醫療保健監管事務外包市場規模 - 按服務、按適應症、按產品階段（臨床前、臨床、PMA）、最終用途（製藥公司、生物技術公司、醫療器材公司）和全球預測，2024 年至 2032 年

由於外包解決方案的採用不斷增加、成本壓力和資源限制不斷升級以及及時產品核准的強烈需求，預計 2024 年至 2032 年醫療保健監管事務外包市場規模將以 8.4% 的複合年成長率成長。

在監管複雜性和合規性要求日益嚴格的時代，製藥、生技和醫療器材公司正在轉向外包解決方案，以有效應對這些挑戰。根據Radixweb 的數據，到2024 年，大約四分之一的小型企業會進行外包以提高效率，而大約70% 的公司將外包視為一種具有成本效益的解決方案，主要是因為它能夠降低與僱用內部員工相關的費用。透過利用專業監管事務服務提供者的專業知識，公司可以簡化營運、提高效率並確保遵守不斷變化的監管標準。此外，外包監管事務任務也使組織能夠專注於其核心能力，同時受益於外包合作夥伴的專業知識和經驗。

醫療監管事務外包市場分為服務、適應症、產品階段、最終用途和區域。

到2032 年，上市後批准(PMA) 服務產品階段細分市場的行業規模預計將以8.5% 的複合年成長率成長。機構的批准診斷。隨著監管要求日益複雜以及監管機構的審查日益嚴格，企業開始尋求外包合作夥伴來有效地完成 PMA 流程。這使公司能夠利用監管專業人員的專業知識，他們在準備和提交 PMA 申請、進行監管評估以及與監管機構聯絡方面擁有豐富的經驗。

以最終用途計算，到2032 年，生技公司領域的醫療保健監管事務外包產業規模預計將以8.3% 的複合年成長率擴大。 。因此，他們依靠外包合作夥伴來協助他們獲得監管部門的批准並確保產品的安全性和有效性。為此，監管事務外包為生物技術公司提供了對區域和全球監管要求有深入了解的監管專家的機會。

預計2024 年至2032 年，亞太地區醫療保健監管事務外包市場規模的複合年成長率將達到9.5%。推動的。此外，熟練的勞動力、具有成本效益的勞動力資源和支持性政府政策的存在將進一步增強該地區作為監管事務服務主要外包目的地的吸引力。

目錄

第 1 章：方法與範圍

第 2 章：執行摘要

第 3 章：產業洞察

• 產業生態系統分析
• 產業影響力
  • 成長動力
    • 遵守監理要求的需求日益成長
    • 對突破性藥物和設備更快核准流程的需求激增
    • 臨床試驗數量不斷增加
    • 監理複雜性增加
  • 產業陷阱與挑戰
    • 資料安全和隱私問題
    • 缺乏標準化
• 成長潛力分析
• 波特的分析
• PESTEL分析
• 服務價格分析
• 監管環境
• 技術景觀
• 未來市場趨勢

第 4 章：競爭格局

• 介紹
• 公司矩陣分析
• 公司市佔率分析
• 競爭定位矩陣
• 戰略儀表板

第 5 章：市場估計與預測：按服務分類，2018 年 - 2032 年

• 主要趨勢
• 產品註冊及臨床試驗申請
• 監理諮詢/策略服務
• 提交管理
• 法律代表
• 監理寫作和出版
• 其他服務

第 6 章：市場估計與預測：按指標分類，2018 年 - 2032 年

• 主要趨勢
• 腫瘤學
• 神經病學
• 心臟病學
• 免疫學
• 其他適應症

第 7 章：市場估計與預測：按產品階段，2018 年 - 2032 年

• 主要趨勢
• 臨床前
• 臨床
• 上市後授權 (PMA)

第 8 章：市場估計與預測：按最終用途，2018 - 2032 年

• 主要趨勢
• 製藥公司
• 生技公司
• 醫療器材企業

第 9 章：市場估計與預測：按地區分類，2018 年 - 2032 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 歐洲其他地區
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
  • 亞太地區其他地區
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
  • 拉丁美洲其他地區
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 中東和非洲其他地區

第 10 章：公司簡介

• 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.