Real-world Evidence (RWE) Solutions Market Size and Demand to Surge by 2030 | Top Key Players: IQVIA Holdings, Parexel, and Syneos Health

The market for real-world evidence (RWE) solutions market is expected to grow CAGR of ~10% during the forecast period. The major reasons for this growth include growing regulatory support for RWE adoption, the growing rate of chronic illnesses and increased investments from pharmaceutical firms, the increasing interest in targeted therapies and personalized medicine as well as the widespread adoption of electronic health records (EHRs) and digital health data, as well as the ability of RWE to reduce the cost of developing drugs and increase the effectiveness of clinical trials.

Real-world evidence (RWE) solutions are advanced analytical tools platforms, methods, and platforms that make use of real-world data (RWD) to provide clinical insights into the use of, the effectiveness and safety of medical treatments, products and other healthcare procedures. These solutions combine information from a variety of sources, including electronic health records (EHRs), patient registries, claims databases and wearable devices. They also provide outcomes reported by patients to aid in the development of drugs and regulatory decision-making, market access post-market surveillance and value-based health initiatives. RWE solutions can help healthcare providers, pharmaceutical companies payers, regulators, and agencies evaluate treatment outcomes improve patient care, improve practices in the clinic, and guide policies and reimbursement decisions. Evidence from real-world situations (RWE) has been used for a number of years but the latest advances in technology and advanced analytics have allowed it to be used in new ways.

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RWE plays a crucial role in assisting regulators to formulate decisions

RWE could help the FDA when making decisions regarding the effectiveness and safety of medical products like identifying new safety concerns post-approval or determining the efficacy of a product for an entirely new indication or group. Contrary to traditional clinical trials that are carried out in controlled settings with smaller patient populations, RWE provides insights from various patient groups, regular clinical practice and post-market monitoring. This allows regulators to assess the outcomes of treatment and monitor adverse events and improve drug labeling in light of real-world usage. Furthermore, RWE supports expedited approvals and label expansions by enhancing the clinical trial data, particularly in the fields of uncommon diseases, personalized medical and oncology. The potential of RWE was highlighted in the 21st Century Cures Act (Cures Act, which was signed in the year 2016) mandated the FDA to develop an outline of an evaluation program for the role of RWE in regulatory decision-making. FDA released the framework for the program in December of 2018. In the context of its RWE Program The FDA is determined to understand the full scope of RWD and RWE in regulatory decision-making. The agency has held workshops, granting demonstration projects, constructing web and mobile applications that collect RWD and RWE data, and collaborating with sponsors about the topic.

Pharmaceutical and biopharma companies are currently focusing on enhancing RWE capabilities

The capability to transform real-world data sources like claims data and electronic medical records (EMRs) into evidence-based decisions improves the health of patients by allowing pharmaceutical companies to streamline their drug development and optimize their commercialization strategies. These insights allow biopharmaceutical companies to speed up the development of successful treatments and provide solid evidence to payers, and improve their position in the health care market. To gain access to high-quality data from the real world and improve study designs Numerous pharmaceutical companies are establishing strategic partnerships with healthcare providers as well as payers and analytics companies. In addition, enhancing RWE capabilities also allows them adapt to the increasing emphasis on value-based healthcare as well as reimbursement models, making sure that new treatments are in line with expectations of both payers and regulatory agencies. As a result, the field is moving towards integrated RWE platforms and real-time evidence generation and adaptable trial designs, which reinforces RWE as a major source of innovation and enhancing outcomes for patients.

Competitive Landscape Analysis

The global real-world evidence (RWE) solutions market is marked by the presence of established and emerging market players such as IQVIA Holdings; Parexel; Icon; PPD; Syneos Health; Clarivate; Cerner; Medpace Holdings; Flatiron Health; Symphony Innovation; Aetion; Cognizant Technology; IBM; Oracle; Data Matrix; SAS Institute Inc.; Clinigen Group; and UnitedHealth Group; among others. Some of the key strategies adopted by market players include new product development, strategic partnerships and collaborations, and investments.

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Global Real-world Evidence (RWE) Solutions Market Segmentation

This report by Medi-Tech Insights provides the size of the global real-world evidence (RWE) solutions market at the regional- and country-level from 2023 to 2030. The report further segments the market based on component, application, and end user.

Market Size & Forecast (2023-2030), By Component, USD Million

• Services
• Data Sets
• Claims Data
• Clinical Settings Data
• Patient-Powered Data
• Pharmacy Data

Market Size & Forecast (2023-2030), By Application, USD Million

• Drug development & approvals
• Medical device development & approvals
• Post-market safety & adverse events monitoring
• Reimbursement/coverage and regulatory decision making

Market Size & Forecast (2023-2030), By End User, USD Million

• Healthcare Companies (Pharmaceutical, Biopharmaceutical, Medical Devices)
• Healthcare Payers
• Healthcare Providers
• Others

Market Size & Forecast (2023-2030), By Region, USD Million

• North America
• US
• Canada
• Europe
• UK
• Germany
• France
• Italy
• Spain
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Rest of Asia Pacific
• Latin America
• Middle East & Africa

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