PUBLISHER: DataM Intelligence | PRODUCT CODE: 1629824
PUBLISHER: DataM Intelligence | PRODUCT CODE: 1629824
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.
The global medical ultrasonic hemostatic knife market is segmented based on product type, type, application, end user and region.
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.
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.
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.
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.
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.
LIST NOT EXHAUSTIVE