The "Real-world Evidence Solutions Market Size, Share, Forecast, & Trends Analysis by Component Application, and End User - Global Forecast to 2031" report has been added to ResearchAndMarkets.com's offering.

Real-world Evidence Solutions 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.

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.

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.

Market Dynamics

Drivers

• Rising Focus on Personalized Healthcare
• Delays in Drug Development and the Consequent Increase in Development Costs
• Growing Incidence of Chronic Diseases
• Shift toward Value-based Care
• Rapidly Growing Big Data in the Healthcare Sector

Restraints

• Reluctance to Rely on Real-world Studies

Opportunities

• Emerging economies
• Rising Focus on End-to-End RWE Services

Challenges

• Lack of Standardized Methodologies for Developing RWE

Key Market Trends

• The Incorporation of Artificial Intelligence (AI) in the RWE Industry
• Clinical Trials Design
• Modeling and Forecasting Patient Enrichment & Recruitment
• Selecting Investigator Site
• Patient Monitoring & Managing and Medication Adherence & Retention
• AI-enabled Clinical Trial Analytics
• Outsourcing Essential AI Solutions via Strategic Partnerships & Collaborations
• Market Access Using AI Solutions
• Post-market Surveillance Using AI Solutions
• Growing Adoption of RWE In Drug Development and Commercialization
• Rising Number of Consolidations
• Improved Patient Outcomes and Value Creation from Real-World Evidence

Case Studies For AI-based RWE Solutions

• AI-based RWE Solutions for Medical Device Post-market Studies - Huma.AI (U.S.)
• AI-enabled RWE Solutions to Support Clinical Decision-making in Drug Research & Development - Owkin, Inc. (France)
• AI-integrated RWE Solutions for Market Access - Medaffcon Oy (Finland)
• Leveraging Real-world Data Insights Using AI & Machine Learning Algorithms - Aetion, Inc. (U.S.) & Quinten Health (France)
• AI-powered RWE Platform to Track Adverse Events - Data2Life (Israel)
• AI-powered RWE Solutions to Predict Patients' Health at Critical Care Units - PHASTAR (U.K.)

Regulatory Analysis

• Overview
• North America
• Europe
• Asia-Pacific
• Rest of the World

Pricing Models (EMR/Genomic/Integrated Datasets)

• Overview
• Pay Per Patient Record (Volume-based Pricing)
• Pay Per Usage (Value-based Pricing)
• Annual Subscription

Competitive Landscape

• Key Growth Strategies
• Competitive Benchmarking
• Competitive Dashboard
• Industry Leaders
• Market Differentiators
• Vanguards
• Emerging Companies
• Market Share Analysis
• IQVIA Holdings Inc. (U.S.)
• Icon plc (IRELAND)
• Thermo Fisher Scientific Inc. (U.S.)

Company Profiles

• 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.)
• HealthVerity Inc. (U.S.)

Scope of the Report:

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

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

End User

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

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

For more information about this report visit https://www.researchandmarkets.com/r/tp5qp4

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