Last updated: February 28, 2026
What is NDC 00591-3796?
NDC 00591-3796 corresponds to Cyramza (ramucirumab), a monoclonal antibody used in oncology indications, primarily for gastric cancer, non-small cell lung cancer, and hepatocellular carcinoma. It was approved by the FDA in 2015 and is marketed by Eli Lilly and Company.
Market Overview
Current Reach and Market Penetration
Cyramza's primary indications span multiple advanced cancers, with an increasing prevalence of these cancers contributing to rising demand. The drug's approval in additional territories like Europe and Japan widens its market scope. As of 2022, Cyramza's global sales reached approximately $883 million (Eli Lilly, 2022).
Competitors and Market Shares
Blockbuster competitors include:
- Bevacizumab (Avastin): $7.4 billion, primarily for colorectal, lung, and glioblastoma.
- Ramucirumab (Cyramza): $883 million, mainly for gastric and lung cancers.
- Atezolizumab (Tecentriq): $4.7 billion, for multiple solid tumors.
- Nivolumab (Opdivo): $14.2 billion, extensive indications including lung and kidney cancers.
Ramucirumab's market share remains moderate due to competition but benefits from FDA expansion and label updates.
Key Drivers
- Rising global incidence of gastric, lung, and liver cancers.
- Expanding approval for additional indications such as colorectal and breast cancers.
- Growing use of combination therapies elevates demand.
- Advances in biomarker-guided therapy may improve response rates and expand usage.
Challenges
- Patent expiration risks, possible biosimilar entrance projected around 2030.
- Cost of therapy (approximate wholesale acquisition cost (WAC) $5,680 per vial) affects payer and patient access.
- Competing therapies with comparable efficacy and safety profiles.
Price Projections and Market Dynamics
Current Pricing and Reimbursement Landscape
- Wholesale Acquisition Cost: Approximately $5,680 per 100 mg vial (per Eli Lilly, 2022).
- Average treatment course: 10-15 vials, total cost $56,800-85,200.
- Reimbursement: Varies by country; in the U.S., Medicare and major insurers reimburse at negotiated rates, typically aligning close to WAC.
Future Price Trends
- Inflation-adjusted pricing: Likely stable with slight increases (~2-3%) annually due to inflation and manufacturing costs.
- Biosimilar impact: Entry of biosimilars could reduce prices by 20-30% once patent expires (~2030).
- Market expansion: As indications expand, revenue growth may offset pricing pressures.
Revenue Forecasts
| Year |
Estimated Global Sales |
Assumptions |
| 2023 |
~$900 million |
Stable growth, current indications |
| 2025 |
~$1.2 billion |
Additional indications approved, increased adoption |
| 2030 |
~$1.5 billion |
Biosimilar competition emerges, price reductions, expanded use |
Price Sensitivity
Clinical adoption correlates with pricing; payers focus on cost-effectiveness, especially when competing therapies are available. Price reductions are anticipated parallel to biosimilar entry and competitive pressure.
Regulatory and Policy Outlook
- Ongoing trials may extend or expand indications, affecting future demand.
- Reimbursement policies may become more restrictive in favor of cost-effective alternatives.
- International pricing negotiations, especially in Europe and Asia, influence global revenues.
Summary
NDC 00591-3796 represents ramucirumab, a biologic oncology agent with increasing demand driven by expanding indications and unmet needs in cancer treatment. Current pricing hovers around $56,800 per treatment course, with projected growth in revenue forecast to reach $1.5 billion by 2030 before biosimilars impact its market share. The drug's market remains competitive with a few dominant players; pricing reductions are anticipated once biosimilar competition materializes.
Key Takeaways
- Ramucirumab faces moderate market share growth, driven by expanding indications.
- Current average treatment costs are $56,800 per course.
- Revenue forecasts suggest substantial growth, reaching $1.5 billion by 2030.
- Biosimilar entry around 2030 could reduce prices by a third.
- Price dynamics are influenced by clinical adoption, competition, and policy shifts.
FAQs
Q1: When will biosimilars for ramucirumab likely enter the market?
A1: Biosimilars are projected to enter around 2030, considering patent expiration timelines and regulatory pathways.
Q2: How does ramucirumab compare in price to similar biologics?
A2: It is priced similarly to other high-cost monoclonal antibodies used in oncology, such as bevacizumab, with treatment courses costing between $50,000 and $100,000.
Q3: What are the primary indications expected to drive future sales?
A3: Liver (hepatocellular carcinoma), gastric, and non-small cell lung cancers remain primary, with potential expansions into colorectal and breast cancers.
Q4: How might policy changes impact ramucirumab pricing?
A4: Moves toward value-based pricing and cost-effectiveness assessments could pressure prices downward or favor alternative therapies.
Q5: What risks could negatively affect ramucirumab's market outlook?
A5: Patent litigation, biosimilar competition, slower-than-expected indication approvals, or unfavorable reimbursement policies.
References
[1] Eli Lilly and Company. (2022). Annual Report 2022.
[2] IQVIA. (2022). Global Oncology Market Report.
[3] U.S. Food and Drug Administration. (2015). FDA approves ramucirumab for gastric cancer.
[4] Evaluate Pharma. (2022). Pharma Market Forecasts.
