Real-world Evidence Solutions Market Size, Share, Forecast, & Trends Analysis by Component (Datasets [Clinical, Claims, Pharmacy], Services) Application (Market Access, Drug Development & Approvals, PMS), and End User

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Real-world Evidence Solutions Market Size, Share, Forecast, & Trends Analysis by Component (Datasets [Clinical, Claims, Pharmacy], Services) Application (Market Access, Drug Development & Approvals, PMS), and End User-Global Forecast to 2031

The global RWE solutions market was valued at $2.62 billion in 2023. This market is expected to reach $6.37 billion by 2031 from an estimated $2.94 billion in 2024, at a CAGR of 11.7% during the forecast period of 2024-2031.

Following a comprehensive primary & secondary study and an in-depth analysis of the market scenario, this report provides the key drivers, constraints, challenges, and opportunities of the industry. This market is driven by the growing incidence of chronic diseases, delays in drug development and the consequent increase in development costs, the rising focus on personalized healthcare, a shift toward value-based care, and the growing adoption of real-world evidence solutions in drug development & commercialization. For instance, IQVIA introduced One Home for Sites in June 2024. This digital platform serves as a dashboard for all the essential systems and tasks needed by a clinical research site to conduct clinical trials.

Furthermore, emerging economies and a rising focus on end-to-end RWE services provide significant growth opportunities for the real-world solutions market. However, the market's expansion may be constrained by the unwillingness to rely on real-world research and the absence of quality control in data collection. Additionally, the lack of standardized methodologies for developing RWE and data privacy and security concerns pose a major challenge for the players operating in this market.

Among components, in 2024, the datasets segment is expected to account for the largest share of the RWE solutions market. RWE datasets originate from a range of sources related to patient outcomes in diverse populations in real-world contexts. With regard to unfulfilled needs and the financial and clinical effects on patients and healthcare systems, this solution offers insightful information. Additionally, it bases results on far larger data sets, lower expenses, and more effective clinical trial management.

Among applications, in 2024, the market access & reimbursement/coverage decisions segment is expected to account for the largest share of the RWE solutions market. Using predictive analysis and data-driven insights, RWE solutions for market access enable a comprehensive assessment of a medical product's efficacy and value, which can support value-based pricing strategies and result in favorable reimbursement outcomes. The significant market share is ascribed to several factors, including escalating healthcare expenses, growing regulatory body acceptance of RWE, expanding significance of clinical value evidence in coverage determinations, and the availability of supplementary data regarding treatment efficacy in routine care environments and heterogeneous patient cohorts.

Among end users, in 2024, the pharmaceutical, biotechnology, and medical device companies segment is expected to account for the largest share of the RWE solutions market. Several variables, including the growing use of RWE to gather real-time post-trial data about medications, monitor drug reactions, and prove the worth of newly created therapies outside of clinical trials, as well as expedited drug trials and extended approvals, are responsible for a substantial share of the segment.

An in-depth analysis of the global RWE solutions market's geographical scenario provides detailed qualitative and quantitative insights for the five major geographies (North America, Europe, Asia-Pacific, the Middle East & Africa, and Latin America). It covers the major countries in each region.

In 2024, North America is expected to account for the largest share of the global RWE solutions market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. The substantial share of North America can be attributed to various factors, including the rising incidence of chronic illnesses, stricter guidelines for medication approvals, the 21st Century Cures Act, the broad accessibility of electronic datasets, a firmly established healthcare industry, and the growing application of big data in healthcare.

The key players operating in the global RWE solutions market are IQVIA Holdings Inc. (U.S.), Elevance Health, Inc. (U.S.), ICON plc (Ireland), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), Revvity, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Thermo Fisher Scientific Inc. (U.S.), Oracle Corporation (U.S.), SAS Institute Inc. (U.S.), Parexel International Corporation (U.S.), and HealthVerity, Inc. (U.S.).

Scope of the Report:

Real-world Evidence Solutions Market Assessment-by Component

Datasets
- Disparate Datasets
EMR/EHR/Clinical Data
Claims & Billing Data
Pharmacy Data
Product/Disease Registries Data
Genomics Data
Other Disparate Datasets
- Integrated Datasets
Consulting Services

Note: Other Disparate Datasets include data generated from mobile devices, wearable devices, and social media.

