Every­body in bio­pharma talks about unmet med­ical needs when they re­view their late-stage pipeline, but it’s the mar­ket po­ten­tial that will ei­ther whip up in­vestors or leave them cold about any in­no­va­tion. The top 10 prospec­tive drug launches loom­ing in 2018 — as se­lected by Eval­u­ate in its 2018 pre­view — un­der­scores all the po­ten­tial of the would-be block­busters that al­ways dom­i­nate bio­pharma R&D news.

So what will we be look­ing out for?

Some very well es­tab­lished mar­ket­ing com­pa­nies are in the mix for a 2018 block­buster launch. There are new ad­vances in HIV and di­a­betes, and it’s not the least bit un­ex­pected to find that 6 of the 10 are ei­ther new can­cer ther­a­pies or drugs for rare dis­eases — two fields where the FDA is now squarely be­hind rapid launches.

The po­ten­tial sales fig­ures are pro­jected for 2022 by Eval­u­ate.

1 Bicte­gravir/F/TAF — Gilead

Peak sales: $5.05 bil­lion
Cat­e­gory: HIV

The scoop: The HIV triplet that Gilead has poised for the mar­ket­place with a Feb­ru­ary 12 PDUFA date il­lus­trates a few things about the com­pany and its po­si­tion in the mar­ket. Gilead has been a dom­i­nant player in HIV for years now, and wasn’t about to let Glax­o­SmithK­line just walk away with any part of their rev­enue with their newly ap­proved two drug combo Ju­luca — which it­self is a land­mark achieve­ment in the drive to make these cock­tail ther­a­pies eas­ier than ever to re­main com­pli­ant with. Gilead’s un­der­stand­ing of the HIV mar­ket is now part of its DNA, and an­a­lysts are quick to give it high marks for being com­pletely prepped on the roll­out when that ap­proval comes through — prob­a­bly sooner than later.

2 Semaglu­tide — Novo Nordisk

Peak sales: $2.7 bil­lion
Cat­e­gory: Di­a­betes

The scoop: Just a few days ago the FDA hit the green light for Novo Nordisk’s semaglu­tide, a once-weekly GLP-1 di­a­betes drug that came through a major Phase III pro­gram with fly­ing col­ors. In fact, their drug — to be sold as Ozem­pic — beat out Trulic­ity in a head-to-head study, which will put con­sid­er­able pres­sure on Eli Lilly’s big new drug. Tapped as a block­buster with more than $2 bil­lion in peak sales po­ten­tial, Novo has also started up a huge obe­sity trial, in­ter­ested in see­ing if it can get pa­tients to shed the weight that can cause di­a­betes in the first place. That makes this drug a clear and pre­sent threat to a whole slate of drugs on the mar­ket, none of which are doing very well.

3 Epaca­do­stat — In­cyte

Peak sales: $1.94 bil­lion
Cat­e­gory: On­col­ogy

Hervé Hop­penot

The scoop: The leader in the IDO1 field is sub­jected to a close-up with every new cut of the data. That hasn’t al­ways gone ac­cord­ing to plan at In­cyte, but re­searchers have stuck close enough to the path to stay on track with fore­casts of a major block­buster fu­ture in can­cer. The im­por­tance of this drug for In­cyte can’t be over­es­ti­mated. And every move from a com­peti­tor, in­clud­ing the pow­er­house team at Bris­tol-Myers Squibb, which paid $1.25 bil­lion to get their hands on theirs, gets equal scrutiny. Get­ting to the top of the field is one thing, stay­ing there will be some­thing else. One part of In­cyte’s plan for main­tain­ing its po­si­tion is by com­bin­ing its drug with sev­eral dif­fer­ent check­points. And In­cyte CEO Hervé Hop­penot even re­cently went out and bought one of his own, after the first deal left him with a check­point with an oddly check­ered his­tory in the clinic.

4 Rova-T — Ab­b­Vie

Peak sales: $1.44 bil­lion
Cat­e­gory: On­col­ogy

The scoop: Ab­b­Vie paid $5.8 bil­lion in cash for this drug, promis­ing up to $4 bil­lion more in mile­stones to ac­quire the lit­tle-known biotech uni­corn Stem­cen­tryx. And with money like that on the table, ex­pec­ta­tions are run­ning high. Com­bined with Bris­tol-Myers’ Op­divo and Yer­voy, Ab­b­Vie is bet­ting that it has a win­ner in small cell lung can­cer, though its first cut of the early data last year failed to im­press any­one out­side of the com­pany. The drug drops a cy­to­toxic bomb right on DLL3-ex­press­ing can­cer cells com­mon in SCLC.

