市場調查報告書
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1345439
全球神經調節設備市場 - 2023-2030Global Neuro Modulation Devices Market - 2023-2030 |
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概述
全球神經調節設備市場在 2022 年達到 54 億美元,預計到 2030 年將達到 76 億美元,2023-2030 年預測期間年複合成長率為 3.6%。
擴大採用有機策略(例如主要市場參與者進行收購以擴大其產品組合)等趨勢預計將主導全球神經調節設備市場。
神經調節裝置在美國被批准用於治療運動障礙、癲癇、疼痛和抑鬱症,並在標籤外用於其他神經系統適應症
神經刺激裝置涉及將電極應用於大腦、脊髓或周圍神經。這些精確放置的導線通過延長電纜連接到脈衝發生器和電源,從而產生必要的電刺激。低壓電流從發生器傳遞到神經,可以抑制疼痛訊號或刺激以前不存在的神經衝動。
此外,全球神經調節設備受到多種因素的推動,慢性疼痛和抑鬱症等生活方式疾病的患病率上升、私人企業對神經疾病研發的投入增加以及神經系統疾病數量的增加是其中一些因素。驅動市場的因素。
此外,技術先進設備的採用、老年人口的激增以及對無創和微創手術需求的成長推動了行業的成長,主要參與者包括美敦力公司(Medtronic Plc)、雅培實驗室(Abbott Laboratories)、波士頓科學公司(Boston Scientific Corp)、LivaNova Plc 和其他
動力學
神經系統疾病患病率上升
神經系統疾病患病率的上升是預測期內幫助市場成長的關鍵因素之一。例如,根據世界衛生組織 2023 年更新的情況說明書,癲癇患病率上升,癲癇影響著全球約 5000 萬人,使其成為最常見的神經系統疾病之一。近 80% 的癲癇患者居住在低收入和中等收入國家。據信,如果癲癇得到正確識別和治療,高達 70% 的人可以擺脫癲癇發作。
癲癇症影響全球 500 萬人,高收入國家每 10 萬例中有 49 例,而低收入和中等收入國家的發病率更高,為每 10 萬例 139 例。這是由於地方病、道路交通傷害、產傷和醫療基礎設施變化的風險增加。近 80% 的癲癇患者生活在低收入和中等收入國家。
技術進步的崛起
主要參與者經常在研發上投入資金,以生產更新穎、更有效的神經調節設備。新的技術突破使得能夠創造出更準確、侵入性更小的技術,從而改善患者的治療結果。
此外,在過去的幾年裡,神經調節技術也取得了各種進展。這些發展的一些例子包括具有無線充電功能的可充電電池、編程的改進、門診環境中侵入性較小的單階段植入以及成本較低的新設備。
在過去的十年中,軟體和硬體技術取得了顯著進步,帶來了重大的技術成功。硬體改進推動了軟體實施和算法整合,而複雜的軟體則實現了高效的巨量資料聚合和生物標記物發現。患者對現有技術的熟悉將促進數位健康與神經調節療法的整合。有效解決方案的構建模組通常用於替代應用,例如用於醫療保健附加組件的智慧手機和智慧手錶。
關鍵參與者推出的產品數量增加
市場主要參與者推出的產品增多將有助於預測期內整體市場的成長。例如,2022 年 7 月,BioMed 和美敦力合作創建了 Orchestra BackBeat CNT,這是一種高度複雜的心臟神經調節療法。它與多種抗高血壓藥物結合使用,其設計方式是自動運行,而不依賴於患者的依從性。此外,它可以簡單地修改為利用標準植入物和引線安裝技術與起搏器和其他心律控制設備一起使用。
此外,2022 年 1 月,美敦力 (Medtronic) 的 Intellis 和 Vanta 可充電神經刺激器設備獲得 FDA 批准,用於治療糖尿病周圍神經病變 (DPN) 的慢性疼痛。 DPN 是一種進行性神經系統疾病,影響 30% 的糖尿病患者,導致麻木、燒灼感和劇烈疼痛。藥物通常只能部分有效,並且可能導致嚴重的副作用。
神經調節手術的高成本
神經調節程序和設備的高成本是限制全球神經調節市場成長的主要因素,特別是在報銷政策較差的發展中國家。標準植入式脈衝發生器的平均成本為 - 美元,植入手術的成本可能高達 25,000-35,000 美元。
脊髓刺激器設備的成本約為 13,000-40,000 美元。由於費用高昂且報銷情況不佳,發展中國家能夠負擔得起神經系統治療的患者非常有限。因此,醫療機構不願意投資新的或技術先進的系統,從而限制了神經調節市場的成長。
Global Neuro Modulation Devices Market reached US$ 5.4 billion in 2022 and is expected to reach US$ 7.6 billion by 2030, growing with a CAGR of 3.6% during the forecast period 2023-2030.