Real-world Evidence Solutions Market Assessment-by Application

Market Access & Reimbursement/Coverage Decisions
Drug Development & Approvals
- Oncology
- Neurology
- Immunology
- Cardiovascular Diseases
- Other Therapeutic Areas
Post Market Surveillance
Medical Device Development & Approvals
Other Applications

Note: 1) Other Therapeutic Areas include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases.

2) Other Applications include regulatory and clinical decision-making.

Real-world Evidence Solutions Market Assessment-by End User

Pharmaceutical, Biotechnology, and Medical Device Companies
Healthcare Payers
Healthcare Providers
Other End Users

Note: Other end users include academic & research institutions, patient advocacy groups, regulators, and health technology assessment agencies.

Real-world Evidence Solutions Market Assessment-by Geography

North America
U.S.
Canada
Europe
Germany
France
U.K
Italy
Spain
Switzerland
Belgium
Rest of Europe (RoE)
Asia-Pacific (APAC)
China
Japan
India
South Korea
Taiwan
Singapore
Australia
Rest of Asia-Pacific (RoAPAC)
Latin America
Brazil
Mexico
Rest of Latin America (RoLATAM)
Middle East & Africa

Product Code: MRHC - 104253

1. Introduction

1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency & Limitations
1.4. Key Stakeholders

2. Research Methodology

2.1. Research Process
2.2. Data Collection & Validation Process
- 2.2.1. Secondary Research
- 2.2.2. Primary Research/Interviews with Key Opinion Leaders from the Industry
2.3. Market Sizing & Forecasting
- 2.3.1. Market Size Estimation Approach
- 2.3.2. Growth Forecast Approach
- 2.3.3. Market Share Analysis
2.4. Assumptions For the Study

3. Executive Summary

4. Market Insights

4.1. Overview
4.2. Factors Affecting Market Growth
- 4.2.1. Market Dynamics
  - 4.2.1.1. Drivers
    - 4.2.1.1.1. Rising Focus on Personalized Healthcare
    - 4.2.1.1.2. Delays in Drug Development and the Consequent Increase in Development Costs
    - 4.2.1.1.3. Growing Incidence of Chronic Diseases
    - 4.2.1.1.4. Shift toward Value-based Care
    - 4.2.1.1.5. Rapidly Growing Big Data in the Healthcare Sector
  - 4.2.1.2. Restraints
    - 4.2.1.2.1. Reluctance to Rely on Real-world Studies
  - 4.2.1.3. Opportunities
    - 4.2.1.3.1. Emerging economies
    - 4.2.1.3.2. Rising Focus on End-to-End RWE Services
  - 4.2.1.4. Challenges
    - 4.2.1.4.1. Lack of Standardized Methodologies for Developing RWE
- 4.2.2. Factors Analysis
4.3. Key Market Trends
- 4.3.1. The Incorporation of Artificial Intelligence (AI) in the RWE Industry
  - 4.3.1.1. The Adoption of AI Technologies is Growing in the Following Areas:
    - 4.3.1.1.1. Clinical Trials Design
    - 4.3.1.1.2. Modeling and Forecasting Patient Enrichment & Recruitment
    - 4.3.1.1.3. Selecting Investigator Site
    - 4.3.1.1.4. Patient Monitoring & Managing and Medication Adherence & Retention
    - 4.3.1.1.5. AI-enabled Clinical Trial Analytics
    - 4.3.1.1.6. Outsourcing Essential AI Solutions via Strategic Partnerships & Collaborations
    - 4.3.1.1.7. Market Access Using AI Solutions
    - 4.3.1.1.8. Post-market Surveillance Using AI Solutions
- 4.3.2. Growing Adoption of RWE In Drug Development and Commercialization
- 4.3.3. Rising Number of Consolidations
- 4.3.4. Improved Patient Outcomes and Value Creation from Real-World Evidence
4.4. Case Studies For AI-based RWE Solutions
- 4.4.1. AI-based RWE Solutions for Medical Device Post-market Studies - Huma.AI (U.S.)
- 4.4.2. AI-enabled RWE Solutions to Support Clinical Decision-making in Drug Research & Development - Owkin, Inc. (France)
- 4.4.3. AI-integrated RWE Solutions for Market Access - Medaffcon Oy (Finland)
- 4.4.4. Leveraging Real-world Data Insights Using AI & Machine Learning Algorithms - Aetion, Inc. (U.S.) & Quinten Health (France)
- 4.4.5. AI-powered RWE Platform to Track Adverse Events - Data2Life (Israel)
- 4.4.6. AI-powered RWE Solutions to Predict Patients' Health at Critical Care Units - PHASTAR (U.K.)
4.5. Regulatory Analysis
- 4.5.1. Overview
- 4.5.2. North America
- 4.5.3. Europe
- 4.5.4. Asia-Pacific
- 4.5.5. Rest of the World
4.6. Pricing Models (EMR/Genomic/Integrated Datasets)
- 4.6.1. Overview
- 4.6.2. Pay Per Patient Record (Volume-based Pricing)
- 4.6.3. Pay Per Usage (Value-based Pricing)
- 4.6.4. Annual Subscription

