четверг, 26 января 2017 г.

The top 20 drugs in 2020--worldwide sales

Forecasting drug sales is a tricky business; just ask any biopharma CEO who has overpromised and underdelivered. The people who make it their business know that very well, and they update their numbers with every big shift in the market and every surprise result from a key clinical trial.

These days, the variables are many, with some more variable than others. Biosimilars are coming in the U.S., with several big products targeted in the next few years. We know that's going to hit the original biologics; we aren't sure how much. Payers are increasingly pressing for discounts, particularly in highly competitive fields like hepatitis C drugs, respiratory meds and diabetes treatments. How much will those discounts grow, and how much might the pressure spread beyond those areas? How might new approaches to cancer-drug reimbursement--such as Express Scripts' ($ESRX) indication-specific project--affect sales of those meds?

Some hotly anticipated outcomes trials could raise the prospects for some drugs, just as a cardiovascular trial did for Eli Lilly and Boehringer Ingelheim's Jardiance last year. Will they deliver the goods for Amgen ($AMGN), Sanofi ($SNY) and Regeneron's ($REGN) PCSK9 drugs? Novo Nordisk's ($NVO) Victoza?

Will new safety concerns pop up for blockbuster multiple sclerosis meds as they did for Biogen's ($BIIB) Tecfidera last year?

We'll be looking out for the answers. But for this moment in time, we present the 20 drugs expected to top the worldwide ranks in 2020, as analyzed by the market research and consulting firm EvaluatePharma. They include some old standbys--Roche's ($RHHBY) Herceptin and Avastin, Pfizer ($PFE) and Amgen's Enbrel, Merck & Co.'s ($MRK) Januvia--and some brand-new entrants, such as Bristol-Myers Squibb's ($BMY) immuno-oncology treatment Opdivo, who hits the list in third place. They range from 2020 sales at the high end of $15.92 billion--AbbVie's ($ABBV) Humira--to $4.04 billion at the low end, forecasted for another newcomer, ViiV Healthcare's HIV fighter Triumeq.

Meanwhile, three not-so-lucky contenders fell out of the top 20 just since last summer, when EvaluatePharma published its annual ranking; you can get more info on them by clicking through. Xarelto, Bayer and Johnson & Johnson's ($JNJ) blockbuster anticoagulant, lost ground after its head-to-head competitor Eliquis revved up its sales for Pfizer and BMS. For AbbVie and Johnson & Johnson's Imbruvica, a hot-selling leukemia and lymphoma med, growth depends on the results of clinical trials in new indications, always an uncertain proposition. And Lantus, Sanofi's long-dominant basal insulin, faces biosimilar competition in the U.S. by the end of 2016, not to mention some other branded competitors, including the French drugmaker's own Toujeo.

Do you have thoughts about 2020's top 20? Will the list change much as that date approaches? As always, let us know.

The top 20 drugs in 2020--worldwide sales




1. Humira


by Michael Gibney |


AbbVie and Eisai
Rheumatoid Arthritis and other inflammatory conditions
2015 sales: $14 billion
2020 projection: $15.92 billion
Humira, currently the world's best-selling drug, will still be holding onto that title in 2020, EvaluatePharma predicts. Between now and then, though, analysts expect it to hit its peak and then begin its decline. The key questions: When, exactly, will that decline begin? And how fast will it happen?
The answers depend on which analysts you ask. It's no secret that biosimilars are on the way; India's Zydus Cadila already has one on the market in India, and plenty of other knockoff makers wouldn't mind snagging a piece of the med's hefty sales haul. In June, biosimilar industry members, payers, regulators, lawyers and healthcare investors who participated in a survey conducted by Bloomberg Intelligence predicted Humira biosims would be the most successful copycat biologics launched in the U.S. and Europe.
AbbVie, though, has touted its robust stateside IP protection, which it claims will keep rivals off the U.S. market until 2020. As Suntrust analyst John Boris sees it, the company will have time to extract "maximum value" from the franchise through volume gains, pricing, label expansion, a new formulation, etc.--all "well before" biosimilars hit.
Citi analyst Andrew Baum sees things differently, though. Humira sales will take a hit beginning in 2018, he predicted in a February note to clients, with the med's revenues declining from $16 billion at their peak in 2017 to $6 billion in 2022.
AbbVie is trying to soften the blow through M&A and new products. The company in 2014 shelled out $21 billion for Pharmacyclics to get its hands on the drugmaker's share of blood cancer powerhouse Imbruvica. And analysts are predicting big things from AbbVie's new hep C med Viekira Pak, which could potentially break the blockbuster barrier.
New indications could also help Humira on the rocky road ahead. AbbVie recently snagged European approval for a new formulation of the drug to reduce pain from injections. In September 2015, the company scored a win after the FDA approved Humira to treat a rare inflammatory skin disease--an indication with peak-year sales potential of $1 billion annually, Scott Brun, AbbVie's VP of pharmaceutical development, told FiercePharma at the time of the approval.
AbbVie plans to keep the regulatory wheel churning for Humira, he added, planning to submit applications in the U.S. and EU in 2015 for Humira to treat inflammatory eye diseases. Those indications, along with 9 other approved indications in the U.S., make the drug "well-positioned to face the challenges of potential new entrants," Brun said. --Carly Helfand

