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市場調查報告書
商品編碼
1813864

美國監管應用市場規模、佔有率和趨勢分析報告：按類型、服務、產品、適應症、產品階段、公司規模、最終用途和細分市場進行預測，2025 年至 2033 年

U.S. Regulatory Affairs Market Size, Share & Trends Analysis Report By Type (In-house, Outsourced), By Service, By Product, By Indication, By Product Stage, By Company Size, By End Use, 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

美國監管應用市場摘要

預計 2024 年美國監管應用市場價值將達到 46.5 億美元，到 2033 年將達到 96.5 億美元，2025 年至 2033 年的複合年成長率為 8.43%。

生物製藥創新的持續進步正在推動成長，增加 FDA 提交的數量以及藥品和設備管道的複雜性。

孤兒藥、腫瘤治療和聯合治療的激增加速了上市需求，需要在整個開發生命週期中提供更全面的監管指導。此外，監管互動（包括新藥臨床研究 (IND) 前會議和滾動提交）的頻繁增加，凸顯了監管提交的重要性，這對該行業至關重要。此外，GxP 標準下的嚴格合規要求和不斷發展的上市後監管框架進一步凸顯了建立強大監管基礎設施的必要性。

以自動化、數位化提交系統和人工智慧主導的監管智慧為重點的新興技術進步，有望推動美國製藥業的成長，從而實現高效的監管提交。此外，美國食品藥物管理局 (FDA) 優先考慮 eCTD 4.0，這迫使企業簡化提交平台並改善文件生命週期管理。雲端基礎的監管科技工具顯著增強了標籤合規性、版本控制和變更管理。此外，自然語言處理和機器學習演算法的整合旨在簡化監管內容創建，最大限度地減少人為錯誤，並加快審核和檢查準備。

投資趨勢顯示，私募股權和企業創業投資正擴大流入監管外包供應商和監管科技平台。大量資金正湧入專門從事數位提交、監管策略諮詢和品質文件的公司。大型合約研究組織 (CRO) 和合約開發生產組織 (CDMO) 正在策略性地收購規模較小的公司，以擴展其監管提交能力並改進其綜合服務產品。同時，製藥和生物技術公司正在增加對監管數位化、合規自動化和員工團隊建設的預算分配，以加快上市時間並降低監管風險。

監管格局不斷發展變化，美國FDA發布了涵蓋眾多治療領域和技術平台的最新指南。美國FDA的「即時腫瘤學審查」和「Orbis計畫」等舉措正在引入結構化互動，以加快核准。同時，全球監管策略正透過ICH和核准協議，擴大納入監管協調工作。人們對提高透明度和資料完整性的期望日益成長，尤其強調透過SPL和IDMP等專案實現可追溯性和結構化資料提交。

然而，儘管該市場具有巨大的成長潛力，但它也面臨著許多挑戰，包括缺乏經驗豐富的監管專業人員、營運成本上升以及頻繁的指導方針變化導致合規不確定性。規模較小的公司通常內部監管專業知識有限且預算受限，這會延遲與監管機構的早期接觸，並最終導致提交申請延遲。此外，某些治療領域的監管審查流程日益嚴格且審查時間延長，加劇了風險規避情緒。此外，公司還面臨舊有系統和現代監管科技平台之間的挑戰，這減緩了數位化採用的步伐並限制了創新的整體影響。預計這些因素將推動將監管提交外包給美國專業服務供應商的需求。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國監理應用市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
    • 市場機會分析
  • 技術格局
  • 定價分析
  • 市場分析工具
    • 波特五力分析
    • PESTEL 與 SWOT 分析
    • COVID-19影響分析

