市場調查報告書
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全球腦電圖設備市場 - 2023-2030Global Electroencephalography Devices Market - 2023-2030 |
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概述
全球腦電圖設備市場於 2022 年達到 13 億美元,預計到 2030 年將達到 26 億美元,2023-2030 年預測期間年複合成長率為 9.4%。
腦電圖 (EEG) 是一種利用固定在頭皮上的小型金屬盤(電極)來估計大腦電活動的檢查。腦細胞通過電刺激進行交流,並且始終處於活動狀態,這是睡眠的不變量。這一運動在腦電圖記錄上呈現出波浪線。腦電圖的主要好處是檢測和檢查癲癇症,這是一種誘發反復發作的疾病。
腦電圖有望幫助醫生查明患者可能患有的癲癇類型、可能引發癲癇發作的原因以及如何令人滿意地治療該病症。偶爾,腦電圖可用於檢查不同的疾病,如癡呆、頭部受傷和外傷、腦腫瘤、腦炎(腦部炎症)和睡眠疾病,包括睡眠呼吸暫停。
神經系統疾病病例的不斷增加,以及收購、兼併、合作、產品發布、產品批准、收購和擴張等市場發展的不斷增加,是預計將推動全球腦電圖設備市場成長的其他主要因素。預測期。此外,腦電圖設備不斷成長的研究活動和技術進步預計也將有助於預測期內的全球市場成長。
動力學
神經系統疾病的患病率不斷增加
阿滋海默症、癲癇、癡呆、多發性硬化症、帕金森氏症和中風等神經系統疾病的日益流行預計將推動全球市場的成長。例如,根據世界衛生組織 2023 年的數據,全球約有 5000 萬人患有癲癇症,使其成為全球最典型的神經系統疾病之一。大約 80% 的癲癇患者生活在低收入和中等收入國家。
據評估,如果診斷和治療得當,大約 70% 的癲癇患者可以無癲癇發作。此外,根據 Cure Epilepsy 的數據,美國每年在癲癇方面的支出約為 155 億美元。此外,根據世界衛生組織2023的數據,目前全球有超過5500萬失智症患者,其中60%以上生活在低收入和中等收入國家。
每年都會發現超過 1000 萬新的失智症病例。失智症是由影響大腦的疾病和損傷共同引起的。阿滋海默症是最典型的失智症,可能佔病例的 60-70%。同樣,據阿滋海默症協會估計,全球患有 AD 癡呆、前驅 AD 和臨床前 AD 的人數分別為 32、69 和 3.15 億。他們在 AD 連續體中總共佔 4.16 億人,佔所有 50 歲及以上人口的 22%。
產品批准和發布數量不斷增加
不同監管機構批准商業化和產品引入市場的產品數量不斷增加,預計將推動預測期內全球市場的成長。例如,2022 年 8 月,計算 QEEG 分析領域的全球領導者 Myneurva 推出了 Starrbase,這是一種完全整合的系統高級神經網路分析 EEG 設備。
此外,2021 年11 月,Brain Scientific 的下一代NeuroCap 腦電圖耳機是一種前衛的腦電圖(EEG) 電極陣列,用於在常規臨床和研究環境中快速獲取腦電圖,其中STAT 腦電圖的記錄獲得了美國食品和藥物管理局的支持贊同。 2022 年 9 月,美國食品和藥物管理局 (FDA) 再次授予 Ceribell, Inc. 的譫妄適應症突破性設備稱號,該系統採用機器學習來檢查腦電圖 (EEG) 訊號以診斷譫妄。
此外,2022 年 10 月,Nihon Kohden 推出了智慧電纜 NMT Pod 和拋棄式電極,這是一種具有智慧電纜程序的儀器。這項開發使臨床醫生能夠在手術時向患者給予神經肌肉阻滯劑(NMBA)(去極化或非去極化)時精確掃描患者的癱瘓深度。
腦電圖設備成本高
設備的成本根據其靈敏度、精度和模式的特點而有所不同。例如,較低的價格範圍(99 美元 - 1,000 美元)從最低數量的電極開始。儘管有研究潛力,但像 NeuroSky 和 Muse 這樣的公司很少承諾神經反饋並提供低成本的解決方案來幫助改善冥想和睡眠。而中間價格範圍(1,000 美元 - 25,000 美元)為每個設備提供更多可用電極,並對硬體單元提供額外獎勵。該價格範圍內的所有設備都是研究級的,但是,研究的精確性質將指定哪種設備最適合該目的。
許多公司(ABM、ANT Neuro、Cognionics、G.tec、mBrainTrain、Neuroelectrics 和 Wearable Sensing)都在此價格範圍內提供無線設備,通過改善移動性和增加舒適度來促進數據收集。此外,較高的價格範圍(25,000 美元以上)可提供大量電極通道,使用 Brain Product 的 ActiCHamp 時可提供 32 個通道,使用 BioSemi 時可恢復至 160 個甚至 256 個通道。如此豐富的電極可以在檢測大腦訊號時顯著提高解析度。然而,這些設備的高成本使得低收入者難以負擔得起,從而減少了高階設備市場需求並減緩了市場成長。
神經科醫生勞動力短缺
預計神經科醫生勞動力的巨大缺口將阻礙預測期間全球腦電圖設備市場的成長。例如,英國神經病學家協會(ABN)發布的數據表明,英國顧問神經病學家的勞動力數量大大低於預期。與法國和德國相比,英國的勞動力水平在很大程度上處於劣勢,即使是在倫敦和鄰近地區,患者與顧問的比例更為合理。 ABN 最近進行了一項勞動力調查,調查了近一半的神經科顧問醫生,佔總數的 46%,以及超過三分之一的神經科實習生,佔總數的 35%。
此外,ABN 還發現,負責患者援助的全職等效 (FTE) 神經病學顧問的比例為每 100,000 人 1.1 人,即每 91,175 名居民 1 人。這與以下事實無關:英國的醫師隊伍密度適中,據世界衛生組織 (WHO) 估計,每 10,000 名居民中有 28 名醫生。此外,2019 年,僅有 400 名神經科醫師開放預約。這一數位已大幅上升,預計到 2025 年,神經科醫生勞動力缺口將達到 19%。
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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