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市场调查报告书
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1401913

到 2030 年的真实世界证据市场预测：按组件、应用、最终用户和地区进行的全球分析

Real-World Evidence Market Forecasts to 2030 - Global Analysis By Component (Services and Data Sets), By Application, By End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，2023 年全球现实世界证据市场规模将达到 17 亿美元，预计到 2030 年将达到 45 亿美元，预测期内复合年增长率为 14.8%。

真实世界证据 (RWE) 是在传统临床试验之外收集的资料，可深入了解现实世界中治疗的有效性。其用途包括为医疗保健决策资讯、了解治疗结果以及评估长期患者结果。

根据 ClinicalTrials.gov 的数据，截至 2022 年 2 月，约有 87,366 项癌症临床试验正在进行，处于不同的发展阶段。

成本效率和节省时间

与传统的临床试验相比，利用真实世界的资料进行研究和决策可以显着减少所需的时间和财务投资。 RWE 能够持续监测不同族群的治疗结果，并以极低的成本提供及时的见解。这种效率对製药公司、监管机构和医疗保健相关人员特别有吸引力，因为它不仅更经济，而且在不断发展的医疗保健环境中对敏捷和适应性方法的需求不断增长。

资料品质和标准化

不同医疗保健系统的资料收集方法、格式和品质的差异可能会导致现实世界资料可靠性的不一致和限制。不完整或不标准化的资讯会阻碍 RWE 的资讯性并影响决策的信心。努力建立标准化的资料收集方法，透过检验流程提高资料质量，并提高不同医疗保健系统之间的互通性至关重要。

扩大对以患者为中心的医疗保健的关注

医疗保健系统越来越重视患者的治疗效果和体验，从而增加了对真实资料的需求，以了解治疗的有效性、安全性和患者的偏好。 RWE 与向个性化、以患者为中心的护理的更广泛转变保持一致，并提供了一个宝贵的工具，可以从患者的日常经历中获得直接洞察。将患者报告的结果与现实世界的证据相结合，可以提高对治疗的整体理解，促进更多以患者为中心的决策，并开发出更符合不同患者群体的需求和期望的治疗方法。

隐私和安全问题

使用敏感的患者资料会带来道德和监管方面的挑战，并有可能侵犯患者的隐私。从现实世界的资料中提取有价值的见解和保护患者隐私之间取得微妙的平衡至关重要。 GDPR 和 HIPAA 等严格的资料保护条例提出了严格的要求，并使 RWE 的工作变得更加复杂。资料外洩的威胁不仅会损害病患的信任，还会为相关人员带来法律和合规问题。

COVID-19 的影响：

COVID-19 的爆发凸显了真实世界证据 (RWE) 在医疗保健决策中的重要性。快速了解治疗效果和结果的迫切需求凸显了利用真实资料的价值。这场大流行促使包括监管机构在内的相关人员之间进行合作，利用莱茵集团来评估干预措施的影响。虽然这场危机凸显了莱茵集团的潜力，但它也凸显了资料品质问题等挑战，以及需要标准化方法来充分利用现实世界证据在公共卫生危机中的潜力。

预计药物开发和核准领域在预测期内将是最大的。

药物开发和核准预计将占据市场开拓的很大占有率。製药公司利用 RWE 来补充传统的临床试验资料，以更全面地了解不同患者群体的药物疗效和安全性。监管机构越来越认识到 RWE 在医药品认证过程中做出资讯决策、使药物开发、监管提交和上市后监测更加高效和对患者友好的重要性，从而可以采取集中的方法。整合 RWE 可以加强依证，有助于做出更资讯的医疗决策并改善患者的治疗结果。

预计製药和医疗设备公司领域在预测期内复合年增长率最高

在预测期内，製药和医疗设备公司部门预计将以最有效的速度成长。 RWE 使这些公司能够评估其治疗方法在不同患者群体中的有效性和安全性，并支持监管备案和市场准入。它影响整个产品生命週期的决策，并有助于在受控临床试验之外更全面地了解产品性能。 RWE 整合使製药和医疗设备公司能够做出资讯的策略决策、驾驭监管环境并展示医疗保健创新的现实影响。

占有率最大的地区

预计北美市场在预测期内将占据大部分市场占有率。该地区先进的电子健康记录(EHR) 系统和医疗资讯的普及为现实世界资料提供了丰富的资讯来源。将 RWE 纳入决策流程的监管支持，加上对医疗保健创新的重视，使北美处于利用现实世界资讯为临床实践、药物开发和健康政策决策提供资讯的最前沿。

复合年增长率最高的地区：

预计亚太地区在预测期内复合年增长率最高。医疗保健数位化程度的提高、对循证决策的需求不断增长以及医疗基础设施的扩展都有助于 RWE 在该地区的采用。由于每个国家都有不同的患者群体，因此有机会获得宝贵的见解。然而，存在许多挑战，包括监管条件和资料隐私问题。随着亚太地区继续优先考虑医疗保健的进步、合作和技术整合，真实世界证据的使用将在製定亚太地区的医疗保健策略和政策方面发挥关键作用。

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  • 公司简介
    • 其他市场参与者的综合分析（最多 3 家公司）
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  • 区域分割
    • 根据客户兴趣对主要国家的市场估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 调查范围
  • 调查方法
    • 资料探勘
    • 资料分析
    • 资料检验
    • 研究途径
  • 调查来源
    • 主要调查来源
    • 二次调查来源
    • 先决条件

第三章市场趋势分析

  • 促进因素
  • 抑制因素
  • 机会
  • 威胁
  • 应用分析
  • 最终用户分析
  • 新兴市场
  • 新型冠状病毒感染疾病（COVID-19）的影响

第4章波特五力分析

  • 供应商的议价能力
  • 买方议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争公司之间的敌对关係

第五章 全球现实世界证据市场：依组成部分

  • 服务
  • 资料集
    • 异质资料集
      • 临床设定资料
      • 申请资料
      • 药房资料
      • 患者丰富的资料
      • 基于註册表的资料集
    • 综合资料集

第六章 全球现实世界证据市场：依应用分类

  • 药物研发及核准
    • 肿瘤学
    • 神经病学
    • 免疫学
    • 循环系统疾病
    • 其他治疗领域
    • 医疗设备开发及核准
  • 上市后监控
  • 市场进入报销/补偿决定
  • 临床和监管决策
  • 其他用途

第七章 全球真实世界证据市场：依最终使用者分类

  • 製药和医疗设备公司
  • 医疗服务提供方
  • 医疗保健付款人
  • 其他最终用户

第八章全球现实世界证据市场：按地区

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲

第九章 主要进展

  • 合约、伙伴关係、协作和合资企业
  • 收购和合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十章 公司简介

  • Cegedim Health Data
  • PerkinElmer, Inc.
  • IBM
  • Syneos Health
  • Icon Plc.
  • PPD, Inc.
  • IQVIA
  • Medpace
  • Parexel International Corporation
  • Oracle
Product Code: SMRC24433

According to Stratistics MRC, the Global Real-World Evidence Market is accounted for $1.7 billion in 2023 and is expected to reach $4.5 billion by 2030 growing at a CAGR of 14.8% during the forecast period. Real-world evidence (RWE) is data collected outside traditional clinical trials, providing insights into a treatment's effectiveness in real-world settings. Its uses include informing healthcare decisions, understanding treatment outcomes, and assessing long-term patient outcomes.

According to Clinicaltrials.gov, as of February 2022, there are around 87,366 cancer clinical trials across different phases of development.

Market Dynamics:

Driver:

Cost-efficiency and time savings

Compared to traditional clinical trials, utilizing real-world data for research and decision-making significantly reduces the time and financial investments required. RWE allows for continuous monitoring of treatment outcomes in diverse populations, providing timely insights at a fraction of the cost. This efficiency is particularly appealing to pharmaceutical companies, regulators, and healthcare stakeholders, fostering a shift toward evidence generation that is not only more economical but also aligns with the increasing demand for agile and adaptive approaches in the evolving healthcare landscape.

