市場調査レポート
商品コード
1347909

医薬品品質管理システム市場:ソリューションタイプ、展開形態、エンドユーザー別-2030年までの世界予測

Pharmaceutical Quality Management Systems Market by Solution Type, Deployment Mode, and End User - Global Forecast to 2030


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ページ情報
英文 215 Pages
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医薬品品質管理システム市場:ソリューションタイプ、展開形態、エンドユーザー別-2030年までの世界予測
出版日: 2023年09月13日
発行: Meticulous Research
ページ情報: 英文 215 Pages
納期: 即納可能 即納可能とは
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  • 全表示
  • 概要
  • 図表
  • 目次
概要

医薬品品質管理システム市場:ソリューションタイプ別(逸脱、CAPA、監査、リスク&コンプライアンス、検査、文書、変更、トレーニング管理)、展開形態別(クラウド、オンプレミス)、エンドユーザー別(医薬品、CDMO/CRO)-2030年までの世界予測

医薬品品質管理システム市場は、2023年から2030年までのCAGR15.6%で、2030年までに39億7,000万米ドルに達すると予測されます。

広範な2次調査と1次調査、市場シナリオの詳細な分析を経て、当レポートでは主要産業の促進要因・抑制要因・課題・機会を調査しています。同市場の成長を牽引しているのは、医薬品製造コストの増加、製薬企業による規制要件への対応ニーズの高まり、製薬業界の急成長、ソフトウェアベースの品質管理システムのメリットなどです。さらに、ジェネリック医薬品やバイオ医薬品市場の成長、製薬企業によるPlatform-as-a-Serviceソリューションの選好の高まりは、同市場のプレーヤーに成長機会をもたらすと予想されます。しかし、医薬品品質管理システムの導入コストが高いことが、同市場の成長を抑制しています。製薬企業におけるオンクラウド展開に関連するセキュリティ上の懸念は、市場成長の大きな課題となっています。

目次

第1章 イントロダクション

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場洞察

  • 概要
  • 市場成長の要因
    • 市場力学
      • 製薬企業による規制要件への対応ニーズの高まりが医薬品品質管理システムの採用を促進
      • 医薬品品質管理システム導入の高コストが採用を制限
      • ジェネリック医薬品とバイオ医薬品市場の成長による市場プレーヤーの成長機会創出
      • 医薬品QMSの導入に影響を与えるオンクラウド導入に関連するセキュリティ上の懸念
    • 要因分析
  • 動向
    • 医薬品品質管理システムへの人工知能と機械学習の統合
    • 個別化医療への志向の高まり
  • 医薬品品質管理システム市場規制分析
    • 概要
    • 国際標準化機構(ISO)
    • 医薬品査察協力スキーム(PIC/S)
    • ICHガイドラインQ10
    • 現行の適正製造基準(cGMP)
  • 価格分析
  • ケーススタディ

第5章 医薬品品質管理システム市場:ソリューションタイプ別評価

  • 概要
  • 不適合/逸脱管理
  • 文書管理
  • CAPAマネジメント
  • リスク・コンプライアンス管理
  • 検査管理
  • 監査管理
  • サプライヤーと資材管理
  • トレーニング管理
  • 変更管理
  • その他のソリューションタイプ

第6章 医薬品品質マネジメントシステム市場の評価:導入形態別

  • 概要
  • クラウド/ウェブベース
  • オンプレミス

第7章 医薬品品質管理システム市場の評価:エンドユーザー別

  • 概要
  • 製薬・バイオテクノロジー企業
  • 開発・製造受託機関/研究受託機関
  • 研究機関

第8章 医薬品品質管理システムの市場評価:エンドユーザー別

  • 概要
  • 病院・クリニック
  • 診断研究所
  • 在宅ヘルスケア
  • その他のエンドユーザー

第9章 医薬品品質管理システム市場評価:地域別

  • イントロダクション
  • 北米
    • 米国
    • カナダ
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • アイルランド
    • ベルギー
    • オランダ
    • その他欧州
  • アジア太平洋
    • 日本
    • 中国
    • インド
    • シンガポール
    • マレーシア
    • フィリピン
    • ベトナム
    • その他アジア太平洋地域
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他ラテンアメリカ
  • 中東・アフリカ

第10章 競合分析

  • 概要
  • 主要成長戦略
  • 競合ベンチマーキング
  • 競合ダッシュボード
    • 業界リーダー
    • 市場差別化要因
    • 先行企業
    • 新興企業
  • 市場プレイヤーランキング(2022年)

第11章 企業プロファイル

  • Honeywell International Inc.
    • 会社概要
    • 財務概要
    • ソリューション・ポートフォリオ
    • 戦略的展開
    • SWOT分析
  • IQVIA Holdings Inc.
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
    • SWOT分析
  • Dassault Systemes SE
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
    • 戦略的展開
    • SWOT分析
  • Korber AG
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
    • 戦略的展開
    • SWOT分析
  • ANTARES VISION S.p.A.
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
    • 戦略的展開
    • SWOT分析
  • EtQ Management Consultants Inc.(A Subsidiary of Hexagon AB)
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
  • Ideagen PLC(A Subsidiary of Rainforest Bidco Limited)
    • 会社概要
    • 財務概要
    • ソリューションポートフォリオ
    • 戦略的展開
  • AssurX, Inc.
    • 会社概要
    • ソリューション・ポートフォリオ
    • 戦略的展開
  • AXSource Consulting, Inc.
    • 会社概要
    • ソリューションポートフォリオ
    • 戦略的開発
  • ComplianceQuest, Inc.
    • 会社概要
    • ソリューションポートフォリオ
    • 戦略的開発
  • LogicGate, Inc.
    • 会社概要
    • 製品ポートフォリオ
    • 戦略的開発
  • MasterControl Solutions Inc.
    • 会社概要
    • ソリューションポートフォリオ
    • 戦略的展開

(注:上位5社のSWOT分析を提供予定)

第12章 付録

図表
  • Table 1 Recent Biopharmaceutical Plant Capacity Expansions
  • Table 2 Overview of Product Lifecycle Stages
  • Table 3 Overview of Standards and Compliance Guidelines Related to Pharmaceutical Quality Management Systems
  • Table 4 GMP Regulations
  • Table 5 Pharmaceutical Quality Management Software: Pricing
  • Table 6 Global Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 7 Global Non-Conformance/Deviation Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 8 Global Document Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 9 Global CAPA Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 10 Global Risk & Compliance Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 11 Global Inspection Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 12 Global Audit Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 13 Global Suppliers & Materials Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 14 Global Training Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 15 Global Change Management Market, by Country/Region, 2021-2030 (USD Million)
  • Table 16 Global Other Solution Types Market, by Country/Region, 2021-2030 (USD Million)
  • Table 17 Global Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 18 Global Cloud/Web-Based Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 19 Global On-Premise Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 20 Global Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 21 Global Pharmaceutical Quality Management Systems Market for Pharmaceutical and Biotechnology Companies, by Country/Region, 2021-2030 (USD Million)
  • Table 22 Global Pharmaceutical Quality Management Systems Market For CDMO/CRO, by Country/Region, 2021-2030 (USD Million)
  • Table 23 Global Pharmaceutical Quality Management Systems Market for Research Laboratories, by Country/Region, 2021-2030 (USD Million)
  • Table 24 Global Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 25 North America: Pharmaceutical Quality Management Systems Market, by Country, 2021-2030 (USD Million)
  • Table 26 North America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 27 North America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 28 North America: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 29 U.S.: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 30 U.S.: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 31 U.S.: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 32 Canada: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 33 Canada: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 34 Canada: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 35 Europe: Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 36 Europe: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 37 Europe: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 38 Europe: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 39 Germany: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 40 Germany: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 41 Germany: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 42 France: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 43 France: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 44 France: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 45 U.K.: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 46 U.K.: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 47 U.K.: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 48 Italy: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 49 Italy: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 50 Italy: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 51 Spain: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 52 Spain: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 53 Spain: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 54 Ireland: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 55 Ireland: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 56 Ireland: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 57 Belgium: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 58 Belgium: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 59 Belgium: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 60 Netherlands: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 61 Netherlands: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 62 Netherlands: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 63 Rest of Europe: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 64 Rest of Europe: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 65 Rest of Europe: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 66 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 67 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 68 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 69 Asia-Pacific: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 70 China: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 71 China: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 72 China: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 73 Japan: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 74 Japan: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 75 Japan: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 76 India: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 77 India: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 78 India: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 79 Singapore: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 80 Singapore: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 81 Singapore: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 82 Malaysia: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 83 Malaysia: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 84 Malaysia: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 85 Philippines: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 86 Philippines: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 87 Philippines: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 88 Vietnam: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 89 Vietnam: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 90 Vietnam: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 91 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 92 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 93 Rest of Asia-Pacific: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 94 Latin America: Pharmaceutical Quality Management Systems Market, by Country/Region, 2021-2030 (USD Million)
  • Table 95 Latin America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 96 Latin America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 97 Latin America: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 98 Brazil: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 99 Brazil: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 100 Brazil: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 101 Mexico: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 102 Mexico: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 103 Mexico: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 104 Rest of Latin America: Regulatory Agencies for Pharmaceutical Quality Management Systems
  • Table 105 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 106 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 107 Rest of Latin America: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 108 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by Solution Type, 2021-2030 (USD Million)
  • Table 109 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by Deployment Mode, 2021-2030 (USD Million)
  • Table 110 Middle East & Africa: Pharmaceutical Quality Management Systems Market, by End User, 2021-2030 (USD Million)
  • Table 111 Recent Developments, by Company, 2020-2023
  • Table 112 Pharmaceutical Quality Management Systems Market: Competitive Benchmarking by Solution
目次
Product Code: MRHC - 104714

Pharmaceutical Quality Management Systems Market By Solution Type (Deviation, CAPA, Audit, Risk & Compliance, Inspection, Document, Change, Training Management), Deployment Mode (Cloud, On-premise), and End User (Pharmaceutical, CDMO/CRO)-Global Forecast to 2030

The pharmaceutical quality management systems market is expected to reach $3.97 billion by 2030, at a CAGR of 15.6% from 2023 to 2030.

Succeeding extensive secondary and primary research and in-depth analysis of the market scenario, the report studies the key industry drivers, restraints, challenges, and opportunities. The growth of this market is driven by the increasing costs of drug manufacturing, pharmaceutical companies growing need to comply with regulatory requirements, the rapid growth of the pharmaceutical industry, and the benefits of software-based quality management systems. Additionally, the growing generic drugs & and biopharmaceuticals markets and pharmaceutical companies' increasing preference for platform-as-a-service solutions are expected to generate growth opportunities for the players in this market. However, the high costs of deploying pharmaceutical quality management systems restrain the growth of this market. Security concerns related to on-cloud deployments among pharmaceutical organizations are a major challenge for market growth.

Based on solution type, the pharmaceutical quality management systems market is segmented into non-conformance/deviation management, CAPA management, audit management, risk & compliance management, suppliers & materials management, inspection management, document management, change management, training management, and other solution types. The CAPA management segment is expected to grow at the highest CAGR during the forecast period. The need for Corrective and Preventive Action (CAPA) management in the pharmaceutical industry is driven by several factors that ensure product quality, patient safety, and regulatory compliance. CAPA management is essential for addressing issues and preventing their recurrence, further contributing to the overall integrity of pharmaceutical operations.

Based on deployment mode, the global pharmaceutical quality management systems market is segmented into cloud/web-based and on-premise. In 2023, the cloud/web-based segment is expected to account for the largest share of the pharmaceutical quality management systems market. The largest share of this segment is attributed to several advantages offered by cloud/web-based deployments over on-premise deployments, such as cost minimization, easy accessibility, adjustability, and updated cloud systems. Another major advantage of web-based deployments is the lower risk of data loss through better encryption and data backup.

Based on end user, the global pharmaceutical quality management systems market is segmented into pharmaceutical and biotechnology companies, contract development and manufacturing organizations/contract research organizations, and research laboratories. The pharmaceutical and biotechnology companies segment is expected to grow at the highest CAGR during the forecast period. The highest CAGR of the segment is attributed to increasing R&D investments by pharmaceutical & biotechnology companies, widespread utilization of quality management systems to ensure product quality, and a growing emphasis on personalized medicine research.

An in-depth analysis of the geographical scenario of the pharmaceutical quality management systems market provides detailed qualitative and quantitative insights into five major geographies: North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa, along with the coverage of major countries in each region. Asia-Pacific is slated to register with the highest CAGR during the forecast period. The healthcare needs of people in Asia-Pacific countries are progressively increasing due to the rising burden of chronic diseases. A large population pool and government initiatives to improve healthcare facilities and services in these countries are the key factors supporting the growth of the Asia-Pacific market. These countries have also been identified as low-cost destinations for pharmaceutical manufacturers for a long time, which further supports the growth of this market in Asia-Pacific.

Some of the key players operating in the global pharmaceutical quality management systems market are Honeywell International Inc. (U.S.), IQVIA Holdings Inc. (U.S.), ANTARES VISION S.p.A (Italy), Dassault Systemes SE (France), EtQ Management Consultants, Inc. (U.S.), Ideagen PLC (U.K.), Korber AG (Germany), LogicGate, Inc. (U.S.), ComplianceQuest, Inc (U.S.), AssurX, Inc. (U.S.), and AXSource Consulting, Inc. (U.S.).

Scope of the Report:

Pharmaceutical Quality Management Systems Market Assessment by Solution Type

  • Non-conformance/Deviation management
  • Document Management
  • CAPA Management
  • Risk & Compliance Management
  • Inspection Management
  • Audit Management
  • Suppliers & Materials Management
  • Training Management
  • Change Management
  • Other Solution Types

(Other solution types include complaint management, out-of-specification, release management, incidents & and occurrence management, post-market surveillance, design control, and asset management.)

Pharmaceutical Quality Management Systems Market Assessment, by Deployment Mode

  • Cloud/Web-based
  • On-Premise

Pharmaceutical Quality Management Systems Market Assessment, by End User

  • Pharmaceutical and Biotechnology Companies
  • CDMO/CRO
  • Research Laboratories

Pharmaceutical Quality Management Systems Market Assessment, by Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Ireland
    • Belgium
    • Netherlands
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Singapore
    • Malaysia
    • Philippines
    • Vietnam
    • Rest of Asia-Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa

TABLE OF CONTENTS

1. Introduction

  • 1.1. Market Definition & Scope
  • 1.2. Market Ecosystem
  • 1.3. Currency & Limitations
  • 1.4. Key Stakeholders

2. Research Methodology

  • 2.1. Research Approach
  • 2.2. Process of Data Collection & Validation
    • 2.2.1. Secondary Research
    • 2.2.2. Primary Research/Interviews with Key Opinion Leaders of the Industry
  • 2.3. Market Sizing and Forecast
    • 2.3.1. Market Size Estimation Approach
    • 2.3.2. Growth Forecast Approach
  • 2.4. Assumptions for this Study

3. Executive Summary

4. Market Insights

  • 4.1. Overview
  • 4.2. Factors Affecting Market Growth
    • 4.2.1. Market Dynamics
      • 4.2.1.1. Pharmaceutical Companies' Growing Need to Comply with Regulatory Requirements Driving the Adoption of Pharmaceutical Quality Management Systems
      • 4.2.1.2. High Costs of Deploying Pharmaceutical Quality Management Systems Limiting their Adoption
      • 4.2.1.3. Growing Generic Drugs & Biopharmaceuticals Markets Generating Growth Opportunities for Market Players
      • 4.2.1.4. Security Concerns Related to On-cloud Deployments Impacting the Implementation of Pharmaceutical QMS
    • 4.2.2. Factor Analysis
  • 4.3. Trends
    • 4.3.1. Integration Of Artificial Intelligence & Machine Learning into Pharmaceutical Quality Management Systems
    • 4.3.2. Increasing Inclination Toward Personalized Medicine
  • 4.4. Pharmaceutical Quality Management Systems Market: Regulatory Analysis
    • 4.4.1. Overview
    • 4.4.2. International Organization for Standardization (ISO)
    • 4.4.3. Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
    • 4.4.4. ICH Guideline Q10
    • 4.4.5. Current Good Manufacturing Practice (cGMP)
  • 4.5. Pricing Analysis
  • 4.6. Case Studies

5. Pharmaceutical Quality Management Systems Market Assessment-by Solution Type

  • 5.1. Overview
  • 5.2. Non-Conformance/Deviation Management
  • 5.3. Document Management
  • 5.4. CAPA Management
  • 5.5. Risk & Compliance Management
  • 5.6. Inspection Management
  • 5.7. Audit Management
  • 5.8. Suppliers & Materials Management
  • 5.9. Training Management
  • 5.10. Change Management
  • 5.11. Other Solution Types

6. Pharmaceutical Quality Management Systems Market Assessment-by Deployment Mode

  • 6.1. Overview
  • 6.2. Cloud/Web-based
  • 6.3. On Premise

7. Pharmaceutical Quality Management Systems Market Assessment-by End User

  • 7.1. Overview
  • 7.2. Pharmaceutical And Biotechnology Companies
  • 7.3. Contract Development and Manufacturing Organization/ Contract Research Organization
  • 7.4. Research Laboratories

