分散型臨床試験市場／バーチャル臨床試験市場（第2版）：臨床試験モード別（ハイブリッド臨床試験、完全バーチャル臨床試験）、治療領域別（循環器疾患、感染症、代謝疾患、神経疾患、腫瘍疾患、呼吸器疾患、その他の疾患）、臨床試験フェーズ別（フェーズI、フェーズII、臨床試験フェーズ（フェーズI、フェーズII、フェーズIV）、企業規模（小規模、中規模、大規模）、エンドユーザー（製薬・バイオテクノロジー企業、学術・研究機関、医療機器産業、その他のエンドユーザー）、主要地域（北米、欧州、アジア太平洋地域、中東・北アフリカ地域、中南米）：産業動向と世界予測、2023-2035年

Decentralized Clinical Trials Market / Virtual Clinical Trials Market (2nd Edition): Distribution by Mode of Clinical Trial (Hybrid Clinical Trial and Fully Virtual Clinical Trial), Type of Therapeutic Area (Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Neurological Disorders, Oncological Disorders, Respiratory Disorders and Other Disorders), Clinical Trial Phase (Phase I, Phase II, Phase III and Phase IV), Company Size (Small, Mid-sized and Large), End Users (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes , Medical Device Industries and Other End Users) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America): Industry Trends and Global Forecasts, 2023-2035

世界の仮想臨床試験市場は、2023年には139億2,000万ドルに達すると予測され、2023年から2035年の予測期間中に10％の年平均成長率で成長すると予測されている。医薬品としての新規分子体の開発には、複雑かつ... もっと見る

出版社	出版年月	電子版価格	ページ数	言語
Roots Analysis ルーツアナリシス	2023年4月14日	US$4,799 シングルユーザライセンスライセンス・価格情報注文方法はこちら	480	英語

サマリー

世界の仮想臨床試験市場は、2023年には139億2,000万ドルに達すると予測され、2023年から2035年の予測期間中に10％の年平均成長率で成長すると予測されている。

医薬品としての新規分子体の開発には、複雑かつ財政的に厳しいプロセスが伴い、通常、処方箋治療薬が実験室での開発から市場に出回るまでに10年以上と25億米ドルを超える投資が必要となる。研究開発（R&D）予算全体のかなりの部分、米国では約40％が臨床研究に割り当てられている。多額の投資が行われているにもかかわらず、患者募集の困難さ、臨床データ管理の非効率性、評価中の安全性への懸念や予期せぬ副作用による予期せぬ遅延や失敗のリスクなど、根強い課題がある。

臨床試験は一般的に遅延に見舞われ、90％以上が、必要な数の参加者を登録または維持することの難しさに起因する挫折を経験している。電子カルテの記録やメンテナンスが一貫しておらず非効率的であることも、臨床データの取り扱いにおける問題の一因となっている。2020年のCOVID-19パンデミックの出現は、臨床研究をさらに混乱させ、医療資源を流用し、進行中の研究を大幅に中断させた。パンデミック後、臨床試験は徐々に再開されたが、新たな業務規範の遵守は依然として極めて重要である。

こうした課題に取り組むため、分散型臨床試験としても知られるバーチャル臨床試験の概念が、製薬業界における重要な進歩として浮上してきた。医薬品開発企業とバーチャル臨床試験企業のコラボレーションにより、分散型臨床試験をサポートするプラットフォームの利用が可能になり、臨床試験実施における重大な懸念事項への解決策を提供し、パンデミック時であっても研究の継続性を促進します。現在、さまざまなバーチャル臨床試験受託機関（CRO）が、臨床試験のさまざまな側面を管理するための多様なサービスとソリューションを提供している。患者中心のアプローチ、治験のアウトリーチの拡大、治験責任医師の負担軽減に重点を置くこれらの進歩は、パンデミックのシナリオにとどまらず、分散型臨床試験に関するサービスの成長を促進している。

分散型臨床試験に不可欠なコンポーネントには、専用のソフトウェア・アプリケーション、遠隔患者モニタリング用ツール、ウェブベースのソーシャル・エンゲージメント・プラットフォームなどがある。専門家は、このようなソリューションを活用することで、臨床試験投資総額の最大25％のコスト削減の可能性を示唆している。注目すべきは、この分野への投資家の関心が急上昇していることで、2021年以降、民間および公的投資は90億米ドルを超えている。継続的な技術革新、投資家の関与の増加、2018年以降の分散型臨床試験の増加により、分散型臨床試験市場は当面大きく成長する態勢が整っている。

レポート対象範囲
 当レポートでは、仮想臨床試験市場の調査を実施し、臨床試験のモード、治療領域のタイプ、臨床試験のフェーズ、企業規模、エンドユーザー、主要地域などの側面を分析しています。
 市場成長に影響を与える要因（促進要因、阻害要因、機会、課題など）を徹底的に分析しています。
 市場内の潜在的な利点と障害の評価は、主要市場プレイヤーの競争環境に関する洞察とともに提供されます。
 市場セグメントの収益予測を主要5地域にわたって予測しています。
 非中央集権型臨床試験/仮想臨床試験に関する調査結果の正確性と信頼性を確保するため、様々な仮定、方法論的アプローチ、厳格な品質管理対策を包含した綿密かつ体系的な調査手法を採用した。
 過去のトレンド、為替変動、外国為替の影響、景気後退、インフレ測定など、分散型臨床試験/バーチャル臨床試験市場に影響を与える経済的要因については、市場ダイナミクスへの影響について包括的に分析している。
 エグゼクティブサマリーには主要な調査洞察が凝縮されており、分散型臨床試験/バーチャル臨床試験市場の現状に関するハイレベルな展望を提供し、中長期的に予想される展開について概説しています。
 分散型臨床試験と従来の臨床試験を比較した包括的な概要では、分散型臨床試験の必要性を強調し、様々なモードやアプリケーション、今後の動向、この分野の将来を形作る関連する課題を取り上げている。
 バーチャル臨床試験/分散型臨床試験に携わる企業の現在の市場状況について、設立情報、企業規模、本社、主要製品、コンプライアンス、試験モード、能力、治療領域、試験フェーズを網羅した詳細な洞察を提供する。
 分散型臨床試験/バーチャル臨床試験のサービスを提供する企業の詳細なプロフィールが掲載されており、設立年、本社、企業規模、主要役員、提供サービス、財務情報、最近の動向、将来の展望などが詳述されている。
 分散型臨床試験/バーチャル臨床試験におけるサービスプロバイダーの綿密な競争力分析では、企業力、サービス内容、治療領域の多様性などのパラメータを評価している。
 終了／進行中の分散型臨床試験／仮想臨床試験の分析では、試験登録年、患者登録、フェーズ、ステータス、患者人口統計、治療領域、スポンサー、新たな重点領域、デザイン、介入、積極的な参加者、地理的分布など様々なパラメータを網羅している。
 2018年から2023年にかけての分散型臨床試験/バーチャル臨床試験市場におけるパートナーシップとコラボレーションは、パートナーシップのタイプ、能力、アクティブプレイヤー、地理的側面を考慮して徹底的に調査されている。
 2018年から2023年にかけての分散型臨床試験/バーチャル臨床試験市場における資金調達と投資の評価を提示し、資金調達の動向、タイプ、地理的分析、主要プレイヤー、投資家について詳述する。
 ケーススタディでは、主要製薬企業による分散型臨床試験/バーチャル臨床試験への取り組みにスポットを当て、この業界における実施済み/計画中の試験、関連する制約、今後の計画について概説している。
 従来の CRO と分散型 CRO の違いを詳述し、従来の CRO を分散型/バーチャル CRO のビジネスモデルに移行するためのロードマップを掲載。
 COVIDパンデミックが分散型臨床試験／バーチャル臨床試験に携わる企業に与えた影響を検証するケーススタディが紹介されている。
 2035年までの分散型臨床試験／バーチャル臨床試験のコスト削減可能性分析について概説し、異なる臨床試験フェーズや地域にわたる削減可能性を強調している。
 詳細な分析により、分散型臨床試験/バーチャル臨床試験市場の成長に影響を与える推進要因、阻害要因、機会、課題を特定する。

主要市場企業
 Aardex
 ケンブリッジ・コグニション
 ケアシェア
 クラリネス
 クリニブ
 クリンスサイエンス
 シミック
 DynamiQ Health
 エモビス
 Ergomed
 フラットワールド・ソリューションズ
 フォートレア
 Gsap
 ギルド
 ヘクサウェア・テクノロジーズ
 ヒューマ
 アイコン
 IQVIA
 Kayentis
 KORE ワイヤレス
 ラボコープ
 メディデータ・ソリューションズ
 メドスペース
 パンアメリカン・クリニカル・リサーチ
 パレクセル
 PPD（サーモフィッシャーカンパニー）
 サイエンス 37
 シグナントヘルス
 シニオス・ヘルス
 タタ・コンサルタンシー・サービシズ
 Veeva
 Viedoc
 WeGuide
 レンヘルスケア

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1. PREFACE
1.1. Introduction
1.2. Key Market Insights
1.3. Project Objectives
1.4. Scope of the Report
1.5. Inclusions and Exclusions
1.6. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
2.7.1. Demographics
2.7.2. Economic Factors
2.7.3. Government Regulations
2.7.4. Supply Chain
2.7.5. COVID Impact / Related Factors
2.7.6. Market Access
2.7.7. Healthcare Policies
2.7.8. Industry Consolidation
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
3.1. Chapter Overview
3.2. Market Dynamics
3.2.1. Time Period
3.2.1.1. Historical Trends
3.2.1.2. Current and Forecasted Estimates
3.2.2. Currency Coverage
3.2.2.1. Overview of Major Currencies Affecting the Market
3.2.2.2. Impact of Currency Fluctuations on the Industry
3.2.3. Foreign Exchange Impact
3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
3.2.4. Recession
3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
3.2.5. Inflation
3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
3.2.5.2. Potential Impact of Inflation on the Market Evolution
4. EXECUTIVE SUMMARY
5. INTRODUCTION
5.1. Chapter Overview
5.2. Traditional Clinical Trials versus Decentralized Clinical Trials
5.3. Need of Decentralized Clinical Trials
5.3.1. Increasing Trial Costs and Complexity
5.3.2. Evolving Regulatory Standards
5.3.3. Patient Recruitment / Retention-related Challenges
5.3.4. Inefficient Data Handling
5.4. Decentralized Clinical Trials
5.4.1. Modes of Decentralized Clinical Trials
5.4.1.1. Fully Virtual Decentralized Clinical Trials
5.4.1.2. Hybrid Decentralized Clinical Trials
5.5. Applications of Decentralized Clinical Trials
5.6. Emerging Trends in Clinical Drug Development
5.6.1. Innovative Trial Designs
5.6.2. Real-world Evidence
5.6.3. Patient-centricity
5.6.4. Big Data Analytics
5.6.5. Blockchain Technology
5.7. Challenges Associated with Decentralized Clinical Trials
5.8. Future Perspectives
6. MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Decentralized Clinical Trials Service Providers: Overall Market Landscape
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Company Size
6.2.3. Analysis by Location of Headquarters (Region)
6.2.4. Analysis by Location of Headquarters (Country)
6.2.5. Analysis by Company Size and Location of Headquarters (Region)
6.2.6. Analysis by Key Offering
6.2.7. Analysis by Compliance
6.2.8. Analysis by Mode of Decentralized Clinical Trial
6.2.9. Analysis by Type of Capability
6.2.10. Analysis by Mode of Decentralized Clinical Trial and Type of Capability
6.2.11. Analysis by Therapeutic Area
6.2.12. Analysis by Mode of Decentralized Clinical Trial and Therapeutic Area
6.2.13. Analysis by Trial Phase
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Detailed Company Profiles of Key Players
7.2.1. Fortrea
7.2.1.1. Company Overview
7.2.1.2. Decentralized Clinical Trial Offerings
7.2.1.3. Recent Developments and Future Outlook
7.2.2. IQVIA
7.2.2.1. Company Overview
7.2.2.2. Financial Information
7.2.1.2. Decentralized Clinical Trial Offerings
7.2.1.3. Recent Developments and Future Outlook
7.2.3. KORE Wireless
7.2.3.1. Company Overview
7.2.3.2. Financial Information
7.2.3.3. Decentralized Clinical Trial Offerings
7.2.3.4. Recent Developments and Future Outlook
7.2.4. Labcorp
7.2.4.1. Company Overview
7.2.4.2. Financial Information
7.2.4.3. Decentralized Clinical Trial Offerings
7.2.4.4. Recent Developments and Future Outlook
7.2.5. Medpace
7.2.5.1. Company Overview
7.2.5.2. Financial Information
7.2.5.3. Decentralized Clinical Trial Offerings
7.2.5.4. Recent Developments and Future Outlook
7.2.6. Parexel
7.2.6.1. Company Overview
7.2.6.2. Decentralized Clinical Trial Offerings
7.2.6.3. Recent Developments and Future Outlook
7.2.7. PPD
7.2.7.1. Company Overview
7.2.7.2. Financial Information
7.2.7.3. Decentralized Clinical Trial Offerings
7.2.7.4. Recent Developments and Future Outlook
7.2.8. Syneos Health
7.2.8.1. Company Overview
7.2.8.2. Financial Information
7.2.8.3. Decentralized Clinical Trial Offerings
7.2.8.4. Recent Developments and Future Outlook
7.2.9. Signant Health
7.2.9.1. Company Overview
7.2.9.2. Decentralized Clinical Trial Offerings
7.2.9.3. Recent Developments and Future Outlook
7.2.10. Veeva
7.2.10.1. Company Overview
7.2.10.2. Financial Information
7.2.10.3. Decentralized Clinical Trial Offerings
7.2.10.4. Recent Developments and Future Outlook
7.2.11. Cambridge Cognition
7.2.11.1. Company Overview
7.2.11.2. Financial Information
7.2.11.3. Decentralized Clinical Trial Offerings
7.2.11.4. Recent Developments and Future Outlook
7.2.12. Medidata Solutions
7.2.12.1. Company Overview
7.2.12.2. Financial Information
7.2.12.3. Decentralized Clinical Trial Offerings
7.2.12.4. Recent Developments and Future Outlook
7.2.13. PanAmerican Clinical Research
7.2.13.1. Company Overview
7.2.13.2. Decentralized Clinical Trial Offerings
7.2.13.3. Recent Developments and Future Outlook
7.2.14. Science 37
7.2.14.1. Company Overview
7.2.14.2. Financial Information
7.2.14.3. Decentralized Clinical Trial Offerings
7.2.14.4. Recent Developments and Future Outlook
7.3. Short Profiles of Other Prominent Players
7.3.1. Aardex
7.3.1.1. Company Overview
7.3.1.2. Decentralized Clinical Trial Offerings
7.3.2. CareShare
7.3.2.1. Company Overview
7.3.2.2. Decentralized Clinical Trial Offerings
7.3.3. Clariness
7.3.3.1. Company Overview
7.3.3.2. Decentralized Clinical Trial Offerings
7.3.4. Cliniv
7.3.4.1. Company Overview
7.3.4.2. Decentralized Clinical Trial Offerings

7.3.5. Clinscience
7.3.5.1. Company Overview
7.3.5.2. Decentralized Clinical Trial Offerings
7.3.6. CMIC
7.3.6.1. Company Overview
7.3.6.2. Decentralized Clinical Trial Offerings
7.3.7. DynamiQ Health
7.3.7.1. Company Overview
7.3.7.2. Decentralized Clinical Trial Offerings
7.3.8. Emovis
7.3.8.1. Company Overview
7.3.8.2. Decentralized Clinical Trial Offerings
7.3.9. Ergomed
7.3.9.1. Company Overview
7.3.9.2. Decentralized Clinical Trial Offerings
7.3.10. Flatworld Solutions
7.3.10.1. Company Overview
7.3.10.2. Decentralized Clinical Trial Offerings
7.3.11. Gsap
7.3.11.1. Company Overview
7.3.11.2. Decentralized Clinical Trial Offerings
7.3.12. Guild
7.3.12.1. Company Overview
7.3.12.2. Decentralized Clinical Trial Offerings
7.3.13. Hexaware Technologies
7.3.13.1. Company Overview
7.3.13.2. Decentralized Clinical Trial Offerings
7.3.14. Huma
7.3.14.1. Company Overview
7.3.14.2. Decentralized Clinical Trial Offerings
7.3.15. ICON
7.3.15.1. Company Overview
7.3.15.2. Decentralized Clinical Trial Offerings
7.3.16. Kayentis
7.3.16.1. Company Overview
7.3.16.2. Decentralized Clinical Trial Offerings
7.3.17. Tata Consultancy Services
7.3.17.1. Company Overview
7.3.17.2. Decentralized Clinical Trial Offerings
7.3.18. Viedoc
7.3.18.1. Company Overview
7.3.18.2. Decentralized Clinical Trial Offerings
7.3.19. WeGuide
7.3.19.1. Company Overview
7.3.19.2. Decentralized Clinical Trial Offerings
7.3.20. Wren Healthcare
7.3.20.1. Company Overview
7.3.20.2. Decentralized Clinical Trial Offerings
8. COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Assumptions and Key Parameters
8.3. Methodology
8.4. Competitiveness Analysis: Companies based in North America
8.5. Competitiveness Analysis: Companies based in Europe
8.6. Competitiveness Analysis: Companies based in Asia-Pacific and Rest of the World
9. CLINICAL TRIAL ANALYSIS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Decentralized Clinical Trials
9.3.1. Analysis by Trial Registration Year
9.3.2. Analysis by Number of Patients Enrolled
9.3.3. Analysis by Trial Phase
9.3.4. Analysis by Trial Registration Year and Trial Phase
9.3.5. Analysis by Patients Enrolled and Trial Phase
9.3.6. Analysis by Trial Status
9.3.7. Analysis by Trial Registration Year and Trial Status
9.3.8. Analysis by Target Patient Population
9.3.9. Analysis by Patient Gender
9.3.10. Analysis by Therapeutic Area
9.3.11. Analysis by Type of Sponsor / Collaborator
9.3.12. Word Cloud Analysis: Emerging Focus Areas
9.3.13. Analysis by Study Design
9.3.13.1. Analysis by Type of Patient Allocation Model Used
9.3.13.2. Analysis by Type of Trial Masking Adopted
9.3.13.3. Analysis by Type of Intervention
9.3.13.4. Analysis by Trial Purpose
9.3.14. Most Active Players: Analysis by Number of Clinical Trials
9.3.15. Analysis by Geography
9.3.15.1. Analysis of Clinical Trials by Geography
9.3.15.2. Analysis of Clinical Trials by Geography and Trial Status
9.3.15.3. Analysis of Patients Enrolled by Geography and Trial Status
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Decentralized Clinical Trials: Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Type of Partner
10.3.5. Analysis by Year of Partnership and Type of Partner
10.3.6. Analysis by Type of Partnership and Type of Partner
10.3.7. Analysis by Type of Capability
10.3.8. Analysis by Type of Partnership and Type of Capability
10.3.9. Most Active Players: Analysis by Number of Partnerships
10.3.10. Analysis by Geography
10.3.10.1. Local and International Agreements
10.3.10.2. Intracontinental and Intercontinental Agreements
11. FUNDING AND INVESTMENTS
11.1. Chapter Overview
11.2. Funding Models
11.3. Decentralized Clinical Trials: Funding and Investments
11.3.1. Analysis by Year of Funding
11.3.2. Analysis by Amount Invested
11.3.3. Analysis by Type of Funding
11.3.4. Analysis by Year and Type of Funding
11.3.5. Analysis by Type of Funding and Amount Invested
11.3.6. Analysis by Geography
11.3.8. Most Active Players: Analysis by Number of Funding Instances
11.3.9. Most Active Players: Analysis by Amount Raised
11.3.10. Leading Investors: Analysis by Number of Funding Instances
11.4. Concluding Remarks
12. CASE STUDY: DECENTRALIZED CLINICAL TRIAL-RELATED INITIATIVES OF BIG PHARMA COMPANIES
12.1. Chapter Overview
12.2. Decentralized Clinical Trial-related Initiatives of Big Pharma Companies
12.2.1. Pfizer
12.2.1.1. Decentralized Clinical Trial-related Initiatives
12.2.1.2. Future Perspective
12.2.2. Amgen
12.2.2.1. Decentralized Clinical Trial-related Initiatives
12.2.2.2. Future Perspective
12.2.3. AstraZeneca
12.2.3.1. Decentralized Clinical Trial-related Initiatives
12.2.3.2. Future Perspective
12.2.4. GlaxoSmithKline
12.2.4.1. Decentralized Clinical Trial-related Initiatives
12.2.4.2. Future Perspective
12.2.5. Johnson & Johnson
12.2.5.1. Decentralized Clinical Trial-related Initiatives
12.2.5.2. Future Perspective
12.2.6. Novartis
12.2.6.1. Decentralized Clinical Trial-related Initiatives
12.2.6.2. Future Perspective
12.2.7. Sanofi
12.2.7.1. Decentralized Clinical Trial-related Initiatives
12.2.7.2. Future Perspective
13. CASE STUDY: TRADITIONAL VERSUS DECENTRALIZED CLINICAL TRIALS
13.1. Chapter Overview
13.2. Comparison between Traditional and Decentralized Clinical Trials
13.3. Key Attributes of Decentralized Clinical Trials
13.4. Decentralized Operating Models
13.5. Concluding Remarks
14. CASE STUDY: COVID-19 IMPACT
14.1. Chapter Overview
14.2. Impact of COVID-19 on Clinical Trials
14.3. Impact of COVID-19 on Future Opportunity for Decentralized Clinical Trial Companies
15. COST SAVING ANALYSIS
15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Overall Cost Saving Potential of Decentralized Clinical Trials, 2023-2035
15.3.1. Cost Saving Potential: Distribution by Key Geographical Regions, 2023 and 2035
15.3.1.1. Cost Saving Potential in North America, 2023-2035
15.3.1.1.1. Cost Saving Potential in Phase I Clinical Trials, 2023-2035
15.3.1.1.2. Cost Saving Potential in Phase II Clinical Trials, 2023-2035
15.3.1.1.3. Cost Saving Potential in Phase III Clinical Trials, 2023-2035
15.3.1.1.4. Cost Saving Potential in Phase IV Clinical Trials, 2023-2035
15.3.1.2. Cost Saving Potential in Europe, 2023-2035
15.3.1.2.1. Cost Saving Potential in Phase I Clinical Trials, 2023-2035
15.3.1.2.2. Cost Saving Potential in Phase II Clinical Trials, 2023-2035
15.3.1.2.3. Cost Saving Potential in Phase III Clinical Trials, 2023-2035
15.3.1.2.4. Cost Saving Potential in Phase IV Clinical Trials, 2023-2035
15.3.1.3. Cost Saving Potential in Asia-Pacific, 2023-2035
15.3.1.3.1. Cost Saving Potential in Phase I Clinical Trials, 2023-2035
15.3.1.3.2. Cost Saving Potential in Phase II Clinical Trials, 2023-2035
15.3.1.3.3. Cost Saving Potential in Phase III Clinical Trials, 2023-2035
15.3.1.3.4. Cost Saving Potential in Phase IV Clinical Trials, 2023-2035
15.3.1.4. Cost Saving Potential in Middle East and North Africa, 2023-2035
15.3.1.4.1. Cost Saving Potential in Phase I Clinical Trials, 2023-2035
15.3.1.4.2. Cost Saving Potential in Phase II Clinical Trials, 2023-2035
15.3.1.4.3. Cost Saving Potential in Phase III Clinical Trials, 2023-2035
15.3.1.4.4. Cost Saving Potential in Phase IV Clinical Trials, 2023-2035
15.3.1.5. Cost Saving Potential in Latin America, 2023-2035
15.3.1.5.1. Cost Saving Potential in Phase I Clinical Trials, 2023-2035
15.3.1.5.2. Cost Saving Potential in Phase II Clinical Trials, 2023-2035
15.3.1.5.3. Cost Saving Potential in Phase III Clinical Trials, 2023-2035
15.3.1.5.4. Cost Saving Potential in Phase IV Clinical Trials, 2023-2035
15.4. Conclusion
16. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
16.1. Chapter Overview
16.2. Market Drivers
16.3. Market Restraints
16.4. Market Opportunities
16.5. Market Challenges
16.6. Conclusion
17. GLOBAL DECENTRALIZED CLINICAL TRIALS MARKET
17.1. Chapter Overview
17.2. Key Assumptions and Methodology
17.3. Global Decentralized Clinical Trials Market, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
17.3.1. Scenario Analysis
17.3.1.1. Conservative Scenario Analysis
17.3.1.2. Optimistic Scenario Analysis
17.4. Key Market Segmentations
17.5. Dynamic Dashboards
18. DECENTRALIZED CLINICAL TRIALS MARKET, BY MODE OF DECENTRALIZED CLINICAL TRIAL
18.1. Chapter Overview
18.2. Key Assumptions and Methodology
18.3. Decentralized Clinical Trials Market: Distribution by Mode of Decentralized Clinical Trial, 2023 and 2035
18.4. Hybrid Clinical Trials: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.5. Fully Virtual Clinical Trials: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.6. Data Triangulation and Validation
19. DECENTRALIZED CLINICAL TRIALS MARKET, BY THERAPEUTIC AREA
19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Decentralized Clinical Trials Market: Distribution by Therapeutic Area, 2023 and 2035
19.4. Cardiovascular Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.5. Infectious Diseases: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.6. Metabolic Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.7. Neurological Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.8. Oncological Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.9. Respiratory Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.10. Other Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.11. Data Triangulation and Validation
20. DECENTRALIZED CLINICAL TRIALS MARKET, BY TRIAL PHASE
20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Decentralized Clinical Trials Market: Distribution by Trial Phase, 2023 and 2035
20.4. Phase I: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
20.5. Phase II: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
20.6. Phase III: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
20.7. Phase IV: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
20.8. Data Triangulation and Validation
21. DECENTRALIZED CLINICAL TRIALS MARKET, BY COMPANY SIZE
21.1. Chapter Overview
21.2. Key Assumptions and Methodology
21.3. Decentralized Clinical Trials Market: Distribution by Company Size, 2023 and 2035
21.4. Small Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
21.5. Mid-sized Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
21.6. Large Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
21.7. Data Triangulation and Validation
22. DECENTRALIZED CLINICAL TRIALS MARKET, BY END-USER
22.1. Chapter Overview
22.2. Key Assumptions and Methodology
22.3. Decentralized Clinical Trials Market: Distribution by End-user, 2023 and 2035
22.4. Pharmaceutical and Biotechnology Companies: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
22.5. Academic and Research Institutes: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
22.6. Medical Device Industries: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
22.7. Other End-users: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
22.8. Data Triangulation and Validation
23. DECENTRALIZED CLINICAL TRIALS MARKET, BY KEY GEOGRAPHICAL REGION
23.1. Chapter Overview
23.2. Key Assumptions and Methodology
23.3. Decentralized Clinical Trials Market: Distribution by Key Geographical Regions, 2023 and 2035
23.4. North America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
23.5. Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
23.6. Asia-Pacific: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
23.7. Middle East and North Africa: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
23.8. Latin America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
23.9. Data Triangulation and Validation
24. CONCLUSION
25. EXECUTIVE INSIGHTS
25.1. Chapter Overview
25.2. Allucent
25.2.1. Interview Transcript: Mark Goldberg (Chief Executive Officer)
25.3. Andaman7
25.3.1. Interview Transcript: Vincent Keumen (Chief Executive Officer and Founder)
25.4. Clariness
25.4.1. Interview Transcript: Richard Higgins (Director Business Development)
25.5. Delve Health
25.5.1. Interview Transcript: Tim Davies (Executive Director)
25.6. Encapsia
25.6.1. Interview Transcript: Chris Tetley (Senior Manager Business Development)
25.7. FindMeCure
25.7.1. Interview Transcript: Ralitsa Vaskova (Head of Operations)
25.8. MedPoint Digital
25.8.1. Interview Transcript: Bill Cooney (Chief Innovation Officer and President)
25.9. RegAsk
25.9.1. Interview Transcript: Ronalt Wright (Senior Business Development Director)
25.10. Science 37
25.10.1. Interview Transcript: Michael Shipton (Chief Commercial Officer), Darcy Forman (Chief Delivery Officer), Troy Bryenton (Chief Technology Officer), Grazia Mohren (Head of Marketing)
25.11. TrialX
25.11.1. Interview Transcript: Paul Donnelly (Chief Strategy Officer)
25.12. WeGuide
25.12.1. Interview Transcript: Sanji Kanagalingam (Chief Executive Officer)
25.13. Woodley Trial Solutions
25.13.1. Interview Transcript: Hassan Ali (Business Development Manager)
25.14. ConsilX
25.14.1. Interview Transcript: Himanshu Verma (Founder and Chief Executive Officer), Rajesh Jain (Co-Founder)
25.15. EmpiraMed
25.15.1. Interview Transcript: Greg Erman (President and Chief Executive Officer)
26. APPENDIX 1: TABULATED DATA
27. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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Table of Contents

Summary

The global virtual clinical trials market is expected to reach USD 13.92 billion in 2023 anticipated to grow at a CAGR of 10% during the forecast period 2023-2035.

The development of a new molecular entity for pharmaceutical use involves a complex and financially demanding process, typically requiring over 10 years and an investment exceeding USD 2.5 billion for a prescription therapeutic to transition from laboratory development to market availability. A considerable portion of the overall research and development (R&D) budget, around 40% in the United States, is allocated to clinical research. Despite substantial investment, persistent challenges include difficulties in recruiting patients, inefficiencies in managing clinical data, and the risk of unforeseen delays or failures due to safety concerns and unexpected drug side effects during evaluation.

Clinical trials commonly encounter delays, with over 90% experiencing setbacks attributed to challenges in enrolling or retaining the required number of participants. Inconsistent and inefficient recording and maintenance of electronic health records contribute to issues in handling clinical data. The emergence of the COVID-19 pandemic in 2020 further disrupted clinical research, diverting medical resources and causing significant halts in ongoing studies. Although clinical trials have gradually resumed post-pandemic, adherence to new operational norms remains crucial.

To tackle these challenges, the concept of virtual clinical trials, also known as decentralized clinical trials, has emerged as a significant advancement in the pharmaceutical industry. Collaboration between drug developers and virtual clinical trial companies enables the use of platforms that support decentralized trials, offering solutions to critical concerns in trial conduct and facilitating research continuity, even during pandemics. Various virtual Contract Research Organizations (CROs) currently offer diverse services and solutions for managing different aspects of clinical trials. Focusing on patient-centric approaches, expanding trial outreach, and reducing investigator workloads, these advancements are driving the growth of services related to decentralized clinical trials, extending beyond pandemic scenarios.

Essential components for decentralized clinical trials include dedicated software applications, tools for remote patient monitoring, and web-based social engagement platforms. Experts suggest potential cost savings of up to 25% of the total trial investment through the utilization of such solutions. Notably, investor interest in this field has surged, with private and public investments surpassing USD 9 billion since 2021. With ongoing innovation, increased investor engagement, and a growing number of decentralized clinical trials since 2018, the decentralized clinical trials market is poised for significant growth in the foreseeable future.

Report Coverage
 The report conducts an examination of the virtual clinical trials market, analyzing aspects such as the mode of clinical trial, therapeutic area type, clinical trial phase, company size, end users, and key geographical regions.
 Factors influencing market growth, including drivers, restraints, opportunities, and challenges, are thoroughly analyzed in the report.
 An assessment of potential advantages and obstacles within the market is provided, along with insights into the competitive landscape for leading market players.
 Revenue forecasts for market segments are projected across five major regions.
 A meticulous and systematic research methodology was employed, encompassing various assumptions, methodological approaches, and stringent quality control measures to ensure the accuracy and reliability of findings regarding decentralized clinical trials/virtual clinical trials.
 Economic factors affecting the decentralized clinical trials/virtual clinical trials market, including historical trends, currency fluctuations, foreign exchange impacts, recession and inflation measurements, are comprehensively analyzed for their influence on market dynamics.
 The executive summary encapsulates key research insights, offering a high-level perspective on the current state of the decentralized clinical trials/virtual clinical trials market and outlining its anticipated evolution in the medium to long term.
 A comprehensive overview comparing decentralized clinical trials with traditional ones highlights the necessity for decentralized trials, covering various modes and applications, upcoming trends, and associated challenges shaping the future of this field.
 Detailed insights into the current market landscape of companies engaged in virtual clinical trials/decentralized clinical trials are provided, encompassing establishment information, company size, headquarters, key offerings, compliance, trial modes, capabilities, therapeutic areas, and trial phases.
 Elaborate profiles of companies offering services for decentralized clinical trials/virtual clinical trials are furnished, detailing establishment year, headquarters, company size, key executives, offerings, financial information, recent developments, and future outlook.
 A meticulous competitiveness analysis of service providers in decentralized clinical trials/virtual clinical trials evaluates parameters such as company strength, service offerings, and therapeutic area diversity.
 Analysis of completed/ongoing decentralized clinical trials/virtual clinical trials covers various parameters like trial registration year, patient enrollment, phases, statuses, patient demographics, therapeutic areas, sponsors, emerging focus areas, designs, interventions, active players, and geographical distribution.
 Partnerships and collaborations in the decentralized clinical trials/virtual clinical trials market between 2018-2023 are thoroughly examined, considering partnership types, capabilities, active players, and geographical aspects.
 An evaluation of funding and investments in the decentralized clinical trials/virtual clinical trials market from 2018-2023 is presented, detailing funding trends, types, geographical analysis, leading players, and investors.
 Case studies highlight initiatives by major pharmaceutical companies in decentralized clinical trials/virtual clinical trials, outlining conducted/planned studies, associated constraints, and future plans in this industry.
 Differences between traditional and decentralized contract research organizations are detailed, accompanied by a roadmap for transitioning a traditional CRO to a decentralized/virtual CRO business model.
 A case study examining the impact of the COVID pandemic on companies engaged in decentralized clinical trials/virtual clinical trials is presented.
 Cost-saving potential analysis for decentralized clinical trials/virtual clinical trials until 2035 is outlined, highlighting potential savings across different trial phases and geographical regions.
 An in-depth analysis identifies drivers, restraints, opportunities, and challenges impacting the growth of the decentralized clinical trials/virtual clinical trials market.

Key Market Companies
 Aardex
 Cambridge Cognition
 CareShare
 Clariness
 Cliniv
 Clinscience
 CMIC
 DynamiQ Health
 Emovis
 Ergomed
 Flatworld Solutions
 Fortrea
 Gsap
 Guild
 Hexaware Technologies
 Huma
 ICON
 IQVIA
 Kayentis
 KORE Wireless
 Labcorp
 Medidata Solutions
 Medpace
 PanAmerican Clinical Research
 Parexel
 PPD (a Thermo Fisher Company)
 Science 37
 Signant Health
 Syneos Health
 Tata Consultancy Services
 Veeva
 Viedoc
 WeGuide
 Wren Healthcare

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Table of Contents

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