According to the Market Statsville Group (MSG), the global real world evidence solutions market size is expected to grow from USD 1,232.6 million in 2021 to USD 4,040.1 million by 2030, at a CAGR of 14.1% from 2022 to 2030. Real-world evidence (RWE) is clinical evidence derived from real-world data on the usage of a medical product and its potential benefits or risks. It is evidence derived from real-world data (RWD), observational data collected outside randomized controlled trials (RCTs), and generated in ordinary clinical practice. Based on observational data, RWD generates insights, extrapolative outcomes, and foresight about illnesses, medical equipment, unmet patient requirements, the value of goods to subpopulations, and patient demographics. Real-world data is also utilized to assess patient outcomes and ensure patients get the best care possible.
RWE is calculated by analyzing data from electronic health records (EHR), medical claims and billing operations databases, registries, patient-generated data, mobile devices, and other sources. It can originate from both retrospective and prospective observational studies and registries. When clinical evaluations cannot account for the entire patient group of diseases, real-world evidence is used. Patients with comorbidities, or those from a different geographic location or age range who have not participated in a clinical study, may not respond to the medication in question as planned. RWE provides answers to these problems and a longer-term assessment of pharmacological effects.
Regulators use RWE to control the safety of marketed pharmaceuticals by combining traditional pharmacovigilance approaches with modern digital tools. Legislators likewise recognize the significance of RWE. It encourages patient-centered medication research and has improved clinical trial design and review. Regulators appear to want RWE to have a big role in their activities. The real-world evidence solutions market is increasing as a result of these changes. Furthermore, market growth is likely to be spurred by drug development delays, which will increase development costs.
With the rise in the prevalence of rare diseases and the trend toward personalized healthcare, healthcare and research organizations will face challenges such as the time-consuming, expensive, and risky process of developing new pharmaceutical entities. Pharmaceutical businesses also conduct clinical trials to get regulatory permission, which is required to develop healing processes. Despite this, increased clinical trial costs and the length of time necessary dissuade pharmaceutical corporations from conducting research, limiting patients' access to new treatments. Because of the high costs of drug research and clinical trials, many businesses are experimenting with innovative techniques to minimize clinical trial expenses and avoid drug development hurdles in order to accelerate medication development.
Government organizations in several nations, research institutes, and numerous biotech and pharmaceutical corporations are concentrating on developing effective and quick diagnostic technologies in the context of COVID-19. Furthermore, many healthcare practitioners and drug developers have been extending their limited resources to halt the spread of the COVID-19 pandemic and create viable medicines/vaccines. Thus, the industry is experiencing a transition toward digitization and patient-centered virtual care. This underlines the need for practical, real-world solutions.
Companies have a chance to embrace RWE early in the product lifecycle to help expedite the development and cut down costs as the volume of RWD rises, and its accessibility improves.
Several firms emphasize RWE adoption to enhance hypothesis development/trial design and speed up trial recruitment. For example, IQVIA (US) teamed with AP-HP in January 2020. This agreement enabled IQVIA to expand complicated clinical trials and real-world evidence investigations throughout France and Europe.
Delays in patient recruiting can cripple a trial and R&D program, with over 80% of clinical studies failing to fulfill initial enrolment expectations. Healthcare providers are spending more on health information systems, which allows them to better track and engage with patients. As a result, patient trial enrollment can occur at the point of treatment. Rising drug development costs and avoidable delays have moved the attention to RWE as a supplement to existing clinical trials for acc6elerating the drug development process.
Despite the rapid acceptance of RWE, several stakeholders are still apprehensive about relying on it. Even though payers have started using RWE, they prefer randomized clinical trials (RCTs) to external observational data when it comes to deciding what medications to fund. The main reason is the availability of numerous standards and procedures for analyzing actual clinical experience evidence. Furthermore, the methods and evidence used to make pharmaceutical coverage determinations differ significantly among US health plan payers. Among health plans, variations in the pharmaceutical technology assessment (PTA) procedure may affect reimbursement, patient access, and, in certain situations, healthcare outcomes. As a result, stakeholders are reluctant to employ evidence of the lack of a consistent data creation approach.
Because most RWD sources are not collected for research objectives, data quality is a concern. Furthermore, corporations are hesitant to use real-world evidence methods since regulatory advice in this area is still being developed.
The healthcare ecosystem is always evolving. Globally, there is greater attention on "value," as players in healthcare funding seek strategies to cope up with the unsustainable cost burden and less return on investment. Companies must have a strong evidence lifecycle management competence in order to demonstrate value. This has provided an opportunity for an end-to-end strategy to use a life sciences organization's data, evidence, and knowledge assets, breaking down conventional silos and enabling insight-driven decision-making from R&D through product commercialization. Establishing an effective governance plan, utilizing technologies such as cloud and self-service analytics, and combine data sets, and comprehending the required resources for the necessary analytics are all part of this (and tactical issues around data access and quality).
Companies like IQVIA, ICON Plc, and Syneos Health already provide end-to-end RWE and late-phase services such as study design, protocol creation, clinical study management, and reporting. The increasing need to provide comprehensive evidence services throughout the product lifecycle is likely to give possibilities for RWE suppliers to boost their investments across the whole drug development cycle.
The study categorizes the real world evidence solutions market based on components, end users, and therapeutic areas at regional and global levels.
Based on end user, the RWE solutions market is divided into pharmaceutical and medical device companies, healthcare payers, healthcare providers, and other end users. In 2021, the pharmaceutical and medical device companies segment accounted for the largest market share due to the growing relevance of RWE studies in medication approvals, the need to avoid costly drug recalls, and the growing requirement to evaluate drug performance in real-world situations.
Based on the regions, the global real world evidence solutions market has been segmented across North America, Asia-Pacific, Europe, South America, and the Middle East & Africa. North America dominated the market with the greatest share in 2021. The North American RWE solutions market is expanding as a result of factors including favorable regulatory conditions, an increase in payers using RWD, an increase in RWE service providers, and an increase in pharmaceutical companies using RWE for drug approval processes.
The global real world evidence solutions market is highly competitive, with key industry players adopting strategies such as partnerships, product development, acquisitions, agreements, and expansion to strengthen their market positions. Most companies in the market are indulged in expanding business across regions, enhancing their capabilities, and molding strong partner relations.
Major players in the global real world evidence solutions market are:
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