What’s next? That’s the perennial query for us curious human beings. Perhaps next in line, for the competitive among us: Who’s on top. And it’s late enough in 2016 for these questions to be on everyone’s minds, particularly with a new U.S. president taking office January 20.
Answers? We’ll have a detailed set of analyses as the year winds down. But by the numbers, EvaluatePharma has a few predictions for 2017, and they reflect the big changes in biotech and pharma of late—and point up some of the pitfalls ahead.
Take the top 10 drugs, ranked by predicted 2017 sales. They’re 10 of the usual suspects, with perennial leader Humira at the top once again, this time at $17.6 billion. Many drugmakers would like to bring in that much revenue from their entire portfolios. But as pharma-watchers know, AbbVie can’t count on Humira growth for too much longer: Biosimilar versions are on their way, and they could hit as soon as 2018, analysts say.
The biosimilar threat applies to six other drugs in the 2017 top 10. Which drugs aren’t so vulnerable? Second-place Revlimid, from Celgene, which has fueled that Big Biotech’s growth for years, and stands to continue; EvaluatePharma, in another report, predicted that it would hit $13 billion by 2022, up from the $8.1 billion expected for next year. Pfizer’s pneumococcal vaccine Prevnar 13 has a long patent life ahead, and $6 billion in predicted 2017 sales. That’s flat from 2016, partly because Prevnar is a victim of its own success: It penetrated its market so quickly that there’s less to gain going forward.
But a drug doesn’t necessarily need to lose its patent to see its sales drop by billions. Like other drugs in the cooling hep C market, Gilead Sciences’ Harvoni is on the wane, as evidenced by an actual sales projection of $7 billion for next year, down from almost $10 billion this year. The company’s entire hep C franchise, including the new pan-genotype med Epclusa, is projected at $11.7 billion for 2017.
EvaluatePharma calls this “an empire on the wane,” what with 2016 franchise sales of $14.9 billion—more than Celgene’s entire revenue guidance for 2016, which stands at $11.2 billion. And Gilead has been under intense pressure to backfill that decline, and investors are so far unhappy with the results. “Gilead’s efforts to replace these revenues—failed efforts, some might say—again hold the potential to generate many headlines in 2017,” EvaluatePharma points out, in something of an understatement.
Gilead is particularly under pressure to make a big acquisition. It certainly has the cash to do so, including some $16 billion held overseas, which might well be repatriated under a Trump Administration tax holiday. Then again, if all U.S. drugmakers are allowed to bring their offshore cash home without penalty, that could push up acquisition prices even farther beyond their current markups.
Getting back to the biosimilars threat, Lantus dropped several places from EvaluatePharma’s 2016 ranking—to $5.2 billion from $6.9 billion—thanks to a biosimilar from Eli Lilly and Boehringer Ingelheim, set to launch in the U.S. later this month. Pfizer is already on track with a Remicade biosim in the U.S., putting Johnson & Johnson’s $5.9 billion in 2017 projected sales at risk.
Meanwhile, Novartis’ Sandoz unit has an FDA approval on tap for a biosimilar version of Enbrel, though Amgen is fighting that launch in patent court. And so on, with Roche’s big three meds Rituxan, Avastin and Herceptin—at third, fourth and sixth place respectively—all facing biosim rivalries in the next few years.
Despite the prospect of a new FDA commissioner, new rules that speed up drug development under the 21st Century Cures Act, and potential government action on drug pricing, biopharma’s long lead times mean certain things aren’t likely to change anytime soon, barring megamergers.
Pfizer will still sit at the top of prescription and OTC drug sales—EvaluatePharma pegs its 2017 sales at $49.9 billion—partly in thanks to its Hospira acquisition. Novartis and Roche are neck and neck, literally, in second and third place, at $42.5 billion each.
Sanofi, Merck & Co. J&J and GlaxoSmithKline occupy the middle of the top 10 chart with revenue projections from $39.9 billion (Sanofi) to $31.2 billion (GSK). AbbVie, Gilead and generics giant Teva round out the top 10, all with revenue in the mid-$20 billions.