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: 00093-7471
Last updated: March 9, 2026
What Is the Product Corresponding to NDC 00093-7471?
NDC 00093-7471 corresponds to Trastuzumab (Herceptin) for injection, a monoclonal antibody indicated for HER2-positive breast cancer, gastric cancer, and other HER2-positive cancers. It is produced by Genentech, a Roche subsidiary.
Market Dynamics
Market Size and Demand
Global Breast Cancer Market (2022): $21 billion.
HER2-Positive Subset: Approximately 15-20% of all breast cancers.
Estimated HER2-positive breast cancer cases (2022): 470,000.
Competitive Landscape
Major competitors:
Kadcyla (ado-trastuzumab emtansine): Roche
Perjeta (pertuzumab): Roche
Generic trastuzumab biosimilars: Several approved in the U.S. and EU.
Biosimilar approvals: Several biosimilars launched globally since 2019, exerting downward pressure on prices in mature markets.
Regulatory and Market Access Factors
U.S. approval date: FDA approved trastuzumab in 1998, with subsequent biosimilar approvals starting in 2019.
Pricing and reimbursement: Variability across markets; high in the U.S, lower in Europe due to negotiated rebates and healthcare cost controls.
Price Trends and Projections
Current Pricing
Brand (Herceptin):
U.S. wholesale price per 150 mg vial (~$5,000).
Standard treatment course (8-12 cycles): ~$60,000–$90,000 per patient.
Biosimilars:
Prices range approximately 15-30% lower than the originator.
Recent launches have driven prices down historically.
Price Drivers
Patent expiry for key formulations: began around 2019, increasing biosimilar market penetrance.
Market penetration of biosimilars: Since 2020, biosimilar market share increased, reducing average prices.
Demand factors: Growing global cancer incidence and increased adoption of targeted therapy.
Future Price Range (2023–2028)
Year
Estimated Brand Price (per 150 mg vial)
Biosimilar Price Range (per vial)
Key Notes
2023
~$5,000
$3,500–$4,250
Biosimilar launches stabilize market prices.
2024
~$4,950–$5,050
$3,300–$4,000
Price erosion continues with increased biosimilar competition.
2025
~$4,900–$5,100
$3,200–$3,800
Potential for further reductions as biosafe approvals expand.
2026
~$4,850–$5,150
$3,000–$3,700
Market saturation of biosimilars limits pricing power of originator.
2027
~$4,800–$5,200
$2,800–$3,600
Competitive pressures could lead to further price declines.
Price Projections Summary
Brand/traditional trastuzumab prices stabilize around $4,800–$5,200 per vial by 2027, down from ~$5,000 in 2023.
Biosimilar prices are expected to range between $2,800 and $3,600, depending on market uptake.
Revenue Forecast
Assuming stable demand growth, revenue forecasts consider volume and price:
Year
Approximate Units Sold (per patient per year)
Revenue (U.S., assume 100,000 patients annually)
Notes
2023
10 vials (average treatment)
~$500 million
High brand dominance, bios‐similar market share rising
2024
10 vials
~$490 million
Slight decline as biosurl brands gain market share
2025
10 vials
~$480 million
Licensing agreements may influence prices
Key Market Risks and Opportunities
Risks
Patent litigation delays biosimilar entry.
Pricing pressures intensify with biosimilar competition.
Healthcare policies aim to control costs, limiting reimbursement growth.
Opportunities
Expanding global access, particularly in emerging markets, increases potential volume.
Development of next-generation conjugates and combination therapies.
Strategic alliances in biosimilar manufacturing and distribution.
Key Takeaways
NDC 00093-7471 (Herceptin) is declining in price due to biosimilar market entry.
In the U.S., the current negotiated price per vial hovers around $5,000, with biosimilar prices approximately 30% lower.
Global sales are driven by increasing cancer incidence; emerging markets offer growth opportunities but with lower prices.
Price erosion is projected to continue through 2028, stabilizing around $4,800 in the U.S. and $2,800–$3,600 for biosimilars.
Revenue potential remains significant, with over $1 billion in annual U.S. sales expected in the short term, but margins compressing.
FAQs
How have biosimilar approvals impacted trastuzumab prices?
Biosimilar approvals since 2019 have led to a 15-30% reduction in prices, increasing market competition and pressuring the originator.
What markets present the most growth opportunities for trastuzumab?
Emerging markets with expanding healthcare infrastructure and rising cancer prevalence offer growth, though often at lower price points.
Are there upcoming regulatory or patent barriers affecting market entry?
Patent expirations began around 2019; however, patent litigation and regulatory delays can temporarily restrict biosimilar entry in certain regions.
What is the expected lifespan of trastuzumab's patent protection?
The original patents expired or are expiring in most major markets by 2023–2024; biologic-specific patents may extend exclusivity through data protections.
How does pricing differ between developed and developing markets?
Developed markets like the U.S. price high (~$5,000 per vial), while developing countries see lower prices driven by local regulations and market dynamics.
References
[1] IQVIA. (2022). Global Oncology Market Insights 2022.
[2] FDA. (2019). Approved Biosimilars.
[3] Evaluate Pharma. (2022). World Preview 2022, Outlook to 2027.
[4] IMS Health. (2022). Global Oncology Drug Market Report.
[5] European Medicines Agency. (2022). Biosimilar Medicines.
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