San Francisco, 20 June 2024: The Report Real World Evidence Solutions Market Size, Share & Trends Analysis Report By Component (Services, Data Sets), By Application (Drug Development & Approvals), By End-use, By Therapeutic Area (Oncology, Cardiology), By Region, And Segment Forecasts, 2024 - 2030

The global real world evidence solutions market size is expected to reach USD 4.6 billion by 2030, registering a CAGR of 8.4% from 2024 to 2030, according to a new report by Grand View Research, Inc. Key driving factors of the market include growing applications of RWE in several fields, favorable government regulations, technological advancements, and a shift from volume to value-based care. Furthermore, a growing number of strategic initiatives by organizations are anticipated to positively influence market growth.

In March 2024, DARWIN EU, the Data Analysis & Real World Interrogation Network, announced plans to enhance its capacity for RWD studies by adding 10 new data partners within the year. With a network of 20 institutions spanning 13 European countries, DARWIN EU collaborates with public & private entities to derive RWE from diverse sources, including hospitals, primary care facilities, health insurance databases, registries, and biobanks.

This RWE supports regulatory activities of the EMA and national regulators across the EU. Leveraging data from approximately 130 million patients across Europe, DARWIN EU aims to deliver robust evidence through RWD studies. Notably, the network employs a common data model to standardize data interpretation while ensuring data privacy through local storage and analysis by data partners. This approach prioritizes data protection and facilitates the efficient execution of large-scale, multi-database studies.

Furthermore, major consumers of RWE are pharmaceutical and medical device companies. This is because it can provide value across the entire product lifecycle. It has applications across life science research, clinical trials & studies, post-market surveillance, and regulatory requirements. In life science research, RWE can inform pretrial study design by assisting researchers in identifying potential patients and creating proper inclusion criteria for clinical trials. Within clinical trials & studies, it helps overcome traditional clinical trials’ limitations by providing information about a broader cross-section of society and supplementing traditional outcome measures, such as patient-reported outcome surveys.

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Moreover, medical product designers are using RWD & RWE to aid clinical trial designing (e.g., pragmatic clinical trials, large simple trials) and observational studies to produce innovative, new treatment approaches. Thus, technology plays a significant role in healthcare decisions, which, in turn, promotes segment growth. For instance, in July 2023, Johnson & Johnson gained approval for certain cardiac ablation devices for fluoroscopy-free use following a prospective observational registry study-an instance of the agency employing RWE in device reviews.

Real World Evidence Solutions Market Report Highlights

• Based on component, the services segment led the market with the largest share of 57.7% in 2023 owing to its increasing demand over the forecast period
• Based on application, the drug development and approvals segment dominated the market with a revenue share of 28.7% in 2023 owing to the rising adoption of RWE solutions in pharmaceutical companies for this application
• Based on end-use, healthcare companies dominated the market with the largest share of 32.8% in 2023. The growth is due to growing use of RWE solutions in several fields by pharmaceutical, biopharmaceutical, and medical device companies
• Based on therapeutic area, the oncology segment led the market with a share of 22.8% in 2023 owing to increased use of RWE solutions to develop therapies for cancer care by research organizations and pharmaceutical companies
• North America led the global market with a revenue share of 43.5% in 2023 owing to the presence of major players in the region. Asia Pacific is expected to be the fastest-growing regional market from 2024 to 2030 owing to the presence of contract research organizations in the region

In addition, several companies are focusing on RWD collection to enhance RWE in the neurology sector. For instance, in September 2023, OM1 announced a curated research-grade dataset focused on Parkinson's disease (PD) as part of its Mental Health and Neuroscience RWD Network expansion. This dataset features premium data from over 7,000 individuals with PD, tracked prospectively by neurologists, along with data from 700,000 PD patients in the OM1 Real-World Data Cloud. The RWE insights from this comprehensive data are anticipated to enhance understanding of PD patient journeys, leading to improved care & outcomes.

Support from regulatory bodies for using real world evidence (RWE) solutions and an increase in R&D spending are anticipated to boost the market growth. For instance, in September 2023, ANVISA, Brazil's health regulatory authority, released guidelines for utilizing RWE in supporting drug safety and efficacy. The guidelines, available in Portuguese, outline best practices for gathering and analyzing RWD deemed acceptable by ANVISA. Furthermore, the shift from volume to value-based care is expected to fuel market growth.

Real World Evidence Solutions Market Report Scope

RWE solutions have been widely used for supporting post-approval safety surveillance studies. Recently, global regulators have started to integrate RWE solutions in the early development of drugs and other phases of the drug life cycle for testing their effectiveness. Several countries leverage RWE solutions for pharmacovigilance activities and for assessing post-marketing effectiveness.

In the U.S. and Canada, the initial regulatory RWE frameworks or announcements were released in 2018. The framework outlines several important RWE-related efforts taken by the FDA for evaluating the potential of RWE for the addition or modification of a new population, an indication, safety profile info, or comparative effectiveness to a product label. As of March 2022, in the U.S., RWE is explicitly stated in the legislation. It mandates the FDA to establish a formal RWE program.

List of Key Players in the Real World Evidence Solutions Market

• IQVIA Inc.
• IBM
• PPD, Inc. (Acquired by Thermo Fisher Scientific, Inc.)
• Parexel International (MA) Corporation
• PerkinElmer Inc.
• ICON plc
• Oracle
• Syneos Health
• Cegedim Health Data
• Medpace