自律神経失調症の市場規模、疫学、治療薬販売、パイプライン、地域別展望2025-2035

• 英文タイトル：Dysautonomia Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

• レポートコード：IMA2994PE4782 • 出版社/出版日：IMARC / 2025年2月 • レポート形態：英語、PDF、約120ページ • 納品方法：Eメール（納期：3日） • 産業分類：製薬

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レポート概要

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2024年における自律神経障害（Dysautonomia）市場は、米国・欧州4カ国（ドイツ、フランス、イタリア、スペイン）、英国、日本を合わせた7主要市場で23億米ドル規模に達し、2035年には62億米ドルに拡大すると予測されている。2025～2035年の年平均成長率（CAGR）は9.39％と高く、主に遺伝子変異、神経変性疾患、糖尿病性神経障害などに起因する自律神経機能障害の増加が市場拡大を牽引している。自律神経障害は、血圧や心拍、消化、体温調節、排泄など無意識下の身体機能を制御する自律神経系がうまく働かなくなる疾患である。症状としては、めまい、失神、頻脈や不整脈、発汗異常、便秘、倦怠感、集中力低下、体温調節障害などがあり、頭痛、不安、筋力低下、血圧変動などを伴うことも多い。診断は問診と身体検査に加え、傾斜試験（Tilt Table Test）や自律神経反射検査、発汗反射検査などの専門的検査で行われる。また血液検査、画像診断、神経学的評価、心機能検査などで他疾患を除外しつつ、自律神経の総合的機能を評価する。 市場成長を支える要因として、遺伝的要因に加え、神経損傷、慢性感染、脊髄損傷、糖尿病性末梢神経障害など複数のリスク因子が挙げられる。さらに、脳深部刺激（DBS）や脊髄刺激（SCS）といった神経刺激療法の需要が拡大しており、これらは電極を埋め込み神経活動を電気的に制御することで症状を緩和する先進的治療法である。また、神経伝達物質受容体やイオンチャネルを標的とする新規薬の研究開発が進んでおり、多くの製薬企業が自律神経機能の改善を目的とした創薬投資を強化している。腸内細菌叢を介した治療（例：糞便微生物移植）も注目されており、炎症軽減や自律神経調節への効果が期待されている。 IMARCの分析によると、米国が最大の患者数と市場規模を持ち、次いで欧州、日本が続く。自律神経障害は世界で7,000万人以上が影響を受けており、生まれつき発症する場合もあれば、50～60歳代で後天的に発症するケースも多い。糖尿病患者の約20％、ギラン・バレー症候群患者の3分の1以上が本症を併発するという報告もある。家族性自律神経障害では新生児の生存率が40歳までに50％程度とされ、重篤な病態であることがうかがえる。レポートでは、治療実態、市販薬および開発中薬剤、各国の治療アルゴリズム、市場課題、補償制度、未充足医療ニーズなども包括的に分析。既存薬と後期開発薬の作用機序、臨床試験結果、市場導入状況などが詳細に整理されており、製薬企業や投資家にとって有用な市場指針となる。総じて、自律神経障害市場は遺伝的要因や慢性疾患の増加、神経刺激技術や新規薬開発の進展により、今後10年で大きな成長が見込まれる。

The dysautonomia market reached a value of USD 2.3 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 6.2 Billion by 2035, exhibiting a growth rate (CAGR) of 9.39% during 2025-2035.

The dysautonomia market has been comprehensively analyzed in IMARC’s new report titled “Dysautonomia Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035”. Dysautonomia is a medical condition characterized by impairment or dysfunction of the autonomic nervous system. The autonomic nervous system controls and regulates involuntary bodily functions, such as blood pressure, heart rate, digestion, temperature regulation, bladder and bowel control, etc. Some of the common symptoms associated with the ailment are dizziness, lightheadedness, fainting or near-fainting episodes, rapid or irregular heart rate, excessive or lack of sweating, constipation, fatigue, cognitive impairment, problems with body temperature regulation, etc. Various other indications may include headaches, sleep disturbances, anxiety, difficulty concentrating, muscle weakness, fluctuations in blood pressure, etc. The diagnostic process typically begins with a thorough medical history and physical examination, where the healthcare provider will assess symptoms and look for signs of autonomic dysfunction. Numerous specialized tests, including autonomic function tests, such as tilt table testing, autonomic reflex testing, quantitative sudomotor axon reflex testing, etc., are also conducted. Additional diagnostic procedures, including blood investigations, imaging studies, neurological assessments, cardiac evaluations, etc., may be utilized to rule out other potential causes and evaluate overall autonomic function.
The increasing cases of gene mutations that predispose individuals to autonomic nerve malfunction or degeneration are primarily driving the dysautonomia market. In addition to this, the rising prevalence of several associated risk factors, such as neurodegenerative disorders, chronic infections, physical trauma or injury to the autonomic nerves or spinal cord, diabetic neuropathy, etc., is acting as another significant growth-inducing factor. Moreover, the inflating demand for neurostimulation techniques, including deep brain stimulation (DBS) and spinal cord stimulation (SCS), which involve the implantation of electrodes that deliver controlled electrical impulses to targeted areas of the nervous system, thereby modulating its activity and alleviating autonomic dysfunction, is further creating a positive outlook for the market. Additionally, numerous key players are making extensive investments in R&D activities to introduce medications that target specific neurotransmitter receptors, modulate ion channels, and enhance autonomic function. This, in turn, is also bolstering the market growth. Furthermore, the emerging popularity of gut microbiome interventions, such as fecal microbiota transplantation, etc., since they aid in restoring gut dysbiosis, reducing inflammation, and improving autonomic function, is expected to drive the dysautonomia market in the coming years.
IMARC Group’s new report provides an exhaustive analysis of the dysautonomia market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for dysautonomia and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the dysautonomia market in any manner.
Key Highlights:
• Dysautonomia is a relatively prevalent illness affecting over 70 million people globally.
• It can be present at birth (congenital) or develop at any time in life, with the usual age of onset being 50 to 60.
• Dysautonomia affects approximately 20% of the diabetic population.
• Dysautonomia affects more than one-third of Guillain-Barré syndrome patients and is more common in those with severe weakness.
• According to current survival statistics, a newborn with familial dysautonomia has a 50% chance of living to the age of forty.
Time Period of the Study
• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035
Countries Covered
• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
Analysis Covered Across Each Country
• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the dysautonomia market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the dysautonomia market
• Reimbursement scenario in the market
• In-market and pipeline drugs
Competitive Landscape:
This report also provides a detailed analysis of the current dysautonomia marketed drugs and late-stage pipeline drugs.
In-Market Drugs
• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

レポート目次

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1 Preface

2 Scope and Methodology
2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
2.3.1 Primary Sources
2.3.2 Secondary Sources
2.4 Market Estimation
2.4.1 Bottom-Up Approach
2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Dysautonomia – Introduction
4.1 Overview
4.2 Regulatory Process
4.3 Epidemiology (2019-2024) and Forecast (2025-2035)
4.4 Market Overview (2019-2024) and Forecast (2025-2035)
4.5 Competitive Intelligence

5 Dysautonomia – Disease Overview
5.1 Introduction
5.2 Symptoms and Diagnosis
5.3 Pathophysiology
5.4 Causes and Risk Factors
5.5 Treatment

6 Patient Journey

7 Dysautonomia – Epidemiology and Patient Population
7.1 Epidemiology – Key Insights
7.2 Epidemiology Scenario – Top 7 Markets
7.2.1 Epidemiology Scenario (2019-2024)
7.2.2 Epidemiology Forecast (2025-2035)
7.2.3 Epidemiology by Age (​2019-2035​)
7.2.4 Epidemiology by Gender (​2019-2035​)
7.2.5 Epidemiology by Type (2019-2035)
7.2.6 Diagnosed Cases (2019-2035)
7.2.7 Patient Pool/Treated Cases (2019-2035)
7.3 Epidemiology Scenario – United States
7.3.1 Epidemiology Scenario (2019-2024)
7.3.2 Epidemiology Forecast (2025-2035)
7.3.3 Epidemiology by Age (​2019-2035​)
7.3.4 Epidemiology by Gender (​2019-2035​)
7.3.5 Epidemiology by Type (2019-2035)
7.3.6 Diagnosed Cases (2019-2035)
7.3.7 Patient Pool/Treated Cases (2019-2035)
7.4 Epidemiology Scenario – Germany
7.4.1 Epidemiology Scenario (2019-2024)
7.4.2 Epidemiology Forecast (2025-2035)
7.4.3 Epidemiology by Age (​2019-2035​)
7.4.4 Epidemiology by Gender (​2019-2035​)
7.4.5 Epidemiology by Type (2019-2035)
7.4.6 Diagnosed Cases (2019-2035)
7.4.7 Patient Pool/Treated Cases (2019-2035)
7.5 Epidemiology Scenario – France
7.5.1 Epidemiology Scenario (2019-2024)
7.5.2 Epidemiology Forecast (2025-2035)
7.5.3 Epidemiology by Age (​2019-2035​)
7.5.4 Epidemiology by Gender (​2019-2035​)
7.5.5 Epidemiology by Type (2019-2035)
7.5.6 Diagnosed Cases (2019-2035)
7.5.7 Patient Pool/Treated Cases (2019-2035)
7.6 Epidemiology Scenario – United Kingdom
7.6.1 Epidemiology Scenario (2019-2024)
7.6.2 Epidemiology Forecast (2025-2035)
7.6.3 Epidemiology by Age (​2019-2035​)
7.6.4 Epidemiology by Gender (​2019-2035​)
7.6.5 Epidemiology by Type (2019-2035)
7.6.6 Diagnosed Cases (2019-2035)
7.6.7 Patient Pool/Treated Cases (2019-2035)
7.7 Epidemiology Scenario – Italy
7.7.1 Epidemiology Scenario (2019-2024)
7.7.2 Epidemiology Forecast (2025-2035)
7.7.3 Epidemiology by Age (​2019-2035​)
7.7.4 Epidemiology by Gender (​2019-2035​)
7.7.5 Epidemiology by Type (2019-2035)
7.7.6 Diagnosed Cases (2019-2035)
7.7.7 Patient Pool/Treated Cases (2019-2035)
7.8 Epidemiology Scenario – Spain
7.8.1 Epidemiology Scenario (2019-2024)
7.8.2 Epidemiology Forecast (2025-2035)
7.8.3 Epidemiology by Age (​2019-2035​)
7.8.4 Epidemiology by Gender (​2019-2035​)
7.8.5 Epidemiology by Type (2019-2035)
7.8.6 Diagnosed Cases (2019-2035)
7.8.7 Patient Pool/Treated Cases (2019-2035)
7.9 Epidemiology Scenario – Japan
7.9.1 Epidemiology Scenario (2019-2024)
7.9.2 Epidemiology Forecast (2025-2035)
7.9.3 Epidemiology by Age (​2019-2035​)
7.9.4 Epidemiology by Gender (​2019-2035​)
7.9.5 Epidemiology by Type (2019-2035)
7.9.6 Diagnosed Cases (2019-2035)
7.9.7 Patient Pool/Treated Cases (2019-2035)

8 Dysautonomia – Treatment Algorithm, Guidelines, and Medical Practices
8.1 Guidelines, Management and Treatment
8.2 Treatment Algorithm

9 Dysautonomia – Unmet Needs

10 Dysautonomia – Key Endpoints of Treatment

11 Dysautonomia – Marketed Products
11.1 List of Dysautonomia Marketed Drugs Across the Top 7 Markets
11.1.1 Drug Name – Company Name
11.1.1.1 Drug Overview
11.1.1.2 Mechanism of Action
11.1.1.3 Regulatory Status
11.1.1.4 Clinical Trial Results
11.1.1.5 Sales Across Major Markets

Kindly note that the complete list of marketed drugs has been provided in the report.

12 Dysautonomia – Pipeline Drugs
12.1 List of Dysautonomia Pipeline Drugs Across the Top 7 Markets
12.1.1 Drug Name – Company Name
12.1.1.1 Drug Overview
12.1.1.2 Mechanism of Action
12.1.1.3 Clinical Trial Results
12.1.1.4 Safety and Efficacy
12.1.1.5 Regulatory Status

Kindly note that the complete list of pipeline drugs has been provided in the report.

