Real World Evidence Solutions Market Size, Share & Trends Analysis Report By Component (Services, Data Sets), By Application, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Real World Evidence Solutions Market Trends

The global real world evidence solutions market size was estimated at USD 2.6 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 8.4% from 2024 to 2030. The market growth is driven by rising demand for enhanced Real-World Evidence (RWE) capabilities within the life science industry, reflecting an increasing market shift from volume to value-based care. Advancements in data analytics and real-world evidence (RWE) contribute to supporting regulatory compliance, research, and solution development efforts in medical device and life sciences organizations. For instance, the increased demand for Real-World Evidence (RWE) solutions is prompting players to introduce new products, fostering market growth. In October 2023, Maxis Clinical Sciences launched Real-World Evidence Solutions, providing diverse real-world data capture and analysis to improve clinical research and care.

Government initiatives supporting Real-World Evidence (RWE) programs, evolving regulations, and actionable real-world data (RWD) enable organizations to conduct outcomes-based analyses, contributing to the overall market expansion. For instance, in December 2022, the FDA launched the Real-World Evidence Program. This program aims to raise awareness that RWE can support regulatory decisions, identify approaches for generating RWE to meet post-approval study requirements or effectiveness labeling and develop agency processes that foster consistent decision-making and shared learning regarding RWE.

The COVID-19 pandemic further accelerated the adoption of RWE solutions, with governments collaborating with market players to implement these solutions. For instance, in June 2021, ConcertAI and the FDA initiated a five-year collaborative research program, 'Evaluation of Real-World Outcomes and Safety in the Treatment of Cancer.' The partnership leverages ConcertAI's oncology real-world data (RWD) and advanced AI technology solutions to generate Real-World Evidence (RWE) for various clinical and regulatory use cases.

Market Dynamics

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 with the objective of innovating and expanding 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 and efficacy. Thus, such kinds of innovations will support the market to enable faster access to new treatment options, which, in turn, will impel market growth during the forecast period.

The RWE solution providers are increasingly forming strategic partnerships with AI solution providers to offer integrated solutions. For instance, in April 2023, ConcertAI, a player in AI SaaS technology and RWE solutions for healthcare and life sciences, partnered with PathAI, an AI-powered pathology provider, to introduce a first-in-class quantitative histopathology and curated clinical real-world data (RWD) solution. This collaboration integrates ConcertAI's Patient360 and RWD360 products with PathAI's PathExplore tumor microenvironment panel.

Component Insights

Based on component, the services segment accounted for a maximum revenue share of over 57.6% in 2023. The market growth is attributed to the high adoption of real-world services by pharmaceutical and biotechnology companies and healthcare providers. The segment is also anticipated to register 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.

The increased need for complete evidence services throughout the product life cycle 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 the healthcare facilities and growing attention for additional insights into epidemiology.

Application Insights

Based on application, the drug development and approvals segment accounted for the largest revenue share of over 28.7% in 2023. Real world evidence solutions allow pharmaceutical companies, healthcare providers, and payers to efficiently manage the operation and accelerate the process of drug development and its approval. This fuels market growth. Top healthcare corporations had a 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.

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 is expected to grow at the fastest rate of 8.8% over the forecast period owing to the rising focus on clinical value evidence for making decisions to provide coverage and the rising therapy costs. The post-market safety and adverse event monitoring segment is anticipated to grow at a significant rate over the forecast period.

End-use Insights

Based on end-use, the healthcare companies (Pharmaceutical, Biopharmaceutical, Medical Device) segment accounted for the largest revenue share of over 32.8% in 2023. The market 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, supporting reimbursement efforts, and 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 rate of 8.7% from 2024 to 2030 owing to the increasing awareness among the payers regarding the importance of medical device/drug safety and their adverse effects and favorable reimbursement scenarios, especially in developed countries.

Regional Insights

North America accounted for the largest revenue share of over 43.5% in 2023. 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 are also expected to contribute to the market growth. Furthermore, the shift from volume to value-based care is expected to fuel market growth. Moreover, rising geriatric population and the subsequent increase in the prevalence of chronic diseases are key factors fueling the growth of this market.

The large share of the North American 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 North America are anticipated to drive the market further.

Asia Pacific is expected to grow at a CAGR of 11.2% from 2024 to 2030 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 the market growth.

Key Companies & Market Share Insights

Global market for real-world evidence solutions is highly competitive and fragmented, with market players employing strategic initiatives such as product development, launches, distribution network expansion, and global footprint enhancement through subsidiaries and partnerships.

Recent Developments

• In August 2023, Targe RWE launched an innovative line of cutting-edge analytical solutions that utilize advanced epidemiological techniques and reliable statistical principles to visualize and analyze data, addressing unmet needs and strategic concerns throughout the pharmaceutical product life cycle.

• In June 2023, Thermo Fisher Scientific announced a definitive agreement to acquire CorEvitas, LLC, valued at USD 912.5 million in cash, from Audax Private Equity.

“The addition of CorEvitas will further advance our capabilities to better serve our pharma and biotech customers and strengthen our value proposition. CorEvitas is an excellent strategic fit for Thermo Fisher and highly complementary to PPD, our leading clinical research business.“

-          Marc N. Casper, chairman, president and chief executive officer, Thermo Fisher Scientific.

• In June 2023, Verana Health launched VeraSite, a solution designed for identifying potential clinical trial sites.

• In May 2023, Inspire Launched Patient-Centered Real-World Evidence, including innovative data and analytic solutions.

“We believe that patient-centered real-world evidence is the key to better patient outcomes. Inspire RWE will enable companies to efficiently synthesize, integrate and disseminate evidence, and ultimately, improve patient lives.”

-          Richard Tsai, senior vice president of Real-World Evidence, Inspire.

Real World Evidence Solutions Market Report Scope

Global Real World Evidence Solutions Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global real world evidence solutions market report based on component, application, end-use, 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-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Healthcare Companies

  • Healthcare Payers

  • Healthcare Providers

  • Others

• 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