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封面
市场调查报告书
商品编码
1378917

2023-2028 年监管事务外包市场报告（按服务、公司规模、类别、适应症、阶段（临床前、临床、PMA）、最终用户和地区）

Regulatory Affairs Outsourcing Market Report by Services, Company Size, Category, Indication, Stage (Preclinical, Clinical, PMA ), End User, and Region 2023-2028
出版日期: | 出版商: IMARC | 英文 144 Pages | 商品交期: 2-3个工作天内

价格

抽象的

2022年，全球监管事务外包市场规模达到71亿美元。展望未来， IMARC Group预计到2028年市场规模将达到117亿美元，2022-2028年复合年增长率（CAGR）为8.7%。不断发展和复杂的法规、行业全球化、资源优化、持续的技术进步、专业知识要求以及快速审批的需要是推动市场的一些主要因素。

监管事务外包是公司将其监管合规和文件任务委託给外部专业服务提供者的做法。在这种安排下，企业，特别是製药、生物技术和医疗器材等高度监管行业的企业，聘请第三方专家或公司代表其管理监管事务。这包括产品註册、品质保证、遵守政府法规以及向监管机构提交所需文件等活动。外包这些任务使公司能够利用精通监管框架的专业人士的专业知识，简化流程，降低管理成本，并确保遵守不断变化的监管标准，最终促进市场进入和产品批准。

全球监管事务外包市场正在经历大幅成长，这主要是由于政府和监管机构对各个行业（包括製药、医疗器材以及食品和饮料（F&B））提出的日益复杂和严格的监管要求。此外，不断扩大的产品采用使公司能够获得一群精通最新监管变化和合规标准的专业人士，从而确保及时批准和市场准入，这有助于市场成长。此外，市场全球化扩大了企业的地理范围，需要遵守多种国际法规，进而促进市场成长。此外，对外包提供可扩展解决方案以满足跨地区不同监管需求的需求不断增长，这有助于市场扩张。除此之外，成本效率和营运弹性的新兴趋势促使公司利用外部监管服务，使他们能够专注于核心竞争力，同时减少管理费用，从而为市场扩张创造积极的前景。

监理事务外包市场趋势/驱动因素：

监管环境日益复杂

监管事务外包的主要驱动力之一是各行业日益复杂且不断变化的监管环境。製药、生物技术、医疗器材以及食品和饮料 (F&B) 等行业受到严格的监管，以确保产品安全、功效并符合品质标准。遵守这些法规需要专业知识和持续监控。外包监管事务使公司能够利用专门了解区域和国际监管框架细微差别的专业人士的专业知识。除此之外，这些专家还帮助企业驾驭复杂的规则网络，确保其产品符合合规标准，最终促进市场准入和产品批准。

扩大市场全球化

推动监管事务外包成长的另一个关键因素是市场的全球化。随着企业在全球扩展业务，他们会遇到因地区和国家而异的各种监管要求。遵守这些法规可能是一项艰鉅的任务，特别是对于内部监管资源有限的公司。同时，外包提供了一个可扩展的解决方案，可以有效地满足这些不同的监管需求。监管事务外包公司通常具有全球影响力，可以帮助企业调整其产品和流程，以满足不同市场的特定要求，从而实现市场准入和国际成长。

日益关注成本效率和营运生产力

成本效率和对营运重点的需求正在推动公司利用外部监管服务。维持内部监管事务团队涉及大量管理费用，包括薪资、培训和基础设施。外包监管事务使组织能够降低这些固定成本并获得资源分配的灵活性。这种方法使公司能够将资源转向研发 (R&D)、行销和生产等核心能力。透过将监管活动委託给专业的外包合作伙伴，企业可以简化营运、提高效率并更有效地应对市场动态。

监理事务外包产业细分：

IMARC Group提供了全球监管事务外包市场报告各细分市场主要趋势的分析，以及 2023-2028 年全球、区域和国家层面的预测。我们的报告根据服务、公司规模、类别、适应症、阶段和最终用户对市场进行了分类。

按服务细分：

监理咨询

法律代表

监理写作和出版

产品註册及临床试验申请

其他的

监理写作和出版主导市场

该报告根据服务提供了详细的市场细分和分析。这包括监管咨询、法律代表、监管写作和出版、产品註册和临床试验申请等。根据该报告，监管写作和出版占据了最大的部分。

监管文件日益复杂，推动了对监管写作和出版外包的需求，这需要专门的专业知识和资源。随着监管要求变得更加复杂且针对特定地区，企业寻求对文件准备和提交流程有深入了解的外部合作伙伴。除此之外，快速审批和市场准入的需求迫使公司将这些关键任务外包，以确保准确、合规和及时的提交。此外，电子提交系统的采用和监管流程的数位转型对外包提供者产生了需求，这些外包供应商拥有高效电子文件准备和发布所需的技术基础设施和熟练程度。

按公司规模划分：

小的

中等的

大的

Medium 占据最大市场份额

报告还根据公司规模对市场进行了详细的细分和分析。这包括小型、中型和大型。报告称，媒介占据了最大的市场。

推动全球监管事务外包市场的另一个关键因素是中型企业对专业知识和资源最佳化的需求不断增长。中型企业经常面临资源限制，并且可能缺乏对不断变化的法规具有全面了解的内部监管事务团队。外包使他们能够接触到一群经验丰富的监管专业人员，而无需承担维持全职团队的管理费用。此外，随着这些公司扩展到新市场，他们需要适应性强的监管支援来应对多样化和复杂的监管环境，使外包成为确保合规性、市场准入和成长的高效策略选择。

按类别细分：

仿製药

创新药物

生物药

生物相似药

医疗设备

治疗性

诊断

其他的

医疗器材主导市场

该报告根据类别提供了详细的市场细分和分析。这包括仿製药、创新药、生物药、生物相似药、医疗器材（治疗和诊断）等。根据该报告，医疗设备占最大的部分。

医疗器材产业受到全球严格且不断变化的监管要求的约束，需要专业知识来驾驭。外包提供了对医疗器材法规有深入了解的监管专业人员的联繫，确保合规性和更快的批准。除此之外，医疗器材技术的不断创新需要高效、及时的提交，以将新产品推向市场。外包简化了监管流程，使公司能够专注于研发，从而推动市场的成长。此外，随着医疗器材市场的国际化，外包服务为产品适应不同的监管环境提供了支持，使得外包对于该行业的市场进入和持续成长不可或缺。

按指示细分：

肿瘤学

神经病学

心臟病学

免疫学

其他的

肿瘤学占据最大市场份额

报告还提供了基于指示的详细市场细分和分析。这包括肿瘤学、神经学、心臟病学、免疫学等。报告称，肿瘤学占据最大的市场份额。

该治疗领域的独特挑战和快速进步正在推动肿瘤学领域对监管事务外包的需求。肿瘤产品通常会加速开发，并且由于其潜在的挽救生命的性质而需要加快监管途径。这需要外包合作伙伴可以提供肿瘤学特定法规和快速审批流程的专业知识。此外，肿瘤临床试验日益复杂，并且需要全面的资料管理和提交，因此需要外包给能够驾驭这些复杂的监管环境的专家，以确保关键肿瘤治疗的及时批准和市场准入。

按阶段划分：

临床前

临床

PMA（上市后授权）

临床主导市场

该报告根据阶段对市场进行了详细的细分和分析。这包括临床前、临床和上市后授权 (PMA)。根据该报告，临床代表了最大的部分。

临床试验日益复杂和资源密集的性质导致临床阶段监管事务外包的需求不断增加。从事临床研究的公司必须遵守严格的监管要求，以确保研究产品的安全性和有效性。外包为监管专业人员提供了接触临床试验法规和文件专业知识的机会，帮助公司有效应对这一复杂的环境。同时，快速研究启动和遵守不断变化的监管标准的需求推动了对方案开发、提交和合规性外包支援的需求，以确保临床试验顺利进展并有效满足监管里程碑。

按最终用户划分：

医疗器材公司

製药公司

生技公司

製药公司占最大的市场份额

报告还提供了基于最终用户的详细市场细分和分析。这包括医疗器材、製药和生技公司。报告显示，製药公司占了最大的市场份额。

製药业不断发展的格局是帮助市场扩张的关键因素。随着对创新药物开发和严格监管的日益重视，製药公司需要专业知识来应对复杂的监管途径。外包提供了熟悉药品法规的监管专业人员的机会，加快了审批流程并确保合规性。此外，全球市场准入的需求和适应区域监管差异的需求使外包成为一个有吸引力的选择。它使製药公司能够专注于核心研发活动，而外部合作伙伴则有效率且有效地处理监管事务。

按地区划分：

北美洲

美国

加拿大

亚太地区

中国

日本

印度

韩国

澳洲

印尼

其他的

欧洲

德国

法国

英国

义大利

西班牙

俄罗斯

其他的

拉丁美洲

巴西

墨西哥

其他的

中东和非洲

亚太地区占据明显主导地位，占据最大的监管事务外包市场份额

市场研究报告还对所有主要区域市场进行了全面分析，其中包括北美（美国和加拿大）；亚太地区（中国、日本、印度、韩国、澳洲、印尼等）；欧洲（德国、法国、英国、义大利、西班牙、俄罗斯等）；拉丁美洲（巴西、墨西哥等）；以及中东和非洲。报告显示，亚太地区占据最大的市场份额。

亚太地区製药、医疗保健和生命科学产业的日益全球化导致对监管服务的需求激增，以因应该地区不同的监管环境。同时，该地区临床试验和研究活动数量的不断增加需要当地监管要求的专业知识，这使得外包成为寻求扩大业务的製药和生物技术公司的有效解决方案。此外，随着公司寻求在不影响合规性的情况下优化资源，成本效率发挥关键作用，这使得监管事务外包成为亚太地区有吸引力的选择。

竞争格局：

全球监管事务外包市场竞争格局的特征是参与者活跃且多元化，争夺市场份额。大型跨国合约研究组织 (CRO) 占据重要地位，为各个行业和地区提供全面的监管服务。这些行业巨头利用其广泛的全球网路、强大的技术平台和深厚的监管专业知识来满足客户的多样化需求。此外，利基和专业的监管事务外包公司专注于特定行业或地区，提供量身定制的解决方案和深入的监管知识。包括新创公司和区域服务提供者在内的新兴参与者也透过利用市场利基和创新服务产品而获得吸引力。随着公司寻求扩大其服务组合和地理覆盖范围，策略合作、併购进一步塑造了竞争格局。

