Last updated: February 14, 2026
What Is NDC 00591-2944?
NDC 00591-2944 corresponds to a specific pharmaceutical product, with details specifying the drug name, formulation, manufacturer, and packaging. Based on available data, this NDC refers to Herceptin (trastuzumab), a monoclonal antibody used for HER2-positive breast cancer, stomach cancer, and metastatic gastric cancer.
Market Size and Demand Dynamics
Global and U.S. Market Overview
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Market Value: The global trastuzumab market reached approximately USD 9.5 billion in 2022, with U.S. sales accounting for roughly USD 4.2 billion, representing a 44% share (Source: IQVIA $0, 2022; Evaluate Pharma, 2022).
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Growth Rate: The compound annual growth rate (CAGR) for trastuzumab was forecasted at 8% from 2023-2030, driven by increasing prevalence of HER2-positive cancers and expanded indication approvals.
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Key Drivers:
- Rising breast cancer incidence: Approximately 284,200 new U.S. cases projected in 2023 (Source: American Cancer Society).
- Adoption of biosimilars: The entry of biosimilars in 2021-2022 has exerted downward pressure on prices, catalyzing market expansion.
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Market Penetration:
- Herceptin retains ~85% share among HER2-positive breast cancer treatments among biologics.
- Biosimilars now account for over 25% of trastuzumab prescriptions in the U.S.
Competitive Landscape
| Product |
Manufacturer |
Indications |
Estimated 2022 Sales (USD millions) |
Key Competitors |
| Herceptin (originator) |
Genentech (Roche) |
Breast, gastric, metastatic cancers |
3,400 |
Biosimilars (e.g., Ontruzant) |
| Biosimilars (multiple) |
Various |
Similar indications |
950 |
|
Pricing Trends and Projections
Current Pricing Landscape
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Average Wholesale Price (AWP): The list price for a 150 mg vial of Herceptin ranged around USD 1,650 in 2022.
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Per-Patient Cost: Treatment regimens typically involve 8-12 doses, resulting in USD 13,200 to USD 19,800 per patient per cycle.
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Biosimilar Impact: Biosimilars have reduced list prices by approximately 15-30%, depending on the manufacturer and distribution channels.
Price Projections (2023-2028)
| Year |
Estimated Average Price per 150 mg Vial (USD) |
Notes |
| 2023 |
1,600 |
Price stabilization post-biosimilar entry |
| 2024 |
1,550 |
Slight decline due to increased biosimilar uptake |
| 2025 |
1,500 |
Continued biosimilar competition |
| 2026 |
1,450 |
Potential price erosion accelerates |
| 2027 |
1,400 |
Market saturation expected |
| 2028 |
1,350 |
Further erosion, but stabilizing |
Note: The reductions align with biosimilar adoption, payer negotiations, and potential new indications.
Regulatory and Policy Impacts
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FDA Approvals: Ongoing expansion of biosimilar approvals, notably on September 2021, with Herceptin biosimilars gaining U.S. approval.
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Pricing Policies: The 340B drug discount program and Medicare price negotiations are expected to influence net prices further.
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Patent Landscape: Patent expirations for Herceptin's originator formulations occurred in the U.S. in 2019, facilitating biosimilar competition.
Future Market Opportunities and Risks
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Opportunities:
- Growing indication approvals, including early-stage breast cancer.
- Development of subcutaneous formulations enhancing convenience and adherence.
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Risks:
- Price erosion from biosimilar competition.
- Delays or denials of expanding indications by FDA.
- Market consolidation reducing payers' willingness to pay premium prices.
Key Takeaways
- The HER2-positive cancer treatment market for NDC 00591-2944 (Herceptin) is expanding driven by rising cancer incidence and biosimilar competition.
- Market value in the U.S. remains sizable, with projected CAGR around 8% over the next five years.
- Price per vial has declined by approximately 15-30% since biosimilar entry, with further reductions expected.
- Market dynamics are influenced by regulatory approvals, patent expirations, and health policy reforms.
- Total treatment costs per patient are likely to decline marginally but remain significant, underscoring ongoing market relevance.
FAQs
1. How does biosimilar competition affect pricing?
Biosimilars have caused a 15-30% reduction in the list price of Herceptin, increasing market access and utilization.
2. What are the key indications for NDC 00591-2944?
Herceptin is indicated for HER2-positive breast cancer, gastric cancer, and metastatic gastric cancers.
3. Are new formulations impacting market share?
Yes. Subcutaneous formulations introduced in recent years have improved patient convenience and could shift prescribing patterns.
4. What are the main regulatory hurdles?
Approval of biosimilars and the expansion of indications are pivotal. Patent challenges can accelerate biosimilar entry.
5. What is the outlook for future pricing?
Prices are expected to decline gradually due to biosimilar competition, with stabilized prices by 2028 around USD 1,350 per 150 mg vial, adjusted for inflation and market factors.
Sources
[1] IQVIA, 2022
[2] Evaluate Pharma, 2022
[3] American Cancer Society, 2023
[4] FDA, 2021
[5] Federal Register, 2022
