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Add to CartGlobal Real-World Evidence Solutions Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Component;
Claims Data, Clinical Settings Data, Patient-Powered Data, Pharmacy Data, and Others.By Therapeutic Area;
Oncology, Immunology, Neurology, Cardiovascular Disease, and Other Therapeutic Areas.By Application;
Pharmaceutical and Medical Device Companies, Healthcare Payers, Healthcare Providers, and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Real-World Evidence Solutions Market (USD Million), 2021 - 2031
In the year 2024, the Global Real-World Evidence Solutions Market was valued at USD 2,024.94 million. The size of this market is expected to increase to USD 5,208.63 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 14.5%.
The global real-world evidence (RWE) solutions market is experiencing significant growth, fueled by the increasing demand for data-driven insights to support healthcare decision-making. Real-world evidence encompasses data derived from real-world patient experiences, including electronic health records, claims data, and patient registries. These data sources offer valuable insights into treatment outcomes, safety profiles, and healthcare utilization patterns, complementing traditional clinical trial data. As healthcare systems worldwide transition towards value-based care and evidence-based medicine, there is growing recognition of the importance of RWE in generating real-world insights to inform clinical practice, regulatory decisions, and health policy development.
Technological advancements in data analytics, artificial intelligence, and machine learning are driving innovation in the RWE solutions market, enabling more efficient analysis and interpretation of large-scale real-world datasets. These advancements allow stakeholders such as pharmaceutical companies, healthcare providers, payers, and regulatory agencies to extract actionable insights from diverse data sources quickly and accurately. Moreover, the COVID-19 pandemic has further underscored the importance of RWE in understanding disease epidemiology, treatment effectiveness, and healthcare resource allocation, leading to accelerated adoption of RWE solutions across the healthcare ecosystem.
Opportunities abound in the global RWE solutions market as stakeholders increasingly recognize the potential of real-world data to drive evidence-based decision-making and improve patient outcomes. Market players are expanding their offerings to include comprehensive RWE platforms that integrate data from multiple sources and provide advanced analytics capabilities. Additionally, partnerships and collaborations between pharmaceutical companies, healthcare providers, technology firms, and academic institutions are driving innovation and expanding the application of RWE across diverse therapeutic areas and healthcare settings. With the continued emphasis on personalized medicine, population health management, and healthcare value optimization, the global RWE solutions market is poised for continued growth and transformation.
Global Real-World Evidence Solutions Market Recent Developments
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In August 2023, Parexel (US) announced a strategic collaboration with Partex NV (Germany) to leverage artificial intelligence powered solutions and accelerate drug discovery and development for biopharmaceutical customers worldwide. This collaboration aims to improve outcomes for patients and create an environment of continues innovation in leveraging advanced technology, data-driven insights and collaborative ecosystem.
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In June 2022, Franscisco Partners (US) acquired IBM Watson Health Business (US) and formed a new standalone company named Merative. This acquisition will help Merative in expanding reach of the healthcare data analytics products and improving healthcare delivery, decision making and performance.
Segment Analysis
The global real-world evidence (RWE) solutions market is segmented by component, therapeutic area, and application, each contributing to its rapid evolution. By component, the market includes data sets, services, and software. Data sets form the foundation of RWE solutions, offering extensive patient information gathered from electronic health records (EHRs), claims databases, registries, and wearable devices. Services, which include analytics, consulting, and integration solutions, are pivotal in transforming raw data into actionable insights. Software solutions, designed for data management and advanced analytics, are becoming increasingly important as they enhance the efficiency and accuracy of RWE studies.
Therapeutic areas in the market include oncology, cardiology, immunology, neurology, and others. Oncology dominates due to the rising prevalence of cancer and the critical role of RWE in supporting drug development, treatment evaluation, and patient outcomes research. Cardiology is another key area, leveraging RWE to assess interventions for cardiovascular diseases and improve long-term management strategies. Immunology and neurology are gaining traction as RWE facilitates deeper understanding and monitoring of complex, chronic conditions, driving advancements in personalized medicine across these fields.