13. Dysautonomia – Attribute Analysis of Key Marketed and Pipeline Drugs

14. Dysautonomia – Clinical Trial Landscape
14.1 Drugs by Status
14.2 Drugs by Phase
14.3 Drugs by Route of Administration
14.4 Key Regulatory Events

15 Dysautonomia – Market Scenario
15.1 Market Scenario – Key Insights
15.2 Market Scenario – Top 7 Markets
15.2.1 Dysautonomia – Market Size
15.2.1.1 Market Size (2019-2024)
15.2.1.2 Market Forecast (2025-2035)
15.2.2 Dysautonomia – Market Size by Therapies
15.2.2.1 Market Size by Therapies (2019-2024)
15.2.2.2 Market Forecast by Therapies (2025-2035)
15.3 Market Scenario – United States
15.3.1 Dysautonomia – Market Size
15.3.1.1 Market Size (2019-2024)
15.3.1.2 Market Forecast (2025-2035)
15.3.2 Dysautonomia – Market Size by Therapies
15.3.2.1 Market Size by Therapies (2019-2024)
15.3.2.2 Market Forecast by Therapies (2025-2035)
15.3.3 Dysautonomia – Access and Reimbursement Overview
15.4 Market Scenario – Germany
15.4.1 Dysautonomia – Market Size
15.4.1.1 Market Size (2019-2024)
15.4.1.2 Market Forecast (2025-2035)
15.4.2 Dysautonomia – Market Size by Therapies
15.4.2.1 Market Size by Therapies (2019-2024)
15.4.2.2 Market Forecast by Therapies (2025-2035)
15.4.3 Dysautonomia – Access and Reimbursement Overview
15.5 Market Scenario – France
15.5.1 Dysautonomia – Market Size
15.5.1.1 Market Size (2019-2024)
15.5.1.2 Market Forecast (2025-2035)
15.5.2 Dysautonomia – Market Size by Therapies
15.5.2.1 Market Size by Therapies (2019-2024)
15.5.2.2 Market Forecast by Therapies (2025-2035)
15.5.3 Dysautonomia – Access and Reimbursement Overview
15.6 Market Scenario – United Kingdom
15.6.1 Dysautonomia – Market Size
15.6.1.1 Market Size (2019-2024)
15.6.1.2 Market Forecast (2025-2035)
15.6.2 Dysautonomia – Market Size by Therapies
15.6.2.1 Market Size by Therapies (2019-2024)
15.6.2.2 Market Forecast by Therapies (2025-2035)
15.6.3 Dysautonomia – Access and Reimbursement Overview
15.7 Market Scenario – Italy
15.7.1 Dysautonomia – Market Size
15.7.1.1 Market Size (2019-2024)
15.7.1.2 Market Forecast (2025-2035)
15.7.2 Dysautonomia – Market Size by Therapies
15.7.2.1 Market Size by Therapies (2019-2024)
15.7.2.2 Market Forecast by Therapies (2025-2035)
15.7.3 Dysautonomia – Access and Reimbursement Overview
15.8 Market Scenario – Spain
15.8.1 Dysautonomia – Market Size
15.8.1.1 Market Size (2019-2024)
15.8.1.2 Market Forecast (2025-2035)
15.8.2 Dysautonomia – Market Size by Therapies
15.8.2.1 Market Size by Therapies (2019-2024)
15.8.2.2 Market Forecast by Therapies (2025-2035)
15.8.3 Dysautonomia – Access and Reimbursement Overview
15.9 Market Scenario – Japan
15.9.1 Dysautonomia – Market Size
15.9.1.1 Market Size (2019-2024)
15.9.1.2 Market Forecast (2025-2035)
15.9.2 Dysautonomia – Market Size by Therapies
15.9.2.1 Market Size by Therapies (2019-2024)
15.9.2.2 Market Forecast by Therapies (2025-2035)
15.9.3 Dysautonomia – Access and Reimbursement Overview

16 Dysautonomia – Recent Events and Inputs From Key Opinion Leaders

17 Dysautonomia Market – SWOT Analysis
17.1 Strengths
17.2 Weaknesses
17.3 Opportunities
17.4 Threats

18 Dysautonomia Market – Strategic Recommendations

19 Appendix

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