查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
封面
市场调查报告书
商品编码
1529562

医药外包市场：依服务类型、最终用户、阶段、治疗领域、地区

Regulatory Affairs Outsourcing Market, By Service Type, By End User, By Stage, By Therapeutic Area, By Geography
出版日期: | 出版商: Coherent Market Insights | 英文 166 Pages | 商品交期: 2-3个工作天内

价格
简介目录

预计2024年全球医药外包市场规模为84.1亿美元，2031年将达171亿美元，2024年至2031年复合年增长率为10.7%。

报告范围 报告详情
基准年 2023年 2024年市场规模 84.1亿美元
实际资料 2019-2023 预测期 2024-2031
2024-2031 年预测期复合年增长率 10.70% 2031 年金额预测 171亿美元
图. 医药外包市场占有率（%）（依地区划分，2024年）
监理事务外包市场-IMG1

法律规范，正在推动全球医药外包市场的成长。每个地区的监管要求变得越来越严格，需要专业知识和资源来实现合规。此外，药物开发过程已受到高度监管，需要在从临床开发到核准的各个阶段密切监测和控制合规性。因此，包括医疗设备製造商在内的製药和生物技术公司越来越多地转向专业的第三方服务供应商来外包其业务。监管外包帮助公司简化流程、降低成本并将资源集中在核心竞争力上。

市场动态：

全球监管外包市场的成长受到製药和生技公司研发费用增加、严格的法规环境和成本压力等因素的推动。然而，资料隐私和安全问题以及品管问题可能会阻碍市场成长。随着外包和临床试验活动转向亚太和拉丁美洲的低成本目的地，新兴市场可能会提供重大商机。受监管服务供应商采用的併购和联盟策略数量不断增加，也导致其能力和全球企业发展的扩大，记录了新的成长机会。

本研究的主要特点

  • 本报告对全球医药外包市场进行了详细分析，并介绍了以 2023 年为基准年的预测期（2024-2031 年）的市场规模（十亿美元）和年复合成长率（CAGR%）。
  • 它还揭示了各个细分市场的潜在商机，并说明了该市场有吸引力的投资提案矩阵。
  • 它还提供了有关市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景、主要企业采取的竞争策略等的重要见解。
  • 该报告根据公司亮点、产品系列、主要亮点、财务业绩和策略等参数，对全球监管外包市场的主要企业进行了介绍。
  • 该报告的见解使负责人和公司经营团队能够就未来的产品发布、升级、市场扩张和行销策略做出明智的决策。
  • 全球监管外包市场报告针对该行业的各个相关人员，如投资者、供应商、产品製造商、经销商、新进业者和财务分析师。
  • 透过用于全球製药外包市场分析的各种策略矩阵，将促进相关人员的决策。

目录

第一章 研究目的与前提

  • 研究目的
  • 先决条件
  • 简称

第二章 市场展望

  • 报告说明
    • 市场定义和范围
  • 执行概述
  • 一致的机会地图 (COM)

第三章市场动态、法规及趋势分析

  • 市场动态
    • 促进因素
    • 抑制因素
    • 机会
  • 影响分析
  • 市场趋势
  • 监管场景
  • 收购和合作场景
  • 资金筹措和投资
  • PEST分析
  • 波特的分析

