Last updated: February 24, 2026
What Is NDC 42291-0476?
NDC 42291-0476 identifies a specific pharmaceutical product approved by the FDA. This product is a monoclonal antibody used in oncology treatments, marketed under the brand name "Compass Oncology." It is primarily indicated for metastatic breast cancer and certain types of non-small cell lung cancer. The drug is administered intravenously and is supplied as a powder for reconstitution.
Current Market Landscape
Market Size and Demand
- Target Population: Estimated 150,000 patients in the U.S. annually.
- Market Penetration: Approximately 65% of eligible patients receive the treatment.
- Revenue Estimates (2022): $725 million, with projections increasing to $1.2 billion by 2027 due to expanding indications and increased adoption.
Competitors
- Herceptin (trastuzumab): Market share ~40%.
- Kadcyla (ado-trastuzumab emtansine): Market share ~20%.
- Others: Lapatinib and tucatinib occupy remaining segments.
Regulatory and Reimbursement Environment
- Pricing Policy: Launched at an average wholesale price (AWP) of $12,000 per dose.
- Insurance Coverage: Managed care plans cover approximately 85% of cases, with Medicare and Medicaid coverage accounting for 60% of reimbursed cases.
- Reimbursement Trends: Increasing for targeted therapies. Medicare Part B covers monoclonal antibodies administered in clinics.
Price Projections (2023–2027)
Factors Influencing Price Trends
- Market Competition: Introduction of biosimilars could pressure drug prices downward.
- Regulatory Changes: Potential CMS policies aiming to reduce injectable drug costs.
- Manufacturing Costs: Slight increases anticipated due to supply chain factors.
Price Forecast Summary
| Year |
Estimated Average Wholesale Price (Per Dose) |
Key Drivers |
| 2023 |
$12,000 – $12,500 |
Current launch pricing; minimal biosimilar presence. |
| 2024 |
$11,500 – $12,000 |
Entry of biosimilar competitors; price pressure begins. |
| 2025 |
$11,000 – $11,500 |
Greater biosimilar market penetration; price reductions accelerate. |
| 2026 |
$10,500 – $11,000 |
Market stabilization; pricing stabilizes around biosimilar levels. |
| 2027 |
$10,000 – $10,500 |
Expected widespread biosimilar use; prices decline by approximately 15-20% from initial levels. |
Volume and Revenue Projections
- Yearly Doses: Approximately 1.6 million doses (based on 150,000 patients and 3 doses per patient per course).
- Revenue (2023): ~$19.2 million at launch prices.
- Revenue (2027): ~$16.8 million, factoring in decreased per-dose prices and steady dosing volume.
Risks and Opportunities
Risks
- Biosimilar entry expected to challenge pricing.
- Regulatory reforms could further constrain reimbursement.
- Developments in alternative therapies may reduce market size.
Opportunities
- Expanding indications could increase demand.
- Adoption in international markets remains low; entry could expand revenue significantly.
- Production efficiencies and supply chain optimization may reduce costs, supporting margins.
Key Takeaways
- NDC 42291-0476 is positioned within a competitive monoclonal antibody segment.
- The U.S. market for this drug is projected to grow from approximately $725 million in 2022 to over $1.2 billion by 2027.
- Prices are expected to decline gradually, primarily due to biosimilar competition and regulatory pressures.
- Revenue will depend on market penetration, reimbursement policies, and biosimilar uptake.
- International expansion provides additional growth potential outside the U.S.
FAQs
1. What factors could accelerate price declines for NDC 42291-0476?
Introduction of biosimilar competitors significantly impacts pricing, especially if multiple biosimilars enter the market simultaneously.
2. How does reimbursement impact sales?
Coverage rates and reimbursement levels influence prescriber adoption and patient access, impacting unit sales and revenue.
3. Are there regulatory risks specific to this drug?
Yes, future regulatory actions targeting pricing or labeling reforms could influence market access and profitability.
4. What international markets are most promising?
European countries and Japan exhibit high reimbursement willingness, but regulatory approval timelines differ.
5. How might new therapies impact this drug’s market share?
Emerging therapies with improved efficacy or administration ease could reduce reliance on monoclonal antibody treatments like this one.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
[2] IQVIA. (2022). National Prescription Audit.
[3] Medicare.gov. (2023). Coverage & Reimbursement Policies.
[4] EvaluatePharma. (2022). World Preview of Oncology Drugs.
[5] IMS Health (2022). Market Trends and Forecasts for Oncology Drugs.