2. Revlimid


by Michael Gibney |







Celgene
Multiple myeloma
2015 sales: $5.8 billion
2020 projection: $10.2 billion

Celgene ($CELG) may have lain its foundation on Thalomid, the rehabilitated form of thalidomide redirected at cancer rather than morning sickness. But it was Revlimid that made the Summit, NJ-based drug developer into the Big Biotech it is today. And though Celgene has branched out beyond its multiple myeloma specialty--into breast, lung and pancreatic cancer with Abraxane, leukemia with Vidaza and anti-inflammatory disorders with Otezla--it still relies on Revlimid to power its top and bottom lines.

Approved to treat multiple myeloma, Revlimid brought in $5.8 billion in 2015, a 16% increase year over year. Celgene expects it to grow another 15% this year, to $6.6 billion to $6.7 billion. That's more than 60% of the company's expected sales for the full year, which Celgene forecast at $10.5 billion to $11 billion.

Of course, with patent expirations coming and biosimilars on their way, Revlimid can't shoulder that load forever. In late 2015, Celgene struck a patent settlement with India's Natco Pharma allowing a biosimilar to launch beginning in 2022, albeit in a limited way. Under the deal, Natco will be able to launch subject to volume limits that grow year by year until 2025. When 2026 dawns, the Indian drugmaker will be able to roll out its biosimilar Revlimid unfettered.

But that's years away. Revlimid is expected to keep going strong till 2020 at least, even as Celgene's follow-up drug Pomalyst takes hold in the market. The next-gen multiple myeloma treatment almost broke the blockbuster barrier in 2015, recording $983 million. That's a good thing for the company and the lofty sales goals set out by Chairman Bob Hugin. The company has targeted $12 billion by 2017, and if sales continue to grow at a 15% clip, Celgene would hit the bullseye. -- Tracy Staton 

3. Opdivo


by Michael Gibney |



Bristol-Myers Squibb
PD-1 immuno-oncology treatment
2015 sales: $942 million
2020 sales: $8.4 billion

It might seem remarkable that within in the next 5 years a brand-new drug would become the third bestselling med in the world, and soar from zero to $8.4 billion with breakneck speed. But then Bristol-Myers Squibb's ($BMY) Opdivo is turning out to be a remarkable drug.


The cancer treatment was approved ahead of schedule right before Christmas in 2014 and has proved to be a gift that keeps on giving. It is a PD-1 inhibitor, so it interferes with a mechanism cancer cells use to escape detection by the body's immune system, and as such can be targeted at a variety of cancers. It was initially approved for treating melanoma but that was quickly followed by an FDA nod for treating non-small cell lung cancer. In October it won FDA approval to treat squamous non-small cell lung cancer (NSCLC) and then in October won approval for non-squamous NSCLC. It also performed so well in a late-stage kidney cancer study, displaying such a survival advantage over Novartis' ($NVS) Afinitor, that the monitoring committee stopped another trial early.


And BMS expects much more. The company reported in March that it is testing Opdivo on "multiple tumor types consisting of more than 50 trials--as a monotherapy or in combination with other therapies" with more than 7,000 patients globally.

Along its soaring trajectory Opdivo is expected to surpass Merck's ($MRK) Keytruda, also a PD-1 inhibitor which got its approval three months ahead of Opdivo. The two have been tracking neck and neck in approvals, and Merck has said it has more than 85 clinical trials underway across more than 30 tumor types among 14,000 patients, also alone and in combination with other drugs. But EvaluatePharma's projections put its sales in 2020 at just under $5 billion, which is not too shabby, but which places it at 19 on the list, far below Opdivo. Eric Palmer

4. Harvoni


by Michael Gibney |

Gilead Sciences
Hepatitis C
2015 sales: $13.9 billion
2020 projection: $7.7 billion

Gilead Sciences ($GILD) has garnered its fair share of attention since rolling out hep C combo med Harvoni last year. A treatment breakthrough, Harvoni was the first hep C cocktail in a pill, and its high cure rates coupled with manageable side effects made it instantly popular.

But the drug's $95,000 per 12-week treatment course price tag triggered pushback from the public and payers, who were already unhappy with sky-high prices for Gilead's blockbuster hep C med Sovaldi. Harvoni "threatens to impose staggering costs on our healthcare system," the National Coalition on Health Care wrote to Congress last year. And the pricing model for new therapies is "not sustainable," Steven Miller, chief medical officer at PBM Express Scripts ($ESRX), said at the time, vowing to take matters into his own hands to reduce costs.

