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Automation and Control Solutions in the European Pharmaceutical Market
Frost & Sullivan, Feb 2008, Pages: 128
Compliance to Regulations and the PAT Initiative Remain Top Market Drivers
The 21 CFR Part 11 regulation stipulated by the Food and Drugs Administration (FDA) was introduced in 1997. Implemented across Europe through the European Medicines Agency (EMEA), this regulation requires pharmaceutical companies to increase transparency in their production processes through audit trails and access control functions. By accepting electronic records and electronic signatures as equivalent to paper-based records and handwritten signatures, the FDA paved the way for significant changes in the way that the pharmaceutical industry maintained its records and allowed the industry to leverage technology to keep pace with the fast growth of the industry. 'Compliance to various regulations such as 21 CFR part 11 and Current Good Manufacturing Practices (cGMP) put forth by the FDA remains a major factor propelling growth in the automation and control solutions market,' comments the analyst of this research. '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 Process Analytical Technology (PAT) initiative arose from a need felt by the pharmaceutical industry to lower production costs due to pricing pressures. Traditionally, a production process was followed, wherein the quality of the manufactured drug was checked at the end of the process. However, with the PAT initiative, pharmaceutical companies have been able to ensure the quality of their drugs during the production process itself, supporting reduced time to market, reduced costs and improved quality of products. These two factors are driving growth in the automation and control solutions market due to the scope they present for the use of automation systems such as electronic batch recording systems, analytical equipment as well as solutions for improving visibility through the production process.
MES Poised for Significant Growth
The manufacturing execution systems (MES) segment is one of the fastest growing product segments within the automation and control solutions market. MES, which acts as a bridge between the shop-floor automation layer such as programmable logic controllers (PLCs), supervisory control and data acquisition (SCADA)/human machine interface (HMI) systems and the enterprise level solutions such as enterprise resource planning (ERP) systems, provides the required visibility through the pharmaceutical production process. MES’s per cent share in the overall automation and control solutions in the European pharmaceutical market is expected to be in the range of 20-25 per cent in 2013.
'The speedy return on investment on such solutions is fast becoming evident to the pharmaceutical industry, resulting in a high rate of uptake of such MES solutions,' notes the analyst. 'Growth in the MES segment also drives growth in the base automation layer, as integrating an MES system often requires an upgrade or replacement of base layer automation solutions.' A $119.9 million market in 2006, MES is expected to grow at a compound annual growth rate (CAGR) of about 15 per cent to reach approximately $320 million in 2013.
This Frost & Sullivan research service titled Automation and Control Solutions in the European Pharmaceutical Market provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and competitive structure. In this research, Frost & Sullivan's expert analysts thoroughly examine the following markets: programmable logic controllers (PLC), distributed control systems (DCS), supervisory control and data acquisition (SCADA), Manufacturing Execution Systems (MES), human machine interface (HMI) and advanced process control (APC) in the European region.
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