인간 피브리노겐 농축물 시장 규모, 점유율, 성장 및 세계 산업 분석 : 유형별, 용도별, 지역별 인사이트 및 예측(2024-2032년)

Growth Factors of human fibrinogen concentrates Market

The global human fibrinogen concentrates market is expanding rapidly as surgical volumes rise, awareness of advanced hemostatic therapies grows, and plasma-derived technologies continue to evolve. According to the latest estimates, the global market size stood at USD 768.7 million in 2024, is projected to reach USD 853.4 million in 2025, and is expected to accelerate to USD 1,901.1 million by 2032, growing at a strong CAGR of 12.1% during the forecast period. Europe dominated the global market with a 48.39% share in 2024, supported by strong manufacturing capabilities, regulatory approvals, and a high prevalence of surgical and bleeding-related disorders.

Human fibrinogen concentrates are essential plasma-derived hemostatic products used to rapidly restore fibrinogen levels in patients suffering from significant bleeding due to trauma, surgical procedures, or congenital deficiencies such as afibrinogenemia. Rising surgical burden worldwide continues to be a major demand driver. For example, the All India Institute of Medical Sciences (AIIMS) reported in September 2022 that over 250,000 total knee replacement surgeries were performed in India, highlighting the growing need for reliable hemostatic solutions. Key industry players-including LFB, CSL, Octapharma AG, and Grifols S.A.-continue to invest in R&D, portfolio expansion, and clinical trials to strengthen their global footing. In February 2024, Grifols reported positive Phase 3 results for Biotest's BT524, a fibrinogen concentrate demonstrating effectiveness in treating acquired fibrinogen deficiency (AFD).

Market Drivers

One of the leading drivers is the surging number of surgical procedures worldwide, driven by an aging population, rising prevalence of chronic diseases, unhealthy lifestyles, and increased trauma cases. As surgical complexity rises, demand for rapid, efficient intraoperative bleeding control increases proportionately. According to NIH's 2024 report on global cardiac surgical volume, high-income countries performed an average of 123.2 cardiac surgeries per 100,000 population annually. The growing need for reduced intraoperative and postoperative complications has strongly accelerated adoption of fibrinogen concentrates over traditional options such as fresh frozen plasma (FFP) and cryoprecipitate.

Market Restraints

However, the high cost associated with human fibrinogen concentrates remains a major limiting factor, particularly in emerging economies. Complex manufacturing processes, donor plasma requirements, and stringent regulatory protocols significantly elevate production costs. For example, the commercial price for FIBRINOREL 1g is approximately USD 185.4, restricting affordability in low-income regions. Limited reimbursement coverage further impedes adoption, slowing market penetration across developing countries.

Market Opportunities

Growing strategic collaborations among global and regional manufacturers are creating strong expansion opportunities. Partnerships between pharmaceutical companies, biotech firms, and plasma fractionation specialists enable faster product development and deeper market penetration. In June 2024, Plasmagen Biosciences partnered with CSL Behring to manufacture and commercialize Haemocomplettan P in India, marking a significant milestone for improving access in developing markets. Expanding R&D pipelines, along with government focus on improving surgical infrastructure, are expected to support long-term growth.

Market Challenges

Supply chain complexities remain a major challenge. Human fibrinogen concentrates require robust donor networks, stringent cold chain logistics, highly skilled personnel, and rigorous regulatory compliance for batch release. These factors create a high entry barrier for new manufacturers, slowing competitive expansion and limiting global supply.

Industry Trends

A key emerging trend is the shift toward pipeline innovations that offer faster administration, standardized dosing, and improved clinical outcomes. Cryoprecipitate-traditionally used for fibrinogen replenishment-faces limitations due to variable dosing and time-consuming thawing requirements. New products like Grifols' BT524, which met primary goals in a 2025 Phase 3 trial, offer more predictable efficacy and rapid administration for managing acquired fibrinogen deficiency (AFD). These advancements are expected to redefine global clinical practice.

Segmentation Overview

By Application

The acquired fibrinogen deficiency & surgical procedures segment dominated in 2024 due to rising trauma cases and increasing surgical volumes globally. For reference, Australia reported 12,700 coronary artery bypass graft (CABG) surgeries in 2020-2021. Congenital fibrinogen deficiency remains the second-largest segment, driven by its prevalence (1-30 cases per 1 million population) and increased awareness and diagnosis.

By End-user

The hospital segment accounted for the largest share in 2024, supported by advanced infrastructure and high surgical caseloads. According to WHO, global surgical volumes exceeded 300 million annually, reinforcing hospital dependency on fibrinogen concentrates.

Regional Insights

Europe

Europe held the largest regional share in 2024 with a market size of USD 372.0 million, supported by strong industry presence and early adoption of products like Octapharma's Fibryga.

North America

Growth is driven by rising bleeding disorder cases-approximately 33,000 U.S. males are estimated to have hemophilia-and a robust healthcare ecosystem.

Asia Pacific

APAC shows strong future growth potential due to aging populations, rising chronic conditions, and infrastructure initiatives like the 2024 100-4-100 Project, aimed at upgrading 100 hospitals.

Latin America & Middle East/Africa

These regions maintain smaller shares but are benefiting from rising awareness initiatives and healthcare investment.

Conclusion

With the global human fibrinogen concentrates market expected to reach USD 1,901.1 million by 2032, sustained growth will be driven by expanding surgical needs, strategic collaborations, and advancements in plasma-derived product innovation. The industry's future hinges on improved accessibility, cost optimization, and continued R&D progress.

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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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, 2019-2032

• 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 (2024)
• 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