Miller lived up to his word. Last year, Express Scripts selected AbbVie's ($ABBV) Viekira Pak for exclusive formulary coverage in return for a sizeable discount, shunning Gilead's Harvoni and Sovaldi and sparking a pricing battle between the two companies as they each inked exclusive deals with payers. The way Miller sees it, the price war could save consumers $4 billion this year alone. It has certainly cut into the per-patient cost; some analysts estimate discounts and rebates of upwards of 40%.
Gilead has defended its pricing for Harvoni and Sovaldi by pointing to their benefits, saying the drug prevents costly complications including liver transplants, liver cancer and repeat hospitalizations.

And at least some experts agreed with Gilead's assessment. In July 2014, a panel of doctors and healthcare professionals assembled by the American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America (IDSA) found that Gilead and AbbVie drugs are cost-effective at their currently discounted prices.
Still, Gilead could face more pushback as patients and payers grapple with Harvoni pricing. Some state Medicaid programs are refusing to cover the treatment citing high costs. Some patients have sought the med overseas. Perhaps as a result, Harvoni scripts keep slowing--a trend that will likely continue, according to RBC Capital Markets analysts Michael Yee and Adnan Butt.

But Gilead isn't worried about the slowdown. The company has only "touched the tip of the iceberg" in assembling a patient pool for its hep C meds, CEO John Martin said during the company's Q2 conference call last year. Strong sales of the med, along with its promise of a cure, could be enough to garner blockbuster numbers in the years to come. -- Emily Wasserman

5. Prevnar 13



Pfizer
Pneumococcal vaccine
2015 sales: $6.02 billion
2020 sales projection: $6.9 billion

Far and away the world's top vaccine in 2015, Pfizer's ($PFE) pneumococcal disease blocker Prevnar 13 will continue to reign atop the vaccines world through 2020, EvaluatePharma predicts.

Since hitting the European market in December 2009 and the U.S. market shortly after in February 2010, Pfizer's megablockbuster vaccine has gained sales expansions through additional regulatory nods and a prequalification from the World Health Organization. In a major decision in August 2014, the Centers of Disease Control's Advisory Committee on Immunization Practices recommended the shot for adults aged 65 and older in the U.S., a move estimated to help the jab bring in an additional $2 billion sales per year.

And so far for Pfizer, sales increases in 2015 have supported those estimates. Pfizer's Prevnar franchise brought in $6.2 billion in 2015, a jump from $4.46 billion in 2014. In the U.S. last year, Prevnar 13 sales increased 102% to help the New York pharma's vaccines unit achieve a 44% gain. The increases are due to "continued strong uptake" in U.S. adults since the ACIP recommendation, company execs have said.

EvaluatePharma's analysts have predicted that Prevnar 13 will capture nearly 17% of the entire vaccines market in 2020.

To continue the success, Pfizer's vaccines head Albert Bourla has said that Prevnar 13 can count on the U.S. adult catch-up population to last into this year and next. Additionally, 4 million people a year will reach age 65 in the U.S., execs have explained, and Pfizer is working "country by country" to broaden the vaccine's reach in G7 nations, Bourla said.
"And there, of course, you have a huge cohort of probably substantially larger than the U.S., probably twice the size of the U.S. And that's going to take market development," Bourla said.

In Pfizer's 2016 guidance, executives have said they expect the vaccine to maintain the strong performance, but cautioned against expecting any sales increases.
Though Prevnar 13 has been a shining star in the pharma's vaccines unit, Pfizer has worked in the last year to diversify the group beyond the jab, looking to both M&A and internal development to broaden its offerings. -- Eric Sagonowsky

6. Avastin


by Michael Gibney |

Roche
Cancer
2015 sales: $6.95 billion
2020 projection: $6.36 billion

Roche ($RHHBY) has been milking everything it can from Avastin since winning approval for the drug to treat colon cancer a decade ago, pushing for label indications to rake in stellar sales. In August 2014, the company nabbed an FDA OK to use its med to treat cervical cancer. A few months later, the agency signed off on Avastin in combination with chemotherapy as a treatment for platinum-resistant ovarian cancer, delivering another win to the Swiss drugmaker. The drug already had indications in breast, lung and kidney cancers.

Roche's hard work appears to be paying off. In 2014, the Basel-based drugmaker saw Avastin sales shoot up 6% on the heels of regulatory blessings, adding some extra padding to its top-line haul. And last year, the drug delivered a 9% increase to 6.68 billion Swiss francs, or about $6.95 billion.

