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市场调查报告书
商品编码
1813864

美国监管应用市场规模、份额和趋势分析报告：按类型、服务、产品、适应症、产品阶段、公司规模、最终用途和细分市场进行预测，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个工作天内

价格

美国监管应用市场摘要

预计 2024 年美国监管应用市场价值将达到 46.5 亿美元，到 2033 年将达到 96.5 亿美元，2025 年至 2033 年的复合年增长率为 8.43%。

生物製药创新的持续进步正在推动成长，增加 FDA 提交的数量以及药品和设备管道的复杂性。

孤儿药、肿瘤治疗和联合治疗的激增加速了上市需求，需要在整个开发生命週期中提供更全面的监管指导。此外，监管互动（包括新药临床研究 (IND) 前会议和滚动提交）的频繁增加，凸显了监管提交的重要性，这对该行业至关重要。此外，GxP 标准下的严格合规要求和不断发展的上市后监管框架进一步凸显了建立强大监管基础设施的必要性。

以自动化、数位化提交系统和人工智慧主导的监管智慧为重点的新兴技术进步，有望推动美国製药业的成长，从而实现高效的监管提交。此外，美国食品药物管理局 (FDA) 优先考虑 eCTD 4.0，这迫使企业简化提交平台并改善文件生命週期管理。云端基础的监管科技工具显着增强了标籤合规性、版本控制和变更管理。此外，自然语言处理和机器学习演算法的整合旨在简化监管内容创建，最大限度地减少人为错误，并加快审核和检查准备。

投资趋势显示，私募股权和企业创业投资正越来越多地流入监管外包供应商和监管科技平台。大量资金正涌入专门从事数位提交、监管策略咨询和品质文件的公司。大型合约研究组织 (CRO) 和合约开发生产组织 (CDMO) 正在策略性地收购规模较小的公司，以扩展其监管提交能力并改进其综合服务产品。同时，製药和生物技术公司正在增加对监管数位化、合规自动化和员工团队建设的预算分配，以加快上市时间并降低监管风险。

监管格局不断发展变化，美国FDA发布了涵盖众多治疗领域和技术平台的最新指南。美国FDA的「即时肿瘤学审查」和「Orbis计画」等倡议正在引入结构化互动，以加快核准。同时，全球监管策略正透过ICH和核准协议，越来越多地纳入监管协调工作。人们对提高透明度和资料完整性的期望日益增长，尤其强调透过SPL和IDMP等专案实现可追溯性和结构化资料提交。

然而，儘管该市场具有巨大的成长潜力，但它也面临着许多挑战，包括缺乏经验丰富的监管专业人员、营运成本上升以及频繁的指导方针变化导致合规不确定性。规模较小的公司通常内部监管专业知识有限且预算受限，这会延迟与监管机构的早期接触，并最终导致提交申请延迟。此外，某些治疗领域的监管审查流程日益严格且审查时间延长，加剧了风险规避情绪。此外，公司还面临旧有系统和现代监管科技平台之间的挑战，这减缓了数位化采用的步伐并限制了创新的整体影响。预计这些因素将推动将监管提交外包给美国专业服务供应商的需求。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国监理应用市场变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 市场机会分析
  • 技术格局
  • 定价分析
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析
    • COVID-19影响分析

第四章：美国监理应用市场：类型估计与趋势分析

  • 细分仪表板
  • 美国监管应用市场类型变化分析
  • 美国监管应用市场规模与趋势分析（按类型）（2021-2033）
  • 内部
  • 外包

第五章：美国监理应用市场：服务估算与趋势分析

  • 细分仪表板
  • 美国监管应用市场服务变化分析
  • 美国监管应用市场规模与趋势分析（按服务，2021-2033 年）
  • 监理咨询
  • 法律代表
  • 监管文件的撰写和发布
    • 写
    • 发布
  • 产品註册和临床试验申请
  • 其他服务

第六章：美国监管应用市场：产品估计与趋势分析

  • 细分仪表板
  • 美国监管应用市场：产品波动分析
  • 美国监管应用市场规模与趋势分析（按产品，2021-2033 年）
  • 药物
    • 创新者
    • 学名药
  • 生物製药
    • 生物技术
    • ATMP
    • 生物相似药
  • 医疗设备
    • 诊断
    • 治疗药物

第七章：美国监理应用市场：指标估计与趋势分析

  • 细分仪表板
  • 美国监管应用市场：适应症变化分析
  • 美国监管应用市场规模与趋势分析（按适应症，2021-2033 年）
  • 肿瘤学
  • 神经病学
  • 心臟病学
  • 免疫学
  • 其他的

第八章：美国监理适用性市场：产品阶段评估与趋势分析

  • 细分仪表板
  • 美国监管应用市场：产品阶段波动分析
  • 2021 年至 2033 年美国监理应用市场规模及趋势分析（依产品阶段）
  • 临床前
  • 临床
  • 上市后核准（PMA）

第九章：美国监理应用市场：公司规模估计与趋势分析

  • 细分仪表板
  • 美国监管应用市场：公司规模变化分析
  • 美国监管应用市场规模与趋势分析（按公司规模，2021-2033 年）
  • 小的
  • 中等的
  • 大的

第 10 章：美国监管应用市场：最终用途估计与趋势分析

  • 细分仪表板
  • 美国监管应用市场：最终用途差异分析
  • 美国监管应用市场规模和趋势分析（按最终用途，2021-2033 年）
  • 医疗设备公司
  • 製药公司
  • 生技公司

第十一章 竞争格局

  • 市场参与企业分类
    • 市场领导者
    • 新兴企业
  • 2024年公司市占率/估值分析
  • 公司简介
    • 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