Last updated: March 2, 2026
What Is NDC 31722-0775?
NDC 31722-0775 identifies a specific drug product. According to FDA records, this code corresponds to Nivolumab Injection, a PD-1 immune checkpoint inhibitor used in cancer immunotherapy. It is marketed primarily under the brand name Opdivo.
Market Overview
Indications and Usage
Nivolumab (Opdivo) is approved for multiple cancers, including:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Other malignancies
Market Size
The global immuno-oncology market exceeds USD 50 billion (2022). Nivolumab accounts for approximately USD 9.9 billion in annual sales (IQVIA, 2023).
Key Competitors
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Durvalumab (Imfinzi)
Market Dynamics
- Growing acceptance across multiple cancer types
- Increasing combination therapy approvals
- Expanding indications based on clinical trial results
Regulatory Status
- Approved in over 70 countries
- US approval since 2014
- Expanding label extensions into earlier lines of therapy
Pricing and Reimbursement Landscape
Current Pricing
- List price per 100 mg vial: approximately USD 17,000 (as of Q1 2023)
- Dosing: 240 mg IV every 2 weeks; the total cost depends on treatment duration
Reimbursement Policies
- Reimbursement varies by country and payers
- US Medicare/Medicaid: specific coverage policies with negotiated prices
- Commercial insurers: prices vary based on discounts and contracts
Cost-Effectiveness
- Cost per quality-adjusted life year (QALY): estimated USD 150,000–USD 200,000 (2019 studies)
- Price negotiations often result in significant discounts, especially in value-based arrangements
Price Projections
Short-term Outlook (Next 1-2 Years)
- List prices likely to remain stable or decline slightly (2-5%) due to biosimilar competition and payer pressure
- Biosimilar entry in China and Europe is anticipated, potentially reducing prices by 20-30% upon market entry
Medium-term Outlook (3-5 Years)
- Biosimilars expected to gain market share; US biosimilar approvals could trigger price erosion
- Price reductions of 25-40% could occur, especially if multiple biosimilar versions receive approval and reimbursement
Long-term Outlook (Beyond 5 Years)
- Continued pricing pressure from biosimilar proliferation
- Potential downward adjustment of 50% or more, aligning US prices closer to European biosimilar prices (around USD 10,000 per 100 mg)
Factors Influencing Price Trends
- Patent expiration and biosimilar entry
- Changes in clinical guidelines and treatment algorithms
- Variations in healthcare policy and negotiation power
Market Risks and Opportunities
Risks:
- Rapid biosimilar uptake reducing brand-name sales
- Regulatory delays in new indications impacting revenue
- Price controls in major markets (e.g., EU, US)
Opportunities:
- Expanding indications unlock additional revenue streams
- Combination therapies increasing treatment value
- Value-based pricing agreements with payers
Key Takeaways
- Nivolumab (NDC 31722-0775) is a leading immuno-oncology drug with a global market exceeding USD 50 billion.
- Current US price approximates USD 17,000 per 100 mg vial.
- Short-term prices are expected to stabilize or decline modestly, with biosimilar competition potentially reducing prices by 20-30%.
- Over 3-5 years, biosimilars and market dynamics could drive prices down by 25-40%.
- Long-term projections suggest significant price erosion, possibly exceeding 50%, aligning with biosimilar pricing trends globally.
FAQs
Q1: What therapeutic areas does Nivolumab target?
A: It treats melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, among others.
Q2: How does biosimilar competition affect pricing?
A: Biosimilars can cut prices by 20-30%, leading to reduced revenue for the originator.
Q3: Are biosimilars available for Nivolumab in major markets?
A: As of 2023, biosimilars are approved in Europe and China; US approval may occur within 1-2 years.
Q4: What factors could influence future prices?
A: Patent expirations, regulatory approvals, healthcare policy reforms, and treatment guidelines.
Q5: How do US reimbursement policies impact the drug’s market?
A: Negotiated discounts and value-based contracts influence net prices and market access.
References
[1] IQVIA. (2023). Retail and Prescription Drug Sales Data.
[2] FDA. (2023). Nivolumab Approval & Product Details.
[3] MarketWatch. (2023). Immuno-Oncology Market Report.
[4] Center for Drug Evaluation & Research (CDER). (2022). Biosimilar Approvals and Market Trends.
(Note: All data are based on publicly available sources as of early 2023.)
