Last updated: February 24, 2026
What is NDC 16571-0856?
NDC 16571-0856 corresponds to Alectinib (sold under the brand name Alecensa). Alectinib is an oral ALK inhibitor used to treat ALK-positive non-small cell lung carcinoma (NSCLC). It was approved by the FDA in December 2015.
Market Overview
Current Market Size
The global non-small cell lung cancer (NSCLC) market was valued at approximately $10.2 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% through 2030[1].
Alectinib's share of this market has increased owing to its status as a preferred first-line treatment for ALK-positive NSCLC, especially after the introduction of more effective therapies.
Key Competitors
| Drug |
Indication |
Approval Year |
Market Share (2022) |
Notes |
| Alectinib (Alecensa) |
ALK-positive NSCLC |
2015 |
45% |
First-line preference in US |
| Crizotinib |
ALK-positive NSCLC |
2011 |
20% |
Replaced in first-line by Alectinib |
| Ceritinib |
ALK-positive NSCLC |
2014 |
10% |
Niche use, resistance issues |
| Brigatinib |
ALK-positive NSCLC |
2017 |
8% |
Growing due to efficacy |
Market Dynamics
- Line of Therapy Shift: Alectinib's approval as a first-line treatment shifted market share from Crizotinib.
- Geographic Penetration: Mainly strong in North America and Europe; growth in Asia, especially China, driven by expanding approval and affordability.
- Pricing Advantage: Alectinib premium pricing reflects its clinical efficacy and safety profile.
Price Analysis
Current Pricing
| Region |
Average Wholesale Price (AWP) per 150 mg capsule |
Notes |
| United States |
$600 |
Pricing varies by pharmacy and insurer contracts |
| Europe (EU) |
€520 (~$565) |
Lower due to negotiated pricing and rebates |
| China |
Approx. ¥6,200 (~$900) |
Price controlled; government negotiations influence pricing |
Price Trends
- Since its launch, the US price for Alectinib has increased roughly 15% over eight years.
- Discounting and rebates reduce net price by about 20-30% in the US.
- European markets exhibit lower prices due to national reimbursement policies.
- Price caps in China impact gross pricing, with actual reimbursement rates influencing net revenue.
Pricing Considerations
- Patent Status: Patent expiry scheduled for 2032 in the US, expected to pressure prices downward.
- Biosimilar Development: No biosimilar exists yet, given the small molecule nature, but generics could emerge post-patent expiry.
- Market Access: Payers demand evidence of cost-effectiveness; high-price models face pressure for reimbursement approval.
Price Projection (2023-2030)
| Year |
Estimated US Wholesale Price |
Assumptions |
| 2023 |
$600 |
Current price, no significant change |
| 2025 |
$630 (5% increase) |
Based on inflation, R&D recovery costs |
| 2028 |
$660 (additional 5% increase) |
Reflects inflation and market dynamics |
| 2030 |
$700 (~16.7% over 2023) |
Patents remaining, minimal biosimilar competition |
In Europe, prices are projected to follow similar inflation-adjusted increases but remain lower than US levels, averaging €600-€650.
Post-2030, generic entry is expected to reduce prices by approximately 40-60%, depending on regional patent statuses and market penetration.
Regulatory and Policy Impact
- US Patent Expiry: 2032, after which generic competition will likely commence.
- Reimbursement Policies: Increasing emphasis on value-based models could moderate price growth.
- Global Access Initiatives: Price reductions in emerging markets aligned with negotiated prices and subsidies.
Conclusion
Alectinib (NDC 16571-0856) stands as a high-value, branded therapy with a dominant market share in ALK-positive NSCLC. Market share consolidation and clinical positioning support stable pricing through 2028, with modest increases forecasted. Significant price erosion is anticipated around 2032 with patent expiration and biosimilar entry.
Key Takeaways
- Market share for Alectinib is driven by its efficacy as a first-line therapy.
- US wholesale prices are approximately $600 per 150 mg capsule, with slight increases projected through 2028.
- The patent expiry in 2032 will likely introduce generics, reducing prices substantially.
- Europe’s lower prices stem from negotiated reimbursement and healthcare systems.
- Regional variations influence pricing strategies and market penetration.
FAQs
Q1: When is patent expiration for Alectinib?
Patent expiry is scheduled for 2032 in the US.
Q2: What are the main competitors to Alectinib?
Crizotinib, Ceritinib, and Brigatinib.
Q3: How does regional pricing differ?
US prices are higher; Europe and China have lower prices due to reimbursement policies and price controls.
Q4: What is the expected post-patent price drop?
Generics could reduce prices by 40-60%, with variability based on region and market conditions.
Q5: Are biosimilars relevant for this product?
No, as it is a small molecule drug; biosimilar development is not applicable.
References
- Market Research Future. (2023). Non-small Cell Lung Cancer Market Forecast.
