Last updated: February 27, 2026
What is the drug identified by NDC 49348-0817?
NDC 49348-0817 corresponds to Alecensa (alectinib). It is an oral ALK (anaplastic lymphoma kinase) inhibitor approved for the treatment of ALK-positive non-small cell lung cancer (NSCLC).
What is the current market landscape?
Market Size
- Global NSCLC treatment market valued at approximately USD 14 billion in 2022.
- ALK-positive NSCLC accounts for 3-5% of all NSCLC cases.
- Estimated U.S. patient population with ALK-positive NSCLC: 20,000–25,000 annually, considering diagnosis rates and prevalence.
Competitive Position
- Alecensa competes primarily with Xalkori (crizotinib), Lorbrena (lorlatinib), and Brigatinib.
- Introduced in 2017; marketed by Roche/Chugai.
- Margins depend on patent exclusivity, with some biosimilar and generic competition expected post-2030.
Market Penetration
- In 2022, Alecensa commanded approximately 65% of the ALK inhibitor market share in the U.S.
- Sales projections for 2023 reached USD 1.2 billion globally, reflecting strong uptake post-FDA approval.
What are the key price points?
U.S. Pricing
- Alecensa (per 150 mg capsule): average wholesale price (AWP) listed at approximately USD 12,500 per month.
- Typical treatment duration: ongoing, with average treatment in clinical settings spanning 12–24 months.
- Actual sale prices might be discounted due to rebates, insurance negotiations, and patient assistance programs.
International Pricing
- European prices range from EUR 8,000–EUR 10,000 per month.
- Other markets (e.g., Japan, Canada) show similar pricing scaled to economic factors.
Price Trends
- Since 2017, prices have remained stable but face downward pressure from biosimilars and policy changes.
- Price erosion is expected post-patent expiration, with biosimilar entries potentially reducing prices by 30–50%.
What are the projected market trends?
Pharmacoeconomic and Policy Influences
- Growing adoption driven by improved efficacy over earlier-generation TKIs.
- Price competition expected with entering biosimilars around 2030.
- Payers increasingly negotiate rebates, impacting net prices.
Future Sales Projections
| Year |
Global Revenue (USD) |
Growth Rate |
Key Drivers |
| 2023 |
1.2 billion |
N/A |
Increased adoption in 1L and 2L settings |
| 2024 |
1.4 billion |
16.7% |
Expanded indications, wider payer coverage |
| 2025 |
1.6 billion |
14.3% |
New market entries, post-pandemic recovery |
Market Expansion Opportunities
- Label expansion to earlier line therapy.
- Potential for combination therapies.
- Integration into treatment algorithms for systemic NSCLC.
Risks impacting market size and prices
- Patent expiration predicted around 2030; biosimilar competition expected.
- Slight declines in pricing due to generic/demographic shifts.
- Patent litigation or regulatory challenges could delay biosimilar entries.
Summary
Alecensa remains a significant contributor to the ALK-positive NSCLC treatment market, with stable pricing and strong market share. Revenue growth depends on pipeline developments, regulatory decisions, competition from biosimilars, and payer negotiations. US prices are circa USD 12,500/month; international markets see comparable pricing with regional variations. Price erosion anticipated post-2030 will influence long-term revenue projections.
Key Takeaways
- NDC 49348-0817 represents Alecensa, a key ALK inhibitor for NSCLC.
- The drug's current annual sales reach around USD 1.2 billion.
- U.S. list prices hover near USD 12,500 per month, with actual net prices potentially lower.
- Market growth driven by indications expansion, but patent expiry risks loom post-2030.
- Biosimilars could cut prices by up to 50%, impacting future revenue.
FAQs
Q1: When does Alecensa face patent expiration?
Patent protections are expected to expire around 2030, after which biosimilars may enter the market.
Q2: What are the main competitors to Alecensa?
Xalkori (crizotinib), Lorbrena (lorlatinib), and Brigatinib.
Q3: How does Alecensa's price compare internationally?
European and Asian prices are roughly EUR 8,000–EUR 10,000 per month, comparable to USD 12,500 in the U.S., adjusted for currency and market factors.
Q4: What factors could accelerate revenue decline?
Patent expiry, biosimilar entry, payer reimbursement pressures, and competitive therapies.
Q5: Are there upcoming indications or label expansions for Alecensa?
Potential for earlier line therapy and combination regimen approvals could expand market penetration.
Sources:
- IQVIA. (2022). Global Oncology Market Data.
- FDA. (2017). Alecensa Approval Summary.
- EvaluatePharma. (2022). World Market Forecasts.
- Roche. (2022). Annual Report.
- Centers for Medicare & Medicaid Services. (2022). Drug Price and Reimbursement Policies.
