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医学影像诊断超音波

市场调查报告书

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1629824

全球医用超音波止血刀市场 - 2024-2031

Global Medical Ultrasonic Hemostatic Knife Market - 2024-2031

出版日期: 2024年12月30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

2023年，全球医用超音波止血刀市场规模达15亿美元，预计2031年将达25亿美元，2024-2031年预测期间复合年增长率为6.9%。

医用超音波止血刀是一种利用超音波能量，兼具切割和凝固功能的手术工具。它提供精确性、减少热损伤和有效止血。该刀透过将电能转化为机械振动来工作，当振动尖端接触组织时，机械振动会产生空化效应。这会产生微小的气泡，分离组织细胞，同时对周围结构的损害最小。超音波振动产生的摩擦热使胶原蛋白和纤维蛋白等蛋白质变性，形成在低温下密封血管的凝固物，与电外科等传统方法相比，减少了热损伤。

市场动态：

驱动程式和限制

对先进手术工具的需求不断增长

对提高手术清晰度、效率和病人安全性的热衷正在推动全球超音波止血刀市场的发展。该装置完成组织切割和凝固，从而最大限度地减少失血和热损伤，使微创手术更容易进行。癌症、心血管疾病和肥胖等慢性疾病的发生率不断增加，促使医院和其他外科机构开始采用超音波止血刀。技术使得强光、紧凑设计、新能源输送系统、机器人手术平台等不同类型和专业的应用前景更加广阔。发展中经济体医疗保健基础设施的蓬勃发展，加上对先进外科技术的日益重视，持续刺激市场需求。

例如，Ethicon HARMONIC ACE+7，采用自适应组织技术的 HARMONIC ACE+7 剪刀旨在提高手术精度和性能。 HARMONIC ACE+7 剪刀是一种无菌、节能的超音波仪器，用于一般解剖、血管密封、背部刻划、切开术创建和肠系膜行进。它具有符合人体工学的手柄、手柄附件、带有两个能量传输按钮的高级止血功能以及三种轴长度（20 厘米、36 厘米和 45 厘米）。

NCBI 发表的一项研究重点关注使用Harmonic、Ethicon Endo-Surgery Inc.、Sonicision、Medtronic 和Medisonic 设备进行大网膜切除术的持续时间、激活时间、切割速度、可视性、刀片粘性和晶状体清洁时间。这些装置用于分割 4 条胃大动脉，每个装置可容纳 10 名患者。

严格的监管要求

由于严格的监管环境，包括广泛的临床试验以及 FDA 和 EMA 等监管机构的合规要求，超音波手术设备面临巨大的市场限制。这会延迟产品发布并增加製造商的开发成本。这些障碍、潜在的设备故障风险以及持续更新的需求给製造商带来了挑战，并可能减缓市场成长。

在美国，超音波止血装置通常属于 II 类或 III 类，需要 510(k) 上市前通知或更严格的上市前批准 (PMA) 流程。 510(k) 流程需要证明与现有设备的实质等效性，由于不同的解释，这可能会很复杂。在中国，国家药品监督管理局的医疗器材分类目录已将某些超音波手术器材从第二类重新分类为第三类，这导致了更严格的监管审查，并可能导致临床试验和註册过程的成本更高。

The medical ultrasonic hemostatic knife is a surgical tool that uses ultrasonic energy to combine cutting and coagulation capabilities. It offers precision, reduced thermal damage, and effective hemostasis. The knife operates by converting electrical energy into mechanical vibrations, which create a cavitation effect when the vibrating tip contacts tissue. This creates tiny bubbles, separating tissue cells with minimal damage to surrounding structures. The frictional heat produced by the ultrasonic vibrations denatures proteins like collagen and fibrin, forming a coagulum that seals blood vessels at low temperatures, reducing thermal injury compared to traditional methods like electrosurgery.

Market Dynamics: Drivers & Restraints

Growing Demand For Advanced Surgical Tools

The lucrative fervor for enhanced surgical sharpness, higher efficiency, and increased patient safety is driving the hemostatic knife market of ultrasound globally. The device accomplishes tissue cutting and coagulation, resulting in minimal blood loss and thermal injury making it easier to work in minimal access surgery. The increasing incidence of chronic diseases that include cancer, cardiovascular disorders, and obesity is moving hospitals and other surgical institutes towards adoption of ultrasonic hemostatic knives. Technologies are making the application of different types and specialities such as strong light, compact design, new energy delivery systems, and robotic surgical platforms more promising. The bustling development of healthcare infrastructure in developing economies coupled with an increasing emphasis on advanced surgical technology continues to spur the demand for the market.

For instance, Ethicon HARMONIC ACE+7 , The HARMONIC ACE+7 Shears with Adaptive Tissue Technology is designed to enhance surgical precision and performance. The HARMONIC ACE+7 Shears is a sterile, energy-efficient ultrasonic instrument used for general dissection, vessel sealing, back-scoring, otomy creation, and mesentery marching. It features an ergonomic handle, hand piece attachment, Advanced Hemostasis with two energy delivery buttons, and three shaft lengths (20cm, 36cm, and 45cm).

One of the study publsihed in NCBI that focuses on the duration, activation times, cutting speed, visibility, blade stickiness, and lens cleansing times of an omentectomy using devices from Harmonic, Ethicon Endo-Surgery Inc., Sonicision, Medtronic, and Medisonic. The devices were used to divide the 4 major gastric arteries, with 10 patients per device.

Stringent Regulatory Requirements

Ultrasonic surgical devices face significant market restraint due to stringent regulatory environments, including extensive clinical trials and compliance requirements from regulatory bodies like the FDA and EMA. This delays product launches and increases development costs for manufacturers. These hurdles, potential device malfunction risks, and the need for continuous updates pose challenges to manufacturers and could slow market growth.

Ultrasonic hemostatic devices in the U.S. typically fall under Class II or III classifications, requiring a 510(k) premarket notification or a more rigorous Premarket Approval (PMA) process. The 510(k) process requires demonstrating substantial equivalence to existing devices, which can be complex due to varying interpretations. In China, the NMPA's Medical Device Classification Catalogue has reclassified certain ultrasonic surgical devices from Class II to Class III, causing stricter regulatory scrutiny and potentially higher costs for clinical trials and registration processes.

Segment Analysis

The global medical ultrasonic hemostatic knife market is segmented based on product type, type, application, end user and region.

Product Type:

Handheld ultrasonic hemostatic knives segment is expected to dominate the medical ultrasonic hemostatic knife market share

The handheld ultrasonic hemostatic knives segment holds a major portion of the medical ultrasonic hemostatic knife market share and is expected to continue to hold a significant portion of the medical ultrasonic hemostatic knife market share during the forecast period.

Handheld ultrasonic hemostatic knives, better known as ultrasonic scalpels, comprise a very important modern surgery technology, offering precise cutting with effective hemostatic characteristics while minimizing injuries to surrounding tissues. These devices further impart ultrasound-induced high-frequency vibration on biological tissues to produce effects of cavitation for both cutting and coagulation at the same time. Comparatively, bleeding is reduced, and so is thermal damage when these devices are compared to conventional surgical instruments. Reduced thermal damage, effective hemostasis, efficiency in surgery, duration of operation, and then the recovery of patients are some of the key advantages.

The global market for ultrasonic hemostatic knives has witnessed growth on account of the rapid demand for minimally invasive surgeries and technology that offers diversified applications across surgeries. North America holds around 92% of this market because of the highly developed healthcare infrastructure and fast adoption of the latest innovative surgical technologies. However, countries in the Asia-Pacific region, such as South Korea and China, have also been rapidly developing owing to their increased healthcare investments and growing number of surgical procedures. Meanwhile, Europe is also increasing its market, mainly by advanced medical devices for improved surgical outcomes.

Application:

General surgery segment is the fastest-growing segment in the medical ultrasonic hemostatic knife market share

The general surgery segment is the fastest-growing segment in the medical ultrasonic hemostatic knife market share and is expected to hold the market share over the forecast period.

General surgery is expected to be a fast growing application in the market for medical ultrasonic hemostatic knives of the world as these knives are being used more and more in various surgical procedures for better results. These knives can serve well in almost all laparoscopic and open surgeries and allow exactly targeted tissue dissection and optimal hemostasis with little blood loss. It has further benefits for thermal damage and operative time and is therefore an inevitable part of complex surgeries such as gastrointestinal, hepatobiliary, and colorectal surgeries. An increasing number of conditions such as hernias, appendicitis, and gallbladder diseases have made such developments more common. Advancements in ultrasonic technology and minimally invasive surgical techniques contribute to the increasing popularity of these knives among general surgeons worldwide.

