市場調査レポート
商品コード
1345412
脳波測定装置の世界市場-2023年~2030年Global Electroencephalography Devices Market - 2023-2030 |
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脳波測定装置の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 約2営業日
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概要
脳波測定装置の世界市場は、2022年に13億米ドルに達し、2023-2030年の予測期間中にCAGR 9.4%で成長し、2030年には26億米ドルに達すると予測されています。
脳電図(EEG)とは、頭皮に貼り付けた小さな金属円盤(電極)を使って脳の電気的活動を推定する検査です。脳細胞は電気刺激を通じてコミュニケーションをとり、常に活動しています。この動きは脳波記録上では波線を示します。脳波測定の主な利点は、てんかんを発見し検査することです。
脳波測定は、医師が患者のてんかんの種類を特定し、何がてんかんのエピソードを引き起こしているのか、どのように治療すればよいのかを明らかにするのに役立つと期待されています。脳波測定は、認知症、頭部外傷、脳腫瘍、脳炎、睡眠時無呼吸症候群などの睡眠障害など、さまざまな疾患の検査に用いられることもあります。
神経疾患の症例の増加、買収、合併、提携、製品発売、製品承認、買収、拡大などの市場動向の拡大が、予測期間における世界の脳波測定装置市場の成長を後押しすると予想される他の主な要因の一つです。さらに、脳波測定装置における研究活動と技術進歩の増加も、予測期間における世界市場の成長に貢献すると期待されています。
ダイナミクス
神経疾患の有病率の増加
アルツハイマー病、てんかん、認知症、多発性硬化症、パーキンソン病、脳卒中などの神経疾患の有病率の増加は、世界市場の成長を促進すると予想されます。例えば、WHO 2023によると、てんかんに罹患している人は世界で約5,000万人おり、世界で最も典型的な神経疾患の一つとなっています。てんかん患者の約80%は中低所得国に居住しています。
てんかん患者の約70%は、適切な診断と治療を受ければ発作を起こさずに生活できると評価されています。また、Cure Epilepsyによると、米国ではてんかんのために年間約155億米ドルが費やされています。さらに、WHOの2023年版によると、現在、全世界で5,500万人以上の認知症患者がおり、そのうち60%以上が中低所得国に居住しています。
毎年、1,000万人以上の認知症患者が新たに発見されています。認知症は、脳に影響を及ぼす障害や傷害の組み合わせから生じます。アルツハイマー病は認知症の最も典型的な病態であり、症例の60~70%を占めています。同様に、アルツハイマー病協会によると、認知症、前駆期AD、前臨床ADの世界の患者数は、それぞれ3,200万人、6,900万人、3億1,500万人と推定されています。また、これらの疾患は、AD全体では4億1,600万人、50歳以上の全個体の22%を占めています。
製品の承認と上市の増加
商業化および市場への製品導入のための明確な規制機関からの製品承認数の増加は、予測期間における世界市場の成長を促進すると予想されます。例えば、2022年8月、計算QEEG解析の世界的リーダーであるMyneurva社は、完全統合システムの高度なニューラルネットワーク解析EEG装置であるStarrbaseを発表しました。
さらに2021年11月には、Brain Scientific社のNext-Gen NeuroCap EEG Headsetが、STAT脳波を記録する日常的な臨床および研究環境において脳波を迅速に取得するために採用された前衛的な脳電図 (EEG) 電極アレイとして、米国食品医薬品局(FDA)の承認を取得しました。また、2022年9月には、米国食品医薬品局(FDA)がCeribell, Inc.のせん妄の適応症にブレークスルーデバイス指定を与え、このシステムはせん妄を診断するために脳波(EEG)信号を調べる機械学習を採用しています。
さらに2022年10月、日本光電はスマートケーブルNMTポッドとディスポーザブル電極を発売しました。この開発により、臨床医は、脱分極または非脱分極の神経筋遮断剤(NMBA)を患者に投与する手術の瞬間に、患者の麻痺の深達度を正確にスキャンできるようになります。
脳波測定装置の多額の費用
装置のコストは、その機能の感度、精度、モダリティによって異なります。例えば、低価格帯(99~1,000米ドル)は、電極の数量が最も少ないものから始まります。ニューロスカイやミューズのように、ニューロフィードバックを約束し、研究の可能性があるにもかかわらず、瞑想や睡眠の改善を支援する低価格のソリューションを提供する企業はほとんどありません。一方、中間の価格帯(1,000~25,000米ドル)では、各デバイスに利用可能な電極が増え、ハードウェア・ユニットにボーナスが追加されます。この価格帯の機器はすべて調査用であるが、調査の正確な性質によって、どの機器がその目的に最も適しているかが特定されます。
多くの企業(ABM、ANT Neuro、Cognionics、G.tec、mBrainTrain、Neuroelectrics、Wearable Sensing)がこの価格帯のワイヤレス・デバイスを提供しており、機動性の向上と快適性の向上により、データ収集が容易になります。さらに、高価格帯(25,000米ドル以上)では、Brain Product社のActiCHampの32チャンネルから始まり、BioSemi社では160チャンネル、さらには256チャンネルまで、多数の電極チャンネルを提供しています。この豊富な電極数により、脳信号を検出する際の分解能が非常に向上します。しかし、これらの機器は高価であるため、低所得の診療所では購入が難しく、ハイエンド機器市場の需要が減少し、市場の成長が鈍化しています。
神経科医の労働力不足
広範な神経科医の労働力不足は、予測期間中、世界の脳波測定装置市場の成長を妨げると予想されます。例えば、英国神経科医協会(ABN)が発表したデータによると、英国の神経科専門医の労働力は予想よりも極端に減少しています。フランスやドイツと比較して、英国の労働力は、患者と指導医の比率がより健全であるロンドンやその近隣の場所でさえ、大きく劣っています。ABNは最近、労働力調査を行い、全体の46%を占めるコンサルタント神経科医の半数近くと、全体の35%を占める神経科研修生の3分の1以上を調査しました。
また、ABNは、患者支援に携わる常勤換算(FTE)の神経学顧問の数が、10万人当たり1.1人、すなわち人口91,175人当たり1人の割合であることを発見しました。これは、世界保健機関(WHO)の推計によれば、英国は人口1万人当たり28人という、医師が全体的に中程度に十分な密度で存在するという事実と不変です。さらに、2019年には、神経内科の開業医の予約はわずか400人だっています。この数は、2025年までに神経内科医の労働力に19%のギャップが生じると推定される点で、大幅に増加しています。
Global Electroencephalography Devices Market reached US$ 1.3 billion in 2022 and is expected to reach US$ 2.6 billion by 2030, growing with a CAGR of 9.4% during the forecast period 2023-2030.
An electroencephalogram (EEG) is an examination that estimates electrical activity in the brain utilizing small, metal discs (electrodes) affixed to the scalp. Brain cells communicate through electrical stimulations and are active all the time, an invariant of sleep. This movement exhibits wavy lines on an EEG recording. The principal benefit of an EEG is to detect and examine epilepsy, a disorder that induces repeated episodes.
An EEG is expected to aid the physician pinpoint the class of epilepsy that the patient may hold, what may be initiating the episodes, and how satisfactorily treat the condition. Less frequently, an EEG might be employed to examine different conditions, like dementia, head injury and trauma, brain tumors, encephalitis (brain inflammation), and sleep ailments, including sleep apnoea.
The growing cases of neurological disorders, and increasing market developments such as acquisitions, mergers, collaborations, product launches, product approvals, takeovers, and expansion among others are among the other primary factors that are expected to boost the global Electroencephalography Devices market growth in the forecast period. Further, the growing research activities and technological advancements in Electroencephalography Devices are also expected to contribute to the global market growth in the forecast period.
The increasing prevalence of neurological disorders such as Alzheimer's, epilepsy, dementia, multiple sclerosis, Parkinson's disease, and stroke among others are expected to drive the global market growth. For instance, according to WHO 2023, around 50 million individuals globally suffer from epilepsy, making it among the most typical neurological disorders worldwide. Approximately 80% of individuals with epilepsy live in low- and middle-income nations.
It is assessed that about 70% of individuals living with epilepsy could live seizure-free if appropriately diagnosed and treated. Further, according to Cure Epilepsy, the United States expends roughly $15.5 billion on epilepsy annually. Moreover, according to the WHO 2023, presently, more than 55 million individuals with dementia globally out of which more than 60% of whom live in low-and middle-income nations.
Each year, over 10 million new cases of dementia are detected. Dementia results from a combination of disorders and injuries that affect the brain. Alzheimer's disease is the most typical state of dementia and may account for 60-70% of cases. Similarly, according to the Alzheimer's Association, estimations the global number of individuals with AD dementia, prodromal AD, and preclinical AD were 32, 69, and 315 million, respectively. Jointly they accounted for 416 million across the AD continuum or 22% of all individuals aged 50 and above.
The increasing number of product approvals from distinct regulatory bodies for commercialization and product introduction into the market are expected to boost the global market growth in the forecast period. For instance, in August 2022, Myneurva, a global leader in computational QEEG analysis introduced Starrbase, a completely integrated system advanced neural network analysis EEG device.
Moreover, in November 2021, Brain Scientific's Next-Gen NeuroCap EEG Headset, an avant-garde Electroencephalogram (EEG) electrode array employed to acquire quick EEGs in routine clinical and research environments where the recording of STAT EEGs acquired the United States Food and Drug Administration approval. Again, in September 2022, the United States Food and Drug Administration (FDA) awarded Breakthrough Device Designation for Ceribell, Inc.'s delirium indication, the system employs machine learning to examine electroencephalography (EEG) signals to diagnose delirium.
Further, in October 2022, Nihon Kohden launched the Smart Cable NMT Pod and disposable electrode, an instrument with the Smart Cable Procedure. The development allows clinicians to precisely scan the patient's profundity of paralysis at the moment of surgery when a neuromuscular blockade agent (NMBA), both depolarizing or non-depolarizing, is given to the patient.
The cost of the device varies based on its features sensitivity, precision, and modality. For instance, the lower price range ($99 - $1,000), begins with the lowest quantity of electrodes. Few corporations such as NeuroSky and Muse promise neurofeedback and offer lower-cost solutions to assist in improving meditation and sleep, despite the research potential. While, the middle price range ($1,000 - $25,000), offers more available electrodes for each device, and additional bonuses to the hardware units. All of the devices within this price range are research-grade, however, the precise nature of the study will specify which unit is best suitable for the purpose.
Many companies (ABM, ANT Neuro, Cognionics, G.tec, mBrainTrain, Neuroelectrics, and Wearable Sensing) present wireless devices at this price scope, facilitating data collection to happen with improved mobility and increased comfort. Furthermore, the upper price range ($25,000+), offers a large number of electrode channels starting at 32 with Brain Product's ActiCHamp and resuming up to 160, or even 256 channels with BioSemi. This abundance of electrodes permits an exceptionally increased resolution when detecting brain signals. However, the high cost of these devices makes it difficult for low-income practices to afford them, decreasing high-end devices market demand and slowing the market growth.
The extensive neurologist workforce gaps are expected to hamper the global electroencephalography devices market growth during the forecast. For instance, the data published by the Association of British Neurologists (ABN) indicates that the UK's workforce of adviser neurologists is extremely down than might be anticipated. In comparison to France and Germany, the UK workforce is largely inferior, even in London and the neighboring places where ratios of patient to adviser are sounder. The ABN performed a workforce survey lately, surveying nearly half of all consultant neurologists accounting for 46% of the total, and over a third of neurology trainees which is 35% of the total.
Also, the ABN discovered that the number of full-time equivalent (FTE) neurology advisors concerned with patient assistance sits at a ratio of 1.1 per 100,000, or 1 per 91,175 inhabitants. This is invariant of the fact that the UK has a moderately adequate density of medical physicians over the board, estimated by the World Health Organisation (WHO) as 28 per 10,000 of the inhabitants. Moreover, in 2019, there were merely 400 open neurology provider appointments. That number has risen greatly to the point that by 2025 there is estimated to be a 19% gap in the neurologist workforce.
The global electroencephalography devices market is segmented based on product type, number of channels, signal frequency, procedure, application, end-user and region.
The Portable EEG devices are expected to hold a prominent share of the global market in the forecast period owing to the increasing number of product approvals and investments in the segment. For instance, in August 2023, Ceribell, Inc.'s new software ClarityPro secured 510(k) approval from the U.S. Food and Drug Administration (FDA) for the presentation of diagnosing Electrographic Status Epilepticus (ESE).
The approval tracks the preliminary receipt of Breakthrough Device Designation from the FDA. Following obtaining Breakthrough Device Designation and 510(k) approval from the FDA, the U.S. Centers for Medicare and Medicaid Services (CMS) awarded a New Procedure Add-on Payment (NTAP) for ClarityPro of around $913.90 per eligible Medicare patient case. Ahainr, in May 2023, the FDA awarded 510(k) approval to Cumulus Neuroscience's novel, dry-sensor EEG headset, a user-friendly device that allows self-directed usage and produces clinical-grade data for remote physician assessment.
