Real World Evidence (RWE) Solutions Market Size, Share & Trends Analysis Report By Component (Services, Data Sets), By Applications (Drug Development and Approvals, Medical Device Development and Approvals, Reimbursement/Coverage and Regulatory Decision Making, Post-Market Safety and Adverse Events Monitoring), By End-User (Pharmaceutical and Medical Device Companies, Healthcare Payers, Healthcare Providers) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Real World Evidence (RWE) Solutions Market Size & Trends

The global real world evidence (RWE) solutions market size was valued at USD 2.91 billion in 2022. It is expected to reach USD 6.01 billion by 2031, growing at a CAGR of 8.4% during the forecast period (2023–2031). Factors such as rising R&D Expenditure for Novel Drugs and Medical Devices, significantly drives the real world evidence (RWE) solutions market demand by 2031.

Healthcare data from non-traditional clinical research settings, such as electronic medical records (EMRs), claims and billing data, product and disease registries, and data gathered by mobile devices and health apps, is real-world evidence. Administrative/claims data, clinical data, patient-generated or -reported data, and emerging data sources, such as social media and cross-industry data collaborations like Project Data Sphere, are the four primary sources of real-time data collection. Pharmaceutical businesses, payors, and providers most frequently use them to manage their organizations more effectively and make comparative efficacy and cost-effectiveness decisions when more trustworthy data sources are not accessible.

Real World Evidence (RWE) Solutions Market Growth Factors

Rising R&D Expenditure for Novel Drugs and Medical Devices

Most pharmaceutical, biopharmaceutical, and medical device companies continue to invest significantly in creating new medications and equipment. R&D is significant in the pharmaceutical industry. Pharmaceutical and biopharmaceutical companies are choosing fully integrated or functional outsourcing services from the early development stage to the late-stage development phase to meet the demands for drug discovery and development due to their increasing R&D expenditure. The pharmaceutical sector of the economy spends the highest proportion of its revenue on research and development. The market is expected to rise due to this increase in R&D spending, driven by the demand for numerous preclinical and clinical services during drug development.

Market Restraints

Reluctance to Use Real-World Studies by Medical Professionals and Researchers

Real-world evidence has spread quickly across applications, but some stakeholders still need to learn to rely on them. For instance, although payers have begun using RWE, they prefer to use internal observational data from randomized clinical trials (RCTs) to inform drug coverage decisions. The primary justification for this preference is the availability of numerous standards and techniques for analyzing data from actual clinical experience. Additionally, there are significant differences between payers regarding the procedures and data used to determine pharmaceutical coverage. During the pharmaceutical technology assessment (PTA) process, these variations may impact patient access, reimbursement, and perhaps even healthcare outcomes across health plans. As a result, stakeholders hesitate to use evidence that was not produced using a consistent methodology.

Market Opportunities

Increased Emphasis on Comprehensive RWE Services

Healthcare stakeholders are looking for new solutions to the unaffordable cost burden and relatively low return on investment, changing the healthcare ecosystem and raising concerns about healthcare costs. Businesses require strong evidence lifecycle management capabilities to demonstrate value. In turn, this has opened the possibility of using an end-to-end strategy to leverage a life sciences organization's data, proof, and knowledge assets, aiding in dismantling traditional silos and enabling insight-driven decision-making from the product R&D stage to its commercialization. This entails implementing an efficient governance strategy, utilizing cloud and self-service analytics technologies, learning to integrate data sets, and comprehending the appropriate resources for the required analytics (and tactical issues around data access and quality).

Regional Analysis

By region, the global real world evidence (RWE) solutions market share is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant shareholder in the global market and is expected to grow remarkably during the forecast period. The region dominated a large portion of the real-world evidence solutions market in 2022, and this dominance is likely to continue over the forecast period due to rising demand for real-world evidence-based products and services, the move toward value-based care over volume-based care, and the strategies they use for their product development.

