And with the approval of electronic batch records and signatures by the US Food and Drug Administration, there is now greater incentive for the regulated industries to move to paperless systems, according to a recently published study from ARC Advisory Group.
The worldwide market for batch process control is expected to grow at a compounded annual growth rate (CAGR) of nearly 6 per cent over the next five years. The market, $2.8 billion in 2004, is forecasted to reach over $3.7 billion in 2009, according to the study, called Batch Control System Worldwide Outlook.
ARC vice president Asish Ghosh, the study's principal author, noted that services constitute the largest part of a batch control system, which include integration and maintenance services provided by control system suppliers, and third party services provided by system integrators and other independent agents. Integration services provided by suppliers will show the largest growth, closely followed by third party services.
In the pharmaceutical sector, the FDA's Process Analytical Technology (PAT) initiative will be the driving force behind the growth in the market. This initiative aims to encourage the concepts of quality by design, use of computerised data gathering and evaluation techniques, and process and product monitoring methods through advanced instrumentation and data evaluation.
ARC feels that the PAT initiative is going to have a significant effect on drug manufacturing and the validation process. It will lead to the storage and analysis of a much larger amount of batch data than what is required today. Accurate time stamping and the security of the stored data will become increasingly important along with their automated analysis. Optimisation of current and future lots based on the analysis of these data will also become increasingly important, according to the report.
Asia will provide impetus to growth
ARC notes that the manufacturing industry in Asia has entered a rapid growth phase with China in the lead. The primary reason s is that the people of Asia, with changing demographics and lifestyles, are creating a massive demand for life science products.
In response, the food, beverage, and pharmaceutical industries are growing. Many countries such as China, India, and Singapore in the region are focusing on setting up pharmaceutical facilities to produce bulk drugs and generics.