Pharmaceutical Quality Management Software Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Pharmaceutical Quality Management Software Market is Segmented by Solution Type (Corrective Action Preventive Action (CAPA) Management, Audit Management, Document Management, Change Management, Training Management, Risk Management, Complaints Management, Regulatory and Compliance Management, Non-Conformances Handling, Supplier Quality Management, Inspection Management, Equipment Management, Calibration Management, and Others.), Deployment (on Cloud, On-premise), Enterprise Size (Small and Medium Enterprise (SME), Large Enterprise, Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above-mentioned segments.

Market Snapshot

Pharmaceutical Quality Management Software Market
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: North America
Largest Market: Asia-Pacific
CAGR: 9.9 %

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Market Overview

The pharmaceutical quality management software market is expected to register a CAGR of 9.9% during the forecast period (2022-2027).

In the last decade, there has been a shift in consumer preference from a paper-based management system to a digital cloud-based system. The global pharmaceutical quality management software market benefited from the pandemic. This is due to government restrictions imposed during the lockdown, as well as a shift toward working remotely. A market player Assurx said that in June 2020, When COVID-19 rolled around 2020, businesses all over the world found themselves at the mercy of processes designed for a different era of manufacturing. As entire industries were upended by broken supply chains, changing production lines and processes, and a shift to remote work, cloud QMS (Quality Management Software) became a priority consideration. Thus, COVID-19 significantly impacted the pharmaceutical quality management software market.

The rising cost of drug manufacturing, constantly changing regulations, and growing technology adoption in the pharmaceutical industry are all factors driving the market growth. Pharmaceutical companies can spend billions of dollars developing a new drug, which drives up demand for automated manufacturing processes. For instance, according to the London School of Hygiene & Tropical Medicine and KU Leuven in March 2021 estimates, the average cost of bringing a new drug to market is USD 1.3 billion, and the median cost is USD 985 million. Thus, software-based quality management systems lower the cost of drug development and present a lucrative market for pharmaceutical quality management software.

Another factor driving the market's growth is pharmaceutical companies' increasing demand to comply with regulatory requirements to compete with other market players. Quality management standards and international technical specifications such as IATF 16949, AS9100 Rev.D, and ISO 9001 are expected to increase the use of QMS across end-use industries.

With the increasing adoption of technology in the pharmaceutical industry, smaller companies are expected to implement software-based systems from the start. Cloud computing, analytics, and big data, among other technological advancements, have enhanced QMS's existing capabilities in terms of scalability, cost-efficiency, flexibility, and platform independence. As a result, end-use industries such as life sciences, manufacturing, pharmaceuticals, and biotechnology are embracing QMS solutions at a rapid pace.

However, various strategies adopted by the key market players are anticipated to drive market growth over the forecast period. In July 2021, LogicGate raised USD 113 million in a Series C funding round. These funds will be used to support all aspects of the company's operations, including significant product advancements, the expansion of the partner ecosystem, international presence, and security posture.

Thus, all the aforementioned factors are expected to boost the market over the forecast period. However, security concerns pertaining to on-cloud deployment and lack of regulations for pharmaceutical quality management software are the major restraining factors for the market growth.

Scope of the Report

Quality management software is an automated system that aids in the achievement of an organization's quality policies and objectives. It is useful for a variety of tasks, including document control, nonconformance tracking, corrective action, and employee management. Quality management software ensures that a product's quality is maintained and that it is manufactured in accordance with industry standards. The pharmaceutical quality management software market is segmented by solution type (corrective action preventive action (CAPA) management, audit management, document management, change management, training management, risk management, complaints management, regulatory and compliance management, non-conformances handling, supplier quality management, inspection management, equipment management, calibration management, and others.), deployment (on cloud, on-premise), enterprise size (small and medium enterprise (SME), large enterprise, geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above-mentioned segments.

By Solution Type
Corrective Action Preventive Action (CAPA) Management
Audit Management
Document Management
Change Management
Training Management
Risk Management
Complaints Management
Regulatory and Compliance Management
Non-Conformances Handling
Supplier Quality Management
Inspection Management
Equipment Management
By Deployment
On Cloud
Enterprize Size
Small and Medium Enterprise (SME)
Large Enterprise
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

Calibration Management Segment is Expected to Hold Significant Market Share in the Process Component Segment

Calibration management software (CMS) is software designed to schedule the calibration of instrumentation and maintenance requirements in all types of industrial settings. As one type of enterprise asset management software, CMS handles maintenance and repair operations.

A calibration management solution connects related maintenance tasks and additional quality processes in regulated life science and high-tech environments. Such solutions help to extend the life of machinery and save the company millions of dollars by reducing the number of recalled products. The calibration management solutions offered by QMS can assist organizations in better managing instrument calibration processes and associated documentation, resulting in increased productivity and efficiency.

Furthermore, major players are employing a variety of strategies to grow their customer base, including expanding their services, launching new products, collaborating, partnering, and merging. For Instance, in January 2021, Beamex LOGiCAL is a modern subscription-based (SaaS) calibration software solution that helps companies streamline and digitize their calibration processes. The software works with Beamex documenting calibrators and is compatible with the Beamex bMobile calibration app. LOGiCAL is the culmination of Beamex's 40 years of calibration software development experience.