Restraint:

Data quality and standardization

Variability in data collection methods, formats, and quality across diverse healthcare systems can result in inconsistencies and limitations in the reliability of real-world data. Incomplete or non-standardized information hinders the robustness of RWE, impacting its credibility for decision-making. Efforts to establish standardized data collection practices, improve data quality through validation processes, and enhance interoperability among different healthcare systems are imperative.

Opportunity:

Expanded focus on patient-centric healthcare

Healthcare systems increasingly prioritize patient outcomes and experiences, the demand for real-world data to understand treatment effectiveness, safety, and patient preferences grows. RWE offers a valuable tool to capture insights directly from patients' everyday experiences, aligning with the broader shift towards personalized and patient-centered care. The integration of patient-reported outcomes and real-world evidence enhances the holistic understanding of treatments, fostering more patient-centric decision-making and facilitating the development of therapies that better meet the needs and expectations of diverse patient populations.

Threat:

Privacy and security concerns

The utilization of sensitive patient data raises ethical and regulatory challenges, with the potential for breaches compromising patient confidentiality. Striking a delicate balance between extracting valuable insights from real-world data and safeguarding patient privacy becomes crucial. Stringent data protection regulations, like GDPR and HIPAA, impose strict requirements, adding complexity to RWE initiatives. The threat of data breaches not only jeopardizes patient trust but also raises legal and compliance issues for stakeholders.

COVID-19 Impact:

The COVID-19 pandemic has accelerated the importance of Real-World Evidence (RWE) in healthcare decision-making. The urgent need for rapid insights into treatment effectiveness and outcomes has underscored the value of leveraging real-world data. The pandemic has prompted increased collaboration between stakeholders, including regulatory bodies, to utilize RWE for evaluating the impact of interventions. While the crisis has highlighted the potential of RWE, it has also revealed challenges such as data quality issues and the need for standardized methodologies, emphasizing the ongoing efforts required to fully harness the potential of real-world evidence in a public health crisis.

The drug development and approvals segment is expected to be the largest during the forecast period

Drug development and approvals in the market is expected to hold a significant share. Pharmaceutical companies leverage RWE to complement traditional clinical trial data, offering a more comprehensive understanding of a drug's effectiveness and safety across diverse patient populations. Regulatory bodies increasingly recognize the significance of RWE in making informed decisions during the drug approval process, enabling a more efficient and patient-centered approach to drug development, regulatory submissions, and post-market surveillance. The integration of RWE enhances the evidence base, contributing to more informed healthcare decisions and improved patient outcomes.

The pharmaceutical & medical device companies segment is expected to have the highest CAGR during the forecast period

During the anticipated period, the pharmaceutical & medical device companies segment is expected to increase at the most effective rate. RWE enables these companies to assess the effectiveness and safety of treatments in diverse patient populations, supporting regulatory submissions and market access. It facilitates a more comprehensive understanding of product performance beyond controlled clinical trials, influencing decision-making throughout the product lifecycle. The integration of RWE empowers pharmaceutical and medical device companies to make informed strategic decisions, navigate regulatory landscapes, and demonstrate the real-world impact of their innovations in healthcare.

Region with largest share:

During the forecast period, it is expected that the North American market will hold a majority of the market share. The region's advanced electronic health records (EHR) systems and widespread adoption of health informatics contribute to a rich source of real-world data. Regulatory support for incorporating RWE into decision-making processes, coupled with a strong emphasis on healthcare innovation, positions North America at the forefront of leveraging real-world evidence to inform clinical practices, drug development, and health policy decisions.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period. Increasing healthcare digitization, rising demand for evidence-based decision-making, and expanding healthcare infrastructures contribute to the region's adoption of RWE. The diverse patient populations across countries present an opportunity to generate valuable insights. However, challenges include varying regulatory landscapes and data privacy concerns. As the region continues to prioritize healthcare advancements, collaborations, and technology integration, the utilization of real-world evidence is poised to play a pivotal role in shaping healthcare strategies and policies in Asia Pacific.