The trend such as the increasing adoption of organic strategies such as acquisition by key market players to expand its product portfolio is expected to dominate the Global Neuromodulation Devices Market.
Neuromodulation devices are approved in the United States for the treatment of movement disorders, epilepsy, pain, and depression, and are used off-label for other neurologic indications
Neurostimulation devices involve the application of electrodes to the brain, the spinal cord or peripheral nerves. These precisely placed leads connect via an extension cable to a pulse generator and power source, which generates the necessary electrical stimulation. A low-voltage electrical current passes from the generator to the nerve and can either inhibit pain signals or stimulate neural impulses where they were previously absent.
Furthermore, the global neuromodulation devices are driven by various factors, the rise in the prevalence of lifestyle diseases such as chronic pain and depression, increased investment by private players for research and development of neurological disorders, and the increasing number of neurological diseases are some of the factors driving the market.
Moreover, the adoption of technologically advanced devices, the surge in the geriatric population, and the rise in demand for non-invasive and minimally invasive surgery fueled the industry growth having key players like Medtronic Plc, Abbott Laboratories, Boston Scientific Corp, LivaNova Plc and others
The rise in the prevalence of neurological disorders is one of the key factors that helps the market to grow during the forecast period. For instance, the rise in the Prevalence of Epilepsy according to the WHO updated factsheet 2023, Epilepsy affects around 50 million individuals worldwide, making it one of the most common neurological illnesses. Almost 80% of epileptics reside in low- and middle-income nations. It is believed that if epilepsy is correctly identified and treated, up to 70% of people can live seizure-free.
Epilepsy affects 5 million people globally, with high-income countries experiencing 49 per 100,000 cases, while low- and middle-income countries have a higher rate of 139 per 100,000. This is due to increased risks of endemic conditions, road traffic injuries, birth-related injuries, and variations in medical infrastructure. Nearly 80% of epilepsy patients live in low- and middle-income countries.
Key players frequently spend in R&D to generate more novel and effective neuromodulation devices. New technical breakthroughs enable the creation of more accurate, less intrusive technologies that provide improved patient results.
For instance, in addition, in the last few years, there have been various developments in neuromodulation technology. Some of examples of these developments are rechargeable batteries with wireless charging, improvements in programming, less invasive single-stage implantation in outpatient settings, and lower-cost new devices.
Over the past decade, software and hardware technologies have advanced significantly, leading to significant technological successes. Hardware improvements have fueled software implementation and algorithmic integration, while sophisticated software enables efficient big data aggregation and biomarker discovery. Patients' familiarity with existing technology will facilitate the integration of digital health with neuromodulation therapies. The building blocks for effective solutions are often used in alternative applications, such as smartphones and smart watches for healthcare add-ons.
A rise in the product launches by key players in the market will help the overall market to grow during the forecast period. For instance, in July 2022 Orchestra BackBeat CNT, a highly sophisticated cardiac neuromodulation therapy, was created by collaboration between BioMed and Medtronic. It is combined with several antihypertensive drugs and is designed in a way that it operates automatically without depending on patient compliance. Furthermore, it can be simply modified to work with pacemakers and other cardiac rhythm control devices utilizing standard implant and lead installation techniques.
