医薬品薬事管理システム市場- 世界の産業規模、シェア、動向、機会、予測、競合別、展開別、エンドユーザー別、地域別、競争別、2020-2030F

医薬品薬事管理システムの世界市場規模は、2024年に99億8,000万米ドルとなり、2030年までの予測期間のCAGRは9.95%で、目覚ましい成長が予測されています。

医薬品薬事管理システムの世界市場とは、製薬・ライフサイエンス分野における規制遵守や規制プロセスの合理化を促進するために設計された、専門的なソフトウェアソリューションやテクノロジーの開発・採用を含む業界を指します。この背景には、がん患者の増加、心血管疾患の増加、人口の高齢化などがあります。例えば、GLOBOCAN 2022のデータによると、世界のがん罹患数は1,990万件を超えました。症例数が最も多かったのはアジアで980万人以上、次いで欧州が440万人、北米が260万人でした。このデータは、がん罹患率の地域格差を浮き彫りにしており、世界のヘルスケア負担の増大を強調しています。そのため、これらの問題を管理するために、医薬品の規制委員会は急速に拡大しています。

市場促進要因

規制の複雑化

主な市場課題

急速に進化する規制

主な市場動向

クラウドベースのソリューションによる柔軟性

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の医薬品薬事管理システム市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • コンポーネント別（サービス、ソリューション）
  • 展開別（クラウド、オンプレミス）
  • エンドユーザー別（政府機関、病院および介護機関、製薬およびバイオテクノロジー企業）
  • 地域別
  • 企業別（2024）
• 製品市場マップ
  • コンポーネント別
  • 展開別
  • エンドユーザー別
  • 地域別

第6章 北米の医薬品薬事管理システム市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • カナダ
  • メキシコ

第7章 欧州の医薬品薬事管理システム市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン

第8章 アジア太平洋地域の医薬品薬事管理システム市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • 日本
  • インド
  • オーストラリア
  • 韓国

第9章 南米の医薬品薬事管理システム市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの医薬品薬事管理システム市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 合併と買収
• 製品上市

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第14章 競合情勢

• 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 戦略的提言

16調査会社について・免責事項

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