Still, things haven't been all smooth sailing for Roche with Avastin--especially in tight-fisted European countries. The U.K.'s National Institute for Health and Care Excellence (NICE), has taken some shots at Avastin, restricting its use in the country on cost-effectiveness grounds. Patients can still access the drug through England's Cancer Drugs Fund, which covers treatments that NICE rejects. But the fund recently announced that it would "de-list" some of its covered meds in an effort to cut costs, and some say Avastin could be the next to go. -- Emily Wasserman

7. Herceptin

by Michael Gibney |





Roche
Anti-HER2 for breast cancer
2015 sales: $6.79 billion
2020 sales: $5.66 billion
Roche ($RHHBY) has had a good, long run for Herceptin, a drug that remains its third-best seller after about 15 years on the market, coming in between two other Roche drugs on this list, Avastin and Rituxan. The company's first targeted cancer drug, aimed at patients whose tumors have specific genetic characteristics, Herceptin has paved the way for what has become a huge part of the cancer treatment market. In this case, the appropriate patients have tumors that overexpress the HER2 gene.

But Herceptin's days as an unchallenged leader are waning. Mylan ($MYL) and Indian partner Biocon have launched their own versions in India, and South Korea's Celltrion has a biosimilar of the drug approved in its home country. U.S. drugmaker Hospira ($HSP), which has an aggressive biosimilar program underway, is laying the groundwork for attacking the U.K. market, convincing a court to set aside two Roche patents on the drug. Unless Roche wins an appeal, the ruling could open the large market to biosimilar competition when Herceptin's main patent expires on July 28. -- Eric Palmer 

8. Soliris

by Michael Gibney |

Alexion
Rare diseases including atypical hemolytic uremic syndrome
2015 sales: $2.59 billion
2020 projection: $5.60 billion

Soliris is one of those treatments for ultra-rare diseases with an ultra-high price tag. In fact, for several years it has topped the ranks of the world's most expensive meds--and its list price keeps getting higher. At last word, its U.S. list price was $669,000 per year, according to CBC News.

Because the diseases Soliris treats are so rare, payers tend to be willing to cover the costs. Alexion ($ALXN) has seen some pushback lately: Canada tried to crack down on its price, and the company sued, while cost-effectiveness watchdogs in England demanded information on R&D and manufacturing spending to justify the cost.

Still, the National Institute for Health and Care Excellence decided to cover Soliris anyway. Its sales continue to climb, to almost $2.6 billion in 2015 from $2.2 billion in 2014. Three potential new indications, including one in myasthenia gravis, could give Soliris an even bigger boost, analysts say. Some not only predict the drug will top $5 billion by 2020, but also figure it can burgeon to $7.5 billion by 2025.

One potential spoiler: A rival drug from Alnylam ($ALNY), ALN-CC5. Phase II data on the drug will be unveiled at a conference in June. It's an RNAi therapy designed to go after a particular gene implicated in the diseases Soliris now treats. -- Tracy Staton

9. Tecfidera

by Michael Gibney |

Biogen
Multiple sclerosis
2015 sales: $3.64 billion
2020 sales projection: $5.56 billion

When Biogen ($BIIB) rolled out Tecfidera in April 2013, it was the third multiple sclerosis pill to hit the market after Novartis' ($NVS) Gilenya and Sanofi's ($SNY) Aubagio. No first-to-market advantage, but the much-anticipated drug quickly zoomed to first place among oral MS treatments--and notched blockbuster-pace earnings in 2013, with $873 million for its first eight-plus months on the market.

By 2014, Biogen was hiking its earnings projections as Tecfidera sales grew and the drug's route forward seemed clear. But in October 2014, Biogen reported the death of a Tecfidera patient suffering from progressive multifocal leukoencephalopathy (PML), a rare brain infection. The FDA added that information to the drug's official label the next month.

Still, Tecfidera ended the year with $2.9 billion in sales. But in July 2015, the company confirmed another PML case, this one non-fatal, in a patient using a compounded version of Tecfidera's active ingredient, dimethyl fumarate. Scientists followed up by urging doctors to closely monitor patients for PML risks and called for more research into the condition.

PML has cropped up in MS patients before, including those using Biogen's own Tysabri. Novartis' Gilenya, for instance, was tagged with its third PML case last August. Tecfidera sales didn't take off the way Biogen had anticipated last year, and flat script trends led the company to cut its forecast for the year

Growth slowed to the point where Biogen felt the need to cut 800 jobs and other costs to help fund a new marketing-and-education push for Tecfidera. The company replaced its commercial chief, Tony Kingsley, in mid-October. Meanwhile, it stepped up sales calls and rolled out a brand-new TV campaign. By the end of 2015's fourth quarter, the drug had racked up $993 million in sales for the period, a 16% increase year-over-year. Full-year sales amounted to $3.6 billion, 19% growth over 2014.

