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市场调查报告书

商品编码

1633586

监管应用市场规模、份额和成长分析（按服务、类别、适应症、产品阶段、类型、公司规模和地区）- 产业预测，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个工作天内

价格

简介目录

2023 年全球监管应用市场规模价值为 152 亿美元，预计将从 2024 年的 165.7 亿美元成长到 2032 年的 330.1 亿美元，预测期内（2025-2032 年）的复合年增长率为 9.0%。

在孤儿药、个人化医疗、免疫疗法和联合治疗等新兴领域的进步的推动下，监管提交市场正在经历显着增长。这种快速增长的推动因素是不断变化的监管要求以及需要有效疫苗和治疗的新型疾病的增加，凸显了严格的安全性和有效性指南的重要性。此外，产业内企业不断增加的併购、联盟和收购预计将进一步推动市场扩张。随着生物製药和医疗设备公司在全球扩张，特别是进入亚太地区、拉丁美洲、中东和非洲的新兴市场，他们遇到了具有成本效益的开发和製造的诱人机会，从而增加了对监管服务的需求。这样的市场条件凸显了医疗保健产业对创新治疗方法和复杂监管途径的重视，反映了市场强劲的成长轨迹。

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
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 其他亚太地区
拉丁美洲
- 巴西
- 其他拉丁美洲国家
中东和非洲
- 海湾合作委员会国家
- 南非
- 其他中东和非洲地区

竞争资讯

前 5 家公司对比
主要企业市场定位（2024年）
主要市场参与者所采用的策略
近期市场趋势
公司市场占有率分析（2024 年）
主要企业简介
- 公司简介
- 产品系列分析
- 按细分市场分析市场份额
- 收益与前一年同期比较（2022-2024 年）

主要企业简介

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）

结论和建议

简介目录

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