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市场调查报告书
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1301010

监管事务市场规模、份额和趋势分析报告：按服务、按类别、按服务提供商、按公司规模、按产品阶段、按适应症、按最终用途、按地区、细分市场趋势，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个工作天内

价格

监管事务市场增长和趋势

GrandView Research, Inc. 最新报告显示，2023 年至 2030 年，全球监管事务市场将以 8.7% 的复合年增长率增长，到 2030 年将达到 270 亿美元，预计将达到

预计将促进市场增长的因素包括业务活动和地理位置不断变化的监管要求、由于监管审批速度加快而增加的临床试验和药物审批以及监管机构的软件技术进步等。 促进市场增长的其他因素包括个性化药物的发展、公司越来越需要专注于其核心业务活动以及经济和市场竞争压力。

製药公司和监管机构联手快速开发对抗 COVID-19 感染所需的疫苗和医疗产品。 监管机构采取许多预防措施来确保临床试验期间患者和人员的安全，并保持数据完整性和良好的实验室实践。 生物仿製药、孤儿药、个性化药物、伴随诊断和适应症研究设计的市场增长预计将推动对这些领域监管专业知识的需求。 随着公司向新领域扩张，遵守法规的需求不断增加，从而推动了对具有监管事务专业知识的专业服务提供商的需求。 Simlect、Vectibix、Mircera 和 Kineret 等生物製剂的专利到期增加了生物仿製药的需求和开发，从而促进了对监管服务的需求。

为了在个性化医疗市场占据领先地位，多家公司正在积极致力于合作伙伴关係和新产品开发，这表明需要监管事务的支持。 例如，2020 年 5 月，Regeneron Pharmaceuticals, Inc. 与科罗拉多州个性化医疗中心合作，设计个性化医疗和人类遗传学方面的进展。

监管事务市场报告要点

  • 按服务划分，监管写作和出版部门在 2022 年占据市场主导地位，销售额份额为 36.6%。 这是由于大中型医疗器械和生物製药公司外包这些服务的增加。
  • 有迹象表明，到 2022 年，肿瘤领域将占据最大的销售额份额，达到 32.9%。 这一细分市场的份额归因于癌症的高患病率创造了对安全有效治疗的需求。
  • 根据最终用途，预计 2023 年至 2030 年製药公司细分市场的增长率最高，为 9.0%。 批准药物数量的增加是该领域增长的主要驱动力。
  • 按公司规模划分，中型企业细分市场将在 2022 年主导全球市场，占当年总销售额的最大份额，超过 47.0%。 越来越多的中型公司正在进入监管事务市场。 因此，在2022年和2022年整体上，该细分市场将占有很大份额。
  • 按类别划分，生物製剂领域预计在分析期间将以 8.0% 的速度稳定增长。 生物製品管道的增加进一步推动了对监管服务的需求，从而支持了该领域的增长。
  • 按产品阶段划分，临床前细分市场预计在分析期间将实现 9.4% 的最快增长。 该细分市场的高增长主要归因于全球小分子和生物仿製药管道的不断增长。
  • 在服务提供商细分市场中，外包细分市场预计在分析期间将实现 10.3% 的最快增长。 该领域的高速增长在很大程度上归因于对具有成本效益的合同服务的需求不断增长。
  • 由于监管环境的改善和生物製药公司风险投资活动的增加，预计亚太地区在预测期内将增长 9.3%。

内容

第一章调查方法及范围

  • 市场细分和范围
  • 区域范围
  • 估计/预测时间表
  • 目的
  • 调查方法
  • 信息获取
  • 信息或数据分析
  • 市场形成和验证
  • 型号详细信息
  • 辅助信息列表
  • 缩写列表

第 2 章执行摘要

  • 市场前景
  • 分部展望
  • 竞争考虑因素

第三章监管事务市场变量、趋势和范围

  • 市场体系展望
    • 母公司市场前景
    • 相关/补充市场前景
  • 市场动态
    • 市场驱动因素分析
    • 市场製约因素分析
    • 行业问题
    • 主要交易和战略联盟分析
    • 生物技术和先进治疗药物 (ATMP) 领域的重大交易和战略联盟分析
  • 监管事务市场分析工具
    • 行业分析-波特分析
    • PESTEL 分析
    • SWOT分析
    • COVID-19 感染的影响分析

第 4 章监管事务市场：服务评估和趋势分析

  • 监管事务市场，按服务分类：细分仪表板
  • 监管事务市场，按服务分类：波动分析
    • 监管咨询
    • 法定代表人
    • 法规的製定和发布
    • 产品註册及临床试验申请
    • 其他受监管的服务

第五章监管事务市场：品类估算与趋势分析

  • 监管事务市场，按类别：细分仪表板
  • 监管事务市场，按类别：动态分析
    • 药品
    • 生物製剂
    • 医疗设备

第六章监管事务市场：指标估算与趋势分析

  • 监管事务市场，按指标划分：细分仪表板
  • 监管事务市场，按指标：变化分析
    • 肿瘤
    • 神经
    • 心脏病
    • 血
    • 免疫
    • 其他

第 7 章监管事务市场：服务提供商细分市场估计和趋势分析

  • 监管事务市场，按服务提供商细分：细分仪表板
  • 监管事务市场，按服务提供商细分：动态分析
    • 内部
    • 外包

第八章监管事务市场：公司规模估算及趋势分析

  • 监管事务市场，按公司规模划分：细分仪表板
  • 按公司规模划分的监管事务市场：波动分析
    • 紧凑型
    • 中
    • 大公司

第九章监管事务市场：产品阶段评估与趋势分析

  • 监管事务市场，按产品阶段：细分仪表板
  • 按产品阶段划分的监管事务市场：波动分析
    • 临床前
    • 临床
    • PMA

第 10 章监管事务市场：最终用途估算和趋势分析

  • 监管事务市场，按最终用途：细分仪表板
  • 监管事务市场，按最终用途：变化分析
    • 医疗器械公司
    • 製药公司
    • 生物科技公司

第十一章监管事务市场：区域估算与趋势分析

  • 2022 年和 2030 年区域市场份额分析
  • 区域市场仪表板
  • 全球区域市场概况
  • 北美
    • 2018-2030 年市场预估和预测（收入）
    • 美国
    • 加拿大
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 意大利
    • 西班牙
    • 俄罗斯
    • 土耳其
    • 荷兰
    • 瑞士
    • 瑞典
  • 亚太地区
    • 日本
    • 印度
    • 中国
    • 韩国
    • 澳大利亚
    • 泰国
    • 印度尼西亚
    • 马来西亚
    • 新加坡
    • 台湾
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 阿根廷
    • 哥伦比亚
    • 智利
  • 中东和非洲
    • 南非
    • 沙特阿拉伯
    • 阿拉伯联合酋长国
    • 埃及
    • 以色列

第12章竞争格局

  • 市场进入者分类
    • 创新者
    • 市场领导者
    • 新兴玩家
    • 2022 年公司市场份额分析
  • 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 Corporation
    • Freyr
    • Pharmalex GmbH
    • NDA Group AB
    • Pharmexon
    • Qvigilance
    • BlueReg
    • Cambridge Regulatory Services
    • VCLS

第 13 章 Kol 评论/主要建议

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