现实世界数据市场报告：趋势、预测和竞争分析（至 2031 年）

全球真实世界数据 (RWD) 市场前景光明，为製药和医疗设备公司、医疗保健支付者、医疗保健提供者和政府机构带来了机会。预计到 2031 年，全球真实世界数据市场规模将达到 29 亿美元，2025 年至 2031 年的复合年增长率为 7.70%。该市场的主要驱动力是电子健康记录的日益普及以及对个人化医疗的日益重视。

• Lucintel 预测，在预测期内，药物开发和核准将在所有应用中经历最高的成长。
• 以最终用途来看，药品和医疗设备预计将达到最高成长。
• 根据地区，预计北美将在预测期内实现最高成长。

现实世界数据市场的策略性成长机会

RWD 市场为各种应用提供了多种策略成长机会。利用这些机会将有助于推动市场扩张并增加 RWD 的影响力。

• 个人化医疗：RWD 在个人化医疗中的应用是一个重要的成长机会。透过利用真实世界的数据根据患者的个人情况量身定制治疗方案，医疗保健提供者可以提高治疗效果和患者治疗效果。
• 药物开发与研究：RWD 为药物开发和研究提供了宝贵的见解，包括上市后监测和真实世界疗效研究。这使得决策更加明智，并改善了对药物安全性和有效性的评估。
• 人口健康管理：RWD 越来越多地用于人口健康管理，以识别健康趋势和优化干预措施。这使医疗保健组织能够应对公共卫生挑战并改善社区的健康状况。
• 数位健康科技：穿戴式装置和行动应用等数位健康科技的兴起为整合 RWD 提供了成长机会。这些技术提供持续的数据收集和监控，提高真实世界证据的品质和范围。
• 健康经济学和结果研究：RWD 对于健康经济学和结果研究 (HEOR) 很有价值，有助于评估治疗的成本效益和价值。这一机会将支持医疗保健领域更好的资源分配和政策制定。

个人化医疗、药物开发、人口健康管理、数位健康技术和卫生经济研究等领域的策略性成长机会正在塑造 RWD 市场。利用这些机会可以促进创新并改善医疗保健服务。

现实世界数据市场的驱动因素与挑战

RWD 市场受到各种驱动因素​​和挑战的影响，包括技术进步、经济因素和监管问题。了解这些因素对于有效驾驭市场至关重要。

现实世界的数据市场受以下因素驱动：

• 技术进步：人工智慧和机器学习等资料收集和分析技术的创新正在推动 RWD 市场的成长。这些进步增强了我们处理和分析大型资料集的能力，为医疗保健提供了宝贵的见解。
• 个人化医疗需求不断增长：对个人化医疗的日益关注正在推动对 RWD 的需求。真实世界的证据有助于根据个别患者制定治疗方案、改善治疗效果并推进个人化医疗方法。
• 对使用 RWD 的监管支援：监管机构越来越多地支持在药物开发和核准过程中使用 RWD。这种支持将为将真实世界证据（RWE）纳入监管决策提供框架，扩大市场潜力。
• 数位健康工具的扩展：穿戴式装置和行动医疗应用程式等数位健康工具的激增，提供了新的资讯来源。此次扩展将增强数据收集，并提供更多可供分析的真实证据。
• 专注于价值为基础的照护：向基于价值的照护模式的转变正在推动使用 RWD 来评估治疗效果和成本效益。这项重点支持基于证据的决策并提高医疗保健的价值。

现实世界数据市场的挑战包括：

资料隐私和安全问题：确保病患资料的隐私和安全是 RWD 市场面临的关键挑战。遵守资料保护条例和维护资料的机密性对于解决这些问题至关重要。

• 数据整合和品质问题：整合来自不同来源的数据并确保数据品质是一项挑战。资料格式和完整性的变化会影响 RWD 的可靠性和分析的效用。
• 监管和合规障碍：满足监管要求和确保遵守不断发展的准则可能很复杂。监管障碍可能会影响 RWD 在某些应用中的使用速度和可行性。

