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

Market Size & 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 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.

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.

For instance, in April 2024, Parexel partnered with Palantir Technologies Inc. to leverage AI to accelerate and enhance the delivery of effective & safe clinical trials for global biopharmaceutical clients. The partnership facilitates Paraxel’s enhancement of its clinical trial processes and expansion of its capabilities in advanced analytics, RWE, and health outcomes.

Case Study Insights

OM1 collaborates with medical societies, healthcare providers, and hospitals to gather clinical-level medical data. This partnership is driven by the goal of monitoring care quality and leveraging data for specialized research, motivating organizations & providers to engage with OM1. While OM1 occasionally compensates clinicians for additional data, typically, there is no financial transaction involved. The company’s main area of focus is chronic disease within the U.S., with aspirations to broaden its scope to include new regions and medical specialties.

Market Concentration & Characteristics

The degree of innovation in the industry is high. Technological advancements can be attributed to the growing utilization of AI & ML, increasing demand for digital health solutions, and IT 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.

M&A activities, such as mergers, acquisitions, and partnerships, enable companies to expand geographically, financially, and technologically. For instance,in September 2023, Syneos Health, a market player, announced its acquisition by a consortium of affiliates from private investment firms, namely Veritas Capital, Patient Square Capital, and Elliott Investment Management L.P.

The impact of regulations is moderate to high in the industry. The industry involves several digital technologies, including AI and ML. It is regulated by different bodies in different countries. For instance, in North America, RWE is defined in Section 505-F (b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) as “data concerning the use, or potential benefits or challenges, of a drug obtained from sources apart from traditional clinical trials” (21 U.S.C. 355g(b)).

Companies in the RWE solutions industry undergo geographic expansion strategies to maintain their position in emerging markets and customer base from these regions. For instance, in December 2021, ICON plc reported the expansion of its Accellacare site network by partnering with six research sites in four countries, enhancing geographical reach, providing more access to patients, and expanding therapeutic capability.

Component Insights

The services segment dominated the market with the largest 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 data sets segment is expected to grow at a significant rate during the forecast period. Real-World Data (RWD) is data collected outside the context of clinical trials from sources such as Electronic Medical Records (EMRs), insurance claims, patient-reported results, and biometric devices. Growth in this segment is primarily due to the increasing need for further understanding of real-world compliance, epidemiology, costs, large amounts of medical data generated in hospitals, and the reliance on results-based research.

Moreover, business initiatives undertaken by market players are among the key factors driving market growth. For instance, in February 2024, Gilead Sciences, Inc. announced its plans to present RWE and new clinical data from its antiviral research and development programs at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024). The data, derived from almost 80 studies covering HIV, COVID-19, and viral hepatitis, is expected to include late-breaking information and four oral presentations.

Application Insights

The drug development and approvals segment dominated the market with the largest revenue share in 2023. Real world evidence solutions allow pharmaceutical companies and healthcare providers and payers for efficient management of operations and acceleration of 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.

Furthermore, governments are undertaking various initiatives to promote the use of RWE in medical device development and approvals. For instance, in December 2023, the FDA published draft guidance outlining its assessment of RWD in medical device clearance or approval decisions, along with anonymized examples of its RWE utilization.

The reimbursement/coverage and regulatory decision-making segment is expected to grow at the fastest CAGR during the forecast period. Most nations in the recent past have leveraged RWE for conducting pharmacovigilance activities and post marketing effectiveness assessments, however, RWE frameworks that address the usage of RWE during the product lifecycle, comprising premarketing activities & post marketing labeling changes for effectiveness, have only recently been issued.

In the U.S., the FDA has established a set of protocols & guidelines in its RWE framework for evaluating the fitness of data for use, as well as data relevance & reliability. In December 2021, the FDA issued draft guidance on the application of RWD and evidence to assist regulatory decision-making for drug & biological products.

End-use Insights

Healthcare companies dominated the market with the largest revenue share in 2023. The growth can be attributed to the rising significance of RWE studies in drug approvals, the necessity to avoid expensive drug recalls, and increasing need to evaluate drug performance in real-world settings.For instance,in February 2024, PINC AI Applied Sciences (PAS), Premier, Inc.'s division, and Datavant expanded their collaboration to enhance healthcare research, improve clinical trial operations, and promote trial diversity & equity. This collaboration aims to expedite the development of innovative therapies and products for enhanced patient outcomes. PAS will utilize Datavant's trial tokenization solution and data connectivity platform to connect clinical trial data with PAS's RWD, generating RWE that drives innovation in clinical research. This initiative offers enhanced insights into the effectiveness and safety of medical interventions in real-world scenarios, both within and beyond the controlled environments of clinical trials.

The healthcare payers segment is expected to grow at the fastest CAGR during the forecast period due to increasing awareness among payers regarding the importance of medical device/drug safety & their adverse effects and favorable reimbursement scenario, especially in developed countries. RWE has been used in nearly 16% of all the clinical findings cited by payers in specialty drug decisions, with EHR data being the most often cited data set used to derive these insights. RWE solutions help payers in reimbursement assessments. RWE also supports patients in budget management and assessing risk-benefit of interventions. The incorporation of RWE in value evaluation frameworks, used for determining drug value, can assist payers in making informed evidence-based reimbursement assessments.

Therapeutic Area Insights

The oncology segment dominated the market with the largest revenue share in 2023. RWE solutions have several applications in cancer drug development processes, such as decreasing cost of clinical trials, improving probability of regulatory success, and increasing product approval rates in a shorter timeline. Owing to the increasing prevalence of cancer across the globe, human medicine companies are focusing more on developing treatments for it and other chronic illnesses.

