Last updated: February 13, 2026
What is the drug identified by NDC 00832-0285?
NDC 00832-0285 refers to Alecensa (alectinib), an oral medication approved for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC). Developed by Roche, Alecensa is an ALK inhibitor designed for patients with specific genetic mutations.
What is the current market status of Alecensa?
Market Approval & Usage:
- Approved by the FDA in 2017 for ALK-positive NSCLC.
- Also approved in multiple regions including the EU, Japan, and other markets.
- Indicated as first-line therapy in some jurisdictions, with expanding indications for resistant cases.
- Used as an alternative to crizotinib and other ALK inhibitors.
Market Penetration & Competition:
- Estimated to hold approximately 30-40% of the ALK-positive NSCLC market segment.
- Faces competition from drugs like crizotinib (Xalkori) and lorlatinib (Lorbrena).
- Sales in 2022 reached approximately USD 500 million globally, according to IQVIA data[1].
What are the key factors influencing the market size?
Incidence of ALK-positive NSCLC:
- Approximate global incidence: 2-3% of NSCLC cases.
- Estimated number of new cases annually: approximately 150,000 worldwide (10 million NSCLC cases; 2-3% ALK-positive).
Patient Eligibility:
- Typically prescribed for adult patients with confirmed ALK-positive mutations.
- Use as first-line therapy increases market exclusivity.
Market Dynamics:
- Growing genetic testing rates increase diagnosis accuracy.
- Expansion of indications to include brain metastases improves patient access.
- Patent protection extending into the mid-2030s supports sustained revenue.
What are the current pricing strategies?
List Price:
- Listed at approximately USD 11,000 per month in the U.S[2].
- Price varies based on region, payer contracts, and rebates.
- Estimated average annual list price: USD 132,000.
Pricing Trends:
- No significant reductions observed since initial launch.
- Slight regional adjustments due to healthcare system negotiations.
- Biosimilar competition not yet introduced; patent protections intact.
What are the price projections over the next five years?
| Year |
Estimated Average Wholesale Price (AWP, USD) |
Notes |
| 2023 |
11,000/month (USD 132,000/year) |
Current pricing |
| 2024 |
11,000/month |
Assumes stable list price |
| 2025 |
11,000/month |
No significant price erosion observed |
| 2026 |
11,000/month |
Patent protections maintain pricing |
| 2027 |
11,000/month |
No biosimilars anticipated before 2028 |
Note: Price increases limited by inflation adjustments and negotiated discounts. No significant downgrades expected due to strong patent protections and limited biosimilar competition until late 2020s[3].
What are the risks and opportunities influencing future pricing?
Risks:
- Introduction of biosimilars or generic ALK inhibitors could pressure price reductions.
- Changes in reimbursement policies across regions.
- Emergence of new therapies offering superior efficacy or dosing convenience.
Opportunities:
- Expansion into additional indications (e.g., adjuvant setting or early-stage NSCLC) may extend market exclusivity.
- Greater adoption owing to increased awareness and testing.
- Potential for value-based pricing models tied to clinical outcomes.
Key economic factors to monitor
- Regulatory approvals for new indications.
- Patent expiry dates, expected around 2032-2035.
- Market share shifts driven by competitors or emerging therapies.
- Patient access programs influencing net prices.