Geographical Analysis

North America is expected to hold a significant position in the medical ultrasonic hemostatic knife market share

North America holds a substantial position in the medical ultrasonic hemostatic knife market and is expected to hold most of the market share due to technological developments in them, increased surgical volumes, and preference toward minimally invasive techniques. The advancement in technology has resulted in more efficient hemostatic knives that are also user-friendly for better precision and safety in surgery. There are many surgical procedures demanded due to the aging population along with chronic diseases, including cancer, cardiovascular, and other conditions among individuals.

Moreover, solid healthcare infrastructure in North America, with high healthcare spending, promotes the taking up of cutting-edge medical techniques in practice. Adoption of advanced surgical techniques, thus, is promoted by the value-based healthcare transition as it drives a shift toward operational efficiency and satisfaction among patients. The market for ultrasonic cutting hemostatic knives in North America is dynamic in composition emerging from interplay among technological innovation, clinical adoption rates, regulatory oversight, and competitive forces in the market.

Thus, stakeholders are encouraged to direct their focus toward product development and clinical evidence generation. With the continued evolution of the abovementioned factors, the projected view indicates that the North American region will remain world's leader in the ultrasonic hemostatic knife market.

Europe is growing at the fastest pace in the medical ultrasonic hemostatic knife market

Europe holds the fastest pace in the medical ultrasonic hemostatic knife market and is expected to hold most of the market share due to the its established healthcare systems and focus on advanced surgical techniques. The aging population and rising prevalence of chronic conditions like cancer, cardiovascular diseases, and gastrointestinal disorders have increased demand for precise and efficient surgical tools. Governments and healthcare organizations emphasize minimally invasive procedures to improve patient outcomes and reduce costs. Technological advancements, such as ergonomic designs and energy delivery systems, support market growth. Leading manufacturers, extensive R&D activities, and favourable regulatory frameworks ensure a steady supply of innovative products.

Competitive Landscape

The major global players in the medical ultrasonic hemostatic knife market include Ethicon, Inc. (Johnson & Johnson), Medtronic plc, Stryker Corporation, Olympus Corporation,Boston Scientific Corporation, Smith & Nephew plc, B. Braun Melsungen AG, CONMED Corporation, Aesculap, Inc. (B. Braun), Erbe Elektromedizin GmbH among others.

Emerging Players

The emerging players in the medical ultrasonic hemostatic knife market include Advanced Medical Technologies, Inc, InnoSound Technologies , ZUDEN Technology Co., Ltd and among others.

Key Developments

In August 2023, The Heal Force UHSIOO Ultrasonic Scalpel System launched, revolutionizing surgical procedures with its advanced technology. The UHSI 00 Ultrasonic Soft Tissue Cutting knife and Hemostasis System provides surgeons with unparalleled control and accuracy, offering a stable power host machine and a specially coated cutter head. This innovative system helps doctors solve various tissue processing challenges during surgery, paving the way for a new era of precision and efficiency.

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 medical ultrasonic hemostatic knife market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Component & 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 Product Type
3.2. Snippet by Type
3.3. Snippet by Application
3.4. Snippet by End User
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Growing Demand For Advanced Surgical Tools
4.2. Restraints
4.3. Opportunity
- 4.3.1. 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

6. By Product Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Handheld Ultrasonic Hemostatic Knives*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Robotic-assisted Ultrasonic Hemostatic Knives
6.4. Others

7. By Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 7.1.2. Market Attractiveness Index, By Type
7.2. Disposable*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Reusable

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. General Surgery*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Laparoscopic Surgery
8.4. Cardiovascular Surgery
8.5. Gynecological Surgery
8.6. Urological Surgery
8.7. Orthopedic Surgery
8.8. Others

9. By End User

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 9.1.2. Market Attractiveness Index, By End User
9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Ambulatory Surgical Centers (ASCs)
9.4. Specialty Clinics
9.5. Others

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. Ethicon, Inc. (Johnson & Johnson)*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio and Description
- 12.1.3. Financial Overview
- 12.1.4. Key Developments
12.2. Medtronic plc
12.3. Stryker Corporation
12.4. Olympus Corporation
12.5. Boston Scientific Corporation
12.6. Smith & Nephew plc
12.7. B. Braun Melsungen AG
12.8. CONMED Corporation
12.9. Aesculap, Inc. (B. Braun)
12.10. Erbe Elektromedizin GmbH

LIST NOT EXHAUSTIVE