監管事務外包市場規模、佔有率、成長分析、按服務、按公司規模、按類別、按適應症、按產品階段、按地區 - 行業預測，2024-2031 年

2022 年，全球監管事務外包市場規模為 61 億美元，從 2023 年的 66.5 億美元成長到 2031 年的 126.2 億美元，預計在預測期內（2024-2031 年）將成長。 %。

監管事務，有時也稱為政府事務，評估和監督各個領域產品的適用性和效率，包括農業化學品、化妝品、殺蟲劑、醫療設備、動物用藥品、藥品和補充藥物，確保公眾健康。這些服務由醫療設備、生物技術和製藥行業的製造商提供。監管事務外包公司可以幫助您有效率且準時地獲得監管授權。在醫療保健領域，監管事務外包的趨勢日益成長。這一轉變的出現是因為區域擴張工作需要當地市場更快的核准。此外，由於研發活動、臨床試驗應用和產品註冊的增加，市場正在擴大。

目錄

介紹

• 研究目的
• 定義
• 市場範圍

調查方法

• 資訊採購
• 二手資料來源和主要資料來源
• 市場規模預測
• 市場假設與限制

執行摘要

• 市場概況展望
• 供需趨勢分析
• 按細分市場的機會分析

市場動態及展望

• 市場動態
  • 促進因素
  • 機會
  • 抑制因素
  • 任務
• 波特的分析

主要市場考察

• 技術分析
• 市場生態系統
• 專利分析
• 價格分析
• PESTEL分析
• 監管環境
• 創新矩陣
• 主要投資分析
• 關鍵成功因素
• 競爭程度

監理事務外包市場：依服務分類

• 市場概況
• 監理諮詢
  • 策略及發展規劃
  • 品質保證諮詢
  • 其他
• 法律代表
• 撰寫和發布規範文件
• 產品註冊及臨床試驗申請
• 監理意見書
• 監管業務
• 其他服務

監理事務外包市場：依公司規模

• 市場概況
• 小規模
• 中等尺寸
• 大規模

監理事務外包市場：依類別

• 市場概況
• 藥品
  • 監理諮詢
  • 策略及發展規劃
  • 品質保證諮詢
  • 其他
  • 法律代表
  • 撰寫和發布規範文件
  • 產品註冊及臨床試驗申請
  • 監理意見書
  • 監管業務
  • 其他服務
• 醫療設備
  • 監理諮詢
  • 策略及發展規劃
  • 品質保證諮詢
  • 其他
  • 法律代表
  • 撰寫和發布規範文件
  • 產品註冊及臨床試驗申請
  • 監理意見書
  • 監管業務
  • 其他服務

監理事務外包市場：依指標分類

• 市場概況
• 腫瘤學
• 神經病學
• 心臟病學
• 免疫學
• 其他

監理事務外包市場：依產品階段

• 市場概況
• 臨床前
• 臨床
• PMA（上市後核准）

監理事務外包市場：依最終用途分類

• 市場概況
• 醫療設備公司
• 製藥公司
• 生技公司

監理事務外包市場：按地區分類的規模

• 市場概況
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲 (MEA)
  • 海灣合作理事會國家
  • 南非
  • 其他中東/非洲地區

競爭格局

• 前5名企業對比
• 主要企業市場定位（2023年）
• 主要市場參與者所採取的策略
• 近期市集活動
• 主要企業市場佔有率（2023年）

主要企業簡介

• Accell Clinical Research, LLC
• Genpact
• CRITERIUM, INC
• Promedica International
• New WuXi Life Science Limited
• Medpace
• Bausch & Lomb
• Freyr
• SSI Strategy Holdings LLC
• Pharmexon
• Quanticate
• PharmaLex
• Cambridge Regulatory Services
• APC Group
• Real Regulatory Ltd
• Ergomed Plc
• Regulatory Pharma Net srl
• Excelya Group SAS
• BioMapas
• REGENOLD GMBH

Global Regulatory Affairs Outsourcing Market size was valued at USD 6.1 billion in 2022 and is poised to grow from USD 6.65 billion in 2023 to USD 12.62 billion by 2031, growing at a CAGR of 8.34% during the forecast period (2024-2031).

Regulatory affairs, sometimes referred to as government affairs, involves evaluating and overseeing the adequacy and efficiency of products across various sectors, including agrochemicals, cosmetics, pesticides, medical devices, veterinary medicines, pharmaceuticals, and complementary medicines, to ensure public health. These services are provided by manufacturers in the medical device, biotechnology, and pharmaceutical industries. Regulatory affairs outsourcing firms help obtain regulatory permits efficiently and on time. The trend of outsourcing regulatory affairs is growing in the healthcare sector. This shift is driven by the need for rapid approvals in local markets due to regional expansion efforts. Additionally, the market is expanding due to increased research and development activities, as well as a rise in clinical trial applications and product registrations.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Regulatory Affairs Outsourcing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Regulatory Affairs Outsourcing Market Segmental Analysis

Global Regulatory Affairs Outsourcing Market is segmented by Services, Company Size, Category, Indication, Product Stage, End Use, and Region. Based on Services, the market is segmented into Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submission, Regulatory Operations, Other Services. Based on Company Size, the market is segmented into Small, Medium, Large. Based on Category, the market is segmented into Pharmaceuticals (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services), Medical Device (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services). Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology, Others. Based on Product Stage, the market is segmented into Preclinical, Clinical, PMA (Post Market Authorization). Based on End Use, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Drivers of the Global Regulatory Affairs Outsourcing Market

The global demand for these services during the forecast period is being driven by several factors, including a rise in chronic illnesses, the expiration of patents for prescription biologics, brand extensions, and the easy availability of over-the-counter (OTC) drugs through various platforms. Additionally, economic and social factors, rising healthcare expenditures, and advancements in regulatory affairs outsourcing are contributing to this growing demand.

Restraints in the Global Regulatory Affairs Outsourcing Market

Nevertheless, the substantial risks associated with data sharing and outsourcing pose significant challenges that are expected to hinder the advancement of the regulatory outsourcing market throughout the forecast period. These concerns, stemming from data security and management issues, could considerably affect the market's growth trajectory and overall progress.

Market Trends of the Global Regulatory Affairs Outsourcing Market

The growth of the global regulatory affairs outsourcing market is significantly driven by several factors. These include a rise in research and development investments aimed at creating orphan, biosimilar, and generic drugs, alongside increased funding for clinical research. Additionally, stringent government regulations and a heightened emphasis on product development to enhance supply chains are playing crucial roles in this expansion.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Technology Analysis
• Ecosystem of the Market
• Patent Analysis
• Pricing Analysis
• PESTEL Analysis
• Regulatory Landscape
• Innovation Matrix
• Top Investment Analysis
• Key Success Factor
• Degree of Competition

Regulatory Affairs Outsourcing Market by Services

• Market Overview
• Regulatory Consulting
  • Strategy & Development Planning
  • QA Consulting
  • Others
• Legal Representation
• Regulatory Writing & Publishing
• Product Registration & Clinical Trial Applications
• Regulatory Submission
• Regulatory Operations
• Other Services

Regulatory Affairs Outsourcing Market by Company Size

• Market Overview
• Small
• Medium
• Large

Regulatory Affairs Outsourcing Market by Category

• Market Overview
• Pharmaceuticals
  • Regulatory Consulting
  • Strategy & Development Planning
  • QA consulting
  • Others
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product Registration & Clinical Trial Applications
  • Regulatory Submissions
  • Regulatory Operations
  • Other Sevices
• Medical Device
  • Regulatory Consulting
  • Strategy & Development Planning
  • QA Consulting
  • Others
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product Registration & Clinical Trial Applications
  • Regulatory Submissions
  • Regulatory Operations
  • Other Services

Regulatory Affairs Outsourcing Market by Indication

• Market Overview
• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Regulatory Affairs Outsourcing Market by Product Stage

• Market Overview
• Preclinical
• Clinical
• PMA (Post Market Authorization)

Regulatory Affairs Outsourcing Market by End Use

• Market Overview
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Accell Clinical Research, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Genpact
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• CRITERIUM, INC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Promedica International
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• New WuXi Life Science Limited
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medpace
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bausch & Lomb
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Freyr
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SSI Strategy Holdings LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pharmexon
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quanticate
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PharmaLex
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cambridge Regulatory Services
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• APC Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Real Regulatory Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ergomed Plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Regulatory Pharma Net srl
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Excelya Group SAS
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioMapas
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• REGENOLD GMBH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments