Cleaning Validation Software for Pharma Market by Type (Software, Services) by Application (Pharma and Biotechnology Companies, CRO, Research Institutes): Growth, Future Prospects, and Competitive Analysis, 2015 - 2027

Cleaning validation software is used to ensure a cleaning process that eliminates microbial and chemical residues of the passive, active, or detergent elements from the equipment used to manufacture various pharmaceuticals. The leading pharmaceutical manufacturers are increasingly adopting cleaning validation software. Cleaning validation carries a high level of importance and hence needs to be undertaken in a highly precise manner as prescribed by the various regulatory authorities. Cleaning validation software is of great help in complying with these regulatory guidelines by assisting these companies in achieving cleaning to predetermined and accepted levels. The 

Cleaning Validation Software for Pharma Marketis projected to garner a market value of USD 1,091.15 million in 2027, growing from USD 509.43 million in 2020. It is anticipated to grow at a CAGR of over 11.25% during the forecast period.

Key Market Drivers and Restraints

The rising demand for cleaning validation software in the pharma industry can be attributed to stringent regulatory measures. Stringent regulatory measures by various regulatory bodies have been forcing pharmaceutical manufacturers to adopt the cleaning validation software. As a result, FDA warnings related to cross-contamination increased significantly from 5% in 2015 to 20% in 2020. Such cross-contamination of pharma manufacturing can result in significant losses of time, money, efforts, etc. Such cross-contamination is the result of inappropriate cleaning validation of manufacturing equipment or aids. Moreover, this software helps the organization manage time, workforce productivity, information security, efficient business processes, and controlling compliance, which are projected to drive the growth of the global market during the forecast period. In addition, rapid technological advancements such as cloud computing and big data, pharma supply chains, and increased pharmaceutical regulatory scrutiny are also expected to drive the global cleaning validation software market.

Secondly, cleaning validation is a very critical and complicated process. Cleaning validation software has greatly contributed to simplifying such a complicated process. Cleaning validation not only simplifies the process but also facilitates access to the data easily. Unlike the manual cleaning validation process, cleaning validation software offers a platform that stores equipment and product-related data instead of maintaining the traditional spreadsheet format.

The price of cleaning validation software varies drastically based on its functionality and features, the number of users, deployment, services offered by the company, duration, etc. The average annual cost for cleaning validation software ranges between USD 35,000 to USD 50,000. A large number of small and medium size pharma and biotech companies are still adhering to the manual cleaning validation process. Therefore, offering this software for an affordable price.

Impact of COVID 19

The appearance of the mutant COVID-19 virus has put meaningful pressure on the pharma industry. Healthcare professionals are striving to develop medicines to counter this virus. During this, the COVID-19 outbreak has been a key catalyst for the adoption and growth of cleaning validation software. Cleaning validation software development systems have adopted a more agile development framework to respond more rapidly to changing demands. Whereas COVID-19 has more heavily impacted other markets, software development is persevering and taking advantage of new niches.

North America to Rule the Global Cleaning Validation Software for Pharma Market

The North American market is projected to account for the highest revenue share in the global cleaning validation software for the pharma market because of the ever-rising adoption of cloud computing and the Internet of Things (IoT) in the region. Stringent implementation of regulations in the region is also one of the major factors compelling major pharma players to exhibit increasing willingness to have cleaning validation software in place. Automation is also growing in popularity in the region, driving the demand for cleaning validation software and expected to keep North America at the forefront of this industry.

Software Segment to drive the Global Cleaning Validation Software for Pharma Market

Software and Services are the two major segments of the Cleaning Validation Software for Pharma Market. In 2020, the Software segment accounted for the two third share of Cleaning Validation Software for the Pharma Market. However, the Services segment is anticipated to grow at a steady CAGR during the forecast period. With the increasing installed base, the service segment is gaining ground across the world.

Pharma and Biotechnology Companies are Expected to Act as a major Revenue Stream.

Pharma and Biotechnology Companies and CROs are some major types of Applications. Pharma and Biotechnology Companies segment accounted for the largest share 2020 of the Cleaning Validation Software for the Pharma Market 2020. CRO segment held over 20% share in 2020. Cleaning validation software is mainly focusing on research & development. Kneat Solutions is a paperless cleaning validation software “Kneat Gx,” which digitalizes the whole Cleaning Validation process during the cycle-time, carrying compelling productivity, Product life cycle, and compliance developments. This software allows managing cleaning validation life cycle initial with requirements through to the Validation of Final Reports in one easy-to-use solution. Documentation is easy with Kneat Gx through pre-approved templates and active data sharing, which reduces the time required to generate a document and decreases human errors by removing the need to move data among documents. Additional productivities are gained because the Kneat Gx work development does not need transporting physical documents, and these documents cannot be damaged or lost.

Major companies are focusing on offering after-sales services to attract clients. For instance, Ofni Systems proactively provides rigorous training to help end-users efficiently handle cleaning validation software. It also helps its clients with detailed training materials and 24/7 assistance to overcome any problem.

Software, Services, are major types of cleaning validation software in pharma, out of which software segment dominated the global market. Cleaning validation software is used in pharma organizations to invoice entry, expiry management, inventory management, sales bill, and reordering, scheduled drug index, and help pharmacies run their businesses easily.

Some of the major players operating in cleaning validation software in pharma include, Novatek International, Kneat, eResidue, Auditrunner, Ofni Systems, LeucineTech, SafetyCulture, ValGenesis, USDM and Kaye Inc. These five players collectively accounted for over 45% share in the global market.

Pharma and Biotechnology Companies is the largest application of cleaning validation software in Pharma. The CRO segment held over 20% share in 2020.

North America hold the largest share owing to large demand of cleaning validation software in several pharma industries

There are four major challenges such as Product Residue Problems, Equipment Problems, Cleaning Process Problems and Laboratory Problems. Product Residue Problems: chemical and physical properties of residue are not used as a basis for cleaning, due to a lack of scientific understanding. Equipment Problems: There are two key equipment problems that outbreak cleaning validation professionals. One is the lack of attention to non-uniform pollution transfer. Another problem was determining the most d

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Published Date:  Jul 2021
Category:  Software & Solutions
Report ID:   60398
Report Format:   PDF
Pages:   120
Rating:    4.9 (71)
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