Assessing the Long-Term Impact of the Novo Nordisk Lawsuit on GLP-1 Market Dynamics and Shareholder Value

The GLP-1 receptor agonist market has become a linchpin in the global fight against obesity and diabetes, with Novo Nordisk's Ozempic and Wegovy dominating sales. Yet, the Danish pharmaceutical giant now faces a seismic challenge: a sprawling multidistrict litigation (MDL) involving over 2,190 plaintiffs alleging severe gastrointestinal and vision-related injuries linked to its semaglutide-based drugs. As the legal and competitive landscape evolves, investors must weigh the risks to Novo Nordisk's market dominance, regulatory scrutiny, and long-term profitability.

Legal Risks: A Daubert Hearing and FDA Scrutiny

The MDL (No. 3094) in Pennsylvania centers on claims that Novo failed to warn patients and doctors about risks like gastroparesis and nonarteritic anterior ischemic optic neuropathy (NAION). A pivotal May 2025 Daubert hearing will test the scientific validity of plaintiffs' expert testimony linking semaglutide to these conditions. If plaintiffs secure admissible evidence, it could open the floodgates for mass settlements, with high-severity cases valued at $200,000–$1 million.

Meanwhile, the FDA's August 2025 updates to Ozempic's warning label—expanding risks to include pulmonary aspiration and signaling pressure to add vision-related warnings—highlight regulatory unease. A 2024 JAMA Ophthalmology study and a Swedish observational trial have already linked semaglutide to retinal vein occlusion and NAION, adding scientific credibility to the lawsuits. While Novo Nordisk argues these injuries stem from pre-existing conditions like diabetes, the growing body of evidence suggests the agency may tighten oversight, potentially complicating future approvals for GLP-1 drugs.

Competitive Landscape: Eli Lilly's Mounjaro and the Rise of Triple Agonists

Novo's dominance in the GLP-1 market is under threat from rivals like Eli Lilly, whose Mounjaro (tirzepatide) and Zepbound (its obesity version) are projected to surpass Ozempic and Wegovy in sales by 2030. Mounjaro, a dual GIP-GLP-1 agonist, demonstrated 22.5% weight loss in trials, outperforming semaglutide. Lilly's pipeline includes Retatrutide, a triple agonist targeting GLP-1, GIP, and glucagon, which showed 24.2% weight loss in Phase II trials—a potential game-changer.

Oral GLP-1 therapies, such as Boehringer Ingelheim's Survodutide and Eli Lilly's Orforglipron, also threaten Novo's injectable dominance. These alternatives cater to patient preferences for easier administration, a critical differentiator in a market where adherence drives success. Meanwhile, Sanofi and Roche are deepening partnerships to develop combination therapies, further fragmenting Novo's market share.

Financial Implications: Liability, Revenue, and Market Share

The litigation's financial toll could be staggering. If 10% of the 2,190 MDL cases result in six-figure settlements, Novo faces a $220 million liability. Add state-level lawsuits for vision injuries—where Texas plaintiffs are already pursuing cases—and the total could escalate rapidly. While Novo's 2025 revenue from Ozempic and Wegovy is forecast at $24.4 billion and $18.1 billion, respectively, prolonged litigation risks eroding these figures through reputational damage, regulatory delays, or reduced prescriptions.

Yet, the GLP-1 market's growth remains robust. Projected to expand from $22.37 billion in 2025 to $31.27 billion by 2029, the sector's tailwinds—driven by rising obesity rates and aging populations—suggest Novo could still thrive. However, rivals like Lilly, with its $36 billion Mounjaro sales projection for 2030, are poised to overtake Novo if the litigation weakens its market position.

Investment Outlook: Balancing Risks and Opportunities

For investors, the key question is whether Novo Nordisk can navigate the legal storm while maintaining its innovation edge. The company's pipeline, including Cagrisema (a semaglutide-cagrilintide combo) and Amycretin (a GLP-1-amylin agonist), offers long-term growth potential. However, the lawsuits and FDA scrutiny could delay approvals or force costly label changes.

A cautious approach is warranted. While Novo's market share remains formidable, the litigation's outcome—and the rise of competitors like Lilly—introduce significant uncertainty. Diversifying exposure to the GLP-1 sector, rather than over-relying on Novo, may mitigate risks. Investors should also monitor the FDA's response to vision-related risks and the Daubert hearing's impact on plaintiffs' ability to prove causation.

In the broader market, the GLP-1 boom is here to stay. But for Novo Nordisk, the path forward hinges on its ability to defend its blockbuster drugs while innovating in a fiercely competitive landscape. For now, the litigation casts a long shadow over its $84 billion GLP-1 sales projection by 2030.