Last updated: February 23, 2026
What is NDC 00591-3875?
NDC 00591-3875 corresponds to Nivolumab (Opdivo), a monoclonal antibody developed by Bristol-Myers Squibb. It is used for treating various cancers, including melanoma, non-small cell lung cancer, renal cell carcinoma, and others. The drug was approved by the FDA in 2014 and has since gained broad indications.
Market Overview
Global and U.S. Market Size
- The global checkpoint inhibitor market, within which nivolumab is classified, was valued at approximately $12.4 billion in 2022.
- The U.S. accounts for over 50% of this market, driven by high prevalence of target cancer types and advanced healthcare infrastructure.
- The U.S. market for nivolumab reached $7.2 billion in 2022, reflecting widespread adoption and expanded indications.
Key Competitors
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Roche)
- Durvalumab (Imfinzi, AstraZeneca)
These drugs dominate PD-1 and PD-L1 inhibitor segments, competing actively with nivolumab across indications.
Market Drivers
- Rising cancer incidence rates: The American Cancer Society reports over 1.9 million new cancer cases annually in the U.S.
- Expanding indications: Nivolumab received approvals for lung, kidney, head and neck, bladder, and Hodgkin lymphoma.
- Increased approval of combination therapies involving nivolumab, increasing patient population.
Market Challenges
- High drug costs: Nivolumab treatment can reach $150,000 annually per patient.
- Patent expirations for certain indications: Easing competition but also potent generic and biosimilar threats.
- Management of side effects: Immune-related adverse events require extensive monitoring, limiting treatment accessibility in certain markets.
Price Analysis and Projections
Current Pricing
- The wholesale acquisition cost (WAC) for nivolumab in the U.S. averages $5,300 to $6,200 per 40 mg vial.
- Typical regimen: 240 mg to 600 mg every 2-4 weeks, depending on indication.
- Per-treatment costs can range from $40,000 to $150,000, considering dosage and duration.
Price Trends (2019–2022)
| Year |
Average Treatment Cost |
Key Factors |
| 2019 |
$38,000–$50,000 |
Expanded indications, increased uptake |
| 2020 |
$40,000–$52,000 |
Pandemic impact, delayed treatments |
| 2021 |
$42,000–$55,000 |
New approvals, rising health expenditures |
| 2022 |
$45,000–$60,000 |
Higher dosing, emphasis on combination therapy |
Price Projections (2023–2028)
- Anticipated average price increase of 2% per year driven by inflation, manufacturing costs, and new indications.
- Emergence of biosimilars, expected by 2025, could pressure prices downward by 10–15% post-approval.
- Price adjustments may vary regionally; U.S. prices are most stable, while international markets face more substantial discounts.
| Year |
Estimated Treatment Cost Range |
Drivers |
| 2023 |
$46,000–$62,000 |
Continued expansion of indications, inflation |
| 2024 |
$47,000–$63,000 |
Biosimilar entry preparation |
| 2025 |
$44,500–$59,000 |
Biosimilar market penetration begins |
| 2026 |
$45,000–$60,000 |
Market stabilization, new combination approvals |
| 2027 |
$46,000–$62,000 |
Patent exclusivity, inflation continue |
Regulatory and Economic Factors Impacting Pricing
- The FDA’s approval of biosimilars, expected around 2025, could induce price reductions and increased market competition.
- Value-based pricing models, which tie reimbursement to clinical outcomes, may influence future price caps.
- Healthcare policies aimed at reducing drug costs, such as the Inflation Reduction Act, may further impact prices.
Key Takeaways
- Nivolumab (NDC 00591-3875) operates in a high-growth, competitive oncology market.
- The U.S. remains the dominant market, with treatment costs averaging $45,000–$60,000 annually.
- Price increases are projected at approximately 2% annually until biosimilar entry, which could reduce prices by 10–15% post-2025.
- Market growth is driven by expanding indications and patient access; cost containment may limit long-term pricing increases.
- Competition from biosimilars and novel immunotherapies will shape future price dynamics.
FAQs
1. What drives the highest costs associated with nivolumab treatment?
Dosing frequency and duration, patient weight, and indication-specific protocols determine total treatment costs.
2. How soon could biosimilars impact nivolumab prices?
Biosimilars are expected approval around 2025, with potential market entry shortly thereafter.
3. Are international prices for nivolumab different from U.S. prices?
Yes, international costs tend to be lower due to price regulation policies; prices vary regionally.
4. What factors could lead to further price reductions?
Introduction of biosimilars, policy reforms, and negotiated pricing agreements are primary influences.
5. How does nivolumab's market share compare to pembrolizumab?
Pembrolizumab generally holds a larger market share due to broader FDA approvals and earlier market entry, but nivolumab maintains significant position across multiple tumor types.
References
[1] MarketWatch. (2023). Global cancer immunotherapy market size.
[2] American Cancer Society. (2023). Cancer statistics.
[3] U.S. Food and Drug Administration. (2022). BLA approvals for nivolumab.
[4] IQVIA Institute. (2022). The impact of biosimilars on oncology drug pricing.
[5] Centers for Medicare & Medicaid Services. (2022). Drug pricing and reimbursement policies.
