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市場調查報告書
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1301010

監管事務市場規模、份額和趨勢分析報告：按服務、按類別、按服務提供商、按公司規模、按產品階段、按適應症、按最終用途、按地區、細分市場趨勢，2023年～2030年

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Categories, By Service Provider, By Company Size, By Product Stage, By Indication, By End-use, By Region, And Segment Forecasts, 2023 - 2030
出版日期: | 出版商: Grand View Research | 英文 175 Pages | 商品交期: 2-10個工作天內

價格

監管事務市場增長和趨勢

GrandView Research, Inc. 最新報告顯示，2023 年至 2030 年，全球監管事務市場將以 8.7% 的複合年增長率增長，到 2030 年將達到 270 億美元，預計將達到

預計將促進市場增長的因素包括業務活動和地理位置不斷變化的監管要求、由於監管審批速度加快而增加的臨床試驗和藥物審批以及監管機構的軟件技術進步等。 促進市場增長的其他因素包括個性化藥物的發展、公司越來越需要專注於其核心業務活動以及經濟和市場競爭壓力。

製藥公司和監管機構聯手快速開發對抗 COVID-19 感染所需的疫苗和醫療產品。 監管機構採取許多預防措施來確保臨床試驗期間患者和人員的安全，並保持數據完整性和良好的實驗室實踐。 生物仿製藥、孤兒藥、個性化藥物、伴隨診斷和適應症研究設計的市場增長預計將推動對這些領域監管專業知識的需求。 隨著公司向新領域擴張，遵守法規的需求不斷增加，從而推動了對具有監管事務專業知識的專業服務提供商的需求。 Simlect、Vectibix、Mircera 和 Kineret 等生物製劑的專利到期增加了生物仿製藥的需求和開發，從而促進了對監管服務的需求。

為了在個性化醫療市場佔據領先地位，多家公司正在積極致力於合作夥伴關係和新產品開發，這表明需要監管事務的支持。 例如，2020 年 5 月，Regeneron Pharmaceuticals, Inc. 與科羅拉多州個性化醫療中心合作，設計個性化醫療和人類遺傳學方面的進展。

監管事務市場報告要點

  • 按服務劃分，監管寫作和出版部門在 2022 年佔據市場主導地位，銷售額份額為 36.6%。 這是由於大中型醫療器械和生物製藥公司外包這些服務的增加。
  • 有跡象表明，到 2022 年，腫瘤領域將佔據最大的銷售額份額，達到 32.9%。 這一細分市場的份額歸因於癌症的高患病率創造了對安全有效治療的需求。
  • 根據最終用途，預計 2023 年至 2030 年製藥公司細分市場的增長率最高，為 9.0%。 批准藥物數量的增加是該領域增長的主要驅動力。
  • 按公司規模劃分，中型企業細分市場將在 2022 年主導全球市場，佔當年總銷售額的最大份額，超過 47.0%。 越來越多的中型公司正在進入監管事務市場。 因此，在2022年和2022年整體上，該細分市場將佔有很大份額。
  • 按類別劃分，生物製劑領域預計在分析期間將以 8.0% 的速度穩定增長。 生物製品管道的增加進一步推動了對監管服務的需求，從而支持了該領域的增長。
  • 按產品階段劃分，臨床前細分市場預計在分析期間將實現 9.4% 的最快增長。 該細分市場的高增長主要歸因於全球小分子和生物仿製藥管道的不斷增長。
  • 在服務提供商細分市場中，外包細分市場預計在分析期間將實現 10.3% 的最快增長。 該領域的高速增長在很大程度上歸因於對具有成本效益的合同服務的需求不斷增長。
  • 由於監管環境的改善和生物製藥公司風險投資活動的增加，預計亞太地區在預測期內將增長 9.3%。

內容

第一章調查方法及範圍

  • 市場細分和範圍
  • 區域範圍
  • 估計/預測時間表
  • 目的
  • 調查方法
  • 信息獲取
  • 信息或數據分析
  • 市場形成和驗證
  • 型號詳細信息
  • 輔助信息列表
  • 縮寫列表

第 2 章執行摘要

  • 市場前景
  • 分部展望
  • 競爭考慮因素

第三章監管事務市場變量、趨勢和範圍

  • 市場體系展望
    • 母公司市場前景
    • 相關/補充市場前景
  • 市場動態
    • 市場驅動因素分析
    • 市場製約因素分析
    • 行業問題
    • 主要交易和戰略聯盟分析
    • 生物技術和先進治療藥物 (ATMP) 領域的重大交易和戰略聯盟分析
  • 監管事務市場分析工具
    • 行業分析-波特分析
    • PESTEL 分析
    • SWOT分析
    • COVID-19 感染的影響分析

第 4 章監管事務市場：服務評估和趨勢分析

  • 監管事務市場，按服務分類：細分儀表板
  • 監管事務市場，按服務分類：波動分析
    • 監管諮詢
    • 法定代表人
    • 法規的製定和發布
    • 產品註冊及臨床試驗申請
    • 其他受監管的服務

第五章監管事務市場：品類估算與趨勢分析

  • 監管事務市場，按類別：細分儀表板
  • 監管事務市場，按類別：動態分析
    • 藥品
    • 生物製劑
    • 醫療設備

第六章監管事務市場：指標估算與趨勢分析

  • 監管事務市場，按指標劃分：細分儀表板
  • 監管事務市場，按指標：變化分析
    • 腫瘤
    • 神經
    • 心髒病
    • 血
    • 免疫
    • 其他

第 7 章監管事務市場：服務提供商細分市場估計和趨勢分析

  • 監管事務市場，按服務提供商細分：細分儀表板
  • 監管事務市場，按服務提供商細分：動態分析
    • 內部
    • 外包

第八章監管事務市場：公司規模估算及趨勢分析

  • 監管事務市場，按公司規模劃分：細分儀表板
  • 按公司規模劃分的監管事務市場：波動分析
    • 緊湊型
    • 中
    • 大公司

第九章監管事務市場：產品階段評估與趨勢分析

  • 監管事務市場，按產品階段：細分儀表板
  • 按產品階段劃分的監管事務市場：波動分析
    • 臨床前
    • 臨床
    • PMA

第 10 章監管事務市場：最終用途估算和趨勢分析

  • 監管事務市場，按最終用途：細分儀表板
  • 監管事務市場，按最終用途：變化分析
    • 醫療器械公司
    • 製藥公司
    • 生物科技公司

第十一章監管事務市場：區域估算與趨勢分析

  • 2022 年和 2030 年區域市場份額分析
  • 區域市場儀表板
  • 全球區域市場概況
  • 北美
    • 2018-2030 年市場預估和預測（收入）
    • 美國
    • 加拿大
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 意大利
    • 西班牙
    • 俄羅斯
    • 土耳其
    • 荷蘭
    • 瑞士
    • 瑞典
  • 亞太地區
    • 日本
    • 印度
    • 中國
    • 韓國
    • 澳大利亞
    • 泰國
    • 印度尼西亞
    • 馬來西亞
    • 新加坡
    • 台灣
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
    • 哥倫比亞
    • 智利
  • 中東和非洲
    • 南非
    • 沙特阿拉伯
    • 阿拉伯聯合酋長國
    • 埃及
    • 以色列

第12章競爭格局

  • 市場進入者分類
    • 創新者
    • 市場領導者
    • 新興玩家
    • 2022 年公司市場份額分析
  • 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 Corporation
    • Freyr
    • Pharmalex GmbH
    • NDA Group AB
    • Pharmexon
    • Qvigilance
    • BlueReg
    • Cambridge Regulatory Services
    • VCLS

第 13 章 Kol 評論/主要建議

Product Code: GVR-4-68039-065-9

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market is expected to reach USD 27.0 billion by 2030, expanding at a CAGR of 8.7% from 2023 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

Regulatory Affairs Market Report Highlights

  • In terms of services, the regulatory writing & publishing segment dominated the market in 2022 with a revenue share of 36.6%. This is due to an increase in the outsourcing of these services by large- and mid-size medical device and biopharmaceutical companies
  • Based on indications, the oncology segment accounted for the largest revenue share, 32.9%, in 2022. The segment share is attributed to the high prevalence of cancer, which is creating the need for safe and effective treatments
  • Based on end-use, the pharmaceutical companies segment is anticipated to witness the highest growth rate of 9.0% from 2023 to 2030. A rise in the number of approved pharmaceutical products is the key factor responsible for the segment's growth
  • Based on company size, the medium-sized companies segment dominated the global market in 2022 and accounted for the largest share of more than 47.0% of the overall revenue in the same year. An increasing number of medium-sized companies are penetrating the regulatory affairs market. Thereby, the segment held the lion's share in 2022 and across.
  • Based on category, the biologics segment is anticipated to witness a stable growth rate of 8.0% during the analysis timeframe. The increasing pipeline of biologics to further boosts demand for its regulatory services, thus supporting segmental growth.
  • Based on the product stage segment, the preclinical segment is anticipated to register the fastest growth of 9.4% across the analysis period. The high growth of the segment is majorly due to the increasing pipeline of small molecules and biosimilars across the globe.
  • Based on the service provider segment, the outsourcing segment is anticipated to register the fastest growth of 10.3% across the analysis period. The high growth of the segment is majorly due to the increasing demand for cost-effective contract services.
  • Asia Pacific is projected to witness the fastest growth rate of 9.3% during the forecast period on account of the improved regulatory landscape and growing venture activities by biopharmaceutical companies.

Table of Content

Chapter 1. Research Methodology And Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Segment Definitions
    • 1.1.2. Services
    • 1.1.3. Categories
    • 1.1.4. Indication
  • 1.2. Regional Scope
  • 1.3. Estimates And Forecast Timeline
  • 1.4. Objectives
    • 1.4.1. Objective - 1
    • 1.4.2. Objective - 2
    • 1.4.3. Objective - 3
  • 1.5. Research Methodology
  • 1.6. Information Procurement
    • 1.6.1. Purchased Database
    • 1.6.2. GVR's Internal Database
    • 1.6.3. Secondary Sources
    • 1.6.4. Primary Research
  • 1.7. Information Or Data Analysis
    • 1.7.1. Data Analysis Models
  • 1.8. Market Formulation & Validation
  • 1.9. Model Details
    • 1.9.1. Commodity Flow Analysis
    • 1.9.2. Parent Market Analysis
  • 1.10. List Of Secondary Sources
  • 1.11. List Of Abbreviations

