Pharmaceutical Technologist - July 2008 - (Page 13)

Digital Vision/Getty Images Overcoming the barriers Regulated markets in the US and Europe offer an attractive option for generics companies from emerging markets. However, accessing these is neither quick nor straightforward he world generic pharmaceuticals market was estimated at $84 billion (€53.7 billion) in 2006, growing at approximately 10% per annum1 and in 2007 the 10 leading generic pharmaceutical markets accounted for an estimated $69.8 billion (€44.6 billion).1 The US is the largest single market and accounts for approximately $29 billion (€19 billion), while the major markets in Germany and the UK account for approximately $21.5 billion (€13.7 billion).2 The US and European regulated markets for generic drugs offer an attractive strategic option for generic pharmaceutical companies in emerging markets such as Asia, the Middle East, North Africa and South America seeking to grow their businesses. Generic pharmaceutical companies have traditionally entered regulated markets as suppliers of APIs to already established generic businesses. The established company assumes responsibility for the ‘finishing’ activities such as the production of the finished dosage form, packaging and regulatory submissions, through to marketing and distribution of the finished product. The API often only accounts for a fraction of the price of the finished product, limiting the value accessible through this route. However, greater penetration of generic companies from emerging into regulated markets is underway, with companies aiming to capture an increased T portion of the value chain by enhancing their capabilities and taking on more of the ‘finishing’ tasks themselves. Accessing these new territories is neither a quick nor straightforward route to growth and the companies that pursue this path face a number of hurdles before their ambitions can be realized. Several barriers to entry — particularly regulatory, intellectual property and marketing — can restrict their progress. As companies develop a number of strategies to overcome these, additional obstacles have emerged. Elizabeth Hill from Cambridge Consultants. Regulatory Before a company can market a generic pharmaceutical product in the US, it must first obtain marketing authorization from FDA via the Office of Generic Drugs (OGD). These applications, known as Abbreviated New Drug Applications (ANDAs), are submitted according to one of four possible certifications related to the patent status of the product of interest. Data from OGD indicate that the average time for ANDA approval was 16.6 months in 20063 and that it took slightly more than 20 months for OGD to review each application.3,4 The process takes time because of several factors, including the high number of applications received by OGD (almost 800 in 2006)5 combined with the multiple review www.ptemagazine.com 13 http://www.ptemagazine.com

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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