Real-world Evidence Solutions Market Size & Forecast

The Real-world Evidence Solutions Market is expected to reach $5.04 billion by 2031 at a CAGR of 9.8% from 2024 to 2031.This market’s growth is driven by the growing incidence of chronic diseases, delays in drug development and the consequent increase in development costs, the rising focus on personalized healthcare, the shift toward value-based care, and the growing adoption of real-world evidence solutions in drug development and commercialization. Emerging economies and the rising focus on end-to-end RWE services offer growth opportunities for the players operating in this market.

Real-world Evidence Solutions Market Growth Drivers

Rising Focus on Personalized Healthcare

Personalized medicine is one of the emerging approaches to improving disease treatment and prevention, considering individuals’ variability in genes, environment, and lifestyle. However, the approach can be challenging, as it is difficult to design an effective treatment plan for a medically complex patient. A large amount of data needs to be analyzed, and providers may lack the resources to extract valuable information. The use of real-world evidence speeds up the transition to precision medicine.

It enables researchers to go beyond the scope of traditional clinical trials with real-world data while obtaining insights from the information collected during patients’ routine clinical care. Researchers can use real-world information to determine which medications are best suited for specific patients, resulting in more personalized therapies and better 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 personalized medicine approved out of total FDA approval increased from 25% in 2019.

Delays in Drug Development and the Consequent Increase in Development Costs

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). In addition, pharmaceutical companies are also facing the challenge of increased costs of clinical trials. Thus, many companies are looking for ways to lower the costs of clinical trials to accelerate drug development. Adopting real-world evidence solutions helps simplify access, address some of the burdens, and better understand medicines used in the real world. Furthermore, the utilization of real-world data is increasing as it helps accelerate drug development, simplify approvals, and reduce drug development 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 offer pharma & biotech companies the ability to increase meaningful RWE output, decrease the time required to draw meaningful insights and make the most of the available data sources. RWE technology platforms that deliver smart data processing, analysis, and outcomes offer an unparalleled opportunity to capitalize on these computing advancements. When used as part of an overall comprehensive RWE strategy, AI innovations can enhance drug development, improve patient treatment & access, and drive new business opportunities. AI-integrated analytics and automation provide access to crucial insights from historical clinical trial real-world data and 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) 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 offer pharma & biotech companies the ability to increase meaningful RWE output, decrease the time required to draw meaningful insights and make the most of the available data sources. RWE technology platforms that deliver smart data processing, analysis, and outcomes offer an unparalleled opportunity to capitalize on these computing advancements. When used as part of a comprehensive RWE strategy, AI innovations can enhance drug development, improve patient treatment & access, and drive new business opportunities. AI-integrated analytics and automation provide access to crucial insights from historical clinical trial real-world data and RWE, expanding end-to-end 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 component, 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 50.2% of real-world evidence (RWE) solutions. Real-world data (RWD) are derived from various sources associated with patient outcomes in a heterogeneous population in real-world settings. The dataset is present in a secondary format in which retrospective studies are conducted to generate RWE. This RWE provides meaningful insights into unmet needs and the clinical and economic impacts on patients and healthcare systems. It also determines the outcomes based on much larger data samples, reduces costs, and improves the efficiency of clinical trials and the recent shift towards personalized medicine, thus contributing to the largest share of this segment. As personalized medicine increasingly relies on the use of larger datasets to identify the patient sub-groups to design and plan treatment accordingly, which provides a beneficial approach for diseases like cancer hence, the requirement for larger datasets is increasing.

However, the consulting & analytics segment is estimated to register the highest CAGR of 11.7% during the forecast period. Consulting services include observational or prospective studies, consisting of primary data collection of individuals over time as their characteristics change. Analytic services include online analytical platforms and software that generates RWE. The demand for consulting & analytics is rising with the increasing complexity of data. With the advancement in technologies such as wearables, electronic health records, and mobile applications, the volume of data generated is increasing over time. Thus, consulting & analytics services are needed to clean, manage and analyze data.

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 the real-world evidence (RWE) solutions market. RWE provides payers with information on how treatments work in the real world to guide their medication coverage and reimbursement decisions, thus increasing the adoption. Monitoring drug safety and effectiveness is important for maintaining market access. RWE solutions can be used to check the pharmaceutical product's performance across a broad range of patients, accounting for factors such as real-world adherence, comorbidities, and concomitant medications, reducing the chances of drug trial failure. FDA also uses the RWE to evaluate and monitor the post-market safety of approved drugs, thus contributing to the largest share 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 42.1% 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 is USD 1 billion to more than USD 2 billion, depending on the type of drug.  These high drug development costs pose various technical, regulatory, and economic challenges to pharmaceutical R&D pipelines. Thus, pharmaceutical companies use RWE solutions to understand the potential risks and benefits of drugs by assessing the RWD, thus helping in optimizing drug design & development.

Geographical Analysis

North America to Dominate the Market

In 2024, North America is expected to account for the largest share of 52.9% of the real-world evidence (RWE) solutions market. The increasing prevalence of chronic diseases, stringent regulations for drug approvals, availability of electronic datasets, advanced healthcare industry, and rising big data in healthcare are the major factors responsible for the largest market share of this region. Supportive government initiatives for the deployment of RWE solutions are contributing to the large share of this region. For instance, in 2024, North America is expected to account for the largest share of the 52.9% of real-world evidence (RWE) solutions market. The increasing prevalence of chronic diseases, stringent regulations for drug approvals, availability of electronic datasets, advanced healthcare industry, and rising big data in healthcare are the major factors responsible for the largest market share of this region.

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 provides a framework for the FDA's approach to using RWE solutions in regulatory decision-making. 

Among all the regions studied in this report, Asia-Pacific is slated to register the highest growth rate of 11.3% during the forecast period. Countries like Japan and Taiwan have begun the incorporation of real-world evidence in their healthcare system owing to the “Rational Medicine” initiative in an attempt to make the Japanese healthcare system more patient-centric and evidence-based is driving the market growth in the region. The supportive government initiatives in the region are further driving the market growth. For instance, In January 2020, the National Medical Products Administration (NMPA), China published a new guideline on "Real-World Evidence," which defines RWD and RWE terminologies and explains their application throughout drug research, development, and registration in China.

Real-world Evidence Solutions Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years (2020–2024). The key players operating in the global real-world evidence solutions market are S Anthem, Inc. (U.S.), IQVIA Holdings Inc. (U.S.), ICON plc (Ireland), PPD Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), Oracle Corporation (U.S.), Parexel International Corporation (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), Merative L.P. (U.S.), Optum, Inc. (U.S.), Elevance Health, Inc. (U.S.), and Flatiron Health, Inc. (U.S.).

Real-world Evidence Solutions Market 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), a provider AI-based platform for drug discovery. The collaboration is aimed at accelerating the drug discovery & development process by combining AI with clinical research expertise. 

Real-world Evidence Solutions Market Research Summary

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