미국의 규제 컨설팅 아웃소싱 서비스 시장 규모, 점유율 및 동향 분석 보고서 : 카테고리별, 적응증별, 최종 용도별, 기업 규모별, 부문 예측(2025-2033년)

U.S. Regulatory Consulting Outsourcing Services Market Summary

The U.S. regulatory consulting outsourcing services market size was estimated at USD 414.9 million in 2024 and is projected to reach USD 875.1 million by 2033, growing at a CAGR of 8.15% from 2025 to 2033. The market growth is driven by increasing regulatory complexity from the FDA and global agencies, cost savings compared to maintaining internal teams, and the need for rapid innovation in drug and device development, which requires faster approvals.

Other factors contributing to market growth include the growing adoption of digital compliance tools, such as RIM and eCTD, as well as market expansion that demands multi-region regulatory alignment and expertise. Such factors are expected to drive the market growth. The rapid expansion of research and development (R&D) activities in the U.S. pharmaceutical, biotechnology, and medical technology (MedTech) sectors is expected to boost the U.S. regulatory consulting outsourcing industry. The rising presence of pharmaceutical, biotechnology, and medical device companies has led to increased investments in innovative drugs, biologics, and advanced medical technologies, making regulatory submissions more complex. This surge in R&D initiatives has caused companies to depend more on consulting firms to navigate the evolving U.S. regulatory consulting outsourcing industry, thereby driving strong growth in outsourcing requirements and market revenue.

In addition, in the country, regulatory requirements have shifted from a primarily operational and compliance-driven discipline to a dynamic, strategic role that is critical to the success of pharmaceutical, biotechnological, and medical device development. This shift has increased the complexity of the regulatory landscape in the U.S. regulatory consulting outsourcing industry, which is expected to drive the requirement for regulatory consulting services.

Currently, the U.S. regulatory consulting outsourcing industry is becoming more fragmented with requirements at both federal and state levels. As a result, companies must comply with various Food and Drug Administration (FDA) divisions, such as those overseeing drugs, biologics, and medical devices, while also addressing evolving guidelines on labeling, advertising, and post-market surveillance. Furthermore, for most companies, maintaining in-house regulatory expertise across all product categories is becoming increasingly complex and costly, driving the need for outsourcing services.

Furthermore, the rapid growth of research and development (R&D) activities in the U.S. pharmaceutical, biotechnology, and medical technology (MedTech) sectors is expected to boost the expansion of the U.S. regulatory consulting outsourcing services industry. The increasing presence of pharmaceutical, biotechnology, and medical device companies has led to increased investments in innovative drugs, biologics, and advanced medical technologies, complicating regulatory submissions more complex. This surge in R&D initiatives has prompted companies to depend more on consulting firms to navigate the evolving U.S. regulatory landscape, thereby driving strong growth in outsourcing demand and market revenue. These factors are expected to drive the market growth over the estimated time period.

U.S. Regulatory Consulting Outsourcing Services Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each sub-segment from 2021 to 2033. For this study, Grand View Research has segmented the U.S. regulatory consulting outsourcing services market report based on category, indication, end use, and company size.

• Category Outlook (Revenue, USD Million, 2021 - 2033)
• Drugs
• Biologics
• Medical Devices
• Indication Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Neurology
• Cardiology
• Immunology
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Biotechnology Companies
• Pharmaceutical Companies
• Medical Device Companies
• Company Size Outlook (Revenue, USD Million, 2021 - 2033)
• Small
• Medium
• Large

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Category
  • 1.2.2. Indication
  • 1.2.3. End Use
  • 1.2.4. Company Size
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Top-Down Analysis
  • 1.7.3. Bottom-Up Approach
  • 1.7.4. Multivariate Analysis
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Regulatory Consulting Outsourcing Services Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Increasing Regulatory Complexity
    • 3.2.1.2. Expansion of U.S. pharma, Biotechnology, and MedTech R&D Pipelines
    • 3.2.1.3. Cost Optimization through External Regulatory Expertise
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Data Security and Confidentiality Concerns
    • 3.2.2.2. Regulatory and Communication Barriers
• 3.3. Business Model Analysis
• 3.4. Pricing Model Analysis
• 3.5. Technological Advancements
• 3.6. Regulatory Framework
• 3.7. Geopolitical & Regulatory Impact Assessment
• 3.8. Market Analysis Tools
  • 3.8.1. Porter's Five Force Analysis
  • 3.8.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Regulatory Consulting Outsourcing Services Market: Category Estimates & Trend Analysis

• 4.1. U.S. Regulatory Consulting Outsourcing Services Market, By Category: Segment Dashboard
• 4.2. U.S. Regulatory Consulting Outsourcing Services Market, By Category: Movement Analysis
• 4.3. U.S. Regulatory Consulting Outsourcing Services Market Estimates & Forecasts, By Category, 2021 - 2033 (USD Million)
• 4.4. Drugs
  • 4.4.1. Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Biologics
  • 4.5.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Medical Devices
  • 4.6.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Regulatory Consulting Outsourcing Services Market: Indication Estimates & Trend Analysis

• 5.1. U.S. Regulatory Consulting Outsourcing Services Market, By Indication: Segment Dashboard
• 5.2. U.S. Regulatory Consulting Outsourcing Services Market, By Indication: Movement Analysis
• 5.3. U.S. Regulatory Consulting Outsourcing Services Market Estimates & Forecasts, By Indication, 2021 - 2033 (USD Million)
• 5.4. Oncology
  • 5.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Neurology
  • 5.5.1. Neurology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Cardiology
  • 5.6.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Immunology
  • 5.7.1. Immunology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Others
  • 5.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Regulatory Consulting Outsourcing Services Market: End Use Estimates & Trend Analysis

• 6.1. U.S. Regulatory Consulting Outsourcing Services Market, By End Use: Segment Dashboard
• 6.2. U.S. Regulatory Consulting Outsourcing Services Market, By End Use: Movement Analysis
• 6.3. U.S. Regulatory Consulting Outsourcing Services Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 6.4. Biotechnology Companies
  • 6.4.1. Biotechnology Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Pharmaceutical Companies
  • 6.5.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Medical Device Companies
  • 6.6.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Regulatory Consulting Outsourcing Services Market: Company Size Estimates & Trend Analysis

• 7.1. U.S. Regulatory Consulting Outsourcing Services Market, By Company Size: Segment Dashboard
• 7.2. U.S. Regulatory Consulting Outsourcing Services Market, By Company Size: Movement Analysis
• 7.3. U.S. Regulatory Consulting Outsourcing Services Market Estimates & Forecasts, By Company Size, 2021 - 2033 (USD Million)
• 7.4. Small
  • 7.4.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Medium
  • 7.5.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Large
  • 7.6.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Key Participant Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
• 8.3. Company Profiles
  • 8.3.1. Parexel International Corporation
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. ICON plc
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. IQVIA Inc.
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Syneos Health
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. ProPharma
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. PharmaLex GmbH (Cencora)
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Freyr
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Lachman Consultants
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. R&Q Solutions (RQM+)
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. The FDA Group
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. Emergo by UL
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service Benchmarking
    • 8.3.11.4. Strategic Initiatives