製藥監管管理系統市場 - 全球行業規模、佔有率、趨勢、機會和預測，按組件、按部署、按最終用戶、按地區和競爭進行細分，2020-2030 年預測

2024 年全球製藥監管管理系統市場價值為 99.8 億美元，預計在預測期內將實現令人矚目的成長，到 2030 年的複合年成長率為 9.95%。全球製藥監管管理系統市場是指涵蓋開發和採用專門的軟體解決方案和技術的行業，旨在促進監管合規並簡化製藥和生命科學領域的監管流程。這是由於癌症病例增加、心血管疾病增加、人口老化等原因。例如，根據GLOBOCAN 2022資料，全球癌症發生率超過1,990萬例。其中亞洲累計確診病例最多，達980多萬例；其次是歐洲，達440萬例；北美洲，達260萬例。這些資料凸顯了癌症盛行率的地區差異，強調了全球醫療負擔日益惡化。因此，為了管理這些問題，藥品監管委員會正在迅速壯大。

主要市場促進因素

監理複雜性不斷上升

主要市場挑戰

快速發展的法規

主要市場趨勢

基於雲端的靈活性解決方案

目錄

第 1 章：產品概述

第 2 章：研究方法

第 3 章：執行摘要

第 4 章：顧客之聲

第5章：全球醫藥監理管理系統市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按組件（服務、解決方案）
  • 按部署（雲端、本機）
  • 按最終用戶（政府機構、醫院及護理機構、製藥及生技公司）
  • 按地區
  • 按公司分類（2024）
• 產品市場圖
  • 按組件
  • 按部署
  • 按最終用戶
  • 按地區

第 6 章：北美醫藥監理管理系統市場展望

• 市場規模和預測
• 市場佔有率和預測
• 北美：國家分析
  • 加拿大
  • 墨西哥

第7章：歐洲醫藥監理管理系統市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 英國
  • 法國
  • 義大利
  • 西班牙

第 8 章：亞太地區醫藥監理管理系統市場展望

• 市場規模和預測
• 市場佔有率和預測
• 亞太地區：國家分析
  • 日本
  • 印度
  • 澳洲
  • 韓國

第9章：南美洲醫藥監理管理系統市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 阿根廷
  • 哥倫比亞

第 10 章：中東和非洲醫藥監管管理系統市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 科威特

第 11 章：市場動態

• 驅動程式
• 挑戰

第 12 章：市場趨勢與發展

• 近期發展
• 合併與收購
• 產品發布

第 13 章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的力量
• 顧客的力量
• 替代產品的威脅

第 14 章：競爭格局

• 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：策略建議

16 關於我們及免責聲明

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