Number of pages: 100 | Report Format: PDF | Published date: March 13, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 1.7 billion |
Revenue forecast in 2031 |
US$ 5 billion |
CAGR |
14.4% |
Base Year for Estimation |
2022 |
Forecast Period |
2023-2031 |
Historical Year |
2021 |
Segments Covered |
Component, Application, End-user, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global real-world evidence solutions market was valued at US$ 1.7 billion in 2022 and is expected to register a revenue CAGR of 14.4% to reach US$ 5 billion by 2031.
Real-world Evidence Solutions Market Fundamentals
Real-world evidence solutions refer to methods, techniques, and technologies used to generate, collect, analyze, and interpret data from real-world settings and patients outside traditional clinical trials. These solutions provide insights into patient outcomes, treatment effectiveness, safety, and healthcare utilization to inform clinical decision-making, regulatory decisions, and healthcare policy. Real-world evidence solutions can include various data sources, such as electronic health records (EHRs), claims and billing data, patient-generated data, registries, social media, and other online sources, and analytics tools, such as machine learning, natural language processing, and data visualization.
The real-world evidence solutions market is expected to grow rapidly in the coming years due to the increasing demand for real-world evidence-based insights to inform clinical decision-making, regulatory decisions, and healthcare policy. The market for real-world evidence solutions includes various stakeholders, such as pharmaceutical and medical device companies, payers, healthcare providers, and regulatory agencies. Pharmaceutical and medical device companies are the largest users of real-world evidence solutions, as they seek to better understand the safety and effectiveness of their products in real-world settings. Payers and healthcare providers use real-world evidence solutions to evaluate treatment outcomes, identify areas for improvement, and inform reimbursement decisions.
North America is expected to account for the largest revenue share of the real-world evidence solutions market, followed by Europe and Asia Pacific. This is due to the presence of many pharmaceutical and medical device companies, favorable regulatory policies, and advanced healthcare infrastructure in these regions.
The market is driven by the increasing demand for real-world evidence-based insights to inform healthcare decision-making and improve patient outcomes. As healthcare stakeholders increasingly recognize the value of real-world evidence solutions, the market is expected to continue growing and evolving in the coming years.
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Real-world Evidence Solutions Market Dynamics
Real-world evidence is being integrated into the clinical trial design to supplement traditional clinical trial data with real-world data. This is helping to improve trial efficiency, reduce costs, and accelerate drug development timelines, driving the revenue growth of the real-world evidence solutions market. The increase in the adoption of EHRs is boosting the amount of health data available for analysis. Real-world evidence solutions enable healthcare providers to use this data to improve patient outcomes and reduce costs. AI and machine learning are increasingly used in real-world evidence solutions to analyze large datasets and identify patterns and trends. These technologies can help identify new treatment options, optimize treatment pathways, and improve patient outcomes.
The adoption of patient-centered care, which involves tailoring treatment plans to individual patients based on their specific needs and preferences, is rising in the past few years. Real-world evidence solutions enable healthcare providers to identify patient subgroups and develop personalized treatment plans. Regulatory agencies increasingly use real-world evidence to inform regulatory decision-making, particularly post-market safety monitoring and label expansions. For instance, the FDA’s 21st Century Cures Act encourages using real-world evidence in regulatory decision-making.
However, the data sources for real-world evidence solutions are often incomplete, inaccurate, and inconsistent, restricting the revenue growth of the real-world evidence solutions market. Moreover, concern over data privacy and security is hindering the revenue growth of the real-world evidence solutions market. Real-world Evidence Solutions require significant infrastructure, technology, and personnel investment. The high cost of implementing these solutions can also restrain the adoption of real-world evidence solutions.
Real-world Evidence Solutions Market Ecosystem
The global real-world evidence solutions market is analyzed from four perspectives: component, application, end-user, and region.
Real-world Evidence Solutions Market by Component
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Based on the component, the global real-world evidence solutions market is segmented into services and data sets.
The services segment dominated the real-world evidence solutions market with the largest revenue share in 2022. Real-world evidence solutions require various services, including consulting, data collection, analysis, and interpretation. Service providers in the real-world evidence solutions market have the expertise and resources to help healthcare providers and pharmaceutical companies use real-world evidence to make informed decisions. Many healthcare providers and pharmaceutical companies lack the necessary infrastructure and resources to carry out real-world evidence solutions in-house. Thus, they rely on third-party vendors to provide the services needed to effectively implement and utilize real-world evidence solutions, propelling segmental growth. Service providers in the real-world evidence solutions market are often at the forefront of innovation. They are continuously developing new and advanced solutions to meet the evolving needs of the healthcare industry, increasing the demand for real-world evidence services. Outsourcing real-world evidence solutions services to third-party vendors can be more cost-effective than building an in-house team, fueling segment growth.
Real-world Evidence Solutions Market by Application
Based on the application, the global real-world evidence solutions market is segmented into drug development and approvals, post-market surveillance, market access reimbursement/coverage decision-making, and clinical and regulatory decision-making.
The drug development and approvals segment accounted for a significant revenue share of the real-world evidence solutions market in 2022. The drug development and approvals segment is further sub-segmented into neurology, oncology, cardiovascular disease, immunology, cardiovascular disease, other therapeutic areas, and medical device development and approvals. The pharmaceutical sector operates in a heavily regulated environment, where obtaining regulatory approval for new drugs is time-consuming, intricate, and costly. Real-world evidence is a crucial resource in providing supplementary evidence to clinical trials, offering valuable insights into the actual effectiveness of a drug, thus becoming vital in securing regulatory approvals. Furthermore, the pharmaceutical sector represents a substantial and expanding market that demands novel solutions to enhance patient outcomes. Consequently, pharmaceutical firms are inclined to invest in real-world evidence solutions to enhance their competitiveness and increase the likelihood of obtaining regulatory approval. The drug development and approvals segment of the real-world evidence solutions market has a strong ecosystem of providers, including data vendors, technology platforms, and analytics firms specializing in providing real-world evidence solutions to pharmaceutical companies. This creates a robust market with a diverse set of players and a range of offerings to meet the specific needs of pharmaceutical companies.
Real-world Evidence Solutions Market by End-user
Based on end-user, the global real-world evidence solutions market is segmented into pharmaceutical & medical device companies, healthcare providers, healthcare payers, and others.
The pharmaceutical & medical device companies segment accounted for the largest revenue share of the real-world evidence solutions market in 2022 as they primarily use real-world evidence solutions. These companies require real-world evidence to support a variety of use cases, such as drug development, clinical trial design, post-marketing surveillance, and commercialization. Pharmaceutical and medical device companies are highly regulated industries requiring extensive testing and clinical trials before drugs or medical devices can be approved. Real-world evidence can provide valuable insights into the real-world effectiveness of drugs and medical devices, supplementing the evidence generated from clinical trials, which is critical in gaining regulatory approval and increasing the demand for real-world evidence in pharma and medical device companies.
Real-world Evidence Solutions Market by Region
Geographically, the global real-world evidence solutions market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for a significant market revenue share in 2022. Real-world evidence solutions are becoming increasingly popular among healthcare stakeholders, including regulators, payers, and providers, due to their ability to provide access to extensive patient data. This data enables stakeholders to make well-informed decisions about healthcare products and services by identifying patterns and trends in patient outcomes. The widespread adoption of EHRs in North America has created a wealth of digital health data that can be utilized through real-world evidence solutions to improve patient outcomes and reduce healthcare costs. With a growing focus on patient-centric healthcare in North America, healthcare providers, and payers are looking for ways to tailor treatments and services to meet individual patient needs. Real-world evidence solutions can help providers and payers better understand patient needs and preferences, leading to more personalized care. The surge in investment in healthcare technology in North America has contributed to the increasing adoption of real-world evidence solutions. These solutions are now recognized as a critical component of healthcare technology, given their ability to unlock the value of patient data and improve healthcare outcomes.
Asia Pacific is expected to be the fastest-growing region during the forecast period due to the increasing burden of chronic diseases, such as diabetes and cancer, which require continuous monitoring and management. The region’s diverse patient population also provides ample data collection and analysis opportunities. The rapidly evolving healthcare infrastructure in Asia Pacific is becoming more digitized and connected. This has led to an increase in the amount of health data being generated, creating opportunities for developing real-world evidence solutions.
Real-world Evidence Solutions Market Competitive Landscape
The prominent players operating in the global real-world evidence solutions market are:
Real-world Evidence Solutions Market Strategic Developments
Real-world evidence solutions refer to methods, techniques, and technologies used to generate, collect, analyze, and interpret data from real-world settings and patients outside traditional clinical trials.
The prominent players operating in the global real-world evidence solutions market are IQVIA, IBM Corporation, Parexel International Corporation, PerkinElmer Inc., PPD, Inc., and Icon Plc.
In 2022, the global real-world evidence solutions market was valued at US$ 1.7 billion.
The services segment dominates the global real-world evidence solutions market.
North America accounts for the largest revenue share of the global market, followed by Europe; and Asia Pacific is the fastest-growing regional market for real-world evidence solutions.
*Insights on financial performance are subject to the availability of information in the public domain