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Manufacturing of Solid Dosage Forms – 2011
Manufacturing of Solid Dosage Forms – 2011
Solid Dosage Forms Market Presence
London,
London,
United Kingdom
(prbd.net)
09/02/2011
After considering more than 20,000 marketed drugs, it has been estimated that more than 66% of drugs in the market are in solid forms, of which there are a number of different categories.
The market size for CMO solid dosage forms was estimated to be $11.2 billion in 2009, and is forecast to grow at a CAGR of 11.8% between 2009 and 2016, reaching $24.5 billion by 2016.
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Major drivers behind the growth of outsourcing of solid dosage manufacturing include the drive to convert fixed costs to variable costs; the ability to access specialized scientific expertise quickly without capital outlay; the desire to expand product sales to new markets; the need to secure a supply of high-value products, meeting variable product volume requirements; maintaining compliance with evolving regulatory requirements in world markets; to avoid extensive capital expenditures in facilities, to bring new molecules to market quickly, to replace high-volume products approaching the end of their patent protection period; and conserve valuable patent protected selling time by implementing lifecycle management strategies.
Guidelines for solid dosage manufacturing are provided by major regulatory bodies such as the Food and Drug Administration (FDA) and EMEA, but a major problem with these guidelines, is their non applicability to new innovative processes, especially continuous manufacturing processes.
Guidelines have been clearly provided for the manufacture of active pharmaceutical ingredient (API), but for excipients, there are no clear cut guidelines to be followed globally.
Although the governments of several major countries are taking steps towards this, other than the US, no other country has been successful in developing proper regulation for manufacturing excipients.
GBI Research's report, “Manufacturing of Solid Dosage Forms - 2011”. The report provides the key market data on the Contract Manufacturing Organization (CMO) market size for solid dosage forms along with forecast from 2009-2016 for API and excipient market. The report also gives insight into challenges, unmet needs, and technology landscape and cGMP guidelines for manufacturing of solid dosage forms. The report also analyzes the strengths, weaknesses, opportunities, and threats leading players involved in manufacturing of solid dosage forms. The report is based on proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts to provide a comprehensive view of the manufacturing of solid dosage forms.
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