Pharmaceutical Quality Management Software (QMS) Market - Global Forecast to 2030
商品番号 : SMB-92038
| 出版社 | MarketsandMarkets |
| 出版年月 | 2025年11月 |
| ページ数 | 302 |
| 図表数 | 299 |
| 価格タイプ | シングルユーザライセンス |
| 価格 | USD 4,950 |
| 種別 | 英文調査報告書 |
医薬品品質管理ソフトウェア（QMS）市場 – プロセス（臨床試験、規制、製造、商業化）、アプリケーション（eSOP、CAPA、コンプライアンス）、規模（大規模、小規模）、エンドユーザー（製薬、バイオテクノロジー、CRO）、地域別 – 2030年までの世界予測
世界の医薬品品質管理ソフトウェア（QMS）市場は、2025年の15億9,000万米ドルから2030年には29億8,000万米ドルに達し、予測期間中は年平均成長率（CAGR）13.3%で成長すると予測されています。医薬品QMS市場は、規制要件の厳格化、コンプライアンスプロセスの合理化、製薬業界におけるデジタルトランスフォーメーションの需要の高まりを背景に、着実な成長を遂げています。企業は、効率性の向上、エラーの最小化、FDA、EMA、ISOガイドラインなどの国際基準へのコンプライアンス確保を目的として、QMSソリューションを導入しています。さらに、医薬品開発、臨床試験、製造業務の複雑化も、QMSソリューションの導入をさらに加速させています。この傾向は、製品全体の品質向上、患者の安全性向上、市場投入までの期間短縮を目的とした、統合型・自動化・データ駆動型の品質管理システムへの業界の移行を反映しています。
調査範囲：
本レポートは、医薬品品質管理ソフトウェア（QMS）市場を分析し、プロセス、アプリケーション、企業規模、エンドユーザー、地域に基づき、様々なセグメントにおける市場規模と将来の成長可能性を予測することを目的としています。また、主要プレーヤーの競合分析に加え、企業概要、製品ラインナップ、最近の動向、主要な市場インサイト戦略も提供しています。
本レポートを購入する理由
本レポートは、既存企業だけでなく、新興企業や小規模企業にとっても、市場動向を理解し、市場シェアの拡大に役立てることができます。本レポートを活用する企業は、以下の戦略のいずれか、または組み合わせを適用することで、市場における地位を強化することができます。
本レポートでは、以下の点について洞察を提供します。
主要な推進要因（厳格な規制遵守のプレッシャーが製薬企業にQMSソリューションの導入を促している、製薬事業のグローバル化がQMSシステムのデジタル化と自動化、コスト圧力、エラー削減、そして製薬業界における業務効率化の必要性を促している、リスク管理と規制基準遵守の重要性が高まっている）、制約要因（新しいソフトウェアソリューションへの適応への抵抗、厳格なデータ保護法（GDPR、HIPAA）によるサイバーセキュリティコストの上昇とソフトウェア導入の遅れ、データセキュリティとプライバシーに関する懸念）、機会（製薬製造における専門的なクラウドベースのソフトウェアソリューションへの需要増加、中小規模の製薬企業の増加による市場成長の促進、製薬製造活動の増加と規制枠組みの進化を背景とした新興地域への進出、プロアクティブな品質管理を可能にするAIとアナリティクスの導入）、課題（製薬QMSソリューションの初期コストの高さ、地域による規制基準のばらつき、AIと高度なデジタルプラットフォームの専門知識を持つ熟練した研究開発・品質管理担当者の不足）の分析。医薬品品質管理ソフトウェア（QMS）市場の成長に影響を与えます。
- 製品開発／イノベーション：医薬品QMS市場における今後の技術、研究開発活動、新製品・新サービスの発売に関する詳細な洞察。
- 市場開発：収益性の高い新興市場、アプリケーション、プロセス、企業規模、エンドユーザー、地域に関する包括的な情報。
- 市場多様化：医薬品QMS市場における製品ポートフォリオ、成長地域、最近の動向、投資に関する包括的な情報。
- 競合評価：医薬品QMS市場の主要企業（Veeva Systems, Inc.（米国）、MasterControl Solutions, Inc.（米国）、Honeywell International Inc.（米国）、IQVIA（米国）、Dassault Systèmes（フランス）など）の市場シェア、成長戦略、製品提供、および能力に関する詳細な評価。
Report Description
The global pharmaceutical QMS market is projected to reach USD 2.98 billion by 2030 from USD 1.59 billion in 2025, at a CAGR of 13.3% during the forecast period. The pharmaceutical QMS market is experiencing consistent growth, driven by increasing regulatory requirements, the need for streamlined compliance processes, and rising demand for digital transformation in the pharmaceutical industry. Companies are adopting QMS solutions to improve efficiency, minimize errors, and ensure compliance with global standards such as FDA, EMA, and ISO guidelines. Additionally, the increasing complexity of drug development, clinical trials, and manufacturing operations is further boosting adoption. This trend reflects the industry’s move toward integrated, automated, and data-driven quality management systems to enhance overall product quality, patient safety, and accelerate time-to-market efficiency.
“Regulatory compliance under the process segment is expected to register the fastest growth rate during the forecast period.”
By process, the regulatory compliance segment is expected to grow the fastest in the pharmaceutical QMS market. This expansion is driven by the growing complexity of global regulatory requirements and the increasing need for pharmaceutical companies to meet stringent quality and safety standards set by agencies such as the FDA, EMA, and WHO. QMS helps organizations efficiently manage audits, documentation, and reporting tasks, thereby reducing the risk of non-compliance and associated penalties. Moreover, the rising demand for automated compliance tracking, real-time data visibility, and centralized document control is boosting the adoption of QMS solutions across the industry.
“CAPA management under the application segment is expected to be the fastest-growing segment during the forecast period.”
By application, the CAPA (Corrective and Preventive Action) management segment is expected to be the fastest-growing area in the pharmaceutical QMS market. This growth is fueled by the rising focus on proactively identifying and fixing quality issues to meet regulatory standards. CAPA solutions help pharmaceutical companies systematically investigate root causes, implement corrective actions, and prevent the recurrence of deviations or nonconformities. The increasing integration of automation, data analytics, and real-time monitoring within CAPA processes further boosts efficiency and accuracy. As companies aim to maintain high-quality standards and reduce operational risks, the demand for advanced CAPA capabilities within QMS platforms continues to grow rapidly.
“The Asia Pacific is expected to witness the highest growth rate during the forecast period.”
The Asia Pacific is expected to experience the fastest growth in the pharmaceutical QMS market, driven by the rapid expansion of pharmaceutical manufacturing capacities, an increasing number of clinical trials outsourced to the region, and greater regulatory alignment with global standards. Additionally, the rise in digitization efforts, combined with investments in advanced IT infrastructure and automation for compliance, is fueling widespread adoption of integrated QMS platforms to improve quality assurance, simplify documentation, and maintain regulatory compliance across complex, multi-site operations.
In-depth interviews have been conducted with chief executive officers (CEOs), Directors, and other executives from various key organizations operating in the authentication and brand protection marketplace. The breakdown of primary participants is as mentioned below:
- By Company Type – Tier 1: 31%, Tier 2: 28%, and Tier 3: 41%
- By Designation – C-level: 31%, Director-level: 25%, and Others: 44%
- By Region – North America: 32%, Europe: 32%, Asia Pacific: 26%, Middle East & Africa: 5%, Latin America: 5%
Key Players in the Pharmaceutical QMS Market
The key players operating in the Pharmaceutical QMS market include Veeva Systems Inc. (US), MasterControl Solutions, Inc. (US), Honeywell International Inc. (US), IQVIA (US), Qualio, Inc. (US), Hexagon AB (Sweden), AssurX, Inc. (US), QT9 Software (US), Dassault Systèmes (France), ComplianceQuest (US), Ideagen (UK), SoftExpert (Brazil), Xybion Digital Inc. (US), Intelex Technologies (Canada), Intellect, Inc. (US), AmpleLogic (India).
Research Coverage:
The report analyzes the pharmaceutical QMS market and aims to estimate its size and future growth potential across various segments based on process, application, enterprise size, end user, and region. It also provides a competitive analysis of the key players in the market, along with their company profiles, product offerings, recent developments, and key market insights strategies.
Reasons to Buy the Report
This report will help both established firms and newer or smaller companies understand the market trends, which can assist them in gaining a larger share of the market. Companies using the report can apply one or a combination of the strategies listed below to strengthen their positions in the market.
This report provides insights into:
Analysis of key drivers (stringent regulatory compliance pressures are pushing pharma companies to adopt QMS solutions, Globalization of pharmaceutical operations is driving the need for digitalization and automation of QMS systems, cost pressures, reduce errors, and the need for operational efficiency in pharma, Increasing emphasis on risk management and adherence to regulatory standards), restraints (reluctance to adapt to new software solutions, strict data protection laws (GDPR, HIPAA) raise cybersecurity costs and slow software adoption, Concerns regarding data security & privacy), opportunities (increasing demand for specialized cloud-based software solutions in pharma manufacturing, Rising number of small & mid-sized pharma companies to propel market growth, expansion across emerging regions, fuelled by rising pharmaceutical manufacturing activities and evolving regulatory frameworks, adoption of AI and analytics to enable proactive quality management), and challenges (high initial costs of pharma QMS solutions, Variability in regulatory standards across regions, Shortages of skilled R&D and quality professionals with expertise in AI and advanced digital platforms) influencing the growth of the pharmaceutical QMS market.
- Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product & service launches in the pharmaceutical QMS market.
- Market Development: Comprehensive information on the lucrative emerging markets, application, process, enterprise size, end user, and region.
- Market Diversification: Exhaustive information about the product portfolios, growing geographies, recent developments, and investments in the pharmaceutical QMS market
- Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, and capabilities of the leading players in the pharmaceutical QMS market, like Veeva Systems, Inc. (US), MasterControl Solutions, Inc. (US), Honeywell International Inc. (US), IQVIA (US), and Dassault Systèmes (France).
Table of Contents
1 INTRODUCTION 28
1.1 STUDY OBJECTIVES 28
1.2 MARKET DEFINITION 28
1.3 MARKET SCOPE 29
1.3.1 MARKET SEGMENTATION AND REGIONAL SCOPE 29
1.3.2 INCLUSIONS AND EXCLUSIONS 30
1.3.3 YEARS CONSIDERED 31
1.4 CURRENCY CONSIDERED 31
1.5 STAKEHOLDERS 32
2 EXECUTIVE SUMMARY 33
2.1 KEY INSIGHTS AND MARKET HIGHLIGHTS 33
2.2 KEY MARKET PARTICIPANTS: INSIGHTS AND STRATEGIC DEVELOPMENTS 34
2.3 DISRUPTIVE TRENDS SHAPING THE MARKET 35
2.4 HIGH-GROWTH SEGMENTS & EMRGING FRONTIERS 36
2.5 SNAPSHOT: GLOBAL MARKET SIZE, GROWTH RATE, AND FORECAST 37
3 PREMIUM INSIGHTS 38
3.1 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET OVERVIEW 38
3.2 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE & REGION 39
3.3 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
GEOGRAPHIC SNAPSHOT 40
3.4 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
DEVELOPED MARKETS VS. EMERGING MARKETS 41
4 MARKET OVERVIEW 42
4.1 INTRODUCTION 42
4.2 MARKET DYNAMICS 42
4.2.1 DRIVERS 43
4.2.1.1 Stringent regulatory compliance 43
4.2.1.2 Globalization of pharmaceutical operations 44
4.2.1.3 Growing demand for operational efficiency and reduce human errors 45
4.2.1.4 Increasing emphasis on risk management and adherence to regulatory standards 45
4.2.2 RESTRAINTS 46
4.2.2.1 Reluctance to adopt new software solutions 46
4.2.2.2 Strict data protection laws 46
4.2.2.3 Data security and privacy concerns 47
4.2.3 OPPORTUNITIES 47
4.2.3.1 Increasing demand for specialized cloud-based software solutions 47
4.2.3.2 Rising number of small & mid-sized pharma companies 48
4.2.3.3 Expanding pharmaceutical industry in emerging regions 49
4.2.3.4 Adoption of AI and advanced analytics 49
4.2.4 CHALLENGES 50
4.2.4.1 High initial costs of implementing quality management systems 50
4.2.4.2 Variability in regulatory standards 50
4.2.4.3 Shortage of skilled R&D and quality professionals 51
4.3 UNMET NEEDS AND WHITE SPACES 51
4.4 INTERCONNECTED MARKETS AND CROSS-SECTOR OPPORTUNITIES 51
4.5 STRATEGIC MOVES BY TIER 1/2/3 PLAYERS 52
5 INDUSTRY TRENDS 53
5.1 PORTER’S FIVE FORCES ANALYSIS 53
5.1.1 THREAT OF SUBSTITUTES 54
5.1.2 THREAT OF NEW ENTRANTS 54
5.1.3 BARGAINING POWER OF BUYERS 54
5.1.4 BARGAINING POWER OF SUPPLIERS 54
5.1.5 INTENSITY OF COMPETITIVE RIVALRY 54
5.2 MACROECONOMIC OUTLOOK 55
5.2.1 INTRODUCTION 55
5.2.2 GDP TRENDS AND FORECAST 55
5.2.3 TRENDS IN GLOBAL HEALTHCARE IT INDUSTRY 56
5.3 VALUE CHAIN ANALYSIS 57
5.4 ECOSYSTEM ANALYSIS 59
5.5 PRICING ANALYSIS 61
5.5.1 INDICATIVE PRICING ANALYSIS, BY KEY PLAYER, 2024 61
5.5.2 INDICATIVE PRICING ANALYSIS, BY REGION, 2024 62
5.6 KEY CONFERENCES AND EVENTS, 2025–2026 62
