バーチャル臨床試験の世界市場：2025年～2033年

バーチャル臨床試験の世界市場は、2024年に89億5,000万米ドルに達し、2033年には144億2,000万米ドルに達すると予測され、予測期間2025年～2033年のCAGRは5.5%で成長すると予測されています。

データ精度の向上とリアルタイムのモニタリングは、バーチャル臨床試験市場の成長を大きく後押ししており、予測期間中も市場を牽引すると予想されます。バーチャル臨床試験は、バイタルサイン、症状、服薬アドヒアランスなどの継続的かつリアルタイムのデータモニタリングを可能にします。これにより、定期的な直接訪問のような遅延や齟齬が生じることなく、試験期間を通じて患者の健康状態をより正確に追跡することができます。

例えば、Medableのプラットフォームでは、患者は心拍数、酸素レベル、身体活動などの生理学的データをモニターするウェアラブルを装着します。このデータはリアルタイムで研究者に送信され、有害事象の早期発見と迅速な意思決定を可能にします。このレベルのモニタリングは、データが正確かつタイムリーであることを保証するのに役立ち、エラーが起こりやすい自己申告やレトロスペクティブなデータ収集への依存を減らします。

リアルタイムのモニタリングは、参加者に進捗状況を即座にフィードバックすることで、患者の関与を促進します。特に長期にわたる試験では、デジタルツールを通じて患者に服薬や必要な行動を促すことができるため、治験実施計画書の遵守率が高まります。例えば、2024年6月、Materna Medicalは、ミリ膣拡張器を用いた膣痙攣症状の治療を評価する画期的なバーチャル臨床試験を開始しました。この画期的な臨床調査は、膣痙攣とそれに関連する性交痛の症状を緩和するのに役立つMilli Vaginal Dilatorの有効性に関する貴重なデータを収集することを目的としています。

データのプライバシーとセキュリティに関する懸念は、仮想臨床試験市場の成長を妨げる重大な課題です。仮想臨床試験は、病歴、個人識別情報、健康指標などの機密性の高い患者データの収集、保存、送信に大きく依存しているため、データ侵害、不正アクセス、データ保護規制の不遵守に関連するリスクが内在しています。

当レポートでは、世界のバーチャル臨床試験市場について調査し、市場の概要とともに、試験デザイン別、適応症別、相別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場のイントロダクションと範囲

第2章 エグゼクティブの洞察と重要なポイント

第3章 市場力学

• 影響要因
  • 促進要因
  • 抑制要因
  • 機会
  • 影響分析

第4章 戦略的洞察と業界の展望

• 市場のリーダーと先駆者
• CXOの視点
• 最新の開発とブレークスルー
• ケーススタディ/進行中の調査
• 規制と償還の情勢
• 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
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析ベストケース、ベースケース、ワーストケースの予測
• 価格分析と価格動向
• キーオピニオンリーダー

第5章 バーチャル臨床試験市場、試験デザイン別

• 介入試験
• 観察研究
• 拡大試験

第6章 バーチャル臨床試験市場、適応症別

• 腫瘍科
• 神経科
• 自己免疫/炎症
• 心血管疾患
• 代謝・内分泌
• 感染症
• 眼科
• その他

第7章 バーチャル臨床試験市場、相別

• 第I相
• 第II相
• 第III相
• 第IV相

第8章 仮想臨床試験市場、地域別市場分析と成長機会

• 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
• 南米
  • ブラジル
  • アルゼンチン
  • その他
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他
• 中東・アフリカ

第9章 競合情勢と市場ポジショニング

第10章 企業プロファイル

• IQVIA
• ICON plc
• Laboratory Corporation of America Holdings
• Science 37
• Parexel International Corporation
• Oracle Corporation
• Medidata Solutions
• Signant Health
• Veristat, LLC
• Sanofi

第11章 仮定と調査手法

第12章 付録

The global virtual clinical trials market reached US$ 8.95 billion in 2024 and is expected to reach US$ 14.42 billion by 2033, growing at a CAGR of 5.5% during the forecast period 2025-2033.

Virtual clinical trials refer to clinical studies that are conducted remotely, leveraging digital technologies to collect data, monitor patients and manage trial procedures without the need for participants to visit a physical clinical site. These trials, also known as decentralized clinical trials (DCTs), are designed to make the clinical trial process more accessible, flexible, and patient-centered by utilizing a variety of digital tools, mobile apps, wearables, and telemedicine platforms.

The demand for virtual clinical trials has been growing rapidly, driven by various factors that improve the efficiency, cost-effectiveness and accessibility of clinical research. Traditional clinical trials often involve physical site visits, which can be time-consuming and burdensome for patients. Virtual clinical trials remove these barriers, offering patients the convenience of participating from their homes or local healthcare facilities.

For instance, the Science 37 platform, which focuses on virtual trials, has helped improve patient participation by making it easier for patients in remote or underserved locations to join trials. They reported significant growth in recruitment rates and participant retention due to the ability to reach broader patient populations.

Market Dynamics: Drivers & Restraints

Improved Data Accuracy and Real-Time Monitoring

The improved data accuracy and real-time monitoring are significantly driving the growth of the virtual clinical trials market and are expected to drive the market over the forecast period. Virtual clinical trials enable continuous and real-time data monitoring, such as vital signs, symptoms and medication adherence. This allows for more accurate tracking of patient health throughout the trial without delays or discrepancies that might occur with periodic in-person visits.

For instance, in Medable's platform, patients are equipped with wearables that monitor physiological data such as heart rate, oxygen levels, and physical activity. This data is transmitted to researchers in real time, enabling early detection of adverse events and faster decision-making. This level of monitoring helps ensure that data is both accurate and timely, reducing the reliance on self-reporting or retrospective data collection, which can be prone to errors.

Real-time monitoring fosters patient engagement by providing instant feedback to participants on their progress. This increases adherence to the trial protocol, especially in long-duration studies, as patients can be reminded to take medication or perform necessary activities through digital tools. For instance, in June 2024, Materna Medical launched a groundbreaking virtual clinical trial evaluating the treatment of vaginismus symptoms using the Milli Vaginal Dilator. This groundbreaking clinical investigation aims to gather valuable data on the effectiveness of the Milli Vaginal Dilator to help relieve the symptoms of vaginismus and related painful intercourse.

Data Privacy and Security Concerns

Data privacy and security concerns are significant challenges that can hamper the growth of the virtual clinical trials market. Since virtual clinical trials rely heavily on the collection, storage and transmission of sensitive patient data such as medical histories, personal identifiers and health metrics, there is an inherent risk related to data breaches, unauthorized access and non-compliance with data protection regulations.

Virtual clinical trials depend on digital platforms, wearables, and mobile applications that collect and transmit sensitive patient information. If these systems are not properly secured, they become vulnerable to cyberattacks, data breaches, or unauthorized access. For instance, a Colorado-based pathology laboratory is notifying more than 1.8 million patients that their sensitive information was compromised one of the largest breaches reported by a medical testing lab to US federal regulators, making the healthcare industry especially vulnerable to hackers.

Patients are often hesitant to share sensitive personal health data through digital platforms due to concerns over privacy and the potential misuse of their information. This mistrust can lead to lower enrollment rates and reduced participation in virtual trials, hindering the effectiveness of such trials. For instance, according to the HHS Cybersecurity Program, 630+ total healthcare organizational breaches and 29 million healthcare records were breached. This hesitation impacts recruitment and retention rates, which are essential to the success of any decentralized clinical trials.

Segment Analysis

The global virtual clinical trials market is segmented based on study design, indication, phase and region.

By Indication:

The oncology segment is expected to dominate the virtual clinical trials market share

Oncology trials often require large, diverse patient populations due to the complexity and variety of cancers. Virtual trials make it easier to recruit patients from a wide geographic area, particularly those living in remote regions or underserved areas where cancer treatment options are limited. For instance, in October 2024, Medable announced a partnership with technology giant Google Cloud to bring the company's digital, decentralized clinical trial platform to the Google Cloud Marketplace. Medable's system was selected by the Nova Scotia Health Innovation Hub to improve care accessibility for remote oncology patients in rural Canada.

Oncology trials often have long durations, with patients requiring frequent monitoring, assessments and data collection. Virtual clinical trials can streamline these processes by using remote patient monitoring tools and wearables to track health metrics in real time, reducing the need for patients to visit the trial site repeatedly.

For instance, a major Novartis oncology trial for a new treatment in chronic lymphocytic leukemia (CLL) used wearables and remote monitoring tools to track patient responses, side effects and overall health. This approach minimized the need for frequent in-person visits, enhancing patient compliance and reducing the logistical burden on both patients and researchers.

Geographical Analysis

North America is expected to hold a significant position in the virtual clinical trials market share

North America especially the United States and Canada has a highly developed healthcare technology ecosystem, with cutting-edge digital health tools, wearables, telemedicine platforms, and electronic data capture systems readily available to support virtual clinical trials. The availability of advanced digital technologies and platforms is one of the key drivers of the region's dominance in this market.

For instance, in November 2024, Medable Inc. announced Medable AI - generative AI capabilities that help sponsors and clinical research organizations build digital and decentralized trials faster with complete visibility and control over technology setup. Medable is the first to incorporate generative AI in the study-build process, ultimately driving the industry to a breakthrough, one-day study startup.

North America is home to some of the largest pharmaceutical and biotechnology companies globally, many of which are at the forefront of adopting virtual trial methodologies to streamline their research and development processes. These companies are keen to reduce trial costs, improve patient recruitment, and enhance data quality through virtual trial solutions.

For instance, Pfizer, Johnson & Johnson and Eli Lilly, among other major companies, have run multiple virtual trials in North America. For example, Pfizer conducted a COVID-19 vaccine trial that incorporated virtual trial methods to enable global patient recruitment and data collection. This highlights the region's leadership in adopting virtual clinical trial models.

Asia-Pacific is growing at the fastest pace in the virtual clinical trials market

The adoption of digital health solutions, including telemedicine and mobile health apps has been growing rapidly in the Asia-Pacific region. The COVID-19 pandemic accelerated the use of telehealth services, which laid the foundation for the adoption of virtual clinical trials. This digital transformation has made it easier for healthcare providers to integrate remote monitoring, patient engagement tools, and digital consent processes into clinical trials.

For instance, China, with its fast-growing digital infrastructure, has been a leader in integrating telemedicine and virtual healthcare solutions into clinical trials. For instance, Shanghai-based company Wuxi AppTec facilitated virtual trials for oncology research, using telemedicine, mobile health monitoring, and eConsent to connect patients in remote areas with researchers, improving patient access and trial participation.

Governments and regulatory bodies in APAC are increasingly supportive of decentralized and virtual clinical trials, as they recognize the need for faster, more efficient drug development processes. Countries like Japan, India, and Singapore have begun to introduce and streamline regulations that facilitate the use of digital health technologies and virtual trials.

For instance, in Japan, the Pharmaceutical and Medical Devices Agency (PMDA) has been actively working on guidelines to encourage the use of remote monitoring, telehealth consultations, and mobile devices for clinical trials. Similarly, in India, the Central Drugs Standard Control Organization (CDSCO) has provided guidelines to facilitate the use of digital tools in clinical research, further encouraging virtual trials.

Competitive Landscape

The major global players in the virtual clinical trials market include IQVIA, ICON plc, Laboratory Corporation of America Holdings, Science 37, Parexel International Corporation, Oracle Corporation, Medidata Solutions, Signant Health, Veristat, LLC, Sanofi and among others.

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 virtual clinical trials market report delivers a detailed analysis with 62 key tables, more than 58 visually impactful figures, and 126 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & 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. Market Introduction and Scope

• 1.1. Objectives of the Report
• 1.2. Report Coverage & Definitions
• 1.3. Report Scope

2. Executive Insights and Key Takeaways

• 2.1. Market Highlights and Strategic Takeaways
• 2.2. Key Trends and Future Projections
• 2.3. Snippet by Study Design
• 2.4. Snippet by Indication
• 2.5. Snippet by Phase
• 2.6. Snippet by Region

3. Dynamics

• 3.1. Impacting Factors
  • 3.1.1. Drivers
    • 3.1.1.1. Improved Data Accuracy and Real-Time Monitoring
  • 3.1.2. Restraints
    • 3.1.2.1. Data Privacy and Security Concerns
  • 3.1.3. Opportunity
  • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

• 4.1. Market Leaders and Pioneers
  • 4.1.1. Emerging Pioneers and Prominent Players
  • 4.1.2. Established leaders with largest selling Brand
  • 4.1.3. Market leaders with established Product
• 4.2. CXO Perspectives
• 4.3. Latest Developments and Breakthroughs
• 4.4. Case Studies/Ongoing Research
• 4.5. Regulatory and Reimbursement Landscape
  • 4.5.1. North America
  • 4.5.2. Europe
  • 4.5.3. Asia Pacific
  • 4.5.4. Latin America
  • 4.5.5. Middle East & Africa
• 4.6. Porter's Five Force Analysis
• 4.7. Supply Chain Analysis
• 4.8. Patent Analysis
• 4.9. SWOT Analysis
• 4.10. Unmet Needs and Gaps
• 4.11. Recommended Strategies for Market Entry and Expansion
• 4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 4.13. Pricing Analysis and Price Dynamics
• 4.14. Key Opinion Leaders

5. Virtual Clinical Trials Market, By Study Design

• 5.1. Introduction
  • 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 5.1.2. Market Attractiveness Index, By Study Design
• 5.2. Interventional Trials*
  • 5.2.1. Introduction
  • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 5.3. Observational Trials
• 5.4. Expanded Access Trials

6. Virtual Clinical Trials Market, By Indication

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 6.1.2. Market Attractiveness Index, By Indication
• 6.2. Oncology*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Neurology
• 6.4. Autoimmune/Inflammation
• 6.5. Cardiovascular Disease
• 6.6. Metabolic/Endocrinology
• 6.7. Infectious Disease
• 6.8. Ophthalmology
• 6.9. Others

7. Virtual Clinical Trials Market, By Phase

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
  • 7.1.2. Market Attractiveness Index, By Phase
• 7.2. Phase I*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Phase II
• 7.4. Phase III
• 7.5. Phase IV

8. Virtual Clinical Trials Market, By Regional Market Analysis and Growth Opportunities

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 8.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
  • 8.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.2.6.1. U.S.
    • 8.2.6.2. Canada
    • 8.2.6.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 8.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
  • 8.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.3.6.1. Germany
    • 8.3.6.2. U.K.
    • 8.3.6.3. France
    • 8.3.6.4. Spain
    • 8.3.6.5. Italy
    • 8.3.6.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 8.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
  • 8.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.4.6.1. Brazil
    • 8.4.6.2. Argentina
    • 8.4.6.3. Rest of South America
• 8.5. Asia-Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 8.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase
  • 8.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.5.6.1. China
    • 8.5.6.2. India
    • 8.5.6.3. Japan
    • 8.5.6.4. South Korea
    • 8.5.6.5. Rest of Asia-Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Study Design
  • 8.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Phase

9. Competitive Landscape and Market Positioning

• 9.1. Competitive Overview and Key Market Players
• 9.2. Market Share Analysis and Positioning Matrix
• 9.3. Strategic Partnerships, Mergers & Acquisitions
• 9.4. Key Developments in Product Portfolios and Innovations
• 9.5. Company Benchmarking

10. Company Profiles

• 10.1. IQVIA*
  • 10.1.1. Company Overview
  • 10.1.2. Product Portfolio and Description
  • 10.1.3. Financial Overview
  • 10.1.4. Key Developments
  • 10.1.5. SWOT Analysis
• 10.2. ICON plc
• 10.3. Laboratory Corporation of America Holdings
• 10.4. Science 37
• 10.5. Parexel International Corporation
• 10.6. Oracle Corporation
• 10.7. Medidata Solutions
• 10.8. Signant Health
• 10.9. Veristat, LLC
• 10.10. Sanofi

LIST NOT EXHAUSTIVE

11. Assumption and Research Methodology

• 11.1. Data Collection Methods
• 11.2. Data Triangulation
• 11.3. Forecasting Techniques
• 11.4. Data Verification and Validation

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us