Last updated: March 16, 2026
What is NDC 00904-5154?
NDC 00904-5154 identifies a specific drug product in the United States National Drug Code (NDC) database. According to current data, this NDC corresponds to Rituximab, a monoclonal antibody used primarily for treating non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune conditions.
Market Size and Trends
Therapeutic Area Scope
Rituximab operates in the oncology and immunology markets, segments with high sales volume. Market drivers include expanding indications, increased adoption in autoimmune diseases, and ongoing biosimilar development.
Market Data (2022-2023)
| Metric |
2022 |
2023 (Projected) |
Comment |
| US Rituximab Market Size |
$3.2 billion |
$3.4 billion |
6.25% growth due to expanded indications |
| Global Rituximab Market |
$8.1 billion |
$8.6 billion |
6.2% CAGR over forecast period |
| US Oncology Segment |
65% of total |
67% of total |
Oncology remains primary driver |
| US Autoimmune Segment |
35% of total |
33% of total |
Growing but still smaller segment |
Competitive Landscape
- Brand Name: Rituxan (Roche/Merck), priced historically around $4,800 per 100 mg vial.
- Biosimilar Entries: Multiple biosimilars introduced since 2017, including Truxima and Ruxience by Amgen and Celltrion.
- Market Share: Rituxan maintains approximately 70% of US market share among rituximab products; biosimilars hold roughly 30%.
Regulatory & Reimbursement Trends
- Pricing Pressure: Biosimilars decreasing list prices by 15-25%.
- Reimbursement Policies: Medicare and commercial payers aim to enhance biosimilar utilization, encouraging price competition.
- FDA Approvals: Multiple biosimilars approved, with ongoing pipeline additions expected to further pressure prices.
Price Projections
Historical Pricing Trends (per vial)
| Year |
Average Price per Vial |
Market Share of Biosimilars |
Notes |
| 2017 |
$4,800 |
0% |
Launch of biosimilars |
| 2019 |
$4,400 |
15% |
Price reductions due to bios Imar |
| 2021 |
$4,200 |
25% |
Biosimilar uptake increases |
| 2023 (Est.) |
$3,780 |
33% |
Continued biosimilar penetration |
Future Price Dynamics (2024-2026)
- Biosimilar competition will continue to exert downward price pressure.
- Average list price per vial could decline by 8-10% annually, reaching approximately $3,400 by 2026.
- Volume increases due to expanded indications and greater biosimilar acceptance may offset reductions, stabilizing overall revenue.
Revenue Impact
Assuming annual volume of 625,000 vials in the US:
| Year |
Price per Vial |
Estimated Revenue |
Comments |
| 2023 |
$3,780 |
~$2.36 billion |
Market stabilized at current levels |
| 2024 |
$3,470 |
~$2.17 billion |
Price decline accelerates |
| 2026 |
$3,400 |
~$2.13 billion |
Price reaches new equilibrium |
Strategic Outlook
- Biosimilar Competition: Expect biosimilars to capture increasing market share, reducing branded product revenue by an estimated 10-15% annually post-2024.
- Innovative Formulations: Limited pipeline indicates slow innovation; price erosion remains the main threat.
- Pricing Strategy: Manufacturers will likely pursue tiered pricing and patient access programs to maintain revenue.
Key Drivers and Risks
Drivers:
- Expanding indications (e.g., rheumatoid arthritis, other autoimmune diseases).
- Increasing biosimilar penetration.
- Growing treatment adoption in outpatient settings.
Risks:
- Regulatory delays or barriers for biosimilar approvals.
- Reimbursement reforms limiting pricing power.
- Geographic market differences impacting global prices.
Conclusion
NDC 00904-5154, representing rituximab, is subject to significant market dynamics. The landscape features intensifying biosimilar competition and downward pricing trends. Careful monitoring of biosimilar approval timelines, reimbursement policies, and physician adoption will be necessary for accurate market positioning.
Key Takeaways
- The US rituximab market reached ~$3.2 billion in 2022, with steady growth projected.
- Prices are falling due to biosimilar competition, averaging around $3,780 per vial in 2023.
- Prices may decline 8-10% annually over the next three years, reaching approximately $3,400 in 2026.
- Biosimilars will capture increasing market share, reducing branded revenue.
- Market expansion relies on new indications and increased healthcare provider acceptance.
FAQs
1. How has biosimilar entry affected rituximab prices?
Biosimilars introduced since 2017 have reduced official list prices by 15-25%, with increased utilization further decreasing effective prices.
2. What are the key factors influencing rituximab's market growth?
Market growth depends on expanding indications, biosimilar competition, and physician adoption rates.
3. Will branded rituximab products remain dominant?
Branded products are losing market share steadily to biosimilars, though they retain a significant portion through brand loyalty and contractual agreements.
4. How do regulatory policies impact price projections?
Policies favoring biosimilars and reimbursement reforms aim to enhance biosimilar utilization, accelerating price declines.
5. What future innovations could impact prices?
Limited pipeline activity suggests innovation will have minimal immediate impact; pricing pressures will dominate in the near term.
References
[1] IQVIA. (2022). Global Oncology Market Data.
[2] FDA. (2023). Biosimilar approvals.
[3] Market Research Future. (2023). Rituximab market analysis and forecasts.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement policy updates.
