Having achieved the biggest drug launch to date by generating an astonishing $2.3bn in its first full quarter on the market, Gilead’s Sovaldi looks set to continue setting records.
Analysts reckon the hepatitis C treatment will be the biggest-selling drug in the world in 2020 with sales of $13.1bn, new data from EvaluatePharma reveal. It will claim the crown from AbbVie’s Humira, although the rheumatoid arthritis therapy is itself forecast to remain a huge product, with $12.6bn in revenues that year (see table below).
Sovaldi’s achievement is only made more remarkable by the speed with which it is expected to scale these heights. It only reached the market at the very tail end of 2013; Humira, by comparison, was launched 10 years earlier.
And consensus for Sovaldi could still rise further. The data, an average of sales forecasts made by sellside analysts, were collected before Gilead unveiled that first-quarter $2.3bn figure, which smashed expectations and prompted a round of upgrades. Leerink analysts, for example, have already upped estimates for sales in 2017 from $13.5bn to $16.6bn.
|Top 15 selling drugs in 2020|
|Global sales ($bn)|
|Product||Company||Therapy area||2013||2020e||Year of first launch|
|Sovaldi + combo pill||Gilead Sciences||Hepatitis C therapy||0.14||13.12||2013|
|Januvia + Janumet||Merck & Co||Anti-diabetic||5.83||6.89||2006|
|Nivolumab||Bristol-Myers Squibb/Ono||Cancer antibody||–||6.33||TBC|
|Tecfidera||Biogen Idec||Multiple sclerosis||0.88||5.74||2013|
|Soliris||Alexion Pharmaceuticals||Rare haematological conditions||1.55||5.12||2007|
The figures in this analysis reflect the Sovaldi franchise, in that they also include sales forecasts for a fixed-dose combination with ledipasvir that could reach the market at the end of this year. This all-oral regimen promises to remove the need for interferon injections and significantly reduce the duration of treatment for large numbers of patients. Its availability is expected to provide a big boost to the franchise.
Expectations around Sovaldi are clearly already huge, but working out just how substantial the product could become is a question that still preoccupies analysts and investors.
Consensus currently has sales peaking in 2017 at $13.6bn and edging slightly lower each year, out to 2020. AbbVie’s Humira is also seen peaking in 2017, at $14.2bn; analysts are modelling a faster decline in sales, prompted by competition from new therapies and biosimilars, with the product dropping below Sovaldi in 2019.
However, for Sovaldi to remain a $13bn+ franchise after 2017, as these numbers suggest, several assumptions need to play out. Critically, the number of new patients seeking treatment for hepatitis C each year must hold up, particularly in the US, while Gilead also needs to maintain the product's price. This could be driven down by payers or aggressive price competition from new entrants.
As such, real questions remain over this franchise's longevity, and Sovaldi’s time at the top is far from assured at this stage.
Established brands and unknown quantities
Elsewhere the top 15 is dominated by hugely successful brands like Sanofi’s insulin Lantus, Merck’s type 2 diabetes treatment Januvia and Bayer’s oral blood thinner Xarelto, while Roche puts in a strong showing with two of its top-selling oncology drugs.
Three anti-rheumatics on the list are sold globally by a handful of different companies, their success driven by broad labels that allow them to be sold in a wide range of autoimmune conditions like RA, psoriasis and Crohn’s disease.
The analysis also highlights the durability of biotechnology – more than half of these drugs are biotech-based – aided by their relatively higher price tags and resistance to competition from cheaper copycats.
These well-established products are highly likely to perform as expected, or thereabouts, in the coming years. It is the most recent launches that are more likely to surprise, although even here the likes of Eylea and Tecfidera are showing no signs of failing to live up to lofty expectations.
The biggest unknown remains Bristol-Myers’ nivolumab, arguably the most advanced anti-PD-1 antibody in development. As an immune checkpoint inhibitor, it promises big improvements in the treatment of cancers like melanoma and lung. With the first phase III data due to start emerging towards the end of this year or early 2015, the real potential of nivolumab and others in its class will soon be judged with greater insight.
The field of immuno-oncology holds great hope for a step change in the treatment of several cancer types, and could well yield products that make it into this analysis in coming years. But at present Sovaldi is showing all the signs of storming its way to the take the top spot five years from now.