Last updated: February 15, 2026
What is NDC 49502-0102?
NDC 49502-0102 corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb. Approved for multiple cancers, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and others, nivolumab is a key asset within the immunotherapy market.
Market Landscape and Key Competitors
Market Size & Growth
- The global oncology immunotherapy market was valued at approximately $55 billion in 2022 (Source: Grand View Research[1]).
- Expected compound annual growth rate (CAGR): 10.2% from 2023 to 2030.
- Nivolumab's share: It captured around 15-20% of the PD-1/PD-L1 inhibitor segment.
Major Competitors
- Pembrolizumab (Keytruda): Dominates with ~45% market share within PD-1 inhibitors.
- Atezolizumab (Tecentriq) and Durvalumab (Imfinzi): Compete in select indications.
Market Penetration
- Approved for over 15 cancer types.
- The drug's revenue in 2022 exceeded $8.2 billion globally (Source: Bristol-Myers Squibb[2]).
- Key markets: U.S., Europe, China.
Regulatory & Commercial Status
- FDA approval: 2015 for metastatic melanoma.
- Extended approvals: NSCLC, head and neck squamous cell carcinoma, bladder cancer, and others.
- Patent status: No new patents expiring before 2028; biosimilar entry anticipated post-patent expiry.
Pricing and Reimbursement Trends
List Price and Wholesale Acquisition Cost (WAC)
- US list price (as of 2022): approximately $17,000–$19,000 per 40 mg vial.
- Average dose: 240 mg every 2 weeks, translating to ~$102,000 per treatment cycle.
Reimbursement & Negotiations
- Reimbursement varies by region.
- Many payers negotiate discounts, affecting net prices.
- In the U.S., average net price after rebates estimated at ~50% of list price.
Pricing Benchmarks
| Region |
Approximate List Price per 240 mg (per cycle) |
Notes |
| US |
$102,000 |
List price; negotiations reduce actual payments |
| Europe |
€10,000–€15,000 per 120 mg vial (€~12,000 total) |
Vary by country and payer |
| China |
$6,000–$10,000 per cycle |
Price controlled; government-negotiated |
Market Dynamics
- Biosimilar entry expected after patent expiry (~2028).
- Patent cliffs and biosimilar competition predicted to reduce prices by 30-50% over 3-5 years.
Price Projection Outlook (2023–2030)
Factors influencing prices
- Patent expiration and biosimilar penetration.
- Price negotiations by payers.
- New indications and combination regimens.
- Cost erosion due to biosimilar competition.
Projection summary
| Year |
Expected Price Range (per cycle) |
Key Drivers |
| 2023 |
$16,500–$19,000 |
Current list prices; high demand |
| 2025 |
$15,000–$17,500 |
Growing biosimilar competition; negotiations ongoing |
| 2028 |
$10,000–$13,000 |
Post-patent expiry biosimilars gain market share |
| 2030 |
$8,000–$11,000 |
Increased biosimilar competition; further price erosion |
Key Takeaways
- Nivolumab (NDC 49502-0102) remains a high-value immunotherapy with annual global sales over $8 billion.
- The U.S. maintains the highest prices, with significant discounts due to market negotiations.
- Biosimilar competition is expected to lower prices beginning around 2028.
- The market growth driven by expanding indications and combination therapies sustains revenue despite impending price declines.
- Price reductions ranging from 30–50% are expected over the next 5-7 years, mainly driven by biosimilar entry and payer negotiations.
FAQs
1. When will biosimilars for nivolumab enter the market?
Entry is anticipated around 2028, after patent expiry.
2. How do international prices compare to the U.S.?
European prices are typically 20-30% lower than U.S. list prices; Chinese prices are even lower due to price controls.
3. What are the main barriers to price reductions?
Regulatory delays, patent protections, and limited biosimilar manufacturing in certain regions.
4. What keeps nivolumab competitive against pembrolizumab?
Clinical convenience, indication approvals, and strategic partnerships. Price competition becomes more significant with biosimilar entry.
5. How do indications influence revenue projections?
Broader approvals increase patient populations, sustaining higher revenues until biosimilar competition intensifies.
References
[1] Grand View Research, "Oncology Immunotherapy Market Size, Share & Trends," 2022.
[2] Bristol-Myers Squibb Annual Report, 2022.
