(PharmaNewsWire.Com, November 19, 2021 ) The global RWE solutions market is projected to reach USD 2.3 billion by 2026 from USD 1.2 billion in 2021, at a CAGR of 14.4% during the forecast period. The rising geriatric population (and the subsequent increase in the prevalence of chronic diseases) is a key factor driving the growth of this market.
The shift from volume- to value-based care, delays in drug development (and the subsequent increase in development costs), growth in RD spending, and support from regulatory bodies for the use of RWE solutions are some of the other major factors that are driving the growth of this market. However, the reluctance to rely on real-world studies and the lack of universally accepted methodological standards for data collection are restraining the growth of this real world evidence solutions market. The emergence of this pandemic has posed severe financial constraints on pharma-biopharma companies in several countries. In this regard, RWE solutions have proven to be very helpful, as they allow industrial and academic researchers to monitor patients using digitally connected platforms while helping to organize and evaluate clinical data for regulatory submissions.
A smaller percentage of the readers identified telemedicine (28%) and artificial intelligence (20%) as the most important emerging trends. Even though emerging technologies, such as telemedicine, have existed for decades, most of healthcare systems rely heavily on in-person interactions between patients and clinicians.
RWE can provide valuable insights to better understand, monitor, and prepare for the challenges caused by outbreaks such as the COVID-19 pandemic. The utilization of RWE in infectious disease control is not a new concept. During the Ebola outbreak in 2014, forecasters successfully used Global Epidemic and Mobility (GLEaM) simulations that combined real-world data on populations and their mobility with rigorous stochastic models of disease transmission to predict the global spread of the disease.
Even though most countries have announced decreasing death rates from COVID-19, real-world evidence may become an essential tool in trying to suppress the disease.
In countries with strict data privacy laws, the implications of contact-tracing apps on individual privacy are considered a major associated concern. While cryptographers are currently working on improving tracing apps to address the issue, tracking apps can only be effective when they are used by a significant proportion of the population. Therefore, it is critical that the functionality and safety of these applications are considered acceptable by the majority of the population.
Accelerated digitalization in the healthcare space has revealed gaps in infrastructure, workforce, and digital education that ultimately need to be bridged. Without intelligent analytics, RWE alone will not be able to produce meaningful and actionable results. Previously, the healthcare industry did not have the ability to gather RWE at the speed and scale needed to address urgent public health crises. However, this scenario has changed due to the pandemic. Advances in analytics and access to broad and diverse real-world data sets have made it possible to rapidly analyze data as it is captured to better understand how pandemics like COVID-19 are unfolding.
Regulators use RWE to monitor the safety of marketed products through traditional pharmacovigilance tools (for instance, Periodic Benefit-Risk Evaluation Report, Periodic Safety Update Report, and Vaccine Adverse Event Reporting System) as well as newer digital aids such as the FDA Sentinel Initiative, a post-market active safety surveillance system. The pre-approved use of RWE in efficacy decisions is being carried out currently, and there is potential for it to be used more broadly, such as in oncology, rare diseases, and pediatric conditions when randomized controlled clinical trials are impossible or unethical to conduct.
This is reflected in the FDA’s efforts to integrate data collected from electronic medical records, claims data, and registries to create a unified system for monitoring the safety of medical products. Similarly, a National Institutes of Health (NIH) Common Fund has been established to build infrastructure, operational knowledge, and capacity for “pragmatic research” that incorporates electronic health records and other real-world data into large-scale distributed research networks to allow researchers to identify cohorts of interest more easily and expedite studies.
Similarly, the European Medicines Agency (EMA) released the EMA Regulatory Science to 2025 Reflection Paper, which included promoting the use of high-quality RWD in decision-making as one of its strategic goals. Organizations such as the Bipartisan Policy Center have also published recommendations to advance the generation and use of RWE for regulatory evaluation. Such developments are expected to drive the growth of the RWE solutions market.
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