Real-World Evidence (RWE) Solutions Market Worth $4.4 Billion by 2028 - Exclusive Report by Meticulous Research®

REDDING, Calif., March 10, 2022 /PRNewswire/ -- According to a new market research report titled "Real-World Evidence (RWE) Solutions Market by Component (Datasets [Clinical, Claims, Pharmacy, Integrated], Services), Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers) - Global Forecast to 2028", published by Meticulous Research®, the Real-World Evidence (RWE) solutions market is expected to grow at a CAGR of 11.8% from 2021 to 2028 to reach $4.4 billion by 2028.

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Real-world evidence (RWE) is clinical evidence gathered via real-world data (RWD) analysis on a medical product's use and potential benefits or risks. RWE can be produced through various study designs or analyses, including but not limited to randomized trials, large simple trials, pragmatic trials, and observational studies (prospective or retrospective). For example, the role of RWE in drug development is expanding as RWE studies are significantly less costly and time-consuming than RCTs, providing easier access to long-term effectiveness data and helping overcome some of the feasibility barriers of running RCTs. RWE is regularly utilized in the drug development & approval process to inform aspects of drug development, such as the natural history and epidemiology of a disease, and provide data on treatment pathways and comparator interventions in clinical practice.

Real-world data (RWD) gathered from various sources associated with outcomes in a heterogeneous patient population in real-world settings. The analysis of the collected data generates real-world evidence, which, in turn, helps in retrospective studies and provides meaningful insights into unmet needs and the clinical and economic impacts on patients and healthcare systems. It also determines the outcomes based on much larger data samples, reduces costs, and improves the efficiency of clinical trials.

With the growing need for evidence generated from real-world data, the increasing importance of epidemiological data in decision making, and a shift from volume to value-based care, there has been an increased focus on patient registries, a rise in the adoption of EMR in hospitals, and exponential growth in mobile health data and social media which have resulted in the generation of huge amounts of medical data. In 2021, the real-world datasets segment accounted for the larger share of the overall real-world evidence solutions market.

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The pharmaceutical, biotech, and medical device industries are facing a list of unprecedented challenges led by the global economic crisis, coronavirus pandemic, and concerns about escalating healthcare costs. A series of well-publicized recalls, and regulatory settlements have left policymakers and consumers questioning the safety of medical products and their trust in manufacturers. The pressures are more significant in the oncological department, where high-cost agents with similar effects compete in the market. With rising challenges, healthcare payers are increasingly focused on evidence of clinical value for making market access & reimbursement/coverage decisions.

Payers infrequently used real-world evidence (RWE), or information on how treatments work in the real world, to guide their medication coverage and reimbursement decisions. RWE helps and provides a means for demonstrating value, ranging from confirming randomized trial benefits in real-world populations to a fuller characterization of resource impacts. In 2021, the market access & reimbursement/coverage decisions segment accounted for the largest share of the overall real-world evidence solutions market.

The healthcare landscape is continuously developing and shifting towards value-based care from volume-based care. Pharmaceutical companies have been looking for new ways to provide the best treatments for patients. Pharmaceutical companies are focusing on evidence to create a more holistic picture of a drug's value and demonstrate the newly developed drug's value outside of clinical trials. Real-world evidence helps in understanding real-life clinical practices and actual health outcomes of drugs. It also helps generate broader scientific evidence and commercial insights, valuable for the pharmaceutical industry. Pharmaceutical and biotech companies are increasingly utilizing real-world evidence for collecting real-time post-trial information about drugs, which helps healthcare providers and researchers understand the negative reactions, side effects, and medication errors related to the drugs, thereby enabling them to control the potential harm caused by the drugs.

Further, with the spread of the COVID-19 pandemic, immediate and long-term consequences have been both for people and health systems worldwide. Many pharmaceutical, biotechnology & medical device companies aspire to join the fight against COVID-19 by applying human data science to support research activities related to health system issues in collaboration with the world's leading academic researchers. The desire to drastically accelerate R&D, reinforced by a greater understanding of data science, has made the healthcare community more receptive to expanding the use of RWE beyond traditional safety-related applications. In 2021, the pharmaceutical, biotechnology, and medical device companies segment accounted for the largest share of the overall real-world evidence solutions market.

The increasing prevalence of chronic diseases, stringent regulations for drug approvals, implementation of the 21^st Century Cures Act, availability of electronic datasets, advanced healthcare industry, and rising big data in healthcare are the major factors responsible for the largest market share of North America. The 21^st Century Cures Act helped accelerate medical product development and brought innovations, and expanded the role of real-world evidence in the U.S. The FDA has already begun to incorporate RWE in regulatory decisions in the U.S. This act required the FDA to release a comprehensive plan to continue advancing these efforts. In September 2021, U.S. FDA released a guidance document for accessing EHR and medical claims data using real-world data to support regulatory decision-making for drug and biological products would promote the adoption of RWE even further.

