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市场调查报告书
商品编码
1493304

美国监管备案市场规模、份额和趋势分析报告：按服务、类别、适应症、产品阶段、服务供应商、公司规模、最终用途和细分市场预测，2024-2030 年

U.S. Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Category, By Indication, By Product Stage, By Service Provider, By Company Size, By End-use, And Segment Forecasts, 2024 - 2030
出版日期: | 出版商: Grand View Research | 英文 80 Pages | 商品交期: 2-10个工作天内

价格

美国监管备案市场的成长与趋势：

Grand View Research, Inc.最新报告显示，到2030年，美国药品监管市场规模预计将达到77.1亿美元，预测期内复合年增长率为9.0%。

监管环境不断发展并变得更加复杂，定期推出新的法律和准则。这种复杂性推动了对能够处理这些复杂要求的监管专业人员的需求。

随着公司在全球扩张，由于各国的法规各不相同，合规性变得更加困难。监管专家帮助公司了解国际法律规范并确保市场准入。例如，根据路透社 2024 年 1 月的通讯，许多美国律师事务所预计将在 2024 年签订合併协议。 Stockton & Kilpatrick Townsend 最近宣布与一家小型企业合併。此外，Fennemore Craig 是一家在凤凰城成立的中型公司，今年宣布将业务扩展到西雅图。

监管机构优先考虑患者安全和产品质量，并制定了公司必须遵守的严格规定。监管负责人对于确保产品符合这些标准并加快核准流程至关重要。随着医疗保健行业的扩张和竞争的加剧，公司需要透过有效遵守法规来保持领先地位。业务专业知识提供了竞争优势，可以将产品更快推向市场，同时满足监管要求。

美国监管应用市场报告亮点

  • 到 2023 年，随着中型和大型医疗设备和生物製药公司越来越多地将这些服务外包，监管写作和出版将占服务业的 16% 以上份额。
  • 预计法律代理领域在预测期内将以最快的复合年增长率成长。
  • 2023年，医疗设备产业占最大的市场占有率。这是因为製药公司越来越多地外包医疗设备，使他们能够专注于自己的核心业务。
  • 2023 年，肿瘤学占据最大的市场收益占有率。这是由于癌症患者的盛行率不断增加以及对有效和安全的治疗方法方案的需求不断增加。
  • 由于免疫学能够促进多种神经、心血管、发炎和肿瘤疾病的治疗，预计在预测期内，免疫学领域将以 10.5% 的复合年增长率增长最快。
  • 由于新疾病的出现和慢性病的增加，临床研究在 2023 年占据最大的市场收益占有率。
  • 外包服务供应商在 2023 年占据最大的市场收益占有率，预计在预测期内将以最快的复合年增长率成长。
  • 2023年，中型企业占据最大的市场收益占有率，这是由于中型企业，尤其是非上市企业的存在，预计将推动该行业的成长。
  • 预计製药公司细分市场将在 2023 年占据市场主导地位，并在预测期内以最快的复合年增长率成长。

目录

第一章调查方法和范围

第 2 章执行摘要

第 3 章美国监理申请市场的变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场推动要素分析
    • 市场限制因素分析
  • 美国监管业务市场分析工具
    • 产业分析-波特五力分析
    • PESTEL分析

第四章美国药品申请市场：服务预估与趋势分析

  • 2023年及2030年服务市场占有率
  • 细分仪表板
  • 美国监理备案市场的服务前景
  • 2018-2030年市场规模、预测及趋势分析
  • 医药顾问
  • 法律代表
  • 药物写作/出版
  • 产品提交/临床试验申请
  • 其他服务

第五章美国药品申请市场：品类估算及趋势分析

  • 2023年及2030年类别市场占有率
  • 细分仪表板
  • 美国监管业务市场前景（按类别）
  • 2018-2030年市场规模、预测及趋势分析
  • 药品
  • 生物製剂
  • 生物相似药
  • 医疗设备

第六章美国监理市场：指标估算与趋势分析

  • 2023年及2030年指示市场占有率
  • 细分仪表板
  • 美国监理市场展望（按指标）
  • 2018-2030年市场规模、预测及趋势分析
  • 肿瘤学
  • 神经
  • 循环系统
  • 免疫学
  • 其他的

第七章美国药品申请市场：产品阶段估算及趋势分析

  • 2023 年及 2030 年产品阶段市场占有率
  • 细分仪表板
  • 美国监理备案市场：按产品阶段分類的前景
  • 2018-2030年市场规模、预测及趋势分析
  • 临床前
  • 临床研究
  • PMA

