Real-world Evidence Solutions Market Size, Share, Forecast, & Trends Analysis by Component (Datasets [Clinical, Claims, Pharmacy], Services) Application (Market Access, Drug Development & Approvals, PMS), and End User - Global Forecast to 2031

The RWE Solutions Market was valued at $2.62 billion in 2023. This market is expected to reach $6.37 billion by 2031 from an estimated $2.94 billion in 2024, at a CAGR of 11.7% during the forecast period of 2024-2031.

Real-world Evidence Solutions Market Size & Forecast

The growth of the real-world evidence solutions market is driven by the rising incidence of chronic diseases, delays in drug development and the consequent increase in development costs, the rising focus on personalized healthcare, a shift toward value-based care, and the growing adoption of real-world evidence solutions in drug development and commercialization. Furthermore, emerging economies and an increasing focus on end-to-end RWE services are expected to offer significant growth opportunities for players operating in the real-world evidence solutions market.

Real-world Evidence Solutions Market Growth Drivers

Increasing Focus on Personalized Healthcare

Personalized medicine is one of the emerging approaches to improve disease treatment and prevention, considering individuals’ variability in genes, environment, and lifestyles. However, this approach can be challenging, as designing an effective treatment plan for a medically complex patient requires a thorough analysis of a large volume of data. Providers may face difficulties due to limited resources, which can hinder their ability to extract and utilize valuable information effectively. The use of real-world evidence accelerates the transition to precision medicine.

It enables researchers to extend beyond the limitations of traditional clinical trials by utilizing real-world data gathered during patients' routine clinical care. This real-world information allows researchers to identify which medications are best suited for individual patients, leading to more personalized therapies and improved outcomes. The increasing approvals for personalized medicines are expected to increase the demand for real-world evidence solutions. According to the Personalized Medicine Coalition (PMC), in the U.S. in 2022, 34% of FDA-approved medicines were classified as personalized medicine, up from 25% in 2019.

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Rising Drug Development Delays and Costs are Accelerating the Adoption of Real-World Evidence (RWE) Solutions

With the shift towards personalized healthcare and the emergence of rare diseases, healthcare, and research organizations are facing challenges such as high costs and lengthy timelines for delivering medicines to patients as the development of new pharmaceutical entities is time-consuming, extremely costly, and of high-risk with fewer chances of successful outcomes. For instance, it is estimated that the average cost of drug development ranges from USD 43.4 million to USD 4.2 billion (Source: WHO 2022 report). Pharmaceutical companies are also confronting rising clinical trial costs and are seeking ways to reduce these expenses to expedite drug development. Real-world evidence (RWE) solutions offer a promising approach by simplifying access, alleviating burdens, and providing deeper insights into the real-world use of medicines. The growing use of real-world data helps to accelerate drug development, streamline approvals, and lower overall costs.

Real-world Evidence Solutions Market Trends

Integration of Artificial Intelligence

Enhancements in data management and data integration have improved the speed & quality of drug discovery and clinical trials. Artificial intelligence (AI) is employed in real-world data (RWD) to enhance data anomaly detection, standardization, and quality checking at the pre-processing stage. AI is expected to provide pharmaceutical and biotech companies with the ability to increase meaningful RWE output, decrease the time required to derive valuable insights and maximize the use of available data sources. RWE technology platforms that offer advanced data processing, analysis, and outcomes present an unparalleled opportunity to leverage these computing advancements. When integrated into a comprehensive RWE strategy, AI innovations can enhance drug development, improve patient treatment, access, and drive new business opportunities. AI-driven analytics and automation provide access to crucial insights from historical clinical trial data and real-world evidence (RWE), expanding end-to-end clinical trial capabilities.

Use of Big Data in the Healthcare Sector

Enhancements in data management and integration have improved the speed & quality of drug discovery and clinical trials. Artificial intelligence (AI) enhances real-world data (RWD) by improving anomaly detection, standardization, and quality checking during pre-processing. AI is expected to boost meaningful RWE output, shorten insight generation time, and optimize data use for pharma and biotech companies. RWE platforms with advanced AI-driven data processing and analysis provide a unique opportunity to leverage these technologies. As part of a comprehensive RWE strategy, AI can accelerate drug development, enhance patient treatment, access, and create new business opportunities. AI-integrated analytics also offer critical insights from historical clinical trial data and RWE, expanding clinical trial capabilities.

Real-world Evidence Solutions Market Opportunity

Rising Focus on End-to-end RWE Services

The healthcare industry has witnessed tremendous change in the last few years, with a shift toward value-based care in developed economies spurred by healthcare organizations’ efforts to reduce costs, improve outcomes, and enhance returns on investment. Various organizations are focusing on population health and driving improved outcomes through value-based care delivery models. Companies must possess strong evidence lifecycle management capabilities to prove and articulate their value propositions. An end-to-end approach to leveraging data, evidence, and knowledge assets of a life sciences organization enables insight-driven decision-making from R&D through commercialization. To leverage the opportunities offered by RWD and RWE, various players are providing end-to-end and late-phase services, such as study planning, protocol development, and clinical study management & reporting. The key players offering end-to-end RWE services are Medstreaming (U.S.), Oracle Corporation (U.S.), SAS Institute Inc. (U.S.), Sciformix Corporation (U.S.), and PAREXEL International Corporation (U.S.).

