The U.S. RWE Solutions Market is expected to grow at a CAGR of 13.1% from 2022 to 2029 to reach $2.22 billion by 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, 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. Rapidly growing big data in healthcare, shift from volume to value-based care, and rising focus towards personalized healthcare have been considered to have a positive impact on the U.S. RWE solutions market.
The key players operating in the U.S. RWE solutions market experienced an initial shrinkage 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. However, after initial shrinkage, the adoption of real-world evidence (RWE) is rising to fight against the COVID-19 outbreak.
Healthcare professionals are working tirelessly on faster diagnosis, rapid response, and effective use of human resources, and ensuring medical personnel's safety. As the COVID-19 outbreak continues to take its toll on U.S. markets, real-world evidence (RWE) is the most influential emerging technology to fight against the COVID-19 outbreak. Real-world evidence is becoming an essential tool in trying to suppress COVID-19.
There is growing interest in whether non-randomized real-world evidence (RWE) can be used to supplement RCT evidence and aid in clinical decision-making but concerns about non-randomized RWE have been highlighted by a proliferation of RWE studies on medications and COVID-19 outcomes with widely varying conclusions. A systematic approach to generating information to support clinical and public health decision-making is needed. Real-world data (RWD) captured directly from patients or through medical claims or electronic medical records (EMRs) have the potential to support clinical decision-making.
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Datasets Generated Larger Proportion of Revenue Compared to Consulting and Analytics
The datasets segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. The large share of this segment is primarily 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 expected to account for the largest share of the U.S. RWE solutions market in 2022. The large share of this segment is primarily attributed to the increasing demand for real-world data and real-world evidence to accelerate drug discovery and development, increasing investments by biopharmaceutical companies in R&D, and the growing inclination of regulatory bodies towards the use of real-world evidence (RWE).
Real-world data (RWD) is being increasingly considered by both industry and payers in the U.S. Payers use the data to support coverage decisions, develop guidelines and decision support tools for use in clinical practice, generate estimates of the potential population they cover that could require the treatment, and estimate potential costs and cost offsets.
Pharmaceutical & Medical Device Companies Segment is Expected to Account for the Largest Share in the U.S. RWE solutions market
The pharmaceutical & medical device companies segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. The large share of this segment is mainly attributed increasing importance of RWE studies in drug development & approvals, and the growing need to avoid costly drug recalls and assess drug performance in real-world settings.
The healthcare landscape continues to shift from volume to value-based care and is continuously developing. Pharmaceutical companies have been looking for new ways to provide the best treatments for patients. Real-world evidence helps understand real-life clinical practices and actual health outcomes of drugs. 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.
Key Players
The report includes a competitive landscape based on extensive assessment of the key strategic developments that led market participants to adopt over the past four years. The key players profiled in the U.S. RWE solutions market report includes Anthem, Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), ICON plc (Ireland), IQVIA HOLDINGS INC. (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, Inc. (U.S.).
Scope of the Report
U.S. RWE Solutions Market, by Component
U.S. RWE Solutions Market, by Application
U.S. RWE Solutions Market, by End User
Key questions answered in the report:
The U.S. RWE solutions market covers the market size & forecasts the various real-world evidence solutions offered by key market players to support pharmaceutical, biotechnology, and medical device companies, healthcare payers, healthcare providers, and other end-users in making key decisions majorly related to market access & reimbursement/coverage decisions, drug development & approvals, post-market surveillance, medical device development & approvals. TheU.S. RWE solutions market studied in this report involves the value analysis of various segments and sub-segments of RWE solutions providers in the U.S.
The U.S. RWE solutions market is projected to reach $2.22 billion by 2029, at a CAGR of 13.1% during the forecast period.
Based on component, the datasets segment is expected to account for the largest share of the U.S. RWE solutions market in 2022. The large share of this segment is primarily 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.
The drug development &approvals segment is estimated to register the fastest CAGR during the forecast period due to increasing demand for real-world data and real-world evidence to accelerate drug discovery and development, increasing investments by biopharmaceutical companies in R&D, and the growing inclination of regulatory bodies towards the use of real-world evidence (RWE).
