Real World Evidence Solutions Market Size, Share & Trends Analysis Report By Component (Services, Datasets), By Application (Drug Development & Approvals), By End-user, By Therapeutic Area, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global real world evidence solutions market size was valued at USD 42.4 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 8.2% from 2023 to 2030. Support from regulatory bodies for using Real World Evidence Solutions (RWE) and an increase in R&D spending are anticipated to boost market growth. Furthermore, the shift from volume to value-based care is also expected to fuel the growth. Due to the COVID-19 pandemic, many market players began to experience general business disruptions, which impeded normal business activities.

For instance, IQVIA reported that it was unable to perform on-site monitoring and deliver offerings that relied on in-person gatherings or face-to-face interactions. However, the company accelerated and expanded a variety of cost containment actions for reducing the impact on profitability.

It also activated business continuity plans, including remote delivery capabilities in technology and analytics, remote monitoring & virtual trials in research & development solutions, and virtual commercial activity with clients wherever possible. Organizations, like the National Patient-Centered Clinical Research Network (PCORnet), National Institutes of Health (NIH) Collaboratory, and FDA’s Sentinel Initiative have collaborated to use the RWE data for improving clinical trial efficiency and drug safety monitoring.

The uncertainty brought on by the pandemic has significantly shifted how and when patients choose to seek medical care. In addition, a shift in healthcare treatment and provision during the pandemic has altered the discovery & reporting of some outcomes in data and the treated populace. This indicates that disease trends may lead to inaccurate interpretations when RWE and Real-world Data (RWD) do not border in the framework of the COVID-19 pandemic and long-term COVID-19 therapy, disease, and lifestyle changes.

A steadily growing market, slightly negatively impacted by the pandemic

The European Medicines Agency has also issued guidelines for RWE studies, requiring risk-benefit data in addition to post-authorization safety studies. Therefore, favorable government initiatives are expected to boost market growth. Furthermore, an industry coalition to innovate and expand the application of RWE promotes market growth.

For instance, in May 2021, five corporations-Aetion, IQVIA, Flatiron Health, Tempus, and Syapse-collaborated to expand the use of data derived from EHRs, claims, and other sources beyond clinical trials. The coalition will also work together with pharma companies, medical device manufacturers, patient groups, and other key stakeholders to support broader efforts around the usage of RWE, which members say supports developers, regulators, and providers in having a greater understanding of medical product safety & efficacy. Thus, such kind of innovations will support the market to enable faster access to new treatment options, which, in turn, will impel growth.

As there is continuous growth in data variety, volume, and speed, and there is a need for quick delivery of insights derived from that data, the need for integrating the right technologies for the implementation of the RWE program is growing. Many life sciences companies are adopting cloud technologies owing to the speed, flexibility, security, and scalability they provide.

Cloud technology can provide various benefits to RWE solutions. These include speed through which cloud-based analytics can be scale-up quickly, which helps as the data volume grows; and security, which helps in protecting patient-level data even in a de-identified format.

Component Insights

The services segment accounted for the maximum revenue share of over 57% in 2022. The growth is attributed to the high adoption of real-world services by pharmaceutical & biotechnology companies as well as healthcare providers. The segment is also anticipated to witness the fastest CAGR during the forecast period.

IQVIA, Syneos Health, and ICON plc are currently offering endwise real world evidence solutions and late-phase services, including research planning, protocol preparation, clinical study management, & reporting. Increased need for complete evidence services throughout the product lifecycle is likely to create opportunities for real world evidence solutions vendors to boost their investments throughout the drug development cycle.

The data sets segment consists of clinical settings data, claims data, pharmacy data, and patient-powered data. The segment is anticipated to witness growth owing to the growth in the volume of data generated in healthcare facilities and growing attention for additional insights into epidemiology.

Application Insights

The drug development and approvals segment accounted for the highest revenue share of over 28.0% in 2022. Real world evidence solutions services allow pharmaceutical companies and healthcare providers as well as payers for efficient management of operations and accelerate the process of drug development and its approval. This fuels market growth.

Top healthcare corporations had the desire to increase the use of RWE beyond traditional safety-related applications because of the need and urgency to develop vaccines and medicines during the COVID-19 pandemic. Thus, in March 2021, a CDC study used RWE to find that mRNA COVID-19 vaccines successfully prevented SARS-CoV-2 infections among the first responders, healthcare personnel, and other essential workers who received the shot in the first vaccine rollout.

The reimbursement/coverage and regulatory decision-making segment are expected to grow at the fastest rate of 8.5% owing to the rising focus on clinical value evidence for making decisions to provide coverage and the rising therapy costs. The post-market safety & adverse event monitoring segment is also anticipated to grow at a significant rate.

End-user Insights

The pharmaceutical & medical device companies segment accounted for the maximum revenue share of over 32.0% in 2022. The growth is attributed to the rising importance of RWE studies in the drug approval process, assessing drug performance in real-world settings, and preventing drug recalls.

RWE can support and advance a variety of processes such as identifying which cohort of patients can benefit most from an intervention, informing regulatory approvals & complementing data from randomized controlled trials, and supporting reimbursement efforts & increasing indications of use. Besides, in August 2020, the Medical Device Innovation Consortium (MDIC) announced the launch of its RWE Framework for regulatory decision-making for in vitro diagnostics

The healthcare payers segment is expected to grow at the fastest CAGR of 8.4% over the forecast period, owing to the increasing awareness among the payers regarding the importance of medical device/drug safety & their adverse effects and favorable reimbursement scenario, especially in developed countries.

Regional Insights

North America accounted for the largest revenue share of over 44.0% in 2022. The large share of the North American region is credited to the presence of key players in the U.S. Rising number of RWE service providers and favorable government regulations in the region is also expected to contribute to the market growth.

Furthermore, the shift from volume to value-based care is expected to fuel market growth. Moreover, the rising geriatric population and the subsequent increase in the prevalence of chronic diseases is a key factor driving the growth of this market. In addition, the high share of the region can be attributed to the presence of key players in the U.S. and Canada. Favorable government regulations and an increasing number of RWE service providers in the region are anticipated to drive the market further.

Asia Pacific region is expected to grow at the fastest CAGR of 11.1% owing to the rising government initiatives for the adoption of RWE studies and the presence of many contract research and manufacturing organizations in countries, such as China and India. Rising demand for better healthcare services is also estimated to fuel market growth.

Key Companies & Market Share Insights

The global market is highly competitive and fragmented. Market players implement strategic initiatives, such as product development & launches, expansion of distribution network, and global footprint through subsidiaries and partnerships. Key players are also involved in portfolio diversification and mergers & acquisition. For instance, in August 2021, Syneos Health partnered with Aetion, to provide a real-world evidence solution and offers analytical-driven data and regulatory grade data. Likewise, in April 2021, Thermo Fisher Scientific announced that it is set to acquire PPD, Inc. for USD 47.50 per share. Some prominent players in the global Real World Evidence (RWE) solutions market include:

• IQVIA

• IBM

• PPD Inc.

• Parexel International Corporation

• PerkinElmer Inc.

• Icon Plc

• Oracle

• Syneos Health

• Cegedim Health Data

• Medpace

Real World Evidence Solutions Market Report Scope

Global Real World Evidence Solutions Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global Real World Evidence (RWE) solutions market report based on component, application, end-user, therapeutic area, and region:

• Component Outlook (Revenue, USD Million, 2018 - 2030)

  • Services

  • Data Sets

    • Clinical Settings Data

    • Claims Data

    • Pharmacy Data

    • Patient-Powered Data

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Drug Development & Approvals

  • Medical Device Development & Approvals

  • Reimbursement/Coverage & Regulatory Decision Making

  • Post Market Safety & Adverse Events Monitoring

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Device)

    • Clinical research

    • Commercial (inclusive of marketing, etc.)

    • HEOR

    • Others (market access, etc.)

  • Healthcare Payers

  • Healthcare Providers

  • Others

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Cardiology

  • Neurology

  • Diabetes

  • Psychiatry

  • Respiratory

  • Other therapeutic areas (Immunology, Gastroenterology, etc.)

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • Israel