Specialty Drugs Dominate Pharmaceutical Frontier in 2025

Jeff Casberg, MS, RPh

In an interview with Managed Healthcare Executive, Jeff Casberg, MS, RPh, senior vice president of clinical pharmacy services at IPD Analytics, provided an overview of the current pharmaceutical landscape, touched on the expanding role of specialty pharmacy, and the way GLP-1 drugs are reshaping the market.

Casberg also serves as a member of the Managed Healthcare Executive Editorial Advisory Board.

The Q&A has been edited for length and clarity.

MHE: What is the difference between specialty and traditional drugs? How has the boundary changed?

Casberg: In the 1970s and 80s, we had the development of these higher tech products for smaller populations, so that's when specialty kind of blossomed. In the 1990s, Medicare Part D was launched and then Part D was put into the specialty tier and was defined by the dollar amount. I believe at the time it was $670 and that helped put some definition around specialty.

Now, about 80% of all approvals are considered specialty. So, there are not that many traditional drugs approved, depending on how you define it.

There has never really been an official definition of what “specialty” is. I work for an organization, IPD Analytics, and when we get asked how we define it, we talk about high cost, basically any drug that you probably want to have a little extra guidance on, beyond retail.

MHE: What effects have the actions of the Trump administration had so far on drug development? Is there any uncertainty causing drug developers to slow down on the number or the size of trials?

Casberg: So far there haven’t been specific actions yet on drug development by the Trump administration. There have been executive orders, but the executive orders haven't directly impacted pharmaceutical manufacturers yet, and there's no new legislation passed yet. There's a lot of commotion, but no clarity. It's kind of a wait-and-see approach right now.

MHE: What are two or three of the most important drugs in the traditional drug pipeline?

Casberg: I'm going to start off and say, overall, there are a lot of loss of exclusivity opportunities coming up for payers and PBMs in the next three to five years. There are all kinds of new approvals coming, and I'll mention a few, but there's also some opportunity for savings with big drugs losing exclusivity, both on the traditional side and the biologic side.

Brensocatib from AstraZeneca would be the first DPP-1 inhibitor for bronchiectasis, which is a lung disease that causes permanent damage and there’s really no treatment for it, there are about 500,000 patients in the United States with it. It’s potentially approvable in August of this year.

The second drug I’ll hit on is elinzanetant from Bayer. In 2023 we had a drug called Veozah approved for vasomotor symptoms due to menopause. Elinzanetant follows a very similar mechanism of action.

The last drug I’ll hit is Journavx (suzetrigine), a twice daily, nonopioid, sodium channel blocker for moderate to severe pain. It’s the first new nonopioid pain drug in more than 20 years.

MHE: Are there any GLP-1s in the pipeline that could challenge semaglutide or tirzepatide for market share?

Casberg: Absolutely. What’s happening right now is expanded indications and as these indications expand, the potential treatment population is getting bigger and bigger. We're going to be talking about GLP-1s for years and years to come.

There is a whole pipeline of products coming, but in the immediate near future, it's really going to be a broken record with Novo [Nordisk] and [Eli] Lily.

Novo has a drug called CagriSema, which is a dual ingredient project product, both the GLP-1 and amylin analog, weekly injectable, potentially approvable in 2027.

The next two drugs I'll hit will be Eli Lilly. Retatrutide, also a weekly injectable, is potentially approvable in 2027 as well.

The other Lily drug I'm going to mention, orforglipron, is an oral product, potentially available in late 2026 or 2027.

I will mention one other molecule, survodutide, from Boehringer. It’s an injectable product similar to tirzepatide and Wegovy.