监管信息管理系统市场 - 全球行业规模.份额.趋势.机会和预测，2018-2028 年：按组件.按部署模式.按应用程序.按最终用户.按地理细分.竞争

监管信息管理系统的全球市场预计在预测期内将出现令人瞩目的增长。

这是由于有效的应用程序交付和程序中的适当规划越来越普遍。 此外，新进入者的数量和最新技术的采用正在取得进展，世界各个地区对监管信息管理系统市场生产力提高的需求正在增加。 此外，预计到 2028 年，公共和私营组织的投资增加以及 IT 部门的支持增加，将进一步增加对监管信息管理系统的需求并推动市场增长。 2016 年，美国在国民医疗保健方面的支出为 33,370 亿美元，占其国内生产总值 (GDP) 的 17.9%，其中 3,290 亿美元用于处方药。 同样，临床试验领域对法规实时监控的需求不断增长，多年来一直是推动市场增长的关键因素。

增加产品开发

随着监管框架的快速发展和产品审批要求的变化，开发人员需要及时了解法规并与市场参与者合作，以确保无差错的监管合规流程。确保软件的效率是必需的。 随着製药.医疗器械和生命科学领域的监管模式不断转变，预计在预测期内对监管信息管理系统的需求将会增加。 在製药行业，监管信息管理系统促进了强大的应用程序，例如整个产品生命週期的规划.查看.发布.註册和控制。 该软件还支持对法规和法规信息进行有效且合规的管理。 此外，2020 年 4 月，Oracle 建立并向美国政府捐赠了一个 COVID-19 治疗学习系统，该系统允许医生和患者记录有前途的 COVID-19 药物的效果。

对基于软件的工作的需求不断增长

由于临床试验数量的增加，对管理和控制发布新数据以及维护现有产品数据的过程的需求不断增加，这是推动预测期内市场增长的主要因素。 在预测期内，对减少人工错误和轻鬆访问监管流程的需求不断增加，预计也将为全球监管信息管理系统市场带来利润丰厚的增长。 此外，最终用户越来越多地采用基于云的监管信息管理系统来创建准确的数据，这也是推动预测期内市场增长的一个关键因素。 由于人工错误，临床试验空间法规的实时监控和全球产品流程整个工作流程的自动化管理是未来几年推动市场增长的因素。 在美国，2021 年药品支出总额将达到约 5740 亿美元。

近期发展

• 例如，像 Calyx 这样的供应商宣布，2021 年 10 月 25 日，世界前 10 大製药公司之一将提供关键的我们很高兴地宣布，我们已经达成协议，继续使用到 2026 年提交的 Calyx 监管信息管理 (RIM) 系统。

可自定义

根据市场数据，TechSci Research 根据公司的具体需求提供定制服务。 该报告可以定制为：

公司信息

• 对其他市场参与者（最多 5 家公司）进行深入分析和概况分析

内容

第 1 章概述

• 市场定义
• 市场范围
  • 目标市场
  • 研究目标年份
  • 主要市场细分

第2章研究方法论

• 调查目的
• 基线调查方法
• 主要行业合作伙伴
• 主要协会和次要信息
• 调查方法
• 数据三角测量和验证
• 假设和限制

第 3 章执行摘要

• 市场概览
• 主要市场细分概述
• 主要市场参与者概览
• 主要地区/国家概览
• 市场驱动因素.挑战和趋势

第4章全球监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件（解决方案和服务）
  • 按部署类型（本地/云端）
  • 按用途（註册管理.监管情报.标籤管理.提交计划和跟踪.发布.文檔管理等）
  • 按最终用户（製药.医疗器械.其他）
  • 按地区
  • 按公司分类（2022 年）
• 市场地图
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按地区

第5章北美监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按国家
• 北美：国家/地区分析
  • 美国
  • 加拿大
  • 墨西哥

第6章欧洲监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按国家
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 意大利
  • 西班牙

第7章亚太监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按国家
• 亚太地区：国家/地区分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳大利亚

第 8 章南美监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按国家
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第9章中东和非洲监管信息管理系统市场展望

• 市场规模和预测
  • 按数量
• 市场份额和预测
  • 按组件
  • 按部署模式
  • 通过使用
  • 最终用户
  • 按国家
• MEA：国家分析
  • 南非监管信息管理系统
  • 沙特阿拉伯监管信息管理系统
  • 阿联酋监管信息管理系统

第 10 章市场动态

• 司机
• 任务

第11章市场趋势与发展

第12章竞争格局

• ArisGlobal LLC
• Arivis AG
• DDi, Inc.
• Ennov SA
• Extedo Gmbh
• Glemser Technologies Corporation
• Instem Group
• MasterControl, Inc.
• Parexel International Corporation
• Samarind Ltd.
• Sparta Systems, Inc.
• Acuta LLC
• Virtify, Inc.
• Amplexor International SA
• Veeva Systems Inc.

第13章 战略建议

The Global Regulatory Information Management System Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to the growing prevalence of delivering effective applications and proper planning in the procedures. Additionally, the growing number of new players and rising adoption of the latest techniques to develop productivity demand for the Regulatory Information Management System Market across different parts of the globe. Additionally, increasing investments by public and private organizations and increasing support from the IT sector are further expected to increase the demand for regulatory information management systems, thereby fuelling market growth through 2028. In 2016, the U.S. spent $3,337 billion, or 17.9 percent of the gross domestic product (GDP), on national health expenditures, of which $329 billion was spent on prescription drugs. Similarly, the growing demand for real-time monitoring of regulations in the clinical trial sector is the major factor fuelling the growth of the market over the years.

Increasing Product Development

Rapidly evolving regulatory frameworks and changing product approval requisites continue to propel developers to stay abreast of the latest regulations and connect with market players to ensure software efficiency for error-free regulation compliance processes. Increasing transformations in regulation paradigms within pharmaceuticals, medical devices, and life science sectors are expected to boost the demand for regulatory information management systems during the forecast period. In the pharmaceutical sector, a regulatory information management system facilitates the robust application of planning, viewing, publishing, registration, and management of products throughout their life cycle. The software also allows effective, compliant management of regulations and regulatory information. Further, in April 2020, Oracle built and donated a COVID-19 Therapeutic Learning System to the U.S. government that allows physicians and patients to record the effectiveness of promising COVID-19 drug therapies.

Rising demand for Software-Based Work

Increasing the number of clinical trials demand for managing and controlling the processes of releasing new data and maintaining existingi8ng product data is the major factor expected to boost the market growth during the forecasting period. The rising need to reduce manual errors in regulatory processes and easy access is further anticipated to create a lucrative growth of Global Regulatory Information Management System Market during the forecast period. Furthermore, the increasing adoption of cloud-based regulatory information management systems among end users to prepare accurate data is an important factor that propels market growth during the forecast period. Due to manual error increasing demand for real-time monitoring of regulations in the clinical trial sector and automated management of the entire workflow of product process worldwide in further real-time fuel the market growth in the upcoming years. In the United States, the total amount of money spent on medicines reached approximately 574 billion U.S. dollars in 2021.

Market Segmentation

The global regulatory information management system market can be segmented by component, deployment mode, application, and by region. Based on components, the market can be divided into Solutions and Services. Based on deployment mode, the market can be divided into On-Premises and Cloud. Based on application, the market can be grouped into Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, and Others. Based on the end user, the market can be segmented into Pharmaceuticals, Medical Devices, and Others. Regionally, North America dominated the market among Asia Pacific, Europe, Middle East & Africa, and South America. Amongst different countries, the United States dominates The Global Regulatory Information Management System Market on account of the growing demand for error-free data.

Market Players

ArisGlobal LLC, Arivis AG, DDi, Inc., Ennov SA, Extedo Gmbh, Glemser Technologies Corporation, Instem Group, MasterControl, Inc., Parexel International Corporation, Samarind Ltd., Sparta Systems, Inc., Acuta LLC, Virtify, Inc., Amplexor International SA, Veeva Systems Inc. are some of the leading players operating in the Global Regulatory Information Management System Market.

Recent Developments

• For instance, a provider such as Calyx reported on October 25, 2021, that one of the top ten pharmaceutical companies in the world had signed a contract to continue using the Calyx Regulatory Information Management (RIM) system for crucial submissions of clinical trial data to international regulators through 2026.

Report Scope

In this report, global regulatory information management system market has been segmented into the following categories, in addition to the industry trends, which have also been detailed below:

Regulatory Information Management System Market, By Component:

• Solution
• Services

Regulatory Information Management System Market, By Deployment Mode:

• On-Premises
• Cloud

Regulatory Information Management System Market, By Application:

• Registration Management
• Regulatory Intelligence
• Labeling Management
• Submission Planning & Tracking Management
• Publishing
• Document Management
• Others

Regulatory Information Management System Market, By End User:

• Pharmaceutical
• Medical Devices
• Others

Regulatory Information Management System Market, By Region:

• North America
  • United States
  • Canada
  • Mexico

• Europe
  • France
  • Germany
  • United Kingdom
  • Italy
  • Spain

• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia

• South America
  • Brazil
  • Argentina
  • Colombia

• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

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

Available Customizations

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. Global Regulatory Information Management System Market Outlook

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
• 4.2. Market Share & Forecast
  • 4.2.1. By Component (Solution v/s Services)
  • 4.2.2. By Deployment Mode (On-Premises v/s Cloud)
  • 4.2.3. By Application (Registration Management, Regulatory Intelligence, Labeling Management, Submission Planning & Tracking Management, Publishing, Document Management, Others)
  • 4.2.4. By End User (Pharmaceutical, Medical Devices, Others)
  • 4.2.5. By Region
  • 4.2.6. By Company (2022)
• 4.3. Market Map
  • 4.3.1. By Component
  • 4.3.2. By Deployment Mode
  • 4.3.3. By Application
  • 4.3.4. By End User
  • 4.3.5. By Region

5. North America Regulatory Information Management System Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Component
  • 5.2.2. By Deployment Mode
  • 5.2.3. By Application
  • 5.2.4. By End User
  • 5.2.5. By Country
• 5.3. North America: Country Analysis
  • 5.3.1. United States Regulatory Information Management System Market Outlook
    • 5.3.1.1. Market Size & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share & Forecast
      • 5.3.1.2.1. By Component
      • 5.3.1.2.2. By Deployment Mode
      • 5.3.1.2.3. By Application
      • 5.3.1.2.4. By End User
  • 5.3.2. Canada Regulatory Information Management System Market Outlook
    • 5.3.2.1. Market Size & Forecast
      • 5.3.2.1.1. By Value
    • 5.3.2.2. Market Share & Forecast
      • 5.3.2.2.1. By Component
      • 5.3.2.2.2. By Deployment Mode
      • 5.3.2.2.3. By Application
      • 5.3.2.2.4. By End User
  • 5.3.3. Mexico Regulatory Information Management System Market Outlook
    • 5.3.3.1. Market Size & Forecast
      • 5.3.3.1.1. By Value
    • 5.3.3.2. Market Share & Forecast
      • 5.3.3.2.1. By Component
      • 5.3.3.2.2. By Deployment Mode
      • 5.3.3.2.3. By Application
      • 5.3.3.2.4. By End User

6. Europe Regulatory Information Management System Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Component
  • 6.2.2. By Deployment Mode
  • 6.2.3. By Application
  • 6.2.4. By End User
  • 6.2.5. By Country
• 6.3. Europe: Country Analysis
  • 6.3.1. France Regulatory Information Management System 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 Mode
      • 6.3.1.2.3. By Application
      • 6.3.1.2.4. By End User
  • 6.3.2. Germany Regulatory Information Management System 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 Mode
      • 6.3.2.2.3. By Application
      • 6.3.2.2.4. By End User
  • 6.3.3. United Kingdom Regulatory Information Management System 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 Mode
      • 6.3.3.2.3. By Application
      • 6.3.3.2.4. By End User
  • 6.3.4. Italy Regulatory Information Management System Market Outlook
    • 6.3.4.1. Market Size & Forecast
      • 6.3.4.1.1. By Value
    • 6.3.4.2. Market Share & Forecast
      • 6.3.4.2.1. By Component
      • 6.3.4.2.2. By Deployment Mode
      • 6.3.4.2.3. By Application
      • 6.3.4.2.4. By End User
  • 6.3.5. Spain Regulatory Information Management System Market Outlook
    • 6.3.5.1. Market Size & Forecast
      • 6.3.5.1.1. By Value
    • 6.3.5.2. Market Share & Forecast
      • 6.3.5.2.1. By Component
      • 6.3.5.2.2. By Deployment Mode
      • 6.3.5.2.3. By Application
      • 6.3.5.2.4. By End User

