Pharmaceutical Manufacturers Employ Software Vendors

As pharmaceutical manufacturers face tighter margins and a host of regulatory and validation issues that are increasing the need to produce drugs at lower costs and at a faster pace, they are likely to turn to automation and software vendors to help them achieve operational efficiency in drug production.

New analysis from Frost & Sullivan, Strategic Analysis of the Automation and Software Solutions in the World Pharmaceutical Markets, reveals that the market earned revenues of $2,729.5 million in 2006 and estimates this to reach $4,273.6 million in 2013.

“The gradual exit of blockbuster drugs and the introduction of generic ones have increased the pressure on profit margins, compelling manufacturers to produce specialized potent drugs that are difficult to replicate and need to be produced in smaller quantities,” notes Frost & Sullivan Research Analyst Sanjeev R. Sridharan. “As this necessitates the production of multiple products on the same equipment, companies are increasingly employing automation and software solutions.”

Process analytical technology (PAT) is encouraging pharmaceutical manufacturers to adopt innovative technologies without fearing validation risks and production delays, thereby fuelling demand for automation and software solutions.

The revised 21 Code of Federal Regulations (CFR) Part 11 regulation stipulated by the Food and Drug Administration (FDA) requires pharmaceutical manufacturers to provide greater production transparency through audit trails and access control functions. It also puts forth the criterion that electronic records and signatures are equivalent to paper records and handwritten documents in manufacturing processes. Therefore, companies are compelled to develop sophisticated means of electronic validation and batch recording.