止血製品の世界市場（2025年～2033年）

世界の止血製品の市場規模は、2024年に21億5,000万米ドルに達し、2033年には34億2,000万米ドルに達すると予測され、予測期間2025年～2033年のCAGRは5.5%で成長する見込みです。

止血とは、傷害後に血液量と圧力を維持しながら出血を防ぎ、止める生理的メカニズムです。血管損傷部位に安定した血栓が形成されるまでの一連の複雑な過程を含みます。止血製品は、外科手術中や緊急事態における出血を抑制するための医療機器や化学物質です。

止血製品に対する需要の増加が、止血製品の世界市場を牽引しています。外科手術の増加、輸血の増加、交通事故の増加が止血製品の需要を高めています。これらの要因の多くは、止血製品が必要とされる制御不能な血流をもたらすものであり、この要求と需要が予測期間中の市場を牽引しています。

市場力学：

促進要因と抑制要因

止血製品需要の増加

止血製品に対する需要の増加は、世界の止血製品市場の成長において重要な要因となることが予想されます。止血製品の需要が増加している背景には、外科手術の増加、輸血の増加、交通事故の増加があります。

外科手術の増加に伴い、複雑な手術中の出血をコントロールする止血製品の必要性が高まっています。例えば、米国国立衛生研究所（National Institute of Health）によると、2023年には毎年約40万件のCABG手術が行われ、主要な外科手術の中で最も普及していると報告されています。さらに、2024年の国立衛生研究所によると、人工股関節置換術と人工膝関節置換術は、米国で最も一般的に行われている手術の2つであり、推定700万人の米国人が人工股関節または人工膝関節の全置換術を必要とし、毎年100万件以上の置換術が行われています。

手術の現場では、特に外傷や困難な手技の場合、迅速な止血の確立が重要です。止血薬や止血器具を使用することで、外科医は出血をうまく調節することができ、その結果、術野が明瞭になり、合併症のリスクが低下します。このように、手術手技が進歩し、世界的に手術件数が増加するにつれて、止血製品の需要は増加し、止血製品の世界市場も急成長しています。

厳しい規制要件

厳しい規制要件などの要因が、止血製品の世界市場を抑制すると予想されます。米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの規制機関は、止血剤を含む医療機器や商品の認可に厳しい要件を設定しています。これにより、製品が市場に出回る前に、安全性、有効性、品質が保証されます。しかし、このような規制の枠組みは複雑であるため、製品開発および承認までの期間が長期化する可能性があり、これらのプロセスを効率的に進めるためのリソースが少ない中小企業や新興企業にとっては特に課題が多いです。製品開発と製品上市のタイムラインが長期化することで、必要な時に必要な需要を満たすことができず、市場開拓に支障をきたす可能性があります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
  • 止血製品の需要増加
  • 抑制要因
  • 厳格な規制要件
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 償還分析
• 特許分析
• SWOT分析
• DMIの見解

第6章 局所止血製品別

• コラーゲン
• 酸化再生セルロース
• ゼラチン
• 多糖類

第7章 注入用止血製品別

• 新鮮凍結血漿
• ドナー血液からの血小板濃縮物
• 第VIII因子
• プロトロンビン複合体
• その他

第8章 高度止血製品別

• 流動性複合体
• トロンビン複合体
• フィブリン複合体
• 合成シーラント
• その他

第9章 用途別

• 外傷
• 手術
• 血友病
• 心筋梗塞
• 血栓症
• その他

第10章 エンドユーザー別

• 病院
• クリニック
• その他

第11章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第12章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第13章 企業プロファイル

• Pfizer Inc.
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• Johnson & Johnson
• Cohera Medical
• Medtronic
• Zimmer Biomet
• Precision BioLogic Incorporated
• Bristol-Myers Squibb Company
• Baxter
• Integra LifeSciences Corporation
• B. Braun SE

第14章 付録

The Global Hemostasis Products Market reached US$ 2.15 Billion in 2024 and is expected to reach US$ 3.42 Billion by 2033, growing at a CAGR of 5.5% during the forecast period 2025-2033.

Hemostasis is the physiological mechanism that prevents and stops bleeding while retaining blood volume and pressure after an injury. It involves a complex series of processes that terminate in the formation of a stable blood clot at the site of vascular damage. Hemostasis products are medical devices or chemical substances that help to control bleeding during surgical procedures or in emergency situations.

The increasing demand for the hemostasis products is driving the global hemostasis products market. The increasing number of surgical procedures, the increasing number of blood transfusions, and the increasing number of road accidents are increasing the demand for hemostasis products. All these factors in most cases, result in uncontrolled blood flow for which hemostasis products are required, this requirement and demand drive the market over the forecast period.

Market Dynamics: Drivers & Restraints

Increasing demand for hemostasis products

The increasing demand for hemostasis products is expected to be a significant factor in the growth of the global hemostasis products market. The demand for hemostasis products is increasing owing to the increasing number of surgical procedures, an increasing number of blood transfusions, and an increasing number of road accidents.

As the number of surgical procedures increases, there is an increasing need for hemostasis products to control bleeding during complex surgeries. For instance, according to the National Institute of Health, In 2023, it was reported that around 400,000 CABG operations are conducted each year, making it the most prevalent major surgical procedure. Moreover, according to the National Institute of Health in 2024, hip and knee arthroplasty surgeries are two of the most common procedures performed in the United States, with an estimated 7 million Americans necessitating a complete hip or knee replacement and more than 1 million replacements were performed each year.

In surgical settings, the ability to establish quick hemostasis is critical, especially in trauma or difficult procedures. The use of hemostatic drugs and devices enables surgeons to successfully regulate bleeding, resulting in a clear surgical field and lowering the risk of complications. Thus, as surgical techniques advance and the number of surgical procedures rises globally, the demand for hemostasis products increases, and the global hemostasis products market upsurges.

Stringent regulatory requirements

Factors such as stringent regulatory requirements are expected to hamper the global hemostasis products market. Regulatory organizations, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), set stringent requirements for the licensing of medical devices and goods, including hemostatic agents. This guarantees that products are safe, effective, and high-quality before they hit the market. However, the complexity of these regulatory frameworks can result in longer timelines for product development and clearance, which can be especially challenging for smaller enterprises and startups with fewer resources to traverse these processes efficiently. Due to longer timelines for product development and product launch, organizations may not meet the demand when there are requirements and this may hamper the market.

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Segment Analysis

The Global Hemostasis Products Market is segmented based on Topical Hemostasis Products, Infusible Hemostasis Products, Advanced Hemostasis Products, Application, End-User, And Region.

Synthetic sealants segment is expected to dominate the global hemostasis products market share

The synthetic sealants are anticipated to dominate the global hemostasis products market owing to their capacity to promote quicker clot formation and give long-lasting hemostatic effects and technological advancements. These products are intended to provide more effective and efficient bleeding control during surgical procedures, hence improving patient outcomes and reducing problems. As surgical techniques progress and become more complex, there is a growing demand for advanced hemostatic technologies that can control bleeding rapidly and reliably. Synthetic sealants, particularly those that use breakthrough technologies like bioactive materials and synthetic polymers, outperform traditional approaches. Their capacity to promote quicker clot formation and give long-lasting hemostatic effects makes them useful, especially in high-risk surgical settings.

The recent technological advancements in synthetic sealants products are one of the major reasons to make it the most dominating segment. There are recent launches of synthetic sealant products that use advanced working principles for quick hemostasis procedures. For instance, in April 2024, Johnson & Johnson (J&J) launched the Ethizia hemostatic sealing patch in Europe, the Middle East, and Africa. Ethizia, which is used for the reduction of bleeding in internal organs other than the nervous and cardiovascular systems, received CE mark approval in November 2023. It works on synthetic polymer technology and claims to be the first and only hemostatic matrix that is equally productive and active on both sides. In a clinical trial of this product, 80% of patients who received the hemostatic sealing patch had their bleeding ceased within 30 seconds.

Technological advancements and an increasing number of surgical procedures that increase the need for quick hemostatic procedures increase the demand for synthetic sealants, making this segment the most dominating in the global hemostasis products market.

Geographical Analysis

North America is expected to hold a significant position in the global hemostasis products market share

North America will likely account for a significant share of the global hemostasis products market, owing to the increasing number of surgical procedures, rising number of chronic diseases, technological advancements, and recent launches and approvals.

The increasing number of surgical procedures in this region drives the market. For instance, in the United States, one in every nine people living in residences reported having at least one surgical treatment by 2023. Individuals aged 65 and older, as well as Medicare beneficiaries, had the greatest rates, with around one in every five reporting having undergone surgery. The increasing number of surgical procedures increases uncontrolled bleeding, which increases the demand for hemostasis products in North America.

Moreover, the technological advancements and the recent product launches drive the market in this region due to the presence of major players and high healthcare investment towards product research and development. For instance, in August 2023, Cresilon Inc. received 510(k) clearance from the United States Food and Drug Administration for TRAUMAGEL, which is intended for temporary external application to reduce moderate to severe bleeding. Cresilon's novel plant-based hemostatic gel technology is capable to stop and control life-threatening bleeding in seconds when applied to a wound at the point of treatment. TRAUMAGEL, which uses Cresilon's proprietary hydrogel technology, is a first-of-its-kind hemostatic medical device that has received FDA approval for temporary external use in moderate to severe bleeding. The technological advancements and the increasing number of surgical procedures increase the demand for hemostasis products and drive the market in this region.

Asia Pacific is growing at the fastest pace in the global hemostasis products market

The Asia Pacific region is emerging as the fastest-growing market for hemostasis products, owing to a combination of demographic trends, an increasing number of surgical procedures, a rising number of chronic diseases, and technological advancements. The increasing number of surgical procedures in this region drives the market. For instance, according to an article published by the Indian Express, each year, an estimated 30 million surgical procedures are performed in India. Significantly, 85% of surgeries are performed in smaller and mid-sized hospitals, with only 15% taking place in corporate hospitals. An increasing number of surgical procedures increases the need for quick hemostasis which increases the demand for hemostasis products and makes this region the fastest-growing region.

Competitive Landscape

The major global players in the global hemostasis products market are Pfizer Inc., Johnson & Johnson, Cohera Medical, Medtronic, Zimmer Biomet, Precision BioLogic Incorporated, Bristol-Myers Squibb Company, Baxter, Integra LifeSciences Corporation, B. Braun SE among others.

Emerging Players

VarmX, Medcura, and Instylla among others

Key Developments

• In September 2024, Toagosei Co., Ltd. launched a dental hemostatic agent for tooth extraction sockets called "Aron Cure Dental". Aron Cure Dental is a new concept of dental hemostatic agent. It stops bleeding after tooth extraction with a hydrogel polymer sponge.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global hemostasis products market report delivers a detailed analysis with 70+ key tables, more than 55 visually impactful figures, and 200 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Topical Hemostasis Product
• 3.2. Snippet by Infusible Hemostasis Product
• 3.3. Snippet by Advanced Hemostasis Product
• 3.4. Snippet by Application
• 3.5. Snippet by End-User
• 3.6. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
  • 4.1.2. Increasing Demand for Hemostasis Products
  • 4.1.3. Restraints
  • 4.1.4. Stringent Regulatory Requirements
  • 4.1.5. Opportunity
  • 4.1.6. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Reimbursement Analysis
• 5.6. Patent Analysis
• 5.7. SWOT Analysis
• 5.8. DMI Opinion

6. By Topical Hemostasis Product

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Product
  • 6.1.2. Market Attractiveness Index, By Topical Hemostasis Product
• 6.2. Collagen*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Oxidized Regenerated Cellulose
• 6.4. Gelatin
• 6.5. Polysaccharides

7. By Infusible Hemostasis Products

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 7.1.2. Market Attractiveness Index, By Infusible Hemostasis Products
• 7.2. Fresh Frozen Plasma*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Platelet Concentrate from Donor Blood
• 7.4. Factor VIII
• 7.5. Prothrombin Complex
• 7.6. Others

8. By Advanced Hemostasis Products

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 8.1.2. Market Attractiveness Index, By Advanced Hemostasis Products
• 8.2. Flowable Complex*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Thrombin Complex
• 8.4. Fibrin Complex
• 8.5. Synthetic Sealants
• 8.6. Others

9. By Application

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.1.2. Market Attractiveness Index, By Application
• 9.2. Trauma*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Surgery
• 9.4. Hemophilia
• 9.5. Myocardial Infarction
• 9.6. Thrombosis
• 9.7. Others

10. By End-User

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.1.2. Market Attractiveness Index, By End User
• 10.2. Hospitals*
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Clinics
• 10.4. Others

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Products
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.8.1. U.S.
    • 11.2.8.2. Canada
    • 11.2.8.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Products
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.8.1. Germany
    • 11.3.8.2. U.K.
    • 11.3.8.3. France
    • 11.3.8.4. Spain
    • 11.3.8.5. Italy
    • 11.3.8.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Products
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.8.1. Brazil
    • 11.4.8.2. Argentina
    • 11.4.8.3. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Products
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.8.1. China
    • 11.5.8.2. India
    • 11.5.8.3. Japan
    • 11.5.8.4. South Korea
    • 11.5.8.5. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Topical Hemostasis Products
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infusible Hemostasis Products
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Advanced Hemostasis Products
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. Pfizer Inc.*
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. Johnson & Johnson
• 13.3. Cohera Medical
• 13.4. Medtronic
• 13.5. Zimmer Biomet
• 13.6. Precision BioLogic Incorporated
• 13.7. Bristol-Myers Squibb Company
• 13.8. Baxter
• 13.9. Integra LifeSciences Corporation
• 13.10. B. Braun SE

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us