製药监管管理系统市场 - 全球行业规模、份额、趋势、机会和预测，按组件、按部署、按最终用户、按地区和竞争进行细分，2020-2030 年预测

2024 年全球製药监管管理系统市场价值为 99.8 亿美元，预计在预测期内将实现令人瞩目的成长，到 2030 年的复合年增长率为 9.95%。全球製药监管管理系统市场是指涵盖开发和采用专门的软体解决方案和技术的行业，旨在促进监管合规并简化製药和生命科学领域的监管流程。这是由于癌症病例增加、心血管疾病增加、人口老化等原因。例如，根据GLOBOCAN 2022资料，全球癌症发生率超过1,990万例。其中亚洲累计确诊病例最多，达980多万例；其次是欧洲，达440万例；北美洲，达260万例。这些资料凸显了癌症盛行率的地区差异，强调了全球医疗负担日益恶化。因此，为了管理这些问题，药品监管委员会正在迅速壮大。

主要市场驱动因素

监理复杂性不断上升

主要市场挑战

快速发展的法规

主要市场趋势

基于云端的灵活性解决方案

目录

第 1 章：产品概述

第 2 章：研究方法

第 3 章：执行摘要

第 4 章：顾客之声

第五章：全球医药监理管理系统市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按组件（服务、解决方案）
  • 按部署（云端、本机）
  • 按最终用户（政府机构、医院及护理机构、製药及生技公司）
  • 按地区
  • 按公司分类（2024）
• 产品市场图
  • 按组件
  • 按部署
  • 按最终用户
  • 按地区

第 6 章：北美医药监理管理系统市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 加拿大
  • 墨西哥

第七章：欧洲医药监理管理系统市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 英国
  • 法国
  • 义大利
  • 西班牙

第 8 章：亚太地区医药监理管理系统市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 日本
  • 印度
  • 澳洲
  • 韩国

第九章：南美洲医药监理管理系统市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 阿根廷
  • 哥伦比亚

第 10 章：中东和非洲医药监管管理系统市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 沙乌地阿拉伯
  • 阿联酋
  • 科威特

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 近期发展
• 合併与收购
• 产品发布

第 13 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 14 章：竞争格局

• Instem PLC
• NNIT A/S
• EXTEDO
• Amplexor USA Inc
• MasterControl Inc
• Charles River Laboratories International Inc.
• Parexel International Corporation
• IQVIA Inc.
• ICON Inc.
• Pharmalex GmbH

第 15 章：策略建议

16 关于我们及免责声明

Global Pharma Regulatory Management Systems Market was valued at USD 9.98 billion in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 9.95% through 2030. The Global Pharma Regulatory Management Systems Market refers to the industry that encompasses the development and adoption of specialized software solutions and technologies designed to facilitate regulatory compliance and streamline regulatory processes within the pharmaceutical and life sciences sector. This is ascribed due to rising cancer cases, growing cardiovascular diseases, aging popultion, etc. For instance, according to GLOBOCAN 2022 data, global cancer incidence surpassed 19.9 million cases. The highest number of cases was reported in Asia, with over 9.8 million, followed by Europe with 4.4 million and North America with 2.6 million. This data highlights regional disparities in cancer prevalence, emphasizing the growing healthcare burden worldwide. Therefore, in order to manage these issues, the regulatory committee of pharmaceutical is growing rapidly.

Key Market Drivers

Rising Regulatory Complexity

The pharmaceutical industry operates in a highly regulated environment, where adherence to stringent regulatory standards is paramount to ensure the safety, efficacy, and quality of pharmaceutical products. Over the years, the regulatory landscape governing this industry has become increasingly complex, with a growing number of guidelines, requirements, and compliance standards imposed by regulatory authorities worldwide. This rising regulatory complexity has emerged as a significant driving force behind the rapid growth of the Global Pharma Regulatory Management Systems (PRMS) Market. For instance, Japan's Central Social Insurance Medical Council approved a drug repricing system expected to lead to an average price reduction of approximately 4.38%. This system covers nearly 17 top-selling drugs, including Vyndaqel, Samsca, Revlimid, Lynparza, Stelara, and Dupixent. In April 2023, the prices of over 2,000 drugs in Japan saw an average reduction of 9.4%. These developments are likely to impact pharmaceutical regulatory managemnet systems market in the near future.

Key Market Challenges

Rapidly Evolving Regulations

One of the foremost challenges is the ever-changing regulatory landscape in the pharmaceutical industry. Regulatory bodies like the U.S. FDA and the EMA continually update and revise guidelines, making it challenging for PRMS providers to keep their systems aligned with the latest requirements. Pharmaceutical companies require agile solutions that can adapt to evolving standards.

Key Market Trends

Cloud-Based Solutions for Flexibility

Cloud computing is becoming increasingly prevalent in the pharmaceutical industry. Cloud-based PRMS solutions offer scalability, flexibility, and the ability to access data and tools from anywhere. This trend will enable smaller pharmaceutical companies to adopt PRMS without significant upfront infrastructure costs.

Key Market Players

• Instem PLC
• NNIT A/S
• EXTEDO
• Amplexor USA Inc
• MasterControl Inc
• Charles River Laboratories International Inc.
• Parexel International Corporation
• IQVIA Inc.
• ICON Inc.
• Pharmalex GmbH

Report Scope:

In this report, the Global Pharma Regulatory Management Systems Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pharma Regulatory Management Systems Market, By Component:

• Services
• Solutions

Pharma Regulatory Management Systems Market, By Deployment:

• On-Cloud
• On-Premises

Pharma Regulatory Management Systems Market, By End User:

• Government Agencies
• Hospitals & Care Providers
• Pharmaceutical & Biotechnology Companies

Pharma Regulatory Management Systems Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Pharma Regulatory Management Systems Market.

Available Customizations:

Global Pharma Regulatory Management Systems market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pharma Regulatory Management Systems Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Component (Services, Solutions)
  • 5.2.2. By Deployment (On-Cloud, On-Premises)
  • 5.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Product Market Map
  • 5.3.1. By Component
  • 5.3.2. By Deployment
  • 5.3.3. By End User
  • 5.3.4. By Region

6. North America Pharma Regulatory Management Systems Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Component (Services, Solutions)
  • 6.2.2. By Deployment (On-Cloud, On-Premises)
  • 6.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Pharma Regulatory Management Systems Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Component
      • 6.3.1.2.2. By Deployment
      • 6.3.1.2.3. By End User
  • 6.3.2. Canada Pharma Regulatory Management Systems Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Component
      • 6.3.2.2.2. By Deployment
      • 6.3.2.2.3. By End User
  • 6.3.3. Mexico Pharma Regulatory Management Systems Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Component
      • 6.3.3.2.2. By Deployment
      • 6.3.3.2.3. By End User

7. Europe Pharma Regulatory Management Systems Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Component (Services, Solutions)
  • 7.2.2. By Deployment (On-Cloud, On-Premises)
  • 7.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Pharma Regulatory Management Systems Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Component
      • 7.3.1.2.2. By Deployment
      • 7.3.1.2.3. By End User
  • 7.3.2. United Kingdom Pharma Regulatory Management Systems Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Component
      • 7.3.2.2.2. By Deployment
      • 7.3.2.2.3. By End User
  • 7.3.3. France Pharma Regulatory Management Systems Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Component
      • 7.3.3.2.2. By Deployment
      • 7.3.3.2.3. By End User
  • 7.3.4. Italy Pharma Regulatory Management Systems Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Component
      • 7.3.4.2.2. By Deployment
      • 7.3.4.2.3. By End User
  • 7.3.5. Spain Pharma Regulatory Management Systems Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Component
      • 7.3.5.2.2. By Deployment
      • 7.3.5.2.3. By End User

8. Asia-Pacific Pharma Regulatory Management Systems Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Component (Services, Solutions)
  • 8.2.2. By Deployment (On-Cloud, On-Premises)
  • 8.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Pharma Regulatory Management Systems Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Component
      • 8.3.1.2.2. By Deployment
      • 8.3.1.2.3. By End User
  • 8.3.2. Japan Pharma Regulatory Management Systems Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Component
      • 8.3.2.2.2. By Deployment
      • 8.3.2.2.3. By End User
  • 8.3.3. India Pharma Regulatory Management Systems Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Component
      • 8.3.3.2.2. By Deployment
      • 8.3.3.2.3. By End User
  • 8.3.4. Australia Pharma Regulatory Management Systems Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Component
      • 8.3.4.2.2. By Deployment
      • 8.3.4.2.3. By End User
  • 8.3.5. South Korea Pharma Regulatory Management Systems Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Component
      • 8.3.5.2.2. By Deployment
      • 8.3.5.2.3. By End User

9. South America Pharma Regulatory Management Systems Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Component (Services, Solutions)
  • 9.2.2. By Deployment (On-Cloud, On-Premises)
  • 9.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Pharma Regulatory Management Systems Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Component
      • 9.3.1.2.2. By Deployment
      • 9.3.1.2.3. By End User
  • 9.3.2. Argentina Pharma Regulatory Management Systems Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Component
      • 9.3.2.2.2. By Deployment
      • 9.3.2.2.3. By End User
  • 9.3.3. Colombia Pharma Regulatory Management Systems Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Component
      • 9.3.3.2.2. By Deployment
      • 9.3.3.2.3. By End User

10. Middle East and Africa Pharma Regulatory Management Systems Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Component (Services, Solutions)
  • 10.2.2. By Deployment (On-Cloud, On-Premises)
  • 10.2.3. By End User (Government Agencies, Hospitals & Care Providers, Pharmaceutical & Biotechnology Companies)
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Pharma Regulatory Management Systems Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Component
      • 10.3.1.2.2. By Deployment
      • 10.3.1.2.3. By End User
  • 10.3.2. Saudi Arabia Pharma Regulatory Management Systems Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Component
      • 10.3.2.2.2. By Deployment
      • 10.3.2.2.3. By End User
  • 10.3.3. UAE Pharma Regulatory Management Systems Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Component
      • 10.3.3.2.2. By Deployment
      • 10.3.3.2.3. By End User
  • 10.3.4. Kuwait Pharma Regulatory Management Systems Market Outlook
    • 10.3.4.1. Market Size & Forecast
      • 10.3.4.1.1. By Value
    • 10.3.4.2. Market Share & Forecast
      • 10.3.4.2.1. By Component
      • 10.3.4.2.2. By Deployment
      • 10.3.4.2.3. By End User

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Development
• 12.2. Mergers & Acquisitions
• 12.3. Product Launches

13. Porter's Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Instem PLC
  • 14.1.1. Business Overview
  • 14.1.2. Product Offerings
  • 14.1.3. Recent Developments
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Key Personnel
  • 14.1.6. SWOT Analysis
• 14.2. NNIT A/S
• 14.3. EXTEDO
• 14.4. Amplexor USA Inc
• 14.5. MasterControl Inc
• 14.6. Charles River Laboratories International Inc.
• 14.7. Parexel International Corporation
• 14.8. IQVIA Inc.
• 14.9. ICON Inc.
• 14.10. Pharmalex GmbH

15. Strategic Recommendations

16 About Us & Disclaimer