These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Price type key:
Federal Supply Schedule (FSS): generally available to all Federal Govt agencies /
'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
National Contracts (NC): Available to specific agencies
Market Analysis and Price Projections for NDC: 00065-4274
Last updated: March 10, 2026
What does the drug NDC 00065-4274 refer to?
The NDC 00065-4274 corresponds to Rituximab, a monoclonal antibody used in the treatment of lymphoma, rheumatoid arthritis, and other autoimmune diseases. It is marketed by various pharmaceutical companies, most notably Roche under the brand name Rituxan.
How is Rituximab positioned in the current market?
Market Size and Demand
Global Rituximab Market Valuation: Estimated at $4.7 billion in 2022.
Compound Annual Growth Rate (CAGR): Projected at 6.3% from 2023 to 2028.
Predominant Indications:
Non-Hodgkin lymphoma (NHL)
Chronic lymphocytic leukemia (CLL)
Rheumatoid arthritis (RA)
Other autoimmune conditions
Market Drivers
Increased prevalence of NHL and RA.
Expanding approved indications, including new auto-immune diseases.
Growing adoption of biosimilars post-patent expiry (Roche's original patent expired in 2018).
Competitive Landscape
Original biologic produces by Roche.
Biosimilar competitors include:
Sandoz's Ruxience since 2019
Celltrion's Truxima since 2017
Teva's Ruxitanki (pending approval)
Biosimilars capture approximately 35% of Rituximab sales in the US as of 2022.
Regulatory and Patent Status
Roche's patent expired in 2018.
Biosimilars market share increasing in the US, EU, and other markets.
Approval timelines for biosimilars vary by region; the US FDA approved the first Rituximab biosimilars in 2017 and 2018.
What are the recent price trends?
Brand-Name Rituxan
Current US list price: Approximately $6,000 to $7,500 per dose depending on treatment protocol.
Annual cost per patient: Estimated at $60,000 to $80,000 for full therapy courses.
Biosimilar Pricing
Launch prices: 15% to 25% lower than Rituxan.
Pricing trends: Biosimilar prices have declined by up to 40% since initial market entry, driven by increased competition.
Price Projections (Next 5 Years)
Year
Projected Average Wholesale Price (AWP) per dose
Estimated Biosimilar Price Reduction
Comments
2023
$5,200–$6,300
15–20%
Biosimilar market solidifies; current competition remains.
United States: Highest prices, significant biosimilar penetration.
European Union: Lower prices due to price regulation, biosimilar adoption varies.
Emerging Markets: Prices remain substantially lower, but market growth is constrained by healthcare infrastructure.
Future market opportunities and risks
Opportunities
Expansion into new indications like pediatric autoimmune diseases.
Biosimilar development and approval may disrupt pricing further.
Mergers and acquisitions could influence market share distribution.
Risks
Patent disputes may delay biosimilar approvals.
Potential supply chain disruptions.
Regulatory changes impacting pricing or reimbursement policies.
Key Financial Metrics & Projections Summary
Metric
2022 Actual
2025 Projection
2028 Projection
Global Rituximab Market Size (USD)
$4.7 billion
$6.2 billion
$8.4 billion
Biosimilar Market Penetration (%)
35%
50%
65%
Average Price per Dose (USD)
$6,600
$5,200
$4,700
Key Takeaways
The Rituximab market is growing at a CAGR of approximately 6.3%, driven by expanding indications and biosimilar competition.
Original biologic prices have declined following biosimilar entries, with prices expected to continue decreasing.
Biosimilars are projected to account for up to 65% of the market by 2028, further pressure on prices.
Market dynamics vary significantly across regions, with the US leading in pricing and biosimilar adoption.
Patent expiry in 2018 has catalyzed biosimilar market development, influencing pricing trajectories and market share.
FAQs
What factors influence Rituximab pricing?
Patent status, biosimilar competition, regional regulatory policies, and reimbursement levels impact Rituximab prices.
When will biosimilar market share surpass 50%?
By 2025, biosimilars are projected to capture around 50% of the Rituximab market.
Are there new Rituximab indications under development?
Yes. Researchers are developing new applications, particularly for autoimmune conditions and off-label uses.
How might regulatory changes affect the Rituximab market?
Price regulation, patent protections, and approval pathways influence overall market dynamics and profitability.
What is the outlook for Rituximab in emerging markets?
Prices remain lower, but market growth depends on healthcare infrastructure development and regional regulatory policies.
References
[1] Grand View Research. (2023). Rituximab Market Size, Share, Trends, and Forecasts.
[2] IQVIA. (2022). Biosimilar Market Insights.
[3] U.S. Food and Drug Administration. (2017). Approval of Rituximab Biosimilars.
[4] European Medicines Agency. (2022). Biosimilar Medicines Market Data.
[5] MarketWatch. (2023). Rituximab Price Trends and Future Projections.
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