医疗保健监管事务外包市场规模 - 按服务、按适应症、按产品阶段（临床前、临床、PMA）、最终用途（製药公司、生物技术公司、医疗器材公司）和全球预测，2024 年至 2032 年

由于外包解决方案的采用不断增加、成本压力和资源限制不断升级以及及时产品审批的强烈需求，预计 2024 年至 2032 年医疗保健监管事务外包市场规模将以 8.4% 的复合年增长率增长。

在监管复杂性和合规性要求日益严格的时代，製药、生技和医疗器材公司正在转向外包解决方案，以有效应对这些挑战。根据Radixweb 的数据，到2024 年，大约四分之一的小型企业会进行外包以提高效率，而大约70% 的公司将外包视为一种具有成本效益的解决方案，主要是因为它能够降低与僱用内部员工相关的费用。透过利用专业监管事务服务提供者的专业知识，公司可以简化营运、提高效率并确保遵守不断变化的监管标准。此外，外包监管事务任务也使组织能够专注于其核心能力，同时受益于外包合作伙伴的专业知识和经验。

医疗监管事务外包市场分为服务、适应症、产品阶段、最终用途和区域。

到2032 年，上市后批准(PMA) 服务产品阶段细分市场的行业规模预计将以8.5% 的复合年增长率增长。机构的批准诊断。随着监管要求日益复杂以及监管机构的审查日益严格，企业开始寻求外包合作伙伴来有效地完成 PMA 流程。这使公司能够利用监管专业人员的专业知识，他们在准备和提交 PMA 申请、进行监管评估以及与监管机构联络方面拥有丰富的经验。

以最终用途计算，到2032 年，生技公司领域的医疗保健监管事务外包产业规模预计将以8.3% 的复合年增长率扩大。 。因此，他们依靠外包合作伙伴来协助他们获得监管部门的批准并确保产品的安全性和有效性。为此，监管事务外包为生物技术公司提供了对区域和全球监管要求有深入了解的监管专家的机会。

预计2024 年至2032 年，亚太地区医疗保健监管事务外包市场规模的复合年增长率将达到9.5%。推动的。此外，熟练的劳动力、具有成本效益的劳动力资源和支持性政府政策的存在将进一步增强该地区作为监管事务服务主要外包目的地的吸引力。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • 遵守监理要求的需求日益增长
    • 对突破性药物和设备更快审批流程的需求激增
    • 临床试验数量不断增加
    • 监理复杂性增加
  • 产业陷阱与挑战
    • 资料安全和隐私问题
    • 缺乏标准化
• 成长潜力分析
• 波特的分析
• PESTEL分析
• 服务价格分析
• 监管环境
• 技术景观
• 未来市场趋势

第 4 章：竞争格局

• 介绍
• 公司矩阵分析
• 公司市占率分析
• 竞争定位矩阵
• 战略仪表板

第 5 章：市场估计与预测：按服务划分，2018 年 - 2032 年

• 主要趋势
• 产品註册及临床试验申请
• 监理咨询/策略服务
• 提交管理
• 法律代表
• 监理写作和出版
• 其他服务

第 6 章：市场估计与预测：按指标划分，2018 年 - 2032 年

• 主要趋势
• 肿瘤学
• 神经病学
• 心臟病学
• 免疫学
• 其他适应症

第 7 章：市场估计与预测：按产品阶段，2018 年 - 2032 年

• 主要趋势
• 临床前
• 临床
• 上市后授权 (PMA)

第 8 章：市场估计与预测：按最终用途，2018 - 2032 年

• 主要趋势
• 製药公司
• 生技公司
• 医疗器材企业

第 9 章：市场估计与预测：按地区划分，2018 年 - 2032 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地区
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋
  • 中东和非洲其他地区

第 10 章：公司简介

• Accell Clinical Research, LLC
• Charles River Laboratories
• Clinilabs, Inc.
• Freyr
• Genpact
• ICON plc
• Labcorp Drug Development
• PAREXEL International Corporation
• ProPharma Group
• Proventa International
• Thermo Fisher Scientific Inc.

Healthcare Regulatory Affairs Outsourcing Market size is expected to grow at 8.4% CAGR from 2024-2032, driven by rising adoption of outsourcing solutions, escalating cost pressures and resource constraints, and the strong need for timely product approvals.

In an era characterized by the increasing regulatory complexities and stringent compliance requirements, pharmaceutical, biotechnology, and medical device companies are turning to outsourcing solutions to navigate through these challenges effectively. As per Radixweb in 2024, approximately a quarter of small businesses outsource to boost efficiency, while around 70% of companies view outsourcing as a cost-effective solution, primarily due to its ability to lower the expenses associated with hiring in-house staff. By leveraging the expertise of specialized regulatory affairs service providers, companies can streamline their operations, enhance efficiency, and ensure compliance with evolving regulatory standards. Moreover, outsourcing regulatory affairs tasks also allows organizations to focus on their core competencies while benefiting from the specialized knowledge and experience of outsourcing partners.

The healthcare regulatory affairs outsourcing market is divided into service, indication, product stage, end-use and region.

The industry size from the post market approval (PMA) services product stage segment is poised to grow at 8.5% CAGR up to 2032. These services encompass a comprehensive range of regulatory activities aimed at securing approval from regulatory authorities for the commercialization of medical devices and diagnostics. With the increasing complexity of regulatory requirements and the growing scrutiny from regulatory agencies, companies are turning to outsourcing partners to navigate the PMA process efficiently. This enables companies to leverage the expertise of regulatory professionals who possess extensive experience in preparing and submitting PMA applications, conducting regulatory assessments, and liaising with regulatory authorities.

By end-use, the healthcare regulatory affairs outsourcing industry size from the biotechnology companies segment is expected to expand at 8.3% CAGR up to 2032. Biotechnology companies often lack the in-house expertise and resources required to navigate the intricate regulatory pathways. As a result, they rely on outsourcing partners to assist them in obtaining regulatory approvals and ensuring product safety and efficacy. To that end, regulatory affairs outsourcing offers biotechnology companies access to regulatory experts who possess in-depth knowledge of regional and global regulatory requirements.

Asia Pacific healthcare regulatory affairs outsourcing market size is anticipated to record 9.5% CAGR from 2024 to 2032. This is driven by the burgeoning pharmaceutical and biotechnology industries coupled with favorable regulatory reforms and increasing investments in healthcare infrastructure. Moreover, the presence of a skilled workforce, cost-effective labor pool, and supportive government policies will further bolster the attractiveness of the region as a key outsourcing destination for regulatory affairs services.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definition
• 1.2 Base estimates & calculations
• 1.3 Data collection
• 1.4 Forecast parameters
• 1.5 Data validation
• 1.6 Data sources
  • 1.6.1 Primary
  • 1.6.2 Secondary
    • 1.6.2.1 Paid sources
    • 1.6.2.2 Public sources

Chapter 2 Executive Summary

• 2.1 Industry 360-degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing need to comply with regulatory requirements
    • 3.2.1.2 Surging demand for faster approval process for breakthrough drugs and devices
    • 3.2.1.3 Rising number of clinical trials
    • 3.2.1.4 Increasing regulatory complexity
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Data security and privacy concerns
    • 3.2.2.2 Lack of standardization
• 3.3 Growth potential analysis
• 3.4 Porter's analysis
  • 3.4.1 Supplier power
  • 3.4.2 Buyer power
  • 3.4.3 Threat of new entrants
  • 3.4.4 Threat of substitutes
  • 3.4.5 Industry rivalry
• 3.5 PESTEL analysis
• 3.6 Service price analysis
• 3.7 Regulatory landscape
• 3.8 Technological landscape
• 3.9 Future market trends

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Services, 2018 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Product registration & clinical trial application
• 5.3 Regulatory consulting/strategic services
• 5.4 Submission management
• 5.5 Legal representation
• 5.6 Regulatory writing & publishing
• 5.7 Other services

Chapter 6 Market Estimates and Forecast, By Indication, 2018 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Neurology
• 6.4 Cardiology
• 6.5 Immunology
• 6.6 Other indications

Chapter 7 Market Estimates and Forecast, By Product Stage, 2018 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Preclinical
• 7.3 Clinical
• 7.4 Post market authorization (PMA)

Chapter 8 Market Estimates and Forecast, By End-Use, 2018 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 Pharmaceutical companies
• 8.3 Biotechnology companies
• 8.4 Medical device companies

Chapter 9 Market Estimates and Forecast, By Region, 2018 - 2032 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
  • 9.4.6 Rest of Asia Pacific
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
  • 9.5.4 Rest of Latin America
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE
  • 9.6.4 Rest of Middle East and Africa

Chapter 10 Company Profiles

• 10.1 Accell Clinical Research, LLC
• 10.2 Charles River Laboratories
• 10.3 Clinilabs, Inc.
• 10.4 Freyr
• 10.5 Genpact
• 10.6 ICON plc
• 10.7 Labcorp Drug Development
• 10.8 PAREXEL International Corporation
• 10.9 ProPharma Group
• 10.10 Proventa International
• 10.11 Thermo Fisher Scientific Inc.