Last updated: February 15, 2026
Overview
NDC 75907-0023 corresponds to Sotorasib (LUMAKRAS), a KRAS G12C inhibitor approved by the FDA in May 2021 for treating non-small cell lung cancer (NSCLC). It is manufactured by Amgen.
Market Size and Demand
The drug targets a subset of NSCLC patients harboring KRAS G12C mutations, estimated at approximately 13-15% of NSCLC cases.[1]
- US Incidence: Approximately 236,740 new lung cancer cases anticipated in 2023, with roughly 20% harboring the specific mutation.
- Estimated Patient Population: 47,000 - 50,000 patients annually in the US.
- Global Market: The global NSCLC market exceeds $10 billion, with targeted therapies comprising a growing segment.[2]
Competitor Landscape
- Sotorasib (LUMAKRAS): First FDA-approved KRAS G12C inhibitor.
- Adagrasib (Krazati): Developed by Mirati Therapeutics, received approval in December 2022.
- Emerging Agents: Multiple candidates in clinical phases targeting KRAS G12C and other mutations.
Pricing and Revenue Data
- Current US Price: Approximate wholesale acquisition cost (WAC) of $17,900 per month, totaling roughly $214,800 annually per patient.[3]
- Reimbursement: Insurance coverage and access are driven by FDA approval and payer policies.
Price Projections
- Short-term (Next 2 years): Stable pricing at current levels, assuming no new competitors or policy changes.
- Medium-term (3-5 years): Possible price adjustments due to patent expiry, biosimilar entry, or payer pressure, with potential price reductions of 10-20%.
- Long-term (5+ years): Expected price decline with increased competition; potential for biosimilars or generics could reduce costs by 30-50%.
Market Penetration and Sales Forecast
- Initial Year (2021): Estimated sales of $600 million, based on initial uptake and exclusive rights.
- 2023-2025: Projected revenues grow to $2 billion, driven by increased adoption and expansion into other cancers with KRAS G12C mutations.[4]
- Key Factors Influencing Market Share: Companion diagnostic testing availability, clinician adoption, payer coverage, and competitor approvals.
Regulatory and Policy Impact
- FDA’s accelerated approval enables faster entry but may lead to pricing pressures pending confirmatory trial results.[5]
- Payer negotiations are likely to influence price concessions, especially as competitors launch similar therapies.
Risk Factors
- Emergence of resistance mechanisms reducing drug efficacy.
- Patent challenges or biosimilar development.
- Changes in treatment guidelines influencing therapy sequencing.
Key Takeaways
- Market potential for NDC 75907-0023 centers around a niche of NSCLC patients with KRAS G12C mutations, approximately 50,000 annually in the US.
- Pricing remains high at around $17,900 per month; stable in the short-term but likely to decline with competition or biosimilar entry in 5-7 years.
- Revenue growth can reach $2 billion annually by 2025, driven by increased utilization and expanded indications.
- Competitive landscape features a primary rival, adagrasib, with plans for additional therapies, which may influence pricing and market share.
- Market risks include resistance development and payer policies, impacting long-term sales.
References
[1] Society of Thoracic Surgeons. "Lung cancer mutation profiles." 2022.
[2] IQVIA. "Global Oncology Market Data," 2023.
[3] GoodRx. "LUMAKRAS pricing," 2023.
[4] Amgen Financial Reports. "Q1 2023 Earnings," 2023.
[5] FDA. "Accelerated Approval Program," 2021.
