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US Pharmaceuticals and Healthcare Report Q3 2007
Business Monitor International, Nov 2007, Pages: 114
The US Pharmaceuticals and Healthcare Report provides independent forecasts and competitive intelligence on USs pharmaceuticals and healthcare industry.
The US is a pharmaceuticals powerhouse, easily dwarfing rival drug markets in term of size and company presence. However, exorbitantly high levels of health expenditure are forcing the government into a containment pattern. As we released Q307 US Pharmaceuticals & Healthcare Report shows, this should help restrain growth, which has been high in the past three years. Over the forecast period we envisage a compound average growth rate of 3.5%.
Average pharmaceutical expenditure in the US stood at US$985.2 in 2006. This compares to an average of US$69.5 in Latin America, and US$98 in another key emerging market, Central & Eastern Europe, giving some idea of the maturity of the US market. In this sense, it is unsurprising that growth is slower than in developing nations. However, the US is unique among the industrialised world in that it allows the free pricing of pharmaceuticals. Also, other inflationary factors experienced elsewhere in the West, such as ageing populations and a high incidence of lifestyle-based health conditions also influence the US market. Therefore, we believe that the US slowdown is partly government engineered, rather than merely a natural economic phenomenon.
Recent austerities include the aggressive promotion of generics and we expect this market to hit US$54.7bn by 2011. The Biologics Price Competition and Innovation Act - recently passed by the US Senate - proposes giving the FDA power to approve biosimilars that are shown to be interchangeable with an off-patent biologic, creating an approval pathway for these products for the first time. Biosimilars will have to provide one or more clinical trials to demonstrate bioequivalence, although the FDA has the right to waive this requirement. As a concession to the biotech industry, and to reward innovation, research-based drugmakers will be given 12 years marketing exclusivity for their new products.
One US company seeking to ride the generics wave is Florida-based Mylan Laboratories., which was the surprise winner in the race to acquire the generics division of Germanys Merck KGaA, agreeing a deal worth US$6.7bn. In 2006, Mylan dispensed 255.6mn prescriptions in the US, representing growth of 10.7%, making it the third largest generic drugmaker in the country, after Israels Teva and Switzerlands Sandoz.
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