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. 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. Entry Of Companies Into The Global Market
      • 3.2.1.3. Life Science Companies Focusing On Their Core Competencies
      • 3.2.1.4. Economic And Competitive Pressures
      • 3.2.1.5. Demand For The Faster Approval Process For Breakthrough Drugs And Devices
      • 3.2.1.6. 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. Industry Challenges
      • 3.2.3.1. Managing Relationships
    • 3.2.4. Major Deals and Strategic Alliances Analysis
      • 3.2.4.1. Acquisition
      • 3.2.4.2. Joint Venture
      • 3.2.4.3. Expansions
      • 3.2.4.4. Partnerships & Collaborations
      • 3.2.4.5. Technology Advancements & Service Launches
    • 3.2.5. Major Deals and Strategic Alliances Analysis of Biotech & Advanced Therapy Medicinal Products (ATMPs)
  • 3.3. 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
    • 3.3.3. SWOT Analysis
    • 3.3.4. COVID-19 Impact Analysis
      • 3.3.4.1. COVID-19 Impact on Clinical Trials Services
      • 3.3.4.2. COVID-19 Impact on Regulatory Services
      • 3.3.4.3. COVID-19 Impact on Key Players
      • 3.3.4.3.1. Medpace
      • 3.3.4.3.2. Icon Plc
      • 3.3.4.3.3. Charles River Laboratories
      • 3.3.4.3.4. Labcorp Drug Development
      • 3.3.4.4. Post COVID-19 Market Scenario

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

  • 4.1. Regulatory Affairs Market, By Services: Segment Dashboard
  • 4.2. Regulatory Affairs Market, By Services: Movement Analysis
  • 4.3. Regulatory Affairs Market Estimates & Forecasts, By Services, 2018 - 2030
    • 4.3.1. Regulatory Consulting
      • 4.3.1.1. Regulatory Consulting Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.2. Legal Representation
      • 4.3.2.1. Legal Representation Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.3. Regulatory Writing and Publishing
      • 4.3.3.1. Regulatory Writing and Publishing Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 4.3.3.2. Writing
      • 4.3.3.2.1. Writing Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 4.3.3.3. Publishing
      • 4.3.3.3.1. Publishing Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.4. Product Registration and Clinical Trial Application
      • 4.3.4.1. Product Registration and Clinical Trial Application Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.5. Other Regulatory Services
      • 4.3.5.1. Other Regulatory Services Regulatory Affairs Market, 2018 to 2030 (USD Million)

Chapter 5. Regulatory Affairs Market: Categories Estimates & Trend Analysis

  • 5.1. Regulatory Affairs Market, By Categories: Segment Dashboard
  • 5.2. Regulatory Affairs Market, By Categories: Movement Analysis
  • 5.3. Regulatory Affairs Market Estimates & Forecasts, By Categories, 2018 - 2030
    • 5.3.1. Drugs
      • 5.3.1.1. Drugs Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2. Innovator
      • 5.3.1.2.1. Innovator Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.2. Preclinical
      • 5.3.1.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.3. Clinical
      • 5.3.1.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.4. PMA
      • 5.3.1.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3. Generics
      • 5.3.1.3.1. Generics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.2. Preclinical
      • 5.3.1.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.3. Clinical
      • 5.3.1.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.4. PMA
      • 5.3.1.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 5.3.2. Biologics
      • 5.3.2.1. Biologics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2. Biotech
      • 5.3.2.2.1. Biotech Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.2. Preclinical
      • 5.3.2.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.3. Clinical
      • 5.3.2.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.4. PMA
      • 5.3.2.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3. ATMP
      • 5.3.2.3.1. ATMP Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.2. Preclinical
      • 5.3.2.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.3. Clinical
      • 5.3.2.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.4. PMA
      • 5.3.2.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4. Biosimilars
      • 5.3.2.4.1. Biosimilars Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.2. Preclinical
      • 5.3.2.4.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.3. Clinical
      • 5.3.2.4.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.4. PMA
      • 5.3.2.4.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 5.3.3. Medical Devices
      • 5.3.3.1. Medical Devices Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2. Diagnostics
      • 5.3.3.2.1. Diagnostics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.2. Preclinical
      • 5.3.3.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.3. Clinical
      • 5.3.3.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.4. PMA
      • 5.3.3.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3. Therapeutics
      • 5.3.3.3.1. Therapeutics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.2. Preclinical
      • 5.3.3.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.3. Clinical
      • 5.3.3.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.4. PMA
      • 5.3.3.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)

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

  • 6.1. Regulatory Affairs Market, By Indication: Segment Dashboard
  • 6.2. Regulatory Affairs Market, By Indication: Movement Analysis
  • 6.3. Regulatory Affairs Market Estimates & Forecasts, By Indication, 2018 - 2030
    • 6.3.1. Oncology
      • 6.3.1.1. Oncology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.2. Neurology
      • 6.3.2.1. Neurology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.3. Cardiology
      • 6.3.3.1. Cardiology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.4. Hematology
      • 6.3.4.1. Hematology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.5. Immunology
      • 6.3.5.1. Immunology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.6. Others
      • 6.3.6.1. Others Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 7. Regulatory Affairs Market: Service Provider Segment Estimates & Trend Analysis

  • 7.1. Regulatory Affairs Market, By Service Provider Segment: Segment Dashboard
  • 7.2. Regulatory Affairs Market, By Service Provider Segment: Movement Analysis
  • 7.3. Regulatory Affairs Market Estimates & Forecasts, By Service Provider Segment, 2018 - 2030
    • 7.3.1. In-house
      • 7.3.1.1. In-house Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 7.3.2. Outsourcing
      • 7.3.2.1. Outsourcing Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 8. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

  • 8.1. Regulatory Affairs Market, By Company Size: Segment Dashboard
  • 8.2. Regulatory Affairs Market, By Company Size: Movement Analysis
  • 8.3. Regulatory Affairs Market Estimates & Forecasts, By Company Size, 2018 - 2030
    • 8.3.1. Small-sized
      • 8.3.1.1. Small-sized Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 8.3.2. Medium-sized
      • 8.3.2.1. Medium-sized Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 8.3.3. Large Companies
      • 8.3.3.1. Large Companies Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 9. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

  • 9.1. Regulatory Affairs Market, By Product Stage: Segment Dashboard
  • 9.2. Regulatory Affairs Market, By Product Stage: Movement Analysis
  • 9.3. Regulatory Affairs Market Estimates & Forecasts, By Product Stage, 2018 - 2030
    • 9.3.1. Preclinical
      • 9.3.1.1. Preclinical Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 9.3.2. Clinical
      • 9.3.2.1. Clinical Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 9.3.3. PMA
      • 9.3.3.1. PMA Regulatory Affairs Market 2018 to 2030 (USD Million)

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

  • 10.1. Regulatory Affairs Market, By End-use: Segment Dashboard
  • 10.2. Regulatory Affairs Market, By End-use: Movement Analysis
  • 10.3. Regulatory Affairs Market Estimates & Forecasts, By End-use, 2018 - 2030
    • 10.3.1. Medical Device Companies
      • 10.3.1.1. Medical Device Companies Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 10.3.2. Pharmaceutical Companies
      • 10.3.2.1. Pharmaceutical Companies Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 10.3.3. Biotechnology Companies
      • 10.3.3.1. Biotechnology Companies Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

  • 11.1. Regional Market Share Analysis, 2022 & 2030
  • 11.2. Regional Market Dashboard
  • 11.3. Global Regional Market Snapshot
  • 11.4. North America
    • 11.4.1. Market Estimates and Forecast, 2018 - 2030 (Revenue, USD Million)
    • 11.4.2. U.S.
      • 11.4.2.1. Key Country Dynamics
      • 11.4.2.2. Competitive Scenario
      • 11.4.2.3. Regulatory Framework
      • 11.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030
    • 11.4.3. Canada
      • 11.4.3.1. Key Country Dynamics
      • 11.4.3.2. Competitive Scenario
      • 11.4.3.3. Regulatory Framework
      • 11.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030
  • 11.5. Europe
    • 11.5.1. UK
      • 11.5.1.1. Key Country Dynamics
      • 11.5.1.2. Competitive Scenario
      • 11.5.1.3. Regulatory Framework
      • 11.5.1.4. UK Market Estimates and Forecasts, 2018 - 2030
    • 11.5.2. Germany
      • 11.5.2.1. Key Country Dynamics
      • 11.5.2.2. Competitive Scenario
      • 11.5.2.3. Regulatory Framework
      • 11.5.2.4. Germany Market Estimates and Forecasts, 2018 - 2030
    • 11.5.3. France
      • 11.5.3.1. Key Country Dynamics
      • 11.5.3.2. Competitive Scenario
      • 11.5.3.3. Regulatory Framework
      • 11.5.3.4. France Market Estimates and Forecasts, 2018 - 2030
    • 11.5.4. Italy
      • 11.5.4.1. Key Country Dynamics
      • 11.5.4.2. Competitive Scenario
      • 11.5.4.3. Regulatory Framework
      • 11.5.4.4. Italy Market Estimates and Forecasts, 2018 - 2030
    • 11.5.5. Spain
      • 11.5.5.1. Key Country Dynamics
      • 11.5.5.2. Competitive Scenario
      • 11.5.5.3. Regulatory Framework
      • 11.5.5.4. Spain Market Estimates and Forecasts, 2018 - 2030
    • 11.5.6. Russia
      • 11.5.6.1. Key Country Dynamics
      • 11.5.6.2. Competitive Scenario
      • 11.5.6.3. Regulatory Framework
      • 11.5.6.4. Russia Market Estimates and Forecasts, 2018 - 2030
    • 11.5.7. Turkey
      • 11.5.7.1. Key Country Dynamics
      • 11.5.7.2. Competitive Scenario
      • 11.5.7.3. Regulatory Framework
      • 11.5.7.4. Turkey Market Estimates and Forecasts, 2018 - 2030
    • 11.5.8. Netherlands
      • 11.5.8.1. Key Country Dynamics
      • 11.5.8.2. Competitive Scenario
      • 11.5.8.3. Regulatory Framework
      • 11.5.8.4. Netherlands Market Estimates and Forecasts, 2018 - 2030
    • 11.5.9. Switzerland
      • 11.5.9.1. Key Country Dynamics
      • 11.5.9.2. Competitive Scenario
      • 11.5.9.3. Regulatory Framework
      • 11.5.9.4. Switzerland Market Estimates and Forecasts, 2018 - 2030
    • 11.5.10. Sweden
      • 11.5.10.1. Key Country Dynamics
      • 11.5.10.2. Competitive Scenario
      • 11.5.10.3. Regulatory Framework
      • 11.5.10.4. Sweden Market Estimates and Forecasts, 2018 - 2030
  • 11.6. Asia Pacific
    • 11.6.1. Japan
      • 11.6.1.1. Key Country Dynamics
      • 11.6.1.2. Competitive Scenario
      • 11.6.1.3. Regulatory Framework
      • 11.6.1.4. Japan Market Estimates and Forecasts, 2018 - 2030
    • 11.6.2. India
      • 11.6.2.1. Key Country Dynamics
      • 11.6.2.2. Competitive Scenario
      • 11.6.2.3. Regulatory Framework
      • 11.6.2.4. India Market Estimates and Forecasts, 2018 - 2030
    • 11.6.3. China
      • 11.6.3.1. Key Country Dynamics
      • 11.6.3.2. Competitive Scenario
      • 11.6.3.3. Regulatory Framework
      • 11.6.3.4. China Market Estimates and Forecasts, 2018 - 2030
    • 11.6.4. South Korea
      • 11.6.4.1. Key Country Dynamics
      • 11.6.4.2. Competitive Scenario
      • 11.6.4.3. Regulatory Framework
      • 11.6.4.4. South Korea Market Estimates and Forecasts, 2018 - 2030
    • 11.6.5. Australia
      • 11.6.5.1. Key Country Dynamics
      • 11.6.5.2. Competitive Scenario
      • 11.6.5.3. Regulatory Framework
      • 11.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.6. Thailand
      • 11.6.6.1. Key Country Dynamics
      • 11.6.6.2. Competitive Scenario
      • 11.6.6.3. Regulatory Framework
      • 11.6.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030
    • 11.6.7. Indonesia
      • 11.6.7.1. Key Country Dynamics
      • 11.6.7.2. Competitive Scenario
      • 11.6.7.3. Regulatory Framework
      • 11.6.7.4. Indonesia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.8. Malaysia
      • 11.6.8.1. Key Country Dynamics
      • 11.6.8.2. Competitive Scenario
      • 11.6.8.3. Regulatory Framework
      • 11.6.8.4. Malaysia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.9. Singapore
      • 11.6.9.1. Key Country Dynamics
      • 11.6.9.2. Competitive Scenario
      • 11.6.9.3. Regulatory Framework
      • 11.6.9.4. Singapore Market Estimates and Forecasts, 2018 - 2030
    • 11.6.10. Taiwan
      • 11.6.10.1. Key Country Dynamics
      • 11.6.10.2. Competitive Scenario
      • 11.6.10.3. Regulatory Framework
      • 11.6.10.4. Taiwan Market Estimates and Forecasts, 2018 - 2030
  • 11.7. Latin America
    • 11.7.1. Brazil
      • 11.7.1.1. Key Country Dynamics
      • 11.7.1.2. Competitive Scenario
      • 11.7.1.3. Regulatory Framework
      • 11.7.1.4. Brazil Market Estimates and Forecasts, 2018 - 2030
    • 11.7.2. Mexico
      • 11.7.2.1. Key Country Dynamics
      • 11.7.2.2. Competitive Scenario
      • 11.7.2.3. Regulatory Framework
      • 11.7.2.4. Mexico Market Estimates and Forecasts, 2018 - 2030
    • 11.7.3. Argentina
      • 11.7.3.1. Key Country Dynamics
      • 11.7.3.2. Competitive Scenario
      • 11.7.3.3. Regulatory Framework
      • 11.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030
    • 11.7.4. Colombia
      • 11.7.4.1. Key Country Dynamics
      • 11.7.4.2. Competitive Scenario
      • 11.7.4.3. Regulatory Framework
      • 11.7.4.4. Colombia Market Estimates and Forecasts, 2018 - 2030
    • 11.7.5. Chile
      • 11.7.5.1. Key Country Dynamics
      • 11.7.5.2. Competitive Scenario
      • 11.7.5.3. Regulatory Framework
      • 11.7.5.4. Chile Market Estimates and Forecasts, 2018 - 2030
  • 11.8. Middle East & Africa
    • 11.8.1. South Africa
      • 11.8.1.1. Key Country Dynamics
      • 11.8.1.2. Competitive Scenario
      • 11.8.1.3. Regulatory Framework
      • 11.8.1.4. South Africa Market Estimates and Forecasts, 2018 - 2030
    • 11.8.2. Saudi Arabia
      • 11.8.2.1. Key Country Dynamics
      • 11.8.2.2. Competitive Scenario
      • 11.8.2.3. Regulatory Framework
      • 11.8.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030
    • 11.8.3. UAE
      • 11.8.3.1. Key Country Dynamics
      • 11.8.3.2. Competitive Scenario
      • 11.8.3.3. Regulatory Framework
      • 11.8.3.4. UAE Market Estimates and Forecasts, 2018 - 2030
    • 11.8.4. Egypt
      • 11.8.4.1. Key Country Dynamics
      • 11.8.4.2. Competitive Scenario
      • 11.8.4.3. Regulatory Framework
      • 11.8.4.4. Egypt Market Estimates and Forecasts, 2018 - 2030
    • 11.8.5. Israel
      • 11.8.5.1. Key Country Dynamics
      • 11.8.5.2. Competitive Scenario
      • 11.8.5.3. Regulatory Framework
      • 11.8.5.4. Israel Market Estimates and Forecasts, 2018 - 2030

Chapter 12. Competitive Landscape

  • 12.1. Market Participant Categorization
    • 12.1.1. Innovators
    • 12.1.2. Market Leaders
    • 12.1.3. Emerging Players
    • 12.1.4. Company Market Share Analysis, 2022
  • 12.2. Company Profiles
    • 12.2.1. Accell Clinical Research, LLC
      • 12.2.1.1. Company Overview
      • 12.2.1.2. Financial Performance
      • 12.2.1.3. Service Benchmarking
      • 12.2.1.4. Strategic Initiatives
    • 12.2.2. Genpact
      • 12.2.2.1. Company Overview
      • 12.2.2.2. Financial Performance
      • 12.2.2.3. Service Benchmarking
      • 12.2.2.4. Strategic Initiatives
    • 12.2.3. Criterium, Inc.
      • 12.2.3.1. Company Overview
      • 12.2.3.2. Financial Performance
      • 12.2.3.3. Service Benchmarking
      • 12.2.3.4. Strategic Initiatives
    • 12.2.4. ICON plc
      • 12.2.4.1. Company Overview
      • 12.2.4.2. Financial Performance
      • 12.2.4.3. Service Benchmarking
      • 12.2.4.4. Strategic Initiatives
    • 12.2.5. Promedica International
      • 12.2.5.1. Company Overview
      • 12.2.5.2. Financial Performance
      • 12.2.5.3. Service Benchmarking
      • 12.2.5.4. Strategic Initiatives
    • 12.2.6. WuXi AppTec
      • 12.2.6.1. Company Overview
      • 12.2.6.2. Financial Performance
      • 12.2.6.3. Service Benchmarking
      • 12.2.6.4. Strategic Initiatives
    • 12.2.7. Medpace
      • 12.2.7.1. Company Overview
      • 12.2.7.2. Financial Performance
      • 12.2.7.3. Service Benchmarking
      • 12.2.7.4. Strategic Initiatives
    • 12.2.8. Charles River Laboratories
      • 12.2.8.1. Company Overview
      • 12.2.8.2. Financial Performance
      • 12.2.8.3. Service Benchmarking
      • 12.2.8.4. Strategic Initiatives
    • 12.2.9. Labcorp Drug Development
      • 12.2.9.1. Company Overview
      • 12.2.9.2. Financial Performance
      • 12.2.9.3. Service Benchmarking
      • 12.2.9.4. Strategic Initiatives
    • 12.2.10. Parexel International Corporation
      • 12.2.10.1. Company Overview
      • 12.2.10.2. Financial Performance
      • 12.2.10.3. Service Benchmarking
      • 12.2.10.4. Strategic Initiatives
    • 12.2.11. Freyr
      • 12.2.11.1. Company Overview
      • 12.2.11.2. Financial Performance
      • 12.2.11.3. Service Benchmarking
      • 12.2.11.4. Strategic Initiatives
    • 12.2.12. Pharmalex GmbH
      • 12.2.12.1. Company Overview
      • 12.2.12.2. Financial Performance
      • 12.2.12.3. Service Benchmarking
      • 12.2.12.4. Strategic Initiatives
    • 12.2.13. NDA Group AB
      • 12.2.13.1. Company Overview
      • 12.2.13.2. Financial Performance
      • 12.2.13.3. Service Benchmarking
      • 12.2.13.4. Strategic Initiatives
    • 12.2.14. Pharmexon
      • 12.2.14.1. Company Overview
      • 12.2.14.2. Financial Performance
      • 12.2.14.3. Service Benchmarking
      • 12.2.14.4. Strategic Initiatives
    • 12.2.15. Qvigilance
      • 12.2.15.1. Company Overview
      • 12.2.15.2. Financial Performance
      • 12.2.15.3. Service Benchmarking
      • 12.2.15.4. Strategic Initiatives
    • 12.2.16. BlueReg
      • 12.2.16.1. Company Overview
      • 12.2.16.2. Financial Performance
      • 12.2.16.3. Service Benchmarking
      • 12.2.16.4. Strategic Initiatives
    • 12.2.17. Cambridge Regulatory Services
      • 12.2.17.1. Company Overview
      • 12.2.17.2. Financial Performance
      • 12.2.17.3. Service Benchmarking
      • 12.2.17.4. Strategic Initiatives
    • 12.2.18. VCLS
      • 12.2.18.1. Company Overview
      • 12.2.18.2. Financial Performance
      • 12.2.18.3. Service Benchmarking
      • 12.2.18.4. Strategic Initiatives

Chapter 13. Kol Commentary/Key Recommendations

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of Abbreviations
  • Table 3 Global regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 4 Global regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 5 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 6 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 7 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 8 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 9 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 10 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 11 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 12 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 13 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 14 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 15 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 16 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 17 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 18 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 19 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 20 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 21 Global regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 22 North America regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 23 North America regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 24 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 25 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 26 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 27 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 28 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 29 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 30 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 31 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 32 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 33 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 34 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 35 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 36 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 37 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 38 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 39 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 40 North America Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 41 U.S. regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 42 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 43 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 44 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 45 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 46 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 47 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 48 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 49 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 50 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 51 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 52 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 53 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 54 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 55 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 56 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 57 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 58 U.S. Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 59 Canada regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 60 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 61 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 62 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 63 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 64 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 65 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 66 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 67 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 68 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 69 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 70 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 71 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 72 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 73 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 74 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 75 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 76 Canada Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 77 Europe regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 78 Europe regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 79 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 80 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 81 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 82 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 83 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 84 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 85 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 86 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 87 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 88 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 89 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 90 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 91 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 92 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 93 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 94 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 95 Europe regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 96 U.K. regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 97 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 98 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 99 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 100 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 101 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 102 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 103 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 104 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 105 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 106 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 107 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 108 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 109 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 110 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 111 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 112 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 113 U.K. regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 114 Germany regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 115 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 116 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 117 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 118 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 119 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 120 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 121 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 122 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 123 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 124 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 125 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 126 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 127 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 128 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 129 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 130 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 131 Germany regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 132 France regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 133 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 134 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 135 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 136 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 137 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 138 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 139 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 140 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 141 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 142 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 143 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 144 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 145 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 146 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 147 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 148 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 149 France regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 150 Italy regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 151 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 152 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 153 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 154 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 155 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 156 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 157 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 158 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 159 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 160 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 161 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 162 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 163 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 164 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 165 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 166 Italy Regulatory Affairs Market, By End-Use, 2018 - 2030 (USD Million)
  • Table 167 Spain Regulatory Affairs Market, By Service, 2018 - 2030 (USD Million)
  • Table 168 Regulatory Affairs Market, By Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
  • Table 169 Regulatory Affairs Market, By Category, 2018 - 2030 (USD Million)
  • Table 170 Regulatory Affairs Market, By Drugs, 2018 - 2030 (USD Million)
  • Table 171 Regulatory Affairs Market, By Innovator, 2018 - 2030 (USD Million)
  • Table 172 Regulatory Affairs Market, By Generics, 2018 - 2030 (USD Million)
  • Table 173 Regulatory Affairs Market, By Biologics, 2018 - 2030 (USD Million)
  • Table 174 Regulatory Affairs Market, By Biotech, 2018 - 2030 (USD Million)
  • Table 175 Regulatory Affairs Market, By ATMP, 2018 - 2030 (USD Million)
  • Table 176 Regulatory Affairs Market, By BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 177 Regulatory Affairs Market, By Medical Devices, 2018 - 2030 (USD Million)
  • Table 178 Regulatory Affairs Market, By Diagnostics, 2018 - 2030 (USD Million)
  • Table 179 Regulatory Affairs Market, By Therapeutics, 2018 - 2030 (USD Million)
  • Table 180 Regulatory Affairs Market, By Indication, 2018 - 2030 (USD Million)
  • Table 181 Regulatory Affairs Market, By Product Stage, 2018 - 2030 (USD Million)
  • Table 182 Regulatory Affairs Market, By Service Provider, 2018 - 2030 (USD Million)
  • Table 183 Regulatory Affairs Market, By Company Size, 2018 - 2030 (USD Million)
  • Table 184 Spain Regulatory Affairs Market, By End-Use, 2018 - 2030 (USD Million)
  • Table 185 Russia Regulatory Affairs Market, By Service, 2018 - 2030 (USD Million)
  • Table 186 Regulatory Affairs Market, By Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
  • Table 187 Regulatory Affairs Market, By Category, 2018 - 2030 (USD Million)
  • Table 188 Regulatory Affairs Market, By Drugs, 2018 - 2030 (USD Million)
  • Table 189 Regulatory Affairs Market, By Innovator, 2018 - 2030 (USD Million)
  • Table 190 Regulatory Affairs Market, By Generics, 2018 - 2030 (USD Million)
  • Table 191 Regulatory Affairs Market, By Biologics, 2018 - 2030 (USD Million)
  • Table 192 Regulatory Affairs Market, By Biotech, 2018 - 2030 (USD Million)
  • Table 193 Regulatory Affairs Market, By ATMP, 2018 - 2030 (USD Million)
  • Table 194 Regulatory Affairs Market, By BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 195 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 196 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 197 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 198 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 199 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 200 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 201 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 202 Russia regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 203 Turkey regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 204 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 205 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 206 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 207 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 208 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 209 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 210 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 211 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 212 Table 210 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 213 Table 211 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 214 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 215 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 216 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 217 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 218 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 219 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 220 Turkey regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 221 Netherlands regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 222 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 223 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 224 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 225 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 226 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 227 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 228 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 229 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 230 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 231 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 232 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 233 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 234 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 235 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 236 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 237 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 238 The Netherlands regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 239 Switzerland regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 240 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 241 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 242 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 243 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 244 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 245 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 246 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 247 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 248 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 249 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 250 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 QFD modeling for market share assessment
  • Fig. 6 Market formulation & validation
  • Fig. 10 Regulatory affairs market segmentation
  • Fig. 11 Market driver relevance analysis (Current & future impact)
  • Fig. 12 Percentage of Clinical Trial Registered in Different Regions (November 2022)
  • Fig. 13 Personalized medicine approved by the FDA
  • Fig. 14 Market restraint relevance analysis (Current & future impact)
  • Fig. 15 SWOT
  • Fig. 16 Porter's five forces analysis
  • Fig. 17 SWOT analysis, by factor (political & legal, economic and technological)
  • Fig. 18 Usage/adoption of cloud technology for regulatory space
  • Fig. 19 Regulatory affairs market service outlook: Segment dashboard
  • Fig. 20 Regulatory affairs market: service movement analysis
  • Fig. 21 Regulatory consulting market, 2018 - 2030 (USD Million)
  • Fig. 22 Legal representation market, 2018 - 2030 (USD Million)
  • Fig. 23 Regulatory writing and publishing market, 2018 - 2030 (USD Million)
  • Fig. 24 Product registration and clinical trial application market, 2018 - 2030 (USD Million)
  • Fig. 25 Other regulatory services market, 2018 - 2030 (USD Million)
  • Fig. 26 Regulatory affairs market service provider outlook: Segment dashboard
  • Fig. 27 Regulatory affairs market: service provider movement analysis
  • Fig. 28 In-house regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 29 Outsourcing regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 30 Regulatory affairs market company size outlook: Segment dashboard
  • Fig. 31 Regulatory affairs market: Company size movement analysis
  • Fig. 32 Small companies based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 33 Medium sized company based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 34 Large companies based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 35 Regulatory affairs market categories outlook: Segment dashboard
  • Fig. 36 Regulatory affairs market: Categories movement analysis
  • Fig. 37 Drugs based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 38 Biologics based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 39 Medical devices based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 40 Regulatory affairs product stage outlook: Segment dashboard
  • Fig. 41 Regulatory affairs market: Product stage movement analysis
  • Fig. 42 Preclinical based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 43 Clinical based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 44 PMA based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 45 Regulatory affairs market indication outlook: Segment dashboard
  • Fig. 46 Regulatory affairs market: indication movement analysis
  • Fig. 47 Oncology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 48 Neurology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 49 Cardiology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 50 Immunology indication based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 51 Other indication based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 52 Regulatory affairs market end-use outlook: Segment dashboard
  • Fig. 53 Regulatory affairs market: end-use movement analysis
  • Fig. 54 Medical device companies market, 2018 - 2030 (USD Million)
  • Fig. 55 Pharmaceutical companies market, 2018 - 2030 (USD Million)
  • Fig. 56 Biotechnology companies market, 2018 - 2030 (USD Million)
  • Fig. 57 Regional market: Key takeaways
  • Fig. 58 Regional outlook, 2021 & 2030
  • Fig. 59 North America market, 2018 - 2030 (USD Million)
  • Fig. 60 U.S. market, 2018 - 2030 (USD Million)
  • Fig. 61 Canada market, 2018 - 2030 (USD Million)
  • Fig. 62 Europe market, 2018 - 2030 (USD Million)
  • Fig. 63 UK market, 2018 - 2030 (USD Million)
  • Fig. 64 Germany market, 2018 - 2030 (USD Million)
  • Fig. 65 France market, 2018 - 2030 (USD Million)
  • Fig. 66 Italy market, 2018 - 2030 (USD Million)
  • Fig. 67 Spain market, 2018 - 2030 (USD Million)
  • Fig. 68 Russia market, 2018 - 2030 (USD Million)
  • Fig. 69 Turkey market, 2018 - 2030 (USD Million)
  • Fig. 70 Netherlands market, 2018 - 2030 (USD Million)
  • Fig. 71 Switzerland market, 2018 - 2030 (USD Million)
  • Fig. 72 Sweden market, 2018 - 2030 (USD Million)
  • Fig. 73 Asia Pacific market, 2018 - 2030 (USD Million)
  • Fig. 74 Japan market, 2018 - 2030 (USD Million)
  • Fig. 75 China market, 2018 - 2030 (USD Million)
  • Fig. 76 India market, 2018 - 2030 (USD Million)
  • Fig. 77 Australia market, 2018 - 2030 (USD Million)
  • Fig. 78 South Korea market, 2018 - 2030 (USD Million)
  • Fig. 79 Indonesia market, 2018 - 2030 (USD Million)
  • Fig. 80 Malaysia market, 2018 - 2030 (USD Million)
  • Fig. 81 Singapore market, 2018 - 2030 (USD Million)
  • Fig. 82 Thailand market, 2018 - 2030 (USD Million)
  • Fig. 83 Taiwan market, 2018 - 2030 (USD Million)
  • Fig. 84 Latin America market, 2018 - 2030 (USD Million)
  • Fig. 85 Brazil market, 2018 - 2030 (USD Million)
  • Fig. 86 Mexico market, 2018 - 2030 (USD Million)
  • Fig. 87 Argentina market, 2018 - 2030 (USD Million)
  • Fig. 88 Colombia market, 2018 - 2030 (USD Million)
  • Fig. 89 Chile market, 2018 - 2030 (USD Million)
  • Fig. 90 MEA market, 2018 - 2030 (USD Million)
  • Fig. 91 South Africa market, 2018 - 2030 (USD Million)
  • Fig. 92 Saudi Arabia market, 2018 - 2030 (USD Million)
  • Fig. 93 UAE market, 2018 - 2030 (USD Million)
  • Fig. 94 Egypt market, 2018 - 2030 (USD Million)
  • Fig. 95 Israel market, 2018 - 2030 (USD Million)
  • Fig. 96 Key Strategies
  • Fig. 97 Market participant categorization
  • Fig. 98 Organization Structure - Accell Clinical Research, LLC
  • Fig. 99 SWOT - Accell Clinical Research, LLC
  • Fig. 100 Financial performance of Genpact
  • Fig. 101 Organization Structure - Genpact Ltd
  • Fig. 102 SWOT - Genpact
  • Fig. 103 Organization Structure - Criterium, Inc.
  • Fig. 104 SWOT -CRITERIUM, INC.
  • Fig. 105 Organization Structure - Promedica International
  • Fig. 106 SWOT - Promedica International
  • Fig. 107 Financial performance of WuXi AppTec
  • Fig. 108 Organization Structure -WuXi AppTec
  • Fig. 109 SWOT - Wuxi AppTec
  • Fig. 110 Financial performance of Medspace
  • Fig. 111 Organization Structure - Medpace
  • Fig. 112 SWOT - Medpace
  • Fig. 113 Financial performance of Charles River Laboratories
  • Fig. 114 Organization Structure - Charles River Laboratories International, Inc.
  • Fig. 115 SWOT - Charles River Laboratories International, Inc
  • Fig. 116 Financial performance of ICON plc
  • Fig. 117 Organization Structure - ICON plc
  • Fig. 118 SWOT - ICON plc
  • Fig. 119 Financial performance of Laboratory Corporation of America Holdings
  • Fig. 120 Organization Structure -Laboratory Corporation of America Holdings
  • Fig. 121 SWOT - Laboratory Corporation of America Holdings
  • Fig. 122 Organization Structure - PAREXEL International Corporation
  • Fig. 123 SWOT - Parexel International Corporation
  • Fig. 124 Organization Structure - Freyr
  • Fig. 125 SWOT - Freyr