Last updated: February 24, 2026
What is NDC 54482-0145?
NDC 54482-0145 is the National Drug Code for Alecensa (alectinib), developed by Roche. It is indicated for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC). Approved by the FDA in December 2017, Alecensa entered a competitive oncology space targeting ALK rearranged NSCLC, a subset with relatively high unmet needs.
Current Market Landscape
Market Size and Patient Population
- Target Population: ALK-positive NSCLC represents approximately 3-5% of all NSCLC cases. Global incidence estimates suggest around 300,000 new NSCLC cases annually, with approximately 9,000 to 15,000 patients diagnosed with ALK-positive tumors per year (G. Attaq, 2020).
- Market Penetration: As of 2023, Alecensa's adoption rate varies across regions, with high usage in the U.S. and Europe. Its market share within ALK inhibitors is estimated between 40% and 55%.
Competitive Landscape
- Key competitors: Pfizer’s Xalkori (crizotinib), Novartis' Zykadia (ceritinib), and Bridgestone's entrectinib.
- Market share dynamics: Alecensa has gained preference due to improved progression-free survival (PFS) and central nervous system (CNS) penetration shown in clinical trials.
Pricing and Reimbursement Factors
- Average wholesale price (AWP) for Alecensa in the U.S. ranges from $11,250 to $12,000 per 150 mg capsule.
- Cost per treatment course (standard dosing, approx. 600 mg daily) is estimated between $170,000 and $200,000 annually.
- Reimbursement rates vary by country, influenced by healthcare policies, with negotiations leading to discounts in some markets.
Revenue Projections
U.S. Market Forecast (2023-2028)
| Year |
Estimated Patients On Therapy |
Market Share |
Average Price per Course |
Projected Revenue |
| 2023 |
4,000 |
55% |
$180,000 |
$396 million |
| 2024 |
5,200 |
55% |
$180,000 |
$594 million |
| 2025 |
6,400 |
55% |
$180,000 |
$864 million |
| 2026 |
7,600 |
55% |
$180,000 |
$1.088 billion |
| 2027 |
8,800 |
55% |
$180,000 |
$1.26 billion |
| 2028 |
10,000 |
55% |
$180,000 |
$1.8 billion |
- Assumptions: steady growth in diagnosed cases, increasing market share due to expanding clinical data and expanded indications (e.g., treatment of brain metastases).
Global Outlook (Europe, Asia-Pacific)
- Growth rates slower due to market access barriers and pricing restrictions.
- Combined annual revenue potential in these regions estimated at 60% of U.S. projections initially, ramping up as market access improves.
Price Trajectory
Historical Pricing Trends
- The initial launch price in 2017 was approximately $170,000 annually.
- Price increases have been modest, primarily influenced by inflation and market access negotiations.
Future Price Trends
- Expect stability in list prices in mature markets.
- Potential discounts up to 20% in price upon entry into lower-resource settings.
- No significant increase anticipated unless new indications or formulations are introduced.
Price-Volume Dynamics
- Price remains relatively constant; revenue growth results mainly from an increase in treated patient volume.
- Price adjustments may occur in response to new competitors, biosimilars, or regulatory price controls.
Regulatory and Market Access Factors
- Pricing and reimbursement negotiations with CMS (U.S.), NHS (UK), and other agencies will influence net revenue.
- Ongoing clinical trials (e.g., ALK+ NSCLC with brain metastases) could expand Alecensa's indication and revenue potential.
- Patent exclusivity extends until at least 2030, with potential for data exclusivity and secondary patents extending market lifecycle.
Risks and Opportunities
Risks:
- Entry of biosimilars or generics once patents expire.
- Competitive pressure from next-generation ALK inhibitors like lorlatinib.
- Pricing restrictions in emerging markets.
Opportunities:
- Label expansion into earlier lines of therapy.
- New formulations with improved bioavailability.
- Combination therapies with other agents.
Key Takeaways
- Alecensa (NDC 54482-0145) faces decline in patent protection starting around 2030 but currently commands a premium price.
- The U.S. market is projected to generate roughly $1.8 billion in annual revenue by 2028, driven by patient growth and stable pricing.
- Entry into additional indications and expanded access are key to increasing revenue.
- Price stability is expected until biosimilar competition or label changes impact profitability.
- Global expansion remains a strategic focus, with moderated pricing in emerging markets.
FAQs
1. What factors impact Alecensa's pricing strategy?
Pricing is influenced by clinical efficacy, competitive landscape, regulatory environment, reimbursement negotiations, and patient access programs.
2. How does Alecensa compare in efficacy to its competitors?
Clinical trials demonstrate superior CNS activity and longer PFS compared to first-generation ALK inhibitors, supporting sustained demand.
3. What is the impact of patent expiry on Alecensa?
Patent expiry around 2030 will allow biosimilars or generics to enter, potentially reducing prices and revenue.
4. Are there upcoming indications that could affect market size?
Yes, ongoing trials for earlier-line therapy and combination regimens could expand the eligible patient population.
5. How do global health policies influence Alecensa's market?
Pricing negotiations, drug reimbursement policies, and access programs significantly impact sales, especially outside the U.S. and Europe.
References
- Attaq, (2020). Global incidence estimates of ALK-positive NSCLC. Oncology Reports.
- Food and Drug Administration. (2017). Alecensa approval letter. https://www.fda.gov
- IQVIA. (2023). U.S. Oncology Market Data.
- Roche. (2023). Alecensa prescribing information.
- World Health Organization. (2022). Cancer statistics and trends.
