The Real-world Evidence (RWE) Solutions Market is expected to reach $4.9 billion by 2029, at a CAGR of 11.8% from 2022 to 2029. Real-world evidence (RWE) is clinical evidence gathered via RWD analysis on the use and potential benefits or risks of a medical product. 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). RWE has several applications, including drug development life cycles, shortening development timelines, reducing the costs of clinical trials, and improving the probability of technical and regulatory success. The growing amount of big data in healthcare, shift from volume to value-based care, and rising focus on personalized healthcare are expected to positively impact the RWE solutions market.
Artificial Intelligence (AI) integration in RWE solutions: Current Industry Trend
Pharma companies are increasingly adopting AI-integrated RWE solutions that offer predictive models, machine/deep learning, probabilistic causal models, and unsupervised algorithms to characterize patients and establish matching techniques to compare groups of patients with related characteristics. AI-integrated RWE solutions enable pharma companies to derive deeper insights from rich patent data sets, better understand outcomes, drug performance, and differentiation at the subpopulation level, and generate hypotheses at scale across multiple therapies, comparisons, and endpoints.
An AI-integrated RWE analytics platform that delivers smart data processing, analysis, and outcomes offers an unparalleled opportunity to capitalize on these computing advancements. When used as part of an overall comprehensive RWE strategy, AI innovations can enhance drug development, improve patient treatment and access, and drive valuable new business opportunities.
The FDA continues to develop its regulations and guidelines in an effort to keep up with emerging digital health and data analytics trends. For instance, In January 2022, the FDA issued draft guidance on real-world evidence related to data sources, data standards, and regulatory considerations to promote understanding and use of RWD and RWE in the regulatory processes.
Similarly, in December 2021, the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH) issued draft guidance on the use of “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” which describes the use of computing platforms, software, and sensors to facilitate remote data acquisition during clinical investigations.
Many companies operating in the RWE market are taking various initiatives to integrate AI technology into their RWE solutions. For instance, in October 2021, Syneos Health, Inc. (U.S.) acquired RxDataScience (U.S.), a healthcare-focused data analytics, AI, and data management company. This acquisition was aimed at offering biopharmaceutical customers technology-enabled, insights-powered solutions to accelerate performance across the product lifecycle. RxDataScience’s product lifecycle solutions include scientific computing for R&D, decentralized trials, patient journey, RWE, predictive analytics, and commercial market research. Furthermore, RxDataScience provides an accelerated consulting-based model with an iterative approach to rapidly develop and deliver advanced analytics solution prototypes in six-to-eight-week sprints. The acquisition brings advanced solutions that range from basic reporting to sophisticated Augmented Intelligent Insights and Biopharma Analytics platforms.
Similarly, in September 2020, Parexel International Corporation (U.S.) acquired the Natural Language Processing (NLP) technology assets and completed the transfer of key personnel of Roam Analytics, Inc. (U.S.), a healthcare software company. This strategic move strengthened Parexel’s commitment to leveraging Artificial Intelligence (AI) and Machine Learning (ML) to drive innovations across drug development and life sciences. The acquisition also enhanced Parexel’s Pharmacovigilance and other Real-world data capabilities by utilizing NLP technology across the company’s various data sets to further streamline and extract insights from unstructured data.
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Key Findings in the RWE Solutions Market Study
Datasets Generated Larger Proportion of Revenue Compared to Consulting Services
The datasets segment is estimated to account for the largest share of the RWE solutions market in 2022. The large market share of this segment is attributed to the increasing need for additional insights on epidemiology, compliance, adherence, and costs in a realistic environment, the growing amount of medical data generated in hospitals, increasing dependence of outcome-based studies on real-world data, and rising demand for information regarding drug safety among payers, regulatory bodies, and providers.
Market Access & Reimbursement/Coverage Decisions to Dominate the Market
The market access & reimbursement/coverage decisions segment is estimated to account for the largest share of the RWE solutions market in 2022. The large market share of this segment is attributed to increasing demand for real-world data and real-world evidence to accelerate market access & reimbursement/coverage decisions, increasing investments by biopharmaceutical companies in R&D, and the growing inclination of regulatory bodies towards the use of real-world evidence (RWE).
Pharmaceutical & Medical Device Companies Segment to Account for the Largest Share of the RWE Solutions Market in 2022
The pharmaceutical & medical device companies segment is expected to account for the largest share of the RWE solutions marketin 2022. The large market share of this segment is attributed to the increasing relevance of RWE studies in drug development & approvals and assessing drug performance in real-world settings and the growing need to avoid costly drug recalls.
Asia-Pacific: Fastest-growing Regional Market
North America is expected to account for the largest share of the global RWE solutions market in 2022, followed by Asia-Pacific, Europe, Latin America, and the Middle East & Africa. However, Asia-Pacific is slated to register the fastest growth rate. The growth of this regional market is driven by the growing demand for data defining the value and effectiveness of medicines, the increasing need for conducting real-world studies in drug R&D, and the rising government initiatives for promoting the use of real-world studies for regulatory decision-making.
Key Players
The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market players from last four years. The key players profiled in the global RWE solutions market report include Anthem, Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), ICON plc (Ireland), IQVIA (U.S.), Oracle Corporation (U.S.), PAREXEL International Corporation (U.S.), PerkinElmer, Inc. (U.S.), PPD, Inc. (U.S.), SAS Institute Inc. (U.S.), UnitedHealth Group Incorporated (U.S.), and Flatiron Health (U.S.).
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 Services
(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)
(Note1 — 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
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe (RoE)
- Asia-Pacific (APAC)
- Japan
- China
- India
- South Korea
- Taiwan
- Singapore
- Rest of Asia-Pacific (RoAPAC)
- Latin America
- Middle East & Africa
Key questions answered in the report: