Real World Evidence Solutions Market worth $12.44 billion by 2031 - Exclusive Report by MarketsandMarkets™

DELRAY BEACH, Fla., Sept. 23, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Real World Evidence Solutions Market is projected to reach USD 12.44 billion by 2031 from USD 6.22 billion in 2026, at a CAGR of 14.9% during the forecast period.

Browse 190 market data Tables and 60 Figures spread through 265 Pages and in-depth TOC on "Real-world Evidence Solutions Market- Global Forecast to 2031"

Real World Evidence Solutions Market Size & Forecast:

• Market Size Available for Years: 2026–2031
• 2026 Market Size: USD 6.22 billion
• 2031 Projected Market Size: USD 12.44 billion
• CAGR (2026–2031): 14.9%

Real World Evidence Solutions Market Trends & Insights:

• North America accounted for the largest share of 58.3% of the real-world evidence solutions market in 2025.
• By component, the data sets segment is projected to grow at the fastest rate of 15.5% during the forecast period.
• By application, the drug development and approvals segment held the largest share of 32.0% in 2025.

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Market growth is driven by the transition from volume to value-based care and increased investment in research and development for innovative pharmaceutical drugs and medical devices. Moreover, the FDA data show that NDA/BLA submissions containing RWE increased from 4 in FY2023 to 10 in FY2025, with RWE contributing to FDA decisions for Onapgo, Isturisa, and Gamifant in 2025. Additionally, Europe is building substantial infrastructure for regulatory-grade RWE; EMA's DARWIN EU network reached 40 data partners across 18 countries, providing access to data from ~250 million patients and completing 88 studies.

RWE technology is evolving toward AI-driven, privacy-preserving, and highly integrated evidence generation, with key advancements including GenAI and AI agents, federated analytics, synthetic data, external control arms, advanced data linkage, multimodal RWD analysis, real-time evidence generation, and regulatory-grade analytics. For example, in September 2025, HealthVerity launched eXOs, an agentic AI evidence studio powered by Medeloop, enabling biopharma companies to generate RWE studies and commercial insights from real-world data using natural-language queries, with auditable and regulatory-ready outputs.

By component, the data sets segment is growing at the fastest rate during the forecast period.

By component, the RWE solutions market is segmented into services and data sets. The data sets segment is expected to grow at the fastest rate in the RWE solutions market, driven by the rapid expansion of real-world data generated from electronic health records (EHRs), insurance claims, patient registries, pharmacy data, wearable devices, and other digital health technologies. The increasing digitization of healthcare is creating larger and more diverse data sets, enabling pharmaceutical and biotechnology companies to generate evidence across broader and more representative patient populations.

By application, the cardiovascular diseases segment accounted for the largest market share in 2025.

By application, the RWE solutions market is segmented into drug development & approvals, medical device development & approvals, post-market surveillance, market access and reimbursement decision-making, clinical & regulatory decision-making, and other applications. The drug development & approvals segment is bifurcated into oncology, cardiovascular diseases, neurology, immunology, rare diseases, and other therapeutic areas. Cardiovascular diseases held the largest share of the RWE solutions market, supported by the high prevalence of cardiovascular conditions and the need for long-term evidence on treatment effectiveness, safety, and patient outcomes. The growing availability of EHRs, claims data, patient registries, and patient-generated data is further expanding RWE use in cardiovascular care.

By end user, the medtech companies segment is growing at the fastest rate during the forecast period.

Based on end user, the RWE solutions market is segmented into pharmaceutical & biotechnological companies, medtech companies, healthcare payers, healthcare providers, and other end users. Medtech companies are expected to register the fastest growth in the RWE solutions market, as manufacturers increasingly use real-world data to demonstrate the safety, performance, and effectiveness of devices throughout their product lifecycles. The growing adoption of connected devices, AI-enabled medical technologies, remote monitoring solutions, and software as a medical device is generating larger volumes of device-generated and patient-generated data, creating greater opportunities for RWE generation.

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By region, North America accounted for the largest share of the market in 2025.

By region, the RWE solutions market is segmented into five regions: North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2025, North America accounted for the largest share of the market. This region's dominance is attributed to the favorable regulatory environment and the increasing adoption of EHR. The US is a major contributor to this regional leadership, with extensive availability of claims, EHR, registry, and other real-world data sets. For example, IQVIA reported in 2025 that its US RWE network covered more than 318 million lives, including claims, EMR, patient-reported outcomes, and real-world wearable data. Additionally, an increase in the number of payers using RWE solution services is also expected to fuel the market growth. Moreover, the presence of key market players such as IQVIA Inc. (US), Optum Inc. (US), and Oracle (US) also contributes to market growth.

Key Players

Leading players in the Real World Evidence Solutions companies include IQVIA Inc. (US), Merative (US), Optum Inc. (US), ICON Plc (Ireland), Syneos Health (US), Parexel International Corporation (US), Tata Consultancy Services (India), Oracle (US), Elevance Health (US), SAS Institute Inc. (US), Datavant (US), TriNetX, LLC (US), Trinity (US), Cognizant (US), Cegedim Health Data (France), Verantos (US), Medpace Holdings Inc. (US), Flatiron Health (US), Fortrea (US), and Medidata (US) (a subsidiary of Dassault Systèmes).

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Real World Evidence Solutions Market - Investment & funding + Merger & Acquisition

Investment and Funding Context

The real-world evidence (RWE) solutions market is attracting increasing investment and strategic activity, driven by demand for AI-enabled evidence generation, connected real-world data, privacy-preserving data linkage, and scalable analytics platforms. Investment is increasingly focused on technologies that combine RWD with AI, advanced analytics, and secure data infrastructure to accelerate evidence generation. For example, in May 2026, RTI International made a strategic equity investment in Navidence to develop AI-enabled infrastructure to standardize disease, treatment, and outcome definitions and improve the efficiency and transparency of RWE generation.

Revenue Shift Context

The RWE solutions market is shifting from standalone, project-based evidence generation to cloud-based, subscription-driven, integrated RWE platforms. Growth is increasingly centered on solutions that combine real-world data, AI-powered analytics, data linkage, and continuous access to longitudinal datasets, enabling faster and more scalable evidence generation. For example, in February 2026, OneMedNet announced the commercial launch of its RWD Platform powered by Palantir Foundry, with subscription-based access to continuously updated multimodal RWD and AI-driven search capabilities. The company reported that customer evaluations were converting into multi-year subscriptions, supporting a recurring-revenue model for RWE generation.

Mergers and Acquisitions

M&A activity in the RWE solutions market is increasingly focused on strengthening real-world data connectivity, advanced analytics, AI-enabled evidence generation, and end-to-end RWE capabilities. Established healthcare-data and life-sciences companies are acquiring specialized RWE platforms and analytics providers to expand their data ecosystems, improve patient-level data linkage, and support regulatory, clinical development, and market-access use cases.

REAL-WORLD EVIDENCE SOLUTIONS MARKET: MERGERS AND ACQUISITIONS, JANUARY 2025–JULY 2026

Company Revenue Share Details

The RWE solutions market is led by established data, analytics, and evidence-generation providers, with IQVIA, Merative, Optum, Syneos Health, and ICON plc consistently identified among the leading players. These companies maintain strong positions through broad RWD/RWE platforms, longitudinal healthcare datasets, advanced analytics, RWE study design, HEOR, regulatory evidence generation, and market-access solutions, serving pharmaceutical, biotechnology, MedTech, payer, and healthcare organizations across the product lifecycle.

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