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市场调查报告书

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1561039

监管事务外包市场规模、份额、成长分析、按服务、按公司规模、按类别、按适应症、按产品阶段、按地区 - 行业预测，2024-2031 年

Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services, By Company Size, By Category, By Indication, By Product Stage, By Region - Industry Forecast 2024-2031

出版日期: 2024年09月21日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5个工作天内

价格

简介目录

2022 年，全球监管事务外包市场规模为 61 亿美元，从 2023 年的 66.5 亿美元成长到 2031 年的 126.2 亿美元，预计在预测期内（2024-2031 年）将成长。 %。

监管事务，有时也称为政府事务，评估和监督各个领域产品的适用性和效率，包括农业化学品、化妆品、杀虫剂、医疗设备、动物用药品、药品和补充药物，确保公众健康。这些服务由医疗设备、生物技术和製药行业的製造商提供。监管事务外包公司可以帮助您有效率且准时地获得监管授权。在医疗保健领域，监管事务外包的趋势日益增长。这一转变的出现是因为区域扩张工作需要当地市场更快的核准。此外，由于研发活动、临床试验应用和产品註册的增加，市场正在扩大。

市场概况
药品
- 监理咨询
- 策略及发展规划
- 品质保证咨询
- 其他的
- 法律代表
- 撰写和发布规范文件
- 产品註册及临床试验申请
- 监理意见书
- 监管业务
- 其他服务
医疗设备
- 监理咨询
- 策略及发展规划
- 品质保证咨询
- 其他的
- 法律代表
- 撰写和发布规范文件
- 产品註册及临床试验申请
- 监理意见书
- 监管业务
- 其他服务

监理事务外包市场：依指标分类

市场概况
肿瘤学
神经病学
心臟病学
免疫学
其他的

监理事务外包市场：依产品阶段

市场概况
临床前
临床
PMA（上市后核准）

监理事务外包市场：依最终用途分类

市场概况
医疗设备公司
製药公司
生技公司

监理事务外包市场：按地区分類的规模

市场概况
北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 义大利
- 其他欧洲国家地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 其他亚太地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
中东和非洲 (MEA)
- 海湾合作委员会国家
- 南非
- 其他中东/非洲地区

竞争格局

前5名企业对比
主要企业市场定位（2023年）
主要市场参与者所采取的策略
近期市集活动
主要企业市场占有率（2023年）

主要企业简介

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

简介目录

Product Code: SQMIG35D2051

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.

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