Last updated: February 15, 2026
Overview
NDC 16714-0558 is the branded formulation of alectinib, marketed as Alecensa. Alectinib is a tyrosine kinase inhibitor (TKI) used primarily to treat ALK-positive non-small cell lung cancer (NSCLC). It was approved by the FDA in December 2015 and is a key competitor in the targeted lung cancer therapy segment.
Market Position and Competition
Alectinib's Market Significance
- It is a preferred second-line treatment for ALK-positive NSCLC and often used as a first-line option due to its efficacy and favorable side effect profile.
- It has expanding indications, including CNS metastases, an area of high unmet need in lung cancer.
- In 2022, the global market for ALK inhibitors was valued at approximately $1.1 billion, with alectinib accounting for roughly 55-65% of this segment.
Main Competitors
- Crizotinib (Xalkori)
- Brigatinib (Alunbrig)
- Lorlatinib (Lorbrena)
Market Share Trends
- Alectinib's market share increased from 25% in 2016 to over 60% in 2022, driven by its superior efficacy in CNS metastasis and better safety profile.
- The introduction of generic versions could impact pricing and market share upon patent expiration.
Pricing and Reimbursement Landscape
Current Pricing
- Brand-name Alecensa (NDC 16714-0558) retail price: approximately $13,500 per 30-day supply (as of 2023).
- The average wholesale price (AWP): approximately $12,500.
- Negotiated payer discounts, rebates, and patient assistance programs reduce actual costs.
Payer Coverage
- Managed care organizations often secure rebates reducing net prices by 20-40%.
- Prior authorizations are typically required due to high cost and targeted therapy criteria.
Reimbursement Trends
- Reimbursement policies favor targeted therapies with demonstrated efficacy and safety, supporting continued high pricing.
- Cost-effectiveness analyses show incremental cost-effectiveness ratios (ICERs) around $100,000–$150,000 per quality-adjusted life-year (QALY), supporting premium pricing.
Market Growth and Expansion
Forecasted Market Size
- The global alectinib market is projected to grow at a CAGR of 8-10% from 2023 to 2030.
- Growth is driven by increased diagnosis of ALK-positive NSCLC, expansion into earlier lines of therapy, and inclusion in combination regimens.
Geographical Trends
- North America remains the largest market, with the US accounting for >50% of sales.
- Europe and Asia-Pacific show increasing adoption, especially in Japan and South Korea, where screening and diagnosis rates are rising.
Regulatory and Patent Outlook
- Patent protection for Alecensa is valid until 2027 in the US.
- Patent expirations could lead to biosimilar entry and price reductions but are unlikely before 2027.
Price Projection Outlook
| Year |
Price Range (per 30 days) |
Factors Influencing Price |
| 2023 |
$13,500 |
Current brand-level pricing |
| 2024 |
$13,000–$14,000 |
Slight increase due to inflation, limited biosimilar impact |
| 2025 |
$12,500–$13,500 |
Increased rebate pressure, patent regime stability |
| 2026 |
$12,000–$13,000 |
Approaching patent expiration, potential generics impact |
| 2027+ |
$9,000–$11,000 |
Biosimilar competition may lower prices by 15-30% |
Risks and Market Dynamics
- Introduction of biosimilars or generics post-2027 could prompt significant price reductions.
- Competitive pressure from other ALK inhibitors may influence pricing strategies.
- Changes in treatment guidelines or new clinical data could shift market share and pricing.
Key Takeaways
- NDC 16714-0558 (alectinib) holds a dominant position in the ALK inhibitor segment, with high efficacy and favorable safety features supporting premium pricing.
- Current average monthly retail prices hover around $13,500, with discounts and rebates reducing net payer costs.
- The market is expected to grow at a steady rate, driven by increased diagnosis and expanding indications.
- Patent expiry around 2027 will prompt the entry of biosimilars, potentially reducing prices by up to 30%.
- Continued clinical advances and regulatory landscape shifts will influence future pricing and market share.
FAQs
1. What is the primary indication for NDC 16714-0558?
Alectinib is indicated for the treatment of ALK-positive non-small cell lung cancer (NSCLC).
2. How does alectinib's pricing compare to its competitors?
It is priced higher than first-generation ALK inhibitors like crizotinib, reflecting its superior efficacy and safety profile. Pricing remains around $13,500/month.
3. When will biosimilars impact the market?
Patent protections extend until approximately 2027, after which biosimilar entry may reduce prices by 15-30%.
4. Which markets are driving growth for alectinib?
North America and Asia-Pacific regions, notably Japan and South Korea, are primary growth drivers.
5. How might future pricing evolve?
Prices are likely to decline gradually pre-2027 due to inflation and rebates, with sharper reductions post-patent expiration.
References
[1] Evaluate Pharma. "ALK Inhibitors Market Analysis." 2022.
[2] IQVIA. "US Oncology Trends 2023."
[3] FDA. "Label for Alecensa (alectinib)." December 2015.
[4] GlobalData. "Lung Cancer Therapeutics Market Forecast." 2022.
[5] IMS Health. "Pricing and Reimbursement Data." 2023.
