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The cardiovascular market, historically one of the mainstays of the pharmaceutical industry, is set to be hit by a 'patent cliff', with six of the current top 10 brands due to lose protection between 2010 and 2013. However, the diabetes market is set to increase in value over this period, providing opportunities to companies that invest in this area of the cardiovascular sector.
A maturing market
Growth in the use of cardiovascular drugs has been steady in the last five years at around 3% compound annual growth rate (CAGR) and growth is expected to continue at a similar rate, in line with population growth. However, sales growth is unlikely to match the growth in the use of cardiovascular drugs. Growth in the last five years has been moderate at 8% CAGR but there is likely to be negligible growth between now and 2016, giving an effective fall of 3% in cardiovascular revenues.
Sales growth is being hindered by the loss of patent protection on key cardiovascular blockbusters and the uptake of generic versions of leading drugs, as cost containment measures are promoted by national healthcare providers. Some of the brands losing patent protection during the 2010 to 2013 window include Pfizer's Lipitor, the world's number one selling brand, Sanofi-Aventis/Bristol-Myers Squibb's (BMS) Plavix, the best selling platelet aggregation inhibitor, and Novartis's anti-hypertensive Diovan.
Many cardiovascular diseases now have an array of generic drugs that provide effective treatment without the need to resort to expensive branded products. This provides a major challenge to pharmaceutical companies as any new drug must be able to demonstrate significant clinical benefit to meet the cost effectiveness criteria determined by healthcare providers. As a consequence, future blockbusters will not be of the same scale as the current crop. Byetta LAR is likely to be the best performing of the drugs currently in development and is predicted to have peak sales of $3 billion in the seven major markets. This compares to the sales of Lipitor in 2006 of $11.2 billion.
Diabetes: a haven in a tough market
The one disease area which will continue to grow in the cardiovascular franchise is diabetes. With the majority of the western world in the grips of an obesity epidemic, the number of sufferers of type 2 diabetes will continue to increase at a rapid clip. Pharmaceutical companies have invested heavily in this area to meet unmet clinical needs and a large proportion of the top 10 cardiovascular brands in 2016 will be diabetes therapies.
The complex nature of insulin formulations and the lack of generic competition from biosimilar versions have safeguarded sales and margins of insulin products after the loss of patent protection. Biosimilar legislation which will provide marketing authorization for biosimilars is currently held up in both the US Congress and Senate as vested interests delay the approval of the bills.
The 'patent cliff' will be most acutely felt by Pfizer as patent protection in the US for Norvasc was lost in 2007 and Lipitor will be lost in 2010. Adding insult to injury, Pfizer's current cardiovascular pipeline is particularly bare after the company dropped the development of the Lipitor replacement, torcetrapib, and the withdrawal of Exubera, an inhaled insulin which some analysts had predicted would generate $2 billion in annual sales but only generated $5 million in the US in the first half of 2007. Datamonitor is predicting revenue losses for many drug makers in the cardiovascular market once the 'patent cliff' takes effect. However, Pfizer will be acutely affected, with a net loss in cardiovascular revenue of $12 billion, with Sanofi-Aventis becoming the largest player in the cardiovascular market by 2009.
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