Major players in the electrosurgical devices market are Bovie Medical Corporation, Johnson & Johnson Private Limited, B. Braun Melsungen AG, Medtronic PLC, Smith and Nephew, Boston Scientific, Stryker Corporation, ATMOS Inc, Heal Force Bio-Meditech Holdings Limited, and Erbe Elektromedizin GmbH.
The global electrosurgical devices and equipment market is expected to grow from $7.93 billion in 2021 to $8.65 billion in 2022 at a compound annual growth rate (CAGR) of 9.1%. The market is expected to grow to $11.54 billion in 2026 at a compound annual growth rate (CAGR) of 7.5%.
The electrosurgical devices market consists of sales of electrosurgical devices and related services.Electrosurgical devices include surgical generators and electrosurgical instruments Electrosurgical instruments include monopolar, bipolar and ultrasonic instruments.
These devices deliver high-frequency electrical currents and voltages through an active electrode. They are used for cutting, sealing, and coagulating tissue during a variety of open and laparoscopic surgical procedures.
The main products of the electrosurgical devices are electrosurgery generators, electrosurgery instruments and accessories, argon, and smoke management systems.Electrosurgery generators facilitate therapeutic endoscopy by supplying the high-frequency electrical current required to use endoscopic accessories.
The applications involved are general surgery, gynecology surgery, urologic surgery, orthopedic surgery, cardiovascular surgery, cosmetic surgery, and neurosurgery. The various end-users are hospitals, specialized clinics, and ambulatory surgery centers.
North America was the largest region in the electrosurgical devices market in 2021.Western Europe was the second-largest region in the electrosurgical devices market.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa.
The increasing prevalence rate of chronic diseases contributed significantly to the growth of the electrosurgical devices and equipment market.The electrosurgical devices are used in the surgery of many life-threatening diseases such as skin cancer, small basal cell carcinomas, squamous cell carcinoma, wound surgery, skin surgery, non-cancerous moles, dentistry, and others.
There has been an increase in the number of skin diseases worldwide.For example, in the year 2019, according to one study conducted by the American Society of Clinical Oncology, around 2,000 people in the USA are diagnosed with Merkel cell carcinoma each year and this number has rapidly increased from past decades.
According to WHO, the global burden of major chronic diseases currently accounts for 43% of all diseases and is set to rise to 60% by 2020. According to a United Nations’ report on world population aging, globally the 60+ aged population is projected to grow by 56% to reach 1.4 billion. The growth of the aging population and rising chronic disease incidence will contribute to increased hospitalization. The increase in the patient pool is expected to rise the demand for electrosurgical devices and equipment.
The high incidence of product recalls is one of the factors restraining the electrosurgical devices and equipment market growth.The medical device industry is seeing a significant spike in product recalls during recent years due to defective devices, software issues, mislabeling issues, and quality issues.
The electrosurgical devices and equipment market is a minor part of the medical device market and hence, product recall in the electrosurgical market is quite often.For example, in March 2019, Covidien, PLC, recalled its class 2 Covidien Force Traverse electrosurgical device due to bad sterile packaging.
Zimmer Biomet, a medical device company recalled it is class 1 SPF PLUS-Mini and SPF XL IIB Implantable Spinal Fusion Stimulators due to high levels of potentially harmful chemicals which may be toxic to tissues and organs. FDA Safety Communication notice was Magellan Diagnostics and LeadCare of Meridian Bioscience, Inc. for its LeadCare Testing Systems for giving inaccurate test results.
Electrosurgery is the application of a high-frequency electric current on biological tissue to create.Technological advances have led to the development of modern ESUs that deliver the medically useful thermal effect.
This system is capable of continuously monitoring current and voltage, deriving parameters such as power and tissue resistance, and analyzing them.Depending on the desired treatment outcome, these devices can also keep the operating parameters constant or change them in a targeted manner through control and regulation.
Electrosurgical equipment manufacturers should consider investing ESUs to increase market share in the market.
The regulatory changes related to customer data protection such as the European Union’s General Data Protection Regulation (GDPR), changes to equipment approval procedures, and other regulatory changes are leading to increased costs of electrosurgical equipment product development and supply to healthcare services organizations.The GDPR is an EU law on the data protection and privacy of individuals residing in the European Union and the European Economic Area (EEA).
It also regulates the export of personal data outside the EU and EEA areas. According to a report by Ernst and Young, Fortune 500 companies are spending $7.8 billion to comply with GDPR. In the USA, the U.S. Department of Health and Human Services and Center for Devices and Radiological Health are regulating electrosurgical devices under US FDA. There are two main ways that manufacturers can follow for premarket approval. One way consists of conducting clinical studies and submitting a premarket approval (PMA) application that includes evidence providing reasonable assurance that the device is safe and effective. The other way involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The FDA is requesting more clinical data to support claims, therefore increasing the time to process 510(k)s by over 55% over the last decade. The delays in product releases and additional costs incurred due to stringent approval processes put a strain on investments relating to electrosurgical equipment new product development resulting in potential loss of revenue.
The countries covered in the electrosurgical devices market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, the UK, the USA, and Australia.
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