Last updated: March 3, 2026
What is NDC 60846-0808?
NDC 60846-0808 identifies a drug marketed as Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor used in oncology. It’s primarily approved for melanoma, non-small cell lung cancer, renal cell carcinoma, and other cancers, reflecting high treatment versatility.
Market Size and Demand
Current Market Overview
- Global Oncology Drug Market (2023): Valued at approximately USD 125 billion.
- Nivolumab (Opdivo): Estimated to represent around USD 8 billion in sales in 2022.
- Market Share: Nivolumab held a dominant position among PD-1 inhibitors, competing directly with pembrolizumab (Keytruda).
Enrollment Estimations
- US Market (2022-2023): Approximately 200,000 eligible patients for Nivolumab-based therapies annually.
- Expanding Indications: Additional approvals for gastric, hepatocellular, and esophageal cancers are expanding the eligible patient pool.
Competitive Landscape
| Competitor |
Market Share (2022) |
Price per Dose (USD) |
Approved Indications |
| Pembrolizumab (Keytruda) |
45% |
USD 7,500-10,000 |
Multiple cancer types |
| Atezolizumab (Tecentriq) |
15% |
USD 8,000-11,000 |
Lung, bladder, breast |
| Nivolumab (Opdivo) |
40% |
USD 6,000-12,000 |
Broad, includes melanoma, lung |
Price Sensitivity and Insurance Coverage
- Prices vary based on indication, line of therapy, and insurance negotiations.
- Out-of-pocket costs for patients can range from USD 500 to USD 2,000 per dose, subject to coverage.
Price Projection Factors
Key Drivers
- Patent Status: Nivolumab’s patent protections expired or are set to expire in multiple jurisdictions by 2028, increasing biosimilar entry.
- Biosimilar Competition: Expected in the next 3-5 years, potentially reducing prices by 20-50% depending on market penetration.
- Regulatory Approvals: Pending approvals may expand indications, boosting sales volume.
- Pricing Policies: Payer adoption strategies and value-based pricing models influence list and net prices.
Short-Term (2023-2025)
- Forecasted Price Range: USD 5,500 to USD 10,500 per dose.
- Average Price: Approximately USD 7,500 per dose.
- Trend: Slight downward pressure due to increasing biosimilar competition and payer negotiations.
Long-Term (2026-2030)
- Projected Price Range: USD 4,000 to USD 8,000 per dose.
- Impact of Biosimilars: Prices expected to decline by 30-50% as biosimilars capture market share.
- Market Share Shifts: Expected reduction of branded Nivolumab share from 40% to approximately 20-25% within this period.
Volume Adjustments
- Total sales volume could grow as additional indications are approved.
- Volume increases anticipated by 10-20% annually, driven by expanding indications and diagnosis rates.
Revenue Projections
| Year |
Estimated Global Sales (USD Billion) |
Key Factors |
| 2023 |
8.2 |
Stable pricing, moderate volume growth |
| 2025 |
9.5 |
Expanded indications, biosimilar entry starting |
| 2030 |
7.8 |
Price reduction outweighs volume gains |
Key Price Drivers by Market
| Region |
Pricing Trends |
Regulatory Environment |
Biosimilar Adoption |
| US |
Slight decline |
Multiple pathways for biosimilar approval |
Leading adopter |
| EU |
Stable decline |
Early biosimilar approvals |
High adoption rate |
| Asia |
Price pressure increasing |
Regulatory reforms |
Variable, highly price-sensitive |
Summary
Nivolumab (NDC 60846-0808) remains a significant revenue driver in oncology. Short-term stability is expected, with gradual price erosion due to biosimilar competition. Long-term decline projected as biosimilars penetrate markets, influenced by regulatory, patent, and reimbursement trends.
Key Takeaways
- Market size in the US exceeds USD 8 billion annually.
- Prices per dose are around USD 7,500, with projections declining to USD 4,000-8,000 by 2030.
- Biosimilar competition will be the primary downward force.
- Additional indications expand market potential, offsetting some price declines.
- Regional differences influence price and adoption, with the US and EU leading biosimilar entry.
FAQs
Q1: When will biosimilars for Nivolumab become available?
Biosimilar entry is expected between 2024 and 2026, with regulatory clearances varying by region.
Q2: How does approval for new indications affect revenue?
New approvals increase patient eligibility, raising volume and revenues despite potential price erosion.
Q3: What are the major competitors to Nivolumab?
Pembrolizumab, atezolizumab, and durvalumab are key competitors offering similar mechanisms.
Q4: How do pricing policies differ globally?
US prices are generally higher due to less regulation, while Europe employs stricter price controls and value-based negotiations.
Q5: What factors could accelerate price declines?
Entry of biosimilars, patent cliffs, and payer pressure are primary drivers of accelerated price reductions.
References
[1] IQVIA. (2022). Global Oncology Market Data.
[2] FDA. (2023). Biosimilar Approval Pathways.
[3] EvaluatePharma. (2023). Price Trends in Oncology.
