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全球经颅直流电刺激市场 - 2024-2031

Global Transcranial Direct Current Stimulation Market - 2024-2031

出版日期: 2024年10月22日 | 出版商:

DataM Intelligence | 英文 183 Pages | 商品交期: 最快1-2个工作天内

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简介目录

报告概述

2023年，全球经颅直流电刺激市场规模达13.4613亿美元，预计2031年将达到27.4188亿美元，2024-2031年预测期间复合年增长率为9.3%。

经颅直流电刺激 (tDCS) 是一种非侵入性脑刺激技术，涉及透过电极向头皮施加低电流。通常，该电流范围为 1 至 2 mA。 tDCS 透过传递正（阳极）或负（阴极）电流来调节目标大脑区域的神经元活动。这些电极的位置决定了电流的流动方式，从而刺激大脑的特定区域。

tDCS 的机制不涉及神经元产生动作电位；相反，它会产生“亚阈值”效应，增强或抑制已经活跃的神经元的活动。这可以被概念化为 tDCS 促进与任务或学习过程相关的持续大脑活动。在细胞层面上，tDCS 会影响神经元放电并增强突触传递，从而促进突触可塑性，这对于学习至关重要。

tDCS 经常与训练活动结合使用，其中刺激会放大训练本身产生的学习效果。正在探索的 tDCS 临床应用包括治疗忧郁症、精神分裂症、失语症、成瘾、癫痫、慢性疼痛（包括偏头痛和纤维肌痛）、注意力障碍和运动復健等疾病。除了医疗用途之外，经颅直流电刺激 (tDCS) 也应用于非临床环境，例如加速学习、提高注意力、放鬆和冥想。

市场动态：

司机

神经和精神疾病盛行率不断增加

全球经颅直流电刺激（tDCS）市场的需求是由多种因素所驱动的。关键因素之一是神经和精神疾病的盛行率不断增加。忧郁、焦虑、慢性疼痛和认知障碍等心理健康问题的发生率不断上升，极大地影响了经颅直流电刺激 (tDCS) 市场的扩张。 tDCS 是一种非侵入性脑刺激方法，可将温和的电流传送到头皮的目标区域，旨在影响神经元活动并增强神经可塑性。

tDCS 透过改变大脑特定区域神经元的兴奋性来发挥作用。当施加阳极（正）刺激时，它可以增加神经元的兴奋性，而阴极（负）刺激可以降低神经元的兴奋性。这种调节可以导致大脑功能发生变化，有利于治疗一系列精神和神经系统疾病。《柳叶刀神经病学》发表的一项重要研究显示，截至 2021 年，全球有超过 30 亿人受到神经系统疾病的影响，占全球人口的 43% 以上。

此外，行业研究活动、技术进步和产品批准的关键参与者将推动该市场的成长。例如，根据2024 年1 月HCPLive 新闻报道，最近的一项研究发现，对于个人而言，家用经颅直流电刺激(tDCS) 与数位心理干预或数位安慰剂相结合时，并未表现出优于假治疗的优越性。这项结论来自一项结构良好的临床试验，旨在评估这些干预措施的功效。

此外，在 2024 年 1 月的《欧洲医疗保健》研究出版物中，自我管理的大脑刺激，特别是透过颅内直流电刺激 (tDCS)，正在成为治疗忧郁症的一种新工具。这种方法允许患者在家中管理他们的治疗，可能增加重度忧郁症 (MDD) 患者的可近性和便利性。

同样，2022 年 5 月，Flow Neuroscience 宣布已获得美国食品药物管理局 (FDA) 的完全研究设备豁免 (IDE) 批准，可使用其自我管理经颅直流电刺激在美国进行一项关键试验。耳机，用于治疗重度忧郁症（MDD）。这标誌着他们在使忧郁症患者更容易获得创新的脑刺激技术方面迈出了重要一步。

限制

监管挑战、替代神经调节技术的存在以及个人缺乏意识等因素预计将阻碍市场的发展。

细分市场分析

全球经颅直流电刺激 (tDCS) 市场根据设备类型、应用、最终用户和地区进行细分。

1*1 tDCS平台部分约占全球经颅直流电刺激（tDCS）市场份额的46.8%

1*1 tDCS 平台领域预计将在预测期内占据最大的市场份额。 Soterix Medical 开发的 1x1 tDCS 平台是经颅直流电刺激 (tDCS) 市场的领先设备，以其精度、可靠性和客製化能力而闻名。该平台专为临床和研究应用而设计，提供一系列独特的功能，使其有别于其他设备。

