North America AI in Regulatory Affairs Market Size, Share, and COVID-19 Impact Analysis, By Component (Software / Platforms and Services), By Deployment Mode (Cloud-Based and On Premises), By Application (Regulatory Intelligence, Dossier Management, Document Management, and Others), By End Use (Pharmaceutical Companies, Contract Research Organizations, and Biotechnology Companies), and North America AI in Regulatory Affairs Market Insights, Industry Trend, Forecasts to 2035

North America AI in Regulatory Affairs Market Insights Forecasts to 2035

• The Market Size is Expected to Grow at a CAGR of Around 19.67% from 2025 to 2035
• The North America AI in Regulatory Affairs Market Size is Expected to grow at a Significant Share by 2035

According to a research report published by Spherical Insights & Consulting, The North America AI In Regulatory Affairs Market Size Is Anticipated To Grow At A Significant Share by 2035, Growing At A CAGR Of 19.67% From 2025 To 2035. The AI in regulatory affairs market in North America is driven by escalating volume of multi-modal healthcare data and the intense pressure to reduce the high costs and lengthy timelines associated with traditional drug development

Market Overview

The North America AI In Regulatory Affairs Market is defined by the application of artificial intelligence (AI), machine learning machine learning (ML), natural language processing (NLP), and generative AI (GenAI) to manage the lifecycle of regulated products primarily in pharmaceuticals, biotech, and medical devices. It transforms the traditionally manual paper-pushing of compliance into a dynamic, data-driven workflow.

Since 2024, the market received a significant boost from proactive federal stances. In the U.S., the FDA moved beyond static guidelines, favouring a total product life cycle approach that accounts for the iterative nature of AI. Furthermore, the 2023 executive order on AI provided a roadmap for agencies to balance rapid innovation with patient safety. Health Canada has mirrored this by collaborating on international standards, ensuring that North America remains a unified, AI-friendly corridor for therapeutic entry. The focus has moved toward regulatory intelligence AI that doesn't just fill out forms, but actually predicts the likelihood of a submission's success.

Report Coverage

This research report categorises the North America AI In Regulatory Affairs Market Size based on various segments and regions, and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the North America AI in regulatory affairs market. Recent market developments and competitive strategies, such as expansion, product launch, 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 AI in regulatory affairs market.

Driving Factors

The North America AI In Regulatory Affairs Market Size is driven by a critical need for efficiency amidst escalating global compliance complexity, the escalating volume of multi-modal data, where traditional manual systems are no longer capable of processing the vast volumes of clinical, genomic, and real-world evidence required for modern filings. Furthermore, the integration of Generative AI (GenAI) has revolutionised document lifecycle management, allowing for the automated drafting of complex dossiers and real-time tracking of shifting regulatory guidelines. This technological shift is strongly supported by proactive regulatory authorities, such as the FDA's internal deployment of AI tools for scientific review and the implementation of risk-based frameworks that provide a clear roadmap for industry adoption. By automating routine tasks like data extraction and pharmacovigilance, AI enables regulatory teams to pivot toward high-level strategy, ultimately reducing time-to-market while enhancing submission accuracy and inspection readiness in a highly competitive landscape.

Restraining Factors

The North America AI in Regulatory Affairs Market Size is constrained by factors such as data privacy and security concerns, as the highly sensitive nature of patient data makes the risk of breaches a critical barrier. Furthermore, the high cost of implementation, including the need for specialised infrastructure and expensive technical talent, limits entry for smaller organisations. The market also faces regulatory uncertainty, where emerging state-level laws frequently conflict with evolving federal guidance from the regulatory authorities in the North American region.

Market Segmentation

The North America AI in regulatory affairs market share is classified into component, deployment type, application, and end use.

• The software /platforms segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America AI In Regulatory Affairs is segmented by component into software/platforms and services. Among these, the software /platforms segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. Because of the need for integrated regulatory information management (RIM) systems. These platforms serve as the nerve centre for compliance, providing the foundational AI tools such as NLP and machine learning required to automate document drafting and track global regulatory changes.

• The cloud-based segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period. 

Based on the deployment type, the North America AI in regulatory affairs market is segmented into cloud-based and on-premises. Among these, the cloud-based segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period.  This is due to the need for scalability and real-time collaboration. Regulatory affairs require seamless data exchange between global teams, contract partners, and health authorities. Cloud deployment offers the flexibility to handle massive clinical datasets without the prohibitive costs of maintaining physical server banks.

• The regulatory intelligence segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America AI In Regulatory Affairs Market Size is segmented by application into regulatory intelligence, dossier management, document management, and others. Among these, the regulatory intelligence segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. This is due to frequent policy updates (such as the FDA’s new AI guidances), companies have prioritised AI tools that can monitor, interpret, and map global regulatory changes in real-time. And the high risk of non-compliance has made predictive intelligence the most valuable and high-revenue application.

• The pharmaceutical segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period. 

Based on the end user, the North America AI in regulatory market is segmented into pharmaceutical companies, contract research organisations, and biotechnology companies. Among these, the pharmaceutical segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period.  possess the massive research and development budgets and the highest volume of global submissions, making them the primary adopters of enterprise-scale AI.

Competitive Analysis:

The report offers the appropriate analysis of the key organisations/companies involved within the North America 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 elaborate 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

• IQVIA
• Clarivate
• ArisGlobal
• Veeva Systems
• Celegnce
• RedgDesk
• Elsevier
• Rimsys
• Ritivel
• Scoop
• Weave Bio

Key Target Audience

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

Recent Developments:

• In November 2025, Aris Global launched NavaX Agents (agentic AI for safety and regulatory) and NavaX Translation, which uses domain-specific LLMs to handle multi-country submission localisations.

• In October 2025, Veeva launched a suite of AI Agents across its Vault platform. By 2026, these agents became central to Vault RIM (Regulatory Information Management), helping automate the drafting of clinical study reports and managing global submission content.

Market Segment

This study forecasts revenue at the North America, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the North America AI in regulatory affairs market based on the below-mentioned segments:

North America AI in Regulatory Affairs Market, By Component

• Software / Platforms
• Services

North America AI in Regulatory Affairs Market, By Deployment Mode

• Cloud-Based
• On Premises

North America AI in Regulatory Affairs Market, By Application

• Regulatory Intelligence
• Dossier Management
• Document Management
• Others

North America AI in Regulatory Affairs Market, By End Use

• Pharmaceutical Companies
• Contract Research Organisations
• and Biotechnology Companies