Asia-Pacific : Fastest Growing Region

Asia-Pacific is predicted to expand at the highest CAGR over the projection period as a result of the rising elderly population and increased prevalence of cancer and other chronic diseases. In addition, growing government initiatives to embrace RWE studies and the prevalence of numerous contract research and manufacturing businesses in nations like China and India are expected to raise the demand over the forecast period. Furthermore, rising consumer desire for better healthcare services is predicted to drive real world evidence (RWE) solutions market growth.

Real World Evidence (RWE) Solutions Market Segmental Analysis

Based on the component 

The global RWE solutions market is bifurcated into services and data sets.

The service segment is the highest contributor to the market and is expected to grow significantly over the forecast period. A clinical evidence solution based on real-world facts about the application of a medical product and any potential advantages or risks is known as real-world evidence. The real-world evidence solutions market includes services that aid healthcare payers, providers, and pharmaceutical firms in operating more successfully while also accelerating drug research and approval. These real-world evidence solutions revolutionize the drug development process, posing new challenges.

Real-world data is information gathered from sources like biometric devices, insurance claims, patient reports, and electronic medical records unrelated to clinical trials. It is possible to identify and profile patients struggling to comprehend their experiences with rare illnesses by gathering data from these various care points. In the coming years, the dataset segment will be predicted to account for a more significant portion of the market for existing evidence solutions. The main drivers of this market's growth are the need for more knowledge about real-world compliance, epidemiology, costs, the abundance of medical data produced in hospitals, and the reliance on results-based research. Additionally, the market is driven by growing government initiatives to adopt real-world evidence solutions research, rising chronic disease burden, rising demand for better medical services, and an aging population.

Based on the application

The global RWE solutions market is bifurcated into drug development and approvals, medical device development and approvals, reimbursement/coverage and regulatory decision-making, and post-market safety and adverse events monitoring.

Drug development and approvals had the most significant revenue share in 2022—more than 28.83%. Real-world Evidence (RWE) solutions services enable pharmaceutical firms, healthcare organizations, and payers to effectively manage business operations and quicken the drug development and approval process. In addition, the COVID-19 pandemic necessitated the development of vaccinations and treatments, and leading healthcare businesses sought to extend the usage of RWE beyond typical safety-related applications. Therefore, a CDC study conducted in March 2021 that employed RWE discovered that the mRNA COVID-19 vaccine effectively prevented SARS-CoV-2 infections in first responders, medical professionals, and other crucial workers who received the shot during the first vaccine rollout. For instance, Johnson & Johnson and Gilead began RWE studies for drugs to treat pulmonary arterial hypertension and large B-cell lymphoma.

Medical product designers are using RWD and RWE to aid in designing clinical trials (such as pragmatic clinical trials, large simple trials, and observational studies) and new, creative treatment modalities. As a result, technology dramatically impacts healthcare choices, which helps the segment grow. The FDA is increasingly accepting RWE for medical devices, as demonstrated by Dexcom's use of RWE to enhance the indication of its G5 Mobile Continuous Glucose Monitoring System as early as 2016. Recently, RWE was used to expand the indications for hemodialysis catheters, to apply for a humanitarian device exemption for a device used to treat adolescent idiopathic scoliosis, and for numerous medical devices used in pediatric surgery.

Based on the end-user 

The global RWE solutions market is bifurcated into pharmaceutical and medical device companies, healthcare payers, and healthcare providers.

The industry segment with the highest revenue share in 2022—more than 30.0%—was pharmaceutical and medical device companies. The market expansion is attributed to the growing significance of RWE studies in determining how well drugs perform in actual environments and preventing drug recalls. RWE can assist and advance several procedures, including determining which patient cohort will benefit from a given intervention the most, assisting with regulatory approvals, enhancing the information from randomized controlled trials, assisting with efforts to get paid, and boosting the number of indications for use.

Recent Developments

• December 2022- Clarivate Plc, a leader in delivering reliable information and insights, announced the integration of linked specialty pharmacy claims data into real-world data solutions. The new U.S. dataset will increase Clarivate's real-world data and analytics offerings.
• December 2022- The Houston-based Utegration LLC, a full-service consulting and solutions provider specializing in SAP technology and SAP-certified products for the energy and utilities sectors, was acquired by Cognizant, according to a press release.