美國真實世界證據解決方案市場機會、成長促進因素、產業趨勢分析及預測（2025-2034年）

2024 年美國真實世界證據解決方案市值為 9.094 億美元，預計到 2034 年將以 16.3% 的複合年成長率成長至 41 億美元。

強勁成長的動力源自於對加速藥物研發、降低成本以及加強上市後安全性和有效性評估的日益重視。利害關係人越來越依賴真實世界證據來指導報銷策略和臨床決策。真實世界證據解決方案能夠收集、分析和解讀來自日常醫療保健環境（例如電子健康記錄、理賠資料庫、註冊登記系統和穿戴式裝置）的資料，從而獲得超越傳統試驗環境的臨床見解。隨著支付方、監管機構和臨床醫生對即時證據的需求不斷成長，真實世界證據在醫療產品的整個生命週期中發揮著至關重要的作用。這種向實證策略的動態轉變，以及對分析領域不斷成長的投資，正在重塑美國市場藥物和醫療器材的研發、核准和監測方式。

2024年，服務板塊佔據58.4%的市佔率。其領先地位得益於訂閱模式和高級分析平台的廣泛應用，以及生命科學公司對真實世界研究（RWE）服務日益成長的需求。這些服務涵蓋研究規劃、資料整合、品質控制和法規支援。它們整合從健康記錄到穿戴式裝置輸出等各種資料流，從而支援符合合規標準和決策需求的可靠真實世界研究。

預計到2034年，藥物研發和核准領域市場規模將達16億美元。這一成長主要得益於臨床試驗活動的增加、最佳化試驗設計的需求以及利用真實世界證據（RWE）支持監管申報和加速核准。該領域涵蓋方案製定、患者招募、試驗最佳化、安全性和有效性監測以及為監管機構提供證據等工作。

預計到2024年，製藥和醫療器材公司將佔據60.4%的市場。這些公司是真實世界證據（RWE）工具和平台的主要採用者，並在產品生命週期的各個階段進行部署。 RWE幫助他們精準定位患者群體，完善試驗方案，並產生符合監管和市場准入要求的真實世界資料，從而補充或在某些情況下替代傳統的隨機對照試驗。

美國真實世界證據解決方案市場的主要參與者包括ICON plc、Oracle Corporation、Aetion, Inc.、TriNetX、Cytel Inc.、Merative、Flatiron Health Inc.、Tempus、Syneos Health Inc.、Medidata Solutions, Inc.、Thermo Fisher Scientific, Inc.、UnitedHealth Group Incorpor Holdings、ParVIA Holdings.S.這些公司正積極推行多項策略措施以鞏固其市場地位。許多公司正大力投資人工智慧和機器學習，以提升預測建模、因果推論和資料分析能力。與醫療系統、支付者和研究機構建立合作關係和聯盟，有助於獲得更豐富、更多樣化的真實世界資料集。此外，公司還透過收購和合併來拓展服務範圍、引入新技術或擴大地域覆蓋範圍。

目錄

第1章：方法論與範圍

第2章：執行概要

第3章：行業洞察

• 產業生態系分析
  • 供應商格局
  • 每個階段的價值增加
  • 影響價值鏈的因素
• 產業影響因素
  • 成長促進因素
    • 日益重視加速藥物研發和降低成本
    • 藥品和醫療器材即時安全性和有效性監測的需求日益成長
    • 提高真實世界證據解決方案在知情報銷決策中的應用
    • 臨床決策中資料分析服務的應用日益廣泛
  • 產業陷阱與挑戰：
    • 現實世界資料的整合和互通性缺乏標準化
    • 熟練專業人員短缺
  • 市場機會：
    • 新興治療領域正擴展到腫瘤學以外的領域
    • 重點關注患者產生的健康資料整合
• 成長潛力分析
• 監管環境
• 技術進步
  • 當前技術趨勢
    • 人工智慧和機器學習的融合
    • 雲端運算和資料基礎設施
    • 用於臨床資料擷取的自然語言處理（NLP）
  • 新興技術
    • 區塊鏈和分散式帳本技術
    • 量子計算應用
    • 聯邦學習與隱私權保護分析
• 未來市場趨勢
  • 將真實世界證據納入藥物研發與市場進入的監管體系
  • 人工智慧驅動的真實世界資料分析助力精準醫療
• 波特的分析
• PESTEL 分析

第4章：競爭格局

• 介紹
• 公司市佔率分析
• 公司矩陣分析
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 關鍵進展
  • 併購
  • 夥伴關係與合作
  • 新產品發布
  • 擴張計劃

第5章：市場估算與預測：依組件分類，2021-2034年

• 主要趨勢
• 服務
  • 資料收集與整合
  • 研究設計與實施
    • 前瞻性觀察研究
    • 回顧性資料庫研究
    • 以地點為中心的研究
    • 基於註冊登記的研究
    • 混合研究
  • 監管和市場准入支持
  • 證據網路
  • 其他服務
• 資料集
  • 不同的資料集
    • 臨床環境資料
    • 索賠資料集
    • 藥房資料集
    • 患者驅動資料集
    • 基於註冊表的資料集
  • 綜合資料集

第6章：市場估算與預測：依應用領域分類，2021-2034年

• 主要趨勢
• 藥物研發及核准
  • 腫瘤學
  • 心血管疾病
  • 神經病學
  • 免疫學
  • 其他治療領域
• 醫療器材開發與核准
• 上市後監測
• 市場准入和報銷/承保決策
• 臨床和監管決策

第7章：市場估計與預測：依所得模式分類，2021-2034年

• 主要趨勢
• 按使用量付費（基於價值的定價）
• 訂閱

第8章：市場估算與預測：依部署模式分類，2021-2034年

• 主要趨勢
• 本地部署
• 基於雲端的

第9章：市場估算與預測：依最終用途分類，2021-2034年

• 主要趨勢
• 製藥和醫療器材公司
• 醫療保健支付方
• 醫療保健提供者
• 其他最終用途

第10章：公司簡介

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

U.S. Real World Evidence Solutions Market was valued at USD 909.4 million in 2024 and is estimated to grow at a CAGR of 16.3% to reach USD 4.1 billion by 2034.

The robust growth is fueled by increased emphasis on expediting drug development, lowering costs, and enhancing post-market safety and efficacy evaluation. Stakeholders are placing greater reliance on real-world evidence to guide reimbursement strategies and clinical decision-making. RWE solutions gather, analyze, and interpret data from everyday healthcare environments such as electronic health records, claims databases, registries, and wearable devices to derive clinical insights beyond conventional trial settings. As payers, regulators, and clinicians demand more real-time evidence, the role of RWE is becoming critical throughout the lifecycle of medical products. This dynamic shift toward evidence-driven strategies, plus growing investments in analytics, is reshaping how drugs and devices are developed, approved, and monitored in the U.S. market.

In 2024, the services segment held a 58.4% share. Its leading position is supported by the widespread offering of subscription models and advanced analytics platforms, and by growing uptake of RWE services among life sciences firms. These services encompass study planning, data integration, quality control, and regulatory support. They harmonize diverse data streams from health records to wearable outputs to enable robust real-world studies that meet compliance standards and decision-making needs.

The drug development and approvals segment is expected to reach USD 1.6 billion by 2034. This growth is driven by increased clinical trial activity, the need to optimize trial designs, and the use of RWE to support regulatory submissions and accelerate approvals. The segment includes protocol formulation, patient recruitment, trial optimization, safety and efficacy monitoring, and evidence generation for regulatory bodies.

The pharmaceutical and medical device companies segment held a 60.4% share in 2024. These organizations are the primary adopters of RWE tools and platforms, deploying them across product lifecycle stages. RWE helps them pinpoint patient cohorts, refine trial protocols, and produce real-world data aligned with regulatory and market access demands, either supplementing or, in some cases, substituting traditional randomized controlled trials.

Prominent participants in the U.S. Real World Evidence Solutions Market include ICON plc, Oracle Corporation, Aetion, Inc., TriNetX, Cytel Inc., Merative, Flatiron Health Inc., Tempus, Syneos Health Inc., Medidata Solutions, Inc., Thermo Fisher Scientific, Inc., UnitedHealth Group Incorporated, IQVIA Holdings Inc., Parexel International Corporation, and Fortrea Holdings Inc. Firms in the U.S. real world evidence solutions market are pursuing several strategic initiatives to solidify their market position. Many are investing heavily in AI and machine learning to improve predictive modeling, causal inference, and data analytics capabilities. Partnerships and alliances with healthcare systems, payers, and research institutions are helping to access richer, more diverse real-world datasets. Acquisitions and mergers are being used to broaden service offerings, add novel technology, or expand geographic reach.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
• 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 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Country trends
  • 2.2.2 Component trends
  • 2.2.3 Application trends
  • 2.2.4 Revenue model trends
  • 2.2.5 Deployment model 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
  • 3.1.1 Supplier landscape
  • 3.1.2 Value addition at each stage
  • 3.1.3 Factor affecting the value chain
• 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
• 3.5 Technological advancements
  • 3.5.1 Current technological trends
    • 3.5.1.1 Artificial intelligence and machine learning integration
    • 3.5.1.2 Cloud computing and data infrastructure
    • 3.5.1.3 Natural language processing (NLP) for clinical data extraction
  • 3.5.2 Emerging technologies
    • 3.5.2.1 Blockchain and distributed ledger technologies
    • 3.5.2.2 Quantum computing applications
    • 3.5.2.3 Federated learning and privacy-preserving analytics
• 3.6 Future market trends
  • 3.6.1 Regulatory integration of RWE in drug development and market access
  • 3.6.2 AI-driven real world data analytics for precision medicine
• 3.7 Porter's analysis
• 3.8 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 Key developments
  • 4.6.1 Mergers and acquisitions
  • 4.6.2 Partnerships and collaborations
  • 4.6.3 New product launches
  • 4.6.4 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
  • 5.3.2 Integrated 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
• 6.6 Clinical and regulatory 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 Company Profiles

• 10.1 Aetion, Inc.
• 10.2 Cytel Inc
• 10.3 Flatiron Health Inc
• 10.4 Fortrea Holdings Inc
• 10.5 IBM Corporation
• 10.6 ICON plc
• 10.7 IQVIA Holdings Inc
• 10.8 Medidata Solutions, Inc.
• 10.9 Merative
• 10.10 Oracle Corporation
• 10.11 Parexel International Corporation
• 10.12 Syneos Health Inc
• 10.13 Tempus
• 10.14 TriNetX
• 10.15 Thermo Fisher Scientific, Inc.
• 10.16 UnitedHealth Group Incorporated