Redding, California, Feb. 15, 2022 (GLOBE NEWSWIRE) -- According to a new market research report titled “U.S. Real-World Evidence Solutions Market by Component [Datasets (Clinical, Claims, Pharmacy, Integrated), Services], Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers)- Forecast to 2028”, published by Meticulous Research®, the U.S. real-world evidence solutions market is expected to grow at a CAGR of 13% from 2021 to 2028 to reach $2.01 billion by 2028.
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Real-world evidence (RWE) is clinical evidence gathered via RWD analysis on a medical product's use and potential benefits or risks. RWE can be produced through various study designs or analyses, not limited to randomized trials, large simple trials, pragmatic trials, and observational studies (prospective or retrospective). RWE has several applications, including drug development life cycles, shortening development timelines, reducing the costs of clinical trials, and improving the probability of technical and regulatory success.
Growth of the overall RWE solutions market in the U.S. is primarily driven by key factors such as the growing incidence of chronic & infectious diseases, delays in drug development and the subsequent increase in development costs, rising focus towards personalized healthcare, a shift from volume to value-based care, and rapidly growing big data in healthcare.
Impact of COVID-19 on the U.S. RWE Solutions Market
The COVID-19 pandemic has put a tremendous burden on the U.S. healthcare sector. As the COVID-19 outbreak continued to take its toll, real-world evidence (RWE) became the most influential emerging technology to fight against the COVID-19 outbreak. Real-world evidence solutions provided valuable insights to better understand, monitor, and prepare for the challenges caused by the COVID-19 pandemic. Technological advancements have made it possible to aggregate the data from conventional reporting tools and technology networks, such as mobile apps.
Real-world data (RWD), captured directly from patients or through medical claims or electronic medical records (EMRs), has the potential to support COVID-19 research in a better manner compared to randomized clinical trials (RCT). RCTs are now underway to evaluate existing and new therapies. Thus, there are opportunities for non-randomized RWE to provide information in the interim and answer additional real-world questions that are not addressed in the studies. Thus, the pandemic is expected to further propel the growth of the U.S. RWE market.
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U.S. RWE Solutions Market Overview
The U.S. RWE solutions market is mainly segmented on the basis of component (datasets and consulting services), application (market access & reimbursement/coverage decisions, drug development & approvals, post market surveillance, medical device development & approvals, and other applications), end user (pharmaceutical, biotechnology, and medical device companies, healthcare payers, healthcare providers, and other end users), and geography.
Based on component, the datasets segment accounted for the largest share of the U.S.RWE solutions market in 2021. The large share of this segment is primarily attributed to the increasing need for additional insights on epidemiology, compliance, adherence, and costs in a realistic environment; the growing amount of medical data generated in hospitals; increasing dependence of outcome-based studies on real-world data; and rising demand for information regarding drug safety among payers, regulatory bodies, and providers.
However, the consulting & analytics segment is expected to show the fastest growth rate during the forecast period. Real-world evidence consulting service providers use robust real-world datasets generated by conducting prospective/observational studies to offer customized consulting services to generate fit-for-purpose data and insights for their stakeholders instead of providing terabytes of data.
Based on application, the market access & reimbursement/coverage decisions segment accounted for the largest share of the U.S. RWE solutions market in 2021. The large share of this segment is primarily attributed to the increasing demand for real-world data and real-world evidence to accelerate drug discovery and development, increasing investments by biopharmaceutical companies in R&D, and the growing inclination of regulatory bodies towards the use of real-world evidence (RWE). Both industry and payers are increasingly considering real-world data (RWD) in the U.S. Payers use the data to support coverage decisions, develop guidelines and decision support tools for use in clinical practice, generate estimates of the potential population they cover that could require the treatment, and estimate potential costs and cost offsets.
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However, the drug development & approvals segment is expected to show the fastest growth rate during the forecast period. Factors attributing towards the growth of this segment are increasing demand for real-world data and real-world evidence to accelerate drug discovery and development and increasing investments by biopharmaceutical companies in R&D. In the field of drug development, quality-of-life metrics, and Patient-Reported Outcome Measures (PROMs) are now becoming common elements in clinical trials.
Based on end user, the pharmaceutical & medical device companies segment is expected to show the fastest growth rate in the forecast period. The growth of this segment is primarily attributed to the increasing importance of RWE studies in drug development & approvals and the growing need to avoid costly drug recalls and assess drug performance in real-world settings. The cost of developing a new drug was more than ~USD 2,600 million in 2020 compared to USD 802 million in 2003. This increase in drug development costs reflects various technical, regulatory, and economic challenges pharmaceutical R&D pipelines face.
Key companies operating in the U.S. RWE solutions market are IQVIA HOLDINGS INC. (U.S.), ICON plc (Ireland), PPD, Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), Flatiron Health (U.S.), SYNEOS HEALTH, INC. (U.S.), CLARIVATE PLC (U.S.), Medpace Holdings, Inc. (U.S.), and Symphony Innovation, LLC (U.S.) among others.
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Scope of the Report
U.S. RWE Solutions Market, by Component
- Datasets
- Disparate Datasets
- EMR/EHR/Clinical Data
- Claims & Billing Data
- Pharmacy Data
- Product/Disease Registries Data
- Other Disparate Datasets
- Integrated Datasets
- Disparate Datasets
- Consulting and Analytics
(Note – Other Disparate Datasets include data generated from mobile devices, wearable devices, and social media)
U.S.RWE Solutions Market, 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 – Other Therapeutic Areas include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases/ Other Applications include regulatory and clinical decision-making)
U.S. RWE Solutions Market, 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)
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