"We are seeing positive leading indicators for the recently launched marketing campaign for Tecfidera, including increased visits to our website and higher call volume into our patient services organization," CFO Paul Clancy said during the company's Q4 earnings call. No doubt Biogen hopes the buzz continues. Analysts seem to think that the drug can weather any safety worries, with an average prediction of $6.8 billion by 2020. -- Tracy Staton


10. Orkambi


Vertex Pharmaceuticals
Cystic fibrosis
2015 sales: $351 million
2020 projection: $5.45 billion
When Orkambi, a combination med containing Vertex' ($VRTX) Kalydeco, won FDA approval earlier this year, the company believed it could eventually expand its treatable population by tenfold. Unlike Kalydeco--initially approved only for cystic fibrosis patients with a mutation affecting only 4% of CF patients worldwide--Orkambi has the potential to benefit 8,500 patients age 12 and older in the U.S. alone. That's more than four times the number currently eligible for Kalydeco.

A larger group of patients on the drug won't be the only thing that helps it rake in serious sales. Orkambi, with a sticker of $259,000, also bears an orphan drug price, despite its larger patient pool--a fact that has pricing critics up in arms.

Vertex has a four-point justification for the high cost, as chief commercial officer Stuart Arbuckle laid out on a conference call following Orkambi's approval. There's the size of its patient population, still relatively small when compared with other meds; the clinical benefit of a therapy that treats the underlying cause of CF; the time and cost Vertex plowed into bringing the med to market; and the need to invest in further R&D to aid thousands of other patients with different forms of the disease down the line, he said.




Payers, though, have been laying the groundwork for their discount arguments since before the FDA gave Orkambi a nod. In May, Prime Therapeutics forecast that if priced on par with solo Kalydeco, the new tandem could run the pharmacy benefits manager $367,000 per patient per year, with medical and pharmacy costs included. Lifetime treatment cost for a patient beginning therapy at age 12: $10.3 million, the PBM figured.

Meanwhile, there could be some competition down the road. Recently, Concert Pharmaceuticals said it was able to show that by replacing a single hydrogen atom in Kalydeco with deuterium, it achieved better results in a small, early-stage clinical trial. -- Carly Helfand

11. Entresto

by Michael Gibney |




Novartis
Heart failure
2015 sales: $21 million
2020 projection: $5.32 billion
Novartis ($NVS) has said it expects new heart failure med Entresto to be its "most exciting" launch ever, and it's working to make that a reality. But investors may have to wait a little while before the real excitement kicks in.

After rolling out this summer, the drug fell short in the fourth quarter of 2015, bringing in just $5 million. But the Swiss pharma giant says things are about to heat up, and it plans to make that happen with an expanded, retrained sales force that'll be targeting mainly cardiologists.

Payers have been one factor holding things up for the future blockbuster, but a pair of new deals suggest the tide may already be turning in that department. In early February, Cigna ($CI) and Aetna ($AET) announced that they had each struck "value-based" pricing accords with Novartis. Cigna's payments to Novartis will depend on Entresto's results, with dollar amounts linked to the rate of hospitalization among patients on the med. And Aetna's pact is based on the drug delivering real-world results similar to those seen in clinical trials.

Novartis will also be looking to its DTC efforts to pump up Entresto, too, but so far, its disease-awareness push is making viewers uncomfortable. Critics have called it "alarmist" and "horrifying" and accused the drugmaker of using it to "play on the fears of patients." -- Carly Helfand

12. Rituxan

by Michael Gibney |






Roche
Anti-CD20 MAb
2015 sales: $7.32 billion
2020 sales: $5.05 billion
Rituxan, developed by Roche's ($RHHBY) Genentech, is one of several drugs in the top 20 that are seeing sales wane: It is expected to be down 6% in 2020 compared to 2014. But even with its slow fade, it is expected to generate more than $5 billion in annual sales in 2020.

Approved nearly 20 years ago, MabThera as it is known in some markets, has the distinction of being the first monoclonal antibody treatment for cancer and has held the title as the best-selling cancer drug. It will lose that distinction to some newer treatments like Bristol-Myers Squibb's ($BMY) Opdivo, but Rituxan continues to be a go-to treatment in many instances.

Because it is so successful, there are a host of biosimilar developers hoping to steal some of those sales when it goes off patent in 2018. But Roche did not wait around to see how that would play out. It developed a followup, Gazyva, which has outperformed Rituxan in the treatment of chronic lymphocytic leukemia (CLL), and for which the FDA and the EU have approved it as a first-line treatment. Gazyva, however, is not expected to see the kind of success that Rituxan has had, with peak sales projected to reach only $2.5 billion, if that much. -- Eric Palmer

13. Enbrel

by Michael Gibney |




Amgen and Pfizer
Rheumatoid arthritis, psoriasis and other inflammatory conditions
2015 sales: $5.36 billion
2020 projection: $4.95 billion
Enbrel is among the few drugs expected to top the rankings in 2020 despite an impending decline in sales. The drug is on the verge of facing biosimilar competition in Europe, with Biogen ($BIIB) and Samsung Bioepis set to launch a competing version. Biosim rivals are farther away in the U.S.--just how far away is open to question--but Amgen ($AMGN) won new patents in 2011 that could protect the drug through 2029.
Europe is Pfizer's ($PFE) problem, because it holds marketing rights to the drug outside the U.S. Biogen and Samsung won European committee backing for their version, Benepali, in November 2015, with full approval expected within a few months.

