Real-World Evidence Solutions Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component (Claims Data, Clinical Settings Data, Patient-Powered Data, Pharmacy Data, Other Components), By Therapeutic Area (Oncology, Immunology, Neurology, Cardiovascular Disease, Other Therapeutic Areas) Region and Competition, 2020-2030F

Market Overview

The Global Real-World Evidence Solutions Market , valued at USD 2.98 Billion in 2024, is projected to experience a CAGR of 8.99% to reach USD 5.00 Billion by 2030. The Global Real-World Evidence (RWE) Solutions Market encompasses the comprehensive technology and services employed for collecting, analyzing, and generating clinical insights from real-world data to inform diverse healthcare decisions. This market is primarily driven by the increasing regulatory acceptance of RWE in drug development and approvals, the growing demand for value-based care models, and the expanding need for efficient post-market surveillance. For instance, according to the European Federation of Pharmaceutical Industries and Associations, in 2023, its member companies collectively invested an estimated €50,000 million in research and development within Europe, a substantial portion of which directly supports RWE initiatives aimed at optimizing product lifecycles.

Despite robust growth, a significant challenge impeding market expansion remains the persistent issue of data interoperability and standardization across fragmented global healthcare systems. This complexity hinders seamless data aggregation and comprehensive analysis, requiring ongoing efforts to harmonize disparate data sources and methodologies.

Key Market Drivers

The global Real-World Evidence Solutions Market is fundamentally influenced by increasing regulatory acceptance and the profound shift towards value-based healthcare models. Regulatory bodies globally are progressively integrating real-world evidence into drug development and post-market surveillance. This evolution supports accelerated therapy development by validating outcomes derived from routine clinical practice. According to GlobeNewswire, in August 2024, 82% of drug submissions to the FDA included Real-World Evidence, up from 73% in 2022, demonstrating growing reliance on these solutions for regulatory decision-making. This emphasis by regulators highlights the need for robust real-world data collection and analysis.

Concurrently, the healthcare industry's pivot from volume-based to value-based care necessitates demonstrable therapeutic effectiveness and cost-efficiency. Payers and providers increasingly require strong patient outcomes to justify treatment decisions and reimbursement. According to CMS data cited by Kaufman Rossin, in June 2024, healthcare provider participation in value-based care models increased by 25% from 2023 to 2024, underscoring the expanding adoption of models dependent on such evidence to prove value. This demand for real-world validation is further amplified by the extensive global clinical research landscape, where real-world evidence plays a critical role in augmenting traditional trial outcomes. According to the International Clinical Trials Registry Platform, as of May 2023, the number of registered clinical trials globally reached 452,604, showcasing the expanding domain where Real-World Evidence is vital for comprehensive understanding beyond controlled settings.

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Key Market Challenges

The persistent issue of data interoperability and standardization across fragmented global healthcare systems directly impedes the growth of the Global Real-World Evidence Solutions Market. This challenge stems from the diverse formats, terminologies, and governance structures prevalent in real-world data generated across various clinical settings, electronic health record systems, and administrative databases worldwide. Consequently, the seamless aggregation and comprehensive analysis of this disparate data are significantly hindered, demanding extensive manual efforts and complex data harmonization processes. This operational complexity escalates the time and resources required to synthesize meaningful clinical insights, thereby diminishing the efficiency and scalability of real-world evidence initiatives.

The inability to efficiently integrate and harmonize data sets delays critical processes such as regulatory submissions and the timely evaluation of drug effectiveness and safety post-market. For example, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), member companies reported that data integration and quality issues contributed to an average of 15% delay in bringing new RWE-driven insights to regulatory bodies in 2024. Such delays directly impact the market by slowing down product lifecycles and limiting the development of robust value-based care models, which rely heavily on accessible and standardized real-world data for their efficacy.

The persistent issue of data interoperability and standardization across fragmented global healthcare systems directly impedes the growth of the Global Real-World Evidence Solutions Market. This challenge stems from the diverse formats, terminologies, and governance structures prevalent in real-world data generated across various clinical settings, electronic health record systems, and administrative databases worldwide. Consequently, the seamless aggregation and comprehensive analysis of this disparate data are significantly hindered, demanding extensive manual efforts and complex data harmonization processes. This operational complexity escalates the time and resources required to synthesize meaningful clinical insights, thereby diminishing the efficiency and scalability of real-world evidence initiatives.

The inability to efficiently integrate and harmonize data sets delays critical processes such as regulatory submissions and the timely evaluation of drug effectiveness and safety post-market. For example, according to a January 2024 HIMSS Market Insights survey, only 53% of healthcare leader respondents were satisfied with their organizations' data quality management, citing difficulties in standardizing unstructured data as a key barrier. Such issues directly impact the market by slowing down product lifecycles and limiting the development of robust value-based care models, which rely heavily on accessible and standardized real-world data for their efficacy.

Key Market Trends

The integration of artificial intelligence (AI) and machine learning (ML) in Real-World Evidence (RWE) analytics represents a transformative trend, enhancing the ability to derive deep insights from complex datasets. These advanced technologies facilitate more efficient data processing, pattern identification, and predictive modeling, which are crucial for accelerating drug development and optimizing treatment pathways. According to eClinical Solutions' 2024 Industry Outlook, 53% of respondents from clinical operations, data management, and biometrics functions believed AI and ML would have the greatest impact on efficiency and outcomes in 2024, signifying growing industry confidence in these tools. For example, IQVIA announced a collaboration with NVIDIA in January 2025, deploying over 50 AI agents trained on 1.2 billion health records to streamline workflows in life sciences, which demonstrates how AI is directly contributing to faster drug discovery timelines and improved decision-making within the RWE solutions market.

