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監管事務外包市場 - 2018-2028 年全球行業規模、佔有率、趨勢、機會和預測，按服務、類別、公司規模、適應症、產品階段、最終用途、地區和競爭細分
市場調查報告書
商品編碼
1331420

監管事務外包市場 - 2018-2028 年全球行業規模、佔有率、趨勢、機會和預測，按服務、類別、公司規模、適應症、產品階段、最終用途、地區和競爭細分

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個工作天內

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簡介目錄

預計監管事務外包市場在預測期內將出現令人印象深刻的成長。這可以歸因於研發活動的不斷成長以及臨床試驗申請和產品註冊量的增加。同樣，各國政府為控製藥品成本而採取的日益嚴格的法規預計將增加經濟和競爭壓力，進而預計將推動生命科學公司對監管事務外包的需求。 2020 年，禮來公司達成協議，收購 Dermira 的免疫學產品組合。此外，COVID-19 大流行造成了對疫苗的迫切需求。因此，COVID-19 疫苗的開發可能會對細分市場的成長產生積極影響。日益全球化

監管複雜性不斷上升

監管複雜性在全球監管事務外包市場的成長中發揮著重要作用。世界各地的監管機構正在加強對各個行業的審查，包括醫療保健、製藥和醫療器械。遵守這些法規可能既耗時又複雜，需要大量資源和專業知識。外包監管事務服務可以幫助公司掌握監管變化並確保遵守適用的法規。監管事務服務提供商對不同地區的監管環境擁有廣泛的了解，包括適用的法律、法規和指南。他們可以就產品註冊、臨床試驗申請、品質保證等合規相關活動提供專家建議。此外，監管事務服務提供商可以幫助企業應對不同地區複雜的監管要求。這包括提供有關產品標籤和包裝要求的指導，以及確保遵守良好生產規範 (GMP) 和良好臨床規範 (GCP)。外包監管事務服務可以幫助公司降低因不遵守監管要求而導致代價高昂的錯誤的風險。這些錯誤可能會導致產品批准延遲、產品召回以及其他負面後果，從而嚴重影響公司的利潤。

對專業知識的需求不斷成長

專業知識一直是全球監管事務外包市場成長的關鍵因素。監管事務是一個複雜且專業的領域，需要深入了解各種監管框架，包括法律、法規和指南。隨著監管要求變得越來越複雜和嚴格，公司對專業知識的需求日益成長，以確保合規性並避免代價高昂的錯誤。外包監管事務服務使公司能夠利用監管事務服務提供商的專業知識。這些提供商對不同地區的監管環境以及適用的法律、法規和準則擁有廣泛的了解。他們可以就產品註冊、臨床試驗申請和品質保證等合規相關活動提供專家建議。

此外，監管事務服務提供商可以提供醫療器械、生物製品和藥品等特定領域的專業知識。對於缺乏這些領域內部監管事務專業知識的公司來說，這種專業知識尤其有價值。通過將監管事務服務外包給專業服務提供商，公司可以確保他們能夠獲得遵守適用監管要求所需的專業知識。專業知識可以幫助公司了解最新的監管發展和變化。監管事務服務提供商不斷監控不同地區的監管變化，並可以就這些變化如何影響公司的產品或營運提供專家指導。

節約成本

節省成本是全球監管事務外包市場成長的重要因素。遵守監管要求可能非常耗時且成本高昂，需要大量資源和專業知識。缺乏內部監管事務專業知識的公司可能需要雇用和培訓員工或使用昂貴的外部顧問來確保合規性。外包監管事務服務可以為企業節省大量成本。監管事務服務提供商可以提供專業知識和資源，通常比僱用和培訓內部員工或使用外部顧問的成本更低。外包可以為監管事務提供更加靈活和可擴展的方法，使公司能夠根據業務需求按需擴大或縮小其監管事務資源。

外包監管事務服務可以幫助公司避免因不遵守監管要求而導致代價高昂的錯誤。這些錯誤可能會導致產品批准延遲、產品召回以及其他負面後果，從而嚴重影響公司的利潤。外包監管事務服務可以幫助企業提高營運效率。通過外包監管事務服務，公司可以釋放內部資源，專注於其核心業務活動，例如產品開發和行銷。這有助於提高生產力和盈利能力，同時仍確保符合監管要求。

技術進步

技術進步對全球監管事務外包市場的成長發揮了重要作用。數位技術的日益普及改變了監管事務格局的許多方面，為外包服務提供商創造了新的機會。影響市場成長的主要因素之一是監管事務流程的自動化。使用先進的軟體系統和人工智慧（AI）工具可以幫助簡化監管事務工作流程，減少執行合規相關活動所需的時間和精力。例如，人工智慧可用於審查大量監管文件，幫助識別潛在問題並提高監管提交的準確性。

技術使監管事務服務提供商與其客戶之間能夠加強協作和溝通。雲端基礎平台和其他協作工具使監管事務專業人員能夠更輕鬆地協同工作，無論他們身在何處。這有助於提高效率並減少與監管事務流程相關的時間和成本。技術對即時數據監控和分析的使用產生影響的另一個領域。先進的數據分析工具可以幫助監管事務專業人員識別新興的監管趨勢和潛在的合規問題，使他們能夠在這些問題成為問題之前主動解決這些問題。最後，技術提高了監管事務流程的透明度和問責制。數位系統和工具可以更輕鬆地追踪合規相關活動並提供審計追踪，從而提高合規性並降低不合規風險。

近期發展

  • 2021年，WIRB-Copernicus Group（WCG）推出了一項名為WCG Oncology的新服務，為腫瘤臨床試驗提供全面的監管和倫理審查服務。
  • 2020 年，Kinapse（Syneos Health 的子公司）推出了一項名為 Kinapse Quality Labs 的新服務，該服務使用先進的數據分析和人工智慧來幫助客戶最佳化其監管合規流程。
  • 2020年，IQVIA推出了一套新的監管資訊管理解決方案，旨在幫助客戶更有效地管理監管提交流程。
  • 2019年，Qserve Group推出了名為QserveConnect的新平台，為客戶提供按需訪問一系列監管事務服務，包括監管策略、臨床評估和品質管理。
  • 2019年，埃森哲推出了監管與合規分析解決方案，這是一套數位工具和服務，旨在幫助企業更有效地管理監管合規性。
  • 2018 年，Parexel 推出了新的監管外包服務，旨在幫助客戶應對複雜的監管環境並縮短上市時間。

可用的客製化：

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公司資訊

  • 其他市場參與者（最多五個）的詳細分析和概況分析。

目錄

第 1 章：產品概述

  • 市場定義
  • 市場範圍
    • 涵蓋的市場
    • 考慮學習的年份
    • 主要市場細分

第 2 章：研究方法

  • 研究目的
  • 基線方法
  • 主要行業合作夥伴
  • 主要協會和二手資料來源
  • 預測方法
  • 數據三角測量和驗證
  • 假設和限制

第 3 章：執行摘要

  • 市場概況
  • 主要市場細分概述
  • 主要市場參與者概述
  • 重點地區/國家概況
  • 市場促進因素、挑戰、趨勢概述

第 4 章：客戶之聲

第 5 章：全球監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按地區（北美、歐洲、亞太地區、南美、中東和非洲）
    • 按公司分類 (2022)
  • 市場地圖
    • 按服務
    • 按類別
    • 按公司規模
    • 按指示
    • 按產品階段
    • 按最終用途

第 6 章：北美監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按國家/地區
  • 北美：國家分析
    • 美國
    • 加拿大
    • 墨西哥

第 7 章：歐洲監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按國家/地區
  • 歐洲：國家分析
    • 法國
    • 德國
    • 英國
    • 義大利
    • 西班牙

第 8 章：亞太地區監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按國家/地區
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳大利亞

第 9 章：南美監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按國家/地區
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第10章 ：中東和非洲監管事務外包市場展望

  • 市場規模及預測
    • 按價值
  • 市場佔有率及預測
    • 按服務分類（監管諮詢、法律代表、監管寫作和出版、產品註冊和臨床試驗申請、監管提交、監管營運、其他服務）
    • 按類別（藥品、醫療器械）
    • 按公司規模（小型公司、中型公司、大型公司）
    • 按適應症（腫瘤學、神經病學、心臟病學、免疫學、其他適應症）
    • 按產品階段（臨床前、臨床、上市前批准）
    • 按最終用途（醫療器械公司、製藥公司、生物技術公司）
    • 按國家/地區
  • MEA：國家分析
    • 南非監管事務外包
    • 沙烏地阿拉伯監管事務外包
    • 阿拉伯聯合大公國監管事務外包

第 11 章：市場動態

  • 司機
  • 挑戰

第 12 章：市場趨勢與發展

  • 近期發展
  • 併購
  • 產品發布

第 13 章：全球監管事務外包市場：SWOT 分析

第 14 章：波特的五力分析

  • 行業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 客戶的力量
  • 替代產品的威脅

第15章：競爭格局

  • 商業概覽
  • 產品供應
  • 最近的發展
  • 財務（據報導）
  • 主要人員
  • 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：戰略建議

簡介目錄
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