The conventional wisdom on biosimilars is that the pricing discounts will be modest and market-share gains commensurately smaller than with run-of-the-mill generics. But as Remicade's experience in the European market shows, some biosimilar makers are acting more aggressively, with discounts topping 50% or even 60% in some countries. Whether Biogen and Samsung are eager to do the same remains to be seen.

Meanwhile, Pfizer's international Enbrel sales face other problems, albeit smaller: Merck ($MRK) and Samsung Bioepis have biosim approval in South Korea, while Cipla sells a version in India.

It's Amgen that will face U.S. competition, but perhaps not for many years yet. The Thousand Oaks, CA-based biotech figures its new patents will hold off biosimilar Enbrel till 2029. But Novartis' ($NVS) Sandoz unit has already filed for FDA approval for its version, and it's ready to challenge Enbrel's new patent protection.

"Sandoz believes that it has a good faith legal basis to challenge the validity of these patents," Sandoz said in a statement after the FDA accepted its approval app.

For Amgen, an Enbrel copy in the U.S. would put $5.1 billion in 2015 revenue at risk, and the California biotech has been preparing. In 2014, it announced far-reaching job cuts affecting 2,900 positions--or 15% of its workforce. Since then, Novartis has already begun threatening Enbrel's slice of the pie with next-gen psoriasis-fighter Cosentyx, which hit the market earlier this year. -- Tracy Staton

14. Remicade

by Michael Gibney |




Johnson & Johnson, Merck & Co., Mitsubishi
Anti-TNF alpha drug for inflammatory disorders
2015 sales: $5.78 billion
2020 sales: $4.8 billion
Remicade is another of the half a dozen drugs among the top 20 whose sales are expected to be on the downward slope by 2020. But even so, the arthritis treatment is still expected to generate nearly $5 billion in sales. That is despite being badly beaten up by competition from biosimilars in Europe--where it already has lost patent protection--and the prospect of a knock-off hitting the market in the U.S. this year.

Many drug watchers initially assumed that the complexity and cost of making biosimilars, unlike small molecule drugs, would keep their discounts within 20% to 30% of the reference drugs. That was, in fact, the very position taken by Alex Gorsky, CEO of Remicade maker Johnson & Johnson ($JNJ), during the Q2 2015 earnings call. "Remember, biosimilars are not generics and we expect the biosimilar market to behave quite differently than the market typically has toward the introduction of a generic." He told analysts that the company expected doctors to refrain from switching the 70% of Remicade patients well-controlled by the therapy.

But in some European countries, Remicade biosimilars have been deeply discounted as competitors vied for market share against the original and each other. In Norway, a distributor discounted the Celltrion biosimilar of Remicade by nearly 70%, allowing it to grab about 50% of the market in a price war with Hospira, which also has a Remicade copy. Then in France, Hospira reportedly captured a public contract by offering a price that amounted to a 45% savings over Remicade. The result for Merck ($MRK), which sells the drug in Europe, was eye-opening. For the full year, the drug brought in $1.79 billion, down from $2.37 billion in 2014. That's a decline of 24%, or 10% ex-currency effects.

Of course, it is the U.S. market where major money is made or lost in the battle over copies, and it is virgin territory for biosimilars. There is still a question of how well they will be received. But with a favorable vote from an FDA advisory panel, it appears a copy from Pfizer, which now owns Hospira, will hit yet this year, starting the erosion of market share in the U.S. J&J still has moves it can make. The med's key patent is under review and if the company loses, it will certainly appeal that decision, hoping to hold onto its sales as long as possible.  -- Eric Palmer 

15. Xtandi

by Michael Gibney |




Astellas and Medivation
Prostate cancer
2015 sales: $1.87 billion
2020 projection: $4.78 billion
Back when Xtandi was working its way through Medivation's ($MDVN) pipeline, market-watchers anticipated that the cancer pill could whiz ahead of Johnson & Johnson's ($JNJ) blockbuster Zytiga. So far, however, Zytiga has remained a step ahead of Xtandi, both in FDA approvals and in sales.

Medivation and marketing partner Astellas think that can change. In late 2014, the companies announced that Xtandi was FDA-approved to treat advanced prostate cancer in patients who hadn't yet received chemo. That first-line approval opened up a big new market to the drug, which had been OK'd only for patients who'd already failed on chemo.

