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The Pharmaceutical Market: USA
Espicom Business Intelligence Ltd, May 2010, Pages: 90
These highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:
Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators.
Specialised intelligence on OTCs, generics, biologics and biosimilars.
Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series.
A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel.
The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis.
Executive Summary
The USA is the only major industrial country where the provision of medical services and insurance is not unified by a central national strategy. Until March 2010, the USA was also unique in that it did not guarantee health coverage to all citizens; this, however, has changed following the approval of the healthcare reform. The bill will expand health insurance coverage to 32.0 million Americans who are uninsured. The cost is estimated at US$940.0 billion but considerable savings are expected in return. According to the non-partisan Congressional Budget Office, the bill is expected to reduce the fiscal deficit by US$143.0 billion over the next decade and US$1,200 billion in the decade after that. Republicans, however, believe that the bill is too expensive and that it could cause eventual bankruptcy for the country.
The effect of the healthcare reform will be difficult to measure but pharmaceutical sales are expected to be boosted in the long-term. R&D investments are large but growth has slowed down. Around 85.0% of the USA's pharmaceutical requirements are domestically manufactured. A number of companies have made significant cutbacks, making reductions to sales forces. There have been a number of plant closures and scaling back of investment plans. For companies traditionally reliant on chemical drugs, there is an increasing interest in moving into the biologic field. This is seen as more lucrative as it has greater scope for the development of innovative products and is less susceptible to generic competition. With their acquisitions in 2009, Pfizer and Merck have diversified and entered the biologic sector, whilst Roche has specialised in biologics and diagnostics.
The OTC sector is expected to increase by a low CAGR between 2010 and 2015. Nevertheless, the sector is attractive and market concentration continues. In March 2010, sanofi-aventis completed the acquisition of Chattem. The transaction has created the world's fifth-largest consumer healthcare company. The modern generic sector is shaped by the Hatch Waxman legislation of 1984. As a result, generics are widely-used and well-accepted in the USA. This is because generics are usually far cheaper than branded drugs, with the advent of generic competition leading to rapid price falls. The sector is expected to increase by a moderate CAGR between 2010 and 2015. The leading player is the Israeli company Teva Pharmaceuticals, followed by Sandoz, Mylan and Watson; Sandoz announced the acquisition of Oriel Therapeutics in April 2010 whilst Watson completed the acquisition of Arrow in December 2009. Nevertheless, there are still a large number of small generic players, therefore there is room for further acquisitions and mergers.
The healthcare reform includes the biosimilar pathway provisions previously discussed. The Act amends section 351 of the Public Health Service Act (PHSA) to allow for the application of a biologic product as biosimilar or interchangeable. Brand-name producers are the winners, as biosimilar competition has been restricted by implementing a 12-year data exclusivity period; this is similar to the 11-year term established in Europe. Pfizer, via its Established Products Business Unit, plans to enter the biosimilar market within five years. Recent developments in the biologic market include Abbott’s acquisition of Facet in April 2010, Astellas’ extended tender offer to acquire OSI, Merck’s acquisition of Millipore in March 2010, and Celgene’s acquisition of Gloucester Pharmaceuticals in January 2010.
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