Last updated: February 14, 2026
What is NDC 23155-0530?
The NDC 23155-0530 corresponds to Alecensa (alectinib), a targeted therapy developed by Roche for ALK-positive non-small cell lung cancer (NSCLC). It was approved by the FDA in December 2017 as a first-line treatment for ALK-positive NSCLC.
Market Landscape
Key Indications and Therapeutic Area
- Indication: First-line and subsequent-line treatment of ALK-positive NSCLC.
- Competitive drugs: Crizotinib (Xalkori), Ceritinib (Zykadia), Brigatinib (Alunbrig), lorlatinib (Lorbrena).
- Market penetration: Growing due to increased detection of ALK-positive NSCLC, which accounts for approximately 3-5% of all NSCLC cases.
Patient Population
- Global incidence of NSCLC: 1.8 million annually.
- ALK-positive subset: 3-5% of NSCLC cases, approximating 54,000 to 90,000 patients globally per year.
- Treatment adoption: Increasing, driven by improved testing and biomarker-driven therapy.
Market Drivers
- FDA approval of Alecensa as a first-line treatment in 2018.
- Increasing use of molecular diagnostics.
- Growing global lung cancer incidence.
- Expansion into earlier stages and combination therapies.
Current Pricing and Reimbursement
Price Point
- Average wholesale price (AWP) for Alecensa (Dose: 150 mg tablets) ranges between $9,500 to $10,500 per month (per patient).
- Variations depend on dosage, packaging, and country-specific factors.
Reimbursement Environment
- Widely covered by Medicare, Medicaid, and private insurers in the US.
- Coverage policies expanding in international markets.
Market Projections (2023-2028)
| Year |
Estimated Patients (Global) |
Market Size (USD Billion) |
Notes |
| 2023 |
60,000 |
600 |
Assumes stable penetration with growing awareness |
| 2024 |
65,000 |
650 |
Market expansion due to increased diagnostics |
| 2025 |
70,000 |
700 |
Entry into emerging markets, possible price adjustments |
| 2026 |
75,000 |
750 |
Competition intensifies, pricing pressures possible |
| 2027 |
80,000 |
800 |
Improved long-term survival rates increase demand |
| 2028 |
85,000 |
850 |
Market stabilizes, potential for price erosion |
Price Trajectory Outlook
- Baseline: Expect stable monthly prices around $10,000 per patient.
- Downward pressure: Price reductions of 5-10% annually could occur due to increased competition and biosimilar concerns.
- Premium pricing: Will likely persist in markets with limited competition or higher premium reimbursement.
Market Entry and Expansion Considerations
- International Markets: Growth prospects are higher outside the US, especially in Europe and Asia-Pacific, where lung cancer prevalence is high.
- Pricing Strategies: Roche may adopt tiered pricing models, patient assistance programs, or value-based agreements to sustain market share.
- Pipeline Impact: The development of next-generation ALK inhibitors or combination therapies could pressure Alecensa’s market dominance, influencing price adjustments.
Key Factors Influencing Future Prices
- Regulatory changes: Biosimilars or generics entering markets.
- Enhanced diagnostics: Broader ALK testing leading to higher diagnosis rates.
- Clinical outcomes: Longer survival and improved quality of life can justify premium prices.
- Reimbursement policies: Shifts towards value-based reimbursement models may impact pricing.
Summary
The global market for Alecensa (NDC 23155-0530) is driven by increasing NSCLC incidence and advances in molecular diagnostics. Current US pricing remains around $10,000 monthly per patient. Market size is projected to grow approximately 10% annually through 2028, with price stability or slight reductions expected due to competitive pressures. Expansion into emerging markets and the impact of pipeline therapies will influence future price trajectories.
Key Takeaways
- The drug targets a niche but growing segment of lung cancer treatment.
- US prices hover near $10,000/month; international pricing varies.
- Market growth primarily driven by rising lung cancer cases and molecular testing.
- Competition from other ALK inhibitors will influence pricing and market share.
- Price stability depends on pipeline progress, diagnostics expansion, and regulation.
FAQs
1. What are the main competitors for Alecensa?
Crizotinib, Ceritinib, Brigatinib, and Lorlatinib.
2. How does the pricing of Alecensa compare internationally?
Prices vary significantly, with higher prices in the US and lower costs in Europe and Asia, often subject to negotiated discounts.
3. What factors could lead to price reductions?
Introduction of biosimilars, increased competition, or reimbursement reforms.
4. How does the patient population influence market size?
Limited to ALK-positive NSCLC patients, roughly 3-5% of all NSCLC cases, constraining overall market size.
5. What future developments could impact Alecensa's market?
New targeted therapies, combination regimens, or improved diagnostic tools expanding eligible patient populations.
Sources
[1] U.S. Food and Drug Administration. Alecensa (alectinib) approval details.
[2] IQVIA. Global Oncology Market Data.
[3] EvaluatePharma. Oncology Market Forecasts.
[4] Roche. Alecensa prescribing information.
