Surgical Navigation Systems Market

Currently, minimally invasive surgery (MIS) is popular owing to small incisions, reduced pain, and short recovery time. To optimize the safety and accuracy of MIS, surgical navigation systems are widely adopted in neurosurgery, orthopedic surgery, etc. It utilizes computers for preoperative planning, intraoperative guidance, and surgical diagnostic purposes.

The growing number of surgeries for neurological, orthopedic, and Ear, Nose & Throat (ENT) disorders, rising preference for minimally invasive surgeries, and increasing product launches & approvals are driving the global surgical navigation systems market. However, stringent regulatory policies and product recalls are expected to hamper the growth of this market during the forecast period. Nevertheless, growth potential in emerging economies is set to be a lucrative opportunity for the growth of this market in the near future.

Over the past decade, there has been a rise in incidences of neurological, orthopedic, and Ear, Nose & Throat (ENT) disorders. According to the Alzheimer's Association, an estimated 5.8 million Americans of all ages were living with Alzheimer's dementia in 2019. By 2050, this number is projected to rise to nearly 14 million. Furthermore, in the UK, approximately 8.5 million people had painful joints attributed to osteoarthritis in 2017. According to the Hearing Loss Association of America, more than 30 million Americans are exposed to dangerous levels of noise in the workplace each year. In addition to this, there were approximately 11 million people in the UK in 2019 with a hearing loss which makes it the second most common disability in this country.

This rise in the number of neurological, orthopedic, and Ear, Nose & Throat (ENT) disorders are leading to an increase in surgical procedures per year. For instance, according to the National Joint Registry UK, 104,695 knee replacement procedures were recorded in 2015 and it further increased to 108,713 in 2016. Moreover, according to the American Academy of Orthopedic Surgeons, in 2014, 370,770 total hip replacements (THR) and 680,150 total knee replacements (TKR) were performed in the US. By 2030, primary THR is projected to grow by 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively.

Surgical navigation systems with the help of imaging modalities can be used to perform these surgical procedures. The surgical navigation system is designed to optimize the treatment effect while minimizing damage to the vital structure. The surgical navigation system offers improved intraoperative feedback and alignment validation to surgeons during surgical procedures. Thus, the rise in the number of neurological, orthopedic, and ENT disorders and their surgical procedures would support the market growth during the forecast period.

The need for surgical navigation systems is growing exponentially in emerging economies to overcome critical issues of traditional surgeries and to provide efficient patient care. Emerging markets, mainly India and China, pose a large growth potential in the global surgical navigation systems market owing to the large patient pool and increasing occurrences of chronic diseases. For instance, according to a research study published in the Lancet Journal, around 1.7 million people have Parkinson's Disease in China.

Similarly, in 2018, around 30,000 people had multiple sclerosis in China. The increasing geriatric population is likely to support the growth of this region in the market. In India, according to the report published by the United Nations Population Fund (UNFPA), the share of the population over the age of 60 was 8% in 2015 and is expected to reach 19% by 2050. Furthermore, the growing interest of key players to expand their presence in the emerging markets is likely to create opportunities in the market. For instance, in April 2018, B. Braun opened five new production facilities in Malaysia to increase the production of pharmaceutical solutions, medical devices for infusion therapy, and surgical instruments.

Moreover, in May 2016, Medtronic PLC opened its new Asia-Pacific headquarter in Singapore. This will help the company to strengthen and support the operations of Medtronic across 80 locations in Asia-Pacific. Such an increasing interest by key players in this region due to the availability of untapped opportunities is expected to drive the growth of the market.

The manufacturing of surgical navigation systems follows crucial steps and processes. These manufacturing processes differ on the basis of manufacturer and country regulations. Companies must comply with the Food and Drug Administration (FDA) regulations in the US and CE mark in the EU to launch their products in respective regions. In some economies such as Japan and China regulatory processes are given utmost importance. The healthcare regulatory authorities of these countries employ strict policies and processes for the approval of the products. In November 2014, the Japanese pharmaceutical and medical device market underwent significant changes due to the replacement of the Japanese Pharmaceutical Affairs Law (JPAL) with the new Pharmaceutical and Medical Device Act (PMD Act). The PMD Act affects major areas of medical device regulations, including quality management system compliance, device registration, the regulation of medical software, and third-party certifications. To market medical devices in Japan, manufacturers must be compliant with the current PMD Act.

It is mandatory for every new system to go through a regulatory approval process and to meet the requirements of the medical devices class II category. This product approval process is very stringent and time-consuming. This is expected to hamper the growth of the market during the forecast period.