FDA将审议放宽肽类注射剂限制，黑市规模已达数十亿美元

Welcome back to Bloomberg this weekend. Next month, the FDA will hold a summer meeting to consider easing restrictions on certain peptide injections. Wellness enthusiasts, biohackers swear by them. They are synthetic strings of amino acids that users say can help with everything from tendonitis to getting a tan. Health and human services secretary, RFK junior, a fan of fixing tendonitis and tans as well, said this to Joe Rogan.

I mean, I'm a big fan of peptides. I've used them myself and used them with really good effect, you know, with a couple of injuries. In the Biden era, compounding pharmacies were effectively banned from producing several peptides that pushed a lot of users underground, but that could be changing. Ricky, you have no idea. And a lot of this stuff that we've looked at is just, you know, is very, very substandard. Oh, I'm very anxious to move.

Not probably not all of those peptides. Some of them are in litigation, but about 14 of them back to making them more accessible. My hope is that they're gonna get moved to a place where people have access from ethical suppliers. So how is this market preparing to move out of the shadows? Bloomberg Businessweek senior writer Amanda Mulli has a new piece looking at the billion dollar peptide gold rush. Amanda, I do wanna say to you, I do know someone who did one of these legally gray.

I wasn't really sure if it was legal or not kind of peptide injections a couple years ago. And now they were just telling me they can go get the same thing essentially somewhere else, and it seems to be more above board. So can you talk to us about the landscape of what this all looks like at the moment and where it's going? Yes. Well, at the moment, everything is still pretty black market, pretty illegal to be, compounded in in a licensed compounding pharmacy.

But what we've seen over the past few years is a lot of drug suppliers in The US being more open minded about how they follow those regulations, shall we say. Because there is a lot of signaling from the Trump administration, from RFK junior in particular, that there is, that there is interest in making these medications legally available in The US through, compounding pharmacies. A lot of suppliers, are saying, well, we're probably not going to be enforced against right now.

So why don't we get into this a little bit early and start building our customer base, basically? Wow. Amanda, what does this economy look like? I mean, I'm I'm still flabbergasted that people are so willing to just inject themselves with stuff. Seems like they are. But what kind of money are we talking about here? And so were this to be opened up by regulators to sort of have a more less gray, more clear space for this stuff?

How much money are we talking about? Well, the back of the napkin math on the current, state of the peptide market in The US, the black market itself, is about a billion to $2,000,000,000 based on, the folks that we talked to for the story, and it could double, triple. It could get a lot bigger if, this this, group of 14 peptides that RFK, referenced in the earlier clip is made, legal to compound. So we're talking about billions and billions of dollars in potential upside, for people who are fast movers into the space in potentially the very near future.

Can you remind us what what qualifies as peptides? Like, what are the most popular ones we're talking about, and what do they do? Right. A lot of the reason that peptide drugs have have become, so interesting to so many people is that GLP one drugs are peptide drugs. The p in GLP one stands for peptide. Uh-huh. So so and they are, of course, legal, widely available, safe, and extremely effective. So you've got millions of people in The US currently on one of these drugs, and then you've got their friends, family members, coworkers looking at them and going, wow.

They're they've lost a ton of weight. They say that they feel incredible. They obviously, these things work. So what other kinds of peptide drugs are out there? Like, you you have this this class of, legal and highly effective drug that has made people go, okay. Well, if this is so effective, like, maybe self injected drugs at home are the future of health. So you you have, an example of something that is that we know to be safe, and then you have all of these other substances that have been over the years developed or experimented with by, researchers or drug companies that are out there that, like, the the structure of them is publicly available.

And, so you've got suppliers overseas and sellers in The US going, well, what what harm could it do? We have a crazy graphic showing the increase of some of these drugs. The volume increased 12000% from 2023 to 2025. And I'm wondering, to David's point, if part of that is just the barrier to getting people to jab themselves with needles has really, really come down because it used to be basically, you know, if you were doing IVF, if you were diabetic, if you had a complicated medical situation, those were the only people who I knew were regularly using needles from a pharmacy.

The rest of us, that's something you would go to the doctor for. Now, you know, I know so many people who are on GLP ones, and then I know so many people who have started ordering them from compounding pharmacies where you don't even get the little hidden needle injector. You get literal vials and syringes, and people seem kind of used to this. So is this is that one of the biggest barriers, or are there other reasons these have seen such an uptick all of a sudden?

I think that the sort of collective population level comfort with self injection is a huge, element in all of this. In the early days of developing the drug that that came to be Ozempic, drug companies were sort of unsure if going forward with this kind of drug would even be worth it on a financial level because there was such a belief that, you know, nobody is self injecting at home unless it's like an existential thing, unless it's insulin in order to continue living, things like that.

So, you know, we have we have come a really, really long way in our understanding of the population level willingness to self inject. And I think that that goes back once again to GLP one drugs and people going, you know, it's, apparently, it is safe and effective to inject these things at home, needles. And on top of that, you also have the med spa phenomenon where, again, you have things like Botox and filler where you get a, quick, highly effective, visible result from an injection.

And a lot of people either have have had these types of injections themselves or know people who get them all the time. So the mystique of self injection and of needles in general has just it's a lot less scary to a lot, to a lot more people. Man, we've talked a lot about kind of the compounding pharmacy side of things. If if I'm an executive at a major pharmaceutical company spending many billions of dollars to develop, you know, traditional pharmaceuticals, how close am I paying attention to this?

How much is this of interest to me? How much am I thinking this is something that could really disrupt the kind of drug landscape more broadly? I think you're paying attention to it quite closely because you've you've got a couple elements involved here. You've got, like, a clear market signal that there is, like, wide consumer demand for a particular type of medication. But then you've also got a signal in the in the market that they are looking to get it other places, that they are, looking to get it cheap, that they are looking to get it from, you know, in situations where they have to mix it together themselves.

So in compounding pharmacies, there's thousands of them across The US. They they play a lot of roles in our medication supply in The US. But one thing that that they do is they can mix up a lot of different types of medications, and they can adjust them to doctor prescriptions or patient needs. So you

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