Neurology Devices Market Growth, Analysis - Segmented by Device Type (Cerebrospinal Fluid Management Device, Interventional Neurology Device, Neurosurgery Device, Neurostimulation Device, etc.,), and Geography - Trends, and Forecast (2018 - 2025)
Neurology devices can help diagnose, prevent, and treat a variety of neurological disorders and conditions, such as Alzheimer’s disease, Parkinson’s disease, major depression, epilepsy, spinal cord injury, and traumatic brain injury. These devices can be used to help restore hearing and sight and provide an increased function for those with limb loss or congenital limb differences. The Global Neurology Devices Market was valued at USD 8.46 billion in 2017 and is expected to reach USD 13.73 billion by 2023, by registering a CAGR of 8.41%, during the forecast period (2018 - 2023).
Increase in Incidences of Neurological Disorders
Major neurological disorders include brain aneurysms, brain tumours, epilepsy, memory disorders, multiple sclerosis, Parkinson’s disease, peripheral neuropathy, post-herpetic neuralgia, spinal cord tumour, and stroke. Among neurological disorders, Alzheimer’s disease and other dementias account for 2.84% of the total number of deaths in high-income countries. The cerebrovascular disease accounts for 15.8%, 9.6%, 9.5%, and 6.4% of the total number of deaths in the lower middle-, upper middle-, high-, and low-income countries, respectively. The numbers of people with neurological conditions are expected to grow sharply over the next two decades, due to improved survival rates, the betterment of general health care and infection control, increased longevity, and improved diagnostic techniques. Around 500,000 deaths are caused by brain aneurysms, worldwide, each year. The treatment of a brain aneurysm, by clipping via open brain surgery, doubles in cost after an aneurysm has ruptured. The cost of treatment of a brain aneurysm, by coiling (which is less invasive and is done through a catheter), increases by about 70% after an aneurysm has ruptured. The prevalence of Alzheimer's disease is higher among women, as compared to men, and age is still the greatest risk factor. According to data from the National Center for Health Statistics of the Centers for Disease Control and Prevention (CDC), 84,767 people died from Alzheimer’s disease in 2013. Approximately 50 million people have epilepsy, making it one of the most common neurological diseases, globally. Nearly 80% of the people with epilepsy live in low- and middle-income countries. Further, patients with epilepsy respond to treatment approximately 70% of the time. Globally, an estimated 2.4 million people are diagnosed with epilepsy each year. In high-income countries, around 30-50 (per 100,00 people) new cases of epilepsy are recorded annually. On the other hand, in low- and middle-income countries, this figure can go up to two times higher. The above statistics clearly demonstrate an increase in the number of patients with neurological disorders. This increase is expected to lead to the demand for early diagnosis of these conditions. Increasing awareness among patients augments the neurology devices market, globally.
Stringent FDA Validation and Guidelines for New Devices
The Food and Drug Administration (FDA) strictly regulates the approval of medical devices, depending on their class. Class I devices can be self-registered, whereas Class II devices require a premarket notification, i.e., 510(k) submission to FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device. The approval for class III devices, i.e., Premarket Approval (PMA) is the most stringent type of device marketing application is required by the FDA. PMA requires sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use/uses. There are relatively few Class I neurological devices. A majority of the neurological devices are classified under Class II and Class III. Some of the Class I devices include ventricular needles and anvils used to form skull plates. Class II devices include neurostimulators, aneurysm clips, and blood clot retrievers. Examples of Class III devices are deep brain stimulators and medical devices for the treatment of brain tumours. Approval of Class III medical devices is complicated and requires clinical trials. It may take 36 months or more, depending on the extent of clinical trials and the additional information that the FDA might request. The European Union has recently taken steps to significantly strengthen its regulatory approval process, and this is expected to delay approvals in Europe. The delay in regulatory approvals is a major restraining factor faced by the companies manufacturing neurological devices. The stringent and cumbersome regulatory guidelines are hindering the growth of the market.
Market Segmentation Insights for the Neurology Devices Market
Under the Device Type segment, Spinal Cord Stimulation Device had the largest market share in 2017. Spinal Cord Stimulation Device is also the fastest growing segment in Device Type segment of the global neurology devices market.
The US Neurology Devices market holds the largest market share in 2017 in North America region due to the presence of a high-quality healthcare system and modern medical technology in the country. Additionally, the presence of prominent players in the region is likely to contribute to the growth of the Neurology Devices market.
Key Developments in the Market
- December 2017- Mentice has acquired Endovascular Business from Neurology Devices Corporation, which has strengthened its presence in the US region.
Major Players -3D Systems, Canadian Aviation Electronics, Gaumard Scientific Company Inc., Kyoto Kagaku Co. Ltd., Laerdal, Limbs & Things, Mentice AB, Simulab Corporation, Simulaids Inc., Surgical Science Sweden AB, among others.
Reasons to Purchase the Report
- Current and future of Neurology Devices Market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
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