Last updated: February 28, 2026
What is the drug with NDC 80005-0152?
The drug identified by NDC 80005-0152 is Tucatinib (brand name: Tukysa). Tucatinib is a kinase inhibitor targeting HER2-positive breast cancer, approved by the FDA in April 2020. It is primarily used in combination with trastuzumab and capecitabine for treatment of advanced unresectable or metastatic HER2-positive breast cancer, including cases with brain metastases.
Market Size and Growth Drivers
current market landscape (2023)
| Metric |
Data |
| Estimated global HER2-positive breast cancer market |
$2.3 billion (2023) [1] |
| Tucatinib's approximate market share (2023) |
8-12% of HER2-positive breast cancer drugs |
| Number of eligible patients in the U.S. |
~ 68,000 with metastatic HER2-positive breast cancer annually [2] |
| Prescriptions filled annually (U.S.) |
Approximately 12,000–15,000 units |
Key growth factors:
- rising prevalence of HER2-positive breast cancer
- increasing use of targeted therapies
- expanding indications, including brain metastases
- pipeline expansions and combination trials
Market growth projections (2023–2028):
| Year |
Estimated Market Size (USD) |
Compound Annual Growth Rate (CAGR) |
| 2023 |
$250 million |
- |
| 2028 |
$550 million |
~17% |
Sources indicate that the HER2-positive breast cancer therapeutics market is expected to grow at a CAGR of approximately 16-18% driven by increased diagnosis rates and adoption of targeted agents [1].
Competitive landscape
| Competitors |
Market Share (2023) |
Key Features |
| Trastuzumab (Herceptin) |
40-45% |
First-line HER2 therapy, biosimilars increasing |
| Pertuzumab (Perjeta) |
12-15% |
Used in combination, expanding indications |
| Tucatinib (Tukysa) |
8-12% |
Effective against brain metastases |
| Neratinib (Nerlynx) |
3-5% |
Extended adjuvant setting |
Tucatinib's niche is its activity in brain metastasis, which differentiates it from competitors.
Price analysis overview
Current pricing (U.S. market)
| Parameter |
Data |
| Wholesale Acquisition Cost (WAC) per month |
$12,900 (approximate) [3] |
| Average Patient Dose |
300 mg twice daily |
| Pack Size |
60 capsules (30 days) |
Pricing comparison with similar agents
| Drug |
Monthly Cost (USD) |
Indications |
| Trastuzumab (Herceptin) |
$4,914 |
First-line HER2 therapy |
| Neratinib (Nerlynx) |
$13,000 |
Extended adjuvant therapy |
| Tucatinib (Tukysa) |
$12,900 |
Metastatic HER2-positive breast cancer |
Price trends and considerations
- Pricing remains steady since approval, but biosimilars and generics for trastuzumab and pertuzumab are expected to influence overall HER2 therapy prices.
- Payer pressure and formulary inclusion influence net pricing.
- New clinical data or expanded indications could lead to price adjustments.
Future price projections (2024–2028)
| Year |
Estimated Monthly Price (USD) |
Remarks |
| 2024 |
$12,900 |
Current level |
| 2025 |
$12,300–$13,200 |
Potential slight decrease/increase |
| 2028 |
$11,500–$13,500 |
Biosimilar entry and market competition |
The price may decrease slightly as biosimilars or alternate therapy options expand, but premium positioning for brain metastasis efficacy will sustain higher prices.
Regulatory and policy factors
- The FDA approved Tucatinib via accelerated approval based on response rate data.
- Ongoing trials could expand use, affecting demand and pricing.
- Medicare and commercial payers negotiate discounts, impacting net revenue.
Key Takeaways
- The HER2-positive breast cancer treatment market is valued at over $2 billion, with rapid growth expected at ~17% annually.
- Tucatinib's market share remains limited but is growing due to better efficacy in brain metastasis.
- Current U.S. price is approximately $12,900/month, with potential for slight variation based on market dynamics and biosimilar competition.
- Pricing pressures are likely to moderate net revenues; however, clinical advantages support sustained pricing levels.
- Expansion into additional indications could impact volume more than price.
FAQs
1. Is Tucatinib likely to see price reductions in the next five years?
While biosimilars and market competition could induce slight price reductions, Tucatinib's niche efficacy in brain metastases and limited competition suggest residual high-value positioning.
2. How does the price of Tucatinib compare to other HER2 therapies?
Tucatinib's monthly cost is comparable to Neratinib but higher than trastuzumab (biosimilars included). Its value is driven by its specific efficacy against brain metastases.
3. What factors most influence Tucatinib’s pricing?
Reimbursement policies, market competition, pipeline development, and regulatory approvals for expanded indications impact pricing.
4. What is the key driver for the growth of the Tucatinib market?
An increase in HER2-positive breast cancer cases and expanded FDA indications, especially for brain metastases, are the main growth drivers.
5. Are there any upcoming regulatory decisions that could impact pricing?
Potential approval of newer combination regimens or expanded indications might affect demand and pricing strategies; current pipeline data suggest no immediate regulatory changes.
References
[1] IQVIA, 2023. HER2+ breast cancer treatment market report.
[2] American Cancer Society, 2023. Breast cancer statistics.
[3] Red Book, 2023. Wholesale acquisition cost (WAC) data for Tucatinib.
