Real World Evidence Solutions Industry Overview

The global real world evidence solutions market size was estimated at USD 2.6 billion in 2023 and is expected to grow at a CAGR of 8.4% from 2024 to 2030.

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.

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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.

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 the 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.

Technological advancements in RWE, such as Artificial Intelligence (AI) and Machine Learning (ML) algorithms, are enabling data-driven decision-making and automation, while Internet of Things (IoT) devices are facilitating real-time data collection & analysis. AI facilitates the analysis of large and complex datasets derived from RWE, assisting practitioners with valuable insights. This capability enables researchers and healthcare professionals to detect patterns & trends within RWD, contributing to more informed clinical decisions, streamlined drug development processes, and enhanced patient care outcomes.

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Real World Evidence Solutions Market Segmentation

Grand View Research has segmented the global real world evidence solutions market based on component, application, end-use, therapeutic area, and region:

Real World Evidence Solutions Component Outlook (Revenue, USD Million, 2018 - 2030)

• Services
• Data Sets

Real World Evidence Solutions Application Outlook (Revenue, USD Million, 2018 - 2030)

• Drug Development & Approvals
• Medical Device Development & Approvals
• Reimbursement/Coverage and Regulatory Decision Making
• Post Market Safety & Adverse Events Monitoring

Real World Evidence Solutions End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Device)
• Healthcare Payers
• Healthcare Providers
• Others

Real World Evidence Solutions Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

• Oncology
• Cardiology
• Neurology
• Diabetes
• Psychiatry
• Respiratory
• Other Therapeutic Areas (Immunology, Gastroenterology, etc.)

Real World Evidence Solutions Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America
  • US
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Israel
  • UAE
  • Kuwait

Key Companies profiled:

• 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

Key Real World Evidence Solutions Company Insights

The 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. For instance, 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 & analyze data, addressing unmet needs and strategic concerns throughout the pharmaceutical product lifecycle. In May 2023, Inspire launched Patient-Centered RWE, 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.

Recent Developments

• In April 2024, IQVIAannounced an expansion of its strategic partnership with Salesforce, aiming to expedite the advancement of Life Sciences Cloud of Salesforce. This initiative represents a next-gen customer interaction platform for the life sciences sector. Through these strategic partnerships, IQVIA aims to advance the development of technological solutions designed to accelerate decision-making processes across various domains, including RWE, discovery, clinical development, medical affairs, and patient safety.
• In April 2024, Parexel partnered with Palantir Technologies Inc. to leverage AI for accelerating & enhancing the delivery of effective and safe clinical trials for global biopharmaceutical clients. The partnership facilitates enhanced clinical trial processes and expands capabilities of Paraxel in advanced analytics, RWE, and Health Outcomes.
• In September 2023, EVERSANA announced an advancement in its patient support services. It introduced its new proprietary electronic prior authorization (ePA) and electronic benefits verification (eBV) platform, ACTICS eAccess.

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