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

Published: Jul 2021 | Report Code: 60398-07-21

Cleaning validation software is used to assure a cleaning process that eliminates microbial and chemical residues of the inactive, active or detergent elements from the equipment’s used to manufacture various pharmaceuticals. Cleaning validation software is increasingly being adopted by the leading pharmaceutical manufacturers. Cleaning validation carries high level of importance and hence need to be undertake in highly precise manner as prescribed by the various regulatory authorities. Cleaning validation software if of great help to comply with these regulatory guidelines by assisting these companies to achieve cleaning to predetermined and accepted levels. The Cleaning Validation Software for Pharma Market is projected to garner the 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.

Cleaning Validation Software for Pharma Market

Key Market Drivers and Restraints

Rising demand for cleaning validation software in the pharma industry can be attributed to the stringent regulatory measures. Stringent regulatory measures by various regulatory bodies has been forcing the pharmaceutical manufacturers to adopt the cleaning validation software. FDA warnings related to cross contamination has been increased significantly from 5% in 2015 to 20% in 2020. Such a cross contamination pharma manufacturing can result into the significant losses of time, money, efforts, etc. Such as cross contamination is result of inappropriate cleaning validation of manufacturing equipment’s or aids. Moreover, this software helps the organization in managing time, workforce productivity, information security, efficient business processes, and controlling compliance are factors projected to drive the growth of the global market during the forecast period. Rapid advancement in technologies 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 very critical and complicated process. Cleaning validation software has greatly contributed towards simplifying such a complicated process. Cleaning validation not only simplifies the process but also facilitate the access to the data easily. Unlike manual cleaning validation process, cleaning validation software offers a platform that stores equipment and product related data instead of maintaining traditional spreadsheet format.

Price of cleaning validation software varies drastically based on its functionality and features offered by the company, number of users, deployment, services offered by the company, duration, etc. Average annual cost for cleaning validation software ranges between USD 35,000 to USD 50,000. Large number of small and medium size pharma and biotech companies are still adhered to manual cleaning validation process. Offering this software for affordable price.

Impact of COVID 19

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

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

North America market is projected to account for highest revenue share in the global cleaning validation software for pharma market on the account of ever rising adoption of cloud computing and 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 also 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, Software segment is accounted for the two third share of Cleaning Validation Software for Pharma Market. However, Services segment is anticipated to grow at 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 major Revenue Stream

Pharma and Biotechnology Companies and CRO are some of the major types of Application. Pharma and Biotechnology Companies segment accounted for the largest share in 2020 of the Cleaning Validation Software for Pharma Market in 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’s life cycle, and compliance developments. This software allows to manage cleaning validation life cycle initial with requirements through to Validation Final Reports in one easy-to-use solution. Documentation is easy with Kneat Gx through pre-approved templates and active data sharing, that reduces time required to generate a document and decreases the human errors by removing the need to move data among documents. Additional productivities are gained the Kneat Gx work development does not need the transporting of 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 is proactively offering a rigorous training to help end-users to efficiently handle cleaning validation software. It also help its clients with detailed training materials and 24/7 assistance to overcome any problem.

Frequently asked questions about global industry

  • Which are the different types of cleaning validation software in pharma by Type?
    • Ans: 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.
  • Who are the key players in the global industry?
    • Ans: Some of the major players operating in cleaning validation software in pharma include, Novatech 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.
  • Which is the fastest growing Application segment for global industry?
    • Ans: Pharma and Biotechnology Companies is the largest application of cleaning validation software in Pharma. The CRO segment held over 20% share in 2020.
  • Which is the leading regional market for global industry?
    • Ans:  North America hold the largest share owing to large demand of cleaning validation software in several pharma industries
  • What will be the CAGR (2021 - 2027) of in global industry?
    • Ans: The market is anticipated to grow at a CAGR of 11.25% throughout the forecast period, in terms of revenue
  • What are the major challenges for the global cleaning validation software in Pharma?
    • Ans: 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 difficult-to-clean locations in equipment. Cleaning Process Problems: These break down to 1) cleaning documentation, 2) qualification of manual cleaning, 3) campaign length, 4) dirty hold time. Laboratory Problems: Laboratory problems in cleaning validation software to analytical methods. Analytical methods measure real residues that are present, including stability and solubility.


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