Additionally, in January 2022 Medtronic received FDA approval for its Intellis and Vanta rechargeable neurostimulator devices for treating chronic pain in diabetic peripheral neuropathy (DPN). DPN is a progressive neurological disorder affecting 30% of diabetes patients, causing numbness, burning, and severe pain. Medications are often only partially effective and can cause serious side effects.
The high cost of neuromodulation procedures and devices is a major factor restraining the growth of the global neuromodulation market, especially in developing countries with poor reimbursement policies. The average cost of a standard implantable pulse generator is -USD implantation procedures can cost as high as USD 25,000-35,000.
Spinal cord stimulator devices cost around USD 13,000-40,000. Owing to high costs and a poor reimbursement scenario, a very limited pool of patients in developing countries can afford neurological treatment. As a result, healthcare facilities are reluctant to invest in new or technologically advanced systems, thus limiting the growth of the neuromodulation market.
The global neuromodulation devices market is segmented based on type, application, biomaterial, end user and region.
The invasive neuromodulation segment from the type segment accounted for 41.7% and it is expected to be dominated during the forecast period. SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as a treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain syndrome, neuropathic pain, and ischemia-related refractory pain. The main benefits of the therapy are the decreased need for pain medication and overall improvement of the quality of life.
For instance, on April 19 2023 the company announced U.S. Food and Drug Administration (FDA) approval for Prospera, a spinal cord stimulation (SCS) system. The system features RESONANCE, the first and only multiphase stimulation paradigm, paired with Embrace One™, a patient-centric care model that makes proactive care possible by offering automatic, objective, daily remote monitoring and ongoing management and support.
Furthermore, in August 2022 Abbott announced that the U.S. Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy. The next generation of Abbott's proprietary BurstDR stimulation, FlexBurst360 therapy offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person's therapeutic needs evolve.
Designed to fit within a person's life, the Proclaim Plus SCS system is recharge-free with a battery that can last up to 10 years.^ It can be used with Abbott's NeuroSphere Virtual Clinic connected care technology, which allows a person to both communicate with a physician through secure in-app video chat and remotely receive stimulation settings in real-time regardless of location.
North America is estimated to hold about 38.4 % of the total market share throughout the forecast period, owing to the presence of major market players and huge pharmaceutical and biopharmaceutical industries, launches by key players, coupled with the rising investments in the country for the adoption of advanced technologies, an increasing number of patients suffering from neurological disorders, which is increasing the need for the adoption of neuromodulation devices, increased competition among market players, and significant expenditure on research and development.
On March 24, 2022, Medtronic plc, a global leader in healthcare technology, announced the first patient implants in the TITAN 2 pivotal study that will evaluate the safety and efficacy of Medtronic's investigational implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). The minimally invasive technology stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate the neural activity of the bladder.
For instance, in December 2022, Abbott announced the U.S. Food and Drug Administration (FDA) approval of the company's Eterna spinal cord stimulation (SCS) system - the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain. Eterna SCS utilizes Abbott's proprietary low-dose BurstDR stimulation, the only SCS waveform technology with the highest level of clinical evidence (1A evidence), proven to reduce pain 23% more than traditional waveform technology approaches.
The major global players in the market include Medtronic Plc, Abbott Laboratories, Boston Scientific Corp, LivaNova Plc , Integer Holdings Corporation, ElectroCore, Caputron, NeuroPce Inc, Nevro Corporation, BrainsWay and among others.
In the wake of the COVID-19 pandemic, the neurostimulation devices industry witnessed a major slump, due to the supply chain challenges and a limited workforce. Several non-emergency surgical procedures were also postponed during the initial months of the crisis.
Also, in the case of TMS, there was already enthusiastic interest in accelerated TMS protocols for depression before the emergence of COVID-19. During a pandemic, potential reductions in time to response, treatment time, and overall days of treatment with accelerated intermittent theta-burst stimulation (aiTBS), in comparison to standard TMS protocols, may have exciting implications for mitigating viral transmission risk as well as for increasing treatment accessibility.
The Global Neuro Modulation Devices Market report would provide approximately 61 tables, 58 figures and 186 Pages.
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