Neurostimulation Devices Market:
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The neurostimulation devices market consists of sales of surgically or externally placed neurostimulators and related services. The neurostimulation devices are designed to deliver electrical stimulation to specific parts of the patient’s brain, spinal cord or peripheral nervous system for the treatment of various conditions such as chronic pain, movement disorders, epilepsy and Parkinson’s disease. The neurostimulation devices includes spinal cord stimulators, deep brain stimulators, sacral nerve stimulators, vagus nerve stimulators and cortical stimulators.
The global neurostimulation devices market is expected to decline from $6.8 billion in 2019 to $5.8 billion in 2020 at a compound annual growth rate (CAGR) of -15.1%. The decline is mainly because of worldwide supply and demand mismatches of resources due to the COVID-19 outbreak. There is an inadequate production of devices used in neurological disease treatment, due to the restrictions imposed by governments of various countries to shutdown factories or function with minimal staffing in order to contain the spread of virus and keep the staff safe. Additionally, the restrictions on non-essential medical services also hampered the market growth. The market is then expected to recover and grow at a CAGR of 11.6% from 2021 and reach $10.5 billion in 2023.
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Rising geriatric population across the globe is driving the growth of the nerostimulation device market. An increasing number of population is ageing and this geriatric population is falling prey to different neurobiological disorders. For instance, according to World Population Ageing Report, in 2017, there were an estimated 962 million people aged 60 or over globally, which is 13% of the total global population. According to the population reference bureau, the number of Americans ageing 65 and older is projected to more than double from 46 million in 2015 to over 98 million by 2060. According to the StastsCan, 2015, over 5.7 million Canadians have aged 65 and older, which was 16.1 % of Canadian population.
The high cost associated with the neurostimulation Devices will impede the growth of the market. For example, the average price of the neuromodulation devices for chronic pain management ranges from $13920 to $17940 and the average price of neuromodulation devices for epilepsy ranges from $25420 to $25970. Although the device construction between neurostimulation and cardiac rhythm management devices is similar, neuromodulation generators are 67 percent more expensive than ardiac rhythm management devices.
Minimally invasive treatments are being developed for the treatment of various neurological disorders. The neurostimulation devices are being innovated in a way to cause minimum invasion during the neurological treatments. For example, Deep Brain Stimulation (DBS) is a minimally invasive surgical procedure to treat neurological symptoms of Parkinson’s disease, including tremors, rigidity, and movement control. DBS uses a neurostimulation device, similar to a heart pacemaker, to deliver electrical pulses to a very precise location in the brain circuits that influence Parkinson’s disease symptoms. The electrical pulses from the DBS device blocks the activity of these circuits so the rest of the brain can function more normally.
USFDA strictly regulates the approval of medical devices depending on their class which is based on the risk associated with the device. There are relatively few class I neurological devices. Majority of the neurological devices are classified under Class II and Class III. 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 tumors. Approval of class III medical devices is complicated and requires clinical trials. The time taken for the trials can be 36 months or more, depending on the extent of clinical trials and additional information that FDA might request. Also, European Union has recently taken steps to strengthen its regulatory approval process significantly, and this is expected to delay approvals in Europe. The delay in regulatory approvals and high cost of interventional devices are the major challenges faced by the companies involved in the manufacture of neurological devices.
In January 2018, LivaNova PLC, a market-leading medical technology company, acquired ImThera medical for USD 225 million. ImThera is a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (“OSA”). ImThera manufactures an implantable device that stimulates multiple tongue muscles via the hypoglossal nerve, which opens the airway while a patient is sleeping. This acquisition has enhanced the neuromodulation business of LivaNova PLC.
Major players in the market are Medtronic, Cyberonics, Boston Scientific Corporation, St. Jude Medical, Nevro Corporation
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