Compliance concerns drive pharma automation

Edited by the Engineeringtalk editorial team Apr 17, 2008

The market for automation and control systems in the European pharmaceutical market is predicted to reach $1.415 billion in 2013.

The pharmaceutical industry in Europe is struggling with various challenges such as price pressures and severe competition from generics companies.

This is marking it as a market with scope for strong growth with respect to automation and control solutions.

As awareness about the ways in which various automation solutions can reduce the impact of the challenges faced by the pharmaceutical companies increases, automation vendors might be assured of a steady market in the pharmaceutical industry.

New analysis from Frost and Sullivan "Automation and control solutions in the European pharmaceutical market", finds that the market earned revenues of US $906 million in 2006, increasing to $952.5 million in 2007 and estimates this to reach $1.415 billion in 2013.

"Compliance to various regulations such as the 21 CFR part 11 regulation and Current Good Manufacturing Practices (cGMP) put forth by the Food and Drug Administration (FDA) remains a major factor propelling growth in the ACS market", comments Frost and Sullivan Research Analyst Shweta Shanker.

"At the same time, operational efficiency in terms of bringing down production costs, reducing time to market and increasing flexibility in production is also a strategic reason for pharmaceutical companies to invest in automation solutions".

The pharmaceutical industry in Europe is suffering from severe cost containment and pricing pressures, pressuring market participants to examine various methods of reducing production costs and achieve greater efficiency in their production process.

While lean manufacturing, six sigma and outsourcing of manufacturing to low-cost regions offer possible approaches to realising these goals, many pharmaceutical companies are also opting for automation solutions as a strategy towards gaining enhanced operational efficiency.

The pharmaceutical industry has traditionally been wary of automation and software and has preferred paper-based records due to the necessity of having to comply with stringent regulations imposed by governing bodies.

Pharmaceutical companies are inclined to be conservative in adopting automation solutions, as they feel that any changes in their manufacturing processes would require additional validation of such new methods and therefore, pose a challenge in compliance.

"Pharmaceutical companies are content to use paper-based records and installed legacy systems rather than shift to newer technologies and automation systems", remarks Shanker.

"Hence, automation vendors face a major challenge in overcoming the conservative attitude of the pharmaceutical industry towards adopting automation solutions".

Higher levels of interaction with clients to accurately assess their automation requirements and creating greater awareness regarding the return on investment would help alleviate the concerns of the pharmaceutical industry about automation solutions.

With the FDA encouraging risk-based manufacturing and the adoption of automation solutions, automation vendors should be emboldened to work towards minimising the impact of this challenge.