Global Pharmaceutical Quality Management Software Market Size (2024 - 2029)

The pharmaceutical quality management software market is anticipated to experience growth over the forecast period, driven by factors such as the increasing adoption of technology and the rising costs associated with drug manufacturing. The market's expansion was initially bolstered by the COVID-19 pandemic, which prompted a shift towards cloud-based solutions due to disruptions in supply chains and production processes. Despite the pandemic's subsiding impact, the market is expected to maintain stable growth. However, challenges such as security concerns related to cloud deployment and the absence of regulatory frameworks for quality management software may hinder market progress.

Market Size of Global Pharmaceutical Quality Management Software Industry

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Pharmaceutical Quality Management Software Market Summary
Study Period 2019 - 2029
Market Size (2024) USD 2.97 Billion
Market Size (2029) USD 5.15 Billion
CAGR (2024 - 2029) 11.62 %
Fastest Growing Market North America
Largest Market Asia-Pacific

Major Players

Pharmaceutical Quality Management Software Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Pharmaceutical Quality Management Software Market Analysis

The Global Pharmaceutical Quality Management Software Market size is estimated at USD 2.97 billion in 2024, and is expected to reach USD 5.15 billion by 2029, growing at a CAGR of 11.62% during the forecast period (2024-2029).

The COVID-19 pandemic impacted the growth of the pharmaceutical quality management software market. Due to government restrictions and a shift toward working remotely, the entire pharmaceutical sector was upended by faulty supply chains, altered production lines and procedures, and a move to remote employment. This increased the focus of the companies toward cloud-based quality management software. Also, as per an article published in Clinical Therapeutics in December 2021, it was observed that the management and operations of regulatory organizations and the pharmaceutical industries globally were impacted by the COVID-19 pandemic. In addition, as per the same source, the pharmaceutical authorities are now using a risk-based inspection approach and encouraging increased reliance on inspections to avoid burdening pharmaceutical companies with unnecessary and repetitive inspections. This has impacted the growth of QMS in the pharmaceutical industry during the pandemic. Hence, the COVID-19 pandemic initially had a favorable impact on the market; currently, as the pandemic has subsided and the market has lost some traction, the market is expected to have stable growth during the forecast period of the study.

Factors such as the increasing cost of drug manufacturing and growing technology adoption in the pharmaceutical industry are boosting market growth. For instance, according to the data published by the London School of Hygiene and Tropical Medicine and KU Leuven in March 2021, the average cost of bringing a new drug to market ranges between USD 1.3 billion and USD 2.6 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.

With the pharmaceutical industry using technology more and more, software-based systems are likely to be used by smaller companies.Cloud computing, analytics, and big data are just a few examples of new technologies that have made QMS more scalable, cost-effective, flexible, and independent of platforms.Because of this, industries that use QMS solutions like life sciences, manufacturing, pharmaceuticals, and biotechnology are adopting them quickly.

Also, the growth of the market is expected to be driven by the different strategies used by the major market players over the next few years.For instance, in July 2021, LogicGate raised USD 113 million in a Series C funding round. These funds will be used to help the company in every way, including making big improvements to its products, growing its network of partners, going global, and improving its security.

Therefore, owing to factors such as the rising technology adoption in the pharmaceutical industry and the increasing cost of drug manufacturing, the studied market is expected to grow over the forecast period. However, the security concerns about on-cloud deployment and the lack of regulations for pharmaceutical quality management software are likely to impede the growth of the pharmaceutical quality management software market over the forecast period.

