What Changed for PBMs in 2025? 5 Trends and a 2026 Preview

December 9, 2025

Summary

In 2025, PBMs adapted to the rapid growth and changing landscape of GLP-1 therapies with new FDA approvals expanding their use beyond diabetes and obesity, driving up both market size and patient utilization.
Biosimilars became preferred formulary options for PBMs, contributing significant cost savings and making treatments more accessible to patients as numerous new products gained FDA approval.
Major biosimilar launches included Stelara®, Kirsty™ (insulin aspart), and Prolia®, with anticipation for a Xolair® biosimilar in 2026, signaling ongoing innovation and expansion in the biosimilar market.
Overall, these developments highlighted PBMs’ evolving strategies to balance innovation, expanded treatment options, and affordability in the pharmaceutical marketplace.

1. GLP-1s

Increased utilization of GLP-1 therapies continues to drive the pharmaceutical market. This year, we saw many of these therapies gain approval for indications that extend beyond type 2 diabetes and weight loss, a trend often referred to as “indication creep.” With this potential for expanded volume, PBMs continued to develop strategies to manage the rising cost and ensure appropriate utilization.

Three GLP-1s were recently approved for use for indications other than obesity. In December 2024, the Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) to treat severe obstructive sleep apnea in adults with obesity. Zepbound became the first drug treatment for this diagnosis. In August 2025, the FDA approved Wegovy® (semaglutide) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis). This was the third FDA-approved indication for Wegovy and the first not requiring a diagnosis of obesity In October 2025, Rybelsus® was granted approval to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes. Development continues on additional drugs in this class along with expanded indications.

People with type 2 diabetes have been using GLP-1s with greater frequency over the past few years. In 2024, 26.5% of those with diabetes used GLP-1s. In 2022, that percentage was 19.4% and in 2018, that percentage was 7.6%. The number of prescriptions for GLP-1s has tripled since 2020, and in 2024, about 12% of Americans said they had taken a GLP-1.

In 2025, the market size of GLP-1s was expected to be about $62.86 billion. This is up from $53.5 billion in 2024. By 2030, the number could reach $150 billion, according to some projections.

2. Biosimilars

As more biologics lose patent exclusivity, the biosimilar market continues to expand. In 2025, biosimilars saw increased adoption rates as PBMs incorporated these products as preferred options on formularies.

As of mid-October, 14 biosimilars have been approved by the FDA this year for eight reference products. In 2024, there were 19 approvals for nine reference products. Biosimilars can help save money for both the healthcare system and patients taking the medications. On average, biosimilars cost about 50% less than their reference products. In 2024, the savings from biosimilars was $20.2 billion. Since 2015, biosimilars have saved approximately $56 billion in overall healthcare expenses

The launch of Stelara® biosimilars was a key event in 2025 as Stelara was among the top 10 best-selling drugs for years. This year also brought Kirsty™, the first and only interchangeable biosimilar to insulin aspart. A biosimilar for Xolair® was also approved with an expected launch date in 2026.

Additionally, as of the beginning of November, there have been four biosimilars approved for Prolia®, which is used to treat osteoporosis in women after menopause, and two biosimilars approved for Xgeva®, which is used to prevent serious bone problems.

3. Regulatory pressure and reform

In 2025, there has been increasing pressure on PBMs on both the state and federal levels, with many calling for reform. This comes in part as a response to a July 2024 report on PBMs from the Federal Trade Commission. In 2024, 33 bills related to PBMs were passed in 24 states.

On the federal level this year, a number of pieces of legislation were introduced, including:

The Pharmacy Benefit Manager Reform Act of 2025 (July).

The Protecting Pharmacies in Medicaid Act (March).

The Patients before Middlemen Act of 2025 (March).

The Prescription Pricing for the People Act of 2025 (February).

The Pharmacy Benefit Manager Transparency Act of 2025 (February).

The Saving Seniors Money on Prescriptions Act (February).

States have also continued to be active in 2025. As of March, more than 1250 bills related to PBMs or prescription drug benefits have been introduced in state legislatures. That is up from 635 bills in 2024. Here’s a look at some of the legislation this year:

Arkansas House Bill 1150 to prohibit a pharmacy benefits manager from obtaining certain pharmacy permits was filed in January, signed into law in April, and goes into effect on January 1, 2026.

Massachusetts S3012, An Act Relative to Pharmaceutical Access, Costs and Transparency was signed into law in January.

Alabama SB 252, the Community Pharmacy Relief Act, was passed in March and most of the bill went into effect in April.

4. Artificial Intelligence (AI)

AI is increasingly being integrated into the operations of PBMs to improve efficiency, cost management, and patient outcomes. By analyzing significant amounts of data from claims and prescriptions, AI can identify the most effective and cost-efficient medicines for patients. AI can also develop tailored drug plans for patients, automate claims processing, determine medication adherence issues, and assist with prior authorization.

AI can also perform utilization management and risk stratification and detect and prevent fraud. For example, AI can pick up patterns of fraudulent activity, which can be difficult to find. Additionally, AI can assist with inventory and supply chain management, predicting drug demand and adjusting inventory. Patients can also receive more personalized support with the integration of AI.

5. Drug pricing

The issue of drug pricing has been up in the air for much of the year in part due to potential tariffs. An April 2025 analysis by Ernst & Young found that a 25% tariff on imported drugs would increase drug costs in the U.S. by $51 billion a year. That tariff, if passed along, could potentially increase drug prices by almost 13%.

In August, the president said that the U.S. would impose a small tariff on pharmaceutical products imported to the U.S., but that that tariff would go up to 150% within a year and a half and then to 250% at some point.

In late September, President Trump announced that 100% tariffs on some pharmaceutical products would go into effect on October 1. As of that date, however, tariffs have not gone into effect. Generics are exempt, and drugs from Japan and the European Union are subject to a 15% tariff.

These proposed tariffs on both drugs and active pharmaceutical ingredients (APIs) can create pressure in the market. Imposing tariffs could raise production and importation costs, which could then be passed on to consumers, insurers, or healthcare providers. The ultimate goal behind the tariffs is to encourage U.S. drug production and reduce supply chain dependency. The impact on drug prices depends on how broadly these tariffs are applied and the availability of American alternatives.

Additionally, this year there has been more focus on direct-to-consumer (DTC) distribution for drugs. DTC could make medicines more accessible and affordable for patients. But this comes with operational and regulatory issues for manufacturers, like building infrastructure to support this model, managing compliance requirements, and handling privacy, data protection, and HIPAA requirements.

What’s ahead in 2026?

In 2026, the PBM sector and the pharmaceutical landscape will be navigating an increasingly complex regulatory environment driven by heightened demand for transparency and simpler contracting. A robust drug pipeline – featuring breakthroughs in cell and gene therapies, precision oncology, and treatments for chronic conditions – signals the potential for new standards of care for multiple disease states. Biosimilars will continue to expand market share, easing the cost burden of high-priced specialty medications, while patent expirations on widely used therapies, such as Xeljanz®, open the door for generic competition. Global biosimilar sales are projected to grow at an annual rate of 18%, reaching nearly $42 billion in 2025 and surpassing $97 billion by 2030.

Together, these dynamics position 2026 as a year of significant innovation, improved patient access, and evolving payer strategies.