医療用超音波止血ナイフの世界市場-2024～2031年

医療用超音波止血ナイフの世界市場は、2023年に15億米ドルに達し、2031年には25億米ドルに達すると予測され、予測期間2024～2031年のCAGRは6.9%で成長すると予測されています。

医療用超音波止血ナイフは、超音波エネルギーを用いて切断と凝固の機能を併せ持つ手術器具です。高精度、熱損傷の低減、効果的な止血を実現します。ナイフは電気エネルギーを機械的振動に変換して作動し、振動する先端が組織に接触するとキャビテーション効果が生じます。これにより小さな気泡が発生し、周囲の構造物へのダメージを最小限に抑えながら組織細胞を分離します。超音波振動によって生じる摩擦熱は、コラーゲンやフィブリンなどのタンパク質を変性させ、低温で血管を密閉する凝固塊を形成するため、電気手術のような従来の方法と比較して熱損傷を軽減します。

市場力学：

促進要因と阻害要因

高度な手術器具に対する需要の高まり

手術の切れ味向上、効率化、患者の安全性向上への熱望が、超音波止血ナイフ市場を世界的に牽引しています。このデバイスは組織の切断と凝固を実現し、最小限の出血と熱傷害をもたらし、ミニマムアクセス手術での作業を容易にします。がん、心血管疾患、肥満などの慢性疾患の増加により、病院やその他の外科機関は超音波止血ナイフの採用に向けて動き出しています。強力な光、コンパクトなデザイン、新しいエネルギー供給システム、ロボット手術プラットフォームなど、さまざまなタイプや特殊性の応用が技術的に有望視されています。新興経済諸国におけるヘルスケアインフラの旺盛な開拓は、高度な手術技術への重点の高まりと相まって、市場の需要に拍車をかけ続けています。

例えば、Ethicon HARMONIC ACE+7、Adaptive Tissue Technology搭載のHARMONIC ACE+7 Shearsは、手術の精度と性能を高めるように設計されています。一般的な剥離、血管シーリング、バックスコアリング、耳切創、腸間膜マーチングに使用される、無菌でエネルギー効率の高い超音波器具です。人間工学に基づいたハンドル、ハンドピースアタッチメント、2つのエネルギー供給ボタンを備えたAdvanced Hemostasis、3種類のシャフトの長さ（20cm、36cm、45cm）が特徴です。

Harmonic、Ethicon Endo-Surgery Inc.、Sonicision、Medtronic、Medisonicの器具を使用した卵巣摘出術の持続時間、起動時間、切断速度、視認性、刃の粘着性、レンズ洗浄時間に焦点を当てた研究の1つがNCBIで発表されました。これらの器具は4本の主要な胃動脈を分割するために使用され、1台の器具につき10人の患者に使用されました。

厳しい規制要件

超音波手術装置は、FDAやEMAなどの規制機関による大規模な臨床試験やコンプライアンス要件など、厳しい規制環境のために市場抑制要因に大きく直面しています。このため、製品の発売が遅れ、メーカーの開発コストが増大します。こうしたハードル、潜在的な機器の誤作動リスク、継続的なアップデートの必要性は、メーカーに課題をもたらし、市場の成長を鈍化させる可能性があります。

米国における超音波止血デバイスは、一般的にクラスIIまたはIIIに分類され、510（k）市販前届出またはより厳格な市販前承認（PMA）プロセスを必要とします。510（k）プロセスでは、既存の機器との実質的同等性を証明する必要がありますが、解釈の違いにより複雑な場合があります。中国では、NMPAの医療機器分類カタログが特定の超音波外科用機器をクラスⅡからクラスⅢに再分類したため、規制当局の監視が厳しくなり、臨床試験や登録手続きにかかるコストが高くなる可能性があります。

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
    • 高度な外科用器具の需要の高まり
• 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

第6章 製品タイプ別

• ハンドヘルド超音波止血ナイフ
• ロボット支援超音波止血ナイフ
• その他

第7章 タイプ別

• 使い捨て
• 再利用可能

第8章 用途別

• 一般外科
• 腹腔鏡手術
• 心臓血管外科
• 婦人科手術
• 泌尿器科手術
• 整形外科
• その他

第9章 エンドユーザー別

• 病院
• 外来手術センター（ASC）
• 専門クリニック
• その他

第10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
  • その他欧州地域
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第12章 企業プロファイル

• Ethicon, Inc.（Johnson & Johnson）
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• 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

第13章 付録

The global medical ultrasonic hemostatic knife market reached US$ 1.5 billion in 2023 and is expected to reach US$ 2.5 billion by 2031, growing at a CAGR of 6.9% during the forecast period 2024-2031.

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.

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 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
  • 4.2.1.1. Stringent Regulatory Requirements
• 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

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us