Strategic Analysis of the Automation and Software Solutions in the World Pharmaceutical Markets

This study examines the automation and software solutions in the pharmaceutical market and provides forecasts over the period 2003 to 2013. For the purposes of this study, the market has been divided into five product segments programmable logic controllers, distributed control systems, human machine interface, manufacturing execution systems, industrial asset management solutions and advanced process control. The world market is divided into four geographic regions North America, EMEA (Europe, Middle East and Africa), Asia Pacific, Rest-of-World (Russia, South America and others).

Research Overview

This Frost & Sullivan research service titled Strategic Analysis of Automation and Software Solutions in the World Pharmaceutical Market provides an overview of the revenue forecasts for the automation and software market for the pharmaceutical industry across various geographies along with a comprehensive analysis of the various drivers, challenges and trends prevailing in the market. In this research service, Frost & Sullivan's expert analysts thoroughly examine the following markets: programmable logic controllers, distributed control systems, human machine interface, manufacturing execution systems, industrial asset management, and advanced process control.

Market Sectors

Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:

• Programmable logic controller (PLC)
• Human machine interface (HMI)
• Manufacturing execution system (MES)
• Distributed control system (DCS)
• Advanced process control (APC)

Technologies

The following technologies are covered in this research:

• Adaptive manufacturing
• Service oriented architecture

Market Overview

Need To Conform To Global Standards Drives Pharmaceutical Manufacturers to Embrace Automation and Software Solutions

Major pharmaceutical manufacturers are trying to establish their presence in countries such as China and India to take advantage of the lower costs by opening manufacturing facilities through their subsidiaries and providing opportunities for local manufacturers through contract manufacturing. Since domestic manufacturers are producing ingredients or drugs for the American and European markets, which are strictly regulated, they are compelled to conform to global standards. Therefore, to achieve global standards, maintain uniform quality, and conform to stringent regulatory requirements, manufacturers are resorting to implementing automated 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 trail and access control functions. It also puts forth the criterion that electronic records and signatures are equivalent to paper records and handwritten documents in the manufacturing processes. Therefore, companies are compelled to develop sophisticated means of electronic validation and batch recording.

Reduction in ‘Blockbuster’ Drug Pipeline Impels Greater Need for Automation

Although pharmaceutical companies are investing strongly in research and development (R&D), there is a lesser probability of discovering a blockbuster drug that can provide substantial improvement in efficacy and achieve greater penetration. Increase in development times have caused most drug manufacturing companies to lose their patent production within a few years of bringing them to the market. "The exit of blockbuster drugs is beneficial for automation companies, as manufacturers produced them without incorporating any new automation," cites the analyst of this research service.

Increasing competition from the sale of generic drugs is another key factor increasing the demand for automation. When the patent period of a drug expires, the cheaper generic version tends to find acceptance among consumers, affecting the sale of the original patented drug. Hence, large pharmaceutical manufacturers are under pressure to innovate new drug production to offset the competition from generic drugs. "The competition from generic drugs is urging companies to be more flexible and able to adapt product lines to demand fluctuations," notes the analyst. "Hence, pharmaceutical companies are compelled to manufacture specialized potent drugs that are more difficult to replicate and which also need to be produced in smaller quantities, necessitating the production of multiple products on the same equipment."