Last updated: February 15, 2026
What is the drug identified by NDC 00054-8550?
The National Drug Code (NDC) 00054-8550 corresponds to Nivolumab (Opdivo), a programmed death-1 (PD-1) immune checkpoint inhibitor. It is approved for multiple oncology indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, Hodgkin lymphoma, and others. The drug is marketed by Bristol-Myers Squibb.
Market Size and Growth Drivers
- The global immuno-oncology market was valued at approximately $13.7 billion in 2021.
- The market is projected to grow at a compound annual growth rate (CAGR) of 13.2% from 2022 to 2027, driven by expanding approval for various indications and increasing prevalence of cancers.
Key indications for Nivolumab:
| Indication |
Approval Year |
Estimated Global Sales (2022) |
Population Estimate (Patients) |
Growth Drivers |
| Melanoma |
2014 |
$1.8 billion |
132,000 (US) |
Adoption as first-line therapy |
| Non-small cell lung cancer |
2015 |
$4.2 billion |
225,000 (US) |
Expanding indications |
| Renal cell carcinoma |
2018 |
$1.0 billion |
62,000 (US) |
Increasing line extension approval |
| Classical Hodgkin lymphoma |
2016 |
$0.5 billion |
8,500 (US) |
Growing treatment adoption |
In the U.S., the drug's sales are driven by its use as a first-line or second-line therapy for multiple cancers, with the largest contribution coming from NSCLC.
Competitive Landscape
| Competitor Drugs |
Key Indications |
Market Share (2022) |
Price Per Dose (USD) |
Notable Features |
| Pembrolizumab (Keytruda) |
Melanoma, NSCLC, others |
48% |
$5,000 (per 200 mg dose) |
Larger indication coverage, higher market penetration |
| Atezolizumab (Tecentriq) |
Bladder cancer, NSCLC |
10% |
$4,500 (per 1200 mg IV) |
Growing adoption, expanding indications |
| Durvalumab (Imfinzi) |
Small cell lung cancer, urothelial carcinoma |
7% |
$6,000 (per 1500 mg IV) |
Key in specific indications, higher dose protocol |
Nivolumab remains competitive based on its broad indication approvals and established patient base. However, price and reimbursement dynamics favor drugs with higher dosing convenience or broader approval.
Price Trends and Projections
- Current Price: The average wholesale price (AWP) for Nivolumab ranges between $4,800 and $5,200 per 200 mg dose (source: Medi-Span).
- Historical Trends: Prices have remained relatively stable since 2020, with modest reductions in some regions due to biosimilar or biosimilar-like competition, pending regulatory and patent statuses.
Price Projections (2023–2028)
| Year |
Expected Price Per 200 mg Dose |
Key Factors |
| 2023 |
$4,900–$5,100 |
Stable demand; no major biosimilar entry; inflation adjustments |
| 2024 |
$4,850–$5,000 |
Patent protections remaining in key markets; value-based pricing strategies |
| 2025 |
$4,700–$4,950 |
Potential biosimilar entry in Europe; patent expirations in U.S. planned for 2028 |
| 2026 |
$4,600–$4,900 |
Biosimilar approvals in major markets; pricing pressures increase |
| 2027 |
$4,500–$4,800 |
Biosimilar biosimilar competition intensifies; price erosion expected |
Impact of Biosimilar Competition
- The U.S. patent for Opdivo is scheduled to expire in 2028, opening markets for biosimilars.
- European markets may see biosimilar entry starting as early as 2025, exerting downward pressure.
Reimbursement and Pricing Policy Factors
- U.S. Centers for Medicare & Medicaid Services (CMS) and private insurers are increasingly adopting value-based reimbursement models.
- Negotiation of discounts and rebates influence net prices significantly.
- Pricing in emerging markets varies, often aligned with local regulatory frameworks and affordability considerations.
Key Takeaways
- The global immuno-oncology market is expanding at over 13% CAGR, with Nivolumab holding a significant share.
- Annual U.S. sales are estimated at approximately $8 billion, driven predominantly by NSCLC and melanoma indications.
- Prices are expected to remain stable until biosimilar competition begins, with declines forecasted post-2028.
- Strategic expansion into new indications and potential biosimilar entry constitute key future risks and opportunities.
- Regulatory developments and reimbursement policies will influence pricing and market dynamics.
FAQs
1. What factors could influence Nivolumab’s future market share?
Expansion of approved indications, patent expirations, biosimilar entry, clinical trial results, and changes in reimbursement policies can alter its market share.
2. How might biosimilar entry impact prices?
Biosimilars are expected to decrease prices by 20-40% once they are approved, starting in markets where patent protections end.
3. Are there any upcoming patent expirations for Nivolumab?
Yes, in the U.S., patent expiry is expected in 2028, potentially opening the market for biosimilars.
4. Which regions are most significant for Nivolumab sales?
The U.S., Europe, China, and Japan are the primary markets, with the U.S. contributing the largest share.
5. What are the main risks to the current pricing projection?
Emergence of biosimilars, regulatory changes reducing reimbursement, and competitive new therapies could lower prices faster than projected.
References
- MarketWatch. "Immuno-Oncology Market Size, Share & Trends Analysis," 2022.
- Medi-Span. Wholesale acquisition cost for Nivolumab, 2022.
- U.S. Food and Drug Administration. Nivolumab approvals and patent timelines.
- EvaluatePharma. "Comparative Oncology Drug Market Report," 2022.
- IQVIA. "Global Oncology Market Data," 2022.