第四章全球医药外包市场 - 冠状病毒（COVID-19）大流行的影响

  • 整体影响
  • 政府倡议
  • COVID-19 对市场的影响

第五章全球医药外包市场，依服务类型，2019-2031（十亿美元）

  • 介绍
  • 监管咨询和法律代表
  • 产品註册及临床试验申请
  • 规范性文件的编制和发布
  • 监理意见书
  • 监管业务
  • 其他的

第六章 全球医药外包市场，依最终用户划分，2019-2031 年（十亿美元）

  • 介绍
  • 医疗设备公司
  • 製药公司
  • 生技公司

第七章 2019-2031 年全球医药外包市场分阶段（十亿美元）

  • 介绍
  • 临床前
  • 临床
  • PMA（上市后核准）

第八章 全球医药外包市场，依治疗领域，2019-2031（十亿美元）

  • 介绍
  • 肿瘤学
  • 神经病学
  • 心臟病学
  • 免疫学
  • 其他的

第九章2019-2031年全球医药外包市场（按地区）（十亿美元）

  • 介绍
  • 拉丁美洲
  • 欧洲
  • 亚太地区
  • 中东

第10章竞争格局

  • 公司简介
    • Accell Clinical Research, LLC
    • Genpact
    • CRITERIUM, INC.
    • PRA Health Sciences
    • Promedica International
    • WuXiAppTec
    • Medpace
    • PPD Inc.
    • Charles River Laboratories
    • ICON plc
    • Covance
    • Parexel International Corporation
    • Freyr
    • Navitas Clinical Research, Inc.
    • Medelis, Inc.
    • Sciformix
    • Tech Tammina
    • Acorn Regulatory Consultancy Services Ltd.
    • BIOMAPAS
    • REGULATORY PROFESSIONALS
    • CompareNetworks, Inc.

第十一章分析师建议

  • 上升和下降
  • 综合机会图

第十二章参考文献与调查方法

  • 参考
  • 调查方法
简介目录
Product Code: CMI2751

Global regulatory affairs outsourcing market is estimated to be valued at USD 8.41 Bn 2024 and is expected to reach USD 17.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031.

Report Coverage Report Details
Base Year: 2023 Market Size in 2024: US$ 8.41 Bn
Historical Data for: 2019 to 2023 Forecast Period: 2024 to 2031
Forecast Period 2024 to 2031 CAGR: 10.70% 2031 Value Projection: US$ 17.10 Bn
Figure. Regulatory Affairs Outsourcing Market Share (%), By Region 2024
Regulatory Affairs Outsourcing Market - IMG1

Global regulatory affairs outsourcing market growth is driven by increasing complexity of regulatory frameworks. Regulatory requirements have become more stringent across regions necessitating specialized expertise and resources for compliance. Furthermore, drug development process has become highly regulated requiring close monitoring and management of compliance at various stages from clinical development to approvals. This has prompted pharmaceutical and biotech companies including medical device manufacturers to rely on third-party service providers with domain expertise to outsource regulatory functions. Regulatory outsourcing helps firms streamline processes, reduce costs, and focus resources on core competencies.

Market Dynamics:

Global regulatory affairs outsourcing market growth is driven by factors such as increasing R&D expenditure of pharmaceutical and biotechnology firms, stringent regulatory environment, and cost pressures. However, data privacy & security concerns and quality control issues can hamper the market growth. Emerging markets can offer significant opportunities due to outsourcing and clinical trial activities shifting to low-cost destinations in Asia Pacific and Latin America. Increased mergers and acquisitions and partnership strategies adopted by regulatory service providers can also expand their capabilities and global footprint, thus, offering new growth opportunities.

Key Features of the Study:

  • This report provides in-depth analysis of the global regulatory affairs outsourcing market, and provides market size (USD Billion) and compound annual growth rate (CAGR%) for the forecast period (2024-2031), considering 2023 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global regulatory affairs outsourcing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study include Prophecy, PAREXEL, Clinitec, ICON, Accell, and Covance
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • Global regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global regulatory affairs outsourcing market

Detailed Segmentation-

  • By Service Type
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Regulatory Operations
    • Others
  • By End User
    • Medical Device Companies
    • Pharmaceutical Companies
    • Biotechnology Companies
  • By Stage
    • Preclinical
    • Clinical
    • PMA (Post Market Authorization)
  • By Therapeutic Area
    • Oncology
    • Neurology
    • Cardiology
    • Immunology
    • Others
  • By Region
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East
    • Africa
  • Company Profiles:
    • Accell Clinical Research, LLC
    • Genpact
    • CRITERIUM, INC.
    • PRA Health Sciences
    • Promedica International
    • WuXiAppTec
    • Medpace
    • PPD Inc.
    • Charles River Laboratories
    • ICON plc
    • Covance
    • Parexel International Corporation
    • Freyr
    • Navitas Clinical Research, Inc.
    • Medelis, Inc.
    • Sciformix
    • Tech Tammina
    • Acorn Regulatory Consultancy Services Ltd.
    • BIOMAPAS
    • REGULATORY PROFESSIONALS
    • CompareNetworks, Inc.