Real-World Evidence Solutions Market Analysis: Key Findings

By Component: In 2024, the Datasets Segment to Dominate the Real-world Evidence Solutions Market

Based on offering, the global real-world evidence (RWE) solutions market is segmented into datasets and consulting & analytics. In 2024, the datasets segment is expected to account for the largest share of 53% of real-world evidence (RWE) solutions. Real-world data (RWD) are collected from diverse sources related to patient outcomes in real-world settings. This data is often used in retrospective studies to generate real-world evidence (RWE). RWE offers valuable insights into unmet needs, as well as the clinical and economic impacts on patients and healthcare systems. It helps determine outcomes based on larger data samples, reduces costs, and enhances the efficiency of clinical trials. The shift towards personalized medicine, which increasingly relies on extensive datasets to identify patient subgroups and tailor treatments, further drives the demand for larger datasets. This approach is particularly beneficial for diseases like cancer, thus contributing significantly to the growth of this segment.

However, the consulting & analytics segment is estimated to register the highest CAGR of 15.2% during the forecast period. Consulting services encompass observational or prospective studies that involve the primary collection of data from individuals over time as their characteristics evolve. Analytic services include online platforms and software that generate real-world evidence (RWE). As data complexity grows, the demand for consulting and analytics services is rising. Technological advancements, such as wearables, electronic health records, and mobile applications, are driving an increase in data volume. Consequently, there is a growing need for consulting and analytics services to clean, manage, and analyze this data effectively.

By Application: In 2024, the Market Access & Reimbursement/Coverage Decisions Segment to Dominate the Real-world Evidence Solutions Market

Based on application, the global real-world evidence (RWE) solutions market is segmented into drug development & approvals, medical device development & approvals, market access & reimbursement/coverage decisions, post-market surveillance, and clinical & regulatory decision-making. In 2024, the market access & reimbursement/coverage decisions segment is expected to account for the largest share of 53.4% of the real-world evidence (RWE) solutions market. Real-world evidence (RWE) offers payers valuable insights into how treatments perform in everyday settings, aiding their decisions on medication coverage and reimbursement, which drives adoption. Monitoring drug safety and effectiveness is crucial for sustaining market access. RWE solutions assess pharmaceutical products' performance across diverse patient populations, considering real-world factors such as adherence, comorbidities, and concomitant medications, thereby reducing the risk of drug trial failures. Additionally, the FDA utilizes RWE to evaluate and monitor the post-market safety of approved drugs, contributing significantly to the growth of this segment.

By End User: In 2024, the Pharmaceutical, Biotechnology, and Medical Device Companies Segment to Dominate the Real-world Evidence Solutions Market

Based on end user, the global real-world evidence (RWE) solutions market is segmented into pharmaceutical, biotechnology, and medical device companies, healthcare payers, healthcare providers, and other end users. In 2024, the pharmaceutical, biotechnology, and medical device companies’ segment is expected to account for the largest share of 39.1% of the real-world evidence (RWE) solutions market. This segment’s large market share is attributed to the increasing importance of RWE studies in drug development & approvals and the growing need to avoid drug recalls and assess drug performance in real-world settings. According to the Congressional Budget Office, the average cost of drug development ranges from USD 1 billion to over USD 2 billion, depending on the type of drug. These high costs present significant technical, regulatory, and economic challenges for pharmaceutical R&D pipelines. Consequently, pharmaceutical companies leverage RWE solutions to assess real-world data (RWD) and understand the potential risks and benefits of drugs, thereby optimizing drug design and development.

Geographical Analysis

In 2024, North America to Dominate the Real-world Evidence Solutions Market

Based on geography, the global real-world evidence solutions market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2024, North America is expected to account for the largest share of 48.9% of the real-world evidence (RWE) solutions market. Several factors, including the rising prevalence of chronic diseases, stringent drug approval regulations, the availability of electronic datasets, advancements in the healthcare industry, and the growing volume of big data in healthcare, drive the significant market share in this region. Additionally, supportive government initiatives for deploying RWE solutions further bolster this market share.

In August 2023, the U.S. FDA released a report titled "Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products." This report outlines the FDA's framework for incorporating RWE solutions into regulatory decision-making processes.

However, Asia-Pacific is slated to register the highest growth rate of 11.2% during the forecast period. Countries like Japan and Taiwan have started integrating real-world evidence (RWE) into their healthcare systems through initiatives such as Japan's "Rational Medicine" program. This effort aims to make the Japanese healthcare system more patient-centric and evidence-based, driving market growth in the region. Additionally, supportive government initiatives in these countries are further fueling market expansion.

Real-world Evidence Market: Key Companies

The report offers a competitive analysis based on an extensive assessment of the product portfolios and geographic presence of leading market players and the key growth strategies adopted by them over the past three to four years. Some of the key players operating in the real-world evidence solutions market are IQVIA Holdings Inc. (U.S.), Elevance Health, Inc. (U.S.), ICON plc (Ireland), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), Revvity, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Thermo Fisher Scientific Inc. (U.S.), Oracle Corporation (U.S.), SAS Institute Inc. (U.S.), Parexel International Corporation (U.S.), and HealthVerity, Inc. (U.S.).

Real-world Evidence Solutions Industry Overview: Latest Developments from Key Industry Players

• In August 2023, Target RWE (U.S.) launched Syndicated Science, a suite of analytical products for real-world evidence generation. The solution is designed to answer strategic questions and identify unmet needs in a pharmaceutical product's life cycle.
• In August 2023, Parexel International (U.S.) collaborated with Partex N.V. (Germany), an AI-based platform for drug discovery. The collaboration is aimed to accelerate the drug discovery & development process by combining AI and clinical research expertise.

Real-world Evidence Solutions Market Research Summary

Key questions answered in the real-world evidence solutions market report: