North America and Europe are expected to dominate the global surgical navigation systems market during the forecast period, while emerging countries in Asia-Pacific and Latin America are projected to offer significant growth opportunities.
Surgical navigation systems market was valued at from $628 million in 2015, and is estimated to reach $963 million by 2022, growing at a CAGR of 6.3% during the forecast period. Surgical navigation systems employ computer software and tools to perform planned surgical procedures.
The major factors that drive the growth of this market include rise in adoption of minimal invasive surgeries, improvement in healthcare infrastructure in emerging economies, numerous technological advancements, increase in incidence of ENT and neurosurgery-related disorders, and growth in knee replacement surgeries globally. However, high cost of these systems and stringent FDA rules are the major barriers that restrain the market growth.
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ENT navigation system segment is anticipated to grow at the highest CAGR, attributed to the increase in prevalence of ENT-related disorders and rise in adoption of surgical navigation systems among ambulatory settings. Neurosurgery navigation system held the largest market share in 2015, accounting for more than two-fifths share, owing to high adoption rate of navigation systems in neurosurgical procedures.
Market Drivers and Restrains
Rise in Technological Advancements
Technological advancements in surgical navigation systems result in added features, higher success rate, and newer application of the device depending on its usage in various surgical procedures. Thus, the demand for such innovative products among medical professionals is on a rise due to ease of operation, improved surgical results, and improved quality of treatment. Key players have invested heavily on R&D to introduce advanced surgical navigation system in the market and gain a competitive edge. Some of the recent technological developments observed in this market are as follows:
- In January 2017, Philips designed and developed its first augmented-reality surgical navigation technology system to assist surgeons in image-guided open and minimally-invasive spine surgery.
- In March 2016, OrthAlign, Inc. received FDA approval for the world’s first handheld navigation device used in knee arthroplasty.
Stringent Rules & Regulations for Product Approval and Product Recall in the Past
Surgical navigation systems guide the surgeons to perform accurate surgical procedures. Any misguidance can harm the patient’s health and put their life at risk. Therefore, it is mandatory for every new product to go through a regulatory approval process and meet the requirements of medical devices class II category. This product approval process is very stringent and time consuming.
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In addition, owing to the stringent regulations, the image-guided surgical products market has witnessed many product recalls in the recent past due to their inaccuracy in displaying the patient’s anatomy. For example, in January 2016, Brainlab recalled its Cranial Image-Guided Surgery (IGS) System because this system provided inaccurate and different results in the display as compared to the patient anatomy. Similarly, X-NAV Technologies, LLC recalled its X-Guide Surgical Navigation System in February 2016.
The report provides a comprehensive analysis of key players operating in this market such as Medtronic plc (Ireland), Stryker Corporation (U.S.), Brainlab AG (Germany), B. Braun Melsungen AG (Germany), Scopis GmbH (Germany), Fiagon AG (Germany), Karl Storz GmbH & Co. KG (Germany), Amplitude Surgical (France), Zimmer Biomet Holdings, Inc. (U.S.), and Siemens Healthineers (Germany).
North America accounted for the largest market share in 2015, that is, nearly half of the global surgical navigation systems market, due to presence of a well-established healthcare system, higher adoption of healthcare information technologies, and increase in the number of neurological & orthopedic disorders. Asia-Pacific possesses maximum growth potential as key players focus on emerging economies and improving healthcare infrastructure in this region.