North America Real World Evidence Solutions Market Size, Share, and COVID-19 Impact Analysis, By Component (Services and Data Sets), By Application (Drug Development & Approvals, Medical Device Development & Approvals, Reimbursement/Coverage & Regulatory Decision Making, and Post Market Safety & Adverse Events Monitoring), and North America Real World Evidence Solutions Market Insights, Industry Trend, Forecasts to 2035

North America Real World Evidence Solutions Market Size Insights Forecasts to 2035

• The North America Real World Evidence Solutions Market Size Was Estimated at USD 1226.2 Million in 2024.
• The Market Size is Growing at a CAGR of 7.54% between 2025 and 2035.
• The North America Real World Evidence Solutions Market Size is Anticipated to Reach USD 2728.8 Million by 2035.

According to a Research Report Published by Spherical Insights & Consulting, The North America Real World Evidence Solutions Market Size is anticipated to Hold USD 2728.8 Million by 2035, Growing at a CAGR of 7.54 % from 2025 to 2035. The North America Real World Evidence Solutions market offers strong opportunities driven by expanding clinical data integration, rising demand for personalized medicine, AI-enabled analytics, and growing regulatory acceptance of RWE to support drug development and healthcare decisions.

Market Overview

The North America real world evidence (RWE) solutions market is experiencing robust growth as healthcare providers, pharmaceutical companies, and regulators increasingly rely on real-world data to enhance clinical decision-making. The region benefits from advanced healthcare IT infrastructure, strong electronic health record adoption, and a high volume of patient data generated across hospitals, insurers, and research organizations. RWE solutions are widely used to optimize drug development, improve post-market surveillance, support value-based care models, and assess long-term treatment outcomes. Additionally, growing collaboration between technology firms and life sciences companies is accelerating innovation in analytics platforms. As precision medicine and outcome-based reimbursement models expand, the demand for accurate, data-driven insights is expected to significantly strengthen the market’s future outlook.

Report Coverage

This research report categorizes the market for the North America real world evidence solutions market based on various segments and regions and forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the North America real world evidence solutions market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the North America real world evidence solutions market.

Driving Factors

Key driving factors for the North America Real World Evidence (RWE) Solutions market include the increasing need for real-time data to improve clinical outcomes and support value-based healthcare models. The region’s strong digital health ecosystem, widespread EHR adoption, and growing volumes of patient-generated data enable more accurate analysis. Pharmaceutical companies are rapidly integrating RWE to enhance drug development efficiency, reduce trial costs, and improve regulatory submissions. Additionally, rising demand for personalized medicine and advanced analytics technologies further accelerates market expansion.

Restraining Factors

Restraining factors include data privacy concerns, interoperability challenges between healthcare systems, and limited standardization in data collection. High implementation costs and reluctance among some providers to adopt advanced digital solutions also hinder wider adoption of real world evidence solutions across North America.

Market Segmentation

The North America real world evidence solutions market share is classified into component and application.

• The Services segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America Real World Evidence Solutions market is segmented by component into services and data sets. Among these, the services segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. This dominance is driven by the rising demand for advanced analytics, consulting support, regulatory compliance services, and customized real-world evidence generation. Pharmaceutical companies, CROs, and healthcare providers increasingly rely on specialized service providers to manage complex data, generate insights, and support clinical decision-making, driving continued growth in this segment.

• The drug development & approvals segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America real world evidence solutions market is segmented by application into drug development & approvals, medical device development & approvals, reimbursement/coverage & regulatory decision making, and post market safety & adverse events monitoring. Among these, the drug development & approvals segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. The segment’s dominance is driven by the increasing use of real-world data to support clinical trial design, accelerate regulatory approvals, reduce development costs, and enhance evidence generation for precision therapies. Growing FDA support for RWE-based submissions and rising adoption among pharmaceutical and biotech companies further fuel the segment’s growth.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the North America real world evidence solutions market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Syneos Health
• PAREXEL
• IQVIA Holdings Inc
• PerkinElmer
• Medpace Holdings Inc
• Icon PLC
• Thermo Fisher Scientific Inc
• International Business Machines Corp

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at North America, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the North America real world evidence solutions market based on the following segments:

North America Real World Evidence Solutions Market, By Component

• Services
• Data Sets

North America Real World Evidence Solutions Market, By Application

• Drug Development & Approvals
• Medical Device Development & Approvals
• Reimbursement/Coverage & Regulatory Decision Making
• Post Market Safety & Adverse Events Monitoring