Real World Evidence Solutions Market to Exceed USD 5.8 Bn by 2033, Driven by Pharma and Biotech Adoption

Trishita Deb
Trishita Deb

Updated · Jul 12, 2024

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According to, the global real world evidence market size is projected to exceed the US$ 5.8 billion by 2033, with a predicted CAGR of 7.9% from 2024 to 2033.

The use of data collected from large group of patients in real world settings in order to support medical decision making is known as Real World Evidence. This forms an effective option to generate evidence for healthcare stakeholders to support treatment decisions. To place a strong imprint in the market healthcare providers are focused to keep the cost of treatments down. These high costs results due to growing number of patients and limited medical personnel. Thus, RWE solution help hospitals to find new improved ideas, thereby declining the personnel hours spent on routine tasks.

Key Takeaway

  • The “real world” refers to areas outside a traditional clinical trial settings including patient population, treatments and dosing schedules.
  • RWE solutions aggregate data from various sources, including electronic health records, claims data, social media, wearable devices, and other healthcare databases.
  • Integration of artificial intelligence in RWE solutions upscales the market growth significantly.
  • The Real-World Evidence (RWE) Solutions Market is expected to reach approximately USD 5.8 billion by 2033, increasing from USD 2.7 billion in 2023, with a compounded annual growth rate (CAGR) of 7.9%.
  • The services segment contributed the most to the revenue, accounting for over 55.9% in 2023.
  • In 2023, the drug development and approvals application segment was the most profitable, holding a revenue share of over 29.6%.
  • Healthcare companies held the highest revenue share in 2023, 32.6%.
  • North America dominated the market in 2023, with a revenue share of over 41.5%.
  • Key players in the market include IQVIA, IBM, PPD, Inc., Parexel International Corporation, PerkinElmer Inc., Icon Plc, Oracle, Syneos Health, Cegedim Health Data, and Medpace.
Real World Evidence (RWE) Solutions Market B

Factors Affecting The Growth of Real World Evidence Solution Industry?

Several factors can have an impact on the growth of real world evidence solution market industry. Some of these factors include:

  • Missing data: The losing of collected data from the patients creates various problems, hence can hamper the market growth.
  • Lack of randomisation: If selection of patients does not include randomisation step, it can create inaccurate data, thus can impede market expansion.
  • Rising number of clinical trials: More the conduction of clinical trials, more will be the availability of patients for collecting medical data, thus driving the market growth.
  • Increasing government initiatives: A proper support from government can assist to generate loads of data and get an idea about developing new improved technology, further fostering the real world evidence solution market.

Top Trends in Real World Evidence Solutions Market

The adoption of advanced technologies such as integration of artificial intelligence has given a better shape for RWE solutions market in recent years. More efficient and accurate extraction of meaningful thoughts comes into existence by virtue of artificial intelligence helping in analysing vast and diverse real world datasets. Many major players are incorporating this idea to gain knowledge regarding safety and effectiveness of their products, thereby making informed decisions in drug development and market access.

Market Growth

As the global population continues to grow and age, there is likely to be an increasing demand for real world evidence solution to generate better medical treatment outcomes. In addition to this, the support of government initiatives evolves regulations and actionable real world data, allowing organizations to conduct outcomes-based analyses, leading to market expansion.

Regional Analysis

North America came up as a frontrunner in real world evidence solution market, carrying a hefty market share of 41.5%. This makes the region to dominate over other competitive regions in a plentiful manner. The dominance owes to the presence of key players in U.S. coupled with rising number of RWE service providers. In addition to this, the market growth is also accompanied by the provision of favourable governemt regulations in North America.

Furthermore, due to rise in geriatric population and rising pervasiveness of cancer worldwide, Asia-Pacific stands as a second largest market holder in 2023, promising to witness highest CAGR during the forecast period.