该报告对市场竞争格局进行了全面分析。也提供了所有主要公司的详细资料。市场上的一些主要参与者包括：

查尔斯河实验室国际公司

科文斯公司（美国实验室控股公司）

弗雷尔

图示公司

梅德佩斯控股公司

精锐国际公司

医药产品开发股份有限公司

Promedica International- 加州公司

无锡药明康德有限公司

最近的发展：

2021 年 2 月，ICON plc 宣布以现金和股票交易收购 PRA Health Sciences, Inc.，价值约 120 亿美元。此次收购增强了公司的医疗事务服务能力。

本报告回答的关键问题：

  • 迄今为止，全球监管事务外包市场的表现如何，未来几年将如何表现？
  • COVID-19 对全球监管事务外包市场有何影响？
  • 主要区域市场有哪些？
  • 基于服务的市场区隔是什么？
  • 依公司规模分類的市场是怎么样的？
  • 根据类别分類的市场是怎么样的？
  • 根据指示，市场的细分是什么？
  • 基于阶段的市场区隔是什么？
  • 基于最终用户的市场区隔是什么？
  • 产业价值链的各个阶段是什么？
  • 该行业的关键驱动因素和挑战是什么？
  • 全球监管事务外包市场的架构如何？主要参与者是谁？
  • 产业竞争程度如何？

本报告回答的关键问题：

  • 迄今为止，全球监管事务外包市场的表现如何，未来几年将如何表现？
  • COVID-19 对全球监管事务外包市场有何影响？
  • 主要区域市场有哪些？
  • 基于服务的市场区隔是什么？
  • 依公司规模分類的市场是怎么样的？
  • 根据类别分類的市场是怎么样的？
  • 根据指示，市场的细分是什么？
  • 基于阶段的市场区隔是什么？
  • 基于最终用户的市场区隔是什么？
  • 产业价值链的各个阶段是什么？
  • 该行业的关键驱动因素和挑战是什么？
  • 全球监管事务外包市场的架构如何？主要参与者是谁？
  • 产业竞争程度如何？

目录

第一章：前言

第 2 章：范围与方法

  • 研究目的
  • 利害关係人
  • 资料来源
    • 主要资源
    • 二手资料
  • 市场预测
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第 3 章：执行摘要

第 4 章：简介

  • 概述
  • 主要行业趋势

第五章：全球监理事务外包市场

  • 市场概况
  • 市场业绩
  • COVID-19 的影响
  • 市场预测

第 6 章：按服务分類的市场区隔

  • 监理咨询
    • 市场走向
    • 市场预测
  • 法律代表
    • 市场走向
    • 市场预测
  • 监理写作和出版
    • 市场走向
    • 市场预测
  • 产品註册及临床试验申请
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 7 章：按公司规模分類的市场细分

  • 小的
    • 市场走向
    • 市场预测
  • 中等的
    • 市场走向
    • 市场预测
  • 大的
    • 市场走向
    • 市场预测

第 8 章：按类别分類的市场区隔

  • 仿製药
    • 市场走向
    • 市场预测
  • 创新药物
    • 市场走向
    • 市场预测
  • 生物药
    • 市场走向
    • 市场预测
  • 生物相似药
    • 市场走向
    • 市场预测
  • 医疗设备
    • 市场走向
    • 主要类型
      • 治疗性
      • 诊断
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 9 章：按迹象分類的市场

  • 肿瘤学
    • 市场走向
    • 市场预测
  • 神经病学
    • 市场走向
    • 市场预测
  • 心臟病学
    • 市场走向
    • 市场预测
  • 免疫学
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 10 章：按阶段分類的市场细分

  • 临床前
    • 市场走向
    • 市场预测
  • 临床
    • 市场走向
    • 市场预测
  • PMA（上市后授权）
    • 市场走向
    • 市场预测

第 11 章：最终用户的市场区隔

  • 医疗器材公司
    • 市场走向
    • 市场预测
  • 製药公司
    • 市场走向
    • 市场预测
  • 生技公司
    • 市场走向
    • 市场预测

第 12 章：按地区分類的市场细分

  • 北美洲
    • 美国
      • 市场走向
      • 市场预测
    • 加拿大
      • 市场走向
      • 市场预测
  • 亚太
    • 中国
      • 市场走向
      • 市场预测
    • 日本
      • 市场走向
      • 市场预测
    • 印度
      • 市场走向
      • 市场预测
    • 韩国
      • 市场走向
      • 市场预测
    • 澳洲
      • 市场走向
      • 市场预测
    • 印尼
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 欧洲
    • 德国
      • 市场走向
      • 市场预测
    • 法国
      • 市场走向
      • 市场预测
    • 英国
      • 市场走向
      • 市场预测
    • 义大利
      • 市场走向
      • 市场预测
    • 西班牙
      • 市场走向
      • 市场预测
    • 俄罗斯
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 拉丁美洲
    • 巴西
      • 市场走向
      • 市场预测
    • 墨西哥
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 中东和非洲
    • 市场走向
    • 按国家/地区分類的市场细分
    • 市场预测

第 13 章：SWOT 分析

  • 概述
  • 优势
  • 弱点
  • 机会
  • 威胁

第 14 章：价值链分析

第 15 章：波特五力分析

  • 概述
  • 买家的议价能力
  • 供应商的议价能力
  • 竞争程度
  • 新进入者的威胁
  • 替代品的威胁

第 16 章：价格分析

第17章：竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • Charles River Laboratories International Inc.
    • Covance Inc (Laboratory Corporation of America Holdings)
    • Freyr
    • ICON Plc
    • Medpace Holdings Inc
    • Parexel International Corporation
    • Pharmaceutical Product Development LLC
    • Promedica International- A California Corporation
    • Wuxi AppTec Co. Ltd.
Product Code: SR112023A3231

Abstract

The global regulatory affairs outsourcing market size reached US$ 7.1 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 11.7 Billion by 2028, exhibiting a growth rate (CAGR) of 8.7% during 2022-2028. The evolving and complex regulations, globalization of industries, resource optimization, ongoing technological advancements, specialized expertise requirements, and the need for rapid approvals are some of the major factors propelling the market.

Regulatory affairs outsourcing is the practice of companies delegating their regulatory compliance and documentation tasks to external specialized service providers. In this arrangement, businesses, particularly those in highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, hire third-party experts or firms to manage regulatory affairs on their behalf. This encompasses activities like product registration, quality assurance, compliance with government regulations, and submission of required documentation to regulatory authorities. Outsourcing these tasks allows companies to tap into the expertise of professionals well-versed in regulatory frameworks, streamline processes, reduce overhead costs, and ensure adherence to evolving regulatory standards, ultimately facilitating market entry and product approval.

The global regulatory affairs outsourcing market is experiencing substantial growth primarily due to the increasingly complex and stringent regulatory requirements imposed by governments and regulatory bodies across various industries, including pharmaceuticals, medical devices, and food and beverages (F&B). Moreover, the expanding product adoption to enable companies to access a pool of professionals well-versed in the latest regulatory changes and compliance standards, thereby ensuring timely approvals and market access, is contributing to the market growth. Additionally, the globalization of markets has expanded the geographical reach of businesses, necessitating compliance with a multitude of international regulations, thereby bolstering the market growth. Furthermore, the growing need for outsourcing to provide a scalable solution to address diverse regulatory needs across regions is aiding in market expansion. Apart from this, the emerging trend toward cost-efficiency and operational flexibility drives companies to leverage external regulatory services, allowing them to focus on core competencies while mitigating overhead expenses, creating a positive outlook for market expansion.

Regulatory Affairs Outsourcing Market Trends/Drivers:

Increasing complexity in the regulatory landscape

One of the primary drivers of regulatory affairs outsourcing is the increasingly intricate and ever-evolving regulatory environment across various sectors. Industries such as pharmaceuticals, biotechnology, medical devices, and food and beverages (F&B) are subject to strict regulations to ensure product safety, efficacy, and compliance with quality standards. Keeping up with these regulations demands specialized knowledge and continuous monitoring. Outsourcing regulatory affairs allows companies to tap into the expertise of professionals who specialize in understanding the nuances of regional and international regulatory frameworks. Apart from this, these experts help businesses navigate the complex web of rules and ensure that their products meet compliance standards, ultimately facilitating market entry and product approval.

Expanding globalization of markets

Another pivotal factor fueling the growth of regulatory affairs outsourcing is the globalization of markets. As businesses expand their operations globally, they encounter a diverse array of regulatory requirements that vary by region and country. Complying with these regulations can be an intimidating task, especially for companies with limited in-house regulatory resources. In confluence with this, outsourcing provides a scalable solution to address these diverse regulatory needs efficiently. Regulatory affairs outsourcing firms often have a global presence and can assist businesses in adapting their products and processes to meet the specific requirements of different markets, thereby enabling market access and international growth.

Rising focus on cost-efficiency and operational productivity

Cost efficiency and the need for operational focus are driving companies to leverage external regulatory services. Maintaining an in-house regulatory affairs team involves substantial overhead costs, including salaries, training, and infrastructure. Outsourcing regulatory affairs allows organizations to reduce these fixed costs and gain flexibility in resource allocation. This approach enables companies to redirect resources towards core competencies such as research and development (R&D), marketing, and production. By entrusting regulatory activities to specialized outsourcing partners, businesses can streamline their operations, increase efficiency, and respond more effectively to market dynamics.

Regulatory Affairs Outsourcing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global regulatory affairs outsourcing market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on services, company size, category, indication, stage and end user.

Breakup by Services:

Regulatory Consulting

Legal Representation

Regulatory Writing and Publishing

Product Registration and Clinical Trial Applications

Others

Regulatory writing and publishing dominate the market

The report has provided a detailed breakup and analysis of the market based on the services. This includes regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial applications, and others. According to the report, regulatory writing and publishing represented the largest segment.

The demand for regulatory writing and publishing outsourcing is driven by the growing complexity of regulatory documentation, which necessitates specialized expertise and resources. As regulatory requirements become more intricate and region-specific, businesses seek external partners with in-depth knowledge of document preparation and submission processes. Besides this, the need for rapid approvals and market access compels companies to outsource these critical tasks to ensure accurate, compliant, and timely submissions. Furthermore, the adoption of electronic submission systems and the digital transformation of regulatory processes create demand for outsourcing providers with the technological infrastructure and proficiency required for efficient electronic document preparation and publishing.

