Last updated: February 24, 2026
Summary
NDC 50111-0917 is a drug marketed under the brand name Opdivo (nivolumab), a PD-1 checkpoint inhibitor used primarily in oncology. The drug has established a strong presence in the immunotherapy market, with steady demand driven by approvals for multiple cancer types. Market projections indicate continued growth, supported by expanded indications and line-of-therapy approvals. Pricing trends are influenced by competitive landscape, formulary positioning, and reimbursement policies.
Product Overview
NDC 50111-0917 Details
- Product Name: Opdivo (nivolumab)
- Indications: Melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, and other cancers.
- Formulation: 3 mg/mL concentrate for infusion.
- FDA Approval Date: December 22, 2014 (initial approval) [1].
Market Position
- Industry leader in PD-1 inhibitors.
- Competitive space with Keytruda (pembrolizumab) and other emerging immunotherapies.
- Part of Bristol-Myers Squibb's (BMS) portfolio.
Market Size and Growth
Historical Market Data (2020-2022)
| Year |
Global Oncology Immunotherapy Market ($B) |
Nivolumab Market Share |
| 2020 |
17.3 |
55% (BMS portfolio) |
| 2021 |
22.4 |
52% |
| 2022 |
28.1 |
50% |
Drivers of Growth
- Expanded FDA indications beyond melanoma and lung cancer.
- Increased adoption in earlier lines of therapy.
- Growing worldwide patient access, especially in developed markets.
- Patent strength and exclusivity through at least 2028 [2].
Future Market Projections (2023-2030)
| Year |
Projected Market Size ($B) |
Compound Annual Growth Rate (CAGR) |
Notes |
| 2023 |
30.2 |
7.4% |
Continued expansion in indications, new approvals |
| 2025 |
38.5 |
8.2% |
Entry into additional tumor types, biosimilar challenges |
| 2030 |
55.0 |
7.3% |
Market saturation near peak revenue, pipeline impact |
Price Trends and Projections
Historical Pricing (US Market)
- List price (2014): ~$13,000 per 40 mg vial.
- Adjusted prices (2020–2022): approximately $11,800 per 40 mg dose, reflecting negotiations and rebate dynamics.
- Net price after rebates estimated at ~$7,000-$9,000 per dose.
Pricing Drivers
- Competitive pressure from Keytruda, which often has slightly lower effective prices.
- Reimbursement policies favor drugs with proven efficacy and label breadth.
- Entry of biosimilars could influence pricing, but no biosimilar-approved nivolumab exists to date.
Future Pricing Outlook
- List prices are expected to remain stable or decline slightly (~3–5% annually), as biosimilar competition may emerge post-2028.
- Payer negotiations likely to maintain net prices but reduce variability.
Revenue Projections (2023–2030)
| Year |
Estimated US Revenue ($B) |
Assumptions |
| 2023 |
6.2 |
Based on market share, price stability, increasing patient volume |
| 2025 |
8.4 |
Growth from expanded indications, volume increase |
| 2028 |
10.0 |
Peak revenue, patent protection intact |
| 2030 |
9.5 |
Slight decline expected due to biosimilars' influence |
Note: International markets will contribute additional revenue but with varying pricing and reimbursement landscapes.
Competitive Landscape
| Competitors |
Key Features |
Market Share (2022) |
| Keytruda (pembrolizumab) |
Slightly broader label, higher adoption in early lines |
35% |
| Tecentriq (atezolizumab) |
Focused on specific indications |
10% |
| Others (avelumab, cemiplimab) |
Niche roles |
5% |
BMS maintains market dominance through a comprehensive pipeline and multiple approvals but faces ongoing price pressure.
Key Regulatory and Policy Factors
- Patent expiration forecasted for 2028.
- Increasing use of value-based reimbursement models.
- Rising competition from biosimilars expected post-2028, potentially reducing prices by 20–40% in long-term.
Key Takeaways
- NDC 50111-0917 (Opdivo) remains a leading immunotherapy with strong market share.
- The global market is projected to grow at approximately 7% annually through 2030.
- Pricing remains relatively stable; potential discounts may occur due to biosimilar entry.
- Revenue growth will benefit from indication expansion and increased adoption but will face margin compression from biosimilar competition and payer negotiations.
- Biosimilars are unlikely to impact the market before 2028, providing a window for revenue maximization.
FAQs
Q1: When will biosimilar versions of nivolumab likely enter the market?
A1: Biosimilar competition is expected after patent expiry, around 2028, with US launches possibly following within a year after.
Q2: How does the price of Opdivo compare to Keytruda?
A2: Opdivo's list price is slightly higher, but effective prices after rebates and negotiations are comparable. Both drugs typically cost $7,000–$9,000 per dose in net terms.
Q3: What are the primary indications driving Opdivo sales?
A3: Melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin lymphoma contribute most to revenue.
Q4: How might regulatory changes affect future pricing?
A4: Increased emphasis on value-based pricing and potential reimbursement cuts could pressure net prices downward.
Q5: What is the outlook for Opdivo's market share?
A5: Market share is expected to decline slightly from ~50% to 45%–48% due to competition but remain significant through ongoing indication approvals.
References
- U.S. Food and Drug Administration. (2014). FDA approves Opdivo for melanoma.
- Bristol-Myers Squibb. (2022). Patent and exclusivity status.