5 Ozan­i­mod — Cel­gene

Peak sales: $1.27 bil­lion
Cat­e­gory: Mul­ti­ple scle­ro­sis

The scoop: Cel­gene execs are not the shy type when it comes to tout­ing an ex­per­i­men­tal drug’s sales po­ten­tial. Their ini­tial mark: $4 bil­lion to $6 bil­lion. That num­ber has been com­ing down, though. Still, Ge­of­frey Porges re­mained a big be­liever at the end of Oc­to­ber as Cel­gene rolled out ap­prov­able num­bers. His es­ti­mate: $2.9 bil­lion in peak sales.

6 Apa­lu­tamide — J&J

Peak sales: $1.24 bil­lion
Cat­e­gory: On­col­ogy

Rich Hey­man

The scoop: This drug (ARN-509) has been on my radar for years. I was fol­low­ing it closely when J&J came in and scooped up Rich Hey­man’s Aragon in one of its block­buster deals, with $650 mil­lion for the up­front alone. It’s thrilling to see it headed to reg­u­la­tors, even though we still haven’t seen the data. J&J is the only top 10 pharma com­pany on this list, and it wouldn’t be here with­out the biotech team at Aragon. It also wouldn’t be here with­out an ag­gres­sive busi­ness de­vel­op­ment team that struck a lineup of bil­lion-dol­lar deals.

7 Elagolix — Ab­b­Vie

Peak sales: $1.21 bil­lion
Cat­e­gory: Women’s health

The scoop: I got a chance to pick through the Phase III data last May, so no big sur­prise that this qual­i­fies as Ab­b­Vie’s sec­ond drug on the top 10. The oral go­nadotropin-re­leas­ing hor­mone (GnRH) re­cep­tor an­tag­o­nist demon­strated some clear, dose-de­pen­dent re­sponses that eas­ily out­paced the placebo arms in two Phase III tri­als, each with more than 800 women en­rolled in them. Both stud­ies tracked clin­i­cal re­sponses for dys­men­or­rhea — acute and po­ten­tially dis­abling men­strual pain — as well as non­men­strual pelvic pain. Ab­b­Vie has been lin­ing up block­busters for the day — prob­a­bly some years from now — when it won’t have the Hu­mira gold mine to rely on any­more. This drug looks like it should make that port­fo­lio.

8 AVXS-101 — Avexis

Peak sales: $1.14 bil­lion
Cat­e­gory: Rare dis­eases

The scoop: Avexis has a piv­otal study in the works for this drug, but it won’t be wait­ing for the data be­fore seek­ing an ap­proval. A few weeks ago we saw some ex­cel­lent data from a tiny study of 15 in­fants treated with this gene ther­apy for spinal mus­cu­lar at­ro­phy. And the agency might well be in a mood to hurry it out to save pa­tients fac­ing a lethal dis­ease. The ther­apy poses a di­rect threat to Bio­gen’s new fran­chise for Spin­raza, priced at $750,000 for the first year — one of the top 10 most ex­pen­sive ther­a­pies in the world.

9 Lanadelumab — Shire

Peak sales: $1.12 bil­lion
Cat­e­gory: Rare dis­eases

Flem­ming Orn­skov

The scoop: Back in May we got a peek at some stel­lar Phase III data for this drug, an­other rare dis­ease ther­apy likely to debut with a six-fig­ure sticker price. Shire paid close to $6 bil­lion for Dyax, largely on the promise of the next-gen HAE ther­apy. And CEO Flem­ming Orn­skov added a $4 CVR worth $656 mil­lion if the drug is ap­proved. That pay­off could be loom­ing in 2018 if the data passes muster with reg­u­la­tors. Orn­skov is trans­form­ing Shire into a rare dis­ease player with global heft. This drug will keep the com­pany pointed in that di­rec­tion.

10 Epid­i­olex — GW Pharma

Peak sales: $960 mil­lion
Cat­e­gory: Rare dis­eases

The scoop: This is close enough to a bil­lion dol­lars to qual­ify for the block­buster mar­ket. The GW crew work­ing on epid­i­olex has been on a roll all year long. They get started with a slate of up­beat data in March, when the drug scored with pos­i­tive piv­otal data for Dravet syn­drome, a rare form of se­vere epilepsy. A few months later, it was Lennox-Gas­taut syn­drome. Not all an­a­lysts have been this con­ser­v­a­tive with peak sales es­ti­mates, with some break­ing the $2 bil­lion mark. But this biotech ap­pears poised for a trans­for­ma­tional year.