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市場調查報告書
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1888882

美國監管諮詢外包服務市場規模、佔有率和趨勢分析報告：按類別、適應症、最終用途、公司規模和細分市場預測（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個工作天內

價格

美國監理事務諮詢外包服務市場摘要

2024年美國監理諮詢外包服務市場規模估計為4.149億美元，預計2033年將達8.751億美元。

預計從 2025 年到 2033 年，該市場將以 8.15% 的複合年成長率成長。推動該市場成長的關鍵因素包括 FDA 和其他全球監管機構日益複雜的監管規定、與維持內部團隊相比節省成本，以及為加快核准而對藥物和醫療設備開發進行快速創新的需求。

其他成長要素包括RIM和eCTD等數位化合規工具的日益普及，以及市場對跨區域監管一致性和專業知識的需求不斷成長。這些因素預計將推動市場成長。美國製藥、生物技術和醫療技術（MedTech）產業研發活動的快速擴張預計將促進美國監管諮詢外包產業的發展。製藥、醫療設備公司數量的不斷成長，推動了對創新藥物、生物製藥和先進醫療技術的投資增加，從而導致監管申報流程更加複雜。研發活動的激增促使企業更加依賴顧問公司來應對不斷變化的美國監管諮詢外包產業，推動了外包需求和市場收入的強勁成長。

此外，在美國，監管要求正從傳統的營運和合規主導領域轉向對製藥、生物技術和醫療設備開發成功至關重要的戰略角色。這種變化為美國監管諮詢外包產業創造了一個複雜的監管環境，預計這將推動對監管諮詢服務的需求。

如今，隨著聯邦和州兩級監管要求的不斷提高，美國監管諮詢外包產業日益分散。因此，企業必須與美國食品藥物管理局(FDA) 的各個部門打交道，這些部門負責監管藥品、生物製藥、醫療設備等，同時也要應對不斷變化的標籤、廣告和上市後監測指南。此外，對於大多數公司而言，在所有產品類型中維持內部監管專業知識變得越來越複雜和昂貴，這促使企業尋求外包服務。

此外，美國製藥、生技和醫療技術（MedTech）領域研發活動的快速擴張預計將推動美國監管諮詢外包服務產業的成長。製藥、生技和醫療設備公司數量的不斷成長，促使企業加強對創新藥物、生物製藥和先進醫療技術的投資，進而使監管申報流程更加複雜。研發活動的激增使得企業更加依賴顧問公司來應對不斷變化的美國監管環境，推動了外包需求和市場收入的強勁成長。預計這些因素將在預測期內推動市場成長。

目錄

第1章調查方法和範圍

第2章執行摘要

第3章美國監理諮詢外包服務市場變數、趨勢與範圍

  • 市場譜系展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
  • 經營模式分析
  • 定價模型分析
  • 技術進步
  • 法律規範
  • 地緣政治和監管影響評估
  • 市場分析工具
    • 波特五力分析
    • PESTEL 分析與 SWOT 分析

第4章：美國監理事務諮詢外包服務市場：按類別分類的估算與趨勢分析

  • 美國監理事務諮詢外包服務市場：按類別分類的變化分析
  • 美國監管事務諮詢外包服務市場按類別分類的估算與預測，2021-2033年
  • 製藥
  • 生物製藥
  • 醫療設備

第5章美國監理諮詢外包服務市場：依指標分類的估算與趨勢分析

  • 美國監管諮詢外包服務市場按領域分類：波動分析
  • 美國監理諮詢外包服務市場按領域分類的估算與預測，2021-2033年
  • 腫瘤學
  • 神經病學
  • 循環系統
  • 免疫學
  • 其他

第6章：美國監理諮詢外包服務市場：依最終用途分類的估算與趨勢分析

  • 美國監理諮詢外包服務市場依最終用途分類：差異分析
  • 美國監管諮詢外包服務市場按最終用途分類的估算與預測，2021-2033年
  • 生技公司
  • 製藥公司
  • 醫療設備製造商

第7章：美國監理事務諮詢外包服務市場：依公司規模分類的估算與趨勢分析

  • 美國監管事務諮詢外包服務市場（依公司規模分類）：波動分析
  • 美國監理事務諮詢外包服務市場規模估算及預測（依公司規模分類），2021-2033年
  • 小規模
  • 中號
  • 主要企業

第8章 競爭情勢

  • 主要參與者的分類
  • 市場佔有率/評估分析（2024 年，熱力圖分析）
  • 公司簡介
    • 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