To better understand what 2026 might bring, we asked three MMIT market access experts to share their perspectives on upcoming market shifts. Read on for key insights into the year ahead (and don’t miss the first post in this two-part series.)
1. Patients are increasingly gravitating to direct-to-consumer platforms. What effects do you think these platforms will have on the PBM industry next year?
Steve Callahan, Senior Director, Advisory & Insights: Direct-to-consumer (DTC) programs offer patients access to specific drugs without any interaction from PBMs, thus removing their revenue from administrative fees and rebates. Currently, most of the drugs offered through DTCs are for patients who experience coverage issues with obtaining the drugs through the standard means.
A common example is patients being denied coverage for GLP-1s for weight loss, because obesity is considered lifestyle condition. Instead, patients turn to DTC programs to obtain the drugs. As these patients were never going to obtain the drug through PBMs, the popularity of DTCs has a low impact to PBMs in the short term.
However, as physicians become more comfortable referring patients directly to DTC programs and more patients begin to take advantage of them, PBMs may see more risk if the DTC programs expand to more drugs and indications. Depending on the scale and adoption of DTCs, PBMs may seek to negotiate with pharma manufacturers to limit the scope of these programs or potentially partner with pharma for dispensing drugs purchased through DTCs.
Madeline Verbeke, Supervisor, Clinical Advisor: Direct-to-consumer programs create an alternative path to access by allowing manufacturers to sell directly to patients, bypassing PBMs completely. PBMs will remain a mainstay for most of the insured population as they manage benefit design, claims processing, and utilization management, which have not been replaced by manufacturers.
However, the increasing popularity of DTCs does put pressure on PBMs. Revenue that would typically be routed through the PBM is instead retained by the manufacturer. We may see PBMs create tighter formularies and increase utilization management through tools like prior authorizations, step therapy, and value-based outcomes to control costs and steer patients towards preferred options.
Carolyn Zele, Advisor, Solution Consulting: DTC programs naturally make patients smarter and more in control of their own treatment. Unfortunately, these DTC programs are not designed to address all the patient’s concerns, so patients need to be diligent about all the drugs they are taking and ensure that both the DTC program and their own doctor are involved in their treatment programs.
While many PBMs would rather the patient find another avenue for paying for the drug they do not cover, they may find in 2026 that they need to determine what happens when a patient has an adverse reaction and needs medical attention. Will the PBM cover the cost of the treatment of the adverse reaction, if they did not cover the cost of the drug that caused the reaction? New liability programs are sure to be developed in 2026, and manufacturers will need to understand who will bear the burden of the cost of patient care when something unforeseen happens.
2. What’s likely to happen in the biosimilar space?
Steve Callahan: We can expect to see more biosimilar launches and more pharmaceutical investments in developing biosimilars. It was 10 years ago when the first biosimilar, Zarxio, was approved. Since then, 75 biosimilars have been approved for 20 reference products. From now until 2030, there are 88 reference biologics which are facing a loss of exclusivity (LOE), including blockbusters such as Eliquis, Keytruda, Opdivo, and Darzalex.
In the past, we have seen some biologic manufacturers successfully delay the launch of biosimilars, sometimes for years. I predict we will see some manufacturers with upcoming biologic LOEs successfully delay a few biosimilar launches, but the opportunity is too great for this to deter biosimilar manufacturers from trying to enter these markets.
Madeline Verbeke: We should see significant market expansion due to both regulatory changes and patent expirations. In October, the FDA drafted guidance to speed up and lessen the cost of development of biosimilar medications through simplifying biosimilarity studies and reducing unnecessary clinical testing. This draft guidance should be finalized in the first half of 2026 and will align the biosimilar approval pathway more closely with the generic drug model, accelerating development and market entry.
Additionally, the FDA is planning to make it easier for biosimilars to be established as interchangeable with brand-name biologics, which helps prescribers feel more confident and makes it easier for pharmacies to offer them as substitutes. In 2026, we expect to see more denosumab (Prolia) and aflibercept (Eylea) biosimilar approvals, along with biosimilars that are the first for their reference drugs such as golimumab (Simponi).
Carolyn Zele: In addition to the restructuring of the biosimilar approval pathways, AI will begin to play a transformative role in biosimilar production by improving efficiency, quality, and scalability across the entire manufacturing lifecycle. AI will not be just an add-on—it will become a core enabler for faster, cheaper, and more reliable biosimilar production, helping manufacturers meet global regulatory standards while continuing to scale to reach a global market.
Payers are adopting a multi-faceted strategy to ensure the increased prescribing of biosimilars in 2026 and beyond. We will see biosimilar preferences grow, with many payers adopting biosimilar-first step therapy requirements, and preferential tier placement for biosimilars. Many payers are also building prescriber education programs, some along with the biosimilar manufacturers, to facilitate increased adoption of biosimilars. Biosimilar manufacturers should be thinking about offering educational assistance to payers as part of their contracting strategy to help them build prescriber confidence.
3. What’s next for the weight loss industry? Any market disruptors in the pipeline?
Madeline Verbeke: Obesity is poised to remain a top-performing area in 2026, driven by the rise of oral and combination drugs. Oral GLP-1 therapies for obesity are anticipated to enter the market in late 2025, with additional drug approvals expected throughout 2026. As competitors work to match Novo Nordisk’s early lead, these treatments should capture meaningful market share, particularly among patients who prefer alternatives to injectables.
Alongside the new obesity drug approvals anticipated in 2026, we also expect existing FDA-approved drugs to receive expanded indications in obesity-related conditions such as chronic heart failure. Looking ahead, combination therapies are emerging as a promising innovation. Early data suggests these drugs address key challenges in obesity care, such as minimizing side effects and reducing dosing frequency, positioning combination GLP-1s as a key area to watch in 2026.
Carolyn Zele: In my opinion, oral GLP-1s will begin to take over the market. It’s much easier to swallow a pill that give yourself a shot. More patients will likely want to be on treatment, therefore further expanding the already immense market. Less frequent dosing and fewer side effects are important changes that will also expand the market.
More employers may want to begin covering GLP-1 products for obesity, and PBMs will need to be able to accommodate these products in their formulary offerings. Today, many patients are required to have a trifecta of obesity-related diagnoses—in addition to obesity—to be covered by most health insurance plans (e.g., obesity + high blood pressure + high cholesterol + chronic heart failure). With the introduction of oral therapies and industry-wide pressure to lower the cost of weight loss treatment, perhaps these policies will change so that otherwise healthy patients with obesity can be treated before they face additional health challenges.
4. Which TAs will become more competitive in 2026?
Carolyn Zele: Oncology is still the biggest competitive space with the most growth. According to Biomed Tracker, more than 2,000 new oncology clinical trials started in 2023, and these drugs will begin their launch processes within the next few years. These areas include precision oncology, radiopharmaceuticals, bispecifics, and ADCs. Cell and gene therapies are the biggest areas of growth and manufacturing spend.
CNS disorders make up the second largest growth area for the future, with over 3,500 new drugs in development. Manufacturers like Interius and Kelonia are beginning trials for in vivo CAR-T, direct gene editing inside of the patient, thus eliminating the need for cell collection and ex vivo cell manipulation, gaining efficiencies and lowering the costs of treatment. Manufacturers like Eli Lilly are utilizing AI and quantum computing for target and molecule design, as well as clinical simulation, to accelerate the early clinical investigation.
Madeline Verbeke: The GLP-1/obesity market will continue to become even more competitive in 2026, driven by both innovation and cost-control measures. The competitive landscape will intensify with anticipated new drug approvals and the growth of direct-to-consumer channels. Payers are also expected to attempt to control the costs of these medications through even stricter UM for not only obesity, but obesity-related conditions as well. A major driver of clinical change will be the introduction of dual-targeted therapies, such as those combining GLP-1 and amylin pathways, which are projected to deliver higher weight loss efficacy compared to currently available single-pathway agents.
Steve Callahan: Madeline and Carolyn covered the key TAs which will become more competitive in 2026, but I also think the Alcohol Use Disorder space is one to watch. Despite the existence of three FDA-approved treatments (Naltrexone, Acamprosate, and Disulfiram), this is an indication with a high unmet need. There are new AUD treatments being studied across a variety of classes, such as GLP-1s, psychedelics, and genetically targeted orals, among others.