Applications of RWE solutions span pharmaceutical and medical device companies, healthcare payers, and healthcare providers. Pharmaceutical and medical device companies are the largest application segment, using RWE to streamline drug development, enhance post-market surveillance, and demonstrate product value to regulatory authorities. Healthcare payers adopt RWE for cost optimization, value-based reimbursement models, and risk stratification. Healthcare providers utilize these solutions to improve care quality, identify treatment gaps, and implement data-driven clinical decision-making practices, highlighting the diverse utility of RWE across the healthcare ecosystem.
The global demand for RWE solutions is driven by the need to improve healthcare outcomes, reduce costs, and accelerate innovation. Advances in data collection technologies, such as wearable devices and integrated EHR systems, coupled with sophisticated analytics tools, are enhancing the scope and accuracy of RWE. Additionally, the growing regulatory emphasis on real-world data for drug approvals and reimbursement decisions underscores the market’s importance. As stakeholders across the healthcare landscape continue to embrace data-driven strategies, the RWE solutions market is poised for significant growth across its components, therapeutic areas, and applications.
Global Real-World Evidence Solutions Segment Analysis
In this report, the Global Real-World Evidence Solutions Market has been segmented by Component, Therapeutic Area, Application and Geography.
Global Real-World Evidence Solutions Market, Segmentation by Component
The Global Real-World Evidence Solutions Market has been segmented by Component into Claims Data, Clinical Settings Data, Patient-Powered Data, Pharmacy Data and Others.
The segmentation of the Global Real-World Evidence (RWE) Solutions Market by component reflects the diverse sources of data utilized to derive insights into healthcare outcomes. Claims data, sourced from insurance claims and billing records, provide valuable information on treatment patterns, healthcare utilization, and costs. Clinical settings data, derived from electronic health records and medical charts, offer insights into patient demographics, medical history, diagnoses, and treatment outcomes. Patient-powered data, including data from patient-reported outcomes, wearable devices, and social media, provide a unique perspective on patient experiences, preferences, and quality of life. Pharmacy data, encompassing prescription records and medication dispensing data, offer insights into medication adherence, prescribing patterns, and drug utilization trends.
Each component of the RWE Solutions Market offers distinct advantages and challenges. Claims data provide a broad view of healthcare utilization and costs but may lack detailed clinical information. Clinical settings data offer comprehensive patient information but may be limited to specific healthcare settings or electronic health record systems. Patient-powered data offer insights into patient experiences and outcomes but may be subjective and require careful validation. Pharmacy data provide insights into medication use patterns but may not capture non-prescription medication usage or adherence issues.
Opportunities for the Global Real-World Evidence Solutions Market lie in leveraging the strengths of each data component to generate comprehensive insights into healthcare outcomes. By integrating multiple data sources and employing advanced analytics techniques, stakeholders can gain a holistic understanding of treatment effectiveness, safety profiles, and healthcare delivery patterns. Furthermore, ongoing advancements in data interoperability, artificial intelligence, and predictive analytics are expanding the capabilities of RWE solutions, enabling more precise and actionable insights. As the importance of evidence-based decision-making continues to grow in healthcare, the demand for robust RWE solutions is expected to rise, driving market expansion and innovation.
Global Real-World Evidence Solutions Market, Segmentation by Therapeutic Area
The Global Real-World Evidence Solutions Market has been segmented by Therapeutic Area into Oncology, Immunology, Neurology, Cardiovascular Disease and Other Therapeutic Areas.
The global real-world evidence (RWE) solutions market has witnessed segmentation by therapeutic area, reflecting the diverse applications of RWE across different medical fields. Oncology stands out as one of the primary segments due to the increasing demand for real-world data to inform cancer treatment decisions. RWE in oncology enables stakeholders to assess treatment effectiveness, understand disease progression, and identify trends in patient outcomes, ultimately leading to more personalized and effective cancer care strategies.