5.7 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS BUSINESS 64
5.8 INVESTMENT AND FUNDING SCENARIO 65
5.9 CASE STUDY ANALYSIS 65
5.10 IMPACT OF 2025 US TARIFF 66
5.10.1 INTRODUCTION 66
5.10.2 KEY TARIFF RATES 67
5.10.3 PRICE IMPACT ANALYSIS 67
5.10.4 IMPACT ON COUNTRY/REGION 68
5.10.4.1 US 68
5.10.4.2 Europe 68
5.10.4.3 Asia Pacific 68
5.10.5 IMPACT ON END-USE INDUSTRIES 68
5.10.5.1 Pharmaceutical companies 68
5.10.5.2 Biotechnology companies 69
5.10.5.3 Contract Research Organizations (CROs) 69
6 TECHNOLOGICAL ADVANCEMENTS, AI-DRIVEN IMPACT, PATENTS, INNOVATIONS, AND FUTURE APPLICATIONS 70
6.1 KEY EMERGING TECHNOLOGIES 70
6.1.1 GENERATIVE AI & MACHINE LEARNING 70
6.1.2 CLOUD COMPUTING & SAAS PLATFORMS 70
6.1.3 ROBOTIC PROCESS AUTOMATION 70
6.2 COMPLEMENTARY TECHNOLOGIES 71
6.2.1 MANUFACTURING EXECUTION SYSTEMS (MES) 71
6.2.2 ENTERPRISE RESOURCE PLANNING (ERP) SYSTEMS 71
6.2.3 ELECTRONIC DATA MANAGEMENT SYSTEMS (EDMS) 71
6.3 TECHNOLOGY/PRODUCT ROADMAP 72
6.4 PATENT ANALYSIS 72
6.4.1 JURISDICTION ANALYSIS 72
6.4.2 MAJOR PATENTS 74
6.4.3 LIST OF PATENTS 74
6.5 FUTURE APPLICATIONS 76
6.5.1 AUTOMATED AUDIT AND INSPECTION 76
6.5.2 AI-POWERED COMPLIANCE MONITORING 76
6.5.3 ADVANCED ANALYTICS DASHBOARDS 76
6.5.4 MOBILE QMS APPLICATIONS 76
6.5.5 SUPPLIER QUALITY MANAGEMENT AUTOMATION 77
6.6 IMPACT OF AI/GEN AI ON PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET 77
6.6.1 INTRODUCTION 77
6.6.2 MARKET POTENTIAL OF AI/GEN AI IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET 78
6.6.3 CASE STUDY RELATED TO AI/GEN AI IMPLEMENTATION 80
6.6.3.1 Use of unified QMS platform for quality documentation 80
6.6.4 IMPACT OF AI/GEN AI ON INTERCONNECTED AND ADJACENT ECOSYSTEMS 81
6.6.4.1 Automated audit simulation 81
6.6.4.2 Real-time monitoring & alerts 81
6.6.4.3 Regulatory & compliance services 82
6.6.4.4 Research laboratories & contract manufacturers 82
6.6.5 USER READINESS AND IMPACT ASSESSMENT 82
6.6.5.1 User readiness 82
6.6.5.1.1 User A: Pharmaceutical companies 82
6.6.5.1.2 User B: Biotechnology companies 82
6.6.5.2 Impact assessment 83
6.6.5.2.1 User A: Pharmaceutical companies 83
6.6.5.2.1.1 Implementation 83
6.6.5.2.1.2 Impact 83
6.6.5.2.2 User B: Biotechnology companies 83
6.6.5.2.2.1 Implementation 83
6.6.5.2.2.2 Impact 83
7 REGULATORY LANDSCAPE 84
7.1 REGIONAL REGULATIONS AND COMPLIANCE 84
7.1.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 84
7.1.2 INDUSTRY STANDARDS 88
7.1.2.1 North America 88
7.1.2.2 Europe 88
7.1.2.3 Asia Pacific 89
7.1.2.4 Middle East & Africa 90
7.1.2.5 Latin America 90
8 CUSTOMER LANDSCAPE & BUYING BEHAVIOUR 91
8.1 DECISION-MAKING PROCESS 91
8.2 BUYERS STAKEHOLDERS AND BUYING EVALUATION CRITERIA 91
8.2.1 KEY STAKEHOLDERS IN BUYING PROCESS 91
8.2.2 KEY BUYING CRITERIA 92
8.3 ADOPTION BARRIERS AND INTERNAL CHALLENGES 93
8.4 UNMET NEEDS FROM VARIOUS END-USE INDUSTRIES 93
9 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS 94
9.1 INTRODUCTION 95
9.2 CLINICAL TRIALS 95
9.2.1 NEED TO ENSURE CLINICAL EXCELLENCE AND REGULATORY INTEGRITY TO EXPEDITE GROWTH 95
9.3 REGULATORY COMPLIANCE 96
9.3.1 INCREASING EMPHASIS ON COMPLYING WITH STRINGENT INTERNATIONAL STANDARDS TO AID GROWTH 96
9.4 MANUFACTURING/PRODUCTION 97
9.4.1 GROWING FOCUS ON CONSISTENT PRODUCT QUALITY TO DRIVE MARKET 97
9.5 QUALITY ASSURANCE/QUALITY CONTROL 98
9.5.1 INCREASING FOCUS ON CONTINUOUS MONITORING, DOCUMENTATION, AND CONTROL IN PHARMA PRODUCTION TO FAVOR GROWTH 98
9.6 DISTRIBUTION & SUPPLY CHAIN 99
9.6.1 COMPLEX GLOBAL SUPPLY NETWORKS TO CONTRIBUTE TO GROWTH 99
9.7 COMMERCIALIZATION, MARKETING, AND SALES 100
9.7.1 RISING INTRODUCTION OF COMPLEX THERAPIES AND EVOLVING REGULATIONS TO SUSTAIN GROWTH 100
9.8 POST-MARKET SURVEILLANCE 101
9.8.1 GROWING FOCUS ON PRODUCT PERFORMANCE AND PATIENT SAFETY TO BOOST MARKET 101
9.9 OTHER PROCESSES 102
10 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION 104
10.1 INTRODUCTION 105
10.2 DOCUMENT CONTROL & ESOP 105
10.2.1 NEED TO MANAGE AND CONTROL CRITICAL QUALITY DOCUMENTS TO FACILITATE GROWTH 105
10.3 CAPA (CORRECTIVE AND PREVENTIVE ACTION) MANAGEMENT 106
10.3.1 ABILITY TO ADDRESS DETECTION, RESOLUTION, AND PREVENTION OF QUALITY AND COMPLIANCE ISSUES TO FUEL MARKET 106
10.4 AUDIT & INSPECTION MANAGEMENT 107
10.4.1 INCREASING FOCUS ON EFFECTIVE AUDIT AND INSPECTION MANAGEMENT TO BOLSTER GROWTH 107
10.5 TRAINING MANAGEMENT 108
10.5.1 RISING AUTOMATION AND STANDARDIZATION IN TRAINING ACTIVITIES TO ADVANCE GROWTH 108
10.6 REGULATORY & COMPLIANCE MANAGEMENT 109
10.6.1 EVOLVING GLOBAL REGULATORY REQUIREMENTS TO ACCELERATE GROWTH 109
10.7 SUPPLIER QUALITY MANAGEMENT 110
10.7.1 NEED TO MAINTAIN SUPPLIER RELIABILITY, MATERIAL INTEGRITY, AND REGULATORY COMPLIANCE TO SPUR GROWTH 110
10.8 RISK MANAGEMENT 111
10.8.1 COMPLEX NATURE OF PHARMACEUTICAL OPERATIONS TO ENCOURAGE GROWTH 111
10.9 CHANGE CONTROL MANAGEMENT 112
10.9.1 RISING TRANSITION TOWARD DIGITAL SYSTEMS TO STIMULATE GROWTH 112
10.10 OTHER APPLICATIONS 113
11 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE 115
11.1 INTRODUCTION 116
11.2 LARGE ENTERPRISES 116
11.2.1 RISING DIGITAL TRANSFORMATION AND COMPLIANCE MODERNIZATION STRATEGIES TO EXPEDITE GROWTH 116
11.3 SMALL & MEDIUM ENTERPRISES 117
11.3.1 INCREASING ADOPTION OF CLOUD-BASED, MODULAR, AND SCALABLE QMS SOLUTIONS TO AID GROWTH 117
12 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER 119
12.1 INTRODUCTION 120
12.2 PHARMACEUTICAL COMPANIES 120
12.2.1 INCREASING INVESTMENTS IN AI AND ANALYTICS-ENABLED QMS PLATFORMS TO PROPEL MARKET 120
12.3 BIOTECHNOLOGY COMPANIES 121
12.3.1 STRONG FOCUS ON INNOVATION, REGULATORY COMPLIANCE, AND MANUFACTURING PRECISION TO FAVOR GROWTH 121
12.4 CONTRACT RESEARCH ORGANIZATIONS 122
12.4.1 INCREASING CLINICAL RESEARCH, DATA MANAGEMENT, AND REGULATORY SUBMISSION ACTIVITIES TO SUSTAIN GROWTH 122
12.5 CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATIONS 123
12.5.1 CRUCIAL ROLE IN GLOBAL DRUG PRODUCTION, FORMULATION DEVELOPMENT, AND SUPPLY CHAIN MANAGEMENT TO DRIVE MARKET 123
12.6 OTHER END USERS 124
13 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY REGION 126
13.1 INTRODUCTION 127
13.2 NORTH AMERICA 128
13.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA 128
13.2.2 US 131
13.2.2.1 Growing need for operational excellence in life sciences sector to boost market 131
13.2.3 CANADA 134
13.2.3.1 Increasing digital transformation initiatives and focus on lifecycle quality management to aid growth 134
13.3 EUROPE 137
13.3.1 MACROECONOMIC OUTLOOK FOR EUROPE 137
13.3.2 GERMANY 140
13.3.2.1 Robust pharma infrastructure to propel market 140
13.3.3 UK 142
13.3.3.1 Increasing focus on comprehensive patient safety and risk management solutions to spur growth 142
13.3.4 FRANCE 145
13.3.4.1 Strict regulatory environment to foster growth 145
13.3.5 ITALY 147
13.3.5.1 Rising compliance mandates to contribute to growth 147
13.3.6 SPAIN 150
13.3.6.1 Need for scalable, cost-effective, and regulatory-ready systems to augment growth 150
13.3.7 REST OF EUROPE 152
13.4 ASIA PACIFIC 155
13.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC 155
13.4.2 CHINA 158
13.4.2.1 Rising clinical & manufacturing volumes and growing number of biotech companies to drive market 158
13.4.3 JAPAN 161
13.4.3.1 Increasing adoption of cloud systems and electronic records to aid growth 161
13.4.4 INDIA 164
13.4.4.1 Expanding pharmaceutical manufacturing base and increasing regulatory scrutiny from global health authorities to drive market 164
13.4.5 AUSTRALIA 166
13.4.5.1 Increasing shift toward electronic integrated quality ecosystems to promote growth 166
13.4.6 SOUTH KOREA 169
13.4.6.1 Growing focus on lifecycle quality management to propel market 169
13.4.7 REST OF ASIA PACIFIC 171
13.5 LATIN AMERICA 174
13.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA 174
13.5.2 BRAZIL 177
13.5.2.1 Growing investments in automated quality systems to drive market 177
13.5.3 MEXICO 179
13.5.3.1 Increasing emphasis on data integrity and electronic documentation to boost market 179
13.5.4 REST OF LATIN AMERICA 181
13.6 MIDDLE EAST & AFRICA 184
13.6.1 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA 184
13.6.2 GCC COUNTRIES 186
13.6.2.1 Saudi Arabia 189
13.6.2.1.1 Increasing local manufacturing and enhanced regulatory compliance to promote growth 189
13.6.2.2 UAE 192
13.6.2.2.1 Rising regulatory modernization and national manufacturing initiatives to sustain growth 192
13.6.2.3 Rest of GCC countries 194
13.6.3 SOUTH AFRICA 197
13.6.3.1 Evolving regulatory expectations and digitalization trends to fuel market 197
13.6.4 REST OF MIDDLE EAST & AFRICA 199
14 COMPETITIVE LANDSCAPE 202
14.1 OVERVIEW 202
14.2 KEY PLAYER COMPETITIVE STRATEGIES/RIGHT TO WIN 202
14.2.1 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS 203
14.3 REVENUE SHARE ANALYSIS 204
14.4 MARKET SHARE ANALYSIS 205
14.5 SOFTWARE COMPARISON 208
14.6 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024 209
14.6.1 STARS 209
14.6.2 EMERGING LEADERS 209
14.6.3 PERVASIVE PLAYERS 209
14.6.4 PARTICIPANTS 209
14.6.5 COMPANY FOOTPRINT: KEY PLAYERS, 2024 211
14.6.5.1 Company footprint 211
14.6.5.2 Region footprint 212
14.6.5.3 Process footprint 213
14.6.5.4 Application footprint 214
14.6.5.5 Enterprise size footprint 215
14.6.5.6 End-user footprint 216
14.7 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024 217
14.7.1 PROGRESSIVE COMPANIES 217
14.7.2 RESPONSIVE COMPANIES 217
14.7.3 DYNAMIC COMPANIES 217
14.7.4 STARTING BLOCKS 217
14.7.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024 219
14.7.5.1 Detailed list of key startups/SMEs 219
14.7.5.2 Competitive benchmarking of key startups/SMEs 220
14.8 COMPANY VALUATION AND FINANCIAL METRICS 221
14.8.1 COMPANY VALUATION 221
14.8.2 FINANCIAL METRICS 221
14.9 COMPETITIVE SCENARIO 222
14.9.1 PRODUCT LAUNCHES AND APPROVALS 222
14.9.2 DEALS 223
14.9.3 EXPANSIONS 224
14.9.4 OTHER DEVELOPMENTS 224
15 COMPANY PROFILES 225
15.1 KEY PLAYERS 225
15.1.1 HONEYWELL INTERNATIONAL INC. 225
15.1.1.1 Business overview 225
15.1.1.2 Products offered 226
15.1.1.3 Recent developments 227
15.1.1.3.1 Product launches and approvals 227
15.1.1.3.2 Deals 228
15.1.1.4 MnM view 228
15.1.1.4.1 Key strengths/Right to win 228
15.1.1.4.2 Strategic choices 228
15.1.1.4.3 Weaknesses/Competitive threats 228
15.1.2 IQVIA 229
15.1.2.1 Business overview 229
15.1.2.2 Products offered 230
15.1.2.3 Recent developments 231
15.1.2.3.1 Deals 231
15.1.2.3.2 Other developments 231
15.1.2.4 MnM view 231
15.1.2.4.1 Key strengths/Right to win 231
15.1.2.4.2 Strategic choices 231
15.1.2.4.3 Weaknesses/Competitive threats 232
15.1.3 VEEVA SYSTEMS INC. 233
15.1.3.1 Business overview 233
15.1.3.2 Products offered 234
15.1.3.3 Recent developments 236
15.1.3.3.1 Product launches and approvals 236
15.1.3.3.2 Deals 236
15.1.3.4 MnM view 237
15.1.3.4.1 Key strengths/Right to win 237
15.1.3.4.2 Strategic choices 237
15.1.3.4.3 Weaknesses/Competitive threats 237
15.1.4 MASTERCONTROL SOLUTIONS, INC. 238
15.1.4.1 Business overview 238
15.1.4.2 Products offered 238
15.1.4.3 Recent developments 239
15.1.4.3.1 Deals 239
15.1.4.4 MnM view 240
15.1.4.4.1 Key strengths/Right to win 240
15.1.4.4.2 Strategic choices 240
15.1.4.4.3 Weaknesses/Competitive threats 240
15.1.5 DASSAULT SYSTÈMES 241
15.1.5.1 Business overview 241
15.1.5.2 Products offered 242
15.1.5.3 MnM view 243
15.1.5.3.1 Key strengths/Right to win 243
15.1.5.3.2 Strategic choices 243
15.1.5.3.3 Weaknesses/Competitive threats 243
15.1.6 QUALIO 244
15.1.6.1 Business overview 244
15.1.6.2 Products offered 244
15.1.7 HEXAGON AB 246
15.1.7.1 Business overview 246
15.1.7.2 Products offered 247
15.1.7.3 Recent developments 249
15.1.7.3.1 Product launches and approvals 249
15.1.7.3.2 Deals 249
15.1.8 ASSURX, INC. 250
15.1.8.1 Business overview 250
15.1.8.2 Products offered 250
15.1.8.3 Recent developments 252
15.1.8.3.1 Deals 252
15.1.9 QT9 SOFTWARE 253
15.1.9.1 Business overview 253
15.1.9.2 Products offered 253
15.1.9.3 Recent developments 254
15.1.9.3.1 Product launches and approvals 254
15.1.9.3.2 Deals 255
15.1.10 COMPLIANCEQUEST 256
15.1.10.1 Business overview 256
15.1.10.2 Products offered 256
15.1.10.3 Recent developments 257
15.1.10.3.1 Deals 257
15.1.11 IDEAGEN 258
15.1.11.1 Business overview 258
15.1.11.2 Products offered 258
15.1.11.3 Recent developments 259
15.1.11.3.1 Product launches and approvals 259
15.1.11.3.2 Deals 259
15.1.12 SOFTEXPERT 260
15.1.12.1 Business overview 260
15.1.12.2 Products offered 260
15.1.12.3 Recent developments 261
15.1.12.3.1 Deals 261
15.1.13 INSTEM 262
15.1.13.1 Business overview 262
15.1.13.2 Products offered 262
15.1.13.3 Recent developments 263
15.1.13.3.1 Deals 263
15.1.14 INTELEX TECHNOLOGIES 264
15.1.14.1 Business overview 264
15.1.14.2 Products offered 264
15.1.14.3 Recent developments 265
15.1.14.3.1 Product launches and approvals 265
15.1.14.3.2 Expansions 266
15.1.15 INTELLECT, INC 267
15.1.15.1 Business overview 267
15.1.15.2 Products offered 267
15.1.15.3 Recent developments 268
15.1.15.3.1 Product launches and approvals 268
15.1.16 AMPLELOGIC 269
15.1.16.1 Business overview 269
15.1.16.2 Products offered 269
15.1.16.3 Recent developments 271
15.1.16.3.1 Deals 271
15.2 OTHER PLAYERS 272
15.2.1 INSTANTGMP 272
15.2.2 SIMPLERQMS 273
15.2.3 DOT COMPLIANCE LTD. 273
15.2.4 SNIC SOLUTIONS 274
15.2.5 QUALITYZE 275
15.2.6 SCIGENIQ 275
15.2.7 KIVO, INC. 276
15.2.8 GMP SOFTWARE INDIA PVT. LTD. 276
15.2.9 VMT SOFT SOL PVT. LTD. 277
16 RESEARCH METHODOLOGY 278
16.1 RESEARCH DATA 278
16.1.1 SECONDARY DATA 279
16.1.1.1 Key data from secondary sources 280
16.1.2 PRIMARY DATA 280
16.1.2.1 Key data from primary sources 281
16.1.2.2 Key primary participants 282
16.1.2.3 Breakdown of primary interviews 282
16.1.2.4 Key industry insights 283
16.2 MARKET SIZE ESTIMATION 284
16.3 DATA TRIANGULATION 289
16.4 FACTOR ANALYSIS 290
16.5 RESEARCH ASSUMPTIONS 292
16.5.1 MARKET SIZING ASSUMPTIONS 292
16.5.2 STUDY ASSUMPTIONS 292
16.6 RESEARCH LIMITATIONS AND RISK ASSESSMENT 293
16.6.1 RESEARCH LIMITATIONS 293
16.6.1.1 Methodology-related limitations 293
16.6.1.2 Scope-related limitations 293
16.6.2 RISK ASSESSMENT 293
17 APPENDIX 294
17.1 DISCUSSION GUIDE 294
17.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 298
17.3 CUSTOMIZATION OPTIONS 300
17.4 RELATED REPORTS 300
17.5 AUTHOR DETAILS 301
LIST OF TABLES
TABLE 1 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE: INCLUSIONS
AND EXCLUSIONS 30
TABLE 2 EXCHANGE RATES UTILIZED FOR CONVERSION TO USD, 2021–2025 31
TABLE 3 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: IMPACT ANALYSIS OF MARKET DYNAMICS 43
TABLE 4 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: PORTER’S FIVE FORCES ANALYSIS 54
TABLE 5 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET: ROLE OF COMPANIES IN ECOSYSTEM 60
TABLE 6 INDICATIVE PRICING ANALYSIS FOR PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE, BY KEY PLAYER, 2024 (USD) 61
TABLE 7 INDICATIVE PRICING ANALYSIS FOR PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE, BY PRICING PLANS, 2024 (USD) 62
TABLE 8 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
KEY CONFERENCES AND EVENTS, 2025–2026 63
TABLE 9 CASE STUDY 1: IMPROVED COMPLIANCE & EFFICIENCY WITH
CONFIGURABLE EQMS 65
TABLE 10 CASE STUDY 2: STREAMLINED CHANGE CONTROL & DOCUMENT MANAGEMENT WITH TRACKWISE DIGITAL 66
TABLE 11 US ADJUSTED RECIPROCAL TARIFF RATES 67
TABLE 12 JURISDICTION ANALYSIS OF TOP APPLICANT COUNTRIES,
JANUARY 2015–NOVEMBER 2025 73
TABLE 13 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: LIST OF PATENTS/PATENT APPLICATIONS 74
TABLE 14 NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 84
TABLE 15 EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 85
TABLE 16 ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 86
TABLE 17 LATIN AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 87
TABLE 18 MIDDLE EAST & AFRICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 87
TABLE 19 REGULATORY SCENARIO OF NORTH AMERICA 88
TABLE 20 REGULATORY SCENARIO OF EUROPE 88
TABLE 21 REGULATORY SCENARIO OF ASIA PACIFIC 89
TABLE 22 REGULATORY SCENARIO OF MIDDLE EAST & AFRICA 90
TABLE 23 REGULATORY SCENARIO OF LATIN AMERICA 90
TABLE 24 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS, BY END USER (%) 92
TABLE 25 KEY BUYING CRITERIA FOR TOP THREE END USERS 92
TABLE 26 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: UNMET NEEDS 93
TABLE 27 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 95
TABLE 28 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR CLINICAL TRIALS, BY REGION, 2023–2030 (USD MILLION) 96
TABLE 29 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR REGULATORY COMPLIANCE, BY REGION, 2023–2030 (USD MILLION) 97
TABLE 30 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR MANUFACTURING/PRODUCTION, BY REGION, 2023–2030 (USD MILLION) 98
TABLE 31 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR QUALITY ASSURANCE/QUALITY CONTROL, BY REGION, 2023–2030 (USD MILLION) 99
TABLE 32 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR DISTRIBUTION & SUPPLY CHAIN, BY REGION, 2023–2030 (USD MILLION) 100
TABLE 33 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR COMMERCIALIZATION, MARKETING, AND SALES, BY REGION,
2023–2030 (USD MILLION) 101
TABLE 34 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR
POST-MARKET SURVEILLANCE, BY REGION, 2023–2030 (USD MILLION) 102
TABLE 35 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR OTHER PROCESSES, BY REGION, 2023–2030 (USD MILLION) 103
TABLE 36 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 105
TABLE 37 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR
DOCUMENT & ESOP, BY REGION, 2023–2030 (USD MILLION) 106
TABLE 38 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR CAPA (CORRECTIVE & PREVENTIVE ACTION) MANAGEMENT, BY REGION,
2023–2030 (USD MILLION) 107
TABLE 39 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR AUDIT & INSPECTION MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 108
TABLE 40 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR TRAINING MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 109
TABLE 41 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR REGULATORY & COMPLIANCE MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 110
TABLE 42 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR SUPPLIER QUALITY MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 111
TABLE 43 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR RISK MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 112
TABLE 44 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR CHANGE CONTROL MANAGEMENT, BY REGION, 2023–2030 (USD MILLION) 113
TABLE 45 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR OTHER APPLICATIONS, BY REGION, 2023–2030 (USD MILLION) 114
TABLE 46 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 116
TABLE 47 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR LARGE ENTERPRISES, REGION, 2023–2030 (USD MILLION) 117
TABLE 48 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR SMALL & MEDIUM ENTERPRISES, BY REGION, 2023–2030 (USD MILLION) 118
TABLE 49 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 120
TABLE 50 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR PHARMACEUTICAL COMPANIES, BY REGION, 2023–2030 (USD MILLION) 121
TABLE 51 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR BIOTECHNOLOGY COMPANIES, BY REGION, 2023–2030 (USD MILLION) 122
TABLE 52 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR CONTRACT RESEARCH ORGANIZATIONS, BY REGION, 2023–2030 (USD MILLION) 123
TABLE 53 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATIONS, BY REGION,
2023–2030 (USD MILLION) 124
TABLE 54 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET FOR
OTHER END USERS, BY REGION, 2023–2030 (USD MILLION) 125
TABLE 55 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY REGION, 2023–2030 (USD MILLION) 127
TABLE 56 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY COUNTRY, 2023–2030 (USD MILLION) 129
TABLE 57 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 130
TABLE 58 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 130
TABLE 59 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 131
TABLE 60 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 131
TABLE 61 US: MAJOR COMPANIES IN PHARMACEUTICAL QUALITY MANAGEMENT
SOFTWARE MARKET 132
TABLE 62 US: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 132
TABLE 63 US: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 133
TABLE 64 US: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 133
TABLE 65 US: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 134
TABLE 66 CANADA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 135
TABLE 67 CANADA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 135
TABLE 68 CANADA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 136
TABLE 69 CANADA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 136
TABLE 70 EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY COUNTRY, 2023–2030 (USD MILLION) 137
TABLE 71 EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 138
TABLE 72 EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 138
TABLE 73 EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 139
TABLE 74 EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 139
TABLE 75 GERMANY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 140
TABLE 76 GERMANY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 141
TABLE 77 GERMANY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 141
TABLE 78 GERMANY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 142
TABLE 79 UK: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 143
TABLE 80 UK: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 143
TABLE 81 UK: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 144
TABLE 82 UK: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 144
TABLE 83 FRANCE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 145
TABLE 84 FRANCE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 146
TABLE 85 FRANCE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 146
TABLE 86 FRANCE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 147
TABLE 87 ITALY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 148
TABLE 88 ITALY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 148
TABLE 89 ITALY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 149
TABLE 90 ITALY: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 149
TABLE 91 SPAIN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 150
TABLE 92 SPAIN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 151
TABLE 93 SPAIN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 151
TABLE 94 SPAIN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 152
TABLE 95 REST OF EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 153
TABLE 96 REST OF EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 153
TABLE 97 REST OF EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 154
TABLE 98 REST OF EUROPE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 154
TABLE 99 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY COUNTRY, 2023–2030 (USD MILLION) 156
TABLE 100 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 157
TABLE 101 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 157
TABLE 102 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 158
TABLE 103 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 158
TABLE 104 CHINA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 159
TABLE 105 CHINA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 160
TABLE 106 CHINA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 160
TABLE 107 CHINA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 161
TABLE 108 JAPAN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 162
TABLE 109 JAPAN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 162
TABLE 110 JAPAN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 163
TABLE 111 JAPAN: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 163
TABLE 112 INDIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 164
TABLE 113 INDIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 165
TABLE 114 INDIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030(USD MILLION) 165
TABLE 115 INDIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 166
TABLE 116 AUSTRALIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 167
TABLE 117 AUSTRALIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 167
TABLE 118 AUSTRALIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 168
TABLE 119 AUSTRALIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 168
TABLE 120 SOUTH KOREA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 169
TABLE 121 SOUTH KOREA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 170
TABLE 122 SOUTH KOREA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 170
TABLE 123 SOUTH KOREA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER 2023–2030 (USD MILLION) 171
TABLE 124 REST OF ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 172
TABLE 125 REST OF ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 172
TABLE 126 REST OF ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 173
TABLE 127 REST OF ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER 2023–2030 (USD MILLION) 173
TABLE 128 LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY COUNTRY, 2023–2030 (USD MILLION) 174
TABLE 129 LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 175
TABLE 130 LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 175
TABLE 131 LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 176
TABLE 132 LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 176
TABLE 133 BRAZIL: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 177
TABLE 134 BRAZIL: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 178
TABLE 135 BRAZIL: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 178
TABLE 136 BRAZIL: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 179
TABLE 137 MEXICO: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 180
TABLE 138 MEXICO: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 180
TABLE 139 MEXICO: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030(USD MILLION) 181
TABLE 140 MEXICO: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 181
TABLE 141 REST OF LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 182
TABLE 142 REST OF LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030(USD MILLION) 182
TABLE 143 REST OF LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030(USD MILLION) 183
TABLE 144 REST OF LATIN AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 183
TABLE 145 MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY COUNTRY, 2023–2030 (USD MILLION) 184
TABLE 146 MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 185
TABLE 147 MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 185
TABLE 148 MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 186
TABLE 149 MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 186
TABLE 150 GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY COUNTRY, 2023–2030 (USD MILLION) 187
TABLE 151 GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 187
TABLE 152 GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 188
TABLE 153 GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 188
TABLE 154 GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 189
TABLE 155 SAUDI ARABIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 190
TABLE 156 SAUDI ARABIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 190
TABLE 157 SAUDI ARABIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 191
TABLE 158 SAUDI ARABIA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 191
TABLE 159 UAE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY PROCESS, 2023–2030 (USD MILLION) 192
TABLE 160 UAE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY APPLICATION, 2023–2030 (USD MILLION) 193
TABLE 161 UAE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 193
TABLE 162 UAE: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET,
BY END USER, 2023–2030 (USD MILLION) 194
TABLE 163 REST OF GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 195
TABLE 164 REST OF GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 195
TABLE 165 REST OF GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030(USD MILLION) 196
TABLE 166 REST OF GCC COUNTRIES: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 196
TABLE 167 SOUTH AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 197
TABLE 168 SOUTH AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 198
TABLE 169 SOUTH AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 198
TABLE 170 SOUTH AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER 2023–2030 (USD MILLION) 199
TABLE 171 REST OF MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY PROCESS, 2023–2030 (USD MILLION) 200
TABLE 172 REST OF MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY APPLICATION, 2023–2030 (USD MILLION) 200
TABLE 173 REST OF MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ENTERPRISE SIZE, 2023–2030 (USD MILLION) 201
TABLE 174 REST OF MIDDLE EAST & AFRICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, BY END USER, 2023–2030 (USD MILLION) 201
TABLE 175 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET,
JANUARY 2022–OCTOBER 2025 203
TABLE 176 PHARMACEUTICAL QUALITY MANAGEMENT MARKET: DEGREE OF COMPETITION 206
TABLE 177 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
REGION FOOTPRINT 212
TABLE 178 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
PROCESS FOOTPRINT 213
TABLE 179 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
APPLICATION FOOTPRINT 214
TABLE 180 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
ENTERPRISE SIZE FOOTPRINT 215
TABLE 181 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
END-USER FOOTPRINT 216
TABLE 182 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
DETAILED LIST OF KEY STARTUPS/SMES 219
TABLE 183 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
COMPETITIVE BENCHMARKING OF KEY STARTUPS/SMES 220
TABLE 184 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
PRODUCT LAUNCHES AND APPROVALS, JANUARY 2022–OCTOBER 2025 222
TABLE 185 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: DEALS,
JANUARY 2022–OCTOBER 2025 223
TABLE 186 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: EXPANSIONS, JANUARY 2022–OCTOBER 2025 224
TABLE 187 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: OTHER DEVELOPMENTS, JANUARY 2022–OCTOBER 2025 224
TABLE 188 HONEYWELL INTERNATIONAL INC.: COMPANY OVERVIEW 225
TABLE 189 HONEYWELL INTERNATIONAL INC.: PRODUCTS OFFERED 226
TABLE 190 HONEYWELL INTERNATIONAL INC.: PRODUCT LAUNCHES AND APPROVALS, JANUARY 2022–OCTOBER 2025 227
TABLE 191 HONEYWELL INTERNATIONAL INC.: JANUARY 2022–OCTOBER 2025 228
TABLE 192 IQVIA: COMPANY OVERVIEW 229
TABLE 193 IQVIA: PRODUCTS OFFERED 230
TABLE 194 IQVIA: DEALS, JANUARY 2022–OCTOBER 2025 231
TABLE 195 IQVIA: OTHER DEVELOPMENTS, JANUARY 2022–OCTOBER 2025 231
TABLE 196 VEEVA SYSTEMS INC.: COMPANY OVERVIEW 233
TABLE 197 VEEVA SYSTEMS INC.: PRODUCTS OFFERED 234
TABLE 198 VEEVA SYSTEMS INC.: PRODUCT LAUNCHES AND APPROVALS,
JANUARY 2022–OCTOBER 2025 236
TABLE 199 VEEVA SYSTEMS INC.: DEALS, JANUARY 2022–OCTOBER 2025 236
TABLE 200 MASTERCONTROL SOLUTIONS, INC.: COMPANY OVERVIEW 238
TABLE 201 MASTERCONTROL SOLUTIONS, INC.: PRODUCTS OFFERED 238
TABLE 202 MASTERCONTROL SOLUTIONS, INC.: DEALS, JANUARY 2022–OCTOBER 2025 239
TABLE 203 DASSAULT SYSTÈMES: COMPANY OVERVIEW 241
TABLE 204 DASSAULT SYSTÈMES: PRODUCTS OFFERED 242
TABLE 205 QUALIO: COMPANY OVERVIEW 244
TABLE 206 QUALIO: PRODUCTS OFFERED 244
TABLE 207 HEXAGON AB: COMPANY OVERVIEW 246
TABLE 208 HEXAGON AB: PRODUCTS OFFERED 247
TABLE 209 HEXAGON AB: PRODUCT LAUNCHES AND APPROVALS,
JANUARY 2022–OCTOBER 2025 249
TABLE 210 HEXAGON AB.: DEALS, JANUARY 2022–OCTOBER 2025 249
TABLE 211 ASSURX, INC.: COMPANY OVERVIEW 250
TABLE 212 ASSURX, INC.: PRODUCTS OFFERED 250
TABLE 213 ASSURX, INC.: DEALS, JANUARY 2022–OCTOBER 2025 252
TABLE 214 QT9 SOFTWARE: COMPANY OVERVIEW 253
TABLE 215 QT9 SOFTWARE: PRODUCTS OFFERED 253
TABLE 216 QT9 SOFTWARE: PRODUCT LAUNCHES AND APPROVALS,
JANUARY 2022–OCTOBER 2025 254
TABLE 217 QT9 SOFTWARE: DEALS, JANUARY 2022–OCTOBER 2025 255
TABLE 218 COMPLIANCEQUEST: COMPANY OVERVIEW 256
TABLE 219 COMPLIANCEQUEST: PRODUCTS OFFERED 256
TABLE 220 COMPLIANCEQUEST: DEALS, JANUARY 2022–OCTOBER 2025 257
TABLE 221 IDEAGEN: COMPANY OVERVIEW 258
TABLE 222 IDEAGEN: PRODUCTS OFFERED 258
TABLE 223 IDEAGEN: PRODUCT LAUNCHES AND APPROVALS, JANUARY 2022–OCTOBER 2025 259
TABLE 224 IDEAGEN: DEALS, JANUARY 2022–OCTOBER 2025 259
TABLE 225 SOFTEXPERT: COMPANY OVERVIEW 260
TABLE 226 SOFTEXPERT: PRODUCTS OFFERED 260
TABLE 227 SOFTEXPERT: DEALS, JANUARY 2022–OCTOBER 2025 261
TABLE 228 INSTEM: COMPANY OVERVIEW 262
TABLE 229 INSTEM: PRODUCTS OFFERED 262
TABLE 230 INSTEM: DEALS, JANUARY 2022–OCTOBER 2025 263
TABLE 231 INTELEX TECHNOLOGIES: COMPANY OVERVIEW 264
TABLE 232 INTELEX TECHNOLOGIES: PRODUCTS OFFERED 264
TABLE 233 INTELEX TECHNOLOGIES: PRODUCT LAUNCHES AND APPROVALS,
JANUARY 2022– OCTOBER 2025 265
TABLE 234 INTELEX TECHNOLOGIES: EXPANSIONS, JANUARY 2022–OCTOBER 2024 266
TABLE 235 INTELLECT, INC.: COMPANY OVERVIEW 267
TABLE 236 INTELLECT, INC.: PRODUCTS OFFERED 267
TABLE 237 INTELLECT, INC.: PRODUCT LAUNCHES AND APPROVALS,
JANUARY 2022–OCTOBER 2025 268
TABLE 238 AMPLELOGIC: COMPANY OVERVIEW 269
TABLE 239 AMPLELOGIC: PRODUCTS OFFERED 269
TABLE 240 AMPLELOGIC: DEALS, JANUARY 2022–OCTOBER 2025 271
TABLE 241 INSTANTGMP: COMPANY OVERVIEW 272
TABLE 242 SIMPLERQMS: COMPANY OVERVIEW 273
TABLE 243 DOT COMPLIANCE LTD.: COMPANY OVERVIEW 273
TABLE 244 SNIC SOLUTIONS: COMPANY OVERVIEW 274
TABLE 245 QUALITYZE: COMPANY OVERVIEW 275
TABLE 246 SCIGENIQ: COMPANY OVERVIEW 275
TABLE 247 KIVO, INC.: COMPANY OVERVIEW 276
TABLE 248 GMP SOFTWARE INDIA PVT. LTD.: COMPANY OVERVIEW 276
TABLE 249 VMT SOFT SOL PVT. LTD.: COMPANY OVERVIEW 277
TABLE 250 FACTOR ANALYSIS 290
TABLE 251 MARKET SIZING ASSUMPTIONS 292
TABLE 252 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
RISK ASSESSMENT 293
LIST OF FIGURES
FIGURE 1 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET SEGMENTATION AND REGIONAL SCOPE 29
FIGURE 2 MARKET SCENARIO 33
FIGURE 3 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET,
2023–2030 34
FIGURE 4 MAJOR STRATEGIES ADOPTED BY KEY PLAYERS IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET, 2023–2030 34
FIGURE 5 DISRUPTIONS INFLUENCING GROWTH OF PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET 35
FIGURE 6 HIGH-GROWTH SEGMENTS IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET, 2025–2030 36
FIGURE 7 ASIA PACIFIC TO REGISTER HIGHEST CAGR IN MARKET DURING FORECAST PERIOD 37
FIGURE 8 INCREASING ENFORCEMENT OF GLOBAL QUALITY STANDARDS AND REGULATORY UPGRADES TO DRIVE MARKET 38
FIGURE 9 LARGE ENTERPRISES AND US LED NORTH AMERICAN MARKET IN 2024 39
FIGURE 10 CANADA TO REGISTER HIGHEST GROWTH RATE DURING FORECAST PERIOD 40
FIGURE 11 EMERGING MARKETS TO HAVE HIGHER GROWTH DURING FORECAST PERIOD 41
FIGURE 12 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 42
FIGURE 13 US MEDIAN HEALTHCARE DATA BREACH, 2009–2024 47
FIGURE 14 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: PORTER’S FIVE FORCES ANALYSIS 53
FIGURE 15 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET:
VALUE CHAIN ANALYSIS 57
FIGURE 16 NEW REVENUE POCKETS AND REVENUE SHIFT IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET 64
FIGURE 17 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: INVESTMENT AND FUNDING SCENARIO 65
FIGURE 18 JURISDICTION ANALYSIS, JANUARY 2015–NOVEMBER 2025 72
FIGURE 19 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET: PATENT ANALYSIS, JANUARY 2015–NOVEMBER 2024 74
FIGURE 20 MARKET POTENTIAL OF AI/GEN AI ON PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE (QMS) MARKET ACROSS INDUSTRIES 78
FIGURE 21 IMPACT OF AI/GEN AI ON INTERCONNECTED AND ADJACENT ECOSYSTEMS 81
FIGURE 22 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS, BY END USER 91
FIGURE 23 KEY BUYING CRITERIA FOR TOP THREE END USERS 92
FIGURE 24 NORTH AMERICA: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET SNAPSHOT 129
FIGURE 25 ASIA PACIFIC: PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET SNAPSHOT 156
FIGURE 26 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
REVENUE ANALYSIS OF KEY PLAYERS, 2020–2024 (USD MILLION) 205
FIGURE 27 MARKET SHARE ANALYSIS OF KEY PLAYERS IN PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET, 2024 206
FIGURE 28 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
SOFTWARE COMPARISON 208
FIGURE 29 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
COMPANY EVALUATION MATRIX (KEY PLAYERS), 2024 210
FIGURE 30 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
COMPANY FOOTPRINT 211
FIGURE 31 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
COMPANY EVALUATION MATRIX (STARTUPS/SMES), 2024 218
FIGURE 32 YEAR-TO-DATE (YTD) PRICE TOTAL RETURN AND 5-YEAR STOCK
BETA OF KEY VENDORS 221
FIGURE 33 EV/EBITDA OF KEY VENDORS 221
FIGURE 34 HONEYWELL INTERNATIONAL INC.: COMPANY SNAPSHOT (2024) 226
FIGURE 35 IQVIA: COMPANY SNAPSHOT (2024) 230
FIGURE 36 VEEVA SYSTEMS INC.: COMPANY SNAPSHOT (2024) 234
FIGURE 37 DASSAULT SYSTÈMES: COMPANY SNAPSHOT (2024) 242
FIGURE 38 HEXAGON AB: COMPANY SNAPSHOT (2024) 247
FIGURE 39 RESEARCH DESIGN 278
FIGURE 40 BREAKDOWN OF PRIMARY INTERVIEWS (DEMAND-SIDE): BY COMPANY TYPE, DESIGNATION, AND REGION 282
FIGURE 41 SUPPLY-SIDE MARKET ESTIMATION 285
FIGURE 42 PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE MARKET:
REVENUE ESTIMATION APPROACH 285
FIGURE 43 BOTTOM-UP APPROACH: END-USER SPENDING ON PHARMACEUTICAL QUALITY MANAGEMENT SOFTWARE 287
FIGURE 44 TOP-DOWN APPROACH 288
FIGURE 45 DATA TRIANGULATION 289
FIGURE 46 CAGR PROJECTIONS FROM ANALYSIS OF MARKET DYNAMICS, 2025–2030 291
FIGURE 47 CAGR PROJECTIONS: SUPPLY-SIDE ANALYSIS 291
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