Real-World Evidence Solution Market Report: Trends, Forecast and Competitive Analysis to 2030

The global real-world evidence solution market is expected to grow with a CAGR of 8.1% from 2024 to 2030. The major drivers for this market are the growing industry need in the biosciences for improved Real-World Evidence (RWE) capabilities, the rise in the occurrence of chronic illnesses and cancer, and an increase in the use of cutting-edge technology for practical evidentiary solutions.

The future of the global real-world evidence solution market looks promising with opportunities in the healthcare companies, healthcare payers, and healthcare providers markets.

• The publisher forecasts that within the application category, drug development & approval will remain the largest segment over the forecast period.
• Within the end-use category, healthcare companies will remain the largest segment due to the increasing significance of real-world evidence studies in the drug approval procedure.
• In terms of regions, North America will remain the largest region over the forecast period due to the increasing count of real-world evidence service providers and favorable government regulations.

Emerging Trends in the Real-World Evidence Solution Market

The Real-World Evidence (RWE) Solution market is influenced by several emerging trends that reflect technological advancements and evolving healthcare needs. These trends are reshaping how real-world data is used to inform healthcare decisions.

• Artificial Intelligence and Machine Learning Integration: RWE analytics can be implemented with AI and ML technologies, which draw on vast health data to perform more efficiently. This improves prediction models by adding more precise parameters to the input of those models.
• Expansion of Data Sources: The range of RWE data sources is widening beyond traditional EHRs and claims to include new sources such as wearable devices, mobile health apps, and social media. This expansion allows for a more in-depth analysis of treatment outcomes and patient experiences in real life.
• Increased Emphasis on Patient-Centric Data: RWE solutions increasingly emphasize the use of patient-reported outcomes (PROs) or patient-centered endpoints (PCEs). PROs capture information from patients through surveys or wearable devices, providing insights into their preferences, quality of life, and treatment impact. This is making medicine more individualized and patient-centered.
• Regulatory Integration and Acceptance: Regulatory agencies have started including RWE in their decision-making systems, acknowledging its role in assessing drug safety, efficacy, and market access. This progress has led to faster approval processes and greater acceptance of RWE for regulatory purposes, often resulting in shorter timelines for new treatments to reach the market and better compliance with regulations.
• Focus on Data Security and Privacy: As the use of real-world data expands, there is a greater focus on ensuring its security. Improved algorithms to secure health data are essential, especially with regulations like GDPR and HIPAA, which require anonymization or encryption techniques. This helps foster trust in RWE solutions while upholding ethical standards in patient information management.

These emerging trends are reshaping the RWE Solution market by advancing data analysis capabilities, focusing on patient-centric approaches, expanding data sources, and increasing regulatory acceptance. The growth of collaborative ecosystems further supports the development and application of RWE solutions, driving innovation and improving decision-making in healthcare.

Recent Developments in the Real-World Evidence Solution Market

Recent developments in the RWE Solution market highlight advancements in technology, data integration, and regulatory practices. These developments are enhancing the effectiveness and scope of RWE solutions, impacting various aspects of healthcare.

• Integration of Advanced Analytics and Machine Learning: Integrating advanced analytics and machine learning with RWE solutions has significantly improved the ability to draw relevant inferences from large amounts of data. Machine learning algorithms can now detect complex patterns, predict patient outcomes, and identify trends that were previously hard to notice. Through this technology, personalized treatment plans are developed, providing more precise predictions and risk assessments, thereby improving decision-making. These advancements facilitate a deeper understanding of how treatments perform in various populations beyond controlled clinical trial settings.
• Enhanced Data Sources and Connectivity: Recent advances have broadened the types of data sources integrated into RWE solutions. Health systems, electronic health records (EHRs), wearable devices, and patient-reported outcomes now blend better together. This broader connectivity helps us understand patients' overall health status and the effects of treatment. By merging different data sets, healthcare providers get a more comprehensive picture of patients' experiences and treatment efficacy, supporting better-informed healthcare decisions for improved care.
• Regulatory Frameworks and Standardization: Progress is being made in developing regulatory frameworks and standards for RWE. Guidelines from organizations such as the FDA and EMA now include the use of real-world data during regulatory submissions. Quality control mechanisms are necessary for maintaining high standards in the development of regulatory practices using RWE, which enforces quality assessment procedures aimed at achieving reliable results. These standards enable harmonized practices for gathering information from patients worldwide, thus providing more credibility for conclusions drawn from RWE accepted by authorities when deciding on inclusion criteria.
• Patient-Centric Approaches and Engagement: Recently, there has been a focus on the direct involvement of patients in generating RWE. Patient-centric approaches, such as patient-reported outcomes (PRO) measures or actively engaging patients during data collection, are becoming more popular. This shows recognition of the importance of patients' own stories about their treatments. By considering patient feedback and preferences, health solutions can be customized to meet different needs, leading to more improved and personalized care strategies.
• Expansion of Real-World Evidence in Comparative Effectiveness Research: The use of RWE in comparative effectiveness research has increased to compare how well treatments work in usual clinical practice or other healthcare settings. RWE looks at how various therapies affect diverse patient populations and environments, which is critical for understanding actual outcomes. The expansion of RWE in this field helps identify the most effective treatments, optimize healthcare delivery, and support evidence-based clinical decision-making.

Recent developments in the RWE Solution market, including advancements in analytics, data integration, regulatory support, patient-centric data collection, and collaborative partnerships, are enhancing the effectiveness and scope of real-world evidence. These developments contribute to more informed decision-making and improved patient outcomes across healthcare systems.

Strategic Growth Opportunities for Real-World Evidence Solution Market

The RWE Solution market presents several strategic growth opportunities across key applications. Leveraging these opportunities can enhance decision-making and improve healthcare outcomes.

• Enhanced Patient-Centric Solutions: Developing enhanced patient-centric solutions represents a significant growth opportunity. This involves creating tools and platforms that focus on collecting and analyzing patient-reported outcomes and experiences. These solutions provide valuable insights into treatment effectiveness and patient satisfaction, driving improvements in personalized care.
• Advanced Analytics Platforms: There is an opportunity to expand advanced analytics platforms that leverage big data, AI, and machine learning. These platforms can offer more sophisticated data analysis and predictive capabilities, enabling healthcare stakeholders to derive actionable insights from real-world data and make informed decisions.
• Integrated Data Ecosystems: Building integrated data ecosystems presents a growth opportunity by combining data from various sources, including electronic health records, claims data, and wearable devices. This integration enhances the comprehensiveness and accuracy of RWE, supporting better decision-making and policy development.
• Regulatory Consulting Services: Providing regulatory consulting services focused on RWE offers growth potential. As regulatory agencies increasingly incorporate real-world data into decision-making, there is a need for expertise in navigating regulatory requirements and ensuring compliance. Consulting services can help organizations leverage RWE effectively for regulatory submissions and approvals.
• Collaboration Platforms for Data Sharing: Developing collaboration platforms for data sharing among healthcare providers, researchers, and technology companies is a strategic opportunity. These platforms facilitate the exchange of real-world data, promote joint research initiatives, and enhance the development of innovative RWE solutions.

Strategic growth opportunities in the RWE Solution market include enhanced patient-centric solutions, advanced analytics platforms, integrated data ecosystems, regulatory consulting services, and collaboration platforms for data sharing. These opportunities support the development and application of RWE solutions, driving market expansion and improving healthcare decision-making.

Real-World Evidence Solution Market Driver and Challenges

The Real-World Evidence (RWE) Solution market is influenced by various drivers and challenges, including technological advancements, economic factors, and regulatory considerations. These elements shape market dynamics and impact the development and adoption of RWE solutions.

The factors responsible for driving the RWE solution market include:

• Technological Advancements: The fast pace of technological development, such as big data analytics, machine learning, and artificial intelligence, increases the ability to analyze large amounts of real-world data. These tools enable more accurate interpretations and offer insights that lead to better decision-making and personalized treatments. As technology advances, it also helps integrate different data sources and analyze them together, making RWE solutions more robust.
• Regulatory Support and Frameworks: Growing acceptance by regulatory agencies that real-world evidence must be included in decision-making processes has been a driving force. For example, the FDA and EMA have issued guidelines aimed at integrating RWE into drug approvals and market assessments. Such regulatory endorsements provide RWE with legal backing, encouraging its use in regulatory submissions and post-marketing evaluations, thus moving towards more evidence-based healthcare.
• Growing Demand for Personalized Medicine: The increasing demand for personalized medicine fuels the need for RWE. By revealing how treatments perform across diverse populations, this information allows for the formation of personalized treatment plans. This demand for customized care drives investments in RWE solutions.
• Increased Data Availability: The availability of real-world data has risen significantly due to the proliferation of electronic health records (EHRs), wearable devices, and other digital health technologies. More available data makes it possible to comprehensively analyze issues such as patient outcomes, treatment effectiveness, and healthcare utilization rates. Better accessibility enhances its usefulness by creating actionable insights that drive improvements in healthcare.
• Focus on Value-Based Healthcare: Value-based healthcare models emphasize outcomes and cost-effectiveness over volume. This shift is supported by RWE, which provides information about treatment effectiveness, patient outcomes, and cost efficiency in real-world settings. This focus on value-based care aligns with the adoption of RWE as a tool to prove the worthiness of interventions and facilitate reimbursement decisions.

Challenges in the RWE solution market include:

• Data Quality and Standardization: Ensuring data quality and standardization has been one of the main challenges in RWE. Variations in data formats, incomplete records, and diverse methods of data collection may make RWE less reliable. To address these issues, it is necessary to develop standardized protocols and ensure complete data collection for improved accuracy and usability.
• Privacy and Security Concerns: Protecting patient privacy and ensuring data security are critical challenges. Concerns about personal health information being disclosed due to more usage of such sensitive materials are prevalent. Regulatory requirements and robust security measures are necessary to safeguard patient information and maintain trust in RWE solutions.
• Integration of Diverse Data Sources: Combining various data types, such as EHRs, patient registries, and wearable devices, presents integration challenges associated with merging this information.

The RWE Solution market is driven by technological advancements, increased demand for data-driven insights, regulatory support, investment in data infrastructure, and collaborations. However, challenges related to regulatory concerns, data quality, and high technology costs impact market dynamics. Balancing these drivers and challenges is essential for advancing RWE solutions and enhancing their impact on healthcare decision-making.

List of Real-World Evidence Solution Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies real-world evidence solution companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base.

Some of the real-world evidence solution companies profiled in this report include:

• IQVIA
• IBM
• PPD
• Parexel
• PerkinElmer
• Icon Plc
• Oracle
• Syneos Health
• Cegedim Health Data
• Medpace

Real-World Evidence Solution by Segment

The study includes a forecast for the global real-world evidence solution by component, application, end use, and region.

Component [Analysis by Value from 2018 to 2030]:

• Services
• Data Sets

Application [Analysis by Value from 2018 to 2030]:

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

End Use [Analysis by Value from 2018 to 2030]:

• Healthcare Companies
• Healthcare Payers
• Healthcare Providers
• Others

Region [Shipment Analysis by Value from 2018 to 2030]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Real-World Evidence Solution Market

The Real-World Evidence (RWE) Solution market is evolving rapidly as healthcare stakeholders increasingly seek insights from real-world data to improve decision-making and patient outcomes. Advances in technology, data analytics, and regulatory changes are driving the development of RWE solutions, influencing various regions differently. Here’s a look at recent developments in key markets: the United States, China, Germany, and India.

• United States: RWE solutions in the US have evolved to incorporate advanced analytics and artificial intelligence (AI), leading to better data insights. The FDA has increasingly embraced RWE in regulatory decisions, paving the way for the use of EHRs and claims data for drug approvals as well as post-market surveillance. Additionally, many tech companies are partnering with health facilities to enhance interoperability among different healthcare systems and improve patient outcomes. Investments in cloud computing and machine learning have further strengthened the functionality of RWE, enabling organizations to obtain more accurate results.
• China: China's RWE solutions have made significant advances due to rapidly growing data collection and analysis technologies. The government is expected to rely more on RWE in its drug approval processes and healthcare policy development, particularly through projects such as the 13th Five-Year Plan on Drug Safety. Investments in big data analytics and AI technology have increased the capacity to analyze large volumes of EHRs and patient registries. Initiatives include increased collaboration between Chinese tech companies and healthcare institutions, leading to better data integration. Furthermore, regulatory bodies in China are increasingly embracing RWE in their decision-making processes.
• Germany: Data protection laws, along with the country’s emphasis on advanced analytics, have enabled Germany to make significant strides toward RWE solutions. The robustness of Germany’s e-health databases, combined with a strong focus on privacy, facilitates these applications by ensuring strict adherence to regulations concerning the storage, sharing, and dissemination of personal medical information. Recent developments include the use of AI and machine learning to analyze patient records and optimize clinical trial designs. Additionally, national initiatives promoting RWD for evidence-based healthcare decisions and policies have enhanced Germany’s capacity for health research.
• India: In India, RWE solutions are advancing through increased investments in digital healthcare infrastructure and data analytics. Initiatives such as the National Digital Health Mission aim to promote the use of RWE for health reforms and improved patient care. With better data collection through EHRs and health information systems, there is a greater ability to track public health trends. Additionally, many local tech start-ups are collaborating with international pharmaceutical companies to accelerate the deployment of RWE in drug discovery and healthcare policy-making.

Features of the Global Real-World Evidence Solution Market

• Market Size Estimates: Real-world evidence solution market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.
• Segmentation Analysis: Real-world evidence solution market size by component, application, end use, and region in terms of value ($B).
• Regional Analysis: Real-world evidence solution market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different component, application, end use, and regions for the real-world evidence solution market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the real-world evidence solution market.
• Analysis of competitive intensity of the industry based on Porter’s Five Forces model.

This report answers the following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the real-world evidence solution market by component (services and data sets), application (drug development & approvals, medical device development & approvals, reimbursement/coverage & regulatory decision making, and post market safety & adverse events monitoring), end use (healthcare companies, healthcare payers, healthcare providers, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?