A parallel significant trend is the pronounced emphasis on patient-centric and diverse data sourcing within RWE solutions. This shift moves beyond readily available administrative data to actively incorporate a broader spectrum of patient experiences and demographic representation, ensuring research findings are applicable to a wider population. By including diverse data, RWE studies can better capture treatment efficacy and safety across varied patient groups, addressing historical underrepresentation in clinical research. According to Within3's 2024 pharmaceutical industry statistics, 61% of surveyed pharmaceutical companies had defined goals and objectives to enhance clinical trial diversity, illustrating the industry's commitment to more inclusive data practices. Medidata launched its Diversity Program in September 2023, which combines AI and Patient Cloud portfolios to support biopharmaceutical companies and contract research organizations in addressing systemic barriers that hinder diverse participation in clinical trials, thereby directly influencing the quality and relevance of RWE generated.

Segmental Insights

The Oncology segment is experiencing rapid growth in the Global Real-World Evidence Solutions Market due to several critical factors. The increasing complexity and personalization of cancer drug development necessitate comprehensive insights into how therapies perform across diverse patient populations, which traditional clinical trials alone cannot fully address. Regulatory bodies, such as the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are increasingly accepting Real-World Evidence to support drug approvals, label expansions, and post-market surveillance, particularly for accelerated pathways. This rising acceptance, coupled with the global increase in cancer prevalence, drives the demand for robust real-world data to evaluate treatment effectiveness, safety, and value in routine clinical practice, ultimately enhancing patient-centered decision-making.

Regional Insights

North America leads the Global Real-World Evidence Solutions Market due to several distinct factors. The region benefits from the widespread adoption of real-world evidence solutions by major pharmaceutical companies and substantial investments in research and development aimed at improving drug discovery and development processes. Furthermore, North America possesses an advanced digital healthcare infrastructure, facilitating the extensive use of electronic health record systems and the generation of valuable real-time data. Crucially, supportive regulatory frameworks from bodies such as the U. S. Food and Drug Administration (FDA) actively encourage the utilization of real-world evidence for regulatory decision-making, notably reinforced by initiatives like the 21st Century Cures Act. This robust ecosystem, including a strong presence of service providers, underpins the region's market dominance.

Recent Developments

• In January 2025, Viz.ai, a leader in AI-powered disease detection and care coordination, announced new partnerships with three major global pharmaceutical companies. These collaborations brought their total to ten partnerships with leading life science firms, signifying an expanding role in leveraging real-world evidence for patient care. Additionally, in 2024, Viz.ai introduced several new products and capabilities to its Viz.ai One™ enterprise platform, including advanced AI algorithms for automated assessments and solutions for acute coronary syndrome. These innovations demonstrate the company's commitment to enhancing real-world impact and accelerating life-saving treatments through AI-driven insights.

• In October 2024, Target RWE, a leader in real-world evidence (RWE) and advanced analytical solutions, presented breakthrough research at the DIA Real-World Evidence conference. The company showcased new methodologies, including research on negative control outcomes to minimize bias in comparative safety and effectiveness analyses, and strategies to enhance the reproducibility of RWE studies. Their presentations explored improving inter-team communication and leveraging advanced IT systems to reduce errors during RWE generation. This commitment to robust epidemiological methods advances the integrity and reliability of real-world evidence for drug development.

• In June 2024, ConcertAI, a prominent oncology real-world evidence (RWE) and AI SaaS technology company, announced a significant collaboration with NVIDIA. This partnership aimed to advance a broad array of translational and clinical development solutions within ConcertAI's CARA AI platform. The collaboration integrated NVIDIA Inference microservices and the NVIDIA NeMo platform to enhance large-scale processing of multi-modal data. This initiative underscores a commitment to accelerating insights and outcomes for oncology patients through innovative AI and RWE technologies, impacting clinical trial patient matching and protocol automation.

• In June 2024, IQVIA introduced "One Home for Sites," a new clinical trial technology platform designed to simplify study management for research sites. This innovative solution aimed to consolidate various clinical applications into a single sign-on and dashboard, directly addressing the challenge of technology overload in research environments. By streamlining daily operations, the platform enhances the focus on patient recruitment and treatment, thereby increasing the capacity to manage multiple trials efficiently. This advancement is crucial for generating high-quality real-world data, ultimately strengthening real-world evidence solutions.

Key Market Players

• Clinigen Group PLC
• Icon PLC
• IBM Corporation
• IQVIA Inc.
• Oracle Corporation
• Parexel International
• PerkinElmer Inc.
• Pharmaceutical Product Development (PPD Inc.)
• SAS Institute Inc.
• Syneos Health Inc.

Report Scope:

In this report, the Global Real-World Evidence Solutions Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Real-World Evidence Solutions Market , By Component:

o   Claims Data

o   Clinical Settings Data

o   Patient-Powered Data

o   Pharmacy Data

o   Other Components

• Real-World Evidence Solutions Market , By Therapeutic Area:

o   Oncology

o   Immunology

o   Neurology

o   Cardiovascular Disease

o   Other Therapeutic Areas

• Real-World Evidence Solutions Market , By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Real-World Evidence Solutions Market .

Available Customizations:

Global Real-World Evidence Solutions Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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