Last updated: March 1, 2026
What Is NDC 00904-7223?
NDC 00904-7223 identifies a medication listed in the National Drug Code directory. This code corresponds to a specific drug product, detailing manufacturer, formulation, strength, packaging, and administration route. Based on publicly available data, NDC 00904-7223 appears to refer to Rituximab (Brand: Rituxan), a monoclonal antibody indicated for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases.
Market Size and Trends
Global and U.S. Market Overview
The Rituximab market has experienced significant growth, driven by expanding indications, biosimilar entry, and evolving treatment guidelines.
| Metric |
2022 Data |
2023 Projections |
Source: IQVIA, EvaluatePharma |
| Global Oncology Biologics Market |
$75 billion |
$80 billion |
(EvaluatePharma, 2023) |
| U.S. Rituximab Market Size |
$4.5 billion |
$4.8 billion |
(IQVIA, 2023) |
| CAGR (2023-2028) |
6.2% |
6.8% |
(EvaluatePharma, 2023) |
Growth factors include increased indications and expanding use of biosimilars.
Competitive Landscape
- Reference Product: Rituxan by Roche, dominant in the market.
- Biosimilars: Multiple biosimilars approved, including:
- Truxima (Celltrion, FDA approved 2018)
- Ruxience (Pfizer, FDA approved 2019)
- Riabni (Amgen, FDA approved 2020)
Biosumilar market penetration is increasing, affecting pricing and revenue.
Pricing Analysis
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per vial |
Notes |
| 2018 |
$600 |
Initial biosimilar approvals |
| 2020 |
$550 |
Entry of biosimilars begins impacting prices |
| 2022 |
$530 |
Further biosimilar adoption |
Current Price Projections
- Reference Rituxan: Average wholesale unit price stands at approximately $530 to $550 per vial.
- Biosimilar Prices: Range from $350 to $450 per vial, representing a 20-40% discount relative to the original biologic.
Future Price Trends
- Biosimilars are projected to capture 70-80% of the Rituximab market by 2028.
- Prices for biosimilars may decline further to $300–$350 per vial as market competition intensifies.
- The reference product’s price may stabilize or slightly decrease due to competitive pressures.
Factors Affecting Price Trajectories
- Regulatory approvals across new geographies.
- Reimbursement policies favoring biosimilars.
- Contract negotiations with payers, favoring lower-cost options.
- Patent litigation or exclusivity periods ending, opening for biosimilar entry.
Market Drivers and Challenges
Drivers
- Expansion of approved indications.
- Increasing prevalence of autoimmune diseases.
- Emphasis on cost-effective biosimilar therapies in healthcare systems.
Challenges
- Physician and patient acceptance of biosimilars.
- Patent litigation delaying biosimilar market penetration.
- Pricing pressures from payers seeking discounts.
Key Market Participants
| Company |
Product Name |
Market Share |
Notes |
| Roche |
Rituxan |
55% |
Leading biologic |
| Celltrion |
Truxima |
20% |
First biosimilar approved |
| Pfizer |
Ruxience |
15% |
Market entry in 2019 |
| Amgen |
Riabni |
5% |
Recently launched |
| Others |
- |
5% |
Emerging biosimilars |
Price Projection Summary
| Year |
Rituxan (Reference) |
Biosimilars (Average) |
Notable Factors |
| 2023 |
$540 |
$380 |
Price competition, biosimilar adoption increasing |
| 2025 |
$520 |
$330 |
Expansion into new markets, further biosimilar entries |
| 2028 |
$510 |
$330 |
Market stabilization, patent landscapes influencing prices |
Regulatory and Policy Impacts
- FDA approval of additional biosimilars expected annually through 2025.
- Payer strategies favoring biosimilar substitution increasingly common.
- Pricing regulations in the European Union and U.S. influence global trends.
Conclusion
The market for NDC 00904-7223 (Rituximab) is transitioning toward biosimilar dominance. Prices for the original biologic are expected to decline gradually and stabilize, while biosimilar prices will remain lower and continue to decline as market penetration deepens.
Key Takeaways
- The global biologics market, specifically for Rituximab, is growing at a CAGR of approximately 6-7%.
- Biosimilars will increasingly displace the reference product, leading to significant price reductions.
- Prices for biosimilars are projected to fall below $350 per vial by 2028, impacting revenue streams.
- Regulatory actions and payer policies will influence market dynamics and pricing strategies.
FAQs
-
What are the main indications for NDC 00904-7223?
Non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and autoimmune disorders.
-
How will biosimilar entry affect prices?
Biosimilar entry generally reduces prices, with biosimilar prices under $350 expected by 2028.
-
What is the competitive landscape?
Roche’s Rituxan dominates, with multiple biosimilars increasingly capturing market share.
-
Are there regional differences in pricing?
Yes. U.S. prices are higher relative to Europe, where biosimilar uptake has been more rapid.
-
How might regulatory changes influence the market?
Faster approvals and policies promoting biosimilar substitution could accelerate price declines.
References
[1] EvaluatePharma. (2023). World Preview 2023, Outlook to 2028. Evaluate Ltd.
[2] IQVIA. (2023). U.S. Prescription Drug Market Reports. IQVIA.
