2023 forecast: With Novo's Wegovy on a supply rebound, 2023 offers course correction and obesity showdown with Lilly

As the obesity market unfolds, it won’t be Wegovy takes all forever. Analysts seem to favor Eli Lilly’s tirzepatide over the Novo Nordisk therapy as the field’s eventual drug of choice. Still, Novo looks best equipped to rule the burgeoning obesity scene writ large.

And after its supply stumbles in 2022, Novo’s 2023 performance will offer the first real glimpse of the massive opportunity in store. Obesity could be the next blockbuster pharma category, multiple analyst camps have prophesized. Analysts’ expectations for the therapeutic area range from $30 billion to $50 billion by 2030 if all goes well.

As Novo’s head of North American operations Doug Langa said in an interview, obesity is winning increasing analyst attention and represents the “biggest market opportunity that I think I know of today.”

You can also hear about expectations for the obesity market in 2023 in our podcast The Top Line

 

While Wegovy is already on the market, an obesity approval for Lilly’s tirzepatide is “very close behind,” Cowen associate Michael Nedelcovych noted in an interview. Plus, the pipelines of Novo and several other companies are rich with clinical prospects.

Last year, Novo threw down the obesity gauntlet. Still, Wegovy’s 2021 launch proved to be a false start. Early demand pressures dovetailed into contract manufacturing mishaps, which ultimately constricted supply for much of 2022.

Nonetheless, interest in obesity drugs boomed this year. Wegovy mustered unofficial celebrity endorsements from the likes of new Twitter owner, Elon Musk. And in Wegovy’s partial absence, Novo’s obesity predecessor Saxenda enjoyed an unprecedented second wind. Furthermore, off-label use of Novo’s type 2 diabetes drug Ozempic—which has the same active ingredient, semaglutide, as Wegovy—proliferated. The phenomenon even garnered mainstream media attention.

Consider 2023 a course correction, then. Whether on the commercial or clinical front, next year is studded with obesity milestones. Besides Wegovy’s relaunch, clinical data and potential approvals for both Wegovy and tirzepatide are on the horizon. There’s still much work left to be done in the space, for sure, and companies with early-stage assets will also look to make their mark.


An expected banner year
 

In November, Novo’s Langa stressed to Fierce Pharma that all Wegovy strengths are expected to be available toward year-end, and next year would see a broader commercial launch. “It’s going to take a few weeks for the product to be broadly available in the retail pharmacies across the country,” Langa noted. Cowen analysts also expect Wegovy’s supply woes to abate by year-end.

Still, since other drugs filled the gap Wegovy left, Wegovy’s 2023 return dynamics are uncertain, Nedelcovych said. Ozempic and Lilly’s Mounjaro are seeing “not insignificant off-label use,” he admitted. Mounjaro is tirzepatide’s brand name in Type 2 diabetes. 

Wegovy will likely have a “choppy” run in 2023’s first half, according to Cowen’s 2023 obesity outlook report. “We know that they are attempting to resupply the market,” Nedelcovych said, “but we don’t know exactly what level of demand they are planning to service and whether that level of supply will satisfy the demand we end up seeing.” While Novo’s Langa declined to detail Wegovy re-launch plans, he teased direct-to-consumer efforts and a salesforce staff-up. Wegovy’s sales will roughly double next year, Cowen’s Nedelcovych predicted. Wegovy clocked in at 3,742 million Danish kroner (about $534 million) over the first nine months of this year, a Novo Nordisk spokesperson said. 

Beyond the relaunch, a Wegovy cardiovascular outcomes trial, dubbed Select, is expected to read out mid-2023. Positive results could compel primary care doctors and those less focused on obesity to prescribe the med, Nedelcovych said. More important, strong Select data could improve payer coverage, he added.

As for tirzepatide, Lilly’s plan as of the fall was to start a rolling submission this year and complete its filing shortly after phase 3 Surmount-2 data rollout around April 2023. Lilly declined to comment for this story.

Still, Novo’s not breaking a sweat. Another obesity med could help eliminate “cultural nuances” around the disease, like stigma and bias, Langa said. More therapeutics could also drive up the slim roughly 10% of patients who seek treatment. Tirzepatide could also help iron out access and reimbursement wrinkles, he added.


The long view
 

Bold claims about the obesity market have been made. In July, Morgan Stanley Research predicted more than $50 billion by 2030 globally. It described the opportunity as the “new hypertension” with the potential to become “the next blockbuster category in pharma.”

While Cowen is pegging expectations at around $30 billion, that’s just one of multiple scenarios, Nedelcovych explained. On the upside, Cowen also sees a $50 billion industry by 2030. If things fail to pan out, however, the researchers are looking at a base case of $12 billion in collective sales.

UBS in September touted Lilly’s tirzepatide as potentially the “biggest drug ever,” estimating the med could clinch $25 billion in peak sales, but Wall Street consensus is only roughly $15 billion.

Yet, UBS analysts also note that Novo has some time to carve out Wegovy’s niche. The fact that Novo has the market to itself will help doctors and patients figure out the “cadence and contours of its clinical profile,” Nedelcovych added.

Even still, Cowen—like UBS—thinks that if approved, tirzepatide will ultimately surface as the “preferred” obesity drug.

But in terms of the overall obesity market, Novo having other assets in development gives it a leg up, Nedelcovych said. Phase 3 drug CagriSema is expected to have data around 2024 or 2025. Novo also has an oral semaglutide and three other candidates in its pipeline.

Come 2030, Cowen expects Novo’s Wegovy sales to top $7 billion, while its full obesity portfolio could reach $14.2 billion. For that same period, Cowen figures Lilly’s tirzepatide will bring home more than $11 billion in obesity.


Rising champs
 

The question remains, what space is there for others like Amgen, AstraZeneca and Novartis. Their assets are in early- or mid-stage development. Pharma companies have answered the call for more effective obesity therapies, Narimon Honarpour, M.D., vice president of general medicine, global clinical development at Amgen, said in an interview.

Next up though, Honarpour posited, the field could be advanced by “more sophisticated therapies” like the ones Amgen is developing. Amgen has two obesity candidates, though it's only shown its hand on the phase 1 antibody-peptide conjugate AMG 133.The drug's antibody component binds to the GIP receptor—a pathway implicated in obesity—while two GLP-1 peptides bound to the antibody stimulate the GLP-1 receptor, which is also Wegovy’s target.

Unlike Wegovy or even Lilly’s dual GIP/GLP-1 med tirzepatide, Amgen’s candidate is “slamming the brakes on one pathway—the GIP pathway—while hitting the accelerator for [the GLP-1 pathway] at the same time,” Honarpour explained.

Further separating AMG 133 from the pack is its longer half-life. Drugs like tirzepatide and Wegovy have to be administered every week, Honarpour said. “We think we can get the molecule to do its work with an every-four-week dosing regimen.”

Amgen is far from alone with its obesity R&D ambitions. Of course, with all the hype surrounding obesity, “much uncertainty remains,” the Cowen team wrote in its obesity outlook report. “Given the sheer size of the total addressable market, it is difficult to keep sales projections from growing to what could be considered unreasonable heights.”

Additionally, one major unknown looms: Just how long are patients expected to take these drugs, and will their weight return if they go off them? Based on Type 2 diabetes data, Wegovy’s median treatment duration is expected to be roughly a year, the Cowen team surmised, noting there could be a “large proportion of patients who stay on for significantly longer.”

“The trajectory of the obesity market will be defined by patient demand and adherence, impetus among physicians to diagnose and prescribe, and payer access,” the analysts concluded.