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Home / India News / 2007 / January / January 24, 2007
Need for Greater Operational Efficiency Drives Pharmaceutical Manufacturers to Employ Automation and Software Solutions

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Need for Greater Operational Efficiency Drives Pharmaceutical Manufacturers to Employ Automation and Software Solutions

Mumbai, Maharashtra, India

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.

If you are interested in a virtual brochure, which provides manufacturers, end users, and other industry participants with an overview of automation and software solutions in the global pharmaceutical markets, send an e-mail to Ravinder Kaur / Nimisha Iyer, Corporate Communications, at / with your full name, company name, title, telephone number, fax number, and e-mail address. Upon receipt of the above information, an overview will be sent to you by e-mail.

With strict regulatory approvals, manufacturers are finding it increasingly difficult to introduce new drugs in the market. This has greatly influenced the number of drugs entering the market. Hence, there is an emerging need to implement lean and flexible concepts to reduce wastage and bring drugs faster to the market.

"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.

However, as the pharmaceutical industry is highly regulated, the FDA audits and approves every new process addition. The risk of non-compliance is too high for pharmaceutical companies and thus, massive investments on automation and software solutions are relatively lesser.

"The key success factor for automation companies is to establish long-term partnership with pharmaceutical customers," says Sanjeev. "Even as pharmaceutical customers look for standardization, automation companies need to grow aggressively with their customers as they expand globally."

The relationship starts from educating and generating awareness among customers. After selecting specific pharmaceutical engagement opportunities, automation vendors need to build critical momentum and achieve a dominant business differentiator. Long-term partnerships could be profitable to the pharmaceutical industry as well as automation vendors.

The Strategic Analysis of the Automation and Software Solutions in the World Pharmaceutical Markets is part of the Factory Automation subscription, which also includes research services in the following markets: Automation and Software Solutions in World Food and Beverage, World Human Machine Interface and Software and World Distributed Control Systems. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants. Interviews are available to the press.

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership service, and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit

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

Ravinder Kaur , Corporate Communications - South Asia & Middle East, Frost & Sullivan, +91 (044) 4204 4515

Nimisha Iyer , Corporate Communications - South Asia & Middle East, Frost & Sullivan, +91 (022) 4001 3400

Source: Frost & Sullivan (Business Wire India)

Press release presented here is sourced from the Source mentioned above and is provided on as-is basis. Please contact the Company / Source directly for any further information in regard to this release. This website will be unable to assist you in regard to the accuracy or correctness of information in this release.

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