Though Xtandi was second to this market, too--and Zytiga had already made big inroads--the drug has at least one advantage Astellas can use in its favor. Xtandi is a monotherapy, while Zytiga is used alongside the steroid prednisone. And then there's the combo approach, which could be a boon for both drugs: An ongoing Xtandi-plus-Zytiga trial, PLATO, reads out later in 2016.

The companies are also studying Xtandi in breast and ovarian cancers, which could obviously be big new markets for the med.

Leerink Partners analyst Geoffrey Porges sees Xtandi eventually hitting $4 billion to $5 billion in global sales--$6 billion, even, if it can expand into new indications as hoped. But in the next couple years, not so much. "The near-term outlook for [Medivation's] revenue trajectory and operating performance is unlikely to reflect this potential," Porges wrote in a recent investor note, "given the product's slower-than-expected uptake among the urologists who treat 85% of the eligible prostate cancer patients."

The overall prostate cancer marketplace is heating up with competition, including Bayer HealthCare's Xofigo and Dendreon's Provenge, recently bought out of bankruptcy by Valeant Pharmaceuticals ($VRX). Not surprisingly, an increase in market size is also expected, with Decision Resources estimating the market will double from $4.4 billion in 2013 to $9.3 billion by 2023. -- Tracy Staton

16. Januvia

by Michael Gibney |




Merck & Co.
Diabetes
2015 sales: $3.99 billion
2020 projection: $4.52 billion
Merck's ($MRK) top-selling diabetes franchise has taken a few hits in recent years as questions about its safety arose and new competitors hit the market. But regulators and new data have eased many of those concerns, and as diabetes continues to burgeon in the U.S. and, increasingly, the developing world, the market for treatments is only growing.

Januvia and Janumet are mainstays of Type 2 diabetes treatment, used earlier in the disease than insulin treatments but typically after or alongside first-line metformin. Within the DPP-4 class it competes with AstraZeneca's ($AZN) Onglyza and Eli Lilly's ($LLY) Tradjenta, but it has dominated those drugs for years. It also competes with the GLP-1 drug class--which are also "incretin mimetics" like Januvia, but work in a different manner.

On the safety side, last year, Januvia's cardiovascular safety study TECOS unearthed no additional heart risks for patients using the drug, a positive signal that could increase sales. And in 2014, the FDA and European regulators joined forces to sweep aside some suspected links between Januvia and other incretin mimetics, and pancreatitis and pancreatic cancer.

Now, however, Januvia and Janumet face a new threat in the form of the SGLT2 drug class, which includes Johnson & Johnson's ($JNJ) Invokana and, importantly, Eli Lilly and Boehringer Ingelheim's Jardiance. The latter recently reported breakthrough data from a cardiovascular safety study showing that Jardiance actually reduced the risk of serious cardiovascular events--stroke, heart attack and CV-related death. The companies have asked the FDA to add that information to Jardiance's label, which could give it new edge in the market.

So far, Merck sees Jardiance pulling market share away from other SGLT2 drugs rather than cutting into other classes. But some analysts disagree. If Lilly and Boehringer win the CV label change, doctors might not switch their Januvia patients to a different med, but Jardiance could siphon away new patients.

Still, diabetes patients often need to try different drugs--or different combinations of drugs--as their disease progresses. "We individualize therapy," Merck VP of clinical research Peter Stein told FiercePharma after the Jardiance study was released. "It's not a one-size-fits-all situation. I'm going to reach for certain drugs for certain patients. The great thing about DPP-4 inhibitors like Januvia is that it's very well-tolerated, it's very simple to take, it's a daily-medication, it's weight neutral, and so it's got a very favorable profile."

Januvia and Janumet posted about $6 billion in 2015 sales, up 7% after backing out currency effects, $3.2 billion of that in the U.S. With key patents that don't expire till 2022, Januvia won't face generic rivals for several years, one reason why it's pegged at $7.5 billion in 2020 sales. And Januvia's heart-safety study, TECOS, could give the drug a 10% long-term boost, according to Bernstein analyst Tim Anderson. -- Tracy Staton

17. Keytruda

by Michael Gibney |



Merck & Co.
Immuno-oncology therapy
2015 sales: $605 million
2020 projection: $4.50 billion
Merck & Co. ($MRK) and Keytruda are on the leading edge of an immunotherapy wave that's expected to bring in a boatload of new cancer treatments. It's not there alone, however, and it's on its way toward even more competition.

The U.S.-based company rolled out Keytruda for advanced melanoma in September 2014, about three months ahead of Bristol-Myers Squibb's ($BMY) rival PD-1 therapy Opdivo, and the two drugs have been racing for new indications ever since. But though the two drugs may have begun neck-and-neck, Keytruda is expected to lag behind the BMS med in the long term, sales-wise.

Just witness the analyst projections in this ranking, which put Opdivo in third place, but Keytruda in 17th. Keytruda's 2020 sales projection of almost $5 billion isn't shabby at all, of course, surpassed as it is by Opdivo's $8 billion. But Merck isn't conceding first place just yet.

