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Last Updated: April 2, 2026

Drug Price Trends for NDC 61269-0605


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Best Wholesale Price for NDC 61269-0605

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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 61269-0605

Last updated: February 20, 2026

What is NDC 61269-0605?

NDC 61269-0605 corresponds to a specific drug product. Based on available listings, it is identified as Kadcyla (ado-trastuzumab emtansine), a targeted therapy for HER2-positive breast cancer.

Market Overview

Market Size

  • The global breast cancer therapeutics market was valued at approximately USD 8.5 billion in 2022.
  • HER2-positive breast cancer accounts for approximately 15-20% of all breast cancer cases globally.
  • Within this segment, trastuzumab-based therapies hold a dominant share, estimated at 75-85%.

Key Players

  • Roche (manufacturer of Kadcyla)
  • Pfizer (competitor products)
  • Seagen and other biotech firms (emerging biosimilars)

Market Drivers

  • Increased prevalence of HER2-positive breast cancer, with 600,000 new cases annually worldwide.
  • Growing adoption of targeted therapies over chemotherapies, driven by better safety profiles.
  • Expanding use in earlier disease stages and adjuvant settings.

Market Constraints

  • High drug costs limit accessibility.
  • Competition from biosimilars, which could reduce prices.
  • Regulatory hurdles for biosimilar approval in key markets.

Price Points and Historical Pricing Trends

Current Pricing (as of 2023)

Market List Price per Vial Treatment Course Notes
U.S. USD 11,000 – 12,000 Approx. USD 50,000 Based on a typical 4–6 cycle regimen
Europe EUR 9,500 – 10,500 Similar to U.S. Slight discounts due to negotiation and healthcare policies
Japan JPY 1,300,000 Similar treatment costs Price adjustments based on national policies

Pricing Factors

  • Vial size: 160 mg.
  • Treatment duration: 4–6 cycles, with each cycle typically involving one vial.
  • Reimbursement policies: Negotiated significantly in Europe and Japan.

Future Price Projections

Factors Influencing Future Prices

  • Introduction of biosimilars expected by 2025-2026.
  • Reimbursement negotiations, especially in the U.S. and Europe.
  • Patent expirations, notably the expiration of the Kadcyla patent in 2028 in the U.S.
  • Manufacturing cost reductions through process innovations.

Projected Trends (2023–2030)

Year Expected Price Range (USD per vial) Comments
2023 11,000 – 12,000 Current pricing, subject to negotiations
2025 9,000 – 11,000 Biosimilar entries reduce premiums
2028 8,000 – 10,000 Patent expiry increases biosimilar penetration
2030 7,500 – 9,000 Increased competition and manufacturing efficiencies

Price Reduction Impact

  • Biosimilars could reduce the price of trastuzumab emtansine by 30-50%.
  • Market share shifts toward biosimilars could further depress prices before stabilization.

Revenue Projections

Market Revenue (2023 – 2030)

Year Estimated Global Revenue (USD billions) Assumptions
2023 1.2 – 1.5 Current market size, premium pricing maintained
2025 1.0 – 1.3 Biosimilar competition gains momentum
2028 0.8 – 1.1 Patent expiry and biosimilar impact
2030 0.7 – 1.0 Market stabilization at reduced prices

Competitive Dynamics

  • Biosimilars of trastuzumab are under development, with generic versions available in some regions.
  • Roche's patent estate and exclusivity protections will influence market share and pricing.
  • Policy shifts towards cost containment can affect pricing negotiations.

Regulatory Environment

  • The FDA approved Kadcyla in 2013.
  • Biosimilar approval pathways in the U.S. (Biologics Price Competition and Innovation Act, 2009) and Europe (EMA guidelines) shape future competition.
  • Price negotiations vary by country, with some regions favoring cost-effective access over high prices.

Key Takeaways

  • NDC 61269-0605 (Kadcyla) is a leading targeted therapy for HER2-positive breast cancer, with a high price point driven by clinical efficacy and limited competition.
  • Market expansion continues, with increasing use in earlier stages of disease.
  • Competition from biosimilars is set to drive significant price reductions starting around 2025, especially after patent expiration.
  • Long-term pricing will depend heavily on regulatory, reimbursement, and patent landscapes.

FAQs

  1. When will biosimilars for trastuzumab emtansine become available?
    Biosimilar candidates are in late-stage development; approvals could occur between 2024 and 2026.

  2. How much can prices decline post-biosimilar entry?
    Biosimilar competition may reduce prices by 30-50%, depending on market dynamics and negotiation strategies.

  3. Which regions will experience the largest price drops?
    Europe and the U.S. are expected to see the largest declines due to active biosimilar markets and reimbursement negotiations.

  4. What is the impact of patent expiry on revenue?
    Patent expiry in 2028 could lead to increased biosimilar market penetration and revenue decline by 20-30% annually afterward.

  5. Are there policies that could prevent biosimilar price reductions?
    Patent litigation, market exclusivity extensions, and regulatory barriers could slow biosimilar adoption.


References

[1] MarketWatch, 2023. "Global Breast Cancer Therapeutics Market Size, Share & Trends."
[2] FDA. "Biosimilar Approval Pathways." 2009.
[3] EMA. "Guidelines on Biosimilar Medicines," 2014.
[4] IQVIA. "Global Oncology Market Report," 2022.
[5] Roche. "Kadcyla Product Information," 2023.

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