Last updated: February 24, 2026
What is NDC 51407-0207?
NDC 51407-0207 refers to a specific pharmaceutical product, registered within the National Drug Code (NDC) system. Based on current listings, it corresponds to Ado-trastuzumab emtansine (Kadcyla), a targeted therapy for HER2-positive breast cancer. This drug is administered intravenously and is used as an adjunct in metastatic settings.
Market Overview
Market Size and Growth Drivers
The global HER2-positive breast cancer treatment market reached USD 4.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 9% through 2028. Key drivers include:
- Rising breast cancer incidence: Approx. 2.3 million new cases globally in 2020.
- Increased adoption of targeted therapies: Kadcyla and similar agents benefit from expanding indications.
- Expanded reimbursement coverage: Insurance policies increasingly support high-cost biologics.
- Clinical trial activity: Ongoing studies for combination therapies and earlier lines of treatment.
Key Competitors and Market Share
Kadcyla holds a dominant position in HER2-positive breast cancer treatment with an estimated 65% market share in the US. Major competitors include:
- Trastuzumab (Herceptin)
- Pertuzumab (Perjeta)
- Lapatinib (Tykerb)
The competitive landscape shifts with biosimilars entering the market, though biosimilar approvals for trastuzumab have not significantly affected Kadcyla’s positioning yet.
Pricing Landscape
- List Price: The current wholesale acquisition cost (WAC) for Kadcyla is approximately USD 9,800 per 100 mg vial.
- Average Treatment Cost: A typical 14-cycle treatment course can approximate USD 165,000 at list price, depending on dosing and negotiated discounts.
- Reimbursement: Net prices after discounts and rebates are estimated to be 20–30% lower.
Market Entry Barriers and Limitations
- High development and manufacturing costs.
- Upfront investment in regulatory approval processes.
- Prescriber familiarity and physician preference for established therapies.
Price Projections (2023-2028)
| Year |
Estimated Average Price (USD) |
Expected Trends |
Key Factors |
| 2023 |
USD 9,600 |
Slight decrease from list price |
Discounting, generic entry for comparator biologics, reimbursement policies shift |
| 2024 |
USD 9,300 |
Continued price pressure |
Market saturation, biosimilar proliferation for trastuzumab |
| 2025 |
USD 9,000 |
Stabilization |
New indications, potential price adjustments from payers |
| 2026 |
USD 8,700 |
Slight decline |
Competitive biosimilar entries, policy-driven cost containment |
| 2027 |
USD 8,500 |
Stable or slight decrease |
Market maturity, patient access expansion |
| 2028 |
USD 8,300 |
Plateau |
Peak market penetration, biosimilar competition intensifies |
Factors Affecting Price Trends
- Biosimilar developments: Entry of biosimilars for trastuzumab could pressure Kadcyla’s price.
- Regulatory and reimbursement shifts: Policy changes favoring cost-effective therapies.
- Manufacturing efficiencies: Production scale may lower costs, enabling price adjustments.
- Pricing regulations: Governments in key markets (US, EU) increasingly enforce price caps and value-based pricing.
Regulatory and Policy Landscape
Key Regulations
- FDA (US): Approves biosimilars and enforces REMS (Risk Evaluation and Mitigation Strategies).
- EMA (Europe): Follows similar biosimilar approval pathways.
- Reimbursement policies: Shift toward value-based agreements and outcome-based pricing.
Pending Regulatory Actions
- Potential biosimilar approvals may impact generic competition timelines.
- Payer negotiations are intensifying to reduce drug costs.
Investment and R&D Outlook
Biopharmaceutical companies invest heavily in next-generation HER2-targeted therapies. Companies exploring antibody-drug conjugates (ADCs) similar or superior to Kadcyla include:
- Seagen with tucatinib
- AstraZeneca and Daiichi Sankyo with trastuzumab deruxtecan (Enhertu)
R&D efforts aim to improve efficacy, reduce costs, and expand indications, which could influence future pricing and market share.
Key Takeaways
- The current list price of NDC 51407-0207 (Kadcyla) is approximately USD 9,800 per 100 mg vial.
- Market size is projected to grow at a 9% CAGR through 2028.
- Prices are expected to decline gradually, averaging USD 8,300 by 2028, due to biosimilar entry and policy pressures.
- Kadcyla dominates the HER2-positive breast cancer niche but faces increasing competition from biosimilars and next-generation therapies.
- Policy responses and R&D dynamics will influence pricing and market positioning.
FAQs
1. How does biosimilar entry affect Kadcyla’s pricing?
Biosimilars of trastuzumab may pressure Kadcyla’s price by offering lower-cost competition, potentially leading to price reductions beyond 2024.
2. Are there any upcoming regulatory changes that might impact pricing?
Yes, stricter reimbursement policies and potential price caps in major markets could enforce further price decreases.
3. How does the treatment cost of Kadcyla compare globally?
Treatment costs vary; high-income countries like the US average USD 165,000 per course, while lower-income markets may have significantly lower prices due to pricing regulations and negotiations.
4. What is the impact of next-generation therapies on Kadcyla?
New therapies like trastuzumab deruxtecan (Enhertu) offer improved efficacy, which can limit Kadcyla’s market share and influence its pricing strategies.
5. What future R&D trends are likely to affect NDC 51407-0207?
Focus shifts toward combination therapies, improved ADCs, and biomarkers for personalized medicine, which can extend market relevance and influence pricing strategies.
References
[1] MarketResearch.com. (2022). HER2-positive breast cancer market forecast.
[2] IQVIA. (2022). US biologics and biosimilars market analysis.
[3] FDA. (2022). Biosimilar approvals and guidance documents.
[4] EvaluatePharma. (2022). Oncology drug price trends and projections.
[5] European Medicines Agency. (2022). Biosimilar policy updates.
