Last updated: February 13, 2026
Product Identification
NDC 72485-0613 is identified as Alecensa (alectinib), an ALK and ROS1 tyrosine kinase inhibitor developed by Roche. It is approved for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC), initially approved in 2017.
Market Landscape
The drug addresses a niche within oncology, primarily serving patients with specific genetic mutations. The global NSCLC market was valued at approximately $13 billion in 2022, with targeted therapies like Alecensa contributing a significant share. Competing agents include Pfizer’s Xalkori (crizotinib), AstraZeneca’s Tagrisso (osimertinib), and newer drugs like Rozlytrek (entrectinib).
Market Penetration and Adoption
- US Sales: Estimated at $850 million in 2022 (IQVIA).
- Global Sales: Approximate $1.2 billion in 2022.
- Market Penetration: Rising, driven by broader genetic testing and expanded indications, including earlier lines of therapy.
Pricing Landscape
- Average Wholesale Price (AWP): Approx. $13,500 per 30-day supply.
- Average Selling Price (ASP): Slightly lower, around $12,000 per month, owing to rebates and discounts.
Pricing is comparable to other targeted therapies in oncology. The drug’s price is influenced by factors including:
- The degree of market competition.
- Patent protections, which extend until at least 2030.
- Medicare and Medicaid reimbursement policies.
- Novo Nordisk’s pricing strategies for similar oncology products.
Historical and Projected Price Trends
| Year |
Average Monthly Price |
Notes |
| 2022 |
$12,000 |
Current market price, stable with slight discounts |
| 2023 |
$12,200 |
Slight increase driven by inflation and market conditions |
| 2024 |
$12,400 |
Expected stabilization; potential adjustments for new competitors |
| 2025 |
$12,500 |
Anticipated plateau unless a new competitor enters or patent rights change |
Forecasting Assumptions
- Market Growth Rate: 8-10% annually, driven by increased testing and off-label use.
- Pricing Adjustment: 2-3% annual increase primarily due to inflation and healthcare policy shifts.
- Competitive Dynamics: Introduction of biosimilars or more effective therapies could pressure prices downward post-2025.
Regulatory and Patent Status
- Patent Expiry: Currently protected until at least 2030.
- Regulatory Approvals: Covers multiple indications globally, with ongoing trials expanding usage.
Potential Market Risks
- Patent expirations or biosimilar entries may erode market share and pricing.
- Changes in reimbursement policies impact net prices.
- Competition from gene-based diagnostics may improve early detection, affecting demand dynamics.
Conclusion
Alecensa (NDC 72485-0613) holds a strong position in targeted NSCLC therapy, with stable pricing and a growing market. Price projections suggest incremental increases in the near term, contingent on competitive landscape stability. The key risk remains patent expiry and emerging therapies, which could lower prices and market share over the next 5-7 years.
Key Takeaways
- Current market price: ~$12,000/month
- Estimated 2023-2025 price growth: 2-3% annually
- Revenue projected to grow at 8-10% annually until 2025
- Patent protections protect revenue streams until at least 2030
- Competition and biosimilar entry could alter the landscape post-2025
FAQs
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What factors influence Alecensa’s price stability?
- Patent protection, market share, reimbursement policies, and competition shape pricing.
-
How does Alecensa compare to similar therapies?
- Its price aligns with targeted oncologic agents like Xalkori and Tagrisso but benefits from patent exclusivity.
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What is the impact of patent expiry on pricing?
- Patent expiration could lead to biosimilar entry, reducing prices and affecting revenue.
-
Are there upcoming regulatory changes that could affect pricing?
- Changes in CMS reimbursement policies could influence net prices, but no immediate regulatory shifts are anticipated.
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How does increased genetic testing impact the market?
- Broader testing expands eligible patient populations, potentially increasing demand and revenue.
Citations
- IQVIA, 2022. Oncology Market Reports.
- FDA. Alecensa (alectinib) approval details.
- Pharmaceutical Market Research, 2022-2023.
- Roche corporate disclosures, 2022 annual report.
- US patent database, 2023.
