Last updated: July 28, 2025
Overview of NDC: 00591-3983
National Drug Code (NDC) 00591-3983 corresponds to Nivolumab (Opdivo), a monoclonal antibody developed by Bristol-Myers Squibb. It is a PD-1 checkpoint inhibitor used primarily in oncology to treat various cancers, including melanoma, non-small-cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, and others. Approved by the FDA since 2014, Nivolumab's therapeutic profile underscores its role as a cornerstone in immuno-oncology.
Market Landscape and Competitive Dynamics
1. Market Size and Epidemiology
The global oncology immunotherapy market is projected to reach approximately $211 billion by 2027, driven by the rising prevalence of cancers and the expanding indication spectrum for agents like Nivolumab [1]. Specifically, Nivolumab targets indications such as melanoma, NSCLC, and Hodgkin lymphoma, collectively representing vast patient populations:
- Non-small-cell lung cancer (NSCLC): The most common lung cancer, with over 2 million new cases annually worldwide [2].
- Melanoma: Incidence rates are increasing, with approximately 324,000 new cases globally each year [3].
- Hodgkin Lymphoma: Impacting roughly 80,000 patients worldwide annually [4].
The sustained growth in these patient populations, coupled with increasing adoption of immunotherapy, is bolstering demand for Nivolumab.
2. Competitive Landscape
Nivolumab faces competition from:
- Pembrolizumab (Keytruda): Also a PD-1 inhibitor, with broad indications and significant market share.
- Atezolizumab (Tecentriq): PD-L1 inhibitor in multiple cancer types.
- Durvalumab (Imfinzi): Approved for specific indications.
- Emerging biosimilars and next-generation immunotherapies: Although biosimilar competition remains nascent for branded monoclonal antibodies, ongoing R&D aims to challenge dominant players with more cost-effective options.
Bristol-Myers Squibb maintains a competitive edge through approved combination therapies (e.g., nivolumab + ipilimumab), expanding clinical utility.
3. Regulatory and Market Access Trends
The continued expansion of approved indications and positive clinical trial outcomes enhance Nivolumab’s market penetration. Market access strategies, including payer negotiation and reimbursement programs, significantly influence product uptake and pricing strategies in various geographies.
Price Trends and Projections
1. Historical Pricing Trajectory
Nivolumab's acquisition cost (per infusion) has steadily increased over recent years, influenced by:
- Pricing strategies to offset R&D investments.
- Complexity of manufacturing of biologics.
- Market exclusivity and patent protections (extended until at least 2030 in key markets).
- Reimbursement policies and negotiated discounts.
In the U.S., the average wholesale price (AWP) per 240 mg dose has hovered around $11,000–$13,000 per infusion, equating to an approximate cost of $45,000–$50,000 for a standard 4-week cycle (assuming multiple doses) [5].
2. Projected Price Trends (2023–2030)
Given market dynamics, pricing is projected to:
- Remain relatively stable in the immediate future due to patent exclusivity and high demand.
- Gradually decline in price per unit driven by payer pressures, competitive biosimilars, and evolving manufacturing efficiencies.
- Potential discounts and biosimilar entry expected post-2030, which could lower prices by approximately 15-30% over the subsequent decade [6].
Figure 1: Price Projection (USD) for Nivolumab (NDC 00591-3983) per Infusion
| Year |
Estimated Price Range |
Key Drivers |
| 2023 |
$11,000 – $13,000 |
Brand exclusivity, high demand |
| 2025 |
$10,500 – $12,500 |
Payer pressure, initial biosimilar development stages |
| 2030 |
$9,500 – $11,000 |
Market saturation, biosimilar competition begins |
| 2035 |
$8,000 – $10,000 |
Biosimilar approvals, increased negotiations |
Implications for Stakeholders
Pharmaceutical Companies
- Continued innovation and expanding indication label could sustain premium pricing.
- Investment in biosimilar development will be crucial post-patent expiry.
Healthcare Providers
- Cost considerations influence line-of-therapy decisions; pricing stability benefits planning.
- Reimbursement frameworks and patient assistance programs mitigate affordability issues.
Payers and Policymakers
- Focus on value-based agreements and outcomes-based pricing to manage expenditures.
- Encouragement for biosimilar uptake to foster market competition and reduce costs.
Investors
- Valuation hinges on patent protection duration and pipeline expansion.
- Entry of biosimilars post-2030 could impact market share and profitability.
Novel Developments and Future Outlook
Emerging data on combination therapies (e.g., nivolumab with ipilimumab or chemotherapy) enhance the therapeutic positioning of Nivolumab, potentially justifying premium pricing for advanced indications. Additionally, ongoing clinical trials exploring neoadjuvant, adjuvant, and earlier-stage disease indications could broaden the revenue base.
Furthermore, advances in manufacturing—such as process optimization and biosimilar development—are expected to gradually reduce production costs, leading to downward pressure on prices in the long term.
Key Takeaways
- Market positioning: Nivolumab remains a dominant immunotherapy with expanding indications, supported by high prevalence rates, especially in NSCLC and melanoma.
- Pricing stability: Current high-cost trajectory is expected to stabilize temporarily, with modest declines anticipated post-2025 due to biosimilar competition and tighter payer controls.
- Competitive threats: The entry of biosimilars and new immuno-oncology agents will influence pricing and market share beyond 2030.
- Economic considerations: Manufacturers and payers are incentivized to engage in value-based pricing arrangements, especially as combination regimens demonstrate improved efficacy.
- Investment outlook: Sustained innovation, pipeline expansion, and patent protections reinforce Nivolumab’s market dominance until at least 2030, after which biosimilar entrants may significantly reshape the landscape.
FAQs
1. What factors influence the price of Nivolumab (NDC: 00591-3983)?
Pricing is affected by manufacturing costs, clinical demand, patent exclusivity, competitive landscape, payer negotiations, and indication expansion.
2. How does biosimilar entry impact Nivolumab's pricing?
Biosimilar competition post-patent expiry generally leads to significant price reductions (15-30%) and increased market competition.
3. Are there any upcoming regulations that could affect Nivolumab pricing?
Regulatory trends favoring value-based pricing, affordability initiatives, and biosimilar approvals may influence future pricing and reimbursement strategies.
4. What is the projected market share of Nivolumab in oncology?
Nivolumab is expected to retain a substantial share until biosimilars and newer agents gain traction, especially with ongoing indication expansions.
5. What are the key indications driving Nivolumab demand?
Major demand drivers include treatment of melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and emerging indications like gastric and bladder cancers.
References
[1] Grand View Research, "Oncology Immunotherapy Market Size & Trends," 2021.
[2] Global Cancer Statistics 2022. International Agency for Research on Cancer.
[3] Melanoma Incidence and Mortality Data, WHO, 2021.
[4] Hodgkin Lymphoma Statistics, Leukemia & Lymphoma Society, 2022.
[5] Red Book Online Reports, Truven Health Analytics, 2022.
[6] IQVIA, "BIOSIMILAR MARKET ANALYSIS," 2022.
This detailed market analysis and projection aims to guide executives, investment professionals, and healthcare strategists in evaluating Nivolumab's commercial prospects and pricing dynamics.
