GLP-1 Inhibitor Demand Shows Strong Growth Among Those Looking to Lose Weight, Less Robust Growth Among Patients with Type 2 Diabetes

There is no denying the explosive growth in GLP-1 inhibitors, especially among those using the drugs to lose weight but do not have a clinical diagnosis of Type 2 diabetes. But we need to consider exactly where the demand is growing most. It is mostly from people just looking for pharmacologic help to lose weight, and less among those with more serious co-morbid medical conditions. 

For example, back in November 2023, research analysts from J.P. Morgan forecast (see their report at https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs for details) that the GLP-1 therapeutic category of drug would exceed $100 bn by 2030, which it predicted would be driven equally by Type 2 diabetes and obesity usage. However, the spit between T2D and obesity was a flawed assumption.

One of the J.P. Morgan authors Chris Schott, a Senior Analyst covering the U.S. Diversified Biopharma sector at J.P. Morgan, acknowledged that his company merely made an assumption when it was developing its financial model. All financial models are required to make various assumptions. Today, GLP-1s are only used by around 10-12% of T2D patients in the U.S. 

Schott noted "We model GLP-1 usage expanding to around 35% of diabetics in the U.S. in 2030, and would not be surprised to see upside to this number, especially as outcomes data continues to emerge". But its GLP-1 inhibitor forecast could account for around 9% of the total U.S. population, but the T2D/obesity split could easily shift. Doctors who treat Type 2 diabetes aren't as enamored with the drug class.

But since that time, U.S. demand has particularly shifted away from Type 2 diabetes and more towards obesity without Type 2 diabetes. Demand among Type 2 users has not grown robustly and even declined slightly, while demand has exploded among those looking for phamacologic assistance to lose weight.

According to a study published in July 2024 in the Annals of Internal Medicine (see the study [behind a paywall] at https://www.acpjournals.org/doi/10.7326/M24-0019 and two articles related to the study itself at https://www.cedars-sinai.org/newsroom/new-cedars-sinai-study-investigates-shifting-trends-in-glp-1ra-prescription/ and also at https://www.forbes.com/sites/ariannajohnson/2024/07/22/glp-1s-are-growing-in-popularity-as-weight-loss-drugs-but-losing-steam-among-diabetics-study-suggests/ for more information), researchers from Cedars-Sinai Medical Center in Los Angeles had examined 1 million first-time GLP-1 prescriptions in the U.S. between 2011 and 2023, but they separated patients by those who took GLP-1s to treat Type 2 diabetes, and those who didn't have Type 2 diabetes, but took the drugs for obesity (or obesity-related health conditions including high blood pressure and heart disease).

That study found that those who were prescribed the drugs for obesity or other obesity-related conditions had more than doubled between 2011 and 2023, particularly since 2020, while the amount of new patients prescribed GLP-1s for Type 2 diabetes decreased by almost 10% during the same period.

We are also seeing many obese people being prescribed Novo Nordisk's semglutide branded as Ozempic which is not even FDA-labeled for the indication of obesity, but for Type 2 diabetes, whereas its Wegovy brand which is labeled for obesity has struggled with a combination of over-exposure due to mass media advertising due to the company's prepaid media buys intended to stimulate demand even while the product has been in shortage, a sky-high price-tag for the drugs, and a somewhat less enthusiastic reception from practicing endocrinologists who have seen their patients struggle to get insurance coverage for the latest overpriced version of these drugs, along with less-than-overwhelming secondary benefits. 

By comparison, the cardiovascular benefits with Lilly/Boehringer Ingelheim's sodium-glucose cotransporter-2 (SGLT2) inhibitor known as Jardiance (empagliflozin) has better cardiovascular benefits than GLP-1 medicines, and it can be taken as a pill. There are a number of rival SGLT2 inhibitors (many are less costly) including Farxiga (dapagliflozin) from AstraZeneca, Invokana (canagliflozin) from J&J's Janssen Pharmaceuticals unit, and Brenzavvy (bexagliflozin) made by TheracosBio and sold by the Mark Cuban Cost Plus Drug Company and costs significantly less by having patients just pay cash instead. Mark Cuban Cost Plus Drug Company's cash-only pharmacy also now sells branded Farxiga [dapagliflozin]). On top of that, FDA has already approved one true generic of Jardiance (empagliflozin) from Zydus Pharmaceuticals, although Lilly/Boehringer Ingelheim sued and Zydus settled out-of-court with Lilly/Boehringer Ingelheim agreeing to keep its approved generic off-market until 2025 in a classic pay-to-delay example. 

On the secondary cardiovascular benefits of GLP-1 inhibitors, those were essentially pre-determined by Novo Nordisk in which trials appear to have been designed to prove a specific outcome, rather than truly randomized blind sampling in its effort to secure CMS (Medicare) coverage for the overpriced drugs. Guess what? weight-loss does improve cardiosvascular outcomes, but it is the weigh-loss and not a specific drug which causes those benefits. But no academic research have replicated those secondary benefits, although few studies have specifically looked for them either. But the U.S. Centers for Medicare and Medicaid Services (CMS) did not give Novo Nordisk a free gift; in order for Medicare to pay for Novo Nordisk's semaglutide products for obesity, a patient must have a clinical diagnosis of cardiovascular disease from a cardiologist (a CV disease diagnosis code must be indicated a prescription, making it very difficult to secure widespread prescriptions for vanity purposes as the drugs are being marketed).

Much of the obesity demand for these drugs is being driven by doctors willing to prescribe the overpriced medications by telephone or online without so much as an examination (so-called "drive-by" doctoring). 

Right now, the news cannot stop talking about GLP-1s and the growth trajectory is good. But remember: cheaper versions are already on the market (Teva's version of liraglutide [fka Victoza/Saxenda] has been available since June, and a bevvy of rival biosimilars of liraglutide are poised to hit the market starting December 26, 2024). We know that biosimilars of liraglutide are pending FDA approval decisions from Biocon, Sandoz, Amphastar Pharmaceuticals, and Lannett Company in addition to Hikma Pharmaceuticals which already has FDA approval, but is awaiting Teva's 6 month exclusivity to expire on December 26, 2024 when Teva's 6-month exclusivity period ends.