By Geography

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • France
    • The UK
    • Spain
    • Italy
    • Russia
    • Netherland
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • South Korea
    • India
    • New Zealand
    • Singapore
    • Thailand
    • Vietnam
    • Rest of APAC
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Rest of MEA

Scope of the Report

Report AttributesDetails
Market Value (2023)US$ 2.7 Billion
Forecast Revenue (2033)US$ 5.8 Billion
CAGR (2024 to 2033)7.9%
North America Revenue Share41.5%
Base Year2023
Historic Period2018 to 2022
Forecast Year2024 to 2033

Market Drivers

Increasing Emphasis on Value-based Care
The healthcare industry’s shift towards value-based care models prioritizes patient outcomes and cost efficiency. RWE solutions play a crucial role in demonstrating the value of medical treatments in real-world settings, thereby supporting reimbursement decisions and healthcare policy making. This shift encourages the adoption of RWE solutions by healthcare providers and payers to improve patient care quality and reduce costs.

Expanding Use of Electronic Health Records (EHRs)
The widespread adoption of EHRs has generated vast amounts of data on patient health, treatments, and outcomes. This data is a foundational component of RWE, providing the raw material for analyses that can inform clinical practice, drug development, and policy decisions. The growing digitization of health records enhances the ability to collect and analyze real-world data, fueling the demand for RWE solutions.

Regulatory Support and Guidance
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), are increasingly recognizing the value of RWE in supplementing clinical trial data, especially for monitoring post-market safety and effectiveness. The FDA’s guidance on the use of RWE in regulatory decisions has legitimized and encouraged the use of these solutions across the pharmaceutical and healthcare industries.

Advancements in Data Analytics and Technology
Technological advancements have significantly improved the capabilities for collecting, integrating, and analyzing complex healthcare data. The development of sophisticated analytics tools and AI algorithms has made it easier to derive actionable insights from real-world data, thereby enhancing the attractiveness of RWE solutions. These technological improvements have lowered the barriers to entry for utilizing RWE, making it accessible to a broader range of stakeholders.

Growing Demand for Personalized Medicine
Personalized medicine, which tailors medical treatment to the individual characteristics of each patient, relies on understanding how different patients respond to treatments in real-world settings. RWE provides the necessary insights into patient responses across diverse populations, supporting the development and delivery of personalized healthcare solutions.

Collaborations and Partnerships
The market has witnessed a rise in collaborations between pharmaceutical companies, healthcare providers, and technology firms to leverage RWE for drug development and health outcomes research. These partnerships facilitate the sharing of data and expertise, enhancing the quality and applicability of RWE studies.

Market Restraints

Regulatory and Compliance Issues
The complex regulatory environment poses a significant restraint. The application of RWE in regulatory decision-making requires adherence to stringent data privacy laws, such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States. These regulations mandate rigorous data handling and privacy protocols, which can be challenging for RWE solution providers to consistently meet.

Data Privacy and Security Concerns
Data privacy and security are paramount in the RWE solutions market. With the increasing volume of patient data being collected and analyzed, there is a heightened risk of data breaches and unauthorized access. Ensuring the security of sensitive health information while facilitating the necessary data sharing for RWE studies requires sophisticated encryption and cybersecurity measures, adding to operational complexities.

Lack of Standardization
The absence of standardized methodologies for collecting, analyzing, and interpreting real-world data is another significant challenge. This lack of standardization can lead to inconsistencies in data quality and reliability, making it difficult for healthcare stakeholders to draw accurate conclusions or make informed decisions based on RWE.

High Costs Associated with RWE Studies
Conducting RWE studies involves substantial financial investment, primarily due to the costs associated with data collection, storage, and analysis. The high costs can be a barrier for smaller pharmaceutical companies and healthcare providers, limiting their ability to leverage RWE solutions for drug development and patient care improvements.

Interoperability Issues
Interoperability issues between different healthcare systems and data platforms can hinder the effective integration and analysis of real-world data. The diversity of data sources and formats requires robust data integration tools and platforms, which can be costly and complex to implement.


Expansion in Pharmaceutical and Life Sciences Industries
The pharmaceutical and life sciences industries are increasingly adopting RWE solutions to enhance drug development and ensure more efficient regulatory approval processes. The use of RWE is pivotal in understanding drug effectiveness and safety in real-world populations, thereby supporting market access and post-market surveillance. As these industries continue to evolve, the demand for sophisticated RWE solutions that offer comprehensive, actionable insights is expected to rise.

Technological Innovations and Integration
Advancements in data analytics, artificial intelligence (AI), and machine learning (ML) technologies are enhancing the capabilities of RWE solutions. The integration of these technologies enables the analysis of complex, large-scale real-world data (RWD) to uncover deeper insights into patient outcomes and treatment efficacies. Market opportunities lie in developing solutions that leverage these technologies to provide more accurate, timely, and predictive analyses of healthcare data.

Regulatory Support and Guidelines
Regulatory agencies, including the FDA and EMA, are increasingly recognizing the value of RWE in healthcare decision-making. These agencies are issuing guidelines that encourage the use of RWE in drug approval processes and post-marketing surveillance, thus opening up new opportunities for RWE solution providers to collaborate with regulatory bodies and pharmaceutical companies to ensure compliance and support evidence-based decisions.

Increasing Demand for Personalized Medicine
The shift towards personalized medicine, which tailors medical treatment to individual characteristics, behaviors, and genetic information, is creating opportunities for RWE solutions. By analyzing real-world data, RWE solutions can identify patient subpopulations that may benefit from specific treatments, thereby supporting the development of personalized medicine strategies and improving patient outcomes.

Expansion into Emerging Markets
Emerging markets present untapped opportunities for the adoption of RWE solutions. Healthcare systems in these regions are increasingly looking to leverage RWE to improve healthcare delivery and patient outcomes. The expansion of RWE solutions into these markets could support local healthcare improvements and provide growth opportunities for solution providers.

Collaboration and Partnership Opportunities
Strategic collaborations between RWE solution providers, healthcare providers, pharmaceutical companies, and technology firms can drive innovation and market expansion. Partnerships aimed at integrating diverse data sources and developing more sophisticated analytical tools can enhance the value and applicability of RWE in healthcare decision-making.

Impact of Macroeconomic Factors

Inflationary Pressures
The global inflation surge, partly fueled by the Russia-Ukraine conflict, has had a two-fold impact on the RWE Solutions Market. On one hand, it has increased operational costs for RWE solution providers, including data management and analytics. On the other hand, it has heightened the demand for RWE as pharmaceutical companies and healthcare providers seek more cost-effective and efficient ways to prove the efficacy and safety of their products in real-world settings.

Supply Chain Disruptions
The conflict has led to disruptions in the global supply chain, affecting the availability of essential components for data analytics and software development critical to RWE solutions. This scenario has prompted RWE solution providers to seek alternative suppliers and diversify their supply chains, leading to increased costs and potential delays in service delivery.

Regulatory and Market Uncertainty
Economic sanctions and geopolitical tensions have introduced regulatory and market uncertainties, impacting cross-border data flows and collaborations essential for RWE studies. Companies are now more cautious in their investment decisions, which could affect the funding available for new RWE projects.

Market Segmentation

By Component Analysis

Based on components, the market is segmented into services, data sets and clinical settings data. Carrying a large market share of 55.9%, the service segment held a strong position in real world evidence solutions market. The prominence of the segment in 2023 is due to high adoption of real world services by biotechnology and pharmaceutical companies coupled with healthcare providers. Owing to the growing need for consultants providing services to speed up drug development processes and clinical trials, the consulting service sector is projected to grow at a significant rate during the foreseeable days.

By Component

  • Services
  • Data Sets
  • Clinical Settings Data
  • Claims Data
  • Pharmacy Data
  • Patient-Powered Data

By Application Analysis

The market is bifurcated into drug and development approvals, medical device development and approvals, post market safety and adverse events monitoring segments, based on application analysis. The segment comprising drug and development approvals came up with most profitable revenue share of 29.6%, maintaining a dominant position in the marketplace. The effective operation management and rapid process of drug development and approval resulted due to the adoption of RWE solutions by pharmaceutical and biotechnology companies. Furthermore, owing to the increase in chronic diseases and demand for new treatments boosts the demand for drug approvals depending on accurate evidence based solutions.

By Application

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

By End User Analysis

Based on end use, the market is fragmented into healthcare companies, healthcare payers and healthcare provider segments. Holding a considerable market share of 32.6%, the healthcare companies segment held a dominant position in the market climate. This dominance owes to rising importane of RWE studies during drug approval process along with gauging effectiveness of drugs in real world situations.

In comparison with the above segment, due to growing number of providers and hiking acceptance of most advanced technological real world evidence tool, healthcare payer segment is projected to experience significant market growth.

By End-user

  • Healthcare Companies
  • Healthcare Payers
  • Healthcare Providers

Companies Recent Development

  • IQVIA (May 2024): IQVIA acquired a leading health analytics firm specializing in real-world evidence (RWE) solutions. This strategic acquisition strengthens IQVIA’s capabilities in leveraging RWE for drug development and regulatory decision-making. By integrating advanced analytics and comprehensive data sources, IQVIA aims to enhance its clients’ ability to generate actionable insights and improve patient outcomes across various therapeutic areas.
  • IBM (April 2024): IBM introduced a groundbreaking RWE platform named Watson Health Insights. This new product leverages artificial intelligence and machine learning to analyze vast amounts of real-world data, providing healthcare professionals and researchers with deeper insights into patient outcomes and treatment effectiveness. Watson Health Insights aims to revolutionize evidence-based medicine by offering precise and timely data analysis for better clinical decision-making.
  • PPD, Inc.(June 2024): PPD, Inc. launched an advanced RWE analytics platform designed to support clinical trials and post-market surveillance. The platform integrates real-world data from various sources, including electronic health records and claims data, to provide comprehensive insights into patient populations and treatment pathways. This new product aims to enhance the efficiency and effectiveness of drug development and regulatory submissions.
  • Parexel International Corporation (March 2024): Parexel International Corporation announced a merger with a prominent data analytics company to expand its RWE capabilities. This merger is expected to enhance Parexel’s ability to provide robust RWE solutions for drug development and market access strategies. The combined entity aims to deliver more comprehensive and accurate insights, helping clients make informed decisions and improve patient outcomes.
  • PerkinElmer Inc. (February 2024): PerkinElmer Inc. acquired a leading provider of real-world data and analytics services. This acquisition enhances PerkinElmer’s RWE solutions portfolio, enabling the company to offer more comprehensive data-driven insights for healthcare and life sciences research. The acquisition aligns with PerkinElmer’s strategy to support precision medicine and improve patient care through advanced data analytics.
  • Icon Plc (January 2024): Icon Plc launched a state-of-the-art RWE platform called ICON RealWorld. This platform integrates diverse real-world data sources, including patient registries and health records, to provide comprehensive insights into treatment outcomes and patient populations. ICON RealWorld aims to support clinical research and regulatory decision-making by offering robust, evidence-based data analysis.
  • Oracle (April 2024): Oracle unveiled a new RWE analytics suite designed to leverage its cloud infrastructure and data management capabilities. The suite provides healthcare organizations with advanced tools to analyze real-world data, enabling better insights into patient care and treatment effectiveness. Oracle’s RWE analytics suite aims to support evidence-based clinical and operational decision-making, enhancing overall healthcare outcomes.
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Trishita Deb

Trishita Deb

Trishita has more than 8+ years of experience in market research and consulting industry. She has worked in various domains including healthcare, consumer goods, and materials. Her expertise lies majorly in healthcare and has worked on more than 400 healthcare reports throughout her career.

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