GLP-1 Weight Loss Drugs: Oral Formulations Set to Reshape Industry Landscape

The pharmaceutical industry is bracing for a significant shift in the weight loss drug market as oral formulations of GLP-1 receptor agonists prepare to join their injectable counterparts. This development promises to expand patient access and simplify manufacturing processes, but also presents new challenges for drug makers and contract manufacturing organizations (CMOs) alike.

Oral GLP-1s: A Game-Changer in Manufacturing and Market Access

The imminent arrival of oral GLP-1 drugs is set to revolutionize both the production and accessibility of these popular weight loss treatments. Unlike their injectable predecessors, which require sterile production environments and specialized manufacturing facilities, oral formulations can be produced using standard solid dose manufacturing equipment. This simplification in the production process is expected to alleviate some of the supply constraints that have plagued the injectable GLP-1 market.

Chris Shibutani, a senior analyst at Goldman Sachs, highlighted the potential impact of this shift: "What's coming next, in terms of treatment options, are oral versions... for which manufacturing will be simpler. Oral versions will enhance the ability to supply a broader, potentially, global market."

The transition to oral formulations is not without its challenges, however. These drugs will likely require daily dosing, as opposed to the weekly schedule of injectables like Novo Nordisk's Wegovy and Eli Lilly's Zepbound. This means a significantly higher number of doses will need to be produced to meet patient demand.

Industry Leaders and Newcomers Prepare for Oral GLP-1 Launch

Major players in the pharmaceutical industry are already taking steps to secure their positions in the oral GLP-1 market. Eli Lilly has invested $550 million to manufacture commercial quantities of its oral GLP-1 candidate, orforglipron, well ahead of potential approval. The drug is currently in Phase III trials for both type 2 diabetes and obesity, with results expected later this year.

Novo Nordisk, already a leader in the injectable GLP-1 space, is planning to file for FDA approval of its oral semaglutide treatment, Rybelsus, for weight loss in the coming months. The company is also developing another oral GLP-1 called amycretin.

Smaller companies are also making moves to capitalize on the oral GLP-1 opportunity. Viking Therapeutics recently partnered with CordenPharma to produce 1 billion tablets of its investigational oral weight loss drug VK2735, as well as injectable versions of the same asset. Similarly, weight loss startup Metsera has secured manufacturing capacity despite only being in Phase I trials.

Manufacturing Challenges and Opportunities

The shift to oral GLP-1s presents both challenges and opportunities for the pharmaceutical manufacturing sector. While the production process for oral formulations is simpler than that of injectables, the sheer volume of doses required may put pressure on manufacturing capacity.

Mimoun Ayoub, global head of peptides and oligonucleotides platforms at CordenPharma, explained that CMOs are likely to compete for contracts with oral GLP-1 developers. He noted that companies able to increase oral bioavailability or improve stability could have an advantage in this market.

The broader manufacturing capabilities for oral drugs may also lower barriers to entry for new players in the weight loss drug market. Matt Phipps, a partner at William Blair, pointed out that the high costs associated with building specialized facilities for injectable peptides have been a significant hurdle for potential competitors to Novo Nordisk and Eli Lilly.

As the industry prepares for this new chapter in weight loss treatment, it remains to be seen how the market will settle between oral and injectable formulations. However, the potential for oral GLP-1s to reach a much broader patient population suggests that this development could significantly reshape the landscape of obesity and diabetes treatment in the coming years.