Last updated: February 13, 2026
What is NDC 42806-0552?
NDC 42806-0552 is the National Drug Code for Tucatinib (Tukysa), an oral medication approved by the FDA in April 2020. It is used for treating HER2-positive metastatic breast cancer, particularly in patients who have received prior therapies.
Market Size and Demand Drivers
Current Market Environment
- FDA Approval: 2020, for HER2-positive breast cancer.
- Indications: Approved for adults with HER2-positive metastatic breast cancer, including those with brain metastases.
- Competing Drugs:
- Trastuzumab (Herceptin)
- Pertuzumab (Perjeta)
- Trastuzumab emtansine (Kadcyla)
- Neratinib (Nerlynx)
Market Demand
- The global breast cancer drug market was valued at approximately $17 billion in 2022.
- Her2-positive breast cancer accounts for 15-20% of breast cancers.
- Estimated annual U.S. market volume for HER2-positive treatments ranges between 25,000 to 35,000 patients.
Growth Projections
- The global HER2-positive breast cancer market CAGR: 8-10% through 2030.
- Based on current prescribing patterns, Tucatinib was estimated to capture 10-15% of the HER2-positive metastatic breast cancer market in the U.S. by 2025.
Competitive Positioning
- Tucatinib offers advantages over other HER2-targeted therapies, especially in patients with brain metastases, due to observed CNS activity in clinical trials.
- Competitively priced relative to existing solutions, although price will depend on payer negotiations and market penetration.
Pricing Analysis
Current U.S. Pricing
- Wholesale acquisition cost (WAC) for Tucatinib (per month): approximately $12,000 - $15,000.
- The average annual cost per patient approximates $144,000 to $180,000.
Pricing Trends
- Orphan and targeted oncology drugs command premiums, with prices often ranging between $100,000 and $200,000 annually.
- Reimbursement largely dictated by insurance coverage, with payers increasingly negotiating discounts.
Future Price Projections (2023-2028)
| Year |
Estimated WAC per Month |
Notes |
| 2023 |
$13,500 |
Initial post-approval pricing, stable market entry |
| 2024 |
$13,800 |
Slight increase accounting for inflation |
| 2025 |
$14,200 |
Market penetration accelerates, potential discounts |
| 2026 |
$14,500 |
Competition intensifies, negotiation pressure |
| 2027 |
$14,800 |
Price stabilization with increased volume |
| 2028 |
$15,000 |
Peak estimated price, barring major policy shifts |
Prices are projected based on inflation, market competition, and payer negotiations. Price erosion is expected as biosimilars or generics emerge or if new therapies replace Tucatinib.
Regulatory and Policy Impact on Pricing
- Patent exclusivity: until at least 2030.
- Potential biosimilar entry could pressure prices after 2028.
- Value-based pricing models may influence actual reimbursement rates.
Key Takeaways
- Market size: HER2-positive metastatic breast cancer represents a multibillion-dollar segment with growing demand.
- Market share: Tucatinib targets a niche with CNS metastases, giving it a competitive edge over some existing therapies.
- Pricing: Starts around $12,000-$15,000/month, with incremental increases driven by inflation and market dynamics.
- Projection: WAC could reach $15,000/month by 2028, assuming continued adoption and competitive pricing dynamics.
FAQs
1. How does Tucatinib compare to other HER2-targeted therapies?
It offers CNS activity, a key benefit over some existing options that lack efficacy in brain metastases.
2. What is the expected market penetration?
By 2025, Tucatinib could capture 10-15% of the HER2-positive metastatic breast cancer market in the U.S.
3. What are the primary factors influencing its pricing?
Market competition, reimbursement negotiations, FDA approval status, and patent protection.
4. When might generics or biosimilars impact Tucatinib prices?
Potentially after patent expiry, expected around 2030–2035, depending on patent disputes and biosimilar development timelines.
5. How is the market for HER2-positive breast cancer treatments expected to evolve?
Continued growth driven by new targeted therapies, combination regimens, and CNS-focused treatments.
Citations
[1] IQVIA. "Global Oncology Market Analysis," 2022.
[2] FDA. "Tucatinib (Tukysa) Approval Details," 2020.
[3] Evaluated data on market size and growth rates from Grand View Research, 2022.
[4] Manufacturer and industry reports on drug pricing and reimbursement, 2023.
