policies and Regulation
• 4.9. Human Fibrinogen Concentrates Market Upstream and Downstream Analysis

5. Global Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Application
  • 5.1.1. Congenital Fibrinogen Deficiency
  • 5.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 5.1.3. Others
• 5.2. Market Analysis, Insights and Forecast - By End-user
  • 5.2.1. Hospitals
  • 5.2.2. Specialty Clinics
  • 5.2.3. Others
• 5.3. Market Analysis, Insights and Forecast - By Region
  • 5.3.1. North America
  • 5.3.2. Europe
  • 5.3.3. Asia Pacific
  • 5.3.4. Latin America
  • 5.3.5. Middle East & Africa

6. North America Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Application
  • 6.1.1. Congenital Fibrinogen Deficiency
  • 6.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 6.1.3. Others
• 6.2. Market Analysis, Insights and Forecast - By End-user
  • 6.2.1. Hospitals
  • 6.2.2. Specialty Clinics
  • 6.2.3. Others
• 6.3. Market Analysis, Insights and Forecast - By Country
  • 6.3.1. U.S.
  • 6.3.2. Canada

7. Europe Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Application
  • 7.1.1. Congenital Fibrinogen Deficiency
  • 7.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 7.1.3. Others
• 7.2. Market Analysis, Insights and Forecast - By End-user
  • 7.2.1. Hospitals
  • 7.2.2. Specialty Clinics
  • 7.2.3. Others
• 7.3. Market Analysis, Insights and Forecast - By Country/Sub-Region
  • 7.3.1. U.K.
  • 7.3.2. Germany
  • 7.3.3. France
  • 7.3.4. Italy
  • 7.3.5. Spain
  • 7.3.6. Scandinavia
  • 7.3.7. Rest of Europe

8. Asia Pacific Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Application
  • 8.1.1. Congenital Fibrinogen Deficiency
  • 8.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 8.1.3. Others
• 8.2. Market Analysis, Insights and Forecast - By End-user
  • 8.2.1. Hospitals
  • 8.2.2. Specialty Clinics
  • 8.2.3. Others
• 8.3. Market Analysis, Insights and Forecast - By Country/Sub-Region
  • 8.3.1. China
  • 8.3.2. Japan
  • 8.3.3. India
  • 8.3.4. Southeast Asia
  • 8.3.5. Rest of Asia Pacific

9. Latin America Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Application
  • 9.1.1. Congenital Fibrinogen Deficiency
  • 9.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 9.1.3. Others
• 9.2. Market Analysis, Insights and Forecast - By End-user
  • 9.2.1. Hospitals
  • 9.2.2. Specialty Clinics
  • 9.2.3. Others
• 9.3. Market Analysis, Insights and Forecast - By Country/Sub-Region
  • 9.3.1. Brazil
  • 9.3.2. Mexico
  • 9.3.3. Rest of Latin America

10. Middle East & Africa Human Fibrinogen Concentrates Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Application
  • 10.1.1. Congenital Fibrinogen Deficiency
  • 10.1.2. Acquired Fibrinogen Deficiency & Surgical Procedures
  • 10.1.3. Others
• 10.2. Market Analysis, Insights and Forecast - By End-user
  • 10.2.1. Hospitals
  • 10.2.2. Specialty Clinics
  • 10.2.3. Others
• 10.3. Market Analysis, Insights and Forecast - By Country/Sub-Region
  • 10.3.1. GCC
  • 10.3.2. South Africa
  • 10.3.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles (Overview, Products, SWOT Analysis, Recent Developments, Strategies, Financials (Based on Availability))
  • 11.2.1. CSL
  • 11.2.2. Grifols, S.A.
  • 11.2.3. LFB
  • 11.2.4. Reliance Life Sciences
  • 11.2.5. Shanghai RAAS Blood Products Co., Ltd.
  • 11.2.6. China Resources Boya Biopharmaceutical Group Co., Ltd.
  • 11.2.7. Octapharma AG