The U.S. RWE Solutions Market is expected to grow at a CAGR of 13.1% from 2022 to 2029 to reach $2.22 billion by 2029. Real-world evidence (RWE) is clinical evidence gathered via RWD analysis on the use and potential benefits or risks of a medical product. 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. Rapidly growing big data in healthcare, shift from volume to value-based care, and rising focus towards personalized healthcare have been considered to have a positive impact on the U.S. RWE solutions market.
Impact of COVID-19 on the U.S. RWE Solutions Market
The key players operating in the U.S. RWE solutions market experienced an initial shrinkage due to uncertainties associated with the impact of the COVID-19 pandemic. The market shrinkage was mainly due to significant restrictions on travel in many countries, shifting resources on COVID-19 treatments in healthcare settings, and limited access to hospitals. However, after initial shrinkage, the adoption of real-world evidence (RWE) is rising to fight against the COVID-19 outbreak.
Healthcare professionals are working tirelessly on faster diagnosis, rapid response, and effective use of human resources, and ensuring medical personnel's safety. As the COVID-19 outbreak continues to take its toll on U.S. markets, real-world evidence (RWE) is the most influential emerging technology to fight against the COVID-19 outbreak. Real-world evidence is becoming an essential tool in trying to suppress COVID-19.
There is growing interest in whether non-randomized real-world evidence (RWE) can be used to supplement RCT evidence and aid in clinical decision-making but concerns about non-randomized RWE have been highlighted by a proliferation of RWE studies on medications and COVID-19 outcomes with widely varying conclusions. A systematic approach to generating information to support clinical and public health decision-making is needed. Real-world data (RWD) captured directly from patients or through medical claims or electronic medical records (EMRs) have the potential to support clinical decision-making.
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Key Findings in the U.S. RWE Solutions Market Study
Datasets Generated Larger Proportion of Revenue Compared to Consulting and Analytics
The datasets segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. 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.
Market access & Reimbursement/Coverage Decisions to Dominate the Market
The market access & reimbursement/coverage decisions segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. 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).
Real-world data (RWD) is being increasingly considered by both industry and payers 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.
Pharmaceutical & Medical Device Companies Segment is Expected to Account for the Largest Share in the U.S. RWE solutions market
The pharmaceutical & medical device companies segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. The large share of this segment is mainly attributed 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 healthcare landscape continues to shift from volume to value-based care and is continuously developing. Pharmaceutical companies have been looking for new ways to provide the best treatments for patients. Real-world evidence helps understand real-life clinical practices and actual health outcomes of drugs. Pharmaceutical and biotech companies are increasingly utilizing real-world evidence for collecting real-time post-trial information about drugs, which helps healthcare providers and researchers understand the negative reactions, side effects, and medication errors related to the drugs, thereby enabling them to control the potential harm caused by the drugs.
The report includes a competitive landscape based on extensive assessment of the key strategic developments that led market participants to adopt over the past four years. The key players profiled in the U.S. RWE solutions market report includes Anthem, Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), ICON plc (Ireland), IQVIA HOLDINGS INC. (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), PPD, Inc. (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), and Flatiron Health, Inc. (U.S.).
Scope of the Report
U.S. RWE Solutions Market, by Component
- Disparate Datasets
- EMR/EHR/Clinical Data
- Claims & Billing Data
- Pharmacy Data
- Product/Disease Registries Data
- Other Disparate Datasets
- Integrated 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
- Cardiovascular Diseases
- Other Therapeutic Areas
- Post Market Surveillance
- Medical Device Development & Approvals
- Clinical and Regulatory Decision-Making
(Note – Other Therapeutic Areas include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases)
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)
Key questions answered in the report: