The global pharmaceutical quality management software market size was estimated to be USD 1.78 billion in 2023 and is expected to reach at USD 6.59 billion by 2034 with a CAGR of 12.64% during the forecast period 2024-2034. Increasing utilization of digital technology in the pharmaceutical industry, rising necessity to align with regulatory standards, growing intricacy of supply chains, escalating costs associated with drug manufacturing, technological advancements including cloud computing, analytics, & big data, have significantly improved the scalability, cost-efficiency, flexibility, & platform independence of Quality Management Systems (QMS), and rising introduction of novel pharmaceutical quality management systems are some of the key factors boosting the market growth.
Rising introduction of novel pharmaceutical quality management systems is predicted to boost the market growth during the forecast period. These advancements have notably broadened the capabilities of Quality Management Systems (QMS), rendering them more scalable, cost-effective, flexible, and platform-agnostic. With the pharmaceutical industry increasingly prioritizing quality, the demand for advanced QMS solutions is expected to surge. Consequently, the pharmaceutical sector is experiencing a rapid and widespread adoption of QMS solutions. For instance, in January 2023, Palantir Technologies Inc., a prominent developer of operating systems for various healthcare organizations, has introduced a tailored Quality Management System designed to assist its life sciences customers utilizing the Foundry Platform in meeting GxP requirements.
By Solution, data management was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the growing volume of inconsistent healthcare data, rising demand from regulatory organizations for reports that meet rigorous quality standards, surge in adoption of big data by the pharmaceutical industry, and increasing introduction of advanced systems. For instance, in August 2022, The National Pharmaceutical Pricing Authority (NPPA) has unveiled the Integrated Pharmaceutical Database Management System 2.0 and Pharma Sahi Daam 2.0 apps to improve the ease of doing business in the pharmaceutical sector. Additionally, regulatory & compliance management is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of counterfeit drugs, increased emphasis on product quality, and surge in strict regulations regarding the sale of drugs, which has elevated the probability of certain drugs being pulled from the market.
By deployment, cloud & web-based was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the adaptability of cloud and web-based solutions allows organizations to easily adjust their software usage to meet changing regulatory and operational demands and growing launch of innovative systems. For instance, in December 2022, FILTEC, a company specializing in in-line inspection solutions, has introduced a new Remote Vision Inspection (RVI) system. This system is a compact and flexible machine vision solution designed for inspection purposes. Additionally, on-premises software is predicted to grow at fastest CAGR during the forecast period owing to its ability to provide robust data security & control makes it an appealing choice for healthcare organizations that place a high value on meeting strict compliance requirements linked to quality management systems. These healthcare entities prioritize the prevention of data breaches, which is why on-premises software solutions have traditionally been preferred due to their capability to meet these rigorous security requirements.
By enterprise size, large enterprise was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the substantial operations, intricate supply chains, & strict compliance obligations within large enterprises, surge in implementation of comprehensive quality management systems to ensure compliance across multiple jurisdictions and increasing launch of new platforms. For instance, in June 2023, Yokogawa Electric Corporation has revealed the development of OpreX Informatics Manager, a new addition to the OpreX Connected Intelligence portfolio. This platform is designed to facilitate the integrated management of research data, particularly in fields like life sciences and chemistry. It offers features for handling documents, projects, skills, and schedules, ultimately enhancing the efficiency of research resource management and laboratory automation. Additionally, small & medium enterprise is predicted to grow at fastest CAGR during the forecast period owing to the surge in installation of quality management software. A Quality Management System (QMS) empowers micro, small, and medium enterprises to compete effectively with larger organizations and provide their customers with the assurance of consistent product and service quality. Implementing a QMS ensures compliance with regulatory requirements, enabling smaller enterprises to access global markets.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising demand for enhanced production & quality control standards in the pharmaceutical sector, growing need for stringent regulatory requirements, increasing focus on drug safety, surge in launch of advanced platforms. For instance, in July 2022, Tealium, a leading independent and trusted customer data platform (CDP), has introduced the Tealium for Pharma solution, an industry-first offering. This specialized platform is specifically tailored to automate and enhance the customer experience for pharmaceutical audiences, taking into consideration the constantly changing privacy and security regulations within the industry. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing adoption of advanced technologies, cloud-based solutions, & quality management software, surge in advanced healthcare infrastructure, and rising collaborations within market players. For instance, in April 2022, ComplianceQuest, a prominent provider of 100% cloud-native, AI-powered enterprise solutions for clinical, quality, health, safety, and environmental management, has entered into a partnership with EZEN, a digital transformation service provider for the life sciences and healthcare sectors. This collaboration aims to assist clients in the healthcare industry in meeting their digital transformation requirements.
Rising introduction of novel pharmaceutical quality management systems is predicted to boost the market growth during the forecast period. These advancements have notably broadened the capabilities of Quality Management Systems (QMS), rendering them more scalable, cost-effective, flexible, and platform-agnostic. With the pharmaceutical industry increasingly prioritizing quality, the demand for advanced QMS solutions is expected to surge. Consequently, the pharmaceutical sector is experiencing a rapid and widespread adoption of QMS solutions. For instance, in January 2023, Palantir Technologies Inc., a prominent developer of operating systems for various healthcare organizations, has introduced a tailored Quality Management System designed to assist its life sciences customers utilizing the Foundry Platform in meeting GxP requirements.
By Solution, data management was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the growing volume of inconsistent healthcare data, rising demand from regulatory organizations for reports that meet rigorous quality standards, surge in adoption of big data by the pharmaceutical industry, and increasing introduction of advanced systems. For instance, in August 2022, The National Pharmaceutical Pricing Authority (NPPA) has unveiled the Integrated Pharmaceutical Database Management System 2.0 and Pharma Sahi Daam 2.0 apps to improve the ease of doing business in the pharmaceutical sector. Additionally, regulatory & compliance management is predicted to grow at fastest CAGR during the forecast period owing to the rising prevalence of counterfeit drugs, increased emphasis on product quality, and surge in strict regulations regarding the sale of drugs, which has elevated the probability of certain drugs being pulled from the market.
By deployment, cloud & web-based was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the adaptability of cloud and web-based solutions allows organizations to easily adjust their software usage to meet changing regulatory and operational demands and growing launch of innovative systems. For instance, in December 2022, FILTEC, a company specializing in in-line inspection solutions, has introduced a new Remote Vision Inspection (RVI) system. This system is a compact and flexible machine vision solution designed for inspection purposes. Additionally, on-premises software is predicted to grow at fastest CAGR during the forecast period owing to its ability to provide robust data security & control makes it an appealing choice for healthcare organizations that place a high value on meeting strict compliance requirements linked to quality management systems. These healthcare entities prioritize the prevention of data breaches, which is why on-premises software solutions have traditionally been preferred due to their capability to meet these rigorous security requirements.
By enterprise size, large enterprise was the highest revenue-grossing segment in the global pharmaceutical quality management software market in 2023 owing to the substantial operations, intricate supply chains, & strict compliance obligations within large enterprises, surge in implementation of comprehensive quality management systems to ensure compliance across multiple jurisdictions and increasing launch of new platforms. For instance, in June 2023, Yokogawa Electric Corporation has revealed the development of OpreX Informatics Manager, a new addition to the OpreX Connected Intelligence portfolio. This platform is designed to facilitate the integrated management of research data, particularly in fields like life sciences and chemistry. It offers features for handling documents, projects, skills, and schedules, ultimately enhancing the efficiency of research resource management and laboratory automation. Additionally, small & medium enterprise is predicted to grow at fastest CAGR during the forecast period owing to the surge in installation of quality management software. A Quality Management System (QMS) empowers micro, small, and medium enterprises to compete effectively with larger organizations and provide their customers with the assurance of consistent product and service quality. Implementing a QMS ensures compliance with regulatory requirements, enabling smaller enterprises to access global markets.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising demand for enhanced production & quality control standards in the pharmaceutical sector, growing need for stringent regulatory requirements, increasing focus on drug safety, surge in launch of advanced platforms. For instance, in July 2022, Tealium, a leading independent and trusted customer data platform (CDP), has introduced the Tealium for Pharma solution, an industry-first offering. This specialized platform is specifically tailored to automate and enhance the customer experience for pharmaceutical audiences, taking into consideration the constantly changing privacy and security regulations within the industry. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing adoption of advanced technologies, cloud-based solutions, & quality management software, surge in advanced healthcare infrastructure, and rising collaborations within market players. For instance, in April 2022, ComplianceQuest, a prominent provider of 100% cloud-native, AI-powered enterprise solutions for clinical, quality, health, safety, and environmental management, has entered into a partnership with EZEN, a digital transformation service provider for the life sciences and healthcare sectors. This collaboration aims to assist clients in the healthcare industry in meeting their digital transformation requirements.
Segmentation: Pharmaceutical Quality Management Software Market Report 2023 - 2034
Pharmaceutical Quality Management Software Market Analysis & Forecast by Solution 2023 - 2034 (Revenue USD Bn)
- Regulatory & Compliance Management
- Training management
- Audit Management
- Supplier management
- Inspection Management
- Data Management
- Risk Management
- Change Management
- Non-Conformances Management
- Corrective Action Preventive Action (CAPA) Management
- Others
Pharmaceutical Quality Management Software Market Analysis & Forecast by Deployment 2023 - 2034 (Revenue USD Bn)
- On-premises
- Cloud-based & Web-Based
Pharmaceutical Quality Management Software Market Analysis & Forecast by Enterprise Size 2023 - 2034 (Revenue USD Bn)
- Small & Medium Enterprise
- Large Enterprise
Pharmaceutical Quality Management Software Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Pharmaceutical Quality Management Software Market: Solution Estimates & Trend Analysis
8. Pharmaceutical Quality Management Software Market: Deployment Estimates & Trend Analysis
9. Pharmaceutical Quality Management Software Market: Enterprise Size Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Pharmaceutical Quality Management Software Market
12. Europe Global Pharmaceutical Quality Management Software Market
13. Asia Pacific Global Pharmaceutical Quality Management Software Market
14. Latin America Global Pharmaceutical Quality Management Software Market
15. MEA Global Pharmaceutical Quality Management Software Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Pilgrim (IQVIA)
- Qualio
- QT9
- Dassault Systèmes
- AmpleLogic
- Qualityze Inc.
- AssurX Inc.
- Ideagen
- ETQ Llc (Hexagon)
- Veeva Systems
- Sparta Systems (TrackWise)
- MasterControl Solutions Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | January 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 1.78 Billion |
| Forecasted Market Value ( USD | $ 6.59 Billion |
| Compound Annual Growth Rate | 12.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 12 |