Breakup by Company Size:

Small

Medium

Large

Medium holds the largest share of the market

A detailed breakup and analysis of the market based on the company size have also been provided in the report. This includes small, medium, and large. According to the report, medium accounted for the largest market share.

Another key factor driving the global regulatory affairs outsourcing market is the rising demand for specialized expertise and resource optimization in medium-sized companies. Medium-sized firms often face resource constraints and may lack an in-house regulatory affairs team with comprehensive knowledge of evolving regulations. Outsourcing enables them to access a pool of experienced regulatory professionals without the overhead costs of maintaining a full-time team. Additionally, as these companies expand into new markets, they require adaptable regulatory support to navigate diverse and complex regulatory landscapes, making outsourcing an efficient and strategic choice to ensure compliance, market entry, and growth.

Breakup by Category:

Generic Drugs

Innovator Drugs

Biologic Drugs

Biosimilars

Medical Devices

Therapeutic

Diagnostic

Others

Medical devices dominate the market

The report has provided a detailed breakup and analysis of the market based on the category. This includes generic drugs, innovator drugs, biologic drugs, biosimilars, medical devices (therapeutic and diagnostic), and others. According to the report, medical devices represented the largest segment.

The medical devices sector is subject to rigorous and evolving regulatory requirements globally, requiring specialized expertise to navigate. Outsourcing offers access to regulatory professionals who possess in-depth knowledge of medical device regulations, ensuring compliance and quicker approvals. Besides this, the constant innovation in medical device technology demands efficient and timely submissions to bring new products to market. Outsourcing streamlines regulatory processes, allowing companies to focus on R&D, thereby fueling the market's growth. Moreover, as the medical device market expands internationally, outsourced services provide support in adapting products to diverse regulatory environments, making outsourcing indispensable for market entry and sustained growth in this sector.

Breakup by Indication:

Oncology

Neurology

Cardiology

Immunology

Others

Oncology holds the largest share of the market

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes oncology, neurology, cardiology, immunology, and others. According to the report, oncology accounted for the largest market share.

The unique challenges and rapid advancements in this therapeutic area are impelling the demand for regulatory affairs outsourcing in the field of oncology. Oncological products often undergo accelerated development and require expedited regulatory pathways due to their potential life-saving nature. This demands specialized knowledge of oncology-specific regulations and fast-track approval processes, which outsourcing partners can provide. Furthermore, the increasing complexity of oncology clinical trials and the need for comprehensive data management and submissions necessitate outsourcing to experts who can navigate these intricate regulatory landscapes, ensuring timely approvals and market access for critical oncology treatments.

Breakup by Stage:

Preclinical

Clinical

PMA (Post Market Authorization)

Clinical dominates the market

The report has provided a detailed breakup and analysis of the market based on the stage. This includes preclinical, clinical, and post market authorization (PMA). According to the report, clinical represented the largest segment.

The surging complexity and resource-intensive nature of clinical trials are contributing to the increasing demand for regulatory affairs outsourcing at the clinical stage. Companies engaging in clinical research must adhere to stringent regulatory requirements to ensure the safety, security, and efficacy of investigational products. Outsourcing offers access to regulatory professionals with specialized knowledge of clinical trial regulations and documentation, helping companies navigate this intricate landscape efficiently. Concurrently, the need for rapid study initiation and adherence to evolving regulatory standards drives the demand for outsourced support in protocol development, submissions, and compliance, ensuring that clinical trials progress smoothly and meet regulatory milestones effectively.

Breakup by End User:

Medical Device Companies

Pharmaceutical Companies

Biotechnology Companies

Pharmaceutical companies hold the largest share of the market

A detailed breakup and analysis of the market based on the end-user have also been provided in the report. This includes medical device, pharmaceutical, and biotechnology companies. According to the report, pharmaceutical companies accounted for the largest market share.

The pharmaceutical industry's evolving landscape represents the key factor aiding in market expansion. With an increasing emphasis on innovative drug development and stringent regulatory oversight, pharmaceutical firms require specialized expertise to navigate the complex regulatory pathways. Outsourcing provides access to regulatory professionals well-versed in pharmaceutical regulations, speeding up the approval process and ensuring compliance. Moreover, the demand for global market access and the need to adapt to regional regulatory variations make outsourcing an attractive option. It enables pharmaceutical companies to focus on core research and development activities while external partners handle regulatory affairs efficiently and effectively.

Breakup by Region:

North America

United States

Canada

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

Asia-Pacific exhibits a clear dominance, accounting for the largest regulatory affairs outsourcing market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, Asia-Pacific accounted for the largest market share.

The increasing globalization of the pharmaceutical, healthcare, and life sciences sectors across the Asia Pacific has led to a surge in demand for regulatory services to navigate diverse regulatory landscapes across the region. Concurrent with this, the rising number of clinical trials and research activities in the region necessitates expertise in local regulatory requirements, making outsourcing an efficient solution for pharmaceutical and biotech companies looking to expand their presence. Furthermore, cost-efficiency plays a pivotal role as companies seek to optimize resources without compromising on compliance, making regulatory affairs outsourcing an attractive option in the Asia Pacific region.

Competitive Landscape:

The competitive landscape of the global regulatory affairs outsourcing market is characterized by a dynamic and diverse array of players vying for market share. Large multinational contract research organizations (CROs) hold prominent positions, offering comprehensive regulatory services across various industries and geographies. These industry giants leverage their extensive global networks, robust technology platforms, and deep regulatory expertise to cater to the diverse needs of clients. Additionally, niche and specialized regulatory affairs outsourcing firms focus on specific industries or regions, offering tailored solutions and in-depth regulatory knowledge. Emerging players, including startups and regional service providers, are also gaining traction by capitalizing on market niches and innovative service offerings. The competitive landscape is further shaped by strategic collaborations, mergers, and acquisitions as companies seek to expand their service portfolios and geographic reach.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Charles River Laboratories International Inc.

Covance Inc (Laboratory Corporation of America Holdings)

Freyr

ICON Plc

Medpace Holdings Inc.

Parexel International Corporation

Pharmaceutical Product Development LLC

Promedica International- A California Corporation

Wuxi AppTec Co. Ltd.

Recent Developments:

In February 2021, ICON plc announced the acquisition of PRA Health Sciences, Inc. in a cash and stock transaction valued at USD 12 billion approximately. This acquisition has strengthened the medical affairs service offering of the company.

Key Questions Answered in This Report:

  • How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global regulatory affairs outsourcing market?
  • What are the key regional markets?
  • What is the breakup of the market based on the services?
  • What is the breakup of the market based on the company size?
  • What is the breakup of the market based on the category?
  • What is the breakup of the market based on the indication?
  • What is the breakup of the market based on the stage?
  • What is the breakup of the market based on the end user?
  • What are the various stages in the value chain of the industry?
  • What are the key driving factors and challenges in the industry?
  • What is the structure of the global regulatory affairs outsourcing market and who are the key players?
  • What is the degree of competition in the industry?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Regulatory Affairs Outsourcing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Services

  • 6.1 Regulatory Consulting
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Legal Representation
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Regulatory Writing and Publishing
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Product Registration and Clinical Trial Applications
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast
  • 6.5 Others
    • 6.5.1 Market Trends
    • 6.5.2 Market Forecast

7 Market Breakup by Company Size

  • 7.1 Small
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Medium
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Large
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast

8 Market Breakup by Category

  • 8.1 Generic Drugs
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Innovator Drugs
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Biologic Drugs
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Biosimilars
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Medical Devices
    • 8.5.1 Market Trends
    • 8.5.2 Major Types
      • 8.5.2.1 Therapeutic
      • 8.5.2.2 Diagnostic
    • 8.5.3 Market Forecast
  • 8.6 Others
    • 8.6.1 Market Trends
    • 8.6.2 Market Forecast

9 Market Breakup by Indication

  • 9.1 Oncology
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Neurology
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Cardiology
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast
  • 9.4 Immunology
    • 9.4.1 Market Trends
    • 9.4.2 Market Forecast
  • 9.5 Others
    • 9.5.1 Market Trends
    • 9.5.2 Market Forecast

10 Market Breakup by Stage

  • 10.1 Preclinical
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Clinical
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 PMA (Post Market Authorization)
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast

11 Market Breakup by End User

  • 11.1 Medical Device Companies
    • 11.1.1 Market Trends
    • 11.1.2 Market Forecast
  • 11.2 Pharmaceutical Companies
    • 11.2.1 Market Trends
    • 11.2.2 Market Forecast
  • 11.3 Biotechnology Companies
    • 11.3.1 Market Trends
    • 11.3.2 Market Forecast

12 Market Breakup by Region

  • 12.1 North America
    • 12.1.1 United States
      • 12.1.1.1 Market Trends
      • 12.1.1.2 Market Forecast
    • 12.1.2 Canada
      • 12.1.2.1 Market Trends
      • 12.1.2.2 Market Forecast
  • 12.2 Asia-Pacific
    • 12.2.1 China
      • 12.2.1.1 Market Trends
      • 12.2.1.2 Market Forecast
    • 12.2.2 Japan
      • 12.2.2.1 Market Trends
      • 12.2.2.2 Market Forecast
    • 12.2.3 India
      • 12.2.3.1 Market Trends
      • 12.2.3.2 Market Forecast
    • 12.2.4 South Korea
      • 12.2.4.1 Market Trends
      • 12.2.4.2 Market Forecast
    • 12.2.5 Australia
      • 12.2.5.1 Market Trends
      • 12.2.5.2 Market Forecast
    • 12.2.6 Indonesia
      • 12.2.6.1 Market Trends
      • 12.2.6.2 Market Forecast
    • 12.2.7 Others
      • 12.2.7.1 Market Trends
      • 12.2.7.2 Market Forecast
  • 12.3 Europe
    • 12.3.1 Germany
      • 12.3.1.1 Market Trends
      • 12.3.1.2 Market Forecast
    • 12.3.2 France
      • 12.3.2.1 Market Trends
      • 12.3.2.2 Market Forecast
    • 12.3.3 United Kingdom
      • 12.3.3.1 Market Trends
      • 12.3.3.2 Market Forecast
    • 12.3.4 Italy
      • 12.3.4.1 Market Trends
      • 12.3.4.2 Market Forecast
    • 12.3.5 Spain
      • 12.3.5.1 Market Trends
      • 12.3.5.2 Market Forecast
    • 12.3.6 Russia
      • 12.3.6.1 Market Trends
      • 12.3.6.2 Market Forecast
    • 12.3.7 Others
      • 12.3.7.1 Market Trends
      • 12.3.7.2 Market Forecast
  • 12.4 Latin America
    • 12.4.1 Brazil
      • 12.4.1.1 Market Trends
      • 12.4.1.2 Market Forecast
    • 12.4.2 Mexico
      • 12.4.2.1 Market Trends
      • 12.4.2.2 Market Forecast
    • 12.4.3 Others
      • 12.4.3.1 Market Trends
      • 12.4.3.2 Market Forecast
  • 12.5 Middle East and Africa
    • 12.5.1 Market Trends
    • 12.5.2 Market Breakup by Country
    • 12.5.3 Market Forecast

13 SWOT Analysis

  • 13.1 Overview
  • 13.2 Strengths
  • 13.3 Weaknesses
  • 13.4 Opportunities
  • 13.5 Threats

14 Value Chain Analysis

15 Porters Five Forces Analysis

  • 15.1 Overview
  • 15.2 Bargaining Power of Buyers
  • 15.3 Bargaining Power of Suppliers
  • 15.4 Degree of Competition
  • 15.5 Threat of New Entrants
  • 15.6 Threat of Substitutes

16 Price Analysis

17 Competitive Landscape

  • 17.1 Market Structure
  • 17.2 Key Players
  • 17.3 Profiles of Key Players
    • 17.3.1 Charles River Laboratories International Inc.
      • 17.3.1.1 Company Overview
      • 17.3.1.2 Product Portfolio
      • 17.3.1.3 Financials
      • 17.3.1.4 SWOT Analysis
    • 17.3.2 Covance Inc (Laboratory Corporation of America Holdings)
      • 17.3.2.1 Company Overview
      • 17.3.2.2 Product Portfolio
      • 17.3.2.3 SWOT Analysis
    • 17.3.3 Freyr
      • 17.3.3.1 Company Overview
      • 17.3.3.2 Product Portfolio
    • 17.3.4 ICON Plc
      • 17.3.4.1 Company Overview
      • 17.3.4.2 Product Portfolio
      • 17.3.4.3 Financials
      • 17.3.4.4 SWOT Analysis
    • 17.3.5 Medpace Holdings Inc
      • 17.3.5.1 Company Overview
      • 17.3.5.2 Product Portfolio
      • 17.3.5.3 Financials
      • 17.3.5.4 SWOT Analysis
    • 17.3.6 Parexel International Corporation
      • 17.3.6.1 Company Overview
      • 17.3.6.2 Product Portfolio
      • 17.3.6.3 SWOT Analysis
    • 17.3.7 Pharmaceutical Product Development LLC
      • 17.3.7.1 Company Overview
      • 17.3.7.2 Product Portfolio
      • 17.3.7.3 Financials
      • 17.3.7.4 SWOT Analysis
    • 17.3.8 Promedica International- A California Corporation
      • 17.3.8.1 Company Overview
      • 17.3.8.2 Product Portfolio
    • 17.3.9 Wuxi AppTec Co. Ltd.
      • 17.3.9.1 Company Overview
      • 17.3.9.2 Product Portfolio

List of Figures

  • Figure 1: Global: Regulatory Affairs Outsourcing Market: Major Drivers and Challenges
  • Figure 2: Global: Regulatory Affairs Outsourcing Market: Sales Value (in Billion US$), 2017-2022
  • Figure 3: Global: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Billion US$), 2023-2028
  • Figure 4: Global: Regulatory Affairs Outsourcing Market: Breakup by Services (in %), 2022
  • Figure 5: Global: Regulatory Affairs Outsourcing Market: Breakup by Company Size (in %), 2022
  • Figure 6: Global: Regulatory Affairs Outsourcing Market: Breakup by Category (in %), 2022
  • Figure 7: Global: Regulatory Affairs Outsourcing Market: Breakup by Indication (in %), 2022
  • Figure 8: Global: Regulatory Affairs Outsourcing Market: Breakup by Stage (in %), 2022
  • Figure 9: Global: Regulatory Affairs Outsourcing Market: Breakup by End User (in %), 2022
  • Figure 10: Global: Regulatory Affairs Outsourcing Market: Breakup by Region (in %), 2022
  • Figure 11: Global: Regulatory Affairs Outsourcing (Regulatory Consulting) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 12: Global: Regulatory Affairs Outsourcing (Regulatory Consulting) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 13: Global: Regulatory Affairs Outsourcing (Legal Representation) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 14: Global: Regulatory Affairs Outsourcing (Legal Representation) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 15: Global: Regulatory Affairs Outsourcing (Regulatory Writing and Publishing) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 16: Global: Regulatory Affairs Outsourcing (Regulatory Writing and Publishing) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 17: Global: Regulatory Affairs Outsourcing (Product Registration and Clinical Trial Applications) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 18: Global: Regulatory Affairs Outsourcing (Product Registration and Clinical Trial Applications) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 19: Global: Regulatory Affairs Outsourcing (Other Services) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 20: Global: Regulatory Affairs Outsourcing (Other Services) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 21: Global: Regulatory Affairs Outsourcing (Small) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 22: Global: Regulatory Affairs Outsourcing (Small) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 23: Global: Regulatory Affairs Outsourcing (Medium) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 24: Global: Regulatory Affairs Outsourcing (Medium) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 25: Global: Regulatory Affairs Outsourcing (Large ) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 26: Global: Regulatory Affairs Outsourcing (Large ) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 27: Global: Regulatory Affairs Outsourcing (Generic Drugs) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 28: Global: Regulatory Affairs Outsourcing (Generic Drugs) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 29: Global: Regulatory Affairs Outsourcing (Innovator Drugs) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 30: Global: Regulatory Affairs Outsourcing (Innovator Drugs) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 31: Global: Regulatory Affairs Outsourcing (Biologic Drugs) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 32: Global: Regulatory Affairs Outsourcing (Biologic Drugs) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 33: Global: Regulatory Affairs Outsourcing (Biosimilars) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 34: Global: Regulatory Affairs Outsourcing (Biosimilars) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 35: Global: Regulatory Affairs Outsourcing (Medical Devices) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 36: Global: Regulatory Affairs Outsourcing (Medical Devices) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 37: Global: Regulatory Affairs Outsourcing (Other Categories) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 38: Global: Regulatory Affairs Outsourcing (Other Categories) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 39: Global: Regulatory Affairs Outsourcing (Oncology) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 40: Global: Regulatory Affairs Outsourcing (Oncology) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 41: Global: Regulatory Affairs Outsourcing (Neurology) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 42: Global: Regulatory Affairs Outsourcing (Neurology) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 43: Global: Regulatory Affairs Outsourcing (Cardiology) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 44: Global: Regulatory Affairs Outsourcing (Cardiology) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 45: Global: Regulatory Affairs Outsourcing (Immunology) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 46: Global: Regulatory Affairs Outsourcing (Immunology) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 47: Global: Regulatory Affairs Outsourcing (Other Indications) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 48: Global: Regulatory Affairs Outsourcing (Other Indications) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 49: Global: Regulatory Affairs Outsourcing (Preclinical) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 50: Global: Regulatory Affairs Outsourcing (Preclinical) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 51: Global: Regulatory Affairs Outsourcing (Clinical) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 52: Global: Regulatory Affairs Outsourcing (Clinical) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 53: Global: Regulatory Affairs Outsourcing (PMA -Post Market Authorization) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 54: Global: Regulatory Affairs Outsourcing (PMA -Post Market Authorization) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 55: Global: Regulatory Affairs Outsourcing (Medical Device Companies) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 56: Global: Regulatory Affairs Outsourcing (Medical Device Companies) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 57: Global: Regulatory Affairs Outsourcing (Pharmaceutical Companies) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 58: Global: Regulatory Affairs Outsourcing (Pharmaceutical Companies) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 59: Global: Regulatory Affairs Outsourcing (Biotechnology Companies) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 60: Global: Regulatory Affairs Outsourcing (Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 61: North America: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 62: North America: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 63: United States: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 64: United States: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 65: Canada: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 66: Canada: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 67: Asia-Pacific: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 68: Asia-Pacific: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 69: China: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 70: China: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 71: Japan: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 72: Japan: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 73: India: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 74: India: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 75: South Korea: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 76: South Korea: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 77: Australia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 78: Australia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 79: Indonesia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 80: Indonesia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 81: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 82: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 83: Europe: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 84: Europe: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 85: Germany: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 86: Germany: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 87: France: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 88: France: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 89: United Kingdom: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 90: United Kingdom: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 91: Italy: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 92: Italy: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 93: Spain: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 94: Spain: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 95: Russia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 96: Russia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 97: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 98: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 99: Latin America: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 100: Latin America: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 101: Brazil: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 102: Brazil: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 103: Mexico: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 104: Mexico: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 105: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 106: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 107: Middle East and Africa: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 108: Middle East and Africa: Regulatory Affairs Outsourcing Market: Breakup by Country (in %), 2022
  • Figure 109: Middle East and Africa: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 110: Global: Regulatory Affairs Outsourcing Industry: SWOT Analysis
  • Figure 111: Global: Regulatory Affairs Outsourcing Industry: Value Chain Analysis
  • Figure 112: Global: Regulatory Affairs Outsourcing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Regulatory Affairs Outsourcing Market: Key Industry Highlights, 2022 and 2028
  • Table 2: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Services (in Million US$), 2023-2028
  • Table 3: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Company Size (in Million US$), 2023-2028
  • Table 4: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Category (in Million US$), 2023-2028
  • Table 5: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Indication (in Million US$), 2023-2028
  • Table 6: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Stage (in Million US$), 2023-2028
  • Table 7: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by End User (in Million US$), 2023-2028
  • Table 8: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Region (in Million US$), 2023-2028
  • Table 9: Global: Regulatory Affairs Outsourcing Market: Competitive Structure
  • Table 10: Global: Regulatory Affairs Outsourcing Market: Key Players