リアルワールドデータ市場レポート：動向、予測、競合分析 (2031年まで)

世界のリアルワールドデータ (RWD) 市場の将来は、製薬・医療機器企業、医療費支払者、医療提供者、政府機関市場に機会があり、有望視されています。世界のリアルワールドデータ市場は、2025年から2031年までのCAGRが7.70%で、2031年までに推定29億米ドルに達すると予想されます。この市場の主な促進要因は、電子カルテの導入拡大と個別化医療の重視の高まりです。

• Lucintel社の予測では、用途別では医薬品開発・承認が予測期間中に最も高い成長を遂げる見込みです。
• 最終用途別では、医薬品・医療機器が最も高い成長が見込まれています。
• 地域別では、北米が予測期間中に最も高い成長が見込まれます。

リアルワールドデータ市場の戦略的成長機会

RWD市場には、さまざまな用途でいくつかの戦略的成長機会があります。これらの機会を活用することで、市場の拡大を促進し、RWDの影響力を高めることができます。

• 個別化医療：個別化医療におけるRWDの活用は重要な成長機会です。実世界のデータを活用して個々の患者のプロファイルに合わせた治療を行うことで、医療提供者は治療効果と患者の転帰を改善することができます。
• 医薬品開発・研究：RWDは、市販後調査やリアルワールドの有効性調査など、医薬品開発と研究に貴重な知見を提供します。これにより、より多くの情報に基づいた意思決定が可能になり、医薬品の安全性と有効性の評価が向上します。
• 集団健康管理：RWDは、健康動向を特定し介入を最適化するために、集団健康管理でますます使用されるようになっています。これにより、医療組織は公衆衛生の課題に対処し、地域社会の健康成果を向上させることができます。
• デジタルヘルス技術：ウェアラブルデバイスやモバイルアプリなどのデジタルヘルス技術の台頭は、RWDを統合する成長機会をもたらします。これらの技術は、継続的なデータ収集とモニタリングを提供し、実世界のエビデンスの質と範囲を向上させます。
• 医療経済とアウトカムリサーチ：RWDは医療経済学およびアウトカム調査（HEOR）にとって価値があり、治療の費用対効果や価値を評価するのに役立ちます。この機会は、医療におけるより良い資源配分と政策立案をサポートします。

個別化医療、医薬品開発、集団健康管理、デジタルヘルス技術、医療経済研究などの分野における戦略的成長機会が、RWD市場を形成しています。これらの機会を活用することで、イノベーションを促進し、医療提供を改善することができます。

リアルワールドデータ市場の促進要因・課題

RWD市場は、技術進歩、経済要因、規制問題など、さまざまな促進要因・課題の影響を受けています。これらの要素を理解することは、市場を効果的にナビゲートする上で極めて重要です。

リアルワールドデータ市場の促進要因には以下のようなものがあります：

• 技術の進歩：AIや機械学習などのデータ収集・分析技術の革新がRWD市場の成長を牽引しています。これらの進歩により、大規模なデータセットの処理・分析能力が強化され、医療に貴重な知見がもたらされます。
• 個別化医療への需要の高まり：個別化医療の重視の高まりがRWDの需要を促進しています。リアルワールドのエビデンスは、個々の患者に合わせた治療を行い、転帰を改善し、個別化医療のアプローチを前進させるのに役立ちます。
• RWD利用に対する規制当局の支援：医薬品開発・承認プロセスにおけるRWDの活用を支援する規制機関の動きが活発化しています。この支援は、規制当局の意思決定にリアルワールドエビデンス (RWE) を組み込むための枠組みを提供し、市場の可能性を拡大します。
• デジタルヘルスツールの拡大：ウェアラブルやモバイルヘルスアプリなどのデジタルヘルスツールの普及は、RWDの新たな情報源を提供します。この拡大により、データ収集が強化され、分析に利用可能なリアルワールドエビデンスが充実します。
• 価値ベースの医療への焦点：価値ベースの医療モデルへのシフトは、治療効果と費用対効果を評価するためのRWDの使用を促進しています。この焦点は、エビデンスに基づく意思決定をサポートし、医療の価値を向上させます。

リアルワールドデータ市場における課題は以下の通りです：

データのプライバシーとセキュリティへの懸念：患者データのプライバシーとセキュリティの確保は、RWD市場における重要な課題です。データ保護規制を遵守し、データの機密性を維持することは、これらの懸念に対処する上で極めて重要です。

• データ統合と品質の問題：多様なソースからのデータを統合し、データの質を確保することは難しい課題です。データ形式や完全性にばらつきがあると、RWDの信頼性や分析の有用性に影響を及ぼす可能性があります。
• 規制とコンプライアンスのハードル：規制要件をナビゲートし、進化するガイドラインへのコンプライアンスを確保することは、複雑な場合があります。規制上のハードルは、特定のアプリケーションでRWDを利用するスピードや実現可能性に影響を与える可能性があります。

技術の進歩、個別化医療の需要、規制上のサポート、デジタルヘルスの拡大、価値に基づく医療などの市場促進要因が、RWD市場の成長を後押ししています。実世界データの可能性を十分に活用し、市場開拓を強化するためには、データプライバシー、統合、規制遵守に関する課題に対処する必要があります。

目次

第1章 エグゼクティブサマリー

第2章 世界のリアルワールドデータ市場：市場力学

• イントロダクション、背景、分類
• サプライチェーン
• 業界の促進要因と課題

第3章 市場動向と予測分析 (2019年～2031年)

• マクロ経済動向 (2019～2024年) と予測 (2025～2031年)
• 世界のリアルワールドデータ市場の動向 (2019～2024年) と予測 (2025～2031年)
• 世界のリアルワールドデータ市場：コンポーネント別
  • サービス
  • データセット
• 世界のリアルワールドデータ市場：用途別
  • 医薬品開発・承認
  • 市場アクセス、償還/補償の決定
  • 市販後調査
  • 臨床調査
  • その他
• 世界のリアルワールドデータ市場：最終用途別
  • 製薬・医療機器企業
  • 医療費支払者
  • 医療提供者
  • 政府機関

第4章 地域別の市場動向と予測分析 (2019年～2031年)

• 世界のリアルワールドデータ市場：地域別
• 北米のリアルワールドデータ市場
• 欧州のリアルワールドデータ市場
• アジア太平洋のリアルワールドデータ市場
• その他地域のリアルワールドデータ市場

第5章 競合分析

• 製品ポートフォリオ分析
• 運用統合
• ポーターのファイブフォース分析

第6章 成長機会と戦略分析

• 成長機会分析
  • 世界のリアルワールドデータ市場の成長機会：コンポーネント別
  • 世界のリアルワールドデータ市場の成長機会：用途別
  • 世界のリアルワールドデータ市場の成長機会：最終用途別
  • 世界のリアルワールドデータ市場の成長機会：地域別
• 世界のリアルワールドデータ市場の新たな動向
• 戦略的分析
  • 新製品の開発
  • 世界のリアルワールドデータ市場の生産能力拡大
  • 世界のリアルワールドデータ市場における企業合併・買収 (M&A)、合弁事業
  • 認証とライセンシング

第7章 主要企業のプロファイル

• 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