Cleaning Validation Software for Pharma Market Expected to Hit USD to Reach USD 1091 MN By 2027

The Global Cleaning Validation Software for Pharma Market generated revenue of approximately USD 509.43 million in 2020 and is expected to grow at a CAGR of more than 11.25 percent during the forecast period, with a target revenue of approximately USD 1,091.15 million in 2027. Global Cleaning Validation Software for Pharma Market, 2020 – 2027 (USD Million) Cleaning validation is a manufacturing protocol that is followed by manufacturing companies either manually or automatically. Cleaning validation is a critical process that must be performed at regular intervals to avoid contamination in the drug manufacturing process. Up until a few years ago, cleaning validation was done manually. However, with the advancement of technology and the growing trend of automating various activities in the healthcare industry, the demand for cleaning validation software is increasing. Furthermore, all software variations must be validated prior to agreement and issuance. Pharmaceutical companies validate the cleaning process to ensure compliance with CGMP regulations. Key Trends in Global Cleaning Validation Software for Pharma Market The FDA has issued a plethora of cross contamination warnings in the last five years. Cross contamination warnings from the FDA increased from 8% in 2015 to around 20% by 2020. Despite its rapid growth in production volume, the pharmaceutical industry has seen a faster increase in regulatory-related noncompliance issues as a result of manual cleaning validation. Regulatory bodies such as the FDA and the MHRA have also observed serious data integrity issues with manual cleaning validation. Due to the limited availability of manual cleaning validation, pharmaceutical companies have been forced to adopt advanced cleaning validation software, which also facilitates process automation. Browse the full report at Cleaning Validation Software Assists Manufacturers in Increasing Production Efficiency When compared to cleaning validation software, the manual cleaning validation process requires more time, resources, and paper work. According to a survey, pharmaceutical manufacturers are losing 14% of their production capacity due to ineffective cleaning validation processes. Furthermore, this loss is likely to increase by up to 20% in the near future. Cleaning validation software can be used to compensate for this loss of production capacity. Furthermore, some of the world’s largest pharmaceutical companies are dealing with issues related to overcleaning and the costs associated with it. This, too, is a result of the drawbacks of the manual process. Top pharmaceutical companies are overcleaning by up to 30% in order to comply with regulations. This also necessitates the use of effective and robust software capable of maintaining an optimal level of cleaning validation. The Influence of the COVID 19 Pandemic on Cleaning Validation Software for the Pharma Market As a result of the impact of COVID-19 on economies around the world, businesses are losing money, workers are out of work, and many people face the challenge of a complete lifestyle disruption. Cleaning validation software in pharmaceutical companies, on the other hand, is taking centre stage at COVID-19. During the COVID-19 pandemic, these companies are utilising their capabilities to reduce the burden of coronavirus on their patients. Cleaning validation software in pharmaceutical firms is responding to the challenges posed by disruptions in supply chains and the need to change business developments. If the COVID-19 pandemic lasts a long time, it may have an impact on the supply of materials and ingredients, as well as import and export. There is also the possibility of negative medium- and long-term effects on R&D and manufacturing activities, as well as delays on projects unrelated to the core supply chain or data management operations. With an increase in installed base, the service segment will gain momentum. With a market share of more than 75% in 2020, software is the leading segment of the cleaning validation software industry. The service segment, on the other hand, is likely to gain traction as the installed base of software grows. Leading players are concentrating on providing value-added services to their customers. In order to attract customers, companies are offering a variety of after-sales services such as rigorous software training on-site, increased data security, and so on. Data Security is Poised to Play Critical Role Data security is one of the major concerns in adoption of cleaning validation software for many companies. Most of the companies are focusing on improved data security for their customers to keep their confidentiality about data. Having additional security measures associated with its software can provide CLEEN with competitive advantage over other players. Data security is one of the prime factors influencing buying behaviors of major pharmaceutical manufacturers. Growth Markets are Likely to Be Next Major Revenue Stream for Cleaning Validation Software North America market is accounts for highest revenue contribution to the global cleaning validation software for pharma market. This is attributed to growing investment in healthcare information technology in the region, emergence of legislative requirements to promote business development in the U.S. and Europe. However, future growth is likely to stem from growth markets such as China, India, Brazil, etc. Cleaning validation software has started taking its root in these emerging markets. Rising non-compliance related issues and increasing production cost is forcing manufacturers to adopt advanced technologies in every aspect of manufacturing operation including cleaning validation. This in turn expected to open a new growth window for the industry participants. Global Cleaning Validation Software for Pharma Market Competitive Landscape Most prominent players in the Global Cleaning Validation Software for Pharma Market include Ofni Systems, LeucineTech, SafetyCulture, ValGenesis, Novatech International, Kneat, eResidue, Auditrunner, USDM, and Kaye Inc. The report covers very detailed profiles of these key players. Top six players accounted for over 45% share of the cleaning validation software for pharma market in 2020. Market Segmentation Global Cleaning Validation Software for Pharma Market by Type, 2015 – 2027

  • Software
  • Services

Global Cleaning Validation Software for Pharma Market by Application, 2015 – 2027

  • Pharma and Biotechnology Companies
  • CRO
  • Research Institutes

Global Cleaning Validation Software for Pharma Market by Region, 2015 – 2027

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

Global Cleaning Validation Software for Pharma Market: Key Players

  • Ofni Systems
  • LeucineTech
  • SafetyCulture
  • ValGenesis
  • Novatech International
  • Kneat
  • eResidue
  • Auditrunner
  • USDM
  • Kaye Inc

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