The global real world evidence solutions market size is expected to advance at a CAGR of 12.40% during 2022–2030, to reach USD 3,974 million by 2030.
The growth can be mainly ascribed to the increasing development of clinical trials. RWE solutions are majorly used in the field of R&D activities for drugs and medical devices. Also, RWE and RWD are used to enhance the protocol design, which will allow to reduce the costly protocol revisions and enable the creation of synthetic control arms. This will speed up trial execution and reduce the overall cost.
The drug development and approval category accounts for the largest revenue share, and it is expected to maintain its dominance throughout the forecast period as well. This is mainly attributed to the rising number of clinical trials, the increasing prevalence of cancer, and the surging focus on cancer treatment and its prevention. Moreover, over the last few years, there is a significant boost in oncology and cardiovascular therapeutics.
North America holds the largest market share, and it is also expected to maintain its dominance over the next few years. This is because of the presence of major players and the well-established pharmaceutical industry, the rising demand for clinical research activities, the surging R&D expenditures, the increasing number of RWE service providers, and the presence of supportive government rules in the region. The FDA uses RWD and RWE to observe post-market safety and adverse circumstances and create regulatory decisions. This data is being used by the healthcare industry to help with coverage decisions and to develop policies and decision-support tools to use in clinical trials.
In addition, medical product developers are using RWD and RWE to assist clinical trial designs and observational analyses to produce new and innovative treatment systems. Moreover, the 21st Century Cures Act, which was passed in 2016, helps regulatory decision-making, contains permission for new signals for authorized drugs, and places additional focus on the application of such types of data. For instance, more than 85% of U.S. office-based physicians depend on the electronic health record approach. From 2012 to 2019, the FDA used RWE in more than 90 medical device regulatory decisions.
Additionally, for randomized clinical evidence, physicians can implement appropriate and well-designed RWE to obtain further data about therapy efficacy and safety to inform their decision-making. Suitable and well-designed RWE has a great capacity, which has the potential to fill the knowledge gap by offering wider, more accessible representative findings, that therapists can use to inform treatment decisions for their patients. Furthermore, almost 6% of the U.S. population participates in federally supported clinical trials.
Some of the major players operating in the real world evidence solutions market are IQVIA Inc., IBM Corporation, ICON plc, PAREXEL International Corporation, PPD LLC, Optum Inc., Cognizant Technology Solutions Corporation, Oracle Corporation, SAS Institute Inc., and Syneos Health Inc.