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How oral GLP-1 drugs could disrupt the weight loss market

FDA-approved oral GLP-1 formulations for weight loss could disrupt the weight management market, outcompete injectables and reduce patient access barriers.

The era of injectable GLP-1 receptor agonist therapy for weight management might soon give way to a new phase of market competition, driven by the entry of oral formulations. The FDA approval of oral GLP-1 drugs could further fuel the demand for GLP-1 therapies in weight management.

Novo Nordisk's new drug application for an oral version of Wegovy (semaglutide) is currently under review. If approved, this oral option could change how patients, payers and prescribers engage with the rapidly growing GLP-1 market.

"Oral delivery formulations could attract new patients who fear injectables, thereby expanding the addressable market," Jayne Hornung, chief clinical officer at Managed Markets Insight & Technology (MMIT), said in an interview. "Oral semaglutide approval in weight loss would be a game-changing milestone and could reshape how [obesity] is treated."

Oral GLP-1s could expand patient access

Blockbuster injectable GLP-1 therapies that have been FDA-approved for weight loss, like Wegovy (Novo Nordisk) and Zepbound (Eli Lilly), have transformed the medical weight loss market, but not without challenges. Fear of needles, administration challenges and cold chain requirements continue to limit uptake among some eligible patients.

An oral GLP-1 formulation could remove many of these barriers. Hornung noted that patients hesitant to use injectables represent a significant and largely untapped segment of the market.

In fact, recent estimates suggest that roughly 129.2 million U.S. adults are eligible for semaglutide for weight loss, highlighting the potential for oral delivery to broaden access and encourage earlier treatment uptake.

"Oral delivery has the potential to unlock a larger, more compliant patient population," she added.

Market dynamics and payer strategy

An oral GLP-1 approval would likely spark immediate competitive responses across the market. Hornung noted that a successful launch might also accelerate timelines for other oral GLP-1 candidates currently in development, particularly from Novo Nordisk's direct competitor, Eli Lilly.

Eli Lilly's oral GLP-1 receptor agonist, orforglipron, is currently in phase 3 clinical trials. The company plans to file for regulatory approval for weight management by late 2025, targeting a potential approval in 2026.

"Investors will look closely for demand curves, pricing strategy and then competitor response," Hornung said.

Investors, manufacturers and payers will all be closely monitoring how demand patterns shift once oral options are introduced. On the payer side, updated formulary strategies will need to be adopted to manage the growing demand and rising costs for GLP-1 therapies.

"We aren't really seeing coverage move tremendously yet," Hornung noted. "Maybe a very slight increase since January 2025 for Wegovy in [cardiovascular risk reduction]. We see about 65% coverage nationally."

For weight management specifically, coverage varies and is often contingent on prior authorization hurdles and step therapy requirements. Hornung expects these controls to intensify if oral options drive broader demand.

"Payers are already using tighter controls to manage the market," she said. "They may require clinical chart notes, documentation of weight loss history and enrollment in structured weight loss programs."

Employer coverage models

Employers are also navigating competing pressures, such as balancing worker demand for GLP-1 access with concerns about long-term costs.

"Employers are under pressure from workers demanding access to GLP-1s, but they also worry about the costs," Hornung reiterated.

She anticipates that innovative contracting models could emerge as oral GLP-1s enter the market. For example, employers might adopt outcomes-based agreements that tie reimbursement to patients achieving specific weight loss or metabolic health targets.

Shifting market balance

If the FDA approves Novo Nordisk's oral semaglutide, it could fundamentally disrupt the GLP-1 market. Oral GLP-1s would introduce a new delivery option that could reshape market share, alter payer and employer coverage strategies and expand patient access to prescription weight management therapies.

"The approval will also add competitive pressure. For the broader market, a successful oral GLP-1 launch might increase the interest of other pharma pipelines in bringing a competitor to the market," she concluded.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.

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