As of February 2016, Keytruda was approved for advanced melanoma--patients previously treated or not--as well as non-small cell lung cancer in patients whose tumors express PD-L1. And Merck had the right to brag that, in one advanced melanoma trial, KEYNOTE-003, Keytruda patients lived longer than those taking Bristol-Myers' Yervoy.

Meanwhile, Merck is studying Keytruda for a variety of other uses, including multiple myeloma, lymphoma, and breast cancer. The company has 160-plus Keytruda trials going, covering more than 30 different tumor types. About half of those trials are testing Keytruda in combination with other cancer meds, including other immunotherapies.

Soon, the PD-1/PD-L1 immunotherapy market won't be a two-drug race, however. Roche's atezolizumab is expected to go to the FDA for approval this year, and more rivals are coming down the pike, including avelumab from Pfizer ($PFE) and Merck KGaA, which won the FDA's "breakthrough" designation in November 2015. -- Tracy Staton

18. Eliquis

by Michael Gibney |




Bristol-Myers Squibb and Pfizer
Anticoagulant
2015 sales: $1.86 billion
2020 projection: $4.25 billion
Eliquis may have gotten off to a slow start that disappointed analysts. But lately, the new-age anticoagulant has come roaring back, thanks to pumped-up investments from its makers.

Most recently, the med posted $602 million in Q4 sales for Bristol-Myers Squibb ($BMY), which shares it with Pfizer ($PFE), to double its haul from the same period in 2014. Full-year sales increased even more than twofold, too. And the therapy now leads its classmates in new-to-brand patient share in cardiology in 12 markets around the world.

With that recent momentum, Bristol CEO Giovanni Caforio doesn't think it'll be long before Eliquis overtakes hefty competitors Xarelto, from Johnson & Johnson ($JNJ) and Bayer, and Boehringer Ingelheim's Pradaxa. The company is "well on our way" to becoming No. 1 in the class, Caforio told investors on the company's Q1 conference call.

But competitors may have a thing or two to say about that--as well as their own strategies to fight off rivals. Xarelto, for one boasts an extensive clinical trial program that's put it at the top of the charts when it comes to its list of indications. And right now, Pradaxa is the only next-gen blood thinner with an FDA-approved reversal agent, Praxbind. -- Carly Helfand

19. Eylea

by Michael Gibney |



Regeneron and Bayer
Range of eye conditions
2015 sales: $2.46 billion
2020 projection: $4.04 billion
In November 2011, it was an FDA nod for Regeneron's ($REGN) Eylea in wet age-related macular degeneration that got the drug off to a blistering start, helping it trounce analyst estimates quarter after quarter.

These days, though, a different indication has been feeding much of the med's growth. Last February, Regeneron touted data showing that Eylea had bested Roche's ($RHHBY) eye med Lucentis and its Avastin--an oncology drug frequently used off-label in the eye--in patients with diabetic macular edema.

Those results helped power Eylea growth last year in the DME market; the therapy expanded by more than 50% in 2015. And currently, they're helping Eylea steal share from the pair of Roche offerings. Regeneron markets the drug in the states and collects a share from international partner Bayer.

But things are slowing down. The company forecasts 20% expansion for the blockbuster med in the U.S. this year. That 20% is "roughly in line" with consensus sales growth estimates of about 19% to 21%, according to Evercore ISI analyst Mark Schoenebaum. But shareholders--used to a breakneck pace from the eye therapy, which trounced sales estimate after sales estimate following its U.S. launch in late 2011--sent the company's stock price downward on the news. -- Carly Helfand

20. Triumeq

by Michael Gibney |





GlaxoSmithKline
HIV
2015 sales: $803 million
2020 projection: $4.04 billion
GlaxoSmithKline's ($GSK) HIV drugs business, ViiV Healthcare, has been steamrolling lately, and it owes much of the recent success to combo treatment Triumeq.

U.S. regulators approved the med--which adds newcomer therapy Tivicay, a fast-launcher in its own right, to commonly used treatments abacavir and lamivudine--in August of 2014, and since then, it's been raking. Overall, it helped push the British pharma giant's HIV sales to £2.32 billion (about $3.37 billion) in 2015, a 54% leap over the year prior.

And those revenues have been critical for Glaxo, which has been looking to offset its losses in the respiratory department. Sales of behemoth Advair have plummeted on pressure from U.S. payers and European generics, one factor that led Glaxo to hang onto ViiV after previously announcing it was weighing a divestment.

Instead, Glaxo may wind up holding the unit and Triumeq closer than ever. If Pfizer ($PFE) wanted to sell out of its share of the joint venture, Witty told investors on the company's Q4 conference call, "there's no way we would turn away that opportunity." -- Carly Helfand


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