Take a look at most global drugmakers' income statements, and it's obvious the U.S. is all-important for pharma. Sales in the country typically outshine those in other regions. And it's no wonder: The U.S. is a $485 billion market, according to IQVIA's latest report on the global drug industry.
That size opportunity is one reason the U.S. is the first place most drugs launch. But the U.S. is also where drugmakers have the most pricing power, and where regulators, for all the criticism they face for any delays, tend to speed worthy new treatments to market.
And these days, when many of the world's biggest drugs are also biologics, the U.S. is also where top brands face less copycat competition. While biosimilars overseas are seriously eating into sales for several big brands—including AbbVie's behemoth Humira—in the U.S., patent protections have kept many biosims at bay.
That's certainly the case for Humira, which now won't face U.S. biosims until 2023, thanks to AbbVie's series of patent settlements with its potential rivals.
Check out the list below, and you'll notice several major blockbusters benefiting from biosimilar delays. You'll also see some small-molecule meds that are about to fall hard to generic competition. Overall, the assortment of drugs spans specialty fields such as cancer and immunology, and mass-market indications such as diabetes.
In general, the top of the list is a lineup of successful legacy drugs, including Humira, Celgene's Revlimid (No. 2), Amgen's Enbrel (No. 3) and Roche's Rituxan (No. 4). But driven by successful launches for some precocious challengers—and a mix of generic competition, tighter discounts and slow growth for older blockbusters—a few newbies are quickly moving up the rankings.
Humira enjoyed another year at the top of the pack in U.S. sales, clearing more than double its nearest competitor with $13.68 billion. While Humira won't face any biosimilar competition in the U.S. until 2023, the drug's first-quarter sales drop in Europe—its first—could offer a vision of the drug's future in the coming years. In a distant second, Revlimid posted $6.47 billion on the year.
A few highlights on the list are Gilead's Genvoya (No. 12), the HIV treatment the drugmaker called the most successful single-tablet launch in its history. The drug, which launched in 2016, scored $3.63 billion in 2018.
The single greatest success story on the list has been Keytruda (No. 6) and its meteoric rise up the list with an 80% sales increase on the year to $4.2 billion. Keytruda, in a neck-and-neck battle with Bristol-Myers Squibb's Opdivo in immuno-oncology, has aggressively pursued new indications and reaped the rewards for its pursuit.
On the other end of the spectrum, Johnson & Johnson's Remicade (No. 11) saw a 20% sales decrease on the year to $3.7 billion, driven by aggressive payer discounting and market share stolen by two biosimilar competitors. If sales continue to decline, it could knock J&J's inflammation blockbuster off of 2019's list.
FiercePharma used corporate financial statements and annual earnings transcripts to assemble this list of the top 20 drugs by 2018 U.S. sales. We limited the universe to single drugs rather than franchises that include combination therapies. For instance, Merck's DPP-4 diabetes franchise—Januvia and Janumet—did not make the list despite sales that in tandem would have earned a spot.
Take a look below for a snapshot of the drugs dominating in the U.S.—at least for now. Thoughts about trends likely to shuffle the rankings in 2020? Feel free to get in touch. — Kyle Blankenship (email) | (Twitter)