Can Eli Lilly Sustain Its Leadership in the Oral GLP-1 Obesity Drug Market Amid Intensifying Competition from Novo Nordisk?

The oral GLP-1 obesity drug market is entering a pivotal phase as Eli Lilly and Novo Nordisk race to secure regulatory approvals and pricing advantages. With both companies leveraging strategic tools to expedite market access and affordability, investors are scrutinizing whether Eli Lilly can maintain its projected dominance in this high-stakes arena.

Regulatory Momentum: CNPVs and Timelines

Eli Lilly's orforglipron has demonstrated robust clinical performance, with the ACHIEVE-1 trial reporting a 7.9% average weight loss at the highest dose. However, Novo Nordisk's oral Wegovy, approved by the FDA in December 2025, already boasts a 14% weight loss in the OASIS-4 trial over 71 weeks. While Eli Lilly aims for global regulatory submissions by year-end 2025, Novo Nordisk's early approval gives it a first-mover advantage.

Both companies, however, are exploiting the Commissioner's National Priority Voucher (CNPV) program to accelerate timelines. Eli Lilly received a CNPV in November 2025, potentially reducing its FDA review period to one month. Novo Nordisk similarly secured a CNPV for its Wegovy 7.2 mg oral formulation, submitted as a supplemental new drug application (sNDA) in the same month. This regulatory parity suggests that while Novo Nordisk has an initial commercial edge, Eli Lilly's CNPV could fast-track its global launch, particularly in markets like the EU and Japan.

Pricing and Access: Balancing Affordability and Profitability

Pricing dynamics are critical in a market where cost barriers have historically limited GLP-1 adoption. Novo Nordisk's oral Wegovy is priced at $149 per month for the 1.5 mg starting dose, supported by partnerships such as TrumpRx, which aims to streamline direct-to-consumer access. Meanwhile, Eli Lilly's orforglipron pricing remains undisclosed, but the company's broader agreements with the U.S. government to cap injectable Wegovy and Zepbound (tirzepatide) at $245 per month-with a $50 copay for Medicare beneficiaries- signal a commitment to affordability.

These strategies reflect a broader industry shift toward mitigating cost-related resistance. Novo Nordisk's collaboration with TrumpRx underscores its focus on bypassing traditional pharmacy benefit managers (PBMs), while Eli Lilly's Medicare/Medicaid agreements align with federal efforts to curb drug prices. However, Eli Lilly's injectable Zepbound, which is projected to dominate the oral market with a 60% share by 2030, may face headwinds if its oral counterpart lacks a similarly aggressive pricing structure.

Market Projections and Competitive Positioning

Goldman Sachs forecasts that oral GLP-1s could capture 24% of the global weight-loss drug market by 2030, generating $22 billion in annual sales. Within this, Eli Lilly is expected to command 60% of the oral segment, compared to Novo Nordisk's 21%. This projection hinges on orforglipron's ability to differentiate itself through superior efficacy or patient adherence. The 7.9% weight loss reported by Eli Lilly, while lower than Novo Nordisk's 14%, still aligns with the GLP-1 class's established benchmarks and emphasizes tolerability-a key factor in long-term patient retention.

Novo Nordisk's early launch of oral Wegovy, coupled with its injectable dominance, positions it as a formidable competitor. Yet Eli Lilly's CNPV-driven regulatory agility and its existing market share in the injectable space (via Zepbound) provide a buffer. The company's CNPV advantage could also enable a staggered global rollout, allowing it to adapt to regional pricing pressures and reimbursement landscapes.

Strategic Implications for Investors

For Eli Lilly to sustain its leadership, it must balance rapid regulatory execution with pricing strategies that address both commercial and public health priorities. The CNPV's potential to shorten approval timelines by 11 months is a significant asset, but its success depends on harmonizing global regulatory requirements. Additionally, Eli Lilly's partnerships with the U.S. government to lower copays and list prices could enhance market penetration, particularly among Medicare beneficiaries, who represent a substantial demographic in the obesity treatment space.

Novo Nordisk's first-mover status and aggressive pricing for oral Wegovy create immediate competition, but Eli Lilly's projected market share dominance by 2030 suggests confidence in its long-term value proposition. Investors should monitor the pace of orforglipron's global approvals, pricing announcements, and real-world adoption rates to gauge whether Eli Lilly can translate clinical data into sustained commercial success.

Conclusion

The oral GLP-1 market is poised for explosive growth, but leadership will hinge on regulatory dexterity and pricing innovation. While Novo Nordisk's early approval and affordability initiatives present a strong challenge, Eli Lilly's CNPV-driven acceleration and injectable market dominance offer a strategic counterbalance. For now, the race remains tightly contested, with the outcome likely to be shaped by how effectively each company navigates the interplay between regulatory timelines, pricing, and patient access.