In addition to this, increasing focus on drug development and easy drug approval also drives the country's real-world evidence solutions market. According to the Center for Drug Evaluation and Research (CDER), on average, 37 novel drugs per year were approved (including novel drugs, biosimilar, new formulations, and new dosage forms) between 2010 and 2019. The process of drug development requires evidence on population size, clinical disease progression, and adherence to similar therapies that can support decision-making.

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Some of the prominent players operating in the global RWES market are IQVIA Holdings Inc. (U.S.), ICON plc (Ireland), PPD, Inc. (U.S.), SYNEOS HEALTH, INC. (U.S.) , CLARIVATE PLC (U.S.), Medpace Holdings Inc. (U.S.), Symphony Innovation, LLC (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), and Flatiron Health (U.S.).

These companies are majorly focused on partnerships, collaborations, and agreements to accelerate the delivery of RWE datasets and consulting & analytics services and explore how real-world evidence can provide information for health technologies and improve clinical and cost-effectiveness. For instance, in April 2020, ICON plc (Ireland) signed a three-year agreement with Pfizer Inc. (U.S.), under which ICON provides expertise in the planning, execution, management, and conduct of clinical trials. Similarly, new solution launches & enhancements were the second most preferred strategy after partnerships, collaborations, and agreements in the market. New solution launches & enhancements enabled companies to broaden their product portfolios, advance the capabilities of existing products and services, and cater to the changing demands of users to ensure a competitive edge in the market. For instance, in May 2020, PAREXEL International Corporation (U.S.) launched the #KeepingPatientsFirst integrated real-world evidence (RWE) research platform focused on aggregating, analyzing, and predicting real-world COVID-19-related disease progression and outcomes using state-of-the-art machine learning, artificial intelligence, and analytics. Thus, the key players in the RWES market are focusing on organic & inorganic growth strategies, which will help them increase their market shares in the coming years.

Despite all positives, the key players experienced an initial shrinkage in the market due to uncertainties associated with the impact of the COVID-19 pandemic. The market shrinkage was mainly due to significant restrictions on travel in many countries, shifting resources on COVID-19 treatments in healthcare settings, and limited access to hospitals. This mainly affected the amount of real-world data generated globally. However, after initial shrinkage, real-world evidence (RWE) is set to become the most influential emerging technology to fight against the COVID-19 outbreak. Real-world evidence solutions can provide valuable insights to understand better, monitor, and prepare for the challenges caused by the COVID-19 pandemic. RWD has been used increasingly to map the progression of the disease and to discover vaccines and immediate treatments. Thus, the effectiveness of the use of RWD made a significant impact during the pandemic and continues to play a more significant role in the treatment of infection.

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Scope of the Report

RWE Solutions Market, by Component

• Datasets
• Disparate Datasets
• EMR/EHR/Clinical Data
• Claims & Billing Data
• Pharmacy Data
• Product/Disease Registries Data
• Other Disparate Datasets
• Integrated Datasets
• Consulting & Analytics

(Note: Other Disparate Datasets include data generated from mobile devices, wearable devices, and social media)

RWE Solutions Market, by Application

• Market Access & Reimbursement/Coverage Decisions
• Drug Development & Approvals
• Oncology
• Neurology
• Immunology
• Cardiovascular Diseases
• Other Therapeutic Areas
• Post Market Surveillance
• Medical Device Development & Approvals
• Other Applications
  (Note: Other Therapeutic Areas include infectious diseases, musculoskeletal disorders, dermatological diseases, and respiratory diseases, Other Applications include regulatory and clinical decision-making)

RWE Solutions Market, by End User

• Pharmaceutical, Biotechnology, and Medical Device Companies
• Healthcare Payers
• Healthcare Providers
• Other End Users 
  (Note: Other end-users include academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies)

RWE Solutions Market, by Geography

• North America
• U.S.
• Canada
• Europe
• Germany
• France
• U.K.
• Italy
• Spain
• Rest of Europe (RoE)
• Asia-Pacific (APAC)
• Japan
• China
• India
• South Korea
• Taiwan
• Singapore
• Rest of APAC (RoAPAC)
• Latin America
• Middle East & Africa

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Related Report-

U.S. Real-World Evidence (RWE) Solutions Market by Component [Datasets (Clinical, Claims, Pharmacy, Integrated), Services], Application (Market Access, Oncology, Neurology, Post Market Surveillance), End User (Pharma Companies, Providers) - Forecast to 2028

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