Key players in the market:

Some of the key players in Real-World Evidence market include Cegedim Health Data, PerkinElmer, Inc., IBM, Syneos Health, Icon Plc., PPD, Inc., IQVIA, Medpace, Parexel International Corporation and Oracle.

Key Developments:

In August 2022, Trinity Life Sciences (US), announced a partnership with Bain & Company (US). The partnership is intended to pair the extensive experience of Bain & Company (US) in the Life Sciences value chain with the evidence-based solutions of Trinity Life Sciences (US).

In July 2022, TriNetX LLC announced the collaboration with Pediatric Medical Centers (US), to help Pediatric Medical Centers including Children's National Hospital (US), WVU Medicine Children's (US), and John Hopkins All Children Hospitals (US), to improvise the investor-initiated research utilizing the pediatric real-world data.

In June 2022, IQVIA partnered with Argenex SE for accelerating the clinical development of new indications for VYVGART. Furthermore, it will leverage its scientific advice and technology in supporting clinical development by Argenx.

Components Covered:

  • Services
  • Data Sets

Applications Covered:

  • Drug Development And Approvals
  • Post-Market Surveillance
  • Market Access Reimbursement/Coverage Decision Making
  • Clinical And Regulatory Decision-Making
  • Other Applications

End Users Covered:

  • Pharmaceutical & Medical Device Companies
  • Healthcare Providers
  • Healthcare Payers
  • Other End Users

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Application Analysis
  • 3.7 End User Analysis
  • 3.8 Emerging Markets
  • 3.9 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Real-World Evidence Market, By Component

  • 5.1 Introduction
  • 5.2 Services
  • 5.3 Data Sets
    • 5.3.1 Disparate Data Sets
      • 5.3.1.1 Clinical Settings Data
      • 5.3.1.2 Claims Data
      • 5.3.1.3 Pharmacy Data
      • 5.3.1.4 Patient-Powered Data
      • 5.3.1.5 Registry-Based Data Sets
    • 5.3.2 Integrated Data Sets

6 Global Real-World Evidence Market, By Application

  • 6.1 Introduction
  • 6.2 Drug Development And Approvals
    • 6.2.1 Oncology
    • 6.2.2 Neurology
    • 6.2.3 Immunology
    • 6.2.4 Cardiovascular Disease
    • 6.2.5 Other Therapeutic Areas
    • 6.2.6 Medical Device Development And Approvals
  • 6.3 Post-Market Surveillance
  • 6.4 Market Access Reimbursement/Coverage Decision Making
  • 6.5 Clinical And Regulatory Decision-Making
  • 6.6 Other Applications

7 Global Real-World Evidence Market, By End User

  • 7.1 Introduction
  • 7.2 Pharmaceutical & Medical Device Companies
  • 7.3 Healthcare Providers
  • 7.4 Healthcare Payers
  • 7.5 Other End Users

8 Global Real-World Evidence Market, By Geography

  • 8.1 Introduction
  • 8.2 North America
    • 8.2.1 US
    • 8.2.2 Canada
    • 8.2.3 Mexico
  • 8.3 Europe
    • 8.3.1 Germany
    • 8.3.2 UK
    • 8.3.3 Italy
    • 8.3.4 France
    • 8.3.5 Spain
    • 8.3.6 Rest of Europe
  • 8.4 Asia Pacific
    • 8.4.1 Japan
    • 8.4.2 China
    • 8.4.3 India
    • 8.4.4 Australia
    • 8.4.5 New Zealand
    • 8.4.6 South Korea
    • 8.4.7 Rest of Asia Pacific
  • 8.5 South America
    • 8.5.1 Argentina
    • 8.5.2 Brazil
    • 8.5.3 Chile
    • 8.5.4 Rest of South America
  • 8.6 Middle East & Africa
    • 8.6.1 Saudi Arabia
    • 8.6.2 UAE
    • 8.6.3 Qatar
    • 8.6.4 South Africa
    • 8.6.5 Rest of Middle East & Africa

