U.S. Real World Evidence Solutions Market 2025 to Grow at 11.6 CAGR with 6.10 USD Billion  Market Size: Analysis and Forecasts 2033

Key Insights

The U.S. Real World Evidence Solutions Market size was valued at USD 6.10 USD Billion in 2023 and is projected to reach USD 13.15 USD Billion by 2032, exhibiting a CAGR of 11.6 % during the forecast period. Real World Evidence (RWE) Solutions stand for the use of methodologies based on data from the real world to provide results concerning the safety, effectiveness, and economic impacts of medical applications. Examples include EHRs, patient registries, and wearable devices that will be the key source data. Functions contain the implementation of an information security policy, data processing, and international regulations. For example, applications can include comparative effectiveness research, post-raid 1 subgenera surgery syndrome withdrawal marking surveillance, and adjustments during therapy. The demand for RWE solutions in the USA is on the rise for their capacity to complement clinical trial data, increase research effectiveness, and make evidence-based decisions in healthcare all while satisfying regulatory requirements set out by the country. 

U.S. Real-World Evidence Solutions Trends

• Increasing use of RWD in clinical research and regulatory decision-making
• Growing adoption of value-based care models
• Rising focus on patient-centricity
• Growing demand for personalized medicine
• Technological advancements in data collection and analysis

Driving Forces: What's Propelling the U.S. Real-World Evidence Solutions Market

• Increasing need for RWD to support regulatory decision-making: Regulatory agencies are increasingly requiring RWD to support new drug and device approvals, as well as label expansions.
• Rising adoption of value-based care models: Value-based care models reward providers for delivering high-quality care at a lower cost. RWD can be used to track patient outcomes and identify areas for improvement.
• Growing focus on patient-centricity: Patients are increasingly demanding a more personalized and patient-centered healthcare experience. RWD can be used to understand patient preferences and develop treatments that are tailored to their individual needs.

Challenges and Restraints in U.S. Real-World Evidence Solutions Market

• Data quality and integrity: RWD can be heterogeneous and inconsistent, which can pose challenges for data analysis and interpretation.
• Data privacy and confidentiality: RWD often contains sensitive patient information, which must be protected from unauthorized access and use.
• Lack of interoperability: RWD is often stored in different formats and systems, which can make it difficult to integrate and analyze.

Emerging Trends in U.S. Real-World Evidence Solutions

• Artificial intelligence (AI) and machine learning (ML): AI and ML are being used to develop new methods for collecting, analyzing, and interpreting RWD.
• Blockchain technology: Blockchain technology is being used to create secure and transparent systems for sharing RWD.
• Patient-generated data: Patient-generated data (PGD) is increasingly being used to supplement traditional sources of RWD.

Growth Catalysts in the U.S. Real-World Evidence Solutions Industry

• Government initiatives: The U.S. government is investing in RWE research and development, which is expected to drive the growth of the market.
• Industry collaborations: Pharmaceutical and medical device companies are partnering with RWE solution providers to develop new and innovative products and services.
• Growing demand for personalized medicine: The growing demand for personalized medicine is driving the need for RWD that can be used to develop tailored treatments for individual patients.

Leading Players in the U.S. Real-World Evidence Solutions Market

• IQVIA Inc. (U.S.) 
• IBM (U.S.)
• Cognizant (U.S.) 
• Syneos Health (U.S.) 
• Oracle (U.S.) 
• Optum Inc. (United Health Group) (U.S.) 
• Flatiron Health (F. Hoffmann-La Roche) (U.S.) 
• Thermo Fisher Scientific Inc. (U.S.) 
• Parexel International Corporation (U.S.)
• SAS Institute Inc. (U.S.) 
• Perkin Elmer Inc. (U.S.)

Significant Developments in the U.S. Real-World Evidence Solutions Sector

• May 2023: Flatiron Health expanded its RWE offerings to include scientific, analytical, and consulting services.
• March 2023: MediMergent announced the implementation of its digital clinical trials platform in national clinical trials. 
• May 2021: Optum, Inc. and Bassett Healthcare Network entered into a strategic collaboration to provide advanced analytical and IT solutions aimed at improving patient experience.

Comprehensive Coverage U.S. Real World Evidence Solutions Market Report

• Market size and forecast
• Market drivers, challenges, and restraints
• Market segmentation and analysis
• Competitive landscape
• Industry trends and developments
• Growth catalysts
• Regional Insights
• Key company profiles

Regional Insight

The U.S. is the largest market for RWE solutions, accounting for over 50% of the global market. The growth of the market in the U.S. is driven by the increasing demand for RWD to support regulatory decision-making, the rising adoption of value-based care models, and the growing focus on patient-centricity.

DROCs

• Drivers:
  • The escalating demand for Real-World Data (RWD) to bolster regulatory submissions and accelerate drug approvals.
  • The widespread shift towards value-based care models, necessitating robust RWD for demonstrating treatment effectiveness and cost-effectiveness.
  • An increasing emphasis on patient-centricity, driving the need for RWD to capture patient experiences and preferences.
  • Significant advancements in technology, particularly in artificial intelligence (AI) and machine learning (ML), enabling the efficient analysis of large, complex RWD datasets and unlocking previously inaccessible insights.
  • Growing investments from both public and private sectors in RWD infrastructure and analytics capabilities.
• Restraints:
  • Ensuring high data quality and integrity, including addressing issues of data completeness, accuracy, and consistency across diverse sources.
  • Maintaining strict adherence to data privacy regulations (e.g., HIPAA) and ensuring patient confidentiality, which requires robust data anonymization and security protocols.
  • Overcoming challenges in data interoperability, stemming from the heterogeneity of data formats and systems across healthcare organizations.
  • Improving patient engagement and participation in data collection and analysis, requiring clear communication and addressing concerns about data privacy and the potential for misuse.
  • The high cost associated with data acquisition, cleaning, and analysis, particularly for large-scale RWD studies.
• Opportunities:
  • Leveraging the power of artificial intelligence (AI) and machine learning (ML) to identify patterns, predict outcomes, and personalize treatments based on RWD insights.
  • Exploring the potential of blockchain technology to enhance data security, transparency, and interoperability within the RWD ecosystem.
  • Integrating patient-generated data (PGD), such as wearable sensor data and online health communities, to enrich RWD datasets and provide a more comprehensive view of patient health.
  • Fostering stronger collaboration among healthcare providers, researchers, technology companies, and regulatory agencies to establish standardized data formats, improve data quality, and accelerate the adoption of RWD in clinical practice and regulatory decision-making.
  • Development of innovative data governance frameworks and ethical guidelines to address privacy and security concerns related to RWD.
• Challenges:
  • Navigating the complex landscape of government regulations and compliance requirements related to the collection, use, and sharing of RWD.
  • Competing with established data sources, such as randomized controlled trials (RCTs) and electronic health records (EHRs), which may still be considered the gold standard in certain contexts.
  • Addressing ethical concerns related to data privacy, patient consent, and the potential for bias in RWD analysis, ensuring fair and equitable access to RWD insights.
  • Establishing robust methods for validating and generalizing findings derived from RWD to ensure their reliability and applicability to broader patient populations.

Pricing Analysis

The pricing of RWE solutions varies depending on the type of data, the size of the study, and the complexity of the analysis. However, the average cost of an RWE study is between USD 100,000 and USD 1 million.

Import And Export Analysis

The U.S. is a net importer of RWE solutions. The major import sources include the European Union, Canada, and Japan.

Segmentation

Type:

• Clinical Setting Data
• Claims Data
• Pharmacy Data
• Patient Powered Data
• Others

End-user:

• Pharmaceutical and Medical Device Companies
• Healthcare Payers
• Healthcare Providers
• Others

Patent/Trademark Analysis

There are a number of patents and trademarks related to RWE solutions. These include patents for methods of collecting, analyzing, and interpreting RWD, as well as trademarks for RWE solution products and services.