查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
监管事务外包市场 - 2018-2028 年全球行业规模、份额、趋势、机会和预测，按服务、类别、公司规模、适应症、产品阶段、最终用途、地区和竞争细分
市场调查报告书
商品编码
1331420

监管事务外包市场 - 2018-2028 年全球行业规模、份额、趋势、机会和预测，按服务、类别、公司规模、适应症、产品阶段、最终用途、地区和竞争细分

Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Service, By Category, By Company Size, By Indication, By Product Stage, By End Use, By Region and Competition
出版日期: | 出版商: TechSci Research | 英文 118 Pages | 商品交期: 2-3个工作天内

价格

We offer 8 hour analyst time for an additional research. Please contact us for the details.

简介目录

预计监管事务外包市场在预测期内将出现令人印象深刻的增长。这可以归因于研发活动的不断增长以及临床试验申请和产品註册量的增加。同样，各国政府为控製药品成本而采取的日益严格的法规预计将增加经济和竞争压力，进而预计将推动生命科学公司对监管事务外包的需求。 2020 年，礼来公司达成协议，收购 Dermira 的免疫学产品组合。此外，COVID-19 大流行造成了对疫苗的迫切需求。因此，COVID-19 疫苗的开发可能会对细分市场的增长产生积极影响。日益全球化

监管复杂性不断上升

监管复杂性在全球监管事务外包市场的增长中发挥着重要作用。世界各地的监管机构正在加强对各个行业的审查，包括医疗保健、製药和医疗器械。遵守这些法规可能既耗时又復杂，需要大量资源和专业知识。外包监管事务服务可以帮助公司掌握监管变化并确保遵守适用的法规。监管事务服务提供商对不同地区的监管环境拥有广泛的了解，包括适用的法律、法规和指南。他们可以就产品註册、临床试验申请、质量保证等合规相关活动提供专家建议。此外，监管事务服务提供商可以帮助企业应对不同地区復杂的监管要求。这包括提供有关产品标籤和包装要求的指导，以及确保遵守良好生产规范 (GMP) 和良好临床规范 (GCP)。外包监管事务服务可以帮助公司降低因不遵守监管要求而导致代价高昂的错误的风险。这些错误可能会导致产品批准延迟、产品召回以及其他负面后果，从而严重影响公司的利润。

对专业知识的需求不断增长

专业知识一直是全球监管事务外包市场增长的关键因素。监管事务是一个复杂且专业的领域，需要深入了解各种监管框架，包括法律、法规和指南。随着监管要求变得越来越复杂和严格，公司对专业知识的需求日益增长，以确保合规性并避免代价高昂的错误。外包监管事务服务使公司能够利用监管事务服务提供商的专业知识。这些提供商对不同地区的监管环境以及适用的法律、法规和准则拥有广泛的了解。他们可以就产品註册、临床试验申请和质量保证等合规相关活动提供专家建议。

此外，监管事务服务提供商可以提供医疗器械、生物製品和药品等特定领域的专业知识。对于缺乏这些领域内部监管事务专业知识的公司来说，这种专业知识尤其有价值。通过将监管事务服务外包给专业服务提供商，公司可以确保他们能够获得遵守适用监管要求所需的专业知识。专业知识可以帮助公司了解最新的监管发展和变化。监管事务服务提供商不断监控不同地区的监管变化，并可以就这些变化如何影响公司的产品或运营提供专家指导。

节约成本

节省成本是全球监管事务外包市场增长的重要因素。遵守监管要求可能非常耗时且成本高昂，需要大量资源和专业知识。缺乏内部监管事务专业知识的公司可能需要雇用和培训员工或使用昂贵的外部顾问来确保合规性。外包监管事务服务可以为企业节省大量成本。监管事务服务提供商可以提供专业知识和资源，通常比僱用和培训内部员工或使用外部顾问的成本更低。外包可以为监管事务提供更加灵活和可扩展的方法，使公司能够根据业务需求按需扩大或缩小其监管事务资源。

外包监管事务服务可以帮助公司避免因不遵守监管要求而导致代价高昂的错误。这些错误可能会导致产品批准延迟、产品召回以及其他负面后果，从而严重影响公司的利润。外包监管事务服务可以帮助企业提高运营效率。通过外包监管事务服务，公司可以释放内部资源，专注于其核心业务活动，例如产品开发和营销。这有助于提高生产力和盈利能力，同时仍确保符合监管要求。

技术进步

技术进步对全球监管事务外包市场的增长发挥了重要作用。数字技术的日益普及改变了监管事务格局的许多方面，为外包服务提供商创造了新的机会。影响市场增长的主要因素之一是监管事务流程的自动化。使用先进的软件系统和人工智能（AI）工具可以帮助简化监管事务工作流程，减少执行合规相关活动所需的时间和精力。例如，人工智能可用于审查大量监管文件，帮助识别潜在问题并提高监管提交的准确性。

技术使监管事务服务提供商与其客户之间能够加强协作和沟通。基于云的平台和其他协作工具使监管事务专业人员能够更轻鬆地协同工作，无论他们身在何处。这有助于提高效率并减少与监管事务流程相关的时间和成本。技术对实时数据监控和分析的使用产生影响的另一个领域。先进的数据分析工具可以帮助监管事务专业人员识别新兴的监管趋势和潜在的合规问题，使他们能够在这些问题成为问题之前主动解决这些问题。最后，技术提高了监管事务流程的透明度和问责制。数字系统和工具可以更轻鬆地跟踪合规相关活动并提供审计跟踪，从而提高合规性并降低不合规风险。

近期发展

  • 2021年，WIRB-Copernicus Group（WCG）推出了一项名为WCG Oncology的新服务，为肿瘤临床试验提供全面的监管和伦理审查服务。
  • 2020 年，Kinapse（Syneos Health 的子公司）推出了一项名为 Kinapse Quality Labs 的新服务，该服务使用先进的数据分析和人工智能来帮助客户优化其监管合规流程。
  • 2020年，IQVIA推出了一套新的监管信息管理解决方案，旨在帮助客户更有效地管理监管提交流程。
  • 2019年，Qserve Group推出了名为QserveConnect的新平台，为客户提供按需访问一系列监管事务服务，包括监管策略、临床评估和质量管理。
  • 2019年，埃森哲推出了监管与合规分析解决方案，这是一套数字工具和服务，旨在帮助企业更有效地管理监管合规性。
  • 2018 年，Parexel 推出了新的监管外包服务，旨在帮助客户应对复杂的监管环境并缩短上市时间。

可用的定制：

根据给定的市场数据，TechSci Research 可根据公司的具体需求提供定制服务。该报告可以使用以下自定义选项：

公司信息

  • 其他市场参与者（最多五个）的详细分析和概况分析。

目录

第 1 章：产品概述

  • 市场定义
  • 市场范围
    • 涵盖的市场
    • 考虑学习的年份
    • 主要市场细分

第 2 章：研究方法

  • 研究目的
  • 基线方法
  • 主要行业合作伙伴
  • 主要协会和二手资料来源
  • 预测方法
  • 数据三角测量和验证
  • 假设和限制

第 3 章：执行摘要

  • 市场概况
  • 主要市场细分概述
  • 主要市场参与者概述
  • 重点地区/国家概况
  • 市场驱动因素、挑战、趋势概述

第 4 章：客户之声

第 5 章：全球监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按地区（北美、欧洲、亚太地区、南美、中东和非洲）
    • 按公司划分 (2022)
  • 市场地图
    • 按服务
    • 按类别
    • 按公司规模
    • 按指示
    • 按产品阶段
    • 按最终用途

第 6 章：北美监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按国家/地区
  • 北美：国家分析
    • 美国
    • 加拿大
    • 墨西哥

第 7 章：欧洲监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按国家/地区
  • 欧洲：国家分析
    • 法国
    • 德国
    • 英国
    • 意大利
    • 西班牙

第 8 章：亚太地区监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按国家/地区
  • 亚太地区：国家分析
    • 中国
    • 印度
    • 日本
    • 韩国
    • 澳大利亚

第 9 章：南美监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按国家/地区
  • 南美洲：国家分析
    • 巴西
    • 阿根廷
    • 哥伦比亚

第10章：中东和非洲监管事务外包市场展望

  • 市场规模及预测
    • 按价值
  • 市场份额及预测
    • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请、监管提交、监管运营、其他服务）
    • 按类别（药品、医疗器械）
    • 按公司规模（小型公司、中型公司、大型公司）
    • 按适应症（肿瘤学、神经病学、心脏病学、免疫学、其他适应症）
    • 按产品阶段（临床前、临床、上市前批准）
    • 按最终用途（医疗器械公司、製药公司、生物技术公司）
    • 按国家/地区
  • MEA：国家分析
    • 南非监管事务外包
    • 沙特阿拉伯监管事务外包
    • 阿联酋监管事务外包

第 11 章：市场动态

  • 司机
  • 挑战

第 12 章：市场趋势与发展

  • 近期发展
  • 併购
  • 产品发布

第 13 章：全球监管事务外包市场：SWOT 分析

第 14 章：波特的五力分析

  • 行业竞争
  • 新进入者的潜力
  • 供应商的力量
  • 客户的力量
  • 替代产品的威胁

第15章：竞争格局

  • 商业概览
  • 产品供应
  • 最近的发展
  • 财务（据报导）
  • 主要人员
  • SWOT分析
    • Accell Clinical Research, LLC.
    • Genpact Ltd.
    • CRITERIUM, INC.
    • Promedica International.
    • WuXi AppTec Co Ltd.
    • Medpace Inc.
    • Charles River Laboratories.
    • ICON plc.
    • Covance, Inc.
    • Parexel International Corporation.
    • Freyr AS
    • PHARMALEX GMBH
    • NDA Group AB
    • Pharmexon Consulting.
    • Qvigilance
    • BlueReg Group.

第 16 章：战略建议

简介目录
Product Code: 15258

Regulatory Affairs Outsourcing Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to growing research and development activities along with augmenting the volume of clinical trial applications and product registrations. Similarly, growing regulations taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among life science companies. In 2020, Eli Lilly entered into an agreement to acquire Dermira's immunology portfolio. In addition, the COVID-19 pandemic created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth. Increasing globalization

Increasing globalization had a significant impact on the growth of the Global Regulatory Affairs Outsourcing market. As companies expand their operations globally, they are faced with the challenge of complying with different regulatory frameworks in various regions. This challenge has driven the demand for regulatory affairs outsourcing services as companies look for specialized service providers who can help them navigate the complexities of different regulatory frameworks.

One of the key benefits of outsourcing regulatory affairs services is the expertise that service providers can bring to the table. Service providers who specialize in regulatory affairs have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. This expertise is critical in ensuring that companies comply with the applicable regulations and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to focus on their core competencies, such as product development and marketing, while leaving compliance-related activities to be specialized service providers. This can help companies improve their operational efficiency, reduce costs, and improve their bottom line. Furthermore, advancements in technology, such as cloud-based regulatory information management systems, have made it easier for companies to outsource regulatory affairs services across different regions. These systems allow service providers to access and manage regulatory information securely, regardless of location. This has made it easier for companies to work with service providers who are located in different parts of the world.

Rising regulatory complexities

Regulatory complexities play a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory authorities around the world are increasing their scrutiny of various industries, including healthcare, pharmaceuticals, and medical devices. Compliance with these regulations can be time-consuming and complex, requiring significant resources and expertise. Outsourcing regulatory affairs services can help companies stay on top of regulatory changes and ensure compliance with applicable regulations. Regulatory affairs service providers have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, quality assurance, and others. Furthermore, regulatory affairs service providers can help companies navigate the complex regulatory requirements of different regions. This includes providing guidance on product labeling and packaging requirements, as well as ensuring compliance with Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs). Outsourcing regulatory affairs services can help companies reduce the risk of costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line.

Growing demand for specialized expertise

Specialized expertise has been a key factor in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory affairs are a complex and specialized field that requires in-depth knowledge of various regulatory frameworks, including laws, regulations, and guidelines. As regulatory requirements become increasingly complex and stringent, companies are facing a growing need for specialized expertise to ensure compliance and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to tap into the specialized expertise of regulatory affairs service providers. These providers have extensive knowledge of the regulatory landscape in different regions, as well as the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, and quality assurance, among others.

Furthermore, regulatory affairs service providers can provide specialized expertise in specific areas, such as medical devices, biologics, and pharmaceuticals. This expertise can be particularly valuable for companies that lack in-house regulatory affairs expertise in these areas. By outsourcing regulatory affairs services to specialized service providers, companies can ensure that they have access to the expertise they need to comply with the applicable regulatory requirements. Specialized expertise can help companies stay up to date with the latest regulatory developments and changes. Regulatory affairs service providers are constantly monitoring regulatory changes in different regions and can provide expert guidance on how these changes may impact a company's products or operations.

Cost savings

Cost savings is a significant factor in the growth of the Global Regulatory Affairs Outsourcing Market. Compliance with regulatory requirements can be time-consuming and costly, requiring significant resources and expertise. Companies that lack in-house regulatory affairs expertise may need to hire and train staff or use costly external consultants to ensure compliance. Outsourcing regulatory affairs services can provide significant cost savings for companies. Regulatory affairs service providers can offer specialized expertise and resources, often at a lower cost than hiring and training in-house staff or using external consultants. Outsourcing can provide a more flexible and scalable approach to regulatory affairs, allowing companies to scale their regulatory affairs resources up or down as needed, depending on business needs.

Outsourcing regulatory affairs services can help companies avoid costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line. Outsourcing regulatory affairs services can help companies improve their operational efficiency. By outsourcing regulatory affairs services, companies can free up internal resources to focus on their core business activities, such as product development and marketing. This can help improve productivity and profitability while still ensuring compliance with regulatory requirements.

Advancements in technology

Advancements in technology have played a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. The increasing adoption of digital technologies has transformed many aspects of the regulatory affairs landscape, creating new opportunities for outsourcing service providers. One major factor that influences the growth of the market is the automation of regulatory affairs processes. The use of advanced software systems and artificial intelligence (AI) tools can help streamline regulatory affairs workflows, reducing the time and effort required to perform compliance-related activities. For example, AI can be used to review large volumes of regulatory documents, helping to identify potential issues and improve the accuracy of regulatory submissions.

Technology has enabled greater collaboration and communication between regulatory affairs service providers and their clients. Cloud-based platforms and other collaboration tools make it easier for regulatory affairs professionals to work together, regardless of their location. This can help improve efficiency and reduce the time and cost associated with regulatory affairs processes. Another area where technology has an impact on the use of real-time data monitoring and analytics. Advanced data analytics tools can help regulatory affairs professionals identify emerging regulatory trends and potential compliance issues, allowing them to proactively address these issues before they become problems. Finally, technology has enabled greater transparency and accountability in the regulatory affairs process. Digital systems and tools make it easier to track compliance-related activities and provide audit trails, improving compliance and reducing the risk of non-compliance.

Recent Development

  • In 2021, WIRB-Copernicus Group (WCG) launched a new service called WCG Oncology, which provides comprehensive regulatory and ethical review services for oncology clinical trials.
  • In 2020, Kinapse (a subsidiary of Syneos Health) launched a new service called Kinapse Quality Labs, which uses advanced data analytics and AI to help clients optimize their regulatory compliance processes.
  • In 2020, IQVIA launched a new suite of regulatory information management solutions designed to help clients manage the regulatory submission process more efficiently.
  • In 2019, Qserve Group launched a new platform called QserveConnect, which provides clients with on-demand access to a range of regulatory affairs services, including regulatory strategy, clinical evaluation, and quality management.
  • In 2019, Accenture launched its Regulatory and Compliance Analytics Solution, a suite of digital tools and services designed to help companies manage regulatory compliance more effectively.
  • In 2018, Parexel launched its new Regulatory Outsourcing service, designed to help clients navigate complex regulatory environments and improve their time to market.

Market Segmentation

Global Regulatory Affairs Outsourcing Market can be segmented by service, category, company size, indication, production stage, end-use, and by region. Based on service, the market can be segmented into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, and other services. Based on category, the market can be divided into pharmaceutical and medical devices. Based on company size, the market can be segmented into small companies, medium companies, and large companies. Based on indication, the market can be differentiated into oncology, neurology, cardiology, immunology, and other indications. Based on the product stage, the market can be segmented into preclinical, clinical, and premarket approval. Based on end use, the market can be differentiated into medical device companies, pharmaceutical companies, and biotechnology companies.

Market Players

Accell Clinical Research, LLC., Genpact Ltd., CRITERIUM, INC., Promedica International. , WuXi AppTec Co Ltd., Medpace Inc., Charles River Laboratories Inc., ICON plc., Covance, Inc.., Parexel International Corporation., Freyr AS, PHARMALEX GMBH, NDA Group AB, Pharmexon Consulting, Qvigilance, and BlueReg Group are some of the leading players operating in the Global Regulatory Affairs Outsourcing Market.

Report Scope:

In this report, Global Regulatory Affairs Outsourcing market has been segmented into the following categories, in addition to the industry trends, which have also been detailed below:

Regulatory Affairs Outsourcing Market, By Service:

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product registration & clinical trial applications
  • Regulatory Submissions
  • Regulatory Operations
  • Other services

Regulatory Affairs Outsourcing Market, By Category:

  • Pharmaceutical
  • Medical Device

Regulatory Affairs Outsourcing Market, By Company Size:

  • Small Companies
  • Medium Companies
  • Large Companies

Regulatory Affairs Outsourcing Market, By Indication:

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Other Indications

Regulatory Affairs Outsourcing Market, By Product Stage:

  • Preclinical, Clinical
  • Premarket Approval

Regulatory Affairs Outsourcing Market, By End Use:

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Regulatory Affairs Outsourcing Market, By Region:

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • Germany
    • United Kingdom
    • Italy
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market.

Available Customizations:

With the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Regulatory Affairs Outsourcing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 5.2.2. By Category (Pharmaceutical, Medical Device)
    • 5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
    • 5.2.8. By Company (2022)
  • 5.3. Market Map
    • 5.3.1 By Service
    • 5.3.2 By Category
    • 5.3.3 By Company Size
    • 5.3.4 By Indication
    • 5.3.5 By Product Stage
    • 5.3.6 By End Use

6. North America Regulatory Affairs Outsourcing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 6.2.2. By Category (Pharmaceutical, Medical Device)
    • 6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 6.2.7. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Regulatory Affairs Outsourcing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Service
        • 6.3.1.2.2. By Category
        • 6.3.1.2.3. By Company Size
        • 6.3.1.2.4. By Indication
        • 6.3.1.2.5. By Product Stage
        • 6.3.1.2.6. By End Use
    • 6.3.2. Canada Regulatory Affairs Outsourcing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Service
        • 6.3.2.2.2. By Category
        • 6.3.2.2.3. By Company Size
        • 6.3.2.2.4. By Indication
        • 6.3.2.2.5. By Product Stage
        • 6.3.2.2.6. By End Use
    • 6.3.3. Mexico Regulatory Affairs Outsourcing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Service
        • 6.3.3.2.2. By Category
        • 6.3.3.2.3. By Company Size
        • 6.3.3.2.4. By Indication
        • 6.3.3.2.5. By Product Stage
        • 6.3.3.2.6. By End Use

7. Europe Regulatory Affairs Outsourcing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 7.2.2. By Category (Pharmaceutical, Medical Device)
    • 7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 7.2.7. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Regulatory Affairs Outsourcing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Service
        • 7.3.1.2.2. By Category
        • 7.3.1.2.3. By Company Size
        • 7.3.1.2.4. By Indication
        • 7.3.1.2.5. By Product Stage
        • 7.3.1.2.6. By End Use
    • 7.3.2. Germany Regulatory Affairs Outsourcing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Service
        • 7.3.2.2.2. By Category
        • 7.3.2.2.3. By Company Size
        • 7.3.2.2.4. By Indication
        • 7.3.2.2.5. By Product Stage
        • 7.3.2.2.6. By End Use
    • 7.3.3. United Kingdom Regulatory Affairs Outsourcing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Service
        • 7.3.3.2.2. By Category
        • 7.3.3.2.3. By Company Size
        • 7.3.3.2.4. By Indication
        • 7.3.3.2.5. By Product Stage
        • 7.3.3.2.6. By End Use
    • 7.3.4. Italy Regulatory Affairs Outsourcing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Service
        • 7.3.4.2.2. By Category
        • 7.3.4.2.3. By Company Size
        • 7.3.4.2.4. By Indication
        • 7.3.4.2.5. By Product Stage
        • 7.3.4.2.6. By End Use
    • 7.3.5. Spain Regulatory Affairs Outsourcing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Service
        • 7.3.5.2.2. By Category
        • 7.3.5.2.3. By Company Size
        • 7.3.5.2.4. By Indication
        • 7.3.5.2.5. By Product Stage
        • 7.3.5.2.6. By End Use

8. Asia-Pacific Regulatory Affairs Outsourcing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 8.2.2. By Category (Pharmaceutical, Medical Device)
    • 8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 8.2.7. By Country
  • 8.3. Asia-Pacific: Country Analysis
    • 8.3.1. China Regulatory Affairs Outsourcing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Service
        • 8.3.1.2.2. By Category
        • 8.3.1.2.3. By Company Size
        • 8.3.1.2.4. By Indication
        • 8.3.1.2.5. By Product Stage
        • 8.3.1.2.6. By End Use
    • 8.3.2. India Regulatory Affairs Outsourcing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Service
        • 8.3.2.2.2. By Category
        • 8.3.2.2.3. By Company Size
        • 8.3.2.2.4. By Indication
        • 8.3.2.2.5. By Product Stage
        • 8.3.2.2.6. By End Use
    • 8.3.3. Japan Regulatory Affairs Outsourcing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Service
        • 8.3.3.2.2. By Category
        • 8.3.3.2.3. By Company Size
        • 8.3.3.2.4. By Indication
        • 8.3.3.2.5. By Product Stage
        • 8.3.3.2.6. By End Use
    • 8.3.4. South Korea Regulatory Affairs Outsourcing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Service
        • 8.3.4.2.2. By Category
        • 8.3.4.2.3. By Company Size
        • 8.3.4.2.4. By Indication
        • 8.3.4.2.5. By Product Stage
        • 8.3.4.2.6. By End Use
    • 8.3.5. Australia Regulatory Affairs Outsourcing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Service
        • 8.3.5.2.2. By Category
        • 8.3.5.2.3. By Company Size
        • 8.3.5.2.4. By Indication
        • 8.3.5.2.5. By Product Stage
        • 8.3.5.2.6. By End Use

9. South America Regulatory Affairs Outsourcing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 9.2.2. By Category (Pharmaceutical, Medical Device)
    • 9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 9.2.7. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Regulatory Affairs Outsourcing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Service
        • 9.3.1.2.2. By Category
        • 9.3.1.2.3. By Company Size
        • 9.3.1.2.4. By Indication
        • 9.3.1.2.5. By Product Stage
        • 9.3.1.2.6. By End Use
    • 9.3.2. Argentina Regulatory Affairs Outsourcing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Service
        • 9.3.2.2.2. By Category
        • 9.3.2.2.3. By Company Size
        • 9.3.2.2.4. By Indication
        • 9.3.2.2.5. By Product Stage
        • 9.3.2.2.6. By End Use
    • 9.3.3. Colombia Regulatory Affairs Outsourcing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Service
        • 9.3.3.2.2. By Category
        • 9.3.3.2.3. By Company Size
        • 9.3.3.2.4. By Indication
        • 9.3.3.2.5. By Product Stage
        • 9.3.3.2.6. By End Use

10. Middle East and Africa Regulatory Affairs Outsourcing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 10.2.2. By Category (Pharmaceutical, Medical Device)
    • 10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 10.2.7. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Regulatory Affairs Outsourcing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Service
        • 10.3.1.2.2. By Category
        • 10.3.1.2.3. By Company Size
        • 10.3.1.2.4. By Indication
        • 10.3.1.2.5. By Product Stage
        • 10.3.1.2.6. By End Use
    • 10.3.2. Saudi Arabia Regulatory Affairs Outsourcing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Service
        • 10.3.2.2.2. By Category
        • 10.3.2.2.3. By Company Size
        • 10.3.2.2.4. By Indication
        • 10.3.2.2.5. By Product Stage
        • 10.3.2.2.6. By End Use
    • 10.3.3. UAE Regulatory Affairs Outsourcing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Service
        • 10.3.3.2.2. By Category
        • 10.3.3.2.3. By Company Size
        • 10.3.3.2.4. By Indication
        • 10.3.3.2.5. By Product Stage
        • 10.3.3.2.6. By End Use

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Development
  • 12.2. Mergers & Acquisitions
  • 12.3. Product Launches

13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Business Overview
  • 15.2. Product Offerings
  • 15.3. Recent Developments
  • 15.4. Financials (As Reported)
  • 15.5. Key Personnel
  • 15.6. SWOT Analysis
    • 15.6.1 Accell Clinical Research, LLC.
    • 15.6.2 Genpact Ltd.
    • 15.6.3 CRITERIUM, INC.
    • 15.6.4 Promedica International.
    • 15.6.5 WuXi AppTec Co Ltd.
    • 15.6.6 Medpace Inc.
    • 15.6.7 Charles River Laboratories.
    • 15.6.8 ICON plc.
    • 15.6.9 Covance, Inc.
    • 15.6.10 Parexel International Corporation.
    • 15.6.11 Freyr AS
    • 15.6.12 PHARMALEX GMBH
    • 15.6.13 NDA Group AB
    • 15.6.14 Pharmexon Consulting.
    • 15.6.15 Qvigilance
    • 15.6.16 BlueReg Group.

16. Strategic Recommendations