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市场调查报告书

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1643902

全球止血产品市场 - 2025-2033

Global Hemostasis Products Market - 2025-2033

出版日期: 2025年01月27日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

全球止血产品市场在2024年达到21.5亿美元，预计到2033年将达到34.2亿美元，在2025-2033年预测期间复合年增长率为5.5%。

止血是指在受伤后防止和止血同时保留血液容积和压力的生理机制。它涉及一系列复杂的过程，最终在血管损伤部位形成稳定的血块。止血产品是有助于在外科手术或紧急情况下控制出血的医疗器械或化学物质。

对止血产品的需求不断增长正在推动全球止血产品市场。外科手术数量的增加、输血次数的增加以及道路事故数量的增加正在增加对止血产品的需求。在大多数情况下，所有这些因素都会导致需要止血产品的血流不受控制，这种要求和需求在预测期内推动市场。

市场动态：

驱动程式和限制

止血产品的需求不断增加

对止血产品的需求不断增长预计将成为全球止血产品市场成长的重要因素。由于外科手术次数的增加、输血次数的增加以及道路事故的增加，对止血产品的需求不断增加。

随着外科手术数量的增加，对复杂手术期间控制出血的止血产品的需求不断增加。例如，根据美国国立卫生研究院的数据，据报道，到 2023 年，每年进行约 40 万例 CABG 手术，使其成为最受欢迎的主要外科手术。此外，根据美国国立卫生研究院的数据，到2024 年，髋关节和膝关节置换手术是美国最常见的两种手术，估计有700 万美国人需要进行完整的髋关节或膝关节置换手术，超过100 万例置换手术每年都进行。

在手术环境中，快速止血的能力至关重要，尤其是在创伤或困难手术中。使用止血药物和设备使外科医生能够成功控制出血，从而获得清晰的手术视野并降低併发症的风险。因此，随着全球手术技术的进步和手术数量的增加，止血产品的需求增加，全球止血产品市场激增。

严格的监管要求

严格的监管要求等因素预计将阻碍全球止血产品市场。美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管组织对包括止血剂在内的医疗器材和商品的许可製定了严格的要求。这保证了产品在推出市场之前是安全、有效和高品质的。然而，这些监管框架的复杂性可能会导致产品开发和批准的时间更长，这对于资源较少的小型企业和新创公司来说尤其具有挑战性，无法有效地完成这些流程。由于产品开发和产品发布的时间较长，当有需求时，组织可能无法满足需求，这可能会阻碍市场。

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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.

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