7. Asia-Pacific Regulatory Information Management System Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Component
  • 7.2.2. By Deployment Mode
  • 7.2.3. By Application
  • 7.2.4. By End User
  • 7.2.5. By Country
• 7.3. Asia-Pacific: Country Analysis
  • 7.3.1. China Regulatory Information Management System 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 Mode
      • 7.3.1.2.3. By Application
      • 7.3.1.2.4. By End User
  • 7.3.2. India Regulatory Information Management System 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 Mode
      • 7.3.2.2.3. By Application
      • 7.3.2.2.4. By End User
  • 7.3.3. Japan Regulatory Information Management System 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 Mode
      • 7.3.3.2.3. By Application
      • 7.3.3.2.4. By End User
  • 7.3.4. South Korea Regulatory Information Management System 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 Mode
      • 7.3.4.2.3. By Application
      • 7.3.4.2.4. By End User
  • 7.3.5. Australia Regulatory Information Management System 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 Mode
      • 7.3.5.2.3. By Application
      • 7.3.5.2.4. By End User

8. South America Regulatory Information Management System Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Component
  • 8.2.2. By Deployment Mode
  • 8.2.3. By Application
  • 8.2.4. By End User
  • 8.2.5. By Country
• 8.3. South America: Country Analysis
  • 8.3.1. Brazil Regulatory Information Management System 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 Mode
      • 8.3.1.2.3. By Application
      • 8.3.1.2.4. By End User
  • 8.3.2. Argentina Regulatory Information Management System 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 Mode
      • 8.3.2.2.3. By Application
      • 8.3.2.2.4. By End User
  • 8.3.3. Colombia Regulatory Information Management System 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 Mode
      • 8.3.3.2.3. By Application
      • 8.3.3.2.4. By End User

9. Middle East and Africa Regulatory Information Management System Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Component
  • 9.2.2. By Deployment Mode
  • 9.2.3. By Application
  • 9.2.4. By End User
  • 9.2.5. By Country
• 9.3. MEA: Country Analysis
  • 9.3.1. South Africa Regulatory Information Management System 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 Mode
      • 9.3.1.2.3. By Application
      • 9.3.1.2.4. By End User
  • 9.3.2. Saudi Arabia Regulatory Information Management System 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 Mode
      • 9.3.2.2.3. By Application
      • 9.3.2.2.4. By End User
  • 9.3.3. UAE Regulatory Information Management System 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 Mode
      • 9.3.3.2.3. By Application
      • 9.3.3.2.4. By End User

10. Market Dynamics

• 10.1. Drivers
• 10.2. Challenges

11. Market Trends & Developments

12. Competitive Landscape

• 12.1. Business Overview
• 12.2. Product Offerings
• 12.3. Recent Developments
• 12.4. Financials (As Reported)
• 12.5. Key Personnel
• 12.6. SWOT Analysis
  • 12.6.1. ArisGlobal LLC
  • 12.6.2. Arivis AG
  • 12.6.3. DDi, Inc.
  • 12.6.4. Ennov SA
  • 12.6.5. Extedo Gmbh
  • 12.6.6. Glemser Technologies Corporation
  • 12.6.7. Instem Group
  • 12.6.8. MasterControl, Inc.
  • 12.6.9. Parexel International Corporation
  • 12.6.10. Samarind Ltd.
  • 12.6.11. Sparta Systems, Inc.
  • 12.6.12. Acuta LLC
  • 12.6.13. Virtify, Inc.
  • 12.6.14. Amplexor International SA
  • 12.6.15. Veeva Systems Inc.

13. Strategic Recommendations