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市場調查報告書
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1493304

美國監管備案市場規模、佔有率和趨勢分析報告：按服務、類別、適應症、產品階段、服務供應商、公司規模、最終用途和細分市場預測，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個工作天內

價格

美國監管備案市場的成長與趨勢：

Grand View Research, Inc.最新報告顯示，到2030年，美國藥品監管市場規模預計將達到77.1億美元，預測期內複合年成長率為9.0%。

監管環境不斷發展並變得更加複雜，定期推出新的法律和準則。這種複雜性推動了對能夠處理這些複雜要求的監管專業人員的需求。

隨著公司在全球擴張，由於各國的法規各不相同，合規性變得更加困難。監管專家幫助公司了解國際法律規範並確保市場准入。例如，根據路透社 2024 年 1 月的通訊，許多美國律師事務所預計將在 2024 年簽訂合併協議。 Stockton & Kilpatrick Townsend 最近宣布與一家小型企業合併。此外，Fennemore Craig 是一家在鳳凰城成立的中型公司，今年宣布將業務擴展到西雅圖。

監管機構優先考慮患者安全和產品質量，並制定了公司必須遵守的嚴格規定。監管負責人對於確保產品符合這些標準並加快核准流程至關重要。隨著醫療保健行業的擴張和競爭的加劇，公司需要透過有效遵守法規來保持領先地位。業務專業知識提供了競爭優勢，可以將產品更快推向市場，同時滿足監管要求。

美國監管應用市場報告亮點

  • 到 2023 年，隨著中型和大型醫療設備和生物製藥公司擴大將這些服務外包，監管寫作和出版將佔服務業的 16% 以上佔有率。
  • 預計法律代理領域在預測期內將以最快的複合年成長率成長。
  • 2023年，醫療設備產業佔最大的市場佔有率。這是因為製藥公司擴大外包醫療設備，使他們能夠專注於自己的核心業務。
  • 2023 年，腫瘤學佔據最大的市場收益佔有率。這是由於癌症患者的盛行率不斷增加以及對有效和安全的治療方法方案的需求不斷增加。
  • 由於免疫學能夠促進多種神經、心血管、發炎和腫瘤疾病的治療，預計在預測期內，免疫學領域將以 10.5% 的複合年成長率成長最快。
  • 由於新疾病的出現和慢性病的增加，臨床研究在 2023 年佔據最大的市場收益佔有率。
  • 外包服務供應商在 2023 年佔據最大的市場收益佔有率，預計在預測期內將以最快的複合年成長率成長。
  • 2023年，中型企業佔據最大的市場收益佔有率，這是由於中型企業，尤其是非上市企業的存在，預計將推動該行業的成長。
  • 預計製藥公司細分市場將在 2023 年佔據市場主導地位，並在預測期內以最快的複合年成長率成長。

目錄

第1章調查方法和範圍

第 2 章執行摘要

第 3 章美國監理申請市場的變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
    • 市場推動要素分析
    • 市場限制因素分析
  • 美國監管業務市場分析工具
    • 產業分析-波特五力分析
    • PESTEL分析

第4章美國藥品申請市場：服務預估與趨勢分析

  • 2023年及2030年服務市場佔有率
  • 細分儀表板
  • 美國監理備案市場的服務前景
  • 2018-2030年市場規模、預測及趨勢分析
  • 醫藥顧問
  • 法律代表
  • 藥物寫作/出版
  • 產品提交/臨床試驗申請
  • 其他服務

第5章美國藥品申請市場：品類估算及趨勢分析

  • 2023年及2030年類別市場佔有率
  • 細分儀表板
  • 美國監管業務市場前景（按類別）
  • 2018-2030年市場規模、預測及趨勢分析
  • 藥品
  • 生物製劑
  • 生物相似藥
  • 醫療設備

第6章美國監理市場：指標估算與趨勢分析

  • 2023年及2030年指示市場佔有率
  • 細分儀表板
  • 美國監理市場展望（按指標）
  • 2018-2030年市場規模、預測及趨勢分析
  • 腫瘤學
  • 神經
  • 循環系統
  • 免疫學
  • 其他

第7章美國藥品申請市場：產品階段估算及趨勢分析

  • 2023 年及 2030 年產品階段市場佔有率
  • 細分儀表板
  • 美國監理備案市場：按產品階段分類的前景
  • 2018-2030年市場規模、預測及趨勢分析
  • 臨床前
  • 臨床研究
  • PMA

第8章美國監理監理應用市場：服務供應商預估及趨勢分析

  • 2023年及2030年服務供應商市場佔有率
  • 細分儀表板
  • 美國監管業務市場服務供應商展望
  • 2018-2030年市場規模、預測及趨勢分析
  • 公司內部
  • 外包

第9章美國藥品申請市場：公司規模估算及趨勢分析

  • 2023年及2030年企業規模市場佔有率
  • 細分儀表板
  • 按公司規模分類的美國監理備案市場前景
  • 2018-2030年市場規模、預測及趨勢分析
  • 小規模
  • 中等大小
  • 規模大

第10章美國監理應用市場：最終用途估計與趨勢分析

  • 2023 年及 2030 年最終用途市場佔有率
  • 細分儀表板
  • 按最終用途分類的美國監理備案市場前景
  • 2018-2030年市場規模、預測及趨勢分析
  • 醫療設備公司
  • 製藥公司
  • 生技公司

第11章美國醫藥應用市場：區域估計與趨勢分析

  • 2023 年和 2030 年按地區分類的市場佔有率佔有率
  • 按地區分類的美國監理備案市場前景
  • 2018-2030年市場規模、預測及趨勢分析
  • 西
  • 中西部
  • 東北
  • 西南
  • 東南

第12章競爭格局

  • 主要市場參與企業的最新趨勢和影響分析
  • 公司/競爭對手分類
  • 供應商情況
  • 公司簡介
    • 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)