South Korea Neurology Devices Market Analysis

South Korea Neurology Device Market Executive Summary

South Korea Neurology Device Market size is at around $184.41 Mn in 2022 and is projected to reach $362.07 Mn in 2030, exhibiting a CAGR of 8.8% during the forecast period. South Korea is a prolific exporter of medical devices and in recent years, it has significantly increased exports to BRICS countries (Brazil, Russia, India, China, and South Africa) as well as Europe and the US. The government has also been eyeing Middle Eastern countries as potential trading partners. In the first quarter of 2020, its global export of medical devices surged by 4.4% – mostly fuelled by international demand for face masks. The high-end products are a different story. Here, the country is still heavily reliant on imports, which comprise around 60% of the total. The research and development projects are likely to change that balance, creating a market for domestically produced ventilators and in vitro diagnostics. South Korean medical device manufacturers are expected to be on the radar of VC investors, and investments are likely to increase in the next few quarters the government is also planning to relax financial regulations by allowing conglomerates to own start-up venture capital firms indicating that the VC funding may go up in times to come. South Korea contributes about 4% of the global medical devices market and 7% of the Asia-Pacific medical devices market – a figure that could be poised to rise in the future. South Korea has a fully formed life sciences industry, but it has tended to focus on serving the local market, so there is a real need to break into the international market and collaborate more globally.

Stroke is a leading cause of death and disability in South Korea. Dementia, including Alzheimer's disease, is a growing health concern in South Korea due to the aging population. Parkinson's disease is a progressive neurodegenerative disorder that affects movement and is becoming more common in South Korea. Epilepsy is a neurological disorder characterized by seizures and is prevalent in South Korea. Multiple sclerosis is a chronic autoimmune disease that affects the central nervous system and is becoming more prevalent in South Korea. These neurological diseases form the major burden in the geography and the diagnosis, treatment, and prevention – all are aided by neurology devices.

Electroencephalography (EEG) machines for brain wave analysis, Magnetic Resonance Imaging (MRI) machines for imaging the brain and spinal cord, Computed Tomography (CT) scanners for imaging the head, Transcranial Magnetic Stimulation (TMS) devices for treatment of depression and migraines, and Deep Brain Stimulation (DBS) devices for treating movement disorders such as Parkinson's disease are some of the most commonly used neurology devices in South Korea. Recent advances in neurology include the creation of more modern and smaller MRI equipment with higher resolution, as well as the expanded usage of portable and wireless EEG devices for ease of use and improved patient comfort. TMS technology advancements include the development of more targeted stimulation methods, as well as the expansion of the use of DBS to treat a broader spectrum of neurological and psychiatric problems. Artificial intelligence and machine learning are being developed for application in the processing of medical images and data from neurology equipment.

Market Dynamics

Market Growth Drivers

There have been several advancements in South Korea that have increased the demand and utilization of neurology devices:

1. Advanced Technology: The introduction of advanced technologies such as artificial intelligence, machine learning, and advanced imaging techniques have improved the accuracy and efficiency of neurology devices
2. Increase in Neurological Disorders: The increasing prevalence of neurological disorders such as Alzheimer's disease, Parkinson's disease, and stroke has led to a rise in demand for neurology devices
3. Government Support: The South Korean government has been actively promoting the development and utilization of medical devices, including neurology devices, through various programs and initiatives
4. Growing Healthcare Industry: The growth of the healthcare industry in South Korea has led to an increase in the demand for medical devices, including neurology devices

Market Restraints

At the moment, the country imports a large number of high-end medical devices from the US, Europe, and Japan, with domestic manufacturers mostly involved in manufacturing low and mid-technology medical devices. The increased funding will be used to develop, manufacture and market innovative and high-end medical devices domestically. Another limiting factor identified is that the country has very stringent regulatory policies. All medical devices, whether domestic or foreign, are subject to pre-market licenses from the Ministry of Drugs and Safety before they can be sold. There is also a long reimbursement approval lead time – it takes at least 150 days, which can delay patient access to new technologies. Reducing the time and cost to market, reducing reimbursement approval lead-time, and reducing import dependence will give the South Korean medical device industry a competitive edge. The cost of neurology devices can be high, making them unaffordable for many patients, particularly those in rural areas. The shortage of skilled personnel trained in the use of neurology devices is a limiting factor in their widespread adoption and use. The stringent regulatory requirements for the approval and marketing of medical devices, including neurology devices, can create challenges for manufacturers and limit the availability of new products. The limited reimbursement for neurology devices by the South Korean government and private insurance companies is a barrier to their widespread use. South Korea faces competition from other countries, such as Japan and China, in the development and production of neurology devices, which can limit its growth in this market.

Competitive Landscape

Key Players

• Medtronic
• Boston Scientific
• Johnson & Johnson
• Stryker

Healthcare Policies and Regulatory Landscape

In South Korea, the regulatory body for medical devices, including neurology devices, is the Korean Food and Drug Administration (KFDA). The KFDA is responsible for ensuring the safety and efficacy of medical devices through pre-market review and clearance, post-market surveillance, and regulatory enforcement. The KFDA also works to promote the development and adoption of new medical technologies in the country. In South Korea, manufacturers and distributors of neurology devices are subject to a number of regulations set by the Ministry of Food and Drug Safety (MFDS), the primary regulatory body responsible for overseeing medical devices in the country. All medical devices, including neurology devices, must be registered with the MFDS before they can be marketed or sold in South Korea. Manufacturers and distributors of neurology devices must have a quality management system in place to ensure the safety and efficacy of their products. New or modified neurology devices may be required to undergo clinical trials in order to demonstrate their safety and efficacy. Neurology devices must meet labeling requirements set by the MFDS, including information on the device's intended use, manufacturer, and product information. Manufacturers and distributors must conduct ongoing post-market surveillance to monitor the safety and performance of their products. These regulations are designed to ensure the safety and quality of neurology devices in South Korea, and failure to comply with these regulations can result in fines, product recalls, and other penalties.

Reimbursement Scenario

The state of reimbursement for neurology devices in South Korea is limited. Reimbursement for medical devices, including neurology devices, is primarily provided by the National Health Insurance Service (NHIS), which is the primary healthcare payer in South Korea. The NHIS has established reimbursement codes for various medical devices, including neurology devices, but the level of reimbursement provided by the NHIS is limited, and patients may be required to pay a portion of the cost of these devices out of pocket. In addition, the NHIS may limit coverage for certain types of neurology devices or for patients with certain medical conditions. There is also limited private insurance coverage for neurology devices in South Korea, and patients may be required to pay the full cost of these devices out of pocket if they are not covered by either the NHIS or private insurance.