The global market for real-world evidence solutions is anticipated to expand at a CAGR of 15% between 2024 and 2032. The increase of clinical trials and the shift from volume-based to value-based treatment are the key drivers driving the expansion of this industry. Utilizing RWE and RWD can enhance protocol design, hence minimizing the number of costly protocol modifications and enabling the creation of synthetic control arms to accelerate trial execution and save costs. Similarly, RWE can speed label expansion and lower the total cost of required filing documentation. Due to these advantages, RWE systems are becoming increasingly popular in drug and medical device research and development. Support from regulatory bodies for the implementation of Real-World Evidence (RWE) solutions and an increase in R&D spending is anticipated to drive market expansion. Additionally, it is projected that the change from volume-based to value-based care would contribute to the increase. Numerous market participants began to endure extensive business interruptions as a result of the COVID-19 pandemic, which impeded ordinary corporate activities.
The bulk of pharmaceutical, biopharmaceutical, and medical device companies continue to invest heavily in the development of novel drugs and technologies. Particularly, the pharmaceutical industry invests considerably in research and development. Due to growing R&D expenditures, pharmaceutical and biopharmaceutical companies are choosing fully integrated or functional outsourcing services from the early development phase through the late-stage development phase in order to satisfy the demands of drug discovery and development. In comparison to other industries, the pharmaceutical industry spends the highest proportion of its revenue on research and development. This rise in R&D investment, driven by the need for different preclinical and clinical services during the drug development process, is expected to propel the growth of the RWE market.
Despite the extensive use of RWE across applications, certain stakeholders remain reluctant to rely on it. Even while payers have begun employing RWE, they prefer to base drug coverage decisions on randomized clinical trials (RCTs) as opposed to external observational data. The provision of multiple criteria and procedures for analyzing clinical experience evidence gained from actual patient care is the fundamental rationale for this preference. In determining pharmaceutical coverage, payers also utilize a diverse array of processes and data. During the pharmaceutical technology assessment (PTA) process, these disparities may have an effect on reimbursement, patient access, and even healthcare outcomes. Consequently, stakeholders are cautious to utilize evidence in the absence of a defined data collection method.
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As healthcare industry participants seek new solutions to address the unsustainable cost burden and relatively low return on investment, the healthcare ecosystem is undergoing a shift, and a greater emphasis is being placed on healthcare expenses. In order to demonstrate value, businesses require robust capabilities in evidence lifecycle management. Consequently, an opportunity for an end-to-end approach to harness the data, evidence, and knowledge assets of a life sciences organization has arisen, aiding in the dismantling of traditional silos and enabling insight-driven decision-making from the product R&D phase to its commercialization. This requires the creation of an effective governance framework, the use of technologies such as cloud and self-service analytics, and the ability to connect data sets and comprehend the essential resources for the required analytics (and tactical issues around data access and quality).
In this industry, the absence of globally accepted standards or principles applicable to the design, analysis, and reporting of RWE has become a significant hurdle. This lack of consensus has rendered RWE insufficient for inclusion in the body of data needed to compare the efficacy of different treatment options. Consequently, the incentive to produce information has lessened. This decreases the possibility that important stakeholders will utilize RWE solutions even further.
In 2023,the services category dominated the RWE solutions market.The increased need to convert data into actionable evidence and the abundance of healthcare data are the key factors driving the rise of this market segment. Instead of gathering data sets and analyzing them to generate useful information, clients can save time and money by relying on suppliers to customize their services to their particular requirements. Consequently, there is a bigger demand for RWE services than for RWE data sets. Experts in RWE collaborate with the subject matter expert of pharmaceutical and medical device companies to give services to build intelligent RWE strategies (consulting services) and utilize analytical capabilities to provide substantial statistical insights.
In 2023, the drug development and approvals segment led the RWE solutions market. The medication development and approvals market sector is the most significant due to the increasing number of clinical studies in oncology and cardiovascular medicines. In addition, post-pandemic improvements in COVID-19 treatment have increased substantially. This category is subdivided further into oncology, cardiovascular disease, neurology, immunology, and additional therapeutic domains. The oncology sector dominates the market due to the rising incidence of cancer and the increasing number of clinical trials and research concentrating on cancer treatment and prevention.
Pharmaceutical And Medical Device Firms Are Anticipated to be The Fastest Growing End Users Segment during the forecast period of 2024 to 2032. The rapid growth of pharmaceutical and medical device companies can be attributed to the increasing importance of RWE studies in medication approvals, the prevention of expensive drug recalls, and the evaluation of therapeutic performance in real-world settings. Moreover, the pharmaceutical industry's utilization of RWE continues to increase due to its application in meeting regulatory compliance requirements and payer obligations associated with HEOR. The pharmaceutical industry requires details on both the approved and medically recognized alternative applications for previously approved pharmaceuticals. RWE data are necessary for innovative drugs to efficiently advance through clinical phases. Therefore, the effective phase transition depends on robust real-world outcomes.
The RWE solutions market was dominated by North America in 2023, but Asia-Pacific is expected to maintain the highest growth rate over the projection period. The rising number of clinical trials, increasing government initiatives for the adoption of RWE studies, the rising incidence of chronic diseases, the rising demand for better healthcare services, and the rising geriatric population all contribute to the expansion of the RWE solutions market in the Asia-Pacific region. Moreover, countries such as Japan and China in the area have the well-established clinical trial infrastructure, a strong medical workforce, solid healthcare capabilities, and stringent quality criteria, all of which contribute to the expansion of the Asia Pacific market.
The global market is very competitive and fragmented. Market participants conduct strategic efforts such as product development and launch, distribution network expansion, and global footprint expansion via subsidiaries and partnerships. Key players engage in portfolio diversification and mergers and acquisitions in addition to portfolio diversification and mergers and acquisitions. In August 2021, for instance, Syneos Health collaborated with Aetion to create a solution based on real-world evidence and to provide analytically-driven data and regulatory-grade data. In April 2021, Thermo Fisher Scientific announced that it would acquire PPD, Inc. for USD 47.50 per share. The key companies in this market include IQVIA, IBM, ICON plc., PAREXEL International Corporation, PPD, LLC, Optum, Inc, Cognizant Technology Solutions Corporation, Oracle Corporation, SAS Institute Inc., Syneos Health, Inc., Anthem, Inc., and others.
