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市场调查报告书
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1888882

美国监管咨询外包服务市场规模、份额和趋势分析报告：按类别、适应症、最终用途、公司规模和细分市场预测（2025-2033 年）

U.S. Regulatory Consulting Outsourcing Services Market Size, Share & Trends Analysis Report By Category (Drugs, Biologics, Medical Devices), By Indication, By End Use, By Company Size, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10个工作天内

价格

美国监理事务咨询外包服务市场摘要

2024年美国监理咨询外包服务市场规模估计为4.149亿美元，预计2033年将达8.751亿美元。

预计从 2025 年到 2033 年，该市场将以 8.15% 的复合年增长率成长。推动该市场成长的关键因素包括 FDA 和其他全球监管机构日益复杂的监管规定、与维持内部团队相比节省成本，以及为加快核准而对药物和医疗设备开发进行快速创新的需求。

其他成长要素包括RIM和eCTD等数位化合规工具的日益普及，以及市场对跨区域监管一致性和专业知识的需求不断增长。这些因素预计将推动市场成长。美国製药、生物技术和医疗技术（MedTech）产业研发活动的快速扩张预计将促进美国监管咨询外包产业的发展。製药、医疗设备公司数量的不断增长，推动了对创新药物、生物製药和先进医疗技术的投资增加，从而导致监管申报流程更加复杂。研发活动的激增促使企业更加依赖顾问公司来应对不断变化的美国监管咨询外包产业，推动了外包需求和市场收入的强劲成长。

此外，在美国，监管要求正从传统的营运和合规主导领域转向对製药、生物技术和医疗设备开发成功至关重要的战略角色。这种变化为美国监管咨询外包产业创造了一个复杂的监管环境，预计这将推动对监管咨询服务的需求。

如今，随着联邦和州两级监管要求的不断提高，美国监管咨询外包产业日益分散。因此，企业必须与美国食品药物管理局(FDA) 的各个部门打交道，这些部门负责监管药品、生物製药、医疗设备等，同时也要应对不断变化的标籤、广告和上市后监测指南。此外，对于大多数公司而言，在所有产品类型中维持内部监管专业知识变得越来越复杂和昂贵，这促使企业寻求外包服务。

此外，美国製药、生技和医疗技术（MedTech）领域研发活动的快速扩张预计将推动美国监管咨询外包服务产业的成长。製药、生技和医疗设备公司数量的不断增长，促使企业加强对创新药物、生物製药和先进医疗技术的投资，进而使监管申报流程更加复杂。研发活动的激增使得企业更加依赖顾问公司来应对不断变化的美国监管环境，推动了外包需求和市场收入的强劲成长。预计这些因素将在预测期内推动市场成长。

目录

第一章调查方法和范围

第二章执行摘要

第三章美国监理咨询外包服务市场变数、趋势与范围

  • 市场谱系展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
  • 经营模式分析
  • 定价模型分析
  • 技术进步
  • 法律规范
  • 地缘政治和监管影响评估
  • 市场分析工具
    • 波特五力分析
    • PESTEL 分析与 SWOT 分析

第四章：美国监理事务咨询外包服务市场：按类别分類的估算与趋势分析

  • 美国监理事务咨询外包服务市场：按类别分類的变化分析
  • 美国监管事务咨询外包服务市场按类别分類的估算与预测，2021-2033年
  • 製药
  • 生物製药
  • 医疗设备

第五章美国监理咨询外包服务市场：依指标分類的估算与趋势分析

  • 美国监管咨询外包服务市场按领域划分：波动分析
  • 美国监理咨询外包服务市场按领域分類的估算与预测，2021-2033年
  • 肿瘤学
  • 神经病学
  • 循环系统
  • 免疫学
  • 其他的

第六章：美国监理咨询外包服务市场：依最终用途分類的估算与趋势分析

  • 美国监理咨询外包服务市场依最终用途划分：差异分析
  • 美国监管咨询外包服务市场按最终用途分類的估算与预测，2021-2033年
  • 生技公司
  • 製药公司
  • 医疗设备製造商

第七章：美国监理事务咨询外包服务市场：依公司规模分類的估算与趋势分析

  • 美国监管事务咨询外包服务市场（依公司规模划分）：波动分析
  • 美国监理事务咨询外包服务市场规模估算及预测（依公司规模划分），2021-2033年
  • 小规模
  • 中号
  • 大公司

第八章 竞争情势

  • 主要参与者的分类
  • 市场占有率/评估分析（2024 年，热力图分析）
  • 公司简介
    • Parexel International Corporation
    • ICON plc
    • IQVIA Inc.
    • Syneos Health
    • ProPharma
    • PharmaLex GmbH（Cencora）
    • Freyr
    • Lachman Consultants
    • R&Q;Solutions（RQM+）
    • The FDA Group
    • Emergo by UL
Product Code: GVR-4-68040-823-9

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

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 US Regulatory Consulting Outsourcing Services Market Estimates and Forecasts, by Category, 2021 - 2033 (USD Million)
  • Table 4 US Regulatory Consulting Outsourcing Services Market Estimates and Forecasts, by Indication, 2021 - 2033 (USD Million)
  • Table 5 US Regulatory Consulting Outsourcing Services Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)
  • Table 6 US Regulatory Consulting Outsourcing Services Market Estimates and Forecasts, by Company Size, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Regulatory consulting outsourcing services market dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. regulatory consulting outsourcing services market: Category outlook and key takeaways
  • Fig. 20 U.S. regulatory consulting outsourcing services market: Category movement analysis
  • Fig. 21 Drugs market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Biologics market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Medical devices market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. regulatory consulting outsourcing services market: Indication outlook and key takeaways
  • Fig. 25 U.S. regulatory consulting outsourcing services market: Indication movement analysis
  • Fig. 26 Oncology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Neurology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Cardiology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Immunology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 U.S. regulatory consulting outsourcing services market: End Use outlook and key takeaways
  • Fig. 32 U.S. regulatory consulting outsourcing services market: End use movement analysis
  • Fig. 33 Biotechnology companies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Pharmaceutical companies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Medical device companies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 U.S. regulatory consulting outsourcing services market: Company size outlook and key takeaways
  • Fig. 37 U.S. regulatory consulting outsourcing services market: Company size movement analysis
  • Fig. 38 Small market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Medium market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Large market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Key company categorization
  • Fig. 42 Service heat map analysis
  • Fig. 43 Strategic framework