9 Key Developments

  • 9.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 9.2 Acquisitions & Mergers
  • 9.3 New Product Launch
  • 9.4 Expansions
  • 9.5 Other Key Strategies

10 Company Profiling

  • 10.1 Cegedim Health Data
  • 10.2 PerkinElmer, Inc.
  • 10.3 IBM
  • 10.4 Syneos Health
  • 10.5 Icon Plc.
  • 10.6 PPD, Inc.
  • 10.7 IQVIA
  • 10.8 Medpace
  • 10.9 Parexel International Corporation
  • 10.10 Oracle

List of Tables

  • Table 1 Global Real-World Evidence Market Outlook, By Region (2021-2030) ($MN)
  • Table 2 Global Real-World Evidence Market Outlook, By Component (2021-2030) ($MN)
  • Table 3 Global Real-World Evidence Market Outlook, By Services (2021-2030) ($MN)
  • Table 4 Global Real-World Evidence Market Outlook, By Data Sets (2021-2030) ($MN)
  • Table 5 Global Real-World Evidence Market Outlook, By Disparate Data Sets (2021-2030) ($MN)
  • Table 6 Global Real-World Evidence Market Outlook, By Clinical Settings Data (2021-2030) ($MN)
  • Table 7 Global Real-World Evidence Market Outlook, By Claims Data (2021-2030) ($MN)
  • Table 8 Global Real-World Evidence Market Outlook, By Pharmacy Data (2021-2030) ($MN)
  • Table 9 Global Real-World Evidence Market Outlook, By Patient-Powered Data (2021-2030) ($MN)
  • Table 10 Global Real-World Evidence Market Outlook, By Registry-Based Data Sets (2021-2030) ($MN)
  • Table 11 Global Real-World Evidence Market Outlook, By Integrated Data Sets (2021-2030) ($MN)
  • Table 12 Global Real-World Evidence Market Outlook, By Application (2021-2030) ($MN)
  • Table 13 Global Real-World Evidence Market Outlook, By Drug Development And Approvals (2021-2030) ($MN)
  • Table 14 Global Real-World Evidence Market Outlook, By Oncology (2021-2030) ($MN)
  • Table 15 Global Real-World Evidence Market Outlook, By Neurology (2021-2030) ($MN)
  • Table 16 Global Real-World Evidence Market Outlook, By Immunology (2021-2030) ($MN)
  • Table 17 Global Real-World Evidence Market Outlook, By Cardiovascular Disease (2021-2030) ($MN)
  • Table 18 Global Real-World Evidence Market Outlook, By Other Therapeutic Areas (2021-2030) ($MN)
  • Table 19 Global Real-World Evidence Market Outlook, By Medical Device Development And Approvals (2021-2030) ($MN)
  • Table 20 Global Real-World Evidence Market Outlook, By Post-Market Surveillance (2021-2030) ($MN)
  • Table 21 Global Real-World Evidence Market Outlook, By Market Access Reimbursement/Coverage Decision Making (2021-2030) ($MN)
  • Table 22 Global Real-World Evidence Market Outlook, By Clinical And Regulatory Decision-Making (2021-2030) ($MN)
  • Table 23 Global Real-World Evidence Market Outlook, By Other Applications (2021-2030) ($MN)
  • Table 24 Global Real-World Evidence Market Outlook, By End User (2021-2030) ($MN)
  • Table 25 Global Real-World Evidence Market Outlook, By Pharmaceutical & Medical Device Companies (2021-2030) ($MN)
  • Table 26 Global Real-World Evidence Market Outlook, By Healthcare Providers (2021-2030) ($MN)
  • Table 27 Global Real-World Evidence Market Outlook, By Healthcare Payers (2021-2030) ($MN)
  • Table 28 Global Real-World Evidence Market Outlook, By Other End Users (2021-2030) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.