神経調節装置の世界市場（2024年～2031年）

世界の神経調節装置の市場規模は、2023年に57億9,000万米ドルに達し、2031年には87億8,000万米ドルに達すると予測され、予測期間2024年～2031年のCAGRは5.3％で成長する見通しです。

神経調節装置は、神経系の特定部位に向けられ、電気インパルスや薬剤などの刺激を正確に伝達して神経の活動を修正する新しい治療装置です。様々な痛み、震え、発作など、神経経路の異常によって引き起こされる様々な疾患の継続的な調節に用いられます。これらの装置に関する作用機序は、一般的に電気刺激または直接薬物投与技術であり、痛み信号のトランスミッションを抑制したり、神経機能を安定させたりすることができます。

市場力学：

促進要因と抑制要因

技術進歩の台頭

技術の進歩により、世界の神経調節装置市場は治療方法と患者の転帰を通じて大きな変化を遂げています。例えば、バッテリー技術や集積回路は、複雑な刺激パターンを効果的に与えることができる小型で充電可能なパルスインプラントジェネレーターを可能にしました。さらに、電極の新しい形状や波形を作り出すことで、神経調節装置の適応は拡大し、標的神経経路の非常に正確な刺激に焦点が当てられるようになりました。

さらに、モバイルプラットフォームや人工知能を含むデジタルヘルス技術の導入により、患者との積極的なコミュニケーションによって、リアルタイムでのデータ収集や患者のモニタリングが可能になり、治療計画のパーソナライズ化が進んでいます。デジタルソリューションの総体への移行は、診察だけでなく、より多くの面で患者集団に対応するものであり、24時間365日の対応とケアの継続が可能になり、エンゲージメントが促進されます。

例えば、メドトロニック・インドは2024年4月、パーキンソン病治療における脳深部刺激療法用のポータブルNeuroSmartTM微小電極記録（MER）ナビゲーションシステムを発売しました。

DBSは、振戦、硬直、歩行困難などのパーキンソン病の症状発現に対する治療法です。DBSでは、小型のペースメーカーのような装置が、「リード」と呼ばれる非常に細いワイヤーを通して、症状が生じる脳の標的部位に電気信号を送ります。高度なDBSインプラントは、植え込まれたDBSシステムを使用して脳信号を捕捉するように設計されています。NeuroSmartポータブルMERナビゲーションシステムは、手術の精度を向上させるので、DBS治療の面で素晴らしい変化をもたらします。

規制上の課題

世界の神経調節装置市場は、医療当局が課す規制上の課題や長い承認プロセスによる大きな抑制要因に直面しています。このような厳しい安全性と有効性の評価は、新しい機器の導入を遅らせ、技術革新を妨げ、有益な治療法への患者のアクセスを制限する可能性があります。規制当局の承認を得るには、多くの場合、大規模な臨床試験が必要となり、時間とコストがかかるため、中小企業の市場参入を阻むことになります。

さらに、安全性の懸念による製品回収のリスクは、状況をさらに複雑にし、メーカーの評判に影響を与え、医療従事者や患者の間に信頼の欠如を引き起こす可能性があります。このような複雑な規制環境は、神経調節装置市場で事業を展開する企業にとって依然として重要な課題です。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 技術進歩の高まり
• 抑制要因
  • 規制上の課題
• 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析

第6章 製品タイプ別

• 脊髄刺激装置
• 脳深部刺激装置
• 仙骨神経刺激装置
• 迷走神経刺激装置
• 胃電気刺激
• その他

第7章 用途別

• パーキンソン病
• 慢性疼痛
• てんかん
• 片頭痛
• 尿失禁および便失禁
• 震え
• うつ
• その他

第8章 エンドユーザー別

• 病院
• 外来手術センター（ASC）
• クリニックと理学療法センター
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第11章 企業プロファイル

• Medtronic Plc
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• Abbott Laboratories
• Boston Scientific Corp
• LivaNova Plc
• Integer Holdings Corporation
• ElectroCore
• Caputron
• NeuroPce lnc
• Nevro Corporation
• BrainsVVay

第12章 付録

The global neuromodulation devices market reached US$ 5.79 billion in 2023 and is expected to reach US$ 8.78 billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031.

Neuromodulation devices are new treatment devices that are directed to a specific region in the nervous system to modify the activity of the nerve through a precisely delivered stimulus such as electrical impulses or even pharmaceutical agents. It attends the continued modulation of various diseases caused by abnormal neural pathways, such as in the case for various pain, tremors, or seizures. The action mechanisms concerning these devices are generally electrical stimulation or direct drug administration techniques that can inhibit the transmission of pain signals or stabilize nerve function.

Market Dynamics: Drivers & Restraints

Rise in the Technological Advancements

Technological advancements have indeed made enormous changes at the global neuromodulation devices market via treatment modalities and patient outcomes. Innovations include the miniaturization of devices which have allowed more sophisticated and less invasive interventions, for example, battery technology and integrated circuits have enabled smaller, rechargeable pulse implant generators that can deliver complex stimulation patterns effectively. In addition, by creating novel geometries and waveforms of electrodes, the indications of neuromodulation devices have expanded to focus on very precise stimulations of target neural pathways.

In addition, with the infusion of digital health technologies-including mobile platforms and artificial intelligence-active communication with the patient opens up greater personalization of treatment plans, as it allows for real-time data collection and patient monitoring. It is this move towards the totality of digital solutions that will address patient populations on more fronts than just consults-24/7 availability and care continuity will be made available, fostering engagement.

For instance, in April 2024, Medtronic India has launched a portable NeuroSmartTM microelectrode recording (MER) navigation system for deep brain stimulation in the treatment of Parkinson's disease.

DBS is a treatment for symptomatic manifestations of Parkinson's disease, including tremors, rigidity, and difficulty walking. In DBS, a small pacemaker-like device sends electrical signals through very thin wires, known as "leads," to a targeted area in the brain where the symptoms arise. The advanced DBS implant is designed such that it captures brain signals using the using implanted DBS system. NeuroSmart Portable MER Navigation system makes wonderful changes in terms of DBS treatment as it improves accuracy of the surgery.

Regulatory Challenges

The global neuromodulation devices market faces significant restraints due to regulatory challenges and lengthy approval processes imposed by health authorities. These stringent safety and efficacy evaluations can delay the introduction of new devices, hindering innovation and limiting patient access to beneficial therapies. Obtaining regulatory approval often involves extensive clinical trials, which can be time-consuming and costly, deterring smaller companies from entering the market.

Additionally, the risk of product recalls due to safety concerns can further complicate the landscape, impacting manufacturers' reputations and causing a lack of trust among healthcare providers and patients. This complex regulatory environment remains a critical challenge for companies operating in the neuromodulation devices market.

Segment Analysis

The global neuromodulation devices market is segmented based on product type, application, end user and region.

Product type:

Spinal Cord Stimulators segment is expected to dominate the neuromodulation devices market share

The spinal cord stimulators segment holds a major portion of the neuromodulation devices market share and is expected to continue to hold a significant portion of the neuromodulation devices market share during the forecast period.

Spinal Cord Stimulation (SCS) implantation involves a minor device implanted under the skin that conducts low-voltage electrical currents into the spinal cord to interrupt pain signals before they reach the brain. This technique really works by alleviating pain and restoring motion to those patients who suffer from ongoing pain. This implantable neurostimulator functions according to the principle of gate control theory, whereby the pain signals are modulated by electrical impulses so that escape is possible from a painful burden- chronic pain that might be found in the back, hands, and feet. In such an innovative idea, it shall allow the affected to bring their lives back to what is almost considered normal.

For instance, in September 2024, Nevro Corp. a worldwide corporation with medical devices rendering exhaustively comprehensive life-changing solutions for chronic pain treatment, has revealed the FDA approval and limited market release of HFX iQ with HFX AdaptivAI, which is part of a responsive, personalized pain management platform powering the HFX iQ spinal cord stimulation (SCS) system.

Moreover, in February 2024, Boston Scientific Corporation announced an expanded indication by the US Food and Drug Administration (FDA) for the WaveWriter SCS Systems in the treatment of chronic low back and leg pain with no prior back surgery, popularly known as non-surgical back pain (NSBP).

Application:

Parkinson's Disease segment is the fastest-growing segment in neuromodulation devices market share

The parkinson's disease segment is the fastest-growing segment in the neuromodulation devices market share and is expected to hold the market share over the forecast period.

Parkinson's disease is a major factor in the Global Neuromodulation Devices Market, as it leads to a growing demand for effective treatments to manage its symptoms. Traditional treatments, such as pharmacotherapy, may become less effective over time, leading to a growing interest in neuromodulation therapies like deep brain stimulation (DBS). DBS alleviates motor symptoms by delivering electrical impulses to targeted brain regions, restoring normal neural activity and improving motor function.

Moreover, advancements in neuromodulation technologies have expanded treatment options beyond invasive methods, exploring non-invasive techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) for enhancing cognitive and motor functions in Parkinson's patients. These innovations reflect a trend towards personalized medicine in treating neurological disorders. The market is expected to see robust growth due to the rising prevalence of Parkinson's disease and the need for more effective management strategies.

For instance, in January 2024, Abbott has declared that the U.S. Food and Drug Administration (FDA) provided clearance for them to launch the smallest rechargeable deep-brain stimulation (DBS) system with remote programming in the world for patients suffering from movement disorders: the Liberta RC DBS system. This system also requires the least number of recharges of any DBS system so far approved by the FDA-just 10 sessions per year for most people.

Geographical Analysis

North America is expected to hold a significant position in the neuromodulation devices market share

North America holds a substantial position in the neuromodulation devices market and is expected to hold most of the market share due to factors such as the increasing incidence of neurological disorders like Parkinson's and Alzheimer's, as well as the preference for minimally invasive techniques due to their short recovery period and lower surgical risks. Technological advancements, digital health technologies, and robust health infrastructures in North America contribute to the market's growth. Government initiatives and funding for neurological research further enhance market growth by raising awareness and accessibility of these therapies. This combination of factors will continue to drive innovation and adoption of neuromodulation devices in North America, ensuring the continued success of this vital healthcare solution.

For instance, in January 2023, Axonics, a global medical technology company, has received approval from the U.S. Food and Drug Administration for its fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator has a functional life of at least 20 years and reduces the frequency of device recharge to once every 6 to 10 months for only one hour.

Moreover, in February 2023, ANEUVO, a platform and therapy development company, has launched a clinical study on the ExaStim TSS system, a wirelessly-controlled neuromodulation system designed for transcutaneous spinal cord stimulation. The study, titled ASPIRE, will evaluate the safety and effectiveness of ExaStim in combination with traditional rehabilitation therapy for individuals with upper extremity paralysis due to spinal cord injury.

Europe is growing at the fastest pace in the neuromodulation devices market

Europe holds the fastest pace in the neuromodulation devices market and is expected to hold most of the market share due to the increasing prevalence of neurological disorders like Parkinson's, epilepsy, and chronic pain. The geriatric population is also growing, increasing demand for neuromodulation therapies. Minimally invasive surgical techniques are becoming more popular due to their reduced recovery times and lower risks. Technological advancements have led to the development of more sophisticated and effective neuromodulation devices, making them more accessible to patients who may not be candidates for invasive procedures. Europe's well-established healthcare infrastructure supports extensive research and development initiatives, facilitating the introduction of new therapies into the market.

For instance, in June 2024, the first teenager to become a patient in the UK trials for deep brain stimulation for the treatment of epilepsy experienced an 80% reduction in seizures. Severe epileptic seizures that have persisted in Oran from the age of four and almost always required resuscitation ended when he became the first child in the UK to have this device implanted at Great Ormond Street Hospital in October 2023 at the age of 12; only eight months have gone and there is already a significant reduction in both frequency and severity of seizures.

Competitive Landscape

The major global players in the neuromodulation devices market include Medtronic Plc, Abbott Laboratories, Boston Scientific Corp, LivaNova Plc, Integer Holdings Corporation, ElectroCore, Caputron, NeuroPce lnc, Nevro Corporation, BrainsVVay among others.

Emerging Players

The emerging players in the neuromodulation devices market include electroCore, Inc, Parasym Ltd, ALEVA NEUROTHERAPEUTICS SA and among others

Key Developments

• In November 2024, Medtronic has launched the InterStim X Sacral Neuromodulation (SNM) system in India for treating overactive bladder, chronic fecal incontinence, and non-obstructive urinary retention. The system offers personalized sacral nerve stimulation therapy, targeting nerve signals that regulate bladder functions. It may reduce symptoms of incontinence, such as frequent bathroom trips and accidents, and is an advanced treatment for those who are not responding to other non-invasive therapies.
• In April 2024, Magnus Medical launched SAINT neuromodulation system, a rapid-acting therapy for treatment-resistant major depressive disorder.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global neuromodulation devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

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 Product 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. Rise in the Technological Advancements
• 4.2. Restraints
  • 4.2.1.1. Regulatory Challenges
• 4.3. Opportunity
  • 4.3.1. 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 Product type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product type
  • 6.1.2. Market Attractiveness Index, By Product type
• 6.2. Spinal Cord Stimulators*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Deep Brain Stimulators
• 6.4. Sacral Nerve Stimulators
• 6.5. Vagus Nerve Stimulators
• 6.6. Gastric Electrical Stimulation
• 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. Parkinson's Disease*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Chronic Pain
• 7.4. Epilepsy
• 7.5. Migraine
• 7.6. Urinary & Faecal Incontinence
• 7.7. Tremor
• 7.8. Depression
• 7.9. Others

8. By End User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 8.1.2. Market Attractiveness Index, By End User
• 8.2. Hospitals*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Ambulatory Surgery Centers (ASC)
• 8.4. Clinics & Physiotherapy 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 Product 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 Product 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 Product 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 Product 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 Product 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. Medtronic Plc*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Abbott Laboratories
• 11.3. Boston Scientific Corp
• 11.4. LivaNova Plc
• 11.5. Integer Holdings Corporation
• 11.6. ElectroCore
• 11.7. Caputron
• 11.8. NeuroPce lnc
• 11.9. Nevro Corporation
• 11.10. BrainsVVay

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1 About Us and Services
• 12.2 Contact Us