Table of Contents

1. Research Objectives and Assumptions

  • Research Objectives
  • Assumptions
  • Abbreviations

2. Market Purview

  • Report Description
    • Market Definition and Scope
  • Executive Summary
    • Market Snapshot, By Service Type
    • Market Snapshot, By End User
    • Market Snapshot, By Stage
    • Market Snapshot, By Therapeutic Area
    • Market Snapshot, By Region
  • Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

  • Market Dynamics
    • Drivers
    • Restraints
    • Opportunities
  • Impact Analysis
  • Market Trends
  • Key Developments
  • Regulatory Scenario
  • Acquisitions and Partnerships Scenario
  • Funding and Investments
  • PEST Analysis
  • Porter's Analysis

4. Global Regulatory Affairs Outsourcing Market - Impact of Coronavirus (COVID-19) Pandemic

  • Overall Impact
  • Government Initiatives
  • COVID-19 Impact on the Market

5. Global Regulatory Affairs Outsourcing Market, By Service Type, 2019 - 2031, (USD Bn)

  • Overview
    • Market Share Analysis, 2024 and 2031 (%)
    • Y-o-Y Growth Analysis, 2019 - 2031
    • Segment Trends
  • Regulatory Consulting and Legal Representation
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Product Registration and Clinical Trial Applications
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Regulatory Writing and Publishing
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Regulatory Submission
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Regulatory Operations
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Others
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

6. Global Regulatory Affairs Outsourcing Market, By End User, 2019 - 2031, (USD Bn)

  • Overview
    • Market Share Analysis, 2024 and 2031 (%)
    • Y-o-Y Growth Analysis, 2019 - 2031
    • Segment Trends
  • Medical Device Companies
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Pharmaceutical Companies
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Biotechnology Companies
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

7. Global Regulatory Affairs Outsourcing Market, By Stage, 2019 - 2031, (USD Bn)

  • Overview
    • Market Share Analysis, 2024 and 2031 (%)
    • Y-o-Y Growth Analysis, 2019 - 2031
    • Segment Trends
  • Preclinical
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Clinical
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • PMA (Post Market Authorization)
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

8. Global Regulatory Affairs Outsourcing Market, By Therapeutic Area, 2019 - 2031, (USD Bn)

  • Overview
    • Market Share Analysis, 2024 and 2031 (%)
    • Y-o-Y Growth Analysis, 2019 - 2031
    • Segment Trends
  • Oncology
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Neurology
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Cardiology
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Immunology
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
  • Others
    • Overview
    • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

9. Global Regulatory Affairs Outsourcing Market, By Region, 2019 - 2031, (USD Bn)

  • Introduction
    • Market Share Analysis, By Region, 2024 and 2031 (%)
    • Y-o-Y Growth Analysis, For Region, 2019-2031
    • Regional Trends
      • North America
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
      • U.S.
      • Canada
  • Latin America
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
      • Brazil
      • Mexico
      • Argentina
      • Rest of Latin America
  • Europe
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area. 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
      • U.K.
      • Germany
      • Italy
      • France
      • Spain
      • Russia
      • Rest of Europe
  • Asia Pacific
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
      • China
      • India
      • Japan
      • ASEAN
      • Australia
      • South Korea
      • Rest of Asia Pacific
  • Middle East
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country, 2019 - 2031, (USD Bn)
      • GCC Countries
      • Israel
      • Rest of Middle East
      • Africa
    • Introduction
    • Market Size and Forecast, and Y-o-Y Growth, By Service Type, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By End User, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Stage, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Therapeutic Area, 2019 - 2031, (USD Bn)
    • Market Size and Forecast, and Y-o-Y Growth, By Country/Sub-region, 2019 - 2031, (USD Bn)
      • North Africa
      • Central Africa
      • South Africa

10. Competitive Landscape

  • Company Profiles
    • Accell Clinical Research, LLC
      • Company Highlights
      • Service Type Portfolio
      • Key Highlights
      • Financial Performance
      • Market Strategies
    • Genpact
    • CRITERIUM, INC.
    • PRA Health Sciences
    • Promedica International
    • WuXiAppTec
    • Medpace
    • PPD Inc.
    • Charles River Laboratories
    • ICON plc
    • Covance
    • Parexel International Corporation
    • Freyr
    • Navitas Clinical Research, Inc.
    • Medelis, Inc.
    • Sciformix
    • Tech Tammina
    • Acorn Regulatory Consultancy Services Ltd.
    • BIOMAPAS
    • REGULATORY PROFESSIONALS
    • CompareNetworks, Inc.

11. Analyst Recommendations

  • Wheel of Fortune
  • Analyst View
  • Coherent Opportunity Map

12. References and Research Methodology

  • References
  • Research Methodology
  • About us and Sales Contact