Pharmaceutical Quality Management Software Market Size
| 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
*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 Market Trends
Regulatory and Compliance Management Segment is Expected to Hold Significant Market Share Over the Forecast Period
Over the next few years, the regulatory and compliance management segment of the pharmaceutical quality management software market is expected to grow a lot. This is because of things like the growing number of fake drugs, the recalling of drugs from the market, and a greater focus on product quality.
The main thing that will drive the growth of regulatory and compliance in pharmaceuticals over the next few years is the growing number of fake drugs. Due to the COVID-19 pandemic, incidents of counterfeit products have increased. According to the World Health Organization report, in 2021, the number of cases of substandard and falsified (SF) medical items increased by 52% from 2020. Recently, most of the incidents involved COVID-19-related medical products, such as vaccines, medicines, COVID test kits, antibiotics, face masks, and sanitizers. Similarly, in 2021, the World Health Organization's worldwide surveillance and monitoring system for substandard and counterfeit medical products discovered fraudulent versions of the COVID-19 vaccine, Covishield, in India and Uganda. Such cases have forced the government to reframe drug quality and take strict measures to make QR codes mandatory on active pharmaceutical ingredients and products due to safety and tracking purposes.
Also, the strict rules for selling drugs have made it more likely that some drugs will be taken off the market. For instance, in March 2022, Pfizer recalled three prescription blood pressure medications: six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/hydrochlorothiazide tablets, due to the presence of elevated levels of a potentially cancer-causing impurity.
Also, the growing use of digital technologies makes it easier to manage large amounts of data, adds value to the organization, and makes compliance tasks easier, which helps businesses avoid unintended and unexpected results.Utilizing technology for data integration, analytics, and visualization, compliance activities are being digitalized to improve understanding. It also helps stop bad things from happening by using robots to automate processes and other cognitive technologies like machine learning and artificial intelligence.Because of these benefits, pharmaceutical companies are likely to use compliance management systems and platforms more. This will help the segment grow.
The growth of the segment is also helped by the fact that more and more companies are focusing on launching digital transformation services.For example, in April 2022, ComplianceQuest, one of the leading providers of 100% cloud-native, AI-powered enterprise clinical, quality, health, safety, and environmental management solutions, partnered with EZEN, a provider of digital transformation services to the life sciences and healthcare industries, to help its clients in the healthcare industry meet their digital transformation needs.
Because of things like more fake drugs, more drug recalls, and more business activities, the studied segment is expected to grow over the next few years.
North America Holds a Significant Share in the Market and Expected to do Same Over the Forecast Period
North America is expected to witness significant growth in the pharmaceutical quality management software market over the forecast period owing to the factors such as the increasing demand for improved production and quality management standards, and the rising adoption of advanced technologies, cloud-based solutions, and QMS softwarein the pharmaceutical industry.
The major players are employing a variety of strategies to grow their customer base, including expanding their services, collaborating, partnering, and merging are expected to fuel market growth. For Instance, in January 2021, Arena Solutions, Inc. partnered with Rimsys Inc., a developer of Regulatory Information Management (RIM) software platforms to provide secure cloud-based end-to-end quality and product-centric regulatory solutions. The collaboration is anticipated to improve both businesses' capacity to automatically track document modifications and notify users of reporting updates based on the location of the document.
Furthermore, the increasing product approvals in the region are also contributing to the market growth. For instance, in July 2022, Tealium launched a Customer Data platform that is designed to fully automate an improved customer experience for Pharma audiences while accounting for the industry's ever-evolving privacy and security regulations. Also, in April 2021, Medidata, a Dassault Systèmes company, launched Medidata Risk Management, a new addition to its Medidata's Risk-Based Quality Management (RBQM) suite, a comprehensive collection of solutions developed to speed up the adoption of proactive clinical operations oversight activities.
Therefore, owing to the factors, such as rising partnerships and increasing product launches, the studied market is expected to grow in the North America region over the forecast period.