Immunology is another key segment in the global RWE solutions market, driven by the rising prevalence of autoimmune diseases and the growing complexity of immunotherapy treatments. RWE in immunology provides valuable insights into treatment responses, adverse events, and long-term outcomes, supporting clinicians in optimizing therapy selection and management for patients with autoimmune disorders such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
Neurology represents a significant segment in the RWE solutions market, given the increasing burden of neurological disorders worldwide. RWE in neurology facilitates the evaluation of treatment effectiveness, disease progression, and healthcare utilization patterns for conditions such as Alzheimer's disease, multiple sclerosis, and Parkinson's disease. By leveraging real-world data, stakeholders can gain a better understanding of neurological disorders' real-world impact, inform clinical practice guidelines, and improve patient care delivery in neurology specialties.
Global Real-World Evidence Solutions Market, Segmentation by Application
The Global Real-World Evidence Solutions Market has been segmented by Application into Pharmaceutical and Medical Device Companies, Healthcare Payers, Healthcare Providers, and Others.
Pharmaceutical and medical device companies are the largest users of RWE solutions, leveraging these insights to improve drug development, post-market surveillance, and regulatory compliance. By analyzing real-world data, these companies can assess treatment effectiveness, identify safety signals, and support value-based pricing strategies. The growing adoption of RWE in clinical trials and market access planning is a key driver of demand in this segment.
Healthcare payers utilize RWE solutions to optimize reimbursement strategies, develop cost-effective care models, and evaluate treatment outcomes. These insights enable payers to design tailored health plans, negotiate value-based contracts, and address population health needs more effectively. The shift toward evidence-based decision-making and the need to balance cost with clinical benefits are propelling the adoption of RWE among insurers and other healthcare payers.
Healthcare providers are increasingly adopting RWE to improve patient care and operational efficiency. By integrating real-world insights, providers can better understand treatment patterns, patient outcomes, and the impact of clinical interventions in real-world settings. These solutions also support quality improvement initiatives and help in identifying gaps in care delivery. The emphasis on patient-centered care and data-driven clinical decisions has bolstered the role of RWE among healthcare providers.
Other users, including regulatory agencies, academic institutions, and contract research organizations, also benefit from RWE solutions. Regulatory bodies leverage real-world data to support decision-making processes, evaluate post-market safety, and streamline the approval of innovative therapies. Academic institutions use RWE for research purposes, exploring trends in healthcare delivery and outcomes. Together, these diverse applications highlight the broad utility of RWE solutions in enhancing healthcare decision-making and advancing clinical research.
Global Real-World Evidence Solutions Market, Segmentation by Geography
In this report, the Global Real-World Evidence Solutions Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Real-World Evidence Solutions Market Share (%), by Geographical Region, 2024
In the global real-world evidence (RWE) solutions market, geographical regions exhibit varying levels of adoption and market share. North America currently holds a significant share, driven by the presence of established healthcare infrastructure, advanced technology adoption, and supportive regulatory frameworks. The region benefits from a robust ecosystem of pharmaceutical companies, healthcare providers, and research institutions that actively utilize RWE solutions for evidence generation, decision-making, and regulatory submissions. Moreover, the high prevalence of chronic diseases, increasing healthcare expenditure, and growing emphasis on value-based care further propel the demand for RWE solutions in North America.
Europe is another prominent region in the global RWE solutions market, characterized by a strong focus on evidence-based medicine and healthcare quality improvement. Countries like the UK, Germany, and France have well-developed healthcare systems and a high level of digitalization, making them conducive environments for RWE adoption. Additionally, regulatory initiatives such as the European Medicines Agency's (EMA) Adaptive Pathways and the Medicines Adaptive Pathways to Patients (MAPPs) program encourage the use of RWE to support drug development and regulatory decision-making. As a result, Europe is witnessing growing utilization of RWE solutions across pharmaceutical research, healthcare delivery, and health technology assessment processes.
Asia-Pacific represents a region with significant growth potential in the global RWE solutions market. Rapidly developing economies such as China, India, and Japan are witnessing increasing investments in healthcare infrastructure, digital health technologies, and research capabilities. The region's large and diverse patient population, coupled with rising healthcare expenditures and the growing burden of chronic diseases, creates a substantial demand for RWE solutions. Moreover, initiatives to strengthen regulatory frameworks, enhance data infrastructure, and promote collaboration between industry stakeholders and regulatory agencies are driving RWE adoption in Asia-Pacific. As a result, the region is expected to witness accelerated growth in RWE utilization, contributing to its expanding share in the global market.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Real-World Evidence Solutions Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Transition to Value-Based Care
- Technological Advancements in Data Analytics
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Increasing Recognition of RWE Importance - The global real-world evidence (RWE) solutions market is witnessing a surge in recognition of its importance in shaping healthcare decision-making processes. Traditionally, clinical trials have been the gold standard for generating evidence to support regulatory approvals and clinical guidelines. However, there is growing acknowledgment that real-world data, derived from everyday patient experiences in clinical practice, complements clinical trial data by providing insights into treatment effectiveness, safety profiles, and healthcare utilization patterns in real-world settings. This recognition is driven by the need for more robust evidence to inform healthcare policies, regulatory decisions, and clinical practice, particularly in the context of value-based care and evidence-based medicine paradigms.
The increasing adoption of value-based care models, which prioritize patient outcomes and cost-effectiveness, is further propelling the importance of RWE in healthcare decision-making. Value-based care requires a comprehensive understanding of treatment outcomes and resource utilization beyond the controlled environment of clinical trials. Real-world evidence offers valuable insights into the long-term effectiveness and real-world impact of interventions across diverse patient populations, helping healthcare stakeholders optimize treatment strategies, improve patient outcomes, and allocate resources efficiently. As healthcare systems worldwide strive to improve quality, reduce costs, and enhance patient-centered care, the role of RWE in generating actionable insights for evidence-based decision-making continues to gain prominence.
The COVID-19 pandemic has underscored the critical role of RWE in understanding disease epidemiology, treatment effectiveness, and healthcare resource allocation in real time. Real-world data has played a crucial role in monitoring disease trends, evaluating the impact of interventions, and informing public health responses during the pandemic. This heightened awareness of the value of RWE in crisis management has accelerated its adoption across the healthcare ecosystem, paving the way for greater integration of real-world evidence into healthcare decision-making processes globally. As stakeholders increasingly recognize the importance of RWE in driving evidence-based healthcare, the global market for RWE solutions is poised for significant growth and innovation.
Restraints:
- Data Quality and Standardization Challenges
- Regulatory and Privacy Concerns
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Limited Adoption in Some Healthcare Systems - Limited adoption in some healthcare systems presents a significant challenge for the global real-world evidence (RWE) solutions market. Despite the growing recognition of the importance of RWE in informing healthcare decision-making, barriers to adoption persist in certain regions or healthcare settings. Factors contributing to limited adoption include infrastructure limitations, data quality concerns, and resource constraints. In many healthcare systems, particularly in developing countries, the lack of standardized electronic health records and interoperable data systems hinders the collection and analysis of real-world data, limiting the use of RWE in clinical practice and research.
Regulatory and privacy concerns pose additional barriers to the adoption of RWE solutions in some healthcare systems. Data privacy regulations, such as the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States, impose stringent requirements on the collection, storage, and use of patient data. Compliance with these regulations can be challenging, particularly when dealing with sensitive health information in real-world datasets. Concerns about data security, patient confidentiality, and regulatory compliance may deter healthcare organizations from fully embracing RWE solutions, thereby limiting their adoption and utilization.
Despite these challenges, opportunities exist to overcome barriers and expand the adoption of RWE solutions in healthcare systems worldwide. Initiatives to improve data infrastructure, standardize data collection and reporting practices, and enhance data interoperability are essential for facilitating the widespread adoption of RWE. Additionally, educational programs, training initiatives, and collaborative efforts between stakeholders can help raise awareness of the benefits of RWE and build capacity for its use in healthcare decision-making. As healthcare systems increasingly prioritize evidence-based medicine and value-based care, addressing barriers to adoption will be critical in unlocking the full potential of RWE to improve patient outcomes and healthcare delivery.
Opportunities:
- COVID-19 Pandemic Accelerating Adoption
- Partnerships and Collaborations Driving Innovation
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Expansion of RWE Applications across Therapeutic Areas - The expansion of real-world evidence (RWE) applications across therapeutic areas is driving significant growth and innovation in the global market. Initially utilized predominantly in areas such as oncology and rare diseases, RWE is now increasingly being applied across a wide range of therapeutic areas, including cardiology, neurology, and immunology. This expansion is fueled by the growing availability of diverse real-world data sources, such as electronic health records, claims data, and patient registries, which provide valuable insights into disease epidemiology, treatment patterns, and patient outcomes.
The COVID-19 pandemic has further accelerated the adoption of RWE solutions across therapeutic areas, as healthcare systems seek data-driven insights to inform pandemic response efforts, treatment strategies, and resource allocation. Real-world data has played a crucial role in understanding COVID-19 disease dynamics, evaluating the effectiveness of interventions such as vaccines and therapeutics, and identifying vulnerable patient populations. The pandemic has underscored the importance of RWE in rapidly generating actionable insights to support public health decision-making and improve patient outcomes, leading to increased investment in RWE infrastructure and capabilities.
Advancements in data analytics, artificial intelligence, and machine learning are enabling more sophisticated analysis of real-world data, facilitating the identification of trends, patterns, and correlations across different therapeutic areas. This enhanced analytical capability allows stakeholders to derive actionable insights from real-world data more efficiently and accurately, supporting evidence-based decision-making in clinical practice, regulatory decision-making, and health policy development. As RWE continues to evolve and expand its applications across diverse therapeutic areas, the global market for RWE solutions is poised for continued growth and innovation, offering new opportunities to improve healthcare outcomes and optimize resource allocation.
Competitive Landscape Analysis
Key players in Global Real-World Evidence Solutions Market include:
- IQVIA
- Optum, Inc. (a subsidiary of UnitedHealth Group)
- IBM Corporation
- Cerner Corporation
- Oracle Corporation
- SAS Institute Inc.
- Clinigen Group plc
- Syneos Health
- PAREXEL International Corporation (a subsidiary of Pamplona Capital Management)
- ICON plc
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Component
- Market Snapshot, By Therapeutic Area
- Market Snapshot, By Application
- Market Snapshot, By Region
- Market Opportunity Map
- Global Real-World Evidence Solutions Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Transition to Value-Based Care
- Technological Advancements in Data Analytics
- Increasing Recognition of RWE Importance
- Restraints
- Data Quality and Standardization Challenges
- Regulatory and Privacy Concerns
- Limited Adoption in Some Healthcare Systems
- Opportunities
- COVID-19 Pandemic Accelerating Adoption
- Partnerships and Collaborations Driving Innovation
- Expansion of RWE Applications across Therapeutic Areas
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Real-World Evidence Solutions Market, By Component, 2021 - 2031 (USD Million)
- Claims Data
- Clinical Settings Data
- Patient-Powered Data
- Pharmacy Data
- Others
- Global Real-World Evidence Solutions Market, By Therapeutic Area, 2021 - 2031 (USD Million)
- Oncology
- Immunology
- Neurology
- Cardiovascular Disease
- Other Therapeutic Areas
- Global Real-World Evidence Solutions Market, By Application, 2021 - 2031 (USD Million)
- Pharmaceutical
- Medical Device Companies
- Healthcare Payers
- Healthcare Providers
- Others
- Global Real-World Evidence Solutions Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Real-World Evidence Solutions Market, By Component, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- IQVIA
- Optum, Inc. (a subsidiary of UnitedHealth Group)
- IBM Corporation
- Cerner Corporation
- Oracle Corporation
- SAS Institute Inc.
- Clinigen Group plc
- Syneos Health
- PAREXEL International Corporation (a subsidiary of Pamplona Capital Management)
- ICON plc
- Company Profiles
- Analyst Views
- Future Outlook of the Market