Thus, all aforementioned factors are expected to boost the segment over the forecast period.

Pharmaceutical Quality Management Software Market

North America Holds a Significant Share in the Market and Expected to do Same Over the Forecast Period

The major factors driving the market growth are an increase in demand for improved production and quality management standards. Furthermore, the market grows as the need to improve customer satisfaction grows. Also, the market is expected to benefit from the adoption of cloud-based solutions and QMS software by various market players in the region.

Strategic mergers and acquisitions, as well as partnerships, are thought to be the most efficient ways for market players to enter emerging markets quickly. in May 2020, ComplianceQuest acquired LifeGuard Solutions, a Salesforce-native EHS solution provider, as a natural extension of leading quality management system.

Furthermore, product differentiation and upgrades are expected to facilitate the growth of businesses in the market. For instance, in August 2020, MasterControl Manufacturing Excellence is a new solution from MasterControl Inc. that aims to boost manufacturing productivity and quality. The new solution would allow manufacturers to create dynamic connections among enterprise systems, processes, data sources, and people to get a holistic view of production and quality data.

Thus, owing to the abovementioned factors, the market is expected to show growth over the forecast period.

Pharmaceutical Quality Management Software Market

Competitive Landscape

The Pharmaceutical Quality Management Software market is fragmented with the presence of players such as ANTARES VISION S.p., AssurX Inc., a source, CLARIVATE PLC, ComplianceQuest, and Dassault Systemes. Quality management software is growing at a very fast pace. In addition, the market is very competitive, so prominent players are adopting different strategies such as an expansion of their services, new product launches, collaborations, partnerships, and mergers to increase their customer base.

Recent Developments

  • In April 2022, ComplianceQuest, one of the leading providers of 100 percent cloud-native, AI-powered Enterprise Clinical, Quality, Health, Safety, and Environmental Management solutions, has partnered with EZEN, a provider of digital transformation services to the Life Sciences and Healthcare Industry, to support the digital transformation needs of its clients in the healthcare industry.
  • In March 2022, Beamex and Siemens collaborated to develop Beamex CMX Calibration Management Software for Siemens Lifecycle Management Suite (LMS) users. With an automated and digitalized workflow, Siemens LMS customers can generate a paperless flow of calibration data, save time, and reduce the risk of errors in their calibration documentation, according to the integration, which was introduced with the launch of version 1.3 of LMS.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Cost of Drugs Manufacturing

      2. 4.2.2 Constantly Evolving Regulations

      3. 4.2.3 Growing Technology Adoption in Pharmaceutical Industry

    3. 4.3 Market Restraints

      1. 4.3.1 Security Concerns Pertaining to On-Cloud Deployment

      2. 4.3.2 Lack of Regulations for Pharmaceutical Quality Management Software

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Solution Type

      1. 5.1.1 Corrective Action Preventive Action (CAPA) Management

      2. 5.1.2 Audit Management

      3. 5.1.3 Document Management

      4. 5.1.4 Change Management

      5. 5.1.5 Training Management

      6. 5.1.6 Risk Management

      7. 5.1.7 Complaints Management

      8. 5.1.8 Regulatory and Compliance Management

      9. 5.1.9 Non-Conformances Handling

      10. 5.1.10 Supplier Quality Management

      11. 5.1.11 Inspection Management

      12. 5.1.12 Equipment Management

      13. 5.1.13 Others

    2. 5.2 By Deployment

      1. 5.2.1 On Cloud

      2. 5.2.2 On-premise

    3. 5.3 Enterprize Size

      1. 5.3.1 Small and Medium Enterprise (SME)

      2. 5.3.2 Large Enterprise

    4. 5.4 Geography

      1. 5.4.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.4.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.4.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.4.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 ANTARES VISION SpA

      2. 6.1.2 AssurX Inc.

      3. 6.1.3 AXSource

      4. 6.1.4 CLARIVATE PLC

      5. 6.1.5 ComplianceQuest

      6. 6.1.6 Dassault Systemes

      7. 6.1.7 EtQ Management Consultants Inc.

      8. 6.1.8 Honeywell International Inc.

      9. 6.1.9 Ideagen PLC

      10. 6.1.10 IQVIA HOLDINGS INC.

      11. 6.1.11 LogicGate Inc

      12. 6.1.12 MasterControl

      13. 6.1.13 PTC Inc.

      14. 6.1.14 Sarjen Systems Pvt. Ltd

      15. 6.1.15 Qualio

      16. 6.1.16 Veeva Systems Inc.

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global Pharmaceutical Quality Management Software Market market is studied from 2019 - 2027.

The Global Pharmaceutical Quality Management Software Market is growing at a CAGR of 9.9% over the next 5 years.

North America is growing at the highest CAGR over 2021- 2026.

Asia-Pacific holds highest share in 2021.

AssurX, Inc., AXSource, Dassault Systemes, EtQ Management Consultants, Inc., IQVIA HOLDINGS INC. are the major companies operating in Global Pharmaceutical Quality Management Software Market.

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