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監管信息管理系統市場 - 全球行業規模.份額.趨勢.機會和預測，2018-2028 年：按組件.按部署模式.按應用程序.按最終用戶.按地理細分.競爭
市場調查報告書
商品編碼
1255248

監管信息管理系統市場 - 全球行業規模.份額.趨勢.機會和預測，2018-2028 年：按組件.按部署模式.按應用程序.按最終用戶.按地理細分.競爭

Regulatory Information Management System Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Component, By Deployment Mode, By Application, By End User, By Region and Competition
出版日期: | 出版商: TechSci Research | 英文 114 Pages | 商品交期: 2-3個工作天內

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簡介目錄

監管信息管理系統的全球市場預計在預測期內將出現令人矚目的增長。

這是由於有效的應用程序交付和程序中的適當規劃越來越普遍。 此外，新進入者的數量和最新技術的採用正在取得進展，世界各個地區對監管信息管理系統市場生產力提高的需求正在增加。 此外，預計到 2028 年，公共和私營組織的投資增加以及 IT 部門的支持增加，將進一步增加對監管信息管理系統的需求並推動市場增長。 2016 年，美國在國民醫療保健方面的支出為 33,370 億美元，佔其國內生產總值 (GDP) 的 17.9%，其中 3,290 億美元用於處方藥。 同樣，臨床試驗領域對法規實時監控的需求不斷增長，多年來一直是推動市場增長的關鍵因素。

增加產品開發

隨著監管框架的快速發展和產品審批要求的變化，開發人員需要及時了解法規並與市場參與者合作，以確保無差錯的監管合規流程。確保軟件的效率是必需的。 隨著製藥.醫療器械和生命科學領域的監管模式不斷轉變，預計在預測期內對監管信息管理系統的需求將會增加。 在製藥行業，監管信息管理系統促進了強大的應用程序，例如整個產品生命週期的規劃.查看.發布.註冊和控制。 該軟件還支持對法規和法規信息進行有效且合規的管理。 此外，2020 年 4 月，Oracle 建立並向美國政府捐贈了一個 COVID-19 治療學習系統，該系統允許醫生和患者記錄有前途的 COVID-19 藥物的效果。

對基於軟件的工作的需求不斷增長

由於臨床試驗數量的增加，對管理和控制發布新數據以及維護現有產品數據的過程的需求不斷增加，這是推動預測期內市場增長的主要因素。 在預測期內，對減少人工錯誤和輕鬆訪問監管流程的需求不斷增加，預計也將為全球監管信息管理系統市場帶來利潤豐厚的增長。 此外，最終用戶越來越多地採用基於雲的監管信息管理系統來創建準確的數據，這也是推動預測期內市場增長的一個關鍵因素。 由於人工錯誤，臨床試驗空間法規的實時監控和全球產品流程整個工作流程的自動化管理是未來幾年推動市場增長的因素。 在美國，2021 年藥品支出總額將達到約 5740 億美元。

近期發展

  • 例如，像 Calyx 這樣的供應商宣布，2021 年 10 月 25 日，世界前 10 大製藥公司之一將提供關鍵的我們很高興地宣布，我們已經達成協議，繼續使用到 2026 年提交的 Calyx 監管信息管理 (RIM) 系統。

可自定義

根據市場數據，TechSci Research 根據公司的具體需求提供定制服務。 該報告可以定制為：

公司信息

  • 對其他市場參與者（最多 5 家公司）進行深入分析和概況分析

內容

第 1 章概述

  • 市場定義
  • 市場範圍
    • 目標市場
    • 研究目標年份
    • 主要市場細分

第2章研究方法論

  • 調查目的
  • 基線調查方法
  • 主要行業合作夥伴
  • 主要協會和次要信息
  • 調查方法
  • 數據三角測量和驗證
  • 假設和限制

第 3 章執行摘要

  • 市場概覽
  • 主要市場細分概述
  • 主要市場參與者概覽
  • 主要地區/國家概覽
  • 市場驅動因素.挑戰和趨勢

第4章全球監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件（解決方案和服務）
    • 按部署類型（本地/雲端）
    • 按用途（註冊管理.監管情報.標籤管理.提交計劃和跟蹤.發布.文檔管理等）
    • 按最終用戶（製藥.醫療器械.其他）
    • 按地區
    • 按公司分類（2022 年）
  • 市場地圖
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按地區

第5章北美監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按國家
  • 北美：國家/地區分析
    • 美國
    • 加拿大
    • 墨西哥

第6章歐洲監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按國家
  • 歐洲：國家分析
    • 法國
    • 德國
    • 英國
    • 意大利
    • 西班牙

第7章亞太監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按國家
  • 亞太地區：國家/地區分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳大利亞

第 8 章南美監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按國家
  • 南美洲：國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第9章中東和非洲監管信息管理系統市場展望

  • 市場規模和預測
    • 按數量
  • 市場份額和預測
    • 按組件
    • 按部署模式
    • 通過使用
    • 最終用戶
    • 按國家
  • MEA：國家分析
    • 南非監管信息管理系統
    • 沙特阿拉伯監管信息管理系統
    • 阿聯酋監管信息管理系統

第 10 章市場動態

  • 司機
  • 任務

第11章市場趨勢與發展

第12章競爭格局

  • 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 戰略建議

簡介目錄
Product Code: 14431

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