FirstWord Lists: The best selling drugs of all time - an updated analysis

Earlier this year, FirstWord produced an analysis of the biggest selling prescription drugs of all time (see here. This is an updated piece that incorporates 2012 full-year sales where applicable.

To date, the pharmaceutical industry has produced 19 products that have generated peak global revenues in excess of $5 billion. A number of these franchises continue to grow – most prominently AbbVie’s Humira (rheumatoid arthritis and other inflammatory conditions), which is expected to record annual sales of around $10 billion this year. In contrast, many have seen revenues decline as a result of generic erosion – a recent example being Sanofi and Bristol-Myers Squibb’s anti-platelet drug Plavix, sales of which declined from $9.9 billion in 2011 to $5.2 billion in 2012.

Whether any other drug will improve on the peak sales performance of Pfizer’s dyslipidaemia treatment Lipitor remains conjecture, although Humira is best positioned to achieve this. Indeed, with AbbVie’s flagship product having exceeded expectations in recent quarters (see ViewPoints: Pfizer and AbbVie – as Xeljanz stalls, Humira soars), a number of analysts are predicting that annual sales for the anti-TNF therapy will peak at above $14 billion in 2018.

Those products included in the list above that have a peak annual sales year of 2012 are drugs that continued to record growth last year and for which revenues are expected to expand further in the future. Unsurprisingly, all six of these products – the aforementioned Humira included – are biologics and their commercial longevity (and ability to continue delivering sales growth) is primarily shaped by lack of an entry point for traditional generic competition. For example, Roche’s non-Hodgkin’s lymphoma treatment Rituxan – which was first launched in 1997 – delivered 9 percent year-on-year growth (in constant exchange rates) during 2012.

Since we published our first version of this list in January, a number of developments have occurred that will shape the commercial outlook for certain products moving forward.

Roche, for example, has further enhanced its HER-2 positive breast cancer franchise via the launch of Kadcyla (which follows the launch of Perjeta in 2012). Both of these products are distinct (and are actually expected to limit future growth for Herceptin), but will build directly on the success of that franchise. Similarly, Roche recently announced positive data from studies of a follow-up compound to Rituxan – GA101 - while the challenges facing developers of biosimilar Rituxan have become increasingly apparent. See ViewPoints: Roche banks on disruptive innovation to counter competitive headwinds.

More directly, the FDA’s decision to reject approval of Novo Nordisk’s Tresiba in early February provides Sanofi an opportunity to significantly enhance the status of Lantus (diabetes) as one of the biggest selling products of all time. See ViewPoints: Sanofi's 'mega brand' Lantus the key beneficiary of Novo Nordisk's degludec setback. Mirroring the life-cycle management strategy at Roche, Sanofi is also developing a new formulation of Lantus.

When it comes to potential new entrants on the list, Eli Lilly’s depression treatment Cymbalta recorded global revenues just shy of $5 billion in 2012. With US patent exclusivity set to expire later this month however, revenues are expected to decline markedly this year.

Another notable blockbuster steadily approaching the $5 billion benchmark is Merck & Co.’s diabetes treatment Januvia (sales of $4.1 billion in 2012); indeed if its metformin-combination cousin (Janumet) is included, then total franchise sales in 2012 stood at $5.7 billion. Despite a number of potential barriers to growth – which have emerged in recent months – sales of this franchise are expected to increase steadily over the next few years (see ViewPoints: Why Merck & Co. is in no hurry to give up on Januvia). Pfizer’s pneumococcal vaccine Prevnar and Celgene’s cancer treatment Revlimid are other marketed franchises expected to join the $5 billion club over the next five years.

In terms of pipeline or recently launched therapies, the aforementioned Perjeta and Kadcyla are longer-term candidates, while analysts continue to upgrade their estimates for Biogen Idec’s oral multiple sclerosis treatment Tecfidera following a stronger than expected launch. See ViewPoints: Data remain early, but Tecfidera "crushing" launches of other oral MS treatments.

Gilead Sciences’ sofosbuvir – an experimental once-daily oral treatment for hepatitis C – remains the most potentially lucrative pipeline compound in development based on current consensus forecasts, while this past weekend has seen further clinical data released for the emerging class of PD-1/PD-L1 cancer immunotherapies. Based on rapidly evolving analyst estimates, these products stand to generate peak annual revenues well in excess of $5 billion.

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