8. Pharmaceutical Quality Management Systems Market Assessment-by End User

  • 8.1. Overview
  • 8.2. Hospitals & Clinics
  • 8.3. Diagnostic Laboratories
  • 8.4. Home Healthcare
  • 8.5. Other End Users

9. Pharmaceutical Quality Management Systems Market Assessment-by Geography

  • 9.1. Introduction
  • 9.2. North America
    • 9.2.1. U.S.
    • 9.2.2. Canada
  • 9.3. Europe
    • 9.3.1. Germany
    • 9.3.2. France
    • 9.3.3. U.K.
    • 9.3.4. Italy
    • 9.3.5. Spain
    • 9.3.6. Ireland
    • 9.3.7. Belgium
    • 9.3.8. Netherlands
    • 9.3.9. Rest of Europe
  • 9.4. Asia-Pacific
    • 9.4.1. Japan
    • 9.4.2. China
    • 9.4.3. India
    • 9.4.4. Singapore
    • 9.4.5. Malaysia
    • 9.4.6. Philippines
    • 9.4.7. Vietnam
    • 9.4.8. Rest of Asia-Pacific
  • 9.5. Latin America
    • 9.5.1. Brazil
    • 9.5.2. Mexico
    • 9.5.3. Rest of Latin America
  • 9.6. Middle East & Africa

10. Competition Analysis

  • 10.1. Overview
  • 10.2. Key Growth Strategies
  • 10.3. Competitive Benchmarking
  • 10.4. Competitive Dashboard
    • 10.4.1. Industry Leaders
    • 10.4.2. Market Differentiators
    • 10.4.3. Vanguards
    • 10.4.4. Emerging Companies
  • 10.5. Market Players Ranking (2022)

11. Company Profiles

  • 11.1. Honeywell International Inc.
    • 11.1.1. Company Overview
    • 11.1.2. Financial Overview
    • 11.1.3. Solution Portfolio
    • 11.1.4. Strategic Developments
    • 11.1.5. SWOT Analysis
  • 11.2. IQVIA Holdings Inc.
    • 11.2.1. Company Overview
    • 11.2.2. Financial Overview
    • 11.2.3. Solution Portfolio
    • 11.2.4. SWOT Analysis
  • 11.3. Dassault Systemes SE
    • 11.3.1. Company Overview
    • 11.3.2. Financial Overview
    • 11.3.3. Solution Portfolio
    • 11.3.4. Strategic Developments
    • 11.3.5. SWOT Analysis
  • 11.4. Korber AG
    • 11.4.1. Company Overview
    • 11.4.2. Financial Overview
    • 11.4.3. Solution Portfolio
    • 11.4.4. Strategic Developments
    • 11.4.5. SWOT Analysis
  • 11.5. ANTARES VISION S.p.A.
    • 11.5.1. Company Overview
    • 11.5.2. Financial Overview
    • 11.5.3. Solution Portfolio
    • 11.5.4. Strategic Developments
    • 11.5.5. SWOT Analysis
  • 11.6. EtQ Management Consultants Inc. (A Subsidiary of Hexagon AB)
    • 11.6.1. Company Overview
    • 11.6.2. Financial Overview
    • 11.6.3. Solution Portfolio
  • 11.7. Ideagen PLC (A Subsidiary of Rainforest Bidco Limited)
    • 11.7.1. Company Overview
    • 11.7.2. Financial Overview
    • 11.7.3. Solution Portfolio
    • 11.7.4. Strategic Developments
  • 11.8. AssurX, Inc.
    • 11.8.1. Company Overview
    • 11.8.2. Solution Portfolio
    • 11.8.3. Strategic Developments
  • 11.9. AXSource Consulting, Inc.
    • 11.9.1. Company Overview
    • 11.9.2. Solution Portfolio
    • 11.9.3. Strategic Developments
  • 11.10. ComplianceQuest, Inc.
    • 11.10.1. Company Overview
    • 11.10.2. Solutions Portfolio
    • 11.10.3. Strategic Developments
  • 11.11. LogicGate, Inc.
    • 11.11.1. Company Overview
    • 11.11.2. Product Portfolio
    • 11.11.3. Strategic Developments
  • 11.12. MasterControl Solutions Inc.
    • 11.12.1. Company Overview
    • 11.12.2. Solution Portfolio
    • 11.12.3. Strategic Developments

(Note: SWOT Analysis of the Top 5 Companies Will Be Provided)

12. Appendix

  • 12.1. Available Customization
  • 12.2. Related Reports