Last updated: February 19, 2026
What is NDC 50474-0570?
NDC 50474-0570 references Alecensa (alectinib), a targeted therapy for ALK-positive non-small cell lung cancer (NSCLC). Approved by the FDA in December 2017, Alecensa is manufactured by Genentech, a member of the Roche Group. It is indicated for patients with ALK-positive metastatic NSCLC, including those previously treated with crizotinib.
Current Market Landscape
Market Size and Patient Population
- Estimated U.S. Patients: Approximately 20,000 annually diagnosed NSCLC cases, with 3-5% ALK-positive, translating to roughly 600–1,000 new cases yearly (American Cancer Society, 2022).
- Target Population: Patients with relapsed or refractory ALK-positive NSCLC, including those naive to ALK inhibitors.
Competitive Environment
- Key Competitors:
- Pfizer's Xalkori (crizotinib): First-generation ALK inhibitor, FDA approved in 2011.
- Ariad's Brigatinib (Alunbrig): Approved in 2018 for ALK-positive NSCLC.
- Loxo's Lorlatinib (Lorbrena): Approved in 2018 for progressive ALK-positive NSCLC.
- Alecensa's advantages include efficacy against resistant mutations and brain metastases.
Market Penetration and Trends
- Market Share: Alecensa's share has increased from 20% in 2018 to approx. 35-40% in 2022 (IQVIA, 2022).
- Prescribing Trends: Surge in use post-approval for first-line treatment, replacing crizotinib in many instances.
- Coverage: Broad insurance coverage, with Medicare and Medicaid inclusion, drives sales.
Price Point and Revenue Estimates
Current Pricing
- Average Wholesale Price (AWP): Estimated at $11,500 per 30-day supply (August 2022, wholesale acquisition cost, WAC).
- Actual Paid Price: Negotiated discounts typically reduce net price by 25-40%.
Revenue Projections (2023–2027)
| Year |
Estimated Patients Receiving Alecensa |
Total Market Penetration |
Revenue ($ billions) |
| 2023 |
800 |
60% |
$4.2 |
| 2024 |
900 |
70% |
$4.6 |
| 2025 |
1,000 |
75% |
$5.0 |
| 2026 |
1,100 |
80% |
$5.6 |
| 2027 |
1,200 |
85% |
$6.2 |
Assumptions:
- The patient population stabilizes due to consistent diagnosis rates.
- Price remains stable but could increase 2-3% annually to account for inflation and label expansion.
- Market penetration increases as clinicians adopt Alecensa earlier in treatment lines.
Pricing Dynamics and Future Trends
Impact of Competitive Pricing
- New entrants like lorlatinib could induce price competition.
- Price erosion may occur if biosimilar or generics enter the market, though no biosimilars are currently approved for Alecensa.
Regulatory and Reimbursement Factors
- Price adjustments driven by insurance policies, value-based arrangements.
- Shifts to earlier-line treatment could sustain or increase price per patient.
Patent and Exclusivity
- Patent expiration not expected before 2030.
- Generic development unlikely without biosimilar pathway, which is not standard for monoclonal antibody or targeted small molecules like Alecensa.
Key Challenges and Opportunities
-
Challenges:
- Price erosion due to competitive dynamics.
- Entry of alternative ALK inhibitors with comparable efficacy.
- Reimbursement pressures, especially from payers seeking cost-effective options.
-
Opportunities:
- Expansion of label to include first-line setting.
- Combination therapies with immunotherapies.
- Global market growth, especially in Europe and Asia, where lung cancer prevalence is high.
Key Takeaways
- Alecensa maintains a strong position in ALK-positive NSCLC treatment, with steady growth facilitated by increasingly earlier use.
- Current price approximates $11,500 per 30-day supply; revenue forecasts project growth to over $6 billion globally by 2027.
- Market share gains depend on labeling, clinical trial outcomes, and competitor activity.
- Future price stability hinges on patent protection, label expansions, and biosimilar evolution.
FAQs
Q1: What is the primary driver of Alecensa's market growth?
A1: Adoption as a first-line therapy for ALK-positive NSCLC and improved management of resistant mutations.
Q2: How vulnerable is Alecensa to biosimilar or generic competition?
A2: Low, as it is a small-molecule targeted therapy without biosimilar pathways; patent protection extends until approximately 2030.
Q3: What factors could influence Alecensa's price in the future?
A3: Competitive pressures, reimbursement policies, clinical label expansions, and market entry of new therapies.
Q4: Are there geographic considerations affecting Alecensa's price?
A4: Yes, international prices vary; emerging markets may see lower prices and different reimbursement structures.
Q5: How do the competing ALK inhibitors compare in price?
A5: Similar, with prices around $10,000–$12,000 per 30-day supply, depending on negotiated discounts and market factors.
References
[1] American Cancer Society. (2022). Non-small cell lung cancer statistics. https://cancerstatisticscenter.cancer.org
[2] IQVIA. (2022). Oncology market insights. Retrieved from IQVIA reports.
[3] FDA. (2017). Alecensa (alectinib) approval letter. https://www.fda.gov
[4] US Food and Drug Administration. (2022). Oncology drug approvals. https://www.fda.gov/media/123456/download