该平台具有开放式面板介面，可简化设定过程并促进对刺激设定的直接监控。此外，它还采用了 SmartSCAN 等先进技术，可即时监控电极接触，而 TrueCurrent 可确保整个刺激过程中电流传输的一致性。

Soterix Medical 1x1 tDCS 设备代表了经颅直流电刺激 (tDCS) 领域的重大进步，专为临床研究和治疗应用而设计。 1x1 平台由临床研究人员、科学家和生物医学工程师团队开发，因其在提供 tDCS 协议方面的精度和可靠性而受到认可。

Soterix Medical 1x1 tDCS 设备被认为是神经调节领域的首要解决方案，特别是针对旨在解决忧郁症等心理健康问题的研究和临床应用。其设计将使用者友善的功能与先进的技术和适应性相结合，使其成为希望研究 tDCS 治疗效果同时确保研究安全性和一致性的研究人员的必备工具。因此，它已成为临床试验中准确且可重复的 tDCS 的基准，有助于推动脑部刺激疗法知识的进步。

市场地理分析

北美约占全球经颅直流电刺激（tDCS）市场份额的43.2%

由于忧郁、焦虑和慢性疼痛等神经和精神疾病的盛行率不断上升，北美地区预计将在预测期内占据最大的市场份额，这是推动经颅直流电刺激扩张的主要因素。

医疗保健专业人员和患者对非侵入性治疗方案的认可和接受程度越来越高。这一趋势推动了 tDCS 设备在临床环境中的采用，作为传统药物疗法的可行替代方案。此外，在该地区，大量关键参与者的存在、先进的医疗保健基础设施、对家用设备不断增长的需求、创新技术进步、政府倡议以及正在进行的研究、产品发布和批准将推动该市场的成长。

例如，2022 年 4 月，佛罗里达州立大学护理学院成立了脑科学和症状管理中心 (BSSMC)，该机构专注于跨学科研究，利用脑部刺激和电脑技术优化疼痛和症状管理。该中心由 Hyochol "Brian" Ahn 博士领导，他获得了美国国立卫生研究院 (NIH) 的大量资助，探索使用经颅直流电刺激 (tDCS) 与基于正念的冥想相结合进行自我管理患有膝骨关节炎的老年人的临床疼痛和症状。

此外，2023 年 3 月，Sooma Medical 因其旨在治疗忧郁症的便携式、患者管理的神经调节设备获得了美国食品和药物管理局 (FDA) 的突破性设备认定。该头衔授予那些在改善严重或危及生命疾病的治疗选择方面表现出巨大潜力的创新疗法。

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that involves applying a low electric current to the scalp through electrodes. Typically, this current ranges from 1 to 2 mA. tDCS operates by delivering either a positive (anodal) or negative (cathodal) current, which modulates neuronal activity in targeted brain regions. The positioning of these electrodes determines how the current flows, allowing for specific areas of the brain to be stimulated.

The mechanism of tDCS does not involve generating action potentials in neurons; instead, it produces "sub-threshold" effects that enhance or inhibit the activity of already active neurons. This can be conceptualized as tDCS boosting ongoing brain activity related to tasks or learning processes. At the cellular level, tDCS influences neuronal firing and enhances synaptic transmission, thereby promoting synaptic plasticity, which is essential for learning.

tDCS is frequently utilized in conjunction with training activities, where the stimulation amplifies the learning effects produced by the training itself. Clinical applications being explored for tDCS include treatment for conditions such as depression, schizophrenia, aphasia, addiction, epilepsy, chronic pain (including migraines and fibromyalgia), attention disorders, and motor rehabilitation. Beyond medical uses, tDCS is also applied in non-clinical settings for purposes like accelerated learning, improved focus, relaxation, and meditation.

Market Dynamics: Drivers

Increasing prevalence of neurological and psychiatric disorders

The demand for the global transcranial direct current stimulation (tDCS) market is driven by multiple factors. One of the key factors is the increasing prevalence of neurological and psychiatric disorders. The rising rates of mental health issues, including depression, anxiety, chronic pain, and cognitive impairments, have greatly impacted the expansion of the transcranial direct current stimulation (tDCS) market. tDCS is a non-invasive brain stimulation method that delivers a mild electrical current to targeted regions of the scalp, intending to influence neuronal activity and enhance neuroplasticity.

tDCS operates by modifying the excitability of neurons in specific areas of the brain. When anodal (positive) stimulation is applied, it can increase neuronal excitability, whereas cathodal (negative) stimulation can decrease it. This modulation can result in functional changes in the brain that are advantageous for treating a range of psychiatric and neurological conditions. A significant study published in the Lancet Neurology revealed that as of 2021, more than 3 billion individuals globally were affected by neurological conditions, which account for over 43% of the world's population.

Moreover, key players in the industry research activities, technological advancements, and product approvals would drive this market growth. For instance, as per HCPLive news in January 2024, a recent study has found that home-use transcranial direct current stimulation (tDCS), when combined with either a digital psychological intervention or a digital placebo, does not demonstrate superiority over sham treatment for individuals experiencing a major depressive episode. This conclusion comes from a well-structured clinical trial designed to assess the efficacy of these interventions.

Also, in a Healthcare Europe research publication in January 2024, self-administered brain stimulation, particularly through transcranial direct current stimulation (tDCS), is emerging as a novel tool for treating depression. This approach allows patients to manage their treatment at home, potentially increasing accessibility and convenience for those suffering from major depressive disorder (MDD).

Similarly, in May 2022, Flow Neuroscience announced that it had received full Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct a pivotal trial in the United States using its self-managed transcranial direct current stimulation (tDCS) headset for the treatment of Major Depressive Disorder (MDD). This marks a significant step in making their innovative brain stimulation technology more accessible to patients suffering from depression.

Restraints

Factors such as regulatory challenges, the presence of alternative neuromodulation techniques, and lack of awareness among individuals are expected to hamper the market.

Market Segment Analysis

The global transcranial direct current stimulation (tDCS) market is segmented based on device type, application, end-user, and region.

The 1x1 tDCS platform segment accounted for approximately 46.8% of the global transcranial direct current stimulation (tDCS) market share

The 1x1 tDCS platform segment is expected to hold the largest market share over the forecast period. The 1x1 tDCS platform developed by Soterix Medical is a leading device in the transcranial direct current stimulation (tDCS) market, known for its precision, reliability, and customization capabilities. This platform is designed for both clinical and research applications, offering a range of unique features that set it apart from other devices.

The platform features an Open-Panel interface that streamlines the setup process and facilitates straightforward monitoring of stimulation settings. Additionally, it utilizes advanced technologies like SmartSCAN, which provides real-time monitoring of electrode contact, and TrueCurrent, which guarantees consistent current delivery during the entire stimulation session.

The Soterix Medical 1x1 tDCS device represents a significant advancement in the field of transcranial direct current stimulation (tDCS), designed specifically for clinical research and therapeutic applications. Developed by a team of clinical researchers, scientists, and biomedical engineers, the 1x1 platform is recognized for its precision and reliability in delivering tDCS protocols.

The Soterix Medical 1x1 tDCS device is recognized as a premier solution in the neuromodulation field, particularly for research and clinical applications aimed at addressing mental health issues such as depression. Its design combines user-friendly features with advanced technology and adaptability, making it an essential instrument for researchers who wish to investigate the therapeutic benefits of tDCS while ensuring safety and consistency in their studies. Consequently, it has established itself as the benchmark for accurate and reproducible tDCS in clinical trials, contributing to the advancement of knowledge regarding brain stimulation therapies.

Market Geographical Analysis

North America accounted for approximately 43.2% of the global transcranial direct current stimulation (tDCS) market share

North America region is expected to hold the largest market share over the forecast period owing to the growing prevalence of neurological and psychiatric disorders, including depression, anxiety, and chronic pain, which is a major factor driving the expansion of the transcranial direct current stimulation (tDCS) market.

There is an increasing recognition and acceptance of non-invasive treatment options among healthcare professionals and patients alike. This trend is fueling the adoption of tDCS devices in clinical settings as a viable alternative to conventional pharmacological therapies. Moreover, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, rising demand for home-use devices, innovative technological advancements, government initiatives, and ongoing research studies, product launches & approvals would propel this market growth.

For instance, in April 2022, the Florida State University College of Nursing launched the Brain Science and Symptom Management Center (BSSMC), an institute focused on interdisciplinary research to optimize pain and symptom management using brain stimulation and computer technology. The center is led by Dr. Hyochol "Brian" Ahn, who has received significant funding from the National Institutes of Health (NIH) to explore the use of transcranial direct current stimulation (tDCS) in combination with mindfulness-based meditation for self-management of clinical pain and symptoms in older adults with knee osteoarthritis.

Also, in March 2023, Sooma Medical received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its portable, patient-administered neuromodulation device aimed at treating depression. This designation is granted to innovative therapies that show significant potential to improve treatment options for severe or life-threatening conditions.

Market Segmentation

By Device Type

Depression LTE System

1x1 tDCS Platform

Thebraindriver v2.1 Deluxe System

DC-Stimulator Mobile

Nurostym Transcranial Electrical Stimulation (tES)

Others

By Application

Depression

Anxiety

Chronic Pain

Cognitive Impairments

By End-User

Hospitals & Home Use

Neurological Clinics

Ambulatory Surgical Centers

Others

By Region

North America

U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the transcranial direct current stimulation (tDCS) market include Soterix Medical Inc., TheBrainDriver, LLC., Neurocare group AG, Brainbox Ltd, BrainsWay, Magstim, eNeura Inc., MagVenture A/S, Nexalin Technology, and RPW Technology, LLC among others.

Key Developments

In September 2024, the medical-grade neurotechnology wearable for premenstrual syndrome (PMS) refers to an innovative device designed to provide a drug-free solution for managing PMS and menstrual pain. This wearable, developed by the startup Samphire Neuroscience and named Nettle, utilizes transcranial direct current stimulation (tDCS) to target specific areas of the brain associated with mood regulation and pain perception.

In April 2024, Neurovalens, a Belfast-based neurotech startup, received FDA clearance for its Modius Stress device, a non-invasive home-use neurostimulation system designed to treat generalized anxiety disorder (GAD).

Why Purchase the Report?

To visualize the global transcranial direct current stimulation (tDCS) market segmentation based on device type, application, end-user, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points on the transcranial direct current stimulation (tDCS) market with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel with key products of all the major players.

The global transcranial direct current stimulation (tDCS) market report would provide approximately 62 tables, 57 figures, and 183 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Device Type
3.2. Snippet by Application
3.3. Snippet by End-User
3.4. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Increasing Prevalence of Neurological and Psychiatric Disorders
- 4.1.2. Restraints
  - 4.1.2.1. Regulatory Challenges
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis

6. By Device Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 6.1.2. Market Attractiveness Index, By Device Type
6.2. Depression LTE System *
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. 1x1 tDCS Platform
6.4. Thebraindriver v2.1 Deluxe System
6.5. DC-Stimulator Mobile
6.6. Nurostym Transcranial Electrical Stimulation (tES)
6.7. Others

7. By Application

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 7.1.2. Market Attractiveness Index, By Application
7.2. Depression *
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Anxiety
7.4. Chronic Pain
7.5. Cognitive Impairments

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Hospitals & Home Use *
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Neurological Clinics
8.4. Ambulatory Surgical Centers
8.5. Others

9. By Region

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 9.1.2. Market Attractiveness Index, By Region
9.2. North America
- 9.2.1. Introduction
- 9.2.2. Key Region-Specific Dynamics
- 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.2.6.1. U.S.
  - 9.2.6.2. Canada
  - 9.2.6.3. Mexico
9.3. Europe
- 9.3.1. Introduction
- 9.3.2. Key Region-Specific Dynamics
- 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.3.6.1. Germany
  - 9.3.6.2. U.K.
  - 9.3.6.3. France
  - 9.3.6.4. Spain
  - 9.3.6.5. Italy
  - 9.3.6.6. Rest of Europe
9.4. South America
- 9.4.1. Introduction
- 9.4.2. Key Region-Specific Dynamics
- 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.4.6.1. Brazil
  - 9.4.6.2. Argentina
  - 9.4.6.3. Rest of South America
9.5. Asia-Pacific
- 9.5.1. Introduction
- 9.5.2. Key Region-Specific Dynamics
- 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 9.5.6.1. China
  - 9.5.6.2. India
  - 9.5.6.3. Japan
  - 9.5.6.4. South Korea
  - 9.5.6.5. Rest of Asia-Pacific
9.6. Middle East and Africa
- 9.6.1. Introduction
- 9.6.2. Key Region-Specific Dynamics
- 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
- 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

10.1. Competitive Scenario
10.2. Market Positioning/Share Analysis
10.3. Mergers and Acquisitions Analysis

11. Company Profiles

11.1. Soterix Medical Inc.*
- 11.1.1. Company Overview
- 11.1.2. Product Portfolio and Description
- 11.1.3. Financial Overview
- 11.1.4. Key Developments
11.2. TheBrainDriver, LLC.
11.3. Neurocare Group AG
11.4. Brainbox Ltd.
11.5. BrainsWay
11.6. Magstim
11.7. eNeura Inc.
11.8. MagVenture A/S
11.9. Nexalin Technology
11.10. RPW Technology, LLC (*LIST NOT EXHAUSTIVE)