Clinical evidence obtained from the examination of real-world data (RWD) is known as real-world evidence (RWE).
The resulting clinical evidence covers the use of a medical product and its possible advantages or disadvantages. Pharmaceutical, biotechnology, and medical device firms, as well as healthcare payers and providers, employ RWE solutions for market access and reimbursement/coverage choices, drug development and approvals, post-market surveillance, and medical device development and approvals.
The market for RWE solutions is expanding due to various causes such as the increasing prevalence of chronic illnesses, the growing emphasis on personalized healthcare, the transition to value-based care, and the increasing use of real-world evidence solutions in drug development and commercialization. Real-world evidence solutions market participants could anticipate substantial development prospects due to the emergence of emerging economies and an increasing emphasis on comprehensive RWE services.
Shift Toward Value-based Care is Driving the Market
The value-based care model has emerged as an alternative and potential replacement for the volume-based/fee-for-service reimbursement model. The strategy seeks to save healthcare costs, enhance population health, and deliver better treatment for individuals. In a value-based care approach where pay-for-value is prioritized, using real-world data aids in demonstrating if the medication produces the same patient outcomes as shown in RCTs.
The CMS has launched several value-based care models, including patient-centric medical homes, the Medicare Shared Savings Program, and the Accountable Care Organization (ACO) model. Private payers have also embraced similar accountable, value-based care models. Since validated outcome indicators based on real-world data are being included in value-based payment contracts, the FDA has come to understand that real-world evidence may make the American healthcare system more efficient and competitive.
Value-based payment plans typically rely on cost information and objective, quantifiable patient outcomes (related to product utilization). In the past, to make decisions about how much to pay for new medications and biologics, payers have required additional information beyond the cost and utilization data from their claims systems and the findings of clinical trials, many of which do not evaluate significant long-term outcomes and resource use.
Value-based care is a difficult, transformative path that is quickly gaining popularity around the globe. Cost-effectiveness trials are designed with the assistance of R&D specialists that adopt a value-based mentality. In the early phases of medication development, the trials aid in assessing the burden of illnesses and creating value propositions based on actual outcomes, such as productivity, absenteeism, quality of life, and frequency of clinical episodes. Employing empirical data and supporting documentation is a is a key element in transitioning to value-based care.
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The key players operating in the global 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.).
Among all the components studied in this report, in 2024, the datasets segment is expected to account for the largest share of 53% of the real-world evidence (RWE) solutions market. The datasets segment is further segmented into disparate datasets and integrated datasets. The global real-world datasets market is anticipated to be dominated by the disparate datasets sector by 2024. Data that are clearly different in kind, quality, or character make up disparate datasets. Because of their heterogeneity, these datasets are easily combined to offer businesses business insights. The significant market share of this segment can be mainly ascribed to the growing use of wearable technology, registries, electronic health records/electronic medical records (EHRs/EMRs) in hospitals, technological advancements in medical data storage, and increased access to claims data.
Among all the applications studied in this report, in 2024, the drug development & approvals segment is anticipated to register the highest CAGR of 13.1% during the forecast period. Because RWE studies are much less costly and time-consuming than randomized clinical trials, they offer easier access to long-term efficacy data and help get around some of the practical issues with randomized clinical trials, which is why their significance in drug development is growing. Patient-reported outcome Measures (PROMs) and quality-of-life metrics are becoming often used in clinical trials for medication development. Evidence derived from real-world data is frequently used to guide medication development, providing information on treatment paths and comparator interventions in clinical settings, as well as the natural history and epidemiology of a disease.
Among all the end users studied in this report 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. Pharmaceutical businesses are using more and more RWE solutions; these solutions are employed at every stage of the drug development process, from drug discovery to post-marketing surveillance, which accounts for the segment’s significant market share. Furthermore, RWE is used by regulatory agencies like the FDA to evaluate the post-market safety of medicines that have been approved, as well as for medication approval. To reduce the likelihood of medication failure, pharmaceutical companies are implementing RWE technologies.
Among all the regions studied in this report, North America is expected to account for the largest share, 48.9%, of the real-world evidence (RWE) solutions market in 2024The presence of important players, significant R&D expenditures made by pharmaceutical and biotechnology corporations for medication development, and encouraging government initiatives are all factors contributing to this region’s significant market share. The region’s stake is also being increased by the growing adoption of EHR in the healthcare sector. The region is seeing an increase in public-private funding for projects utilizing RWE technology. For example, the U.S. Food and Drug Administration stated in 2023 that four more U01 grant awards would be made for the projects, which included using RWE technologies to cure cancer and to improve the effectiveness of clinical trials (refer to U.S. FDA).
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Scope of the Report:
Real-world Evidence Solutions Market Assessment—by Component
- Datasets
- Disparate Datasets
- EMR/EHR/Clinical Data
- Claims & Billing Data
- Pharmacy Data
- Product/Disease Registries Data
- Genomics Data
- Other Disparate Datasets
- Integrated Datasets
- Disparate Datasets
- Consulting Services
Note: Other Disparate Datasets include data generated from mobile devices, wearable devices, and social media.
Real-world Evidence Solutions Market Assessment—by Application
- Market Access & Reimbursement/Coverage Decisions
- Drug Development & Approvals
- Oncology
- Neurology
- Immunology
- Cardiovascular Diseases
- Other Therapeutic Areas
- Post Market Surveillance
- Medical Device Development & Approvals
- Other Applications
Note: 1) Other Therapeutic Areas include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases.
2) Other Applications include regulatory and clinical decision-making.
Real-world Evidence Solutions Market Assessment—by End User
- Pharmaceutical, Biotechnology, and Medical Device Companies
- Healthcare Payers
- Healthcare Providers
- Other End Users
Note: Other end users include academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies.
Real-world Evidence Solutions Market Assessment—by Geography
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- U.K
- Italy
- Spain
- Switzerland
- Belgium
- Rest of Europe (RoE)
- Asia-Pacific (APAC)
- China
- Japan
- India
- South Korea
- Taiwan
- Singapore
- Australia
- Rest of Asia-Pacific (RoAPAC)
- Latin America
- Brazil
- Mexico
- Rest of Latin America (RoLATAM)
- Middle East & Africa
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