According to GLOBOCAN, in 2022, approximately 10.0 million new cancer cases were detected and around 9.7 million cancer-related deaths were recorded globally. According to the Indian Council of Medical Research (ICMR), the incidence of cancer in the country increased from 1.39 million cases in 2020 to 1.46 million cases in 2022. Therefore, the growing demand for effective drug development in the oncology therapeutic space has further increased the deployment rate of RWE solutions to expedite the pace of drug discovery.

The cardiology segment is expected to grow at a significant CAGR during the forecast period. RWE solutions offer a potentially rich source of information from clinical trial experiments conducted at different locations and set-ups. In the therapeutic area of cardiology, RWE solution correlates with the evaluation of the potential risks or benefits of an intended drug, using real-world patient data from several other sources. This information helps researchers in clinical decisions revolving around a diverse patient population encountered in the comparison studies. The benefits of RWE in cardiology have been evaluated by the American College of Cardiology Foundation (ACCF), which indicated that about 64% of U.S. cardiologists were very interested in the educational programs regarding RWE software, considering its varied applications.

Regional Insights

North America dominated the real world evidence solutions market with a revenue share of over 43.5% in 2023. It accounted for the largest share of the global market in 2023, which can be attributed to a significant support from regulatory bodies for using RWE solutions. Moreover, the shift from volume to value-based care, coupled with an increase in R&D spending, also contributes to the market growth.

U.S. Real World Evidence Solutions Market Trends

The real world evidence solutions market in the U.S. is being driven by the increasing number of payers using Real World Data (RWD), a favorable regulatory environment, an increasing number of RWE service providers, and a rising number of pharmaceutical companies adopting RWE solutions for drug approval processes. For instance, in October 2022, the FDA announced its Advancing Real World Evidence Program initiative. This program aims to enhance the quality and acceptance of RWE-based methodologies for supporting new labeling claims, including approving new applications for existing medical products or meeting post approval study obligations. This initiative is part of the FDA's commitment outlined in the Prescription Drug User Fee Act VII, included in the FDA User Fee Reauthorization Act of 2022.

Europe Real World Evidence Solutions Market Trends

The real world evidence solutions market in Europe is expected to grow significantly during the forecast period. The market growth can be attributed to increase in hospital visits due to the rising prevalence of chronic & infectious diseases and the rapid rise in geriatric population across the region. Major market players are focused on various business strategies, such as product launches, to expand their product portfolios and other initiatives. For instance, ICON plc, based in Ireland, acquired PRA Health Sciences for USD 12 billion and USD 80 per share in cash in July 2021. In addition, increasing R&D investments and rising demand for RWE solutions & RWD are anticipated to fuel market growth over the forecast period.

Germany real world evidence solutions market had a substantial share in 2023. This can be attributed to the increasing partnerships among market players. In November 2023, Cegedim Health Data, a supplier of clinical RWE and RWD, expanded its European database, THIN, to incorporate German RWD. With data from the UK, France, Spain, Italy, Belgium, and Romania, the database now integrates German electronic health records. This expansion makes the database accessible to healthcare stakeholders, such as academic researchers and health authorities.

The real world evidence solutions market in the UK is expected to grow significantly during the forecast period. The increasing government support in the form of initiatives aimed at promoting the adoption of RWE is driving market growth in the country. For instance, in October 2022, the National Institute for Health and Care Excellence (NICE) conducted a virtual workshop as a part of the IMI-funded project, the European Health Data and Evidence Network (EHDEN), in collaboration with the GetReal Institute. The initiative aims to establish a network of healthcare databases across Europe, each adhering to the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM).

Asia Pacific Real World Evidence Solutions Market Trends

Asia Pacific is anticipated to register the fastest growth in the real world evidence solutions market over the forecast period. Growth is 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. Moreover, major players are contributing to the region's market growth by entering into partnerships or expanding their product portfolios. These include Medpace; Cegedim Health Data; Parexel International Corporation; IQVIA, Inc.; and IBM.

The real world evidence solutions market in Japan has a significant market share in 2023. The market is expected to be driven by the increasing adoption of RWE solutions by local pharmaceutical companies. Key players in the market are developing devices that integrate RWD to deliver patient-centric care. For instance, in February 2024, ZimVie, Inc., a global player in the life sciences sector specializing in dental and spine markets, introduced the TSX Implant in Japan. This implant integrates design elements supported by over 20 years of clinical and RWD, aiming to provide benefits such as peri-implant health, sustained osseointegration, crestal bone preservation, and prosthetic stability.

India real world evidence solutions market is expected to grow significantly during the forecast period. Increasing government initiatives to digitize healthcare infrastructure are expected to drive the market. For instance, the National Digital Health Mission, launched in August 2020, seeks to build a unified digital healthcare infrastructure that links healthcare practitioners to patients, allowing them to access real-time health records. This would enable healthcare providers to trace patients' medical histories and provide quality care. 

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, IQVIA announced 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.

• In September 2023, ICON plc launched its advanced clinical trial tokenization solution. This innovative solution merges ICON's exclusive tokenization technology, RWD integration, and clinical analytics expertise into a unified & efficient operational framework. This approach produces insightful, enduring perspectives on the safety and effectiveness of drugs across the entire product development process.

• In April 2023, Cerner Enviza, an Oracle company, announced a collaboration with the FDA to create advanced AI applications for enhancing drug safety and conducting studies based on RWE. It was expected to assist FDA in understanding the outcomes of drugs on large populations. 

Real World Evidence Solutions Market Report Scope

Global Real World Evidence Solutions Market Report Segmentation

This report forecasts revenue growth at global, regional and country levels and provides an analysis of the latest trends 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, 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 and Regulatory Decision Making

  • Post Market Safety & Adverse Events Monitoring

• End-use 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

    • 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