The Cumulus EEG device, developed for both adult and adolescent individuals is obtainable in 4 measures and is effortlessly self-applied in not more than 5 minutes with direction from the Cumulus mobile app, therefore eliminating the requirement for EEG technician or healthcare professional aid. The platform unites clinical-grade, at-home data with machine learning analytics and a large real-world database of annotated, longitudinal, matched data.
The growing number of neurological cases in this region along with funding from government associations for research activities in neurology are expected to boost the North American market growth dominating the global market throughout the forecast period. For instance, according to the statistics from the Alzheimer's Association, almost 6.5 million Americans aged 65 years and older were expected to be suffering from Alzheimer's in 2022 and 73% were of age 75 or older which are at more elevated risk or developing the disorder.
Moreover, according to the information from the ALS Association, by 2050, around 12.7 million individuals aged 65 and older are estimated to suffer from Alzheimer's. Further, the estimates from the National Vital Statistics Report gathered by the Centers for Disease Control and Prevention (CDC) demonstrate that stroke was the fifth among the foremost reasons of death in the U.S.
The statistics from the same source indicate that the moderate years of potential life lost under 75 years of age owing to cerebrovascular disorders was 187.1 in the U.S. In addition, the National Institute of Neurological Disorders and Stroke (NINDS) in the U.S. funds investigations into neurological disorders their diagnosis, and treatment along with raising public understanding of neurological conditions.
Furthermore, new product introductions into the North American Electroencephalography Devices market also contribute to the regional market growth. For instance, in August 2021, Natus Medical, a top provider of medical device developments in the U.S., successfully conducted a clinical trial by utilizing Natus' recently introduced XactTrode family of platinum subdural electrodes which are expected to be employed for Epilepsy Surgical Monitoring.
During the COVID-19 pandemic, elective and routine examinations and operations were postponed or discontinued because of redirecting aids to additional emergent therapy for extremely sick individuals and to avert the spread and contraction of COVID-19. Additionally, the workforce was pulled narrow, and healthcare structures witnessed growing turnover rates for full-time and agreement workers, which pushed the system and decreased the capacity to deliver clinical assistance.
One of the losses of these shifts was electroencephalography (EEG) practices, which have been conducted less repeatedly all over the globe since the pandemic. Whether assumed standard or emergent, the deferral of EEG studies caused downstream consequences, such as the delay in diagnosis and beginning treatment for epilepsy and non-epileptic episodes inducing a more raised threat of morbidity and mortality.
Regardless of these restrictions, the significance and benefits of EEG and EEG approaches have been re-enacted with the evolution of COVID-associated neurological intricacies, such as encephalopathy and seizures, which need EEG for detection and treatment. Further, since the pandemic, dependence on remote telemonitoring emphasized the importance and comfort of utilizing EEG. There has also been an elevated interest in quick EEG devices that non-technologist experts can connect fast, permitting the lowest patient contact to evade vulnerability to COVID-19 and enduring the benefit of remote EEG monitoring.
The war in Ukraine has caused staggering casualties, an exceptional refugee situation, and devastation of infrastructure including infirmaries and basic needs reserves depletion. The war has even damaged the delivery of medical care. Considerable provincial medical bases have individually documented thousands of trauma case entries from February 2022. The scarcity of dependable air transportation leaves the logistics for health care significantly difficult.
Extreme disturbances to multinational markets generated by Russia's war on Ukraine have revealed susceptibilities to the safety of the supply of raw materials necessary for industrial production and for the green transition. These supply chain exposures are the consequences of export restrictions, bilateral dependences, a deficiency of clarity, and constant market asymmetries, including the engagement of production in only a few nations. For nations influenced by supply chain susceptibilities, there are possibilities to diversify sourcing via extended production and accessing comprehended critical raw materials resources.
The major global players in the market include: EMS Handels Gesellschaft m.b.H., KONINKLIJKE PHILIPS N.V., Medtronic, Allengers, EB NEURO S.P.A., Shenzhen Delica Medical Equipment Co., Ltd., Micromed Group, NIHON KOHDEN CORPORATION, Cadwell , Natus Medical Incorporated and Icare USA among others.
The global electroencephalography devices market report would provide approximately 61 tables, 58 figures and 186 Pages.
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