The prevalence of diabetes is growing globally, and with that the size of the diabetes drug market. There are more than 370 million people in the world with diabetes, about 90% of those with Type 2 diabetes. More children are developing the disease and more people are dying from diabetes, and so more and more people need treatment. Standard & Poor's has estimated the annual market will hit $58 billion by 2018, from about $35 billion today.
But the market has gotten increasingly competitive and increasingly complex. Just this year, we have seen the FDA ask Novo Nordisk ($NVO) for more risk data on its new long-lasting drug Tresiba, then revisit the safety profile of GlaxoSmithKline's ($GSK) Avandia, a drug that was pulled from the market in Europe and regulated into near irrelevance in the U.S. Regulators and the industry are now doing a deeper dive into the cancer risks of incretin mimetics, a group of drugs for Type 2 diabetes that includes blockbusters like Merck's ($MRK) Januvia and Novo Nordisk's Victoza.
Still, these and other drugs remain big sellers. In fact, all of the top 10 best-selling drugs in the diabetes category are blockbusters, according to EvaluatePharma. So who makes them? Not surprisingly, Novo makes half of the top sellers, but it does not make either of the two top sellers. Some of the top diabetes drugs have lost their patents or soon will, making room for new, different products in this lucrative category. The list follows. Give it a read and tell us what you think. Maybe go to our LinkedIn group and share your insights. We want to hear from you. -- Eric Palmer (email | Twitter)
Sanofi's ($SNY) Lantus is the undisputed king of the diabetes drug category. Its sales are up 20% from the year before, and it sold 66% more than the next-best-selling diabetes drug on the list, Merck's Januvia. The long-lasting insulin product looked as if it would going to get serious competition this year from Tresiba, Novo Nordisk's entry into the category, but the FDA threw Novo an unexpected curve, asking for further study of its cardiovascular risks. That has delayed Tresiba's launch in the U.S. until 2018. Meanwhile, Sanofi is working on a new formulation of Lantus that is expected to last longer and lead to fewer episodes of low blood sugar, one of the selling points of Novo's Tresiba.
The Type 2 diabetes drug Januvia sits near the top of the list but is teetering. There are lots of forces trying to tip it off. The FDA is taking a closer look at the increased risk of pancreatic cancer from incretin mimetics--a group that includes drugs like Byetta from Bristol-Myers Squibb ($BMY) and Novo Nordisk's Victoza, as well as Januvia. The drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin. The FDA concerns may have contributed to the softness seen in Januvia's first-quarter sales. They were down 4% from last year and off almost 19% from forecasts. Janumet, a combination of Januvia and metformin, grew by 4% to $409 million, but it also fell short of expectations. Going forward, Januvia faces new competition. In March the FDA approved Invokana, the first of a class of drugs called SGLT2 inhibitors to be approved in the U.S. These drugs work by causing the body to eliminate sugar in the urine instead of affecting insulin, like Januvia. Invokana, developed by Mitsubishi Tanabe Pharma, will be sold by Johnson & Johnson ($JNJ).
NovoLog, or NovoRapid outside the U.S., is Novo Nordisk's fast-acting insulin used before eating to control blood sugar. Like so many insulin makers today, Novo sells prefilled cartridges that allow users to dial in a dose and discreetly take their shots, making them handy at restaurants. NovoLog can also be used in an insulin pump for up to 6 days before needing to be changed.
Humalog is another synthetic, fast-acting insulin used for mealtimes. It has been a huge seller for Eli Lilly, but its patents began falling off this year, leaving Lilly looking for replacements. Its sales had weakened ahead of the the patent loss as third-party payers demanded discounts and doctors turned to new diabetes drugs, like Lilly's own Tradjenta, to try to control blood sugar ahead of insulins.
Human insulin and devices
Doctors and patients prefer synthetic insulins, or insulin analogs, because they work faster, absorb at a predictable rate and don't have the same kind of peak effect seen in human insulin. That said, emerging markets and what Novo refers to as "frontier markets" can't afford the analogs, and so human insulins are the mainstay. Novo lumps these insulins together and as a combined group, they hit midway on the list.
Novo's Type 2 diabetes drug Victoza continues to be a big seller for the company. Its first-quarter sales were up 36%. It is facing some competing forces. It is among the class of incretin mimetics that the FDA is looking into for their potential risk of pancreatic cancer. At the same time, Novo has reported impressive results in studies of its use for weight loss. If the FDA approves it for that indication, it would be expected to accelerate its use.
It is nowhere near a Lantus, and it can't ease the sting of having Tresiba delayed by the FDA, but Novo's long-acting insulin Levemir does pretty well. In fact, sales in the first quarter were up 17% to about $458 million. It is approved for children and adults with Type 1 diabetes and adults with Type 2. It has the distinction of being the only long-acting insulin that can be used during pregnancy without an increased risk to the baby.
Janumet rides the coattails of Januvia, Merck's ($MRK) major blockbuster for Type 2 diabetes. That is because it is a combination of Januvia and the generic metformin, the most common treatment for Type 2 diabetes. That means both drugs are part of the FDA evaluation of the risk of pancreatic cancer for incretin mimetics, which nudge the body to stimulate insulin production. Sales of Janumet were up 4% in the first quarter to $409 million but fell short of expectations.
Novo Mix 30
Novo Mix is just another of the products that Novo has in its extensive portfolio of insulins. A combination of 30% soluble insulin aspart and 70% insulin aspart crystallized with protamine, it is considered an intermediate-acting insulin. It takes a bit longer to act than rapid-acting insulins but lasts longer in controlling blood sugar.
Japan's Takeda Pharmaceutical has been pretty much defined by the Type 2 diabetes drug Actos, which accounted for more than half of Takeda's U.S. revenues and 18% of its overall sales before going off patent in August. The revenue loss hit hard, and Japan's largest drugmaker has been scrambling to recover. Earlier this year, it did get three new diabetes drugs approved--Nesina and two combination pills, which revolve around the active ingredient alogliptin. But they are latecomers to this class of drugs, coming in behind Merck's behemoth Januvia as well as Onglyza, the Bristol-Myers Squibb and AstraZeneca ($AZN) drug, and Galvus, the Novartis ($NVS) drug.