第八章美国监理监理应用市场：服务供应商预估及趋势分析

  • 2023年及2030年服务供应商市场占有率
  • 细分仪表板
  • 美国监管业务市场服务供应商展望
  • 2018-2030年市场规模、预测及趋势分析
  • 公司内部
  • 外包

第九章美国药品申请市场：公司规模估算及趋势分析

  • 2023年及2030年企业规模市场占有率
  • 细分仪表板
  • 按公司规模分類的美国监理备案市场前景
  • 2018-2030年市场规模、预测及趋势分析
  • 小规模
  • 中等大小
  • 规模大

第10章美国监理应用市场：最终用途估计与趋势分析

  • 2023 年及 2030 年最终用途市场占有率
  • 细分仪表板
  • 按最终用途分類的美国监理备案市场前景
  • 2018-2030年市场规模、预测及趋势分析
  • 医疗设备公司
  • 製药公司
  • 生技公司

第十一章美国医药应用市场：区域估计与趋势分析

  • 2023 年和 2030 年按地区分類的市场占有率份额
  • 按地区分類的美国监理备案市场前景
  • 2018-2030年市场规模、预测及趋势分析
  • 西
  • 中西部
  • 东北
  • 西南
  • 东南

第十二章竞争格局

  • 主要市场参与企业的最新趋势和影响分析
  • 公司/竞争对手分类
  • 供应商情况
  • 公司简介
    • Accell Clinical Research, LLC
    • Genpact
    • CRITERIUM, INC.
    • ICON plc
    • Promedica International
    • WuXi AppTec
    • Medpace
    • Charles River Laboratories
    • Labcorp Drug Development
    • Parexel International（MA）Corporation
    • Freyr
    • Pharmalex GmbH
    • NDA Group AB
    • Qvigilance
    • BlueReg
    • Cambridge Regulatory Services
    • VCLS
Product Code: GVR-4-68040-278-3

U.S. Regulatory Affairs Market Growth & Trends:

The U.S. regulatory affairs market is anticipated to reach USD 7.71 billion by 2030 and is anticipated to expand at a CAGR of 9.0% during the forecast period, according to a new report by Grand View Research, Inc. The regulatory landscape constantly evolves and becomes more complex, with new laws and guidelines being introduced regularly. This complexity drives the demand for regulatory affairs professionals who can navigate these intricate requirements.

As the company expands its operations globally, regulatory compliance becomes more challenging due to varying regulations across different countries. Regulatory affairs professionals help organizations navigate international regulatory frameworks and ensure market access. For instance, as per Reuters update of Jan 2024, many U.S. law corporations are expected to enter into merger agreements in 2024. Stockton & Kilpatrick Townsend recently announced a merger with smaller companies. In addition, Fennemore Craig, a Phoenix-founded medium-sized company, announced its expansion into Seattle in the current year.

Regulatory bodies prioritize patient safety and product quality, leading to stringent regulations that companies must adhere to. Regulatory affairs professionals are vital in ensuring products meet these standards while expediting the approval process. As the healthcare industry expands and competition increases, companies must stay ahead by complying with regulations efficiently. Regulatory affairs expertise becomes a competitive advantage in launching products faster while meeting regulatory requirements.

U.S. Regulatory Affairs Market Report Highlights:

  • Regulatory writing & publishing dominated the services segment with more than 16% share in 2023 owing to increasing outsources of these services by mid- and large size medical device and biopharmaceutical firms.
  • The legal representation segment is expected to grow at the fastest CAGR over the forecast period.
  • The medical devices segment held the largest market share in 2023. This is attributable to the rising outsource activities of medical devices by pharmaceutical firms allowing them to focus on their underlying competencies.
  • Oncology accounted for the largest market revenue share in 2023.This can be attributed to the growing prevalence of cancer cases, encouraging a demand for effective and safe treatment selections.
  • The immunology segment is expected to grow at the fastest CAGR of 10.5% during the forecast period owing to its capability to facilitate the treatment of several neurological, cardiovascular, inflammatory, and oncological diseases.
  • Clinical studies accounted for the largest market revenue share in 2023 owing to the growing incidences of new diseases and the increasing occurrence of chronic illnesses.
  • Outsourced service provider accounted for the largest market revenue share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period.
  • The medium size companies accounted for the largest market revenue share in 2023 owing to the existence of several mid-sized recognized providers, specifically privately held, is anticipated to promote to the segment's growth.
  • The pharmaceutical companies segment dominated the market in 2023 and is anticipated to grow at the fastest CAGR over the forecast period attributing to the expansion in the number of authorized pharmaceutical products.

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Service
    • 1.2.2. Category
    • 1.2.3. Indication
    • 1.2.4. Product Stage
    • 1.2.5. Service Provider
    • 1.2.6. Company Size
    • 1.2.7. End-use
    • 1.2.8. Estimates and forecasts timeline
  • 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 (Model 1)
    • 1.7.2. Volume price analysis (Model 2)
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Service outlook
    • 2.2.2. Category outlook
    • 2.2.3. Indication outlook
    • 2.2.4. Product stage outlook
    • 2.2.5. Service provider outlook
    • 2.2.6. Company size outlook
    • 2.2.7. End-use 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
    • 3.2.2. Market restraint analysis
  • 3.3. U.S. Regulatory Affairs Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Supplier power
      • 3.3.1.2. Buyer power
      • 3.3.1.3. Substitution threat
      • 3.3.1.4. Threat of new entrant
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political landscape
      • 3.3.2.2. Technological landscape
      • 3.3.2.3. Economic landscape

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

  • 4.1. Service Market Share, 2023 & 2030
  • 4.2. Segment Dashboard
  • 4.3. U.S. Regulatory Affairs Market by Service Outlook
  • 4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 4.4.1. Regulatory Consulting
      • 4.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.2. Legal Representation
      • 4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.3. Regulatory Writing & Publishing
      • 4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.4.3.1.1. Writing
      • 4.4.3.1.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.4.3.1.2. Publishing
      • 4.4.3.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.4. Product Registration & Clinical Trial Applications
      • 4.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.5. Other Services
      • 4.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 5.1. Category Market Share, 2023 & 2030
  • 5.2. Segment Dashboard
  • 5.3. U.S. Regulatory Affairs Market by Category Outlook
  • 5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 5.4.1. Drugs
      • 5.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2. Innovator
      • 5.4.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.2. Preclinical
      • 5.4.1.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.3. Clinical
      • 5.4.1.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.4. Pre-Maker Approval (PMA)
      • 5.4.1.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3. Generics
      • 5.4.1.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.2. Preclinical
      • 5.4.1.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.3. Clinical
      • 5.4.1.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.4. Pre-Maker Approval (PMA)
      • 5.4.1.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.2. Biologics
      • 5.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2. Biotech
      • 5.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.2. Preclinical
      • 5.4.2.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.3. Clinical
      • 5.4.2.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.4. Pre-Maker Approval (PMA)
      • 5.4.2.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3. ATMP
      • 5.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.2. Preclinical
      • 5.4.2.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.3. Clinical
      • 5.4.2.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.4. Pre-Maker Approval (PMA)
      • 5.4.2.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.3. Biosimilars
      • 5.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.2. Preclinical
      • 5.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.3. Clinical
      • 5.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.4. Pre-Maker Approval (PMA)
      • 5.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.4. Medical Devices
      • 5.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2. Diagnostics
      • 5.4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.2. Preclinical
      • 5.4.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.3. Clinical
      • 5.4.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.4. Pre-Maker Approval (PMA)
      • 5.4.4.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3. Therapeutics
      • 5.4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.2. Preclinical
      • 5.4.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.3. Clinical
      • 5.4.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.4. Pre-Maker Approval (PMA)
      • 5.4.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 6.1. Indication Market Share, 2023 & 2030
  • 6.2. Segment Dashboard
  • 6.3. U.S. Regulatory Affairs Market by Indication Outlook
  • 6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 6.4.1. Oncology
      • 6.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2. Neurology
      • 6.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.3. Cardiology
      • 6.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.4. Immunology
      • 6.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.5. Others
      • 6.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 7.1. Product Stage Market Share, 2023 & 2030
  • 7.2. Segment Dashboard
  • 7.3. U.S. Regulatory Affairs Market by Product Stage Outlook
  • 7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 7.4.1. Preclinical
      • 7.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 7.4.2. Clinical studies
      • 7.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 7.4.3. PMA
      • 7.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 8. U.S. Regulatory Affairs Market: Service Provider Estimates & Trend Analysis

  • 8.1. Service Provider Market Share, 2023 & 2030
  • 8.2. Segment Dashboard
  • 8.3. U.S. Regulatory Affairs Market by Service Provider Outlook
  • 8.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 8.4.1. In-house
      • 8.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 8.4.2. Outsourced
      • 8.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 9.1. Company Size Market Share, 2023 & 2030
  • 9.2. Segment Dashboard
  • 9.3. U.S. Regulatory Affairs Market by Company Size Outlook
  • 9.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 9.4.1. Small
      • 9.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 9.4.2. Medium
      • 9.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 9.4.3. Large
      • 9.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 10.1. End-use Market Share, 2023 & 2030
  • 10.2. Segment Dashboard
  • 10.3. U.S. Regulatory Affairs Market by End-use Outlook
  • 10.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 10.4.1. Medical Device Companies
      • 10.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 10.4.2. Pharmaceutical Companies
      • 10.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 10.4.3. Biotechnology Companies
      • 10.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 11. U.S. Regulatory Affairs Market: Region Estimates & Trend Analysis

  • 11.1. Regional Market Share, 2023 & 2030
  • 11.2. U.S. Regulatory Affairs Market by Region Outlook
  • 11.3. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
    • 11.3.1. West
      • 11.3.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.2. Midwest
      • 11.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.3. Northeast
      • 11.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.4. Southwest
      • 11.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.5. Southeast
      • 11.3.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 12. Competitive Landscape

  • 12.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 12.2. Company/Competition Categorization
  • 12.3. Vendor Landscape
    • 12.3.1. List of key distributors and channel partners
    • 12.3.2. Key customers
    • 12.3.3. Key company market share analysis, 2023
  • 12.4. Company Profiles
    • 12.4.1. Accell Clinical Research, LLC
      • 12.4.1.1. Company overview
      • 12.4.1.2. Financial performance
      • 12.4.1.3. Product benchmarking
      • 12.4.1.4. Strategic initiatives
    • 12.4.2. Genpact
      • 12.4.2.1. Company overview
      • 12.4.2.2. Financial performance
      • 12.4.2.3. Product benchmarking
      • 12.4.2.4. Strategic initiatives
    • 12.4.3. CRITERIUM, INC.
      • 12.4.3.1. Company overview
      • 12.4.3.2. Financial performance
      • 12.4.3.3. Product benchmarking
      • 12.4.3.4. Strategic initiatives
    • 12.4.4. ICON plc
      • 12.4.4.1. Company overview
      • 12.4.4.2. Financial performance
      • 12.4.4.3. Product benchmarking
      • 12.4.4.4. Strategic initiatives
    • 12.4.5. Promedica International
      • 12.4.5.1. Company overview
      • 12.4.5.2. Financial performance
      • 12.4.5.3. Product benchmarking
      • 12.4.5.4. Strategic initiatives
    • 12.4.6. WuXi AppTec
      • 12.4.6.1. Company overview
      • 12.4.6.2. Financial performance
      • 12.4.6.3. Product benchmarking
      • 12.4.6.4. Strategic initiatives
    • 12.4.7. Medpace
      • 12.4.7.1. Company overview
      • 12.4.7.2. Financial performance
      • 12.4.7.3. Product benchmarking
      • 12.4.7.4. Strategic initiatives
    • 12.4.8. Charles River Laboratories
      • 12.4.8.1. Company overview
      • 12.4.8.2. Financial performance
      • 12.4.8.3. Product benchmarking
      • 12.4.8.4. Strategic initiatives
    • 12.4.9. Labcorp Drug Development
      • 12.4.9.1. Company overview
      • 12.4.9.2. Financial performance
      • 12.4.9.3. Product benchmarking
      • 12.4.9.4. Strategic initiatives
    • 12.4.10. Parexel International (MA) Corporation
      • 12.4.10.1. Company overview
      • 12.4.10.2. Financial performance
      • 12.4.10.3. Product benchmarking
      • 12.4.10.4. Strategic initiatives
    • 12.4.11. Freyr
      • 12.4.11.1. Company overview
      • 12.4.11.2. Financial performance
      • 12.4.11.3. Product benchmarking
      • 12.4.11.4. Strategic initiatives
    • 12.4.12. Pharmalex GmbH
      • 12.4.12.1. Company overview
      • 12.4.12.2. Financial performance
      • 12.4.12.3. Product benchmarking
      • 12.4.12.4. Strategic initiatives
    • 12.4.13. NDA Group AB
      • 12.4.13.1. Company overview
      • 12.4.13.2. Financial performance
      • 12.4.13.3. Product benchmarking
      • 12.4.13.4. Strategic initiatives
    • 12.4.14. Qvigilance
      • 12.4.14.1. Company overview
      • 12.4.14.2. Financial performance
      • 12.4.14.3. Product benchmarking
      • 12.4.14.4. Strategic initiatives
    • 12.4.15. BlueReg
      • 12.4.15.1. Company overview
      • 12.4.15.2. Financial performance
      • 12.4.15.3. Product benchmarking
      • 12.4.15.4. Strategic initiatives
    • 12.4.16. Cambridge Regulatory Services
      • 12.4.16.1. Company overview
      • 12.4.16.2. Financial performance
      • 12.4.16.3. Product benchmarking
      • 12.4.16.4. Strategic initiatives
    • 12.4.17. VCLS
      • 12.4.17.1. Company overview
      • 12.4.17.2. Financial performance
      • 12.4.17.3. Product benchmarking
      • 12.4.17.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. regulatory affairs market, by services, 2018 - 2030 (USD Million)
  • Table 3 U.S. regulatory affairs market, by writing & publishing, 2018 - 2030 (USD Million)
  • Table 4 U.S. regulatory affairs market, by category, 2018 - 2030 (USD Million)
  • Table 5 U.S. regulatory affairs market, by drugs, 2018 - 2030 (USD Million)
  • Table 6 U.S. regulatory affairs market, by innovator, 2018 - 2030 (USD Million)
  • Table 7 U.S. regulatory affairs market, by generics, 2018 - 2030 (USD Million)
  • Table 8 U.S. regulatory affairs market, by biologics, 2018 - 2030 (USD Million)
  • Table 9 U.S. regulatory affairs market, by biotech, 2018 - 2030 (USD Million)
  • Table 10 U.S. regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 11 U.S. regulatory affairs market, by biosimilars, 2018 - 2030 (USD Million)
  • Table 12 U.S. regulatory affairs market, by medical devices, 2018 - 2030 (USD Million)
  • Table 13 U.S. regulatory affairs market, by diagnostics, 2018 - 2030 (USD Million)
  • Table 14 U.S. regulatory affairs market, by therapeutics, 2018 - 2030 (USD Million)
  • Table 15 U.S. regulatory affairs market, by indication, 2018 - 2030 (USD Million)
  • Table 16 U.S. regulatory affairs market, by product stage, 2018 - 2030 (USD Million)
  • Table 17 U.S. regulatory affairs market, by service provider, 2018 - 2030 (USD Million)
  • Table 18 U.S. regulatory affairs market, by company size, 2018 - 2030 (USD Million)
  • Table 19 U.S. regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 20 U.S. regulatory affairs market, by region, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Value-chain-based sizing & forecasting
  • Fig. 6 QFD modeling for market share assessment
  • Fig. 7 Market formulation & validation
  • Fig. 8 U.S. regulatory affairs market: market outlook
  • Fig. 9 U.S. regulatory affairs competitive insights
  • Fig. 10 Parent market outlook
  • Fig. 11 Related/ancillary market outlook
  • Fig. 12 Penetration and growth prospect mapping
  • Fig. 13 U.S. regulatory affairs market driver impact
  • Fig. 14 U.S. regulatory affairs market restraint impact
  • Fig. 15 U.S. regulatory affairs market: Services movement analysis
  • Fig. 16 U.S. regulatory affairs market: Services outlook and key takeaways
  • Fig. 17 Regulatory consulting market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 18 Legal representation estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 19 Regulatory writing & publishing market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 20 Writing estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 21 Publishing market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 22 Product Registration & Clinical Trial Applications market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 23 Others services estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 24 U.S. regulatory affairs market: Category movement Analysis
  • Fig. 25 U.S. regulatory affairs market: Category outlook and key takeaways
  • Fig. 26 Drugs market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 27 Innovator market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 28 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 29 Generics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 30 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 31 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 32 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 33 Biologics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 34 Biotech market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 35 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 36 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 37 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 38 ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 39 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 40 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 41 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 42 Biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 43 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 44 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 45 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 46 Medical Devices market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 47 Diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 48 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 49 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 50 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 51 Therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 52 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 53 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 54 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 55 U.S. regulatory affairs market: indication movement analysis
  • Fig. 56 U.S. regulatory affairs market: indication outlook and key takeaways
  • Fig. 57 Oncology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 58 Neurology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 59 Cardiology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 60 Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 61 Others market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 62 U.S. regulatory affairs market: product stage outlook and key takeaways
  • Fig. 63 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 64 Clinical studies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 65 PMA market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 66 U.S. regulatory affairs market: service provider outlook and key takeaways
  • Fig. 67 In-house market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 68 Outsourced market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 69 U.S. regulatory affairs market: company size outlook and key takeaways
  • Fig. 70 Small market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 71 Medium market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 72 Large market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 73 U.S. regulatory affairs market: end-use outlook and key takeaways
  • Fig. 74 Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 75 Pharmaceutical companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 76 Biotechnology companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 77 U.S. regulatory affairs market: Regional movement analysis
  • Fig. 78 U.S. regulatory affairs market: Regional outlook and key takeaways
  • Fig. 79 West market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 80 Midwest market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 81 Northeast market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 82 Southwest market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 83 Southeast market estimates and forecasts, 2018 - 2030 (USD Million)