Antihypertensives: Generics striking at heart of the market
SummaryDespite almost 200 million people suffering from high blood pressure in the western world alone, the growth rate of the antihypertensive market is actually slowing, largely as a result of generic incursion. In fact many pharmaceutical companies, including those with strong cardiovascular portfolios, are turning their back on this market in favor of more profitable indications, such as oncology.
The generic invasion
Pfizer's Norvasc (amlodipine), the biggest selling calcium chanel blocker (CCB) has already lost patent protection in Spain and the UK. In the UK alone, sales of Norvasc decreased by more than 50% between 2004 and 2005. The expected patent expiry of Norvasc in the US in September 2007 is therefore set to be a major event in the antihypertensive market. Genericization of the product is certain to start almost immediately and Dr Reddy's Laboratories has already attempted to launch a generic version of a slightly different amlodipine salt (amlodipine besylate versus amlodipine mesylate).
Pfizer has attempted to protect amlodipine revenues by launching Caduet (amlodipine and atorvastatin) in advance of the Norvasc patent loss, but so far this strategy has been disappointing. The impact of Norvasc's patent loss in the US on Pfizer's sales is expected to be significant, as has been the case in certain EU markets where the Norvasc patent has already expired. With sales of Caduet reaching only $178 million in the US in 2005, Pfizer will need to develop additional strategies to protect Norvasc revenues, as Caduet is unlikely to make up the loss in revenues expected after Norvasc loses patent protection.
The first angiotensin receptor blocker (ARB) to lose patent protection will be Merck & Co.'s Cozaar (losartan) in Spain in 2007. In the US, Cozaar will lose protection in 2010. This event has the potential to not only dramatically affect the antihypertensive market, but alter its entire structure. Threats of generic and therapeutic substitution alongside money-saving healthcare strategies which have plagued other markets, are now intruding upon the successful ARB class. As the ARBs are popular therapies and are the last major class to be losing patent protection, the effects on the whole market may be damaging.
In the US, healthcare regulations and reforms are working to make generic substitution policies widely implemented. Pharmacists are now incentivized to dispense generics, generic A type dispensers make dispensing generics easier, patient co-payments are less for generic products, and some healthcare providers are giving away generics free.
The generic revolution is only limited by physicians that order 'dispense as written' which can prevent substitution. Carve-out systems (a group of drugs that are not allowed to be substituted for generics due to the generic version being slightly different to the branded product) also prevent generic substitution, as does the fact that patient awareness of generics has only recently been addressed.
In the face of sky-rocketing healthcare costs, public and private payers across Europe, the US and Japan are all implementing cost containment policies, which are having an impact on the margins of drug-makers.
Big Pharma changes strategy
Consequently, a number of large pharmaceutical companies are actually re-examining their involvement in the cardiovascular market. For example, although Novartis has enjoyed previous success in the cardiovascular franchise it is now actively exploring other avenues of growth, steering away from further development in the antihypertensive market. Novartis' focus is shifting towards oncology, and to other less developed markets that are exploiting new developments and technologies in biologic therapies to deliver sales growth.
This trend can also be seen in the product-pipeline of other companies, such as Roche, which may have double the number of products in development in areas like oncology than in the cardio-related markets.
Big Pharma are strategically shifting their developments to gain a maximum return of investment. However, with less R&D investment in the cardio-related markets, there is less chance for the development of new and novel products to advance treatment for diseases like hypertension.