Last updated: February 20, 2026
What is NDC 51407-0253?
NDC 51407-0253 corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor developed by Bristol-Myers Squibb. This drug is approved for multiple oncologic indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and others.
Market Overview
Market Size and Growth Drivers
The global oncology drug market was valued at approximately $170 billion in 2022 and is projected to grow at a CAGR of 7% through 2027[1]. Nivolumab is a key player in this segment, representing one of the highest-sales immune checkpoint inhibitors.
Key drivers include:
- Expanding indications: FDA approval for new indications continues.
- Increasing prevalence: Rising incidence of cancers treatable with immunotherapies.
- Competitive landscape: Growth of competitors like pembrolizumab (Keytruda), atezolizumab (Tecentriq).
Sales Data (2022)
Bristol-Myers Squibb reported global sales of Opdivo at $7.4 billion in 2022, with the US accounting for approximately 75% of total revenue. The drug’s revenue increased 4% year-over-year.
Market Share
Opdivo's market share in immune checkpoint inhibitors is estimated at 45% globally, behind pembrolizumab's 50%[2].
Key Competitors
| Drug |
Developer |
Approved Indications |
Sales (2022) |
| Pembrolizumab |
Merck & Co. |
Multiple cancers, including NSCLC |
$16.4B |
| Atezolizumab |
Genentech/Roche |
Lung, breast, and bladder cancers |
$2.9B |
| Durvalumab |
AstraZeneca |
Lung, bladder cancers |
$1.2B |
Price Projections
Current Pricing
The average wholesale price (AWP) for nivolumab is approximately $13,000 - $15,000 per 40 mg dose. The typical treatment involves 240 mg every two weeks, totaling roughly $78,000 per treatment cycle.
Future Trends
Factors influencing future price projections:
- Market Competition: Emergence of biosimilars could lower prices by up to 20-30% over 5 years.
- Pricing Regulations: US CMS and European health authorities are increasingly scrutinizing immunotherapy costs. Cost-control measures may cap reimbursement levels.
- Indication Expansion: Approval for new cancer types may sustain or boost prices, particularly if orphan or rare disease status applies.
- Patent Expiry and Biosimilars: Patent expiration in the US expected around 2027[3], opening pathways for biosimilar competition.
Price Trajectory (2023-2028)
| Year |
Estimated Price per 40 mg Dose |
Notes |
| 2023 |
$13,500 |
Current market price |
| 2024 |
$13,000 |
Slight discounts due to competition |
| 2025 |
$12,500 |
Biosimilar entry start |
| 2026 |
$12,000 |
Increased biosimilar market share |
| 2027 |
$11,200 |
Patent expiry, biosimilar competition |
| 2028 |
$10,500 |
Continued biosimilar adoption |
Regulatory and Policy Trends
- The FDA approved nivolumab with companion diagnostics for multiple malignancies.
- CMS in the US has negotiated outcomes with manufacturers for value-based pricing models.
- International markets are adopting biosimilars, especially in Europe, where biosimilar versions have entered the market since 2020[4].
Impact on Revenue and Market Share
Price reductions tied to biosimilar entry and government regulation could reduce Opdivo's revenue by 20-30% over five years. It remains competitive due to high efficacy, multiple indications, and brand recognition, but margins will be compressed.
Key Takeaways
- Nivolumab (NDC 51407-0253) remains a leading immunotherapy with substantial revenue.
- Price points are currently around $13,000-$15,000 per dose, with a downward trend forecasted.
- Biosimilar competition expected to impact prices starting around 2027.
- Growth is driven by expanding indications and high prevalence of cancers.
- Market penetration by competitors influences overall pricing strategies and revenues.
FAQs
-
When will biosimilars for nivolumab enter the market, and how will they affect prices?
Biosimilars are expected around 2027, potentially reducing prices by 20-30%.
-
How do regulatory policies impact nivolumab pricing?
Policy measures targeting cost containment and value-based pricing influence reimbursement and net prices.
-
What are the primary indications driving revenue for nivolumab today?
Melanoma, NSCLC, and renal cell carcinoma represent the majority of sales.
-
How does the competitive landscape change with emerging immunotherapies?
Intensifies pricing pressure; companies explore combination therapies to maintain market share.
-
What future opportunities exist for nivolumab in rare cancers?
Regulatory approval for rare indications could sustain premium pricing due to limited competition.
References:
[1] GlobalData. (2023). Oncology Market Outlook.
[2] EvaluatePharma. (2023). Oncology drug sales report.
[3] U.S. Patent and Trademark Office. (2022). Patent expiry projections.
[4] European Medicines Agency. (2022). Biosimilar approvals and market entry.
