Expert: Exploring the Growing Market of GLP-1 Medications

In this interview, James Shehan, JD, chair of FDA Regulatory Practice at Lowenstein Sandler, provides a comprehensive overview of the burgeoning GLP-1 receptor agonist market for weight loss drugs. He traces the history and expansion of indications that have fueled growth, examines factors driving investor interest, and offers his perspective on future competitive dynamics and regulatory pathways.

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Q: How have we seen the market for weight-related drugs, specifically GLP-1, grow within recent years?

James Shehan: Well, I think we should take a bit of a step back saying that this is not a new class of drugs. I was at Novo Nordisk in 2010 when Victoza or liraglutide was approved with a label that included information about weight loss, and although it was approved for control of type 2 diabetes, but the weight loss data was clearly mentioned in the labeling, therefore, it was talked about in marketing. I think from that beginning, you've seen steps forward, with Lily coming into the market, with Mounjaro and Zepbound, or even prior to that, the second generation from Novo Nordisk of Ozempic/Wegovy, and explicit weight loss approval. Now even additional things like cardiac benefits being added into the labeling. So I think the combination of greater effectiveness, expanded indications, and kind of more remarkably, this kind of mania that has occurred in the last, say 2 years about the products, which is somewhat remarkable to me, because it was there in plain sight in 2010, and even before that, in the scientific data.

Q: What are some key factors that are attacking investors and general interest to GLP-1 drugs and weight-related medication?

James Shehan: One, you have the clear fact that so much of the US in the world population is overweight, struggles with obesity, or, let's say, higher than healthier weight levels, and, of course, that's a phenomenon that happened first in industrialized countries, as people came to desk jobs like yours and mine. As that kind of lifestyle has spread, to much more of the world, and you've seen kind of the processed foods and the easy availability of calories has driven like, a huge global epidemic of being overweight. So that's one factor. Then I think the other factor is that investors have seen that these products do make a difference, and some of them, some of them, extrapolations are crazy that people look at I've seen like, wow, these can be trillion dollar drugs, which, that never happens. Drugs rarely, if ever, achieve that high penetration for multiple reasons, but on the other hand, you would think that the sum of the interest is certainly justified because it is a big market and it's only been scratched so far really only a small percentage of people who could benefit the drugs are actually taking them.

Q: What are some of the most promising trends you see shaping the GLP-1 and weight-loss medication market?

James Shehan: I mean, to me, the promising trends is the expansion of indication. Let's talk about a couple things. One, given that liraglutide came onto the market in 2010, and you're now 14 years in, and there haven't been significant safety issues. So that drives interest, people are more interested in safer products rather than ones that have, hugely significant side effects. Now, of course, there is nausea-associated events that frequently happened to people when they first take these products. For most people that goes away, and I think for those who it doesn't go away, they stopped taking them. So you have a safe product, and then you've had the industry is rushing into this field. So there's dozens of products in development, and I think that answers that question.

Q: How will the potential approval for GLP-1 medications in indications separate of obesity-related conditions affect the marketplace for these drugs?

James Shehan: That's a big unknown, but it could be gigantic. I mean, there's seems to be a pretty sound scientific basis for the drugs, which everyone knows have an effect in the brain as well as in other parts of the body to perhaps alter what's kind of the addiction mechanism in human beings, and you've seen intriguing results and some relatively small studies and all kinds of things alcohol, opioids, even gambling. So those can be that would be really intriguing if you were to see those early results hold up in later trials.