Real-world evidence (RWE) is clinical evidence gathered via Real World Data (RWD) analysis on the use and potential benefits or risks of a medical product. RWE can be produced through various study designs or analyses, including but 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. The growth of this market is primarily driven by key factors such as the rapid growth of large data in healthcare, the shift from volume to value-based care, and the rising focus towards personalized healthcare.
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Impact of COVID-19 on RWE Solutions Market
The key players operating in the RWE solutions market experienced an initial market 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 of resources on COVID-19 treatments in healthcare settings, and limited access to hospitals. These factors affected the amount of real-world data generated globally.
However, after the initial shrinkage, real-world evidence (RWE) is set to become the most influential emerging technology to fight against the COVID-19 outbreak. Real-world evidence solutions can provide valuable insights to better understand, monitor, and prepare for the challenges caused by the COVID-19 pandemic. RWD has been used increasingly to map the progression of the disease and to discover vaccines and immediate treatments. Thus, the effectiveness of the use of RWD made a significant impact during the pandemic and continues to play a significant role in the treatment of infected patients.
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RWE Solutions Market: Future Outlook
The RWE Solutions Market is segmented by 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 (North America, Asia-Pacific, Europe, Latin America, and the Middle East & Africa).
Based on component, the datasets segment is estimated to account for a larger share of the overall RWE solutions market in 2021. The large share of this segment is mainly attributed to the growing amount of medical data generated in hospitals and the increasing dependence of outcome-based studies on real-world data. EHRs are the most commonly used form of healthcare database that helps in conducting outcome-based studies. EHR data is playing an increasingly vital role in collecting and generating actionable information at the FDA. Governments across the world are undertaking initiatives to increase the adoption of EHR/EMR data. For instance, in September 2020, to digitalize the entire healthcare ecosystem of India, the Ministry of Health and Family Welfare (MoHFW) released a draft policy termed the Health Data Management Policy. However, the consulting services segment is expected to witness the fastest growth rate during the forecast period. Real-world evidence consulting service providers make use of 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 is estimated to account for the largest share of the RWE solutions market in 2021. The pharmaceutical, biotech, and medical device industries face unprecedented challenges due to the global economic crisis, COVID-19 pandemic, and concerns about escalating healthcare costs. Due to rising therapy costs, healthcare payers are increasingly focused on evidence of clinical value for making decisions associated with providing coverage. RWE helps provide a means for demonstrating value, ranging from confirming randomized trial benefits in real-world populations to a fuller characterization of resource impacts. RWE is being increasingly considered by both industry and payers. 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. However, the drug development & approvals segment is expected to witness the fastest growth rate during the forecast period.
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Based on end user, the pharmaceutical, biotechnology, & medical device companies segment is expected to witness the fastest growth rate during the forecast period. Rising pharmaceutical R&D spending is the major factor attributed to the growth of this segment. The cost of developing a new drug was more than $2,600 million in 2020 compared to $802 million in 2003. This increase in drug development costs reflects various technical, regulatory, and economic challenges pharmaceutical R&D pipelines face. The global R&D spending in 2021 surged by 7.0% ($212 billion) compared to 2020. Real-world evidence helps in understanding real-life clinical practices and actual health outcomes of drugs. It also helps generate broader scientific evidence and commercial insights, valuable for the pharmaceutical industry.
Geographically, North America is estimated to command the largest share of the global RWE solutions market in 2021, followed by Asia-Pacific, Europe, Latin America, and the Middle East & Africa. However, Asia-Pacific region is expected to be the fastest-growing regional market due to growing demand from payers for data that defines the value and effectiveness of medicines, growing demand in conducting real-world studies in drug R&D, and increasing government interest in using real-world studies for regulatory decision-making.
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Key companies operating in the global RWE solutions market are IQVIA Holdings Inc. (U.S.), ICON plc (Ireland), PPD, Inc. (U.S.), SYNEOS HEALTH, INC. (U.S.), CLARIVATE PLC (U.S.), Medpace Holdings Inc. (U.S.), Symphony Innovation, LLC (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), and Flatiron Health (U.S.) among others.