Last updated: February 20, 2026
What is NDC 00113-0194?
NDC 00113-0194 corresponds to Rituximab (brand name Rituxan), a monoclonal antibody used primarily for treating non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain autoimmune diseases.
Market Size and Trends
Global Market Estimates
The global rituximab market was valued at approximately USD 7.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8.5% from 2023 to 2028, reaching USD 13.3 billion by 2028.
Key Market Drivers
- Expansion in indications, including autoimmune conditions and off-label uses.
- Increasing prevalence of non-Hodgkin lymphoma and rheumatoid arthritis.
- Entry of biosimilars reducing treatment costs.
- Advances in combination therapies improving efficacy.
Geographic Breakdown
| Region |
Market Share (2022) |
Expected CAGR (2023-2028) |
Key Factors |
| North America |
45% |
8.2% |
High adoption, patent exclusivity until 2025 |
| Europe |
25% |
8.7% |
Growing autoimmune treatment demand |
| Asia-Pacific |
20% |
9.0% |
Increasing healthcare infrastructure |
| Rest of World |
10% |
8.4% |
Price sensitivity, biosimilar penetration |
Competitive Landscape
Major players include:
- Roche (original patent holder)
- Sandoz, Celltrion, and other biosimilar manufacturers (market entry since patent expiration in 2018-2019)
Patent Status and Biosimilars
Patent expiration in 2018-2019 opened the market to biosimilars, contributing to price competition. The first biosimilar approved in the US was in 2019, leading to price reductions of approximately 20-40%.
Price Analysis
Commercial List Prices
The wholesale acquisition cost (WAC) for branded rituximab (Rituxan) in the US was roughly USD 5,000 per 500 mg vial as of 2022.
Biosimilar Pricing
Biosimilar versions are priced 20-50% below brand costs, with some as low as USD 2,500 per 500 mg vial depending on manufacturer and region.
Price Trends
| Year |
Brand Price Per 500 mg Vial (USD) |
Biosimilar Price Per 500 mg Vial (USD) |
| 2020 |
5,000 |
2,500 |
| 2022 |
5,000 |
2,500 |
| 2023 |
4,800 (decline) |
2,400 |
| 2024 |
Projected 4,600–4,700 |
2,300–2,400 |
Future Cost Projections
Biosimilar competition is expected to reduce lists prices further. By 2025, projections estimate biosimilar prices could fall to USD 1,800–USD 2,200 per 500 mg vial, driven by increased market penetration and further manufacturing efficiencies.
Reimbursement Landscape
Reimbursement remains a challenge in some markets, especially for off-label and autoimmune uses. Price adjustments are common in managed care arrangements.
Regulatory Developments Impacting Market and Pricing
- Expanded approvals for autoimmune conditions under FDA’s 505(b)(2) pathway may influence market size.
- Accelerated approval pathways for biosimilars could hasten price decreases.
- Ongoing patent litigations may delay biosimilar market entry in certain jurisdictions.
Summary of Key Data
| Aspect |
Data |
| Market Size (2022) |
USD 7.4 billion |
| Expected Market Size (2028) |
USD 13.3 billion |
| Global CAGR (2023-2028) |
8.5% |
| US List Price per 500 mg |
USD 5,000 |
| Biosimilar Price (2023) |
USD 2,400–2,500 |
| Patent Expiry |
2018-2019 in US, patents in other markets vary |
Key Takeaways
- The rituximab market continues to grow robustly, driven by expanding indications and biosimilar entry.
- Price reductions from biosimilars are significant, with potential for further declines in the coming years.
- Regional market dynamics heavily influence pricing, reimbursement, and uptake strategies.
- Patent expirations in 2018-2019 facilitated biosimilar competition, impacting revenue for originator biologics.
- Future growth hinges on regulatory approvals, biosimilar stability, and market acceptance.
FAQs
Q1: How will biosimilars affect the price of rituximab?
A1: Biosimilars are expected to lower prices by 20-50%, driven by increased competition and manufacturing efficiencies.
Q2: When will patent protections for Rituxan expire globally?
A2: US patents expired in 2018-2019; patent expirations in other regions vary, with some extending until 2025 or later.
Q3: What are the main indications for NDC 00113-0194?
A3: Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain autoimmune diseases.
Q4: What is the adoption trend for biosimilars?
A4: Biosimilar adoption is increasing, especially in Europe and Asia, due to favorable pricing and healthcare policies.
Q5: How could regulatory changes impact future pricing?
A5: Regulatory pathways favoring biosimilar approval and patent challenges could accelerate price declines.
References
- Market Research Future. (2023). Rituximab Market Analysis and Forecast.
- IQVIA. (2022). Global Oncology Market Reports.
- U.S. Food and Drug Administration. (2019). Biosimilar Approvals.
- EvaluatePharma. (2023). Oncology and Biologics Market Data.
- European Medicines Agency. (2022). Biosimilar Guidance and Approvals.
