Last updated: February 17, 2026
What is NDC 59651-0776?
NDC 59651-0776 refers to Alecensa (alectinib), developed by Roche. It is approved for treating ALK-positive metastatic non-small cell lung cancer (NSCLC). The drug was approved by the FDA in December 2017 and is marketed for advanced-stage ALK+ NSCLC patients.
Market Size and Growth Dynamics
Current Market Landscape
- Target Population: Approximately 3-5% of NSCLC cases harbor ALK mutations, translating to roughly 30,000-50,000 patients in the U.S. annually.
- Market Penetration: As of 2023, Alecensa's penetration among eligible patients is estimated at 60-70%. This figure is expected to increase with expanded indications and earlier line treatment usage.
- Competitive Products: The primary competitor is Xalkori (crizotinib), with newer options including Lorbrena (lorlatinib) and Rozlytrek (entrectinib) with overlapping indications.
Market Drivers
- Expansion of indications to earlier lines of therapy; FDA approved Alecensa for first-line treatment in 2020.
- Growing prevalence of ALK-positive NSCLC, with an annual increase of approximately 3% in diagnosed cases.
- Increasing awareness and testing rates for ALK mutations in lung cancer patients.
Market Constraints
- Pricing and reimbursement pressures, especially as more competitors obtain approval.
- Limited patient pool compared to non-specific NSCLC treatments.
Price Projections
Current Pricing
- Alecensa's current wholesale acquisition cost (WAC): approximately $13,603 per month (as of H2 2023).
- Average annual cost: approximately $163,236 per patient.
Historical Pricing Trends
- Price has increased modestly (~3-5%) annually since 2018.
- Price stability reflects Roche's strategy to maintain premium positioning amid rising competition.
Future Price Trends
| Year |
Projection |
Rationale |
| 2024 |
$13,800/month |
Slight increase; ongoing inflation adjustments. |
| 2025 |
$14,200/month |
Introduction of new formulations, possible market expansion. |
| 2026 |
$14,600/month |
Anticipated price stabilization or minor increments. |
Projected annual treatment cost in 2025: $170,400.
Factors Influencing Price Projections
- Inflation and supply chain costs.
- Market competition: Entry of biosimilars or generics could pressure Roche to reduce prices.
- Regulatory decisions: Expanded indications could justify higher pricing to recoup R&D.
- Reimbursement policies: Increased payer scrutiny might hold prices steady or force discounts.
Revenue Projections
Based on current market penetration and pricing:
| Year |
Estimated Patients |
Revenue (USD millions) |
Assumptions |
| 2023 |
21,000 |
$3,410 |
70% penetration of 30,000 eligible patients, $13,603/month. |
| 2024 |
22,000 |
$3,630 |
73% penetration, slight increase in diagnosed cases. |
| 2025 |
23,000 |
$3,920 |
Market expansion, stability in prices. |
Strategic Outlook
- The market will likely shift toward increased usage in first-line therapy, expanding patient access.
- Price competition could emerge if biosimilars or generics enter the market post-patent expiration, expected around 2033 under US patent law.
- Roche's strategy may include maintaining premium pricing through high efficacy evidence and expanding indications.
Key Takeaways
- NDC 59651-0776 (Alecensa) is positioned in a niche but growing segment of targeted lung cancer therapies.
- The U.S. market size is approximately 30,000-50,000 patients annually, with revenues exceeding $3 billion.
- Current prices are around $13,600/month, with projections indicating gradual increases until patent expiry.
- Market expansion, competition, and regulatory factors will influence future pricing and sales.
FAQs
Q1: When is Alecensa expected to face generic competition?
A1: Likely around 2033, assuming 12-year exclusivity granted at approval.
Q2: How does Alecensa's price compare with other ALK inhibitors?
Prices are comparable; Xalkori averages around $14,000/month, with lorlatinib slightly higher.
Q3: What factors could accelerate price reductions?
Introduction of biosimilars, increased payer pressure, or regulatory price controls.
Q4: Is there potential for increased reimbursement?
Yes, with evidence of superior efficacy or expanded indications, reimbursement rates could improve.
Q5: How might emerging therapies impact Alecensa's market share?
New formulations, combination therapies, or novel agents with superior efficacy could reduce Alecensa's market penetration.
References
- FDA approval document for Alecensa, 2017.
- IQVIA National Prescription Audit, 2023.
- Roche corporate filings, 2022.
- Market research reports on NSCLC targeted therapies, 2023.
- Industry price trend data, 2018-2023.
[1] FDA. "Alecensa (alectinib) label." December 2017.
[2] IQVIA. "National Prescription Audit," 2023.
[3] Roche. "Annual Report 2022."
[4] MarketWatch. "Targeted Cancer Therapies Market Size & Trends," 2023.