Pharmaceutical Quality Management Software Industry Overview
The pharmaceutical quality management software market is fragmented due to the presence of several players. 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. Some of the players in the market are Antares Vision, AssurX Inc., AXsource, Clarivate Plc, ComplianceQuest, and Dassault Systemes, among others.
Pharmaceutical Quality Management Software Market Leaders
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AssurX, Inc.
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AXSource
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Dassault Systemes
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EtQ Management Consultants, Inc.
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IQVIA
*Disclaimer: Major Players sorted in no particular order
Pharmaceutical Quality Management Software Market News
- January 2023: Palantir Technologies Inc. launched a fit-for-purpose Quality Management System to help its life sciences customers using the Foundry platform meet GxP requirements.
- December 2022: FILTEC, a provider of in-line inspection solutions, launched a new Remote Vision Inspection (RVI) system, a compact and flexible machine vision solution for inspection.
- August 2022: The National Pharmaceutical Pricing Authority (NPPA) launched Integrated Pharmaceutical Database Management System 2.0 and Pharma Sahi Daam 2.0 apps for enhancing ease of business.
Pharmaceutical Quality Management Software Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Increasing Cost of Drugs Manufacturing
- 4.2.2 Growing Technology Adoption in Pharmaceutical Industry
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4.3 Market Restraints
- 4.3.1 Security Concerns Pertaining to On-Cloud Deployment
- 4.3.2 Lack of Regulations for Pharmaceutical Quality Management Software
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
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5.1 By Solution Type
- 5.1.1 Corrective Action Preventive Action (CAPA) Management
- 5.1.2 Audit Management
- 5.1.3 Document Management
- 5.1.4 Change Management
- 5.1.5 Training Management
- 5.1.6 Complaints Management
- 5.1.7 Regulatory and Compliance Management
- 5.1.8 Non-Conformances Handling
- 5.1.9 Supplier Quality Management
- 5.1.10 Inspection Management
- 5.1.11 Other solution Types
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5.2 By Deployment
- 5.2.1 On Cloud
- 5.2.2 On-premise
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5.3 Enterprize Size
- 5.3.1 Small and Medium Enterprise (SME)
- 5.3.2 Large Enterprise
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Antares Vision
- 6.1.2 AssurX Inc.
- 6.1.3 AXSource
- 6.1.4 Clarivate Plc
- 6.1.5 ComplianceQuest
- 6.1.6 Dassault Systemes
- 6.1.7 EtQ Management Consultants Inc.
- 6.1.8 Honeywell International Inc.
- 6.1.9 Ideagen PLC
- 6.1.10 IQVIA
- 6.1.11 Qualio
- 6.1.12 Veeva Systems Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityPharmaceutical 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 | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Pharmaceutical Quality Management Software Market Research FAQs
How big is the Global Pharmaceutical Quality Management Software Market?
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.
What is the current Global Pharmaceutical Quality Management Software Market size?
In 2024, the Global Pharmaceutical Quality Management Software Market size is expected to reach USD 2.97 billion.
Who are the key players in Global Pharmaceutical Quality Management Software Market?
AssurX, Inc., AXSource, Dassault Systemes, EtQ Management Consultants, Inc. and IQVIA are the major companies operating in the Global Pharmaceutical Quality Management Software Market.
Which is the fastest growing region in Global Pharmaceutical Quality Management Software Market?
North America is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Pharmaceutical Quality Management Software Market?
In 2024, the Asia-Pacific accounts for the largest market share in Global Pharmaceutical Quality Management Software Market.
What years does this Global Pharmaceutical Quality Management Software Market cover, and what was the market size in 2023?
In 2023, the Global Pharmaceutical Quality Management Software Market size was estimated at USD 2.62 billion. The report covers the Global Pharmaceutical Quality Management Software Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Pharmaceutical Quality Management Software Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
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