피브린 실란트 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the fibrin sealants market size is expected to grow from USD 1.17 billion in 2025 to USD 1.26 billion in 2026 and is forecast to reach USD 1.92 billion by 2031 at 8.74% CAGR over 2026-2031.

This report is Segmented by Product (Liquid Two-Component Kit, Absorbable Fibrin Sealant Patch), Source (Human, and More), Application (Cardiovascular Surgery, General Surgery, Neurosurgery, Orthopedic Surgery, Urology, Others), End-User (Hospitals, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Fibrin Sealants Market Trends and Insights

Rising Surgical Volumes in Cardiovascular and General Surgery

Cardiovascular and general surgery together drive the highest per-case consumption of fibrin sealants because large anastomotic areas require rapid, diffuse hemostasis. The United Kingdom aims to perform 500,000 robotic surgeries annually by 2035, a policy that increases sealant demand in high-bleed procedures. In the United States, the decline in open-heart volumes has stabilized, thanks to transcatheter valve replacements that still require topical adjuncts. General surgery retained 34.55% of 2025 revenue and continues to benefit from bariatric, hepatobiliary, and colorectal cases that prioritize early discharge, an outcome improved by sealant use. According to a 2025 report by the National Library of Medicine, fibrin sealants are already widely used due to their advantageous properties, such as in situ polymerization, high adhesion, biocompatibility, biodegradability, and biological activity. Fibrin sealants are in high demand in almost all areas of surgery: general surgery, neurosurgery, vascular and nephron-sparing surgery, traumatology and orthopedics, ophthalmic surgery, and reconstructive plastic surgery. Collectively, rising procedure counts provide a dependable volume floor for the Fibrin sealants market.

Wider Adoption in Minimally Invasive and Robotic Procedures

Intuitive Surgical logged 2.4 million da Vinci procedures in 2024, up 17% year over year, with general surgery representing half of all robot-assisted cases . Sealant formulators now engineer catheters sized for 5 mm and 8 mm ports, while patch suppliers pre-cut matrices to fit robotic graspers. Spray applicators face headwinds after European Medicines Agency advisories linked pressurized gas to embolism; manufacturers are therefore commercializing gasless devices that use mechanical atomization. Reimbursement also boosts uptake: the U.S. decision to cover total-knee arthroplasty in ambulatory surgical centers accelerates outpatient orthopedic work, a setting that depends on fast, clean hemostasis delivered by fibrin sealants. These forces collectively enlarge the addressable case mix for the Fibrin sealants market.

Spray Application Safety Constraints Require Training and Limit Use

Surgeons must now use devices at defined pressures and distances, and many centers demand formal credentialing. In practice, these stipulations fragment usage because operating-room staff often rotate between multiple specialties and cannot maintain device-specific competencies. Absorbable patches have therefore gained share in laparoscopic, thoracic, and neuro cases where spray is either impractical or contraindicated. Manufacturers are countering with gasless systems and pre-filled syringes, but regulatory review adds time, limiting near-term market penetration.

Other drivers and restraints analyzed in the detailed report include:

1. Hospital Protocols Favoring Blood Conservation and Hemostasis Adjuncts
2. Product Approvals Expanding Indications and Pediatric Use
3. High Product Cost and Reimbursement Variability Versus Alternatives

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Liquid two-component kits accounted for 62.4% of 2025 revenue, giving them the largest single slice of the Fibrin sealants market share. They excel in cardiovascular and hepatobiliary surgery because intraoperative mixing preserves thrombin activity until the moment of application, maximizing clot strength. The segment also benefits from delivery flexibility: dual-syringe guns can drip, spray, or stream, enabling surgeons to coat large, irregular surfaces. Yet cold-chain storage, thawing protocols, and setup time challenge ambulatory centers with lean staff. Absorbable patches and sponges are forecast to log a 8.94% CAGR, the fastest within the product category. Patches ride the robotic-surgery wave because 5 mm ports restrict spray-gun maneuvering. Ethicon's EVARREST, which couples fibrin with oxidized cellulose, underscores physicians' appetite for shelf-stable, ready-to-use products that avoid gas-propulsion risks.

Longer term, the patch subcategory may raise its Fibrin sealants market size share as manufacturers pair fibrin with growth factors or antimicrobials, creating multifunctional matrices for infection-prone patients. However, kit manufacturers defend incumbency by rolling out gasless applicators that meet EMA safety guidance and by miniaturizing nozzles for 5 mm trocars. Evidence from large cardiac centers continues to favor liquid kits in redo sternotomies where broad coverage outperforms patches. Consequently, the market is unlikely to witness wholesale substitution, but rather a pragmatic procedural split: liquids for open and large-field surgery, patches for endoscopic and robotic cases.

Autologous formulations captured 58.39% of source-based revenue in 2025, aligning with hospitals that prioritize zero viral-transmission risk and immunologic compatibility. Vivostat's platform processes 120 ml of the patient's blood to yield 5 ml of sealant with stable fibrinogen content, eliminating donor-pool exposure. Adoption is particularly strong in orthopedic revisions and cardiac cases involving Jehovah's Witness patients. The autologous segment is expected to post a 8.96% CAGR, bolstered by new compact centrifuges that cut prep time below 20 minutes.

Human plasma-derived products still underpin global supply because vertically integrated giants Grifols, CSL Behring, Takeda, Octapharma control donor pools and fractionation plants. Rigorous solvent-detergent, nanofiltration, and pasteurization regimes meet EMA Plasma Master File standards, sustaining clinician trust. Pricing pressure looms as immunoglobulin demand rises 8-9% annually, competing for the same plasma pool. Animal-derived offerings remain niche because equine or bovine proteins raise immunogenicity flags; Baxter's collagen-based TachoSil, therefore, finds use mainly in situations where human plasma access is constrained.

Geography Analysis

North America retained 45.87% of global revenue in 2025, underwritten by the region's 9,539-unit da Vinci installed base and bundled-payment models that penalize transfusion-related complications. FDA pediatric approval for VISTASEAL in 2024 and Baxter's neonatal label update in 2025 have opened high-acuity children's hospitals to commercial sales. Canada and Mexico trail in absolute volumes but are catching up as aging populations swell cardiovascular caseloads.

Europe is more fragmented. Germany reimburses sealants separately in cardiac DRGs, but the U.K. imposes price ceilings under centralized procurement. Chronic plasma deficits. Octapharma's EUR 200 million expansion in Vienna and its NHS contract to process domestic plasma mark strategic moves to buffer supply shocks. The National Health Service's aim of 500,000 robotic surgeries per year by 2035 furnishes a long-term tailwind for sealants compatible with endoscopic ports.

Asia-Pacific is the fastest-growing region with a projected 9.98% CAGR. Regional healthcare expenditure jumped from USD 3.2 trillion in 2020 to USD 4.2 trillion in 2024 and is on pace for USD 5.7 trillion by 2030. China and India direct public funds into tertiary surgical centers, and local players like Shanghai RAAS and Guangzhou Bioseal are broadening product lines. Japan and South Korea boast high robotic-surgery density, mirroring utilization patterns seen in the United States. While the Middle East, Africa, and South America collectively hold smaller shares, Gulf Cooperation Council investments in medical tourism and Brazil's push to manage non-communicable diseases are slowly enlarging the addressable base. Cold-chain gaps and reimbursement limitations keep adoption concentrated in private hospitals, but rising trauma volumes linked to road-traffic injuries provide an unserved need that fibrin sealants meet.

1. Asahi Kasei
2. Baxter
3. Corza Medical
4. CSL Behring
5. GC Biopharma
6. Grifols
7. Guangzhou Bioseal Biotechnology Co., Ltd.
8. Hemarus
9. Instituto Grifols, S.A.
10. Johnson & Johnson
11. Kedrion Biopharma
12. KM Biologics Co., Ltd.
13. LFB S.A.
14. Octapharma
15. Pfizer
16. Shanghai RAAS Blood Products Co., Ltd.
17. Stryker
18. Takeda Pharmaceuticals
19. Vivostat

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Surgical Volumes in Cardiovascular and General Surgery
  • 4.2.2 Wider Adoption of Minimally Invasive and Robotic Procedures
  • 4.2.3 Hospital Protocols Favoring Blood Conservation and Hemostasis Adjuncts
  • 4.2.4 Product Approvals Expanding Indications, and Pediatric Use
  • 4.2.5 Shift Toward Autologous Fibrin Systems in Centers Prioritizing Pathogen-Risk Mitigation
  • 4.2.6 Optimized Delivery Systems for Endoscopic/Robotic Ports and Gasless Spray Applicators
• 4.3 Market Restraints
  • 4.3.1 Spray Application Safety Constraints (Air/Gas Embolism Risk) Require Training and Limit Use
  • 4.3.2 High Product Cost and Reimbursement Variability Versus Alternatives
  • 4.3.3 Plasma-Derived Input Constraints and Stringent Viral-Inactivation/Testing Steps
  • 4.3.4 Mixed Clinical Benefit Across Certain Indications Limits Routine Use
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Liquid (two-component kit)
  • 5.1.2 Absorbable fibrin sealant patch
• 5.2 By Source
  • 5.2.1 Human
  • 5.2.2 Autologous
  • 5.2.3 Animal-derived
• 5.3 By Application (Surgery)
  • 5.3.1 Cardiovascular surgery
  • 5.3.2 General surgery
  • 5.3.3 Neurosurgery
  • 5.3.4 Orthopedic surgery
  • 5.3.5 Urology
  • 5.3.6 Others
• 5.4 By End-User
  • 5.4.1 Hospitals
  • 5.4.2 Ambulatory Surgical Centers (ASCs)
  • 5.4.3 Specialty Clinics
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Asahi Kasei Corporation
  • 6.3.2 Baxter International Inc.
  • 6.3.3 Corza Medical
  • 6.3.4 CSL Behring
  • 6.3.5 GC Biopharma
  • 6.3.6 Grifols, S.A.
  • 6.3.7 Guangzhou Bioseal Biotechnology Co., Ltd.
  • 6.3.8 Hemarus
  • 6.3.9 Instituto Grifols, S.A.
  • 6.3.10 Johnson & Johnson
  • 6.3.11 Kedrion S.p.A.
  • 6.3.12 KM Biologics Co., Ltd.
  • 6.3.13 LFB S.A.
  • 6.3.14 Octapharma AG
  • 6.3.15 Pfizer Inc.
  • 6.3.16 Shanghai RAAS Blood Products Co., Ltd.
  • 6.3.17 Stryker
  • 6.3.18 Takeda Pharmaceutical Company
  • 6.3.19 Vivostat A/S

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment