真实世界证据解决方案市场机会、成长驱动因素、产业趋势分析及预测（2025-2034年）

2024 年全球真实世界证据解决方案市值为 23 亿美元，预计到 2034 年将以 16.2% 的复合年增长率增长至 102 亿美元。

市场成长的驱动力来自对即时临床洞察日益增长的需求、对经济高效的药物研发需求不断增长以及巨量资料分析在医疗保健领域的广泛应用。真实世界证据（RWE）解决方案正在变革药物研发，帮助企业利用电子健康记录、保险资料库和病患登记的真实世界资料，分析病患预后、治疗效果和安全性。医疗服务提供者、监管机构和支付方日益重视循证决策，进一步推动了市场成长。此外，人工智慧和机器学习的进步正在提升RWE平台的准确性和预测能力，从而加速临床试验设计和上市后监测。

市场主要按组件划分，其中服务板块预计在2024年将占据58.4%的市场份额。这一主导地位归因于资料管理、分析和监管报告等工作越来越多地外包给专业服务提供者。服务板块在协助生物製药和医疗器材公司进行实际资料整合、解读和合规管理方面发挥着至关重要的作用，从而缩短产品上市时间并降低研发成本。

就最终用途而言，製药和医疗器材公司预计将在2024年占据60.4%的市场份额，这主要得益于企业日益增长的在临床试验环境之外验证药物有效性和安全性的需求。这些公司正在利用真实世界证据（RWE）解决方案进行标籤扩展、生命週期管理和策略决策，以改善患者疗效并确保符合监管要求。

2024年，北美真实世界证据解决方案市场将占据43.2%的份额，这主要得益于该地区先进的医疗基础设施、完善的监管框架以及数位医疗技术的广泛应用。美国在该地区处于领先地位，这得益于其众多大型製药公司的存在、政府大力推动基于真实世界证据的临床研究，以及电子健康记录和理赔资料库的广泛使用。该地区对精准医疗和以病人为中心的照护的重视，持续推动着真实世界证据在整个医疗生态系统中的应用。

全球真实世界证据解决方案市场的主要参与者包括IQVIA、Syneos Health、Oracle Corporation、Flatiron Health、ICON plc和Medidata Solutions。这些公司正透过策略合作、资料整合能力和人工智慧驱动的分析创新来巩固其市场地位。许多公司正在扩大与医疗服务提供者和支付方的合作，以提高资料可及性并提升真实世界研究的品质。主要参与者也正在投资可扩展的云端平台，以简化资料收集、储存和解读流程，同时确保符合不断变化的资料隐私法规。此外，併购也被用于拓展服务组合和地理覆盖范围。

目录

第一章：方法论与范围

第二章：执行概要

第三章：行业洞察

• 产业生态系分析
• 产业影响因素
  • 成长驱动因素
    • 日益重视加速药物研发和降低成本
    • 药品和医疗器材即时安全性和有效性监测的需求日益增长
    • 提高真实世界证据解决方案在知情报销决策中的应用
    • 资料分析服务在临床决策中的应用日益广泛。
  • 产业陷阱与挑战
    • 现实世界资料的整合和互通性缺乏标准化
    • 熟练专业人员短缺
  • 市场机会
    • 新兴治疗领域正扩展到肿瘤学以外的领域
    • 重点关注患者产生的健康资料整合
• 成长潜力分析
• 监管环境
  • 北美洲
  • 欧洲
• 技术格局
• 未来市场趋势
• 差距分析
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 战略仪錶板
• 关键进展
  • 併购
  • 伙伴关係与合作
  • 新产品发布
  • 扩张计划

第五章：市场估算与预测：依组件划分，2021-2034年

• 主要趋势
• 服务
  • 资料收集与整合
  • 研究设计与实施
    • 前瞻性观察研究
    • 回顾性资料库研究
    • 以地点为中心的研究
    • 基于註册登记的研究
    • 混合研究
  • 监管和市场准入支持
  • 证据网络
  • 其他服务
• 数据集
  • 不同的资料集
    • 临床环境资料
    • 索赔资料集
    • 药房资料集
    • 患者驱动资料集
    • 基于註册表的资料集

第六章：市场估算与预测：依应用领域划分，2021-2034年

• 主要趋势
• 药物研发及审批
  • 肿瘤学
  • 心血管疾病
  • 神经病学
  • 免疫学
  • 其他治疗领域
• 医疗器材开发与审批
• 上市后监测
• 市场准入和报销/承保决策

第七章：市场估计与预测：依所得模式划分，2021-2034年

• 主要趋势
• 按使用量付费（基于价值的定价）
• 订阅

第八章：市场估算与预测：依部署模式划分，2021-2034年

• 主要趋势
• 本地部署
• 基于云端的

第九章：市场估算与预测：依最终用途划分，2021-2034年

• 主要趋势
• 製药和医疗器材公司
• 医疗保健支付方
• 医疗保健提供者
• 其他最终用途

第十章：市场估计与预测：依地区划分，2021-2034年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十一章：公司简介

• Aetion, Inc.
• Cytel Inc.
• Flatiron Health Inc.
• Fortrea Inc.
• ICON plc
• IBM Corporation
• IQVIA Holdings Inc.
• Medidata Solutions
• Merative
• Optum, Inc.
• Oracle Corporation
• Parexel International Corporation
• Syneos Health Inc.
• Tempus Labs Inc.
• Thermo Fisher Scientific Inc.
• TriNetX LLC.

The Global Real World Evidence Solutions Market was valued at USD 2.3 billion in 2024 and is estimated to grow at a CAGR of 16.2 % to reach USD 10.2 billion by 2034.

Market growth is driven by the rising need for real-time clinical insights, the growing demand for cost-effective drug development, and the expanding use of big data analytics in healthcare. RWE solutions are transforming pharmaceutical research, helping companies analyze patient outcomes, treatment efficacy, and safety using real-world data from electronic health records, insurance databases, and patient registries. The growing emphasis on evidence-based decision-making by healthcare providers, regulators, and payers is further fueling market growth. Moreover, advancements in AI and machine learning are enhancing the accuracy and predictive capabilities of RWE platforms, enabling faster clinical trial design and post-market surveillance.

The market is primarily segmented by component, with the services segment held 58.4% share in 2024. This dominance is attributed to the increasing outsourcing of data management, analytics, and regulatory reporting to specialized service providers. The services segment plays a crucial role in assisting biopharma and medical device firms in real-world data integration, interpretation, and compliance management, reducing time-to-market and research costs.

In terms of end-use, the pharmaceutical and medical devices companies segment held 60.4% in 2024, driven by the growing need to demonstrate drug effectiveness and safety beyond clinical trial environments. These companies are leveraging RWE solutions for label expansion, lifecycle management, and strategic decision-making to improve patient outcomes and regulatory compliance.

North America Real World Evidence Solutions Market held 43.2% share in 2024, owing to the region's advanced healthcare infrastructure, supportive regulatory frameworks, and widespread adoption of digital health technologies. The U.S. leads the region due to the presence of major pharmaceutical companies, strong government initiatives promoting RWE-based clinical research, and extensive use of electronic health records and claims databases. The region's focus on precision medicine and patient-centric care continues to drive RWE adoption across healthcare ecosystems.

Key players operating in the Global Real World Evidence Solutions Market include IQVIA, Syneos Health, Oracle Corporation, Flatiron Health, ICON plc, and Medidata Solutions. Companies in the Real World Evidence Solutions Market are strengthening their presence through strategic partnerships, data integration capabilities, and AI-driven analytics innovations. Many are expanding collaborations with healthcare providers and payers to enhance data accessibility and improve real-world study quality. Key players are also investing in scalable cloud-based platforms to streamline data capture, storage, and interpretation while ensuring compliance with evolving data privacy regulations. Additionally, mergers and acquisitions are being leveraged to expand service portfolios and geographic reach.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Component trends
  • 2.2.3 Application trends
  • 2.2.4 Revenue model trends
  • 2.2.5 Deployment trends
  • 2.2.6 End use trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players
• 2.4 Future outlook and strategic recommendations