Growing incidence of chronic & infectious diseases, delays in drug development and the subsequent increase in development costs, rising focus towards personalized healthcare, a shift from volume to value-based care, and rapidly growing big data in healthcare have been considered to have a positive impact on the U.S. RWE solutions market. Further, significant opportunities for existing market players and new entrants are provided by rising focus on end-to-end RWE services, and rising adoption of wearable devices and AI in RWE
Key companies operating in the U.S. RWE solutions market are Anthem, Inc. (U.S.), Clinigen Group plc (U.K.), Cognizant Technology Solutions Corporation (U.S.), IBM Corporation (U.S.), ICON plc (Ireland), IQVIA HOLDINGS INC. (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, Inc. (U.S.).
This report provides pre & post COVID-19 market estimates.
1. Introduction
1.1. Market Definition
1.2. Market Ecosystem
1.3. Currency
2. Research Methodology
2.1. Research Process
2.2. Data Collection & Validation
2.2.1. Secondary Research
2.2.2. Primary Research
2.3. Market Assessment
2.3.1. Market Size Estimation
2.3.1.1. Bottom-Up Approach
2.3.1.2. Top-Down Approach
2.3.1.3. Growth Forecast
2.3.2. Market Share Analysis
2.4. Assumptions for the Study
2.5. Limitations for the Study
3. Executive Summary
4. Market Insights
4.1. Market Overview
4.2. Drivers
4.2.1. Growing Burden of Chronic and Infectious Diseases
4.2.2. Rising Focus Towards Personalized Healthcare
4.2.3. Delays in Drug Development and the Subsequent Increase in Development Costs
4.2.4. Shift Towards Value-Based Care
4.2.5. Rapidly Growing Big Data in Healthcare
4.3. Restraints
4.3.1. Reluctance to Rely on Real-World Studies
4.4. Opportunities
4.4.1. Rising Focus on End-to-End RWE Services
4.4.2. Rising Adoption of Wearable Devices and Artificial Intelligence in RWE
4.5. Challenges
4.5.1. Lack of Standardized Methodologies to Develop RWE
4.6. Key Market Trends
4.6.1. Growing Adoption of RWE in Drug Development and Commercialization
4.6.2. Rising Number of Consolidations
4.6.3. Improved Patient Outcomes and Value Creation from Real-World Evidence
4.7. Impact Assessment of COVID-19 on the U.S. RWE Solutions Market
5. Regulatory Analysis – U.S. Real-World Evidence (RWE) Solutions Market
6. Pricing Models (EMR/Genomic/Integrated Datasets)
6.1. Introduction
6.2. Pay Per Patient Record (Volume-Based Pricing)
6.3. Pay Per Usage (Value-Based Pricing)
6.4. Annual Subscription
7. U.S. Real-World Evidence Solutions Market, by Component
7.1. Introduction
7.2. Datasets
7.2.1. Disparate Datasets
7.2.1.1. EMR/EHR/Clinical Data
7.2.1.2. Claims & Billing Data
7.2.1.3. Pharmacy Data
7.2.1.4. Product/Disease Registries Data
7.2.1.5. Other Disparate Datasets
7.2.2. Integrated Datasets
7.3. Consulting & Analytics
8. U.S. Real-World Evidence Solutions Market, by Application
8.1. Introduction
8.2. Market Access & Reimbursement/Coverage Decisions
8.3. Drug Development & Approvals
8.3.1. Oncology
8.3.2. Neurology
8.3.3. Immunology
8.3.4. Cardiovascular Diseases
8.3.5. Other Therapeutic Areas
8.4. Medical Device Development & Approvals
8.5. Post-Market Surveillance
8.6. Other Applications
9. U.S. Real-World Evidence Solutions Market, by End User
9.1. Introduction
9.2. Pharmaceutical, Biotechnology, and Medical Device Companies
9.3. Healthcare Payers
9.4. Healthcare Providers
9.5. Other End Users
10. Competitive Landscape
10.1. Introduction
10.2. Key Growth Strategies
10.3. Competitive Benchmarking
10.4. Market Share Analysis (2020)
10.4.1. IQVIA Holdings, Inc. (U.S.)
10.4.2. ICON plc (Ireland)
10.4.3. PPD, Inc. (U.S.)
11. Company Profiles (Business Overview, Financial Overview, Solution Portfolio, Strategic Developments)
11.1. Anthem, Inc.
11.2. Clinigen Group plc.
11.3. Cognizant Technology Solutions Corporation
11.4. ICON plc
11.5. IQVIA HOLDINGS INC.
11.6. Oracle Corporation
11.7. PAREXEL International Corporation
11.8. PerkinElmer, Inc.
11.9. PPD, Inc.
11.10. SAS Institute Inc.
11.11. UnitedHealth Group Incorporated
11.12. Flatiron Health, Inc.
List of Tables
Table 1 U.S. Real-World Evidence Solutions Market Drivers: Impact Analysis (2022-2029)
Table 2 Total Per-Study Cost (In Usd Million), by Phase and Therapeutic Area
Table 3 Sources of Healthcare Data
Table 4 U.S. Real-World Evidence Solutions Market Restraints: Impact Analysis (2022-2029)
Table 5 Observed Indicative Prices of Real-World Data by Type (USD Per Patient Record)
Table 6 U.S. Real-World Evidence Solutions Market Size, by Component, 2012–2029 (USD Million)
Table 7 U.S. Real-World Evidence Datasets Market Size, by Type, 2020–2029 (USD Million)
Table 8 U.S. RWE Disparate Datasets Market Size, by Type, 2020–2029 (USD Million)
Table 9 U.S. Real-World Evidence Solutions Market Size, by Application, 2020–2029 (USD Million)
Table 10 U.S. RWE Solutions Market Size for Drug Development & Approvals, by Therapeutic Area, 2020–2029 (USD Million)
Table 11 Estimated Number of New Cancer Cases in the U.S. (2019–2023)
Table 12 Medical Costs Associated With Cardiovascular Diseases (2010-2030) (USD Billion)
Table 13 Other Therapeutic Areas: Drugs in the R&D Pipeline
Table 14 U.S. RWE Solutions Market Size, by End User, 2020–2029 (USD Million)
Table 15 Recent Developments, by Company, 2018–2022
List of Figures
Figure 1 Key Stakeholders
Figure 2 Research Process
Figure 3 Key Secondary Sources
Figure 4 Primary Research Techniques
Figure 5 Key Executives Interviewed
Figure 6 Breakdown of Primary Interviews (Supply-Side & Demand-Side)
Figure 7 Market Size Estimation
Figure 8 U.S. Real-World Evidence Solutions Market, by Component, 2022 Vs. 2029 (USD Million)
Figure 9 U.S. Real-World Evidence Solutions Market, by Application, 2022 Vs. 2029 (USD Million)
Figure 10 U.S. Real-World Evidence Solutions Market, by End User, 2022 Vs. 2029 (USD Million)
Figure 11 Market Dynamics
Figure 12 Number of People in the U.S. With Chronic Conditions (2000–2030)
Figure 13 Percentage of Personalized Medicines Approved (2015-2020)
Figure 14 U.S. Real-World Evidence Solutions Market Size, by Component, 2022–2029 (USD Million)
Figure 15 U.S.: Number of E-Prescriptions, 2013–2020 (Billions)
Figure 16 U.S. Real-World Evidence Solutions Market Size, by Application, 2022–2029 (USD Million)
Figure 17 Dalys of Neurological Disorders in the U.S., 2010–2021 (In Thousands)
Figure 18 U.S.: Hepatitis A Virus (HAV) Infections, 2013–2020
Figure 19 U.S. Real-World Evidence Solutions Market Size, by End User, 2022–2029 (USD Million)
Figure 20 U.S. Pharmaceutical R&D Spending, 1980–2019 (USD Billion)
Figure 21 Key Growth Strategies Adopted by Leading Players (2018–2022)
Figure 22 U.S. Real-World Evidence Solutions: Competitive Benchmarking
Figure 23 Market Share Analysis: U.S. Real-World Evidence Solutions Industry (2021)
Figure 24 Anthem, Inc.: Financial Overview (2021)
Figure 25 Clinigen Group plc: Financial Overview (2021)
Figure 26 Cognizant Technology Solutions Corporation: Financial Overview (2021)
Figure 27 ICON plc: Financial Overview (2021)
Figure 28 IQVIA HOLDINGS INC.: Financial Overview (2021)
Figure 29 Oracle Corporation: Financial Overview (2021)
Figure 30 PerkinElmer, Inc.: Financial Overview (2022)
Figure 31 PPD, Inc.: Financial Overview (2020)
Figure 32 SAS Institute Inc.: Financial Overview (2021)
Figure 33 UnitedHealth Group Incorporated.: Financial Overview (2021)
This report provides pre & post COVID-19 market estimates.
This report provides pre & post COVID-19 market estimates.
Published Date: Aug-2023
Published Date: Jul-2023
Published Date: Dec-2022
Published Date: Jul-2022
