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市場調查報告書

商品編碼

1633586

監管應用市場規模、佔有率和成長分析（按服務、類別、適應症、產品階段、類型、公司規模和地區）- 產業預測，2025-2032 年

Regulatory Affairs Market Size, Share, Growth Analysis, By Services (Regulatory Consulting, Legal Representation), By Category (Drugs, Biologics), By Indication, By Product Stage, By Type, By Company Size, By Region - Industry Forecast 2025-2032

出版日期: 2025年01月12日 | 出版商:

SkyQuest | 英文 234 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

2023 年全球監管應用市場規模價值為 152 億美元，預計將從 2024 年的 165.7 億美元成長到 2032 年的 330.1 億美元，預測期內（2025-2032 年）的複合年成長率為 9.0%。

在孤兒藥、個人化醫療、免疫療法和聯合治療等新興領域的進步的推動下，監管提交市場正在經歷顯著成長。這種快速成長的推動因素是不斷變化的監管要求以及需要有效疫苗和治療的新型疾病的增加，凸顯了嚴格的安全性和有效性指南的重要性。此外，產業內企業不斷增加的併購、聯盟和收購預計將進一步推動市場擴張。隨著生物製藥和醫療設備公司在全球擴張，特別是進入亞太地區、拉丁美洲、中東和非洲的新興市場，他們遇到了具有成本效益的開發和製造的誘人機會，從而增加了對監管服務的需求。這樣的市場條件凸顯了醫療保健產業對創新治療方法和複雜監管途徑的重視，反映了市場強勁的成長軌跡。

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
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 其他亞太地區
拉丁美洲
- 巴西
- 其他拉丁美洲國家
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前 5 家公司對比
主要企業市場定位（2024年）
主要市場參與者所採用的策略
近期市場趨勢
公司市場佔有率分析（2024 年）
主要企業簡介
- 公司簡介
- 產品系列分析
- 按細分市場分析市場佔有率
- 收益與前一年同期比較（2022-2024 年）

主要企業簡介

IQVIA Holdings Inc.（USA）
ICON plc（Ireland）
Charles River Laboratories International, Inc.（USA）
Labcorp Drug Development（USA）
WuXi AppTec（China）
Syneos Health（USA）
Medpace, Inc.（USA）
Parexel International Corporation（USA）
Amicus GMP（USA）
Pace Life Sciences（USA）
CTI Clinical Trial & Consulting（USA）
Accell Clinical Research LLC（USA）
Consumer Product Testing Co（USA）
Promedica International（USA）
Clinilabs Inc.（USA）
CliniExperts Pvt Ltd.（India）

結論和建議

簡介目錄

Product Code: SQMIG35A2460

Global Regulatory Affairs Market size was valued at USD 15.2 billion in 2023 and is poised to grow from USD 16.57 billion in 2024 to USD 33.01 billion by 2032, growing at a CAGR of 9.0% during the forecast period (2025-2032).

The regulatory affairs market is experiencing significant growth, driven by advancements in emerging sectors like orphan drugs, personalized medicines, immunotherapies, and combination therapies. This surge is bolstered by evolving regulatory requirements and an increase in novel diseases necessitating effective vaccines and treatments, highlighting the importance of stringent safety and efficacy guidelines. Additionally, the rise of mergers, partnerships, and acquisitions among industry players is expected to further propel market expansion. As biopharmaceutical and medical device companies expand globally, particularly into emerging markets in Asia Pacific, Latin America, and the Middle East & Africa, they encounter attractive opportunities for cost-efficient development and manufacturing, enhancing the demand for regulatory services. This landscape underscores the healthcare sector's emphasis on innovative therapies and complex regulatory pathways, reflecting a robust growth trajectory in the market.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Regulatory Affairs 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 Market Segmental Analysis

Global Regulatory Affairs Market is segmented by Services, Category, Indication, Product Stage, Type, Company Size, End User and region. Based on Services, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications and Others. Based on Category, the market is segmented into Drugs, Biologics and Medical Devices. Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology and Others. Based on Product Stage, the market is segmented into Preclinical, Clinical and Pre-Market Approval (PMA). Based on Type, the market is segmented into In-house and Outsourced. Based on Company Size, the market is segmented into Small, Medium and Large. Based on End User, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Regulatory Affairs Market

One of the key drivers of the Global Regulatory Affairs market is the globalization of biopharmaceuticals. As biopharmaceutical companies increasingly venture into emerging markets-particularly in regions such as Asia Pacific, Latin America, and the Middle East-there is a pressing need for robust regulatory strategies. These strategies must navigate the complexities and variations in regional regulations, ensuring compliance with local requirements while facilitating market entry and product availability. This expansion not only enhances the reach of biopharmaceutical products but also underscores the importance of adept regulatory affairs to align with the diverse regulatory landscapes found in these burgeoning markets.

Restraints in the Global Regulatory Affairs Market

The Global Regulatory Affairs market faces significant restraints primarily due to its resource and cost-intensive nature. Ensuring regulatory compliance demands considerable investment in both skilled personnel and financial resources, which can stretch the budgets of organizations. This burden often proves to be a challenge, particularly for smaller companies, ultimately impeding their growth and ability to compete in the market. As these companies navigate complex regulatory landscapes, the requirement for extensive resources can limit their capacity to innovate and expand, creating a challenging environment that disproportionately affects less established players in the industry.

Market Trends of the Global Regulatory Affairs Market

The Global Regulatory Affairs market is witnessing a significant trend towards accelerated approval programs, driven by an urgent need to address unmet medical demands, especially for orphan drugs and breakthrough therapies. Regulatory authorities are increasingly adopting expedited pathways that allow for faster market entry of critical medications, facilitating quicker patient access to innovative treatments. This shift is influencing the operational strategies of pharmaceutical companies, as they must navigate these evolving regulatory landscapes while ensuring compliance and risk management. Consequently, the emphasis on agile regulatory strategies is shaping a dynamic environment, fostering collaboration between stakeholders and enhancing the overall efficiency of drug development processes.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Case Studies
Technological Advancement

Global Regulatory Affairs Market Size by Services & CAGR (2025-2032)

Market Overview
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
- Writing
- Publishing
Product Registration & Clinical Trial Applications
Others

Global Regulatory Affairs Market Size by Category & CAGR (2025-2032)

Market Overview
Drugs
- Innovator
- Generics
Biologics
- Biotech
- ATMP
- Biosimilars
Medical Devices
- Diagnostics
- Therapeutics

Global Regulatory Affairs Market Size by Indication & CAGR (2025-2032)

Market Overview
Oncology
Neurology
Cardiology
Immunology
Others

Global Regulatory Affairs Market Size by Product Stage & CAGR (2025-2032)

Market Overview
Preclinical
Clinical
Pre-Market Approval (PMA)

Global Regulatory Affairs Market Size by Type & CAGR (2025-2032)

Market Overview
In-house
Outsourced

Global Regulatory Affairs Market Size by Company Size & CAGR (2025-2032)

Market Overview
Small
Medium
Large

Global Regulatory Affairs Market Size by End User & CAGR (2025-2032)

Market Overview
Medical Device Companies
Pharmaceutical Companies
Biotechnology Companies
Others

Global Regulatory Affairs Market Size & CAGR (2025-2032)

North America (Services, Category, Indication, Product Stage, Type, Company Size, End User)
- US
- Canada
Europe (Services, Category, Indication, Product Stage, Type, Company Size, End User)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Services, Category, Indication, Product Stage, Type, Company Size, End User)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Services, Category, Indication, Product Stage, Type, Company Size, End User)
- Brazil
- Rest of Latin America
Middle East & Africa (Services, Category, Indication, Product Stage, Type, Company Size, End User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2024
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2024
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

IQVIA Holdings Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
ICON plc (Ireland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories International, Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Labcorp Drug Development (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Syneos Health (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Medpace, Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Parexel International Corporation (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Amicus GMP (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pace Life Sciences (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CTI Clinical Trial & Consulting (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Accell Clinical Research LLC (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Consumer Product Testing Co (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Promedica International (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Clinilabs Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CliniExperts Pvt Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments