During the next few years, the pharmaceutical quality management software (QMS) market is expected to register a CAGR of 9.9%.
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.
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.
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.
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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.Additional Benefits:
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Antares Vision
- AssurX Inc.
- AXSource
- Clarivate Plc
- ComplianceQuest
- Dassault Systemes
- EtQ Management Consultants Inc.
- Honeywell International Inc.
- Ideagen PLC
- IQVIA
- Qualio
- Veeva Systems Inc.
Methodology
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