技术进步、个人化医疗需求、监管支援、数位健康扩展和基于价值的医疗等市场驱动因素正在推动 RWD 市场的成长。为了充分利用现实世界资料的潜力并促进市场发展，必须解决资料隐私、整合和法规遵循的挑战。

目录

第一章执行摘要

第二章 全球现实世界数据市场：市场动态

• 简介、背景和分类
• 供应链
• 产业驱动力与挑战

第三章市场趋势与预测分析（2019-2031）

• 宏观经济趋势（2019-2024）及预测（2025-2031）
• 全球现实世界资料市场趋势（2019-2024）及预测（2025-2031）
• 全球真实世界数据市场（按组成部分）
  • 服务
  • 数据集
• 全球真实世界数据市场（按应用）
  • 药物研发与核准
  • 市场进入、报销/覆盖决策
  • 上市后监测
  • 临床研究
  • 其他的
• 全球真实世界数据市场（依最终用途划分）
  • 製药和医疗设备公司
  • 医疗保健付款人
  • 医疗保健提供者
  • 政府

第四章区域市场趋势与预测分析（2019-2031）

• 全球真实世界数据市场（按地区）
• 北美真实世界数据市场
• 欧洲现实世界数据市场
• 亚太真实世界数据市场
• 其他地区的现实世界数据市场

第五章 竞争分析

• 产品系列分析
• 营运整合
• 波特五力分析

第六章 成长机会与策略分析

• 成长机会分析
  • 全球真实世界数据市场成长机会（按组成部分）
  • 全球真实世界数据市场成长机会（按应用）
  • 全球真实世界数据市场成长机会（按最终用途划分）
  • 全球现实世界数据市场成长机会（按地区）
• 全球现实世界数据市场的新兴趋势
• 战略分析
  • 新产品开发
  • 扩大全球现实世界数据市场的容量
  • 全球现实世界数据市场的企业合併
  • 认证和许可

第七章主要企业简介

• IQVIA
• Optum
• Cerner
• Flatiron Health
• IBM
• Tempus Labs
• Syneos Health
• Evidera
• Palantir Technologies
• SAS Institute

The future of the global real world data market looks promising with opportunities in the pharmaceutical and medical device companies, healthcare payers, healthcare providers, and government agencies markets. The global real world data market is expected to reach an estimated $2.9 billion by 2031 with a CAGR of 7.70% from 2025 to 2031. The major drivers for this market are growing adoption of electronic health records and the increasing emphasis on personalized medicine.

• Lucintel forecasts that, within the application category, drug development & approval is expected to witness the highest growth over the forecast period.
• Within the end use category, pharmaceutical & medical device are expected to witness the highest growth.
• In terms of regions, North America is expected to witness the highest growth over the forecast period.

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Emerging Trends in the Real World Data Market

Emerging trends in the real world data (RWD) market reflect the ongoing evolution of data collection, analysis, and application practices. These trends are reshaping the market and influencing how real-world evidence is utilized across various sectors.

• Integration of AI and Machine Learning: AI and machine learning technologies are increasingly being used to analyze large volumes of RWD, providing deeper insights and predictive analytics. This trend enhances the ability to identify patterns and trends, improve disease management, and personalize treatments based on real-world evidence.
• Expansion of Data Sources: The range of data sources for RWD is expanding beyond traditional EHRs to include wearable devices, mobile health apps, and social media. This trend increases the richness of the data and allows for a more comprehensive analysis of patient behaviors and outcomes.
• Regulatory Embrace of RWD: Regulatory agencies are increasingly recognizing the value of RWD for drug development and post-market surveillance. This trend includes efforts to streamline the use of RWD in regulatory submissions and approvals, making it a more integral part of the drug evaluation process.
• Focus on Data Privacy and Security: As the use of RWD grows, there is a heightened focus on ensuring data privacy and security. This trend involves implementing robust data protection measures and compliance with regulations to safeguard patient information and maintain trust in the data.
• Rise of Patient-Centric Data Collection: There is a growing emphasis on patient-centric approaches to data collection, where patients are actively involved in providing and managing their health data. This trend improves data accuracy and relevance, as well as patient engagement in their healthcare.

Emerging trends such as AI integration, expansion of data sources, regulatory support, data privacy focus, and patient-centric data collection are significantly reshaping the RWD market. These trends enhance the capabilities and applications of RWD, driving innovation and improving healthcare outcomes.

Recent Developments in the Real World Data Market

Recent developments in the real world data (RWD) market reflect advancements in technology and changes in regulatory landscapes. These developments are influencing how RWD is utilized across various applications and sectors.

• Enhanced Data Integration: Advances in technology have improved the integration of RWD from diverse sources, including EHRs, wearables, and patient registries. This development allows for more comprehensive data analysis and better insights into patient health and treatment outcomes.
• Adoption of AI and Machine Learning: The use of AI and machine learning algorithms is becoming more prevalent in analyzing RWD. These technologies enable more sophisticated data processing, predictive modeling, and personalized treatment approaches, enhancing the value of real-world evidence.
• Strengthened Regulatory Frameworks: Regulatory bodies are increasingly incorporating RWD into drug development and approval processes. Recent changes in regulatory frameworks are supporting the use of RWD for evaluating drug safety and efficacy, providing more robust evidence for decision-making.
• Expansion of Data Privacy Measures: With the growth of RWD usage, there is a heightened focus on data privacy and security. New measures and compliance standards are being implemented to protect patient information and ensure that data usage adheres to regulatory requirements.
• Growth in Patient-Reported Outcomes: The integration of patient-reported outcomes (PROs) into RWD collections is gaining traction. This development provides valuable insights into patients' perspectives on their health and treatment experiences, contributing to more patient-centered care.

Key developments such as enhanced data integration, AI adoption, strengthened regulatory frameworks, expanded data privacy measures, and growth in patient-reported outcomes are impacting the RWD market. These advancements improve data utilization and contribute to better healthcare outcomes.

Strategic Growth Opportunities for Real World Data Market

The RWD market offers several strategic growth opportunities across different applications. Capitalizing on these opportunities can drive market expansion and enhance the impact of RWD.

• Personalized Medicine: The use of RWD in personalized medicine is a key growth opportunity. By leveraging real-world data to tailor treatments to individual patient profiles, healthcare providers can improve treatment efficacy and patient outcomes.
• Drug Development and Research: RWD provides valuable insights for drug development and research, including post-market surveillance and real-world effectiveness studies. This opportunity allows for more informed decision-making and better assessment of drug safety and efficacy.
• Population Health Management: RWD is increasingly used in population health management to identify health trends and optimize interventions. This opportunity enables healthcare organizations to address public health challenges and improve community health outcomes.
• Digital Health Technologies: The rise of digital health technologies, such as wearable devices and mobile apps, presents growth opportunities for integrating RWD. These technologies provide continuous data collection and monitoring, enhancing the quality and scope of real-world evidence.
• Health Economics and Outcomes Research: RWD is valuable for health economics and outcomes research (HEOR), helping to assess the cost-effectiveness and value of treatments. This opportunity supports better resource allocation and policy-making in healthcare.

Strategic growth opportunities in areas such as personalized medicine, drug development, population health management, digital health technologies, and health economics research are shaping the RWD market. Leveraging these opportunities can drive innovation and improve healthcare delivery.

Real World Data Market Driver and Challenges

The RWD market is influenced by various drivers and challenges, including technological advancements, economic factors, and regulatory issues. Understanding these elements is crucial for navigating the market effectively.

The factors responsible for driving the real world data market include:

• Technological Advancements: Innovations in data collection and analysis technologies, such as AI and machine learning, are driving the growth of the RWD market. These advancements enhance the ability to process and analyze large datasets, providing valuable insights for healthcare.
• Increased Demand for Personalized Medicine: The growing emphasis on personalized medicine is driving demand for RWD. Real-world evidence helps tailor treatments to individual patients, improving outcomes and advancing personalized healthcare approaches.
• Regulatory Support for RWD Utilization: Regulatory bodies are increasingly supporting the use of RWD in drug development and approval processes. This support provides a framework for incorporating real-world evidence into regulatory decision-making, expanding the market's potential.
• Expansion of Digital Health Tools: The proliferation of digital health tools, such as wearables and mobile health apps, provides new sources of RWD. This expansion enhances data collection and enriches the real-world evidence available for analysis.
• Focus on Value-Based Healthcare: The shift towards value-based healthcare models is driving the use of RWD to assess treatment effectiveness and cost-effectiveness. This focus supports evidence-based decision-making and improves healthcare value.

Challenges in the real world data market are:

Data Privacy and Security Concerns: Ensuring the privacy and security of patient data is a significant challenge in the RWD market. Compliance with data protection regulations and maintaining data confidentiality are critical to addressing these concerns.

• Data Integration and Quality Issues: Integrating data from diverse sources and ensuring data quality can be challenging. Variability in data formats and completeness can impact the reliability of RWD and its usefulness for analysis.
• Regulatory and Compliance Hurdles: Navigating regulatory requirements and ensuring compliance with evolving guidelines can be complex. Regulatory hurdles may impact the speed and feasibility of utilizing RWD in certain applications.

Drivers such as technological advancements, demand for personalized medicine, regulatory support, digital health expansion, and value-based healthcare are fueling the growth of the RWD market. Challenges related to data privacy, integration, and regulatory compliance need to be addressed to fully leverage the potential of real-world data and enhance market development.

List of Real World Data Companies

Companies in the market compete based on product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies, real world data companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the real world data companies profiled in this report include-

• IQVIA
• Optum
• Cerner
• Flatiron Health
• IBM
• Tempus Labs
• Syneos Health
• Evidera
• Palantir Technologies
• SAS Institute

Real World Data by Segment

The study includes a forecast for the global real world data market by component, application, end use, and region.

Real World Data Market by Component [Analysis by Value from 2019 to 2031]:

• Services
• Datasets

Real World Data Market by Application [Analysis by Value from 2019 to 2031]:

• Drug Development & Approvals
• Market Access & Reimbursement/Coverage Decisions
• Post-Market Surveillance
• Clinical Research
• Others

Real World Data Market by End Use [Analysis by Value from 2019 to 2031]:

• Pharmaceutical & Medical Device Companies
• Healthcare Payers
• Healthcare Providers
• Government Agencies

Real World Data Market by Region [Analysis by Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Real World Data Market

The RWD market is evolving rapidly as organizations leverage data from real-world settings to enhance research, healthcare delivery, and decision-making. Innovations in data collection and analysis are transforming how this data is utilized across different regions, including the United States, China, Germany, India, and Japan.

• United States: In the U.S., recent developments in the RWD market include increased integration of electronic health records (EHRs) and patient registries. Advances in data analytics and machine learning are being used to extract actionable insights from large datasets. Additionally, regulatory support from agencies like the FDA is encouraging the use of RWD in clinical trials and post-market surveillance, enhancing the relevance and application of real-world evidence in healthcare decision-making.
• China: China is seeing significant growth in RWD as the government invests in digital health infrastructure. The expansion of EHR systems and patient databases is driving improvements in data quality and accessibility. Chinese companies are also focusing on integrating RWD with artificial intelligence (AI) to develop predictive models for disease management and treatment outcomes. Moreover, regulatory reforms are promoting the use of RWD for evaluating drug safety and efficacy.
• Germany: In Germany, advancements in RWD are driven by initiatives aimed at improving healthcare data interoperability and patient-centered research. The country is enhancing its data-sharing capabilities through national health data networks and platforms. Germany is also focusing on using RWD to support personalized medicine and outcomes-based research, leveraging high-quality health data to tailor treatments and interventions to individual patient needs.
• India: India's RWD market is growing as healthcare providers and researchers increasingly use real-world evidence to address public health challenges. The adoption of digital health tools and telemedicine is expanding the sources of RWD, which are being used to monitor treatment effectiveness and disease prevalence. Indian organizations are also working on improving data collection methodologies and integrating RWD into healthcare policies to enhance overall health outcomes.
• Japan: Japan is experiencing growth in RWD through advancements in digital health technologies and health information systems. The integration of RWD with genomic data is enabling more precise research and personalized treatment approaches. Additionally, Japan is focusing on expanding the use of RWD in clinical trials and regulatory submissions to enhance the robustness of evidence for new therapies and medical interventions.

Features of the Global Real World Data Market

Market Size Estimates: Real world data market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.

Segmentation Analysis: Real world data market size by component, application, end use, and region in terms of value ($B).

Regional Analysis: Real world data market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different components, applications, end uses, and regions for the real world data market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the real world data market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

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This report answers the following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the real world data market by component (services and datasets), application (drug development & approvals, market access & reimbursement/coverage decisions, post-market surveillance, clinical research, and others), end use (pharmaceutical & medical device companies, healthcare payers, healthcare providers, and government agencies), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Global Real World Data Market : Market Dynamics

• 2.1: Introduction, Background, and Classifications
• 2.2: Supply Chain
• 2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2019 to 2031

• 3.1. Macroeconomic Trends (2019-2024) and Forecast (2025-2031)
• 3.2. Global Real World Data Market Trends (2019-2024) and Forecast (2025-2031)
• 3.3: Global Real World Data Market by Component
  • 3.3.1: Services
  • 3.3.2: Datasets
• 3.4: Global Real World Data Market by Application
  • 3.4.1: Drug Development & Approvals
  • 3.4.2: Market Access & Reimbursement/Coverage Decisions
  • 3.4.3: Post-Market Surveillance
  • 3.4.4: Clinical Research
  • 3.4.5: Others
• 3.5: Global Real World Data Market by End Use
  • 3.5.1: Pharmaceutical & Medical Device Companies
  • 3.5.2: Healthcare Payers
  • 3.5.3: Healthcare Providers
  • 3.5.4: Government Agencies

4. Market Trends and Forecast Analysis by Region from 2019 to 2031

• 4.1: Global Real World Data Market by Region
• 4.2: North American Real World Data Market
  • 4.2.1: North American Real World Data Market by Application: Drug Development & Approvals, Market Access & Reimbursement/Coverage Decisions, Post-Market Surveillance, Clinical Research, and Others
  • 4.2.2: North American Real World Data Market by End Use: Pharmaceutical & Medical Device Companies, Healthcare Payers, Healthcare Providers, and Government Agencies
• 4.3: European Real World Data Market
  • 4.3.1: European Real World Data Market by Application: Drug Development & Approvals, Market Access & Reimbursement/Coverage Decisions, Post-Market Surveillance, Clinical Research, and Others
  • 4.3.2: European Real World Data Market by End Use: Pharmaceutical & Medical Device Companies, Healthcare Payers, Healthcare Providers, and Government Agencies
• 4.4: APAC Real World Data Market
  • 4.4.1: APAC Real World Data Market by Application: Drug Development & Approvals, Market Access & Reimbursement/Coverage Decisions, Post-Market Surveillance, Clinical Research, and Others
  • 4.4.2: APAC Real World Data Market by End Use: Pharmaceutical & Medical Device Companies, Healthcare Payers, Healthcare Providers, and Government Agencies
• 4.5: ROW Real World Data Market
  • 4.5.1: ROW Real World Data Market by Application: Drug Development & Approvals, Market Access & Reimbursement/Coverage Decisions, Post-Market Surveillance, Clinical Research, and Others
  • 4.5.2: ROW Real World Data Market by End Use: Pharmaceutical & Medical Device Companies, Healthcare Payers, Healthcare Providers, and Government Agencies

5. Competitor Analysis

• 5.1: Product Portfolio Analysis
• 5.2: Operational Integration
• 5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

• 6.1: Growth Opportunity Analysis
  • 6.1.1: Growth Opportunities for the Global Real World Data Market by Component
  • 6.1.2: Growth Opportunities for the Global Real World Data Market by Application
  • 6.1.3: Growth Opportunities for the Global Real World Data Market by End Use
  • 6.1.4: Growth Opportunities for the Global Real World Data Market by Region
• 6.2: Emerging Trends in the Global Real World Data Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Real World Data Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Real World Data Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: IQVIA
• 7.2: Optum
• 7.3: Cerner
• 7.4: Flatiron Health
• 7.5: IBM
• 7.6: Tempus Labs
• 7.7: Syneos Health
• 7.8: Evidera
• 7.9: Palantir Technologies
• 7.10: SAS Institute