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InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the“ AI-Powered Real-Worl Evidence (RWE) Solutions Market”- , By Component(Software/Platforms, Services), By Data Source(EHR/EMR Data, Claims Data, Genomics, Wearables/IoT, Patient-Reported Data, Imaging), By Therapeutic Area(Oncology, Neurology, Cardiology, Rare Diseases, Immunology), By End-User (Pharma/Biotech, Payers/PBMs, Hospitals/IDNs, Regulators, CROs), By Deployment Model (Cloud-Based, On-Premise, Hybrid), By Technology (NLP, Computer Vision, Federated Learning, Graph ML), By Application (Drug Development, Regulatory Submissions, Market Access, Precision Medicine), and Global Forecasts, 2025-2034 And Segment Revenue and Forecast To 2034.”

Global AI-Powered Real-World Evidence (RWE) Solutions Market Size is predicted to reach grow at a 14.6 % CAGR during the forecast period for 2025-2034.

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Real-World Evidence (RWE) is derived from Real-World Data (RWD), which encompasses health-related information obtained outside the context of traditional randomized controlled trials. Key sources of RWD include electronic health records (EHRs), insurance claims, patient registries, wearable devices, and patient-reported outcomes.

By leveraging these diverse datasets, RWE enables improved patient outcomes, more efficient drug development, and evidence-based decision-making across the healthcare ecosystem. The integration of artificial intelligence (AI) into RWE generation is fundamentally transforming clinical trial design and execution within the pharmaceutical sector.

Pharmaceutical companies are increasingly utilizing real-world patient data to gain insights into treatment patterns, disease progression, and population heterogeneity-elements that are often underrepresented in conventional clinical trials. AI technologies are applied to optimize study design, including the selection of inclusion and exclusion criteria, trial scenario simulations, and identification of optimal patient cohorts.

This approach enhances recruitment efficiency, reduces protocol amendments, and lowers overall clinical trial costs. For example, a multinational pharmaceutical firm recently applied AI-driven analytics to extensive historical clinical trial datasets, improving patient stratification, accelerating study design, and achieving a competitive advantage in early-phase development.

Regulatory authorities have also developed frameworks supporting the use of RWE in submissions. The U.S. Food and Drug Administration (FDA) provide guidance on incorporating RWE for post-marketing surveillance, label expansions, and therapeutic approvals, while the European Medicines Agency (EMA) promotes adaptive methodologies for integrating RWE into regulatory decision-making. These measures reflect a growing recognition that traditional clinical trial environments may not fully capture real-world effectiveness and safety outcomes.

Nonetheless, challenges persist in the regulatory adoption of RWE. RWD must meet rigorous standards for data quality, statistical robustness, traceability, and reproducibility. As a result, many pharmaceutical organizations continue to treat RWE as a complementary tool rather than a primary strategic asset.

To fully harness its potential throughout the drug development lifecycle, AI-driven RWE solutions-designed to be scalable, domain-specific, and regulatory-compliant-are becoming increasingly essential. Forward-looking pharmaceutical companies are leveraging these capabilities to transform how real-world data is collected, analyzed, and applied across the life sciences industry.

List of Prominent Players in the AI-Powered Real-World Evidence (RWE) Solutions Market:

• Aetion
• Atropos Health
• ConcertAI
• Envision Pharma Group
• Flatiron Health
• Health Compiler
• Huma
• IQVIA
• ai
• Komodo Health
• NVIDIA CLARA
• OM1
• ai
• Optum
• Owkin
• Panalgo
• Realyze Intelligence
• Syntropy
• Tempus
• AI
• Veradigm
• Other Prominent Players

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Market Dynamics

Drivers:

The global healthcare landscape is progressively shifting toward a value-based care model that emphasizes clinical outcomes and quality of care over the volume of services delivered. This approach relies on evidence-based metrics to evaluate the effectiveness, efficiency, and cost-effectiveness of healthcare interventions.

Value-based care frameworks aim to enhance patient quality of life while ensuring adherence to standardized performance measures. In response to inefficiencies inherent in traditional care delivery models, an increasing number of healthcare institutions are adopting strategies focused on improving patient outcomes and optimizing operational performance.

Challenges:

The growth of the real-world evidence (RWE) market is hindered by a shortage of skilled professionals proficient in managing advanced digital platforms and analyzing complex datasets. The clinical research sector faces a significant talent gap in data analytics and interpretation, which limits the widespread deployment of sophisticated RWE tools in clinical trials and evidence-based healthcare decision-making.

Regional Trends:

North America is expected to retain a leading position in the RWE market throughout the forecast period, supported by robust adoption of real-world data (RWD) by payers, comprehensive regulatory frameworks, and a mature ecosystem of RWE solution providers.

The region benefits from extensive utilization of RWE in drug development and regulatory submissions, a high burden of chronic diseases, advanced healthcare infrastructure, stringent drug approval processes, and widespread access to electronic health records. Government initiatives promoting RWE integration further reinforce market growth.

In contrast, the Asia-Pacific region is projected to experience the fastest growth. This expansion is driven by the presence of numerous contract research and manufacturing organizations in key markets, including China and India, coupled with increasing government support for RWE adoption.

Rising demand for enhanced healthcare delivery, along with strategic initiatives by industry stakeholders-such as regional collaborations, partnerships, and portfolio diversification-is contributing to accelerated market development across the region.

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Recent Developments:

• In Jan 2025, Atropos Health and xCures declared a collaboration to use RWE-based analytics to improve patient care. Through this collaboration, the businesses will use AI, the xCures Platform, and the Atropos EvidenceTM Network to create and distribute highly proven prognostic and decision support tools to healthcare providers throughout the healthcare ecosystem. The collaboration marks a major advancement in the analysis and use of RWE using AI. Atropos Health and xCures will collaborate to create solutions that provide traceable, source-verified insights straight into clinical processes from raw clinical notes, analytics, and imaging data.
• In July 2021, Syneos Health and Aetion declared a collaboration to offer analytics-driven solutions and regulatory-grade data to enhance medication development and improve patient outcomes. The collaboration combines Aetion Evidence Platform (AEP) with Syneos Health's in-house data collecting and research tools to produce evidence through real-world evidence (RWE) analytics and patient data curation. Biopharmaceutical companies can reduce risk through evidence-based decision-making, speed up product development and patient access to new therapies, and prove value to a wide range of healthcare stakeholders, including patients, regulators, payers, and healthcare providers, with Syneos Health's offerings, such as its Biopharmaceutical Acceleration Model, Dynamic Assembly, and RWE Solutions.

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Component

• Software/Platforms
• Services

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Data Source

• EHR/EMR Data
• Claims Data
• Genomics
• Wearables/IoT
• Patient-Reported Data
• Imaging

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Therapeutic Area

• Oncology
• Neurology
• Cardiology
• Rare Diseases
• Immunology

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By End-User

• Pharma/Biotech
• Payers/PBMs
• Hospitals/IDNs
• Regulators
• CROs

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Deployment Model

• Cloud-Based
• On-Premise
• Hybrid

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Technology

• NLP
• Computer Vision
• Federated Learning
• Graph ML

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Application

• Drug Development
• Regulatory Submissions
• Market Access
• Precision Medicine

Global AI-Powered Real-World Evidence (RWE) Solutions Market – By Region

North America-

• The US
• Canada

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa-

• GCC Countries
• South Africa
• Rest of the Middle East and Africa

About Us:

InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

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