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1401913

到 2030 年的真實世界證據市場預測：按組件、應用、最終用戶和地區進行的全球分析

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個工作天內

價格

根據 Stratistics MRC 的數據，2023 年全球現實世界證據市場規模將達到 17 億美元，預計到 2030 年將達到 45 億美元，預測期內複合年成長率為 14.8%。

真實世界證據 (RWE) 是在傳統臨床試驗之外收集的資料，可深入了解現實世界中治療的有效性。其用途包括為醫療保健決策資訊、了解治療結果以及評估長期患者結果。

根據 ClinicalTrials.gov 的數據，截至 2022 年 2 月，約有 87,366 項癌症臨床試驗正在進行，處於不同的發展階段。

成本效率和節省時間

與傳統的臨床試驗相比，利用真實世界的資料進行研究和決策可以顯著減少所需的時間和財務投資。 RWE 能夠持續監測不同族群的治療結果，並以極低的成本提供及時的見解。這種效率對製藥公司、監管機構和醫療保健相關人員特別有吸引力，因為它不僅更經濟，而且在不斷發展的醫療保健環境中對敏捷和適應性方法的需求不斷成長。

資料品質和標準化

不同醫療保健系統的資料收集方法、格式和品質的差異可能會導致現實世界資料可靠性的不一致和限制。不完整或不標準化的資訊會阻礙 RWE 的資訊性並影響決策的信心。努力建立標準化的資料收集方法，透過檢驗流程提高資料質量，並提高不同醫療保健系統之間的互通性至關重要。

擴大對以患者為中心的醫療保健的關注

醫療保健系統越來越重視患者的治療效果和體驗，從而增加了對真實資料的需求，以了解治療的有效性、安全性和患者的偏好。 RWE 與向個性化、以患者為中心的護理的更廣泛轉變保持一致，並提供了一個寶貴的工具，可以從患者的日常經歷中獲得直接洞察。將患者報告的結果與現實世界的證據相結合，可以提高對治療的整體理解，促進更多以患者為中心的決策，並開發出更符合不同患者群體的需求和期望的治療方法。

隱私和安全問題

使用敏感的患者資料會帶來道德和監管方面的挑戰，並有可能侵犯患者的隱私。從現實世界的資料中提取有價值的見解和保護患者隱私之間取得微妙的平衡至關重要。 GDPR 和 HIPAA 等嚴格的資料保護條例提出了嚴格的要求，並使 RWE 的工作變得更加複雜。資料外洩的威脅不僅會損害病患的信任，還會為相關人員帶來法律和合規問題。

COVID-19 的影響：

COVID-19 的爆發凸顯了真實世界證據 (RWE) 在醫療保健決策中的重要性。快速了解治療效果和結果的迫切需求凸顯了利用真實資料的價值。這場大流行促使包括監管機構在內的相關人員之間進行合作，利用萊茵集團來評估干預措施的影響。雖然這場危機凸顯了萊茵集團的潛力，但它也凸顯了資料品質問題等挑戰，以及需要標準化方法來充分利用現實世界證據在公共衛生危機中的潛力。

預計藥物開發和核准領域在預測期內將是最大的。

藥物開發和核准預計將佔據市場開拓的很大佔有率。製藥公司利用 RWE 來補充傳統的臨床試驗資料，以更全面地了解不同患者群體的藥物療效和安全性。監管機構越來越認知到 RWE 在醫藥品認證過程中做出資訊決策、使藥物開發、監管提交和上市後監測更加高效和對患者友好的重要性，從而可以採取集中的方法。整合 RWE 可以加強依證，有助於做出更資訊的醫療決策並改善患者的治療結果。

預計製藥和醫療設備公司領域在預測期內複合年成長率最高

在預測期內，製藥和醫療設備公司部門預計將以最有效的速度成長。 RWE 使這些公司能夠評估其治療方法在不同患者群體中的有效性和安全性，並支持監管備案和市場准入。它影響整個產品生命週期的決策，並有助於在受控臨床試驗之外更全面地了解產品性能。 RWE 整合使製藥和醫療設備公司能夠做出資訊的策略決策、駕馭監管環境並展示醫療保健創新的現實影響。

佔有率最大的地區

預計北美市場在預測期內將佔據大部分市場佔有率。該地區先進的電子健康記錄(EHR) 系統和醫療資訊的普及為現實世界資料提供了豐富的資訊來源。將 RWE 涵蓋決策流程的監管支持，加上對醫療保健創新的重視，使北美處於利用現實世界資訊為臨床實踐、藥物開發和健康政策決策提供資訊的最前沿。

複合年成長率最高的地區：

預計亞太地區在預測期內複合年成長率最高。醫療保健數位化程度的提高、對循證決策的需求不斷成長以及醫療基礎設施的擴展都有助於 RWE 在該地區的採用。由於每個國家都有不同的患者群體，因此有機會獲得寶貴的見解。然而，存在許多挑戰，包括監管條件和資料隱私問題。隨著亞太地區繼續優先考慮醫療保健的進步、合作和技術整合，真實世界證據的使用將在製定亞太地區的醫療保健策略和政策方面發揮關鍵作用。

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目錄

第1章執行摘要

第2章 前言

  • 概述
  • 相關利益者
  • 調查範圍
  • 調查方法
    • 資料探勘
    • 資料分析
    • 資料檢驗
    • 研究途徑
  • 調查來源
    • 主要調查來源
    • 二次調查來源
    • 先決條件

第3章市場趨勢分析

  • 促進因素
  • 抑制因素
  • 機會
  • 威脅
  • 應用分析
  • 最終用戶分析
  • 新興市場
  • 新型冠狀病毒感染疾病（COVID-19）的影響

第4章波特五力分析

  • 供應商的議價能力
  • 買方議價能力
  • 替代品的威脅
  • 新進入者的威脅
  • 競爭公司之間的敵對關係

第5章 全球現實世界證據市場：依組成部分

  • 服務
  • 資料集
    • 異質資料集
      • 臨床設定資料
      • 申請資料
      • 藥房資料
      • 患者豐富的資料
      • 基於註冊表的資料集
    • 綜合資料集

第6章 全球現實世界證據市場：依應用分類

  • 藥物研發及核准
    • 腫瘤學
    • 神經病學
    • 免疫學
    • 循環系統疾病
    • 其他治療領域
    • 醫療設備開發及核准
  • 上市後監控
  • 市場進入報銷/補償決定
  • 臨床和監管決策
  • 其他用途

第7章 全球真實世界證據市場：依最終使用者分類

  • 製藥和醫療設備公司
  • 醫療服務提供方
  • 醫療保健付款人
  • 其他最終用戶

第8章全球現實世界證據市場：按地區

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 義大利
    • 法國
    • 西班牙
    • 其他歐洲國家
  • 亞太地區
    • 日本
    • 中國
    • 印度
    • 澳洲
    • 紐西蘭
    • 韓國
    • 其他亞太地區
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地區
  • 中東和非洲
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 卡達
    • 南非
    • 其他中東和非洲

第9章 主要進展

  • 合約、夥伴關係、協作和合資企業
  • 收購和合併
  • 新產品發布
  • 業務擴展
  • 其他關鍵策略

第10章 公司簡介

  • 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.