Global Real-World Evidence Solutions Market Size (2024 - 2029)

Global Real-World Evidence Solutions Market Analysis

The Global Real-World Evidence Solutions Market size is estimated at USD 1.47 billion in 2024, and is expected to reach USD 2.31 billion by 2029, growing at a CAGR of 9.40% during the forecast period (2024-2029).

The growing initiatives by the government, coupled with research and development investments, are expected to increase the adoption of real-world evidence services and software for developing pharmaceuticals and medical devices more efficiently by reducing cost and time, which will drive the market during the forecast period.

For instance, in September 2023, Anvisa (Agência Nacional de Vigilância Sanitária), the Brazilian health regulatory agency, reported the publication of new guidance to support companies using RWE to support drug safety and effectiveness. The guide details the best practices for collecting and analyzing real-world data (RWD) that Anvisa can consider appropriate.

In December 2023, the US Food and Drug Administration (FDA) issued a draft guidance to provide clarity on how the FDA assesses real-world data (RWD) to ascertain the quality of producing real-world evidence (RWE). This evidence can be utilized in FDA regulatory decision-making for medical devices. Hence, such government regulatory bodies' initiatives are expected to increase the adoption of real-world evidence solutions, which ultimately drive the market during the forecast period.

Also, the increasing technological advancements, such as the incorporation of artificial intelligence and machine learning algorithms in real-world evidence solutions, are expected to increase the accessibility and affordability of RWD solutions and drive the market during the forecast period.

For instance, in April 2024, Parexel, a clinical research organization (CRO), and Palantir Technologies Inc. entered a multi-year strategic partnership to leverage AI to improve clinical trial execution and advance the offerings in real-world evidence, advanced analytics, and health outcomes. Hence, such collaborations are expected to increase the launch of new technologically advanced real-world evidence solutions, which ultimately drive the market during the forecast period.

In conclusion, the growing government initiatives and increasing technological advancements in real-world evidence solutions are expected to drive the market during the forecast period. However, a lack of skilled professionals is expected to restrain the market during the forecast period.

Global Real-World Evidence Solutions Industry Segmentation

As per the scope of the report, real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD).

The real-world evidence solutions market is segmented into components, therapeutic areas, applications, end users, and geography. By component, the market is segmented into services and data sets (clinical setting data, claims data, pharmacy data, patient-powered data, and other components (disease registries and electronic health records). By therapeutic area, the market is segmented into oncology, cardiology, diabetes, neurology, psychiatry, and other therapeutic areas (orthopedics and respiratory). By application, the market is segmented into drug development and approvals, medical device development and approvals, pharmacovigilance studies, and regulatory decision-making and reimbursement/coverage. By end user, the market is segmented into pharmaceutical and medical device companies, clinical research organizations, and healthcare providers. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (USD) for the above segments.