5. Real-World Evidence (RWE) Solutions Market Assessment-by Component

5.1. Overview
5.2. Datasets
- 5.2.1. Disparate Datasets
  - 5.2.1.1. EMR/EHR/Clinical Data
  - 5.2.1.2. Claims & Billing Data
  - 5.2.1.3. Pharmacy Data
  - 5.2.1.4. Product/Disease Registries Data
  - 5.2.1.5. Genomics Data
  - 5.2.1.6. Other Disparate Datasets
- 5.2.2. Integrated Datasets
5.3. Consulting & Analytics

6. Real-World Evidence Solutions Market Assessment-by Application

6.1. Overview
6.2. Market Access & Reimbursement/Coverage Decisions
6.3. Drug Development & Approvals
- 6.3.1. Oncology
- 6.3.2. Neurology
- 6.3.3. Immunology
- 6.3.4. Cardiovascular Diseases
- 6.3.5. Other Therapeutic Areas
6.4. Post-market Surveillance
6.5. Medical Device Development & Approvals
6.6. Other Applications

7. Real-World Evidence (RWE) Solutions Market Assessment-by End User

7.1. Overview
7.2. Pharmaceutical, Biotechnology, and Medical Device Companies
7.3. Healthcare Payers
7.4. Healthcare Providers
7.5. Other End Users

8. Real-world Evidence Solutions Market Assessment-by geography

8.1. Overview
8.2. North America
- 8.2.1. U.S.
- 8.2.2. Canada
8.3. Europe
- 8.3.1. U.K.
- 8.3.2. Germany
- 8.3.3. France
- 8.3.4. Italy
- 8.3.5. Spain
- 8.3.6. Switzerland
- 8.3.7. Belgium
- 8.3.8. Rest of Europe
8.4. Asia-Pacific
- 8.4.1. Japan
- 8.4.2. China
- 8.4.3. India
- 8.4.4. South Korea
- 8.4.5. Australia
- 8.4.6. Taiwan
- 8.4.7. Singapore
- 8.4.8. Rest of Asia-Pacific
8.5. Latin America
- 8.5.1. Brazil
- 8.5.2. Mexico
- 8.5.3. Rest of Latin America
8.6. Middle East & Africa

9. Competitive Landscape

9.1. Introduction
9.2. Key Growth Strategies
9.3. Competitive Benchmarking
9.4. Competitive Dashboard
- 9.4.1. Industry Leaders
- 9.4.2. Market Differentiators
- 9.4.3. Vanguards
- 9.4.4. Emerging Companies
9.5. Market Share Analysis
- 9.5.1. IQVIA Holdings Inc. (U.S.)
- 9.5.2. Icon plc (IRELAND)
- 9.5.3. Thermo Fisher Scientific Inc. (U.S.)

10. Company Profiles

10.1. IQVIA Holdings, Inc.
10.2. Icon plc
10.3. Thermo Fisher Scientific Inc.
10.4. F. Hoffmann-La Roche Ltd
10.5. Oracle Corporation
10.6. Elevance Health, Inc.
10.7. Clinigen Group Plc
10.8. Cognizant Technology Solutions Corporation
10.9. Revvity, Inc.
10.10. SAS Institute Inc.
10.11. Parexel International Corporation
10.12. Healthverity, Inc.

11. Appendix

11.1. Available Customization
11.2. Related Reports