Japan Neurology Devices Market Analysis

Japan Neurology Device Market Executive Summary

The demand for neurological devices in Japan is high and growing, driven by the country's aging population, increasing prevalence of neurological conditions, and the development of new medical technologies. Japan has one of the largest aging populations in the world, and the number of people with neurological conditions, such as Parkinson's disease, dementia, and Alzheimer's disease, is expected to increase significantly in the coming years. This is driving the demand for neurological devices, such as deep brain stimulation (DBS) devices, electroencephalography (EEG) devices, transcranial magnetic stimulation (TMS) devices, and spinal cord stimulation (SCS) devices. Japan is also known for its advanced medical technology industry and its commitment to high-quality healthcare, which further supports the demand for neurological devices. Japan's investment in research and development of new medical technologies, as well as the availability of advanced healthcare facilities and skilled medical professionals, also contribute to the growing demand for these devices.

Japan's Neurology Device Market size is at around $784.44 Mn in 2022 and is projected to reach $1484.53 Bn in 2030, exhibiting a CAGR of 8.3% during the forecast period. The most commonly used neurological devices in Japan are - Electroencephalography (EEG) devices, Magnetic Resonance Imaging (MRI) machines, Computed Tomography (CT) scanners, Deep Brain Stimulation (DBS) devices, and Transcranial Magnetic Stimulation (TMS) devices. EEG devices are used to measure and record the electrical activity of the brain and are commonly used to diagnose neurological conditions, such as epilepsy and sleep disorders. MRI machines are used to produce detailed images of the brain and are commonly used to diagnose and monitor a variety of neurological conditions, such as tumors, strokes, and degenerative diseases. CT scanners are used to produce cross-sectional images of the brain and are commonly used to diagnose and monitor conditions such as brain injuries, strokes, and tumors. DBS devices are used to treat Parkinson's disease, essential tremors, and other movement disorders. They work by delivering electrical stimulation to specific areas of the brain to control symptoms and improve quality of life. TMS devices are used to treat depression and other mental health conditions. They work by delivering magnetic pulses to the brain to stimulate nerve cells and improve symptoms. These devices are in high demand in Japan due to the country's aging population and the increasing prevalence of neurological conditions, as well as Japan's strong commitment to high-quality healthcare and advanced medical technology. The combination of these factors drives the demand for these devices, which are considered essential tools for the diagnosis and treatment of a variety of neurological conditions.

Wearable devices for monitoring and managing neurological conditions, brain-machine interfaces for rehabilitation and assistive technology, non-invasive brain stimulation devices for the treatment of neurological disorders, Artificial intelligence, and machine learning in neurology diagnostics, and 3D printing for customizing and improving neurology devices – are the major trends in the medical device industry in Japan in the domain of neurology. Wearable devices such as smartwatches, sensors, and patches are being used to monitor and manage neurological conditions like epilepsy, Parkinson's disease, and sleep disorders in real time. These devices are equipped with sensors that can track physiological signals like heart rate, body temperature, and brain activity. Brain-machine interfaces (BMIs) are devices that allow for direct communication between the brain and a machine. In Japan, BMIs are being used for the rehabilitation of patients with conditions like paralysis, stroke, and spinal cord injuries. These devices help patients regain lost motor function by stimulating their muscles using electrical signals generated from their brain activity. Non-invasive brain stimulation devices like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are being used to treat various neurological disorders like depression, anxiety, and chronic pain. These devices use magnetic or electrical fields to stimulate specific regions of the brain to improve symptoms. Artificial intelligence and machine learning are being used in Japan to improve the accuracy of diagnosis and treatment of neurological disorders. These technologies are being used to analyze large amounts of medical data, including brain imaging and patient records, to identify patterns and make predictions about patient outcomes. 3D printing technology is being used in Japan to customize and improve neurology devices for patients. For example, 3D printing can be used to create customized prosthetics for patients with spinal cord injuries or to create personalized brain implants for patients with Parkinson's disease. This technology allows for the creation of devices that are tailored to a patient's specific needs, improving the overall efficacy of treatment.

Market Dynamics

Market Growth Drivers

1. The aging population and the increase in neurological diseases
2. Government initiatives and investment in healthcare
3. Advances in technology and the miniaturization of devices
4. Growing awareness and acceptance of neurology devices
5. High healthcare spending and strong insurance coverage

Market Restraints

1. High cost of neurology devices and limited reimbursement coverage
2. Lack of trained professionals and shortage of specialists
3. Stringent regulatory requirements and a long approval process
4. Limited access to advanced neurology devices in rural areas
5. Ethical and privacy concerns regarding the use of neurology devices

Competitive Landscape

Key Players

• B. Braun Melsungen
• Stryker
• Boston Scientific
• Medtronic
• Abbott Laboratories

Healthcare Policies and Regulatory Landscape

The regulatory body for neuro devices in Japan is the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The Agency is responsible for regulatory measures for reasonable assurance of safety and efficacy. The marketing paths are premarket notification that requires submission of protocol and approval of the prototype, classification request exemption, humanitarian use exemption, and biologics license application. The international medical device guidelines are also checked and listed and together medical device regulators from around the world with Japan aim to achieve medical device regulatory harmonization. Depending upon the technology – laser, radiotherapy, cautery, chemical usage, tissue involvement, and risk to biology assessment, must be done along with establishing that the new device performs equally to a predicate item in terms of intended use, technological attributes, and performance testing.

Reimbursement Scenario

Medical device businesses concentrated on securing regulatory approval for commercialization in Japan. Obtaining reimbursement, on the other hand, is more important for the bottom line. The use of non-reimbursed equipment indicates that there is no universal healthcare coverage, and all payments must be made out of pocket. To evaluate reimbursement trends in Japan, a database was created. The information was gathered from the Ministry of Health, Labour, and Welfare's (MHLW) website. The Central Social Health Insurance Council (Chuikyo), the MHLW council that establishes all of the codes, coverages, and prices for Japan's universal healthcare insurance system—basically the CMS of Japan—evaluated 138 requests for a new designation of Specially Reimbursed Medical Device (SRMD) on 2021. The Japanese Pharmaceutical Association and the Japan Trade Union Confederation both hold seats on Chuikyo. After receiving a new SRDM classification, cardiovascular and orthopaedic devices received payment in roughly 200 days, whereas neurology devices required about 390 days. The issue with that chronology is that the data does not indicate when the request was filed to the MHLW. It is possible that cardiovascular and orthopaedic industries simply did this more efficiently than others. However, in terms of pricing, orthopaedic devices are reimbursed at roughly half of the list price in the United States. Cardiovascular devices are reimbursed at approximately 85% of the US list price on average, followed by neurology equipment at approximately 73% of the US list price.