Pharmaceutical Quality Management Software Industry Segmentation

Quality management software is an automated system that helps an organization meet its quality policies and goals, according to the report's scope. It can be used for many things, like keeping track of documents, tracking nonconformance, taking corrective action, and managing employees. Quality management software makes sure that a product keeps its quality and is made according to 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, Complaints Management, Regulatory and Compliance Management, Non-Conformances Handling, Supplier Quality Management, Inspection Management, and Others), Deployment (on Cloud, On-premise), Enterprise Size (Small and Medium Enterprise (SME), LargeEnterprise),), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America) and by geography (large enterprise)agement, Audit Management, Document Management, Change Management, Training Management, Complaints Management, Regulatory and Compliance Management, Non-Conformances Handling, Supplier Quality Management, Inspection Management, and Others), Deployment (on Cloud, On-premise), Enterprise Size (Small and Medium Enterprise (SME), Large Enterprise) and 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
Complaints Management
Regulatory and Compliance Management
Non-Conformances Handling
Supplier Quality Management
Inspection Management
Other solution Types
By Deployment
On Cloud
On-premise
Enterprize Size
Small and Medium Enterprise (SME)
Large Enterprise
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Global Pharmaceutical Quality Management Software Market Size Summary

The pharmaceutical quality management software market is poised for substantial growth, driven by the increasing adoption of technology and the rising costs associated with drug manufacturing. The COVID-19 pandemic initially spurred interest in cloud-based quality management solutions due to disruptions in supply chains and production processes. As the industry shifted towards remote work and digital solutions, the focus on scalable and cost-effective software systems grew. This trend is expected to continue, with software-based quality management systems becoming more prevalent, even among smaller companies. The market is also witnessing a surge in the adoption of advanced technologies such as cloud computing, analytics, and big data, which enhance the flexibility and efficiency of quality management processes across various sectors, including pharmaceuticals, biotechnology, and life sciences.

The regulatory and compliance management segment is anticipated to experience significant growth, driven by the increasing incidence of counterfeit drugs and product recalls. The pandemic highlighted the need for stricter quality controls and regulatory measures, prompting a shift towards risk-based inspection approaches and digital compliance solutions. The use of digital technologies for data integration and analytics is streamlining compliance tasks, making them more efficient and less prone to errors. This digital transformation is further supported by strategic partnerships and product launches aimed at enhancing regulatory compliance capabilities. North America is expected to lead the market growth, fueled by the demand for improved production standards and the adoption of advanced QMS software. The competitive landscape is characterized by numerous players employing various strategies, such as collaborations and new product introductions, to expand their market presence.

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Global Pharmaceutical Quality Management Software Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Cost of Drugs Manufacturing

      2. 1.2.2 Growing Technology Adoption in Pharmaceutical Industry

    3. 1.3 Market Restraints

      1. 1.3.1 Security Concerns Pertaining to On-Cloud Deployment

      2. 1.3.2 Lack of Regulations for Pharmaceutical Quality Management Software

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 2.1 By Solution Type

      1. 2.1.1 Corrective Action Preventive Action (CAPA) Management

      2. 2.1.2 Audit Management

      3. 2.1.3 Document Management

      4. 2.1.4 Change Management

      5. 2.1.5 Training Management

      6. 2.1.6 Complaints Management

      7. 2.1.7 Regulatory and Compliance Management

      8. 2.1.8 Non-Conformances Handling

      9. 2.1.9 Supplier Quality Management

      10. 2.1.10 Inspection Management

      11. 2.1.11 Other solution Types

    2. 2.2 By Deployment

      1. 2.2.1 On Cloud

      2. 2.2.2 On-premise

    3. 2.3 Enterprize Size

      1. 2.3.1 Small and Medium Enterprise (SME)

      2. 2.3.2 Large Enterprise

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 Germany

        2. 2.4.2.2 United Kingdom

        3. 2.4.2.3 France

        4. 2.4.2.4 Italy

        5. 2.4.2.5 Spain

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 China

        2. 2.4.3.2 Japan

        3. 2.4.3.3 India

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Global Pharmaceutical Quality Management Software Market Size FAQs

The Global Pharmaceutical Quality Management Software Market size is expected to reach USD 2.97 billion in 2024 and grow at a CAGR of 11.62% to reach USD 5.15 billion by 2029.

In 2024, the Global Pharmaceutical Quality Management Software Market size is expected to reach USD 2.97 billion.

Pharma Quality Management Software Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)