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing focus towards accelerating drug development and cost reduction
    • 3.2.1.2 Growing demand for real-time safety and efficacy monitoring of drugs and medical devices
    • 3.2.1.3 Increasing adoption of RWE Solutions for informed reimbursement decision-making
    • 3.2.1.4 Increasing adoption of data analytics services in clinical decision making.
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Lack of standardization in integration and interoperability of real-world data
    • 3.2.2.2 Shortage of skilled professionals
  • 3.2.3 Market opportunities
    • 3.2.3.1 Emerging therapeutic areas expansion beyond oncology
    • 3.2.3.2 Focus on patient-generated health data integration
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
• 3.5 Technology landscape
• 3.6 Future market trends
• 3.7 Gap analysis
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard
• 4.7 Key developments
  • 4.7.1 Mergers and acquisitions
  • 4.7.2 Partnerships and collaborations
  • 4.7.3 New product launches
  • 4.7.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Component, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Services
  • 5.2.1 Data collection and integration
  • 5.2.2 Study design and execution
    • 5.2.2.1 Prospective observational studies
    • 5.2.2.2 Retrospective database studies
    • 5.2.2.3 Site-centric studies
    • 5.2.2.4 Registry-based studies
    • 5.2.2.5 Hybrid studies
  • 5.2.3 Regulatory and market access support
  • 5.2.4 Evidence network
  • 5.2.5 Other services
• 5.3 Data sets
  • 5.3.1 Disparate data sets
    • 5.3.1.1 Clinical settings data
    • 5.3.1.2 Claims data sets
    • 5.3.1.3 Pharmacy data sets
    • 5.3.1.4 Patient powered data sets
    • 5.3.1.5 Registry-based data sets

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Drug development and approval
  • 6.2.1 Oncology
  • 6.2.2 Cardiovascular disease
  • 6.2.3 Neurology
  • 6.2.4 Immunology
  • 6.2.5 Other therapeutic areas
• 6.3 Medical device development and approvals
• 6.4 Post-market surveillance
• 6.5 Market access and reimbursement/coverage decision-making

Chapter 7 Market Estimates and Forecast, By Revenue Model, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Pay-per-use (value-based pricing)
• 7.3 Subscription

Chapter 8 Market Estimates and Forecast, By Deployment Model, 2021 - 2034 ($ Mn)

• 8.1 Key trends
• 8.2 On-premise
• 8.3 Cloud-based

Chapter 9 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 9.1 Key trends
• 9.2 Pharmaceutical and medical device companies
• 9.3 Healthcare payers
• 9.4 Healthcare providers
• 9.5 Other End use

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 1.1.1 U.S.
  • 1.1.2 Canada
• 10.3 Europe
  • 1.1.3 Germany
  • 1.1.4 UK
  • 1.1.5 France
  • 1.1.6 Spain
  • 1.1.7 Italy
  • 1.1.8 Netherlands
• 10.4 Asia Pacific
  • 1.1.9 China
  • 1.1.10 Japan
  • 1.1.11 India
  • 1.1.12 Australia
  • 1.1.13 South Korea
• 10.5 Latin America
  • 1.1.14 Brazil
  • 1.1.15 Mexico
  • 1.1.16 Argentina
• 10.6 Middle East and Africa
  • 1.1.17 South Africa
  • 1.1.18 Saudi Arabia
  • 1.1.19 UAE

Chapter 11 Company Profiles

• 11.1 Aetion, Inc.
• 11.2 Cytel Inc.
• 11.3 Flatiron Health Inc.
• 11.4 Fortrea Inc.
• 11.5 ICON plc
• 11.6 IBM Corporation
• 11.7 IQVIA Holdings Inc.
• 11.8 Medidata Solutions
• 11.9 Merative
• 11.10 Optum, Inc.
• 11.11 Oracle Corporation
• 11.12 Parexel International Corporation
• 11.13 Syneos Health Inc.
• 11.14 Tempus Labs Inc.
• 11.15 Thermo Fisher Scientific Inc.
• 11.16 TriNetX LLC.