臨床試験管理サービスの世界市場（2024年～2031年）

世界の臨床試験管理サービスの市場規模は、予測期間（2024年～2031年）にCAGR7.8%で成長すると予測されます。臨床試験管理サービス（CTMS）市場は、臨床試験の複雑性、研究の成長、グローバル化、技術の進歩、データ品質、患者中心主義、費用対効果によって促進されています。クラウドベースのソリューション、人工知能、機械学習、モバイルアプリケーションは効率を高め、費用対効果の高いソリューションは患者のエンゲージメントとリテンションに重点を置いています。

市場力学

神経疾患の有病率と負担の増加

てんかんのような神経疾患の有病率の増加は、効果的な治療に対する世界の需要を引き起こし、CTMS市場の成長につながっています。世界保健機関（WHO）によると、2024年2月には世界で約5,000万人がてんかんに罹患しており、広く発生している神経疾患としてその有病率が示されています。低・中所得国がこれらの症例の80.0%近くを占めています。適切な診断と治療が提供されれば、てんかん患者の最大70.0%が発作を経験せずに生活できる可能性があると推定されています。

臨床研究に対する需要の高まり

慢性疾患により、新たな治療法やケアマネジメントの需要が高まっているため、効率的なCTMSソリューションは臨床試験を簡素化し、データの品質、安全性、有効性を保証するために不可欠です。National Center for Chronic Disease Prevention and Health Promotionによると、米国では2024年2月に主要な慢性疾患の有病率が約1億2,900万人に達すると推定されています。このデータによると、過去20年間で、慢性疾患を持つ人の数は着実に増加しており、今後も増え続けると予想されています。さらに、人口の42.0%というかなりの割合が、2つ以上の慢性疾患を抱えています。

市場セグメンテーション

• 市場はタイプ別に、臨床試験モニタリング、薬事申請、臨床試験データ管理、メディカルライティング、治験施設管理・モニタリング、その他に区分されます。
• エンドユーザー別では、製薬・バイオテクノロジー企業、医療機器企業、CRO（医薬品開発業務受託機関）、その他（学術研究機関、医療機器メーカー、政府機関）に区分されます。

製薬・バイオテクノロジー企業が最大セグメントとして台頭予測

このセグメントの成長を支える主要因として、バイオテクノロジーおよび製薬分野の研究開発費増加による完全な臨床研究サービスに対する需要の高まりが挙げられ、CTMSプロバイダーは必要なサービスを提供するのに適した立場にあります。例えば、2023年11月には、前臨床試験から後期臨床試験、FDA承認に至るまで、バイオテクノロジーおよび製薬企業の顧客にサービスを提供するIchor Clinical Trial Services社が設立されました。同社は、プロトコールデザイン、施設特定、リクルート、リテンション戦略に重点を置き、カスタマイズされた臨床試験ソリューションを提供しています。同社の機敏なアプローチは、大規模CROの複雑な問題に対処します。

地域別展望

臨床試験管理サービス市場は、北米（米国、カナダ）、欧州（英国、イタリア、スペイン、ドイツ、フランス、その他欧州）、アジア太平洋（インド、中国、日本、韓国、その他アジア太平洋）、世界のその他の地域（中東・アフリカ、ラテンアメリカ）を含む地域別にさらに細分化されています。

アジア太平洋の新興市場の重要性の高まり

インドの膨大な患者数、多様な遺伝子プロファイル、運営コストの削減により、インドは臨床研究にとってより望ましい場所となっており、アジア太平洋におけるCTMSソリューションの需要を押し上げています。例えば、ロシュ・ファーマ・インドは2023年10月、臨床試験と医薬品研究のための公的医療機関の能力を強化するため、インドで臨床試験エクセレンス・プロジェクトを開始しました。このイニシアチブは、政府病院を臨床研究の卓越した拠点とし、バリューチェーンを向上させることを目的としています。同社は10の病院と提携し、研修、プロセス開発、書類提出のデジタル化などの能力強化を図りました。

北米が主要市場規模を占める

北米では、医療技術の進歩、グローバル化、精密医療を背景に臨床試験の件数が増加しており、CTMSソリューションの需要が高まっています。臨床試験管理サービス市場に参入している主要企業は、Dassault Systemes S.E.、IBM Corp.、IQVIA Inc.、Oracle Corp.、Wipro Ltd.などです。市場競争力を維持するため、各社は提携やM&Aなどの戦略を適用して事業拡大や製品開発にますます注力しています。例えば、2024年4月、アイコンはClinical Research Management, Inc.を買収しました。この買収により、アイコンは政府委託研究におけるプレゼンスを拡大し、ワクチンと感染症における能力を強化しました。Clinical Research Managementの専門知識は基礎研究、応用研究、感染症、ワクチン開発、生物脅威対応に及びます。

目次

第1章 レポート概要

• 業界の現状分析と成長可能性の展望
• 調査方法とツール
• 市場内訳
  • セグメント別
  • 地域別

第2章 市場概要と洞察

• 調査範囲
• アナリストの洞察と現在の市場動向
  • 主要市場動向
  • 推奨事項
  • 結論

第3章 競合情勢

• 主要企業分析
• Dassault Systemes S.E.
  • 概要
  • 財務分析
  • SWOT分析
  • 最近の動向
• IBM Corp.
  • 概要
  • 財務分析
  • SWOT分析
  • 最近の動向
• IQVIA Inc.
  • 概要
  • 財務分析
  • SWOT分析
  • 最近の動向
• 主要戦略分析

第4章 市場セグメンテーション

• 臨床試験管理サービスの世界市場：タイプ別
  • 臨床試験モニタリング
  • 薬事申請
  • 臨床試験データ管理
  • メディカルライティング
  • 治験施設管理・モニタリング
  • その他
• 臨床試験管理サービスの世界市場：エンドユーザー別
  • 製薬・バイオテクノロジー企業
  • 医療機器企業
  • 開発業務受託機関（CRO）
  • その他（学術研究機関、医療機器メーカー、政府機関）

第5章 地域別分析

• 北米
  • 米国
  • カナダ
• 欧州
  • 英国
  • ドイツ
  • イタリア
  • スペイン
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第6章 企業プロファイル

• Advarra, Inc.
• Anju Software, Inc.
• ArisGlobal LLC
• Calyx
• Clario
• DSG, Inc.
• ICON Plc
• Laboratory Corporation of America Holdings
• LePro PharmaCompass OPC Pvt. Ltd.
• MedNet Solutions, Inc.
• Medpace, Inc.
• Oracle Corporation
• PHARMASEAL
• RealTime Software Solutions, LLC
• Syneos Health
• Wipro Ltd.
• WuXi AppTec Co., Ltd.

LIST OF TABLES

• 1. Global Clinical Trial Management Services Market Research And Analysis By Type 2023-2031 ($ Million)
• 2. Global Clinical Trial Monitoring Services Market Research And Analysis, 2023-2031 ($ Million)
• 3. Global Regulatory Submissions Services Market Research And Analysis, 2023-2031 ($ Million)
• 4. Global Clinical Trial Data Management Services Market Research And Analysis, 2023-2031 ($ Million)
• 5. Global Medical Writing Services Market Research And Analysis, 2023-2031 ($ Million)
• 6. Global Site Management & Monitoring Services Market Research And Analysis, 2023-2031 ($ Million)
• 7. Global Others Clinical Trial Management Services Market Research And Analysis, 2023-2031 ($ Million)
• 8. Global Clinical Trial Management Services Market Research And Analysis By Region, 2023-2031 ($ Million)
• 9. Global Clinical Trial Management Services Market Research And Analysis By End-User, 2023-2031 ($ Million)
• 10. Global Clinical Trial Management Services For Pharmaceutical And Biotechnology Companies Market Research And Analysis By Region, 2023-2031 ($ Million)
• 11. Global Clinical Trial Management Services For Medical Device Companies Market Research And Analysis By Region, 2023-2031 ($ Million)
• 12. Global Clinical Trial Management Services For Contract Research Organizations Market Research And Analysis By Region, 2023-2031 ($ Million)
• 13. Global Clinical Trial Management Services For Other End-User Market Research And Analysis By Region, 2023-2031 ($ Million)
• 14. Global Clinical Trial Management Services Market Research And Analysis By Region, 2023-2031 ($ Million)
• 15. North American Clinical Trial Management Services Market Research And Analysis By Country, 2023-2031 ($ Million)
• 16. North American Clinical Trial Management Services Market Research And Analysis By Component, 2023-2031 ($ Million)
• 17. North American Clinical Trial Management Services Market Research And Analysis By End-User, 2023-2031 ($ Million)
• 18. European Clinical Trial Management Services Market Research And Analysis By Country, 2023-2031 ($ Million)
• 19. European Clinical Trial Management Services Market Research And Analysis By Component, 2023-2031 ($ Million)
• 20. European Clinical Trial Management Services Market Research And Analysis By End-User, 2023-2031 ($ Million)
• 21. Asia-Pacific Clinical Trial Management Services Market Research And Analysis By Country, 2023-2031 ($ Million)
• 22. Asia-Pacific Clinical Trial Management Services Market Research And Analysis By Component, 2023-2031 ($ Million)
• 23. Asia-Pacific Clinical Trial Management Services Market Research And Analysis By End-User, 2023-2031 ($ Million)
• 24. Rest Of The World Clinical Trial Management Services Market Research And Analysis By Region, 2023-2031 ($ Million)
• 25. Rest Of The World Clinical Trial Management Services Market Research And Analysis By Component, 2023-2031 ($ Million)
• 26. Rest Of The World Clinical Trial Management Services Market Research And Analysis By End-User, 2023-2031 ($ Million)

LIST OF FIGURES

• 1. Global Clinical Trial Management Services Market Share By Type, 2023 Vs 2031 (%)
• 2. Global Clinical Trial Monitoring Services Market Share By Region, 2023 Vs 2031 (%)
• 3. Global Regulatory Submissions Services Market Share By Region, 2023 Vs 2031 (%)
• 4. Global Clinical Trial Data Management Services Share By Region, 2023 Vs 2031 (%)
• 5. Global Medical Writing Services Market Share By Region, 2023 Vs 2031 (%)
• 6. Global Site Management & Monitoring Services Share By Region, 2023 Vs 2031 (%)
• 7. Global Others Clinical Trial Management Services Market Share By Region, 2023 Vs 2031 (%)
• 8. Global Clinical Trial Management Services Market Share By End-User, 2023 Vs 2031 (%)
• 9. Global Clinical Trial Management Services For Pharmaceutical And Biotechnology Companies Market Share By Region, 2023 Vs 2031 (%)
• 10. Global Clinical Trial Management Services For Medical Device Companies Market Share By Region, 2023 Vs 2031 (%)
• 11. Global Clinical Trial Management Services For Contract Research Organizations Market Share By Region, 2023 Vs 2031 (%)
• 12. Global Clinical Trial Management Services For Other End-User Market Share By Region, 2023 Vs 2031 (%)
• 13. Global Clinical Trial Management Services Market Share By Region, 2023 Vs 2031 (%)
• 14. US Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 15. Canada Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 16. UK Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 17. France Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 18. Germany Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 19. Italy Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 20. Spain Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 21. Rest Of Europe Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 22. India Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 23. China Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 24. Japan Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 25. South Korea Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 26. Rest Of Asia-Pacific Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 27. Latin America Clinical Trial Management Services Market Size, 2023-2031 ($ Million)
• 28. Middle East And Africa Clinical Trial Management Services Market Size, 2023-2031 ($ Million)

Clinical Trial Management Services Market Size, Share & Trends Analysis Report By Type (Clinical Trial Monitoring, Regulatory Submissions, Clinical Trial Data Management, Medical Writing, Site Management & Monitoring, and Others), and by End User (Pharmaceutical and Biotechnology Companies, Medical Device Companies, Contract Research Organizations (CROs), and Others), Forecast Period (2024-2031)

Clinical trial management services market is anticipated to grow at a CAGR of 7.8% during the forecast period (2024-2031). The clinical trial management services (CTMS) market is fueled by the complexity of clinical trials, research growth, globalization, technological advancements, data quality, patient-centricity, and cost-effectiveness. Cloud-based solutions, artificial intelligence, machine learning, and mobile applications enhance efficiency, while cost-effective solutions focus on patient engagement and retention.

Market Dynamics

Rising Prevalence and Burden of Neurological Conditions

The increasing prevalence of neurological conditions, such as epilepsy, is causing a global demand for effective treatments, leading to a growth in the CTMS market. According to the World Health Organization, in February 2024, approximately 50 million individuals globally are affected by epilepsy, indicating its prevalence as a widely occurring neurological condition. Low- and middle-income countries account for nearly 80.0% of these cases. It is estimated that if adequate diagnosis and treatment were provided, up to 70.0% of those with epilepsy could potentially live without experiencing seizures.

Growing Demand for Clinical Research

The demand for novel treatments and care management is rising owing to chronic illnesses, which renders efficient CTMS solutions essential for simplifying clinical trials and promising data quality, safety, and efficacy. According to the National Center for Chronic Disease Prevention and Health Promotion, in February 2024, the prevalence of major chronic diseases in the US is estimated to affect around 129 million individuals, according to the US Department of Health and Human Services. The data indicates that over the past two decades, the number of people with chronic diseases has steadily increased and is expected to continue rising. Additionally, a significant proportion of the population, 42.0%, is managing two or more chronic conditions.

Market Segmentation

• Based on type, the market is segmented into clinical trial monitoring, regulatory submissions, clinical trial data management, medical writing, site management & monitoring, and others).
• Based on end-users, the market is segmented into pharmaceutical and biotechnology companies, medical device companies, contract research organizations (CROs), and others (academic research institutions, medical device manufacturers, and government agencies).

Pharmaceutical and Biotechnology Companies are Projected to Emerge as the Largest Segment

The primary factor supporting the segment's growth includes the growing demand for complete clinical research services as a result of the biotechnology and pharmaceutical sectors' increased R&D spending, and CTMS providers are well-positioned to provide the services needed. For instance, in November 2023, Ichor Clinical Trial Services, launched, serving biotechnology and pharmaceutical clients from preclinical studies to late-stage clinical trials and FDA approval. The company offers customized trial solutions, focusing on protocol design, site identification, recruitment, and retention strategies. Its agile approach addresses complexities for larger CROs.

Regional Outlook

The clinical trial management services market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).

Growing Significance of Emerging Markets in the Asia-Pacific Region

India's immense patient populations, varied genetic profiles, and reduced operating costs have rendered it a more desirable location for clinical research, which is driving up demand for CTMS solutions in Asia-Pacific. For instance, in October 2023, Roche Pharma India launched a clinical trial excellence project in India to enhance public health institutions' capabilities for clinical trials and drug research. The initiative aims to make government hospitals centers of excellence in clinical research and move up the value chain. The company partnered with 10 hospitals to enhance capabilities, including training, process development, and digitization of dossier submissions.

North America Holds Major Market Size

The growing number of clinical trials in North America, driven by advancements in medical technology, globalization, and precision medicine, is increasing the demand for CTMS solutions. The major companies serving the clinical trial management services market are Dassault Systemes S.E., IBM Corp., IQVIA Inc., Oracle Corp., and Wipro Ltd., among others. The market players are increasingly focusing on business expansion and product development by applying strategies such as collaborations, mergers and acquisitions to stay competitive in the market. For instance, in April 2024, ICON acquired Clinical Research Management, Inc. The acquisition extends ICON's presence in government-sponsored research and enhances its capabilities in vaccines and infectious diseases. ClinicalRM's expertise spans basic and applied research, infectious diseases, vaccine development, and bio-threat response.

Table of Contents

1. Report Summary

• Current Industry Analysis and Growth Potential Outlook
• 1.1. Research Methods and Tools
• 1.2. Market Breakdown
  • 1.2.1. By Segments
  • 1.2.2. By Region

2. Market Overview and Insights

• 2.1. Scope of the Report
• 2.2. Analyst Insight & Current Market Trends
  • 2.2.1. Key Market Trends
  • 2.2.2. Recommendations
  • 2.2.3. Conclusion

3. Competitive Landscape

• 3.1. Key Company Analysis
• 3.2. Dassault Systemes S.E.
  • 3.2.1. Overview
  • 3.2.2. Financial Analysis
  • 3.2.3. SWOT Analysis
  • 3.2.4. Recent Developments
• 3.3. IBM Corp.
  • 3.3.1. Overview
  • 3.3.2. Financial Analysis
  • 3.3.3. SWOT Analysis
  • 3.3.4. Recent Developments
• 3.4. IQVIA Inc.
  • 3.4.1. Overview
  • 3.4.2. Financial Analysis
  • 3.4.3. SWOT Analysis
  • 3.4.4. Recent Developments
• 3.5. Key Strategy Analysis

4. Market Segmentation

• 4.1. Global Clinical Trial Management Services Market by Type
  • 4.1.1. Clinical Trial Monitoring
  • 4.1.2. Regulatory Submissions
  • 4.1.3. Clinical Trial Data Management
  • 4.1.4. Medical Writing
  • 4.1.5. Site Management & Monitoring
  • 4.1.6. Others
• 4.2. Global Clinical Trial Management Services Market by End-user
  • 4.2.1. Pharmaceutical and Biotechnology Companies
  • 4.2.2. Medical Device Companies
  • 4.2.3. Contract Research Organizations (CROs)
  • 4.2.4. Others (Academic Research Institutions, Medical Device Manufacturers, and Government Agencies)

5. Regional Analysis

• 5.1. North America
  • 5.1.1. United States
  • 5.1.2. Canada
• 5.2. Europe
  • 5.2.1. UK
  • 5.2.2. Germany
  • 5.2.3. Italy
  • 5.2.4. Spain
  • 5.2.5. France
  • 5.2.6. Rest of Europe
• 5.3. Asia-Pacific
  • 5.3.1. China
  • 5.3.2. India
  • 5.3.3. Japan
  • 5.3.4. South Korea
  • 5.3.5. Rest of Asia-Pacific
• 5.4. Rest of the World
  • 5.4.1. Latin America
  • 5.4.2. Middle East and Africa

6. Company Profiles

• 6.1. Advarra, Inc.
• 6.2. Anju Software, Inc.
• 6.3. ArisGlobal LLC
• 6.4. Calyx
• 6.5. Clario
• 6.6. DSG, Inc.
• 6.7. ICON Plc
• 6.8. Laboratory Corporation of America Holdings
• 6.9. LePro PharmaCompass OPC Pvt. Ltd.
• 6.10. MedNet Solutions, Inc.
• 6.11. Medpace, Inc.
• 6.12. Oracle Corporation
• 6.13. PHARMASEAL
• 6.14. RealTime Software Solutions, LLC
• 6.15. Syneos Health
• 6.16. Wipro Ltd.
• 6.17. WuXi AppTec Co., Ltd.