第4章：美國監理應用市場：類型估計與趨勢分析

  • 細分儀表板
  • 美國監管應用市場類型變化分析
  • 美國監管應用市場規模與趨勢分析（按類型）（2021-2033）
  • 內部
  • 外包

第5章：美國監理應用市場：服務估算與趨勢分析

  • 細分儀表板
  • 美國監管應用市場服務變化分析
  • 美國監管應用市場規模與趨勢分析（按服務，2021-2033 年）
  • 監理諮詢
  • 法律代表
  • 監管文件的撰寫和發布
    • 寫
    • 發布
  • 產品註冊和臨床試驗申請
  • 其他服務

第6章：美國監管應用市場：產品估計與趨勢分析

  • 細分儀表板
  • 美國監管應用市場：產品波動分析
  • 美國監管應用市場規模與趨勢分析（按產品，2021-2033 年）
  • 藥物
    • 創新者
    • 學名藥
  • 生物製藥
    • 生物技術
    • ATMP
    • 生物相似藥
  • 醫療設備
    • 診斷
    • 治療藥物

第7章：美國監理應用市場：指標估計與趨勢分析

  • 細分儀表板
  • 美國監管應用市場：適應症變化分析
  • 美國監管應用市場規模與趨勢分析（按適應症，2021-2033 年）
  • 腫瘤學
  • 神經病學
  • 心臟病學
  • 免疫學
  • 其他

第8章：美國監理適用性市場：產品階段評估與趨勢分析

  • 細分儀表板
  • 美國監管應用市場：產品階段波動分析
  • 2021 年至 2033 年美國監理應用市場規模及趨勢分析（依產品階段）
  • 臨床前
  • 臨床
  • 上市後核准（PMA）

第9章：美國監理應用市場：公司規模估計與趨勢分析

  • 細分儀表板
  • 美國監管應用市場：公司規模變化分析
  • 美國監管應用市場規模與趨勢分析（按公司規模，2021-2033 年）
  • 小的
  • 中等的
  • 大的

第 10 章：美國監管應用市場：最終用途估計與趨勢分析

  • 細分儀表板
  • 美國監管應用市場：最終用途差異分析
  • 美國監管應用市場規模和趨勢分析（按最終用途，2021-2033 年）
  • 醫療設備公司
  • 製藥公司
  • 生技公司

第11章 競爭格局

  • 市場參與企業分類
    • 市場領導者
    • 新興企業
  • 2024年公司市佔率/估值分析
  • 公司簡介
    • Accell Clinical Research, LLC.
    • Charles River Laboratories
    • Genpact
    • ICON plc
    • iuvo BioScience, LLC.
    • WuXi AppTec
    • Medpace
    • IQVIA, Inc.
    • Freyr
    • PharmaLex（Cencora）
    • ProPharma
Product Code: GVR-4-68040-278-3

U.S. Regulatory Affairs Market Summary

The U.S. regulatory affairs market size was estimated at USD 4.65 billion in 2024 and is projected to reach USD 9.65 billion by 2033, growing at a CAGR of 8.43% from 2025 to 2033. Continuous advancements in biopharmaceutical innovation drive the growth, increased FDA submission volumes, and the complexity of drug and device pipelines.

The upsurge in orphan drugs, oncology treatments, and combination therapies has required more comprehensive regulatory guidance throughout the development lifecycle, thereby accelerating market demand. Besides, the rising frequency of regulatory interactions like pre-IND meetings and rolling submissions has highlighted the importance of regulatory affairs as a foundational aspect of the industry. Moreover, the stringent compliance requirements under GxP standards and evolving post-marketing surveillance frameworks further highlight the necessity for a strong regulatory infrastructure.

The growing technological advancements, with a notable focus on automation, digital submission systems, and AI-driven regulatory intelligence for effective regulatory operations, are anticipated to drive the growth of the U.S. regulatory affairs industry. Moreover, the U.S FDA's prioritization of eCTD 4.0 has prompted organizations to streamline their submission platforms and improve document lifecycle management. Cloud-based RegTech tools have significantly enhanced labeling compliance, version control, and change management. In addition, the integration of natural language processing and machine learning algorithms aims to streamline regulatory content generation, minimize manual errors, and accelerate readiness for audits and inspections.

The investment trends showcased increasing private equity and corporate venture capital flow towards regulatory outsourcing providers and RegTech platforms. Significant funding rounds have been noted in companies that specialize in digital submissions, regulatory strategy consulting, and quality documentation. Larger CROs and CDMOs are strategically acquiring smaller companies to expand their regulatory affairs capabilities and improve integrated service offerings. Whereas, pharmaceutical and biotech companies have enhanced the budget allocations for regulatory digitalization, compliance automation, and workforce development to accelerate time-to-market while mitigating regulatory risks.

The regulatory landscape is constantly evolving, with the U.S. FDA issuing updated guidelines across numerous therapeutic areas and technology platforms. Structured interactions under initiatives like the U.S. FDA's Real-Time Oncology Review and Project Orbis have been introduced to expedite approvals. Simultaneously, global regulatory strategies are increasingly incorporating regulatory harmonization efforts via the ICH and mutual recognition agreements. Expectations for enhanced transparency and data integrity are rising, with particular emphasis on traceability and structured data submissions under programs such as SPL and IDMP.

However, despite its strong growth potential, the market faces challenges such as a shortage of experienced regulatory professionals, rising operational costs, and the frequent changes in guidance that create compliance uncertainty. Smaller companies often struggle with limited internal regulatory expertise and budget constraints, which can delay early engagement with regulatory agencies and result in submission setbacks. In addition, increased scrutiny and lengthening review timelines in specific therapeutic areas have led to increased risk aversion. Besides, the organizations also encounter challenges between legacy systems and modern RegTech platforms, slowing the pace of digital adoption and limiting the overall impact of innovation. Such factors are expected to drive the demand for outsourcing regulatory affairs services to specialized service providers in the U.S.

U.S. Regulatory Affairs Market Report Segmentation

This report forecasts revenue growth at the country level and analyzes the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. regulatory affairs market report based on type, service, product, indication, product stage, company size, and end use:

  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • In-house
  • Outsourced
  • Service Outlook (Revenue, USD Million, 2021 - 2033)
  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
    • Writing
    • Publishing
  • Product Registration & Clinical Trial Applications
  • Other Services
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Drugs
    • Innovator
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
    • Generics
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
  • Biologics
    • Biotech
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
    • ATMP
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
    • Biosimilars
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
  • Medical Devices
    • Diagnostics
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
    • Therapeutics
    • Preclinical
    • Clinical
    • Post Market Approval (PMA)
  • Indication Outlook (Revenue, USD Million, 2021 - 2033)
  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others
  • Product Stage Outlook (Revenue, USD Million, 2021 - 2033)
  • Preclinical
  • Clinical studies
  • Post Market Approval (PMA)
  • Company Size Outlook (Revenue, USD Million, 2021 - 2033)
  • Small
  • Medium
  • Large
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Type
    • 1.2.2. Service
    • 1.2.3. Product
    • 1.2.4. Indication
    • 1.2.5. Product Stage
    • 1.2.6. Company Size
    • 1.2.7. End Use
  • 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. Value-Chain-Based Sizing & Forecasting
    • 1.7.3. Multivariate Model 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 Affairs 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. Changing Regulatory Landscape
      • 3.2.1.2. Life Science Companies Focusing on Their Core Competencies
      • 3.2.1.3. Economic and Competitive Pressures
      • 3.2.1.4. Demand for the Faster Approval Process for Breakthrough Drugs and Devices
      • 3.2.1.5. Growth in Emerging Areas such as Personalized Medicine, Biosimilars, and Orphan Drugs
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Risk Associated with Data Security
      • 3.2.2.2. Monitoring Issues and Lack of Standardization
    • 3.2.3. Market Opportunity Analysis
  • 3.3. Technology Landscape
  • 3.4. Pricing Analysis
  • 3.5. Market Analysis Tools
    • 3.5.1. Porter's Five Force Analysis
    • 3.5.2. PESTEL by SWOT Analysis
    • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Regulatory Affairs Market: Type Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Regulatory Affairs Market Type Movement Analysis
  • 4.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Type, 2021 - 2033 (USD Million)
  • 4.4. In-house
    • 4.4.1. In-house Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Outsourced
    • 4.5.1. Outsourced Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Regulatory Affairs Market: Service Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Regulatory Affairs Market Service Movement Analysis
  • 5.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Service, 2021 - 2033 (USD Million)
  • 5.4. Regulatory Consulting
    • 5.4.1. Regulatory Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Legal Representation
    • 5.5.1. Legal Representation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Regulatory Writing & Publishing
    • 5.6.1. Regulatory Writing & Publishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.6.2. Writing
      • 5.6.2.1. Writing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.6.3. Publishing
      • 5.6.3.1. Publishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.7. Product Registration & Clinical Trial Applications
    • 5.7.1. Product Registration & Clinical Trial Applications Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.8. Other Services
    • 5.8.1. Other Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Regulatory Affairs Market: Product Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Regulatory Affairs Market: Product Movement Analysis
  • 6.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Product, 2021 - 2033 (USD Million)
  • 6.4. Drugs
    • 6.4.1. Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.2. Innovator
      • 6.4.2.1. Innovator Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.2.2. Preclinical
        • 6.4.2.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.2.3. Clinical
        • 6.4.2.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.2.4. Post Market Approval (PMA)
        • 6.4.2.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.3. Generics
      • 6.4.3.1. Generics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.3.2. Preclinical
        • 6.4.3.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.3.3. Clinical
        • 6.4.3.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.4.3.4. Post Market Approval (PMA)
        • 6.4.3.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Biologics
    • 6.5.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.5.2. Biotech
      • 6.5.2.1. Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.2.2. Preclinical
        • 6.5.2.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.2.3. Clinical
        • 6.5.2.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.2.4. Post Market Approval (PMA)
        • 6.5.2.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.5.3. ATMP
      • 6.5.3.1. ATMP Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.3.2. Preclinical
        • 6.5.3.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.3.3. Clinical
        • 6.5.3.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.3.4. Post Market Approval (PMA)
        • 6.5.3.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.5.4. Biosimilars
      • 6.5.4.1. Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.4.2. Preclinical
        • 6.5.4.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.4.3. Clinical
        • 6.5.4.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.5.4.4. Post Market Approval (PMA)
        • 6.5.4.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Medical Devices
    • 6.6.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.6.2. Diagnostics
      • 6.6.2.1. Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.2.2. Preclinical
        • 6.6.2.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.2.3. Clinical
        • 6.6.2.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.2.4. Post Market Approval (PMA)
        • 6.6.2.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.6.3. Therapeutics
      • 6.6.3.1. Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.3.2. Preclinical
        • 6.6.3.2.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.3.3. Clinical
        • 6.6.3.3.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 6.6.3.4. Post Market Approval (PMA)
        • 6.6.3.4.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Regulatory Affairs Market: Indication Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Regulatory Affairs Market Indication Movement Analysis
  • 7.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Indication, 2021 - 2033 (USD Million)
  • 7.4. Oncology
    • 7.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Neurology
    • 7.5.1. Neurology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Cardiology
    • 7.6.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7. Immunology
    • 7.7.1. Immunology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8. Others
    • 7.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

  • 8.1. Segment Dashboard
  • 8.2. U.S. Regulatory Affairs Market Product Stage Movement Analysis
  • 8.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Product Stage, 2021 - 2033 (USD Million)
  • 8.4. Preclinical
    • 8.4.1. Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.5. Clinical
    • 8.5.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.6. Post Market Approval (PMA)
    • 8.6.1. Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. U.S. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

  • 9.1. Segment Dashboard
  • 9.2. U.S. Regulatory Affairs Market Company Size Movement Analysis
  • 9.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by Company Size, 2021 - 2033 (USD Million)
  • 9.4. Small
    • 9.4.1. Small Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.5. Medium
    • 9.5.1. Medium Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 9.6. Large
    • 9.6.1. Large Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 10. U.S. Regulatory Affairs Market: End Use Estimates & Trend Analysis

  • 10.1. Segment Dashboard
  • 10.2. U.S. Regulatory Affairs Market End Use Movement Analysis
  • 10.3. U.S. Regulatory Affairs Market Size & Trend Analysis, by End Use, 2021 - 2033 (USD Million)
  • 10.4. Medical Device Companies
    • 10.4.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 10.5. Pharmaceutical Companies
    • 10.5.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 10.6. Biotechnology Companies
    • 10.6.1. Biotechnology Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 11. Competitive Landscape

  • 11.1. Market Participant Categorization
    • 11.1.1. Market Leaders
    • 11.1.2. Emerging Players
  • 11.2. Company Market Share/Assessment Analysis, 2024
  • 11.3. Company Profiles
    • 11.3.1. Accell Clinical Research, LLC.
      • 11.3.1.1. Company Overview
      • 11.3.1.2. Financial Performance
      • 11.3.1.3. Service Benchmarking
      • 11.3.1.4. Strategic Initiatives
    • 11.3.2. Charles River Laboratories
      • 11.3.2.1. Company Overview
      • 11.3.2.2. Financial Performance
      • 11.3.2.3. Service Benchmarking
      • 11.3.2.4. Strategic Initiatives
    • 11.3.3. Genpact
      • 11.3.3.1. Company Overview
      • 11.3.3.2. Financial Performance
      • 11.3.3.3. Service Benchmarking
      • 11.3.3.4. Strategic Initiatives
    • 11.3.4. ICON plc
      • 11.3.4.1. Company Overview
      • 11.3.4.2. Financial Performance
      • 11.3.4.3. Service Benchmarking
      • 11.3.4.4. Strategic Initiatives
    • 11.3.5. iuvo BioScience, LLC.
      • 11.3.5.1. Company Overview
      • 11.3.5.2. Financial Performance
      • 11.3.5.3. Service Benchmarking
      • 11.3.5.4. Strategic Initiatives
    • 11.3.6. WuXi AppTec
      • 11.3.6.1. Company Overview
      • 11.3.6.2. Financial Performance
      • 11.3.6.3. Service Benchmarking
      • 11.3.6.4. Strategic Initiatives
    • 11.3.7. Medpace
      • 11.3.7.1. Company Overview
      • 11.3.7.2. Financial Performance
      • 11.3.7.3. Service Benchmarking
      • 11.3.7.4. Strategic Initiatives
    • 11.3.8. IQVIA, Inc.
      • 11.3.8.1. Company Overview
      • 11.3.8.2. Financial Performance
      • 11.3.8.3. Service Benchmarking
      • 11.3.8.4. Strategic Initiatives
    • 11.3.9. Freyr
      • 11.3.9.1. Company Overview
      • 11.3.9.2. Financial Performance
      • 11.3.9.3. Service Benchmarking
      • 11.3.9.4. Strategic Initiatives
    • 11.3.10. PharmaLex (Cencora)
      • 11.3.10.1. Company Overview
      • 11.3.10.2. Financial Performance
      • 11.3.10.3. Service Benchmarking
      • 11.3.10.4. Strategic Initiatives
    • 11.3.11. ProPharma
      • 11.3.11.1. Company Overview
      • 11.3.11.2. Financial Performance
      • 11.3.11.3. Service Benchmarking
      • 11.3.11.4. Strategic Initiatives

List of Tables

  • Table 1. List of Secondary Sources
  • Table 2. List of Abbreviations
  • Table 3. U.S. Regulatory Affairs Market Estimates and Forecasts, by Type, 2021 - 2033 (USD Million)
  • Table 4. U.S. Regulatory Affairs Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
  • Table 5. U.S. Regulatory Affairs Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
  • Table 6. U.S. Regulatory Affairs Market Estimates and Forecasts, by Indication, 2021 - 2033 (USD Million)
  • Table 7. U.S. Regulatory Affairs Market Estimates and Forecasts, by Product Stage, 2021 - 2033 (USD Million)
  • Table 8. U.S. Regulatory Affairs Market Estimates and Forecasts, by Company Size, 2021 - 2033 (USD Million)
  • Table 9. U.S. Regulatory Affairs Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S. Regulatory Affairs Market Segmentation
  • Fig. 2 Data Analysis Models
  • Fig. 3 Market Formulation and Validation
  • Fig. 4 Data Validating & Publishing
  • Fig. 5 Market Research Process
  • Fig. 6 Information Procurement
  • Fig. 7 Primary Research
  • Fig. 8 Value-chain-Based Sizing & Forecasting
  • Fig. 9 QFD Modelling for Market Share Assessment
  • Fig. 10 Market Formulation & Validation
  • Fig. 11 Commodity Flow Analysis
  • Fig. 12 Market Outlook
  • Fig. 13 Segment Snapshot 1
  • Fig. 14 Segment Snapshot 2
  • Fig. 15 Competitive Landscape Snapshot
  • Fig. 16 Market Dynamics
  • Fig. 17 Porter's Five Force Analysis
  • Fig. 18 PESTEL Analysis
  • Fig. 19 U.S. Regulatory Affairs Market: Type outlook key takeaways
  • Fig. 20 U.S. Regulatory Affairs Market: Type movement analysis
  • Fig. 21 In-house Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Outsourced Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Regulatory Affairs Market: Service outlook key takeaways
  • Fig. 24 U.S. Regulatory Affairs Market: Service movement analysis
  • Fig. 25 Regulatory Consulting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Legal Representation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Regulatory Writing & Publishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Writing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Publishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Product Registration & Clinical Trial Applications Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Other Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 U.S. Regulatory Affairs Market: Product outlook key takeaways
  • Fig. 33 U.S. Regulatory Affairs Market: Product movement analysis
  • Fig. 34 Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Innovator Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Preclinical Innovator Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 Clinical Innovator Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 38 Post Market Approval (PMA) Innovator Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Generic Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Preclinical Generic Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Clinical Generic Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 Post Market Approval (PMA) Generic Drugs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Preclinical Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Clinical Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Post Market Approval (PMA) Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 ATMP Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 49 Preclinical ATMP Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 50 Clinical ATMP Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 51 Post Market Approval (PMA) ATMP Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 52 Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 53 Preclinical Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 54 Clinical Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 55 Post Market Approval (PMA) Biosimilars Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 56 Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 57 Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 58 Preclinical Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 59 Clinical Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 60 Post Market Approval (PMA) Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 61 Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 62 Preclinical Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 63 Clinical Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 64 Post Market Approval (PMA) Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 65 U.S. Regulatory Affairs Market: Indication outlook key takeaways
  • Fig. 66 U.S. Regulatory Affairs Market: Indication movement analysis
  • Fig. 67 Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 68 Neurology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 69 Cardiology companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 70 Immunology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 71 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 72 U.S. Regulatory Affairs Market: Product stage outlook key takeaways
  • Fig. 73 U.S. Regulatory Affairs Market: Product stage movement analysis
  • Fig. 74 Preclinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 75 Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 76 Post Market Approval (PMA) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 77 Immunology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 78 U.S. Regulatory Affairs Market: Company size outlook key takeaways
  • Fig. 79 U.S. Regulatory Affairs Market: Company size movement analysis
  • Fig. 80 Small Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 81 Medium Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 82 Large Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 83 U.S. Regulatory Affairs Market: End use outlook key takeaways
  • Fig. 84 U.S. Regulatory Affairs Market: End use movement analysis
  • Fig. 85 Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 86 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 87 Biotechnology Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 88 Market Participant Categorization
  • Fig. 89 U.S. Regulatory Affairs Market Share/Assessment Analysis, 2024
  • Fig. 90 Strategic framework