Cleaning Validation Software for Pharma Market to Reach USD 1091 MN By 2027 | Credence Research

The latest market report published by Credence Research, Inc. “Global Cleaning Validation Software for Pharma Market: Growth, Future Prospects, and Competitive Analysis, 2015 – 2027”. The Global Cleaning Validation Software for Pharma Market generated revenue of around USD 509.43 million in 2020 and poised to grow at a CAGR of over 11.25% during the forecast period and targeted to reach around USD 1,091.15 million in 2027.

Global Cleaning Validation Software for Pharma Market, 2020 – 2027 (USD Million)

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Cleaning validation is a manufacturing protocol followed by the manufacturing companies through either manual or automated process. Cleaning validation is very necessary process to be carried out after certain intervals in order to avoid any kind of contamination in drugs manufacturing. Cleaning validation use to be carried out manually until few years back. However, with advancement of technologies and growing trend of automation of various activities in healthcare industry, the demand for cleaning validation software is on the rise. Also, all software variations shall be validated before agreement and issuance. Pharmaceutical manufacturers validate cleaning process in order to confirm compliance with CGMP regulations.

Key Trends in Global Cleaning Validation Software for Pharma Market

Increasing Cross Contamination Incidents Across the World

Last five years has witnessed tremendous increase in cross contamination warning from FDA. FDA warning for cross contamination raised from 8% in 2015 to around 20% in 2020. Despite of its strong growth in production volume, pharmaceutical industry has experienced faster growth in regulatory related noncompliance issues due to manual cleaning validation. Regulatory bodies such as FDA and MHRA have also noticed that there are serious data integrity issues with manual cleaning validation. Such a short comes of manual cleaning validation has forced the pharmaceutical players to adopt advanced cleaning validation software that also facilitate the automation of the process.

Cleaning Validation Software Aids Manufacturers to Optimize the Production

Manual cleaning validation process need more time, resources and paper work as compared to cleaning validation software. According to survey, pharma manufacturers are fetching loss of 14% of their production capacity due to ineffective cleaning validation process. Moreover this loss is likely increase up to 20% in near future. This loss of production capacity can be overcome by installing cleaning validation software. Moreover, some of the top pharmaceutical companies are facing issues related to overcleaning and cost associated with it. This again is a result of drawbacks of manual process. In order to abide by regulations, top pharmaceutical companies are over cleaning as much as 30%. This also calls for an effective and robust software that can maintain optimum level of cleaning validation.

Impact of COVID 19 Pandemic on Cleaning Validation Software for Pharma Market

As economies across the world are suffering from the impact of COVID-19, businesses are suffering losses, workers are short of jobs, and many people faces the challenge of a complete disturbance of lifestyle. Though, cleaning validation software in pharma companies captivating center stage in the COVID-19. These companies during the COVID-19 pandemic and using their capabilities to reduce the burden of coronavirus on their patients. Cleaning validation software in pharma companies are replying to the challenges rising from disturbance in supply chains and the need to change business developments. Suppose the COVID-19 pandemic persists for a medium or long span of time, it may affect the supply of material and ingredients, and the import and export. Also, there is the probable for negative impacts of both a medium-term and longer-term nature on Research & Development and manufacturing activities, and delay on projects not related to the core supply chain or data management operations.

Service Segment to Gain Momentum with Rise in Installed Base

Software is leading segment of cleaning validation software industry with over 75% share in 2020. However, the service segment is likely to gain momentum with rise in installed base of the software. Leading players are focusing on to offer value added services to their clients. In an attempt to attract the consumers, the companies are engaged in offering various after sales services such as rigorous training of software onsite, higher data security, etc.

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, Novateck 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
  • Novateck International
  • Kneat
  • eResidue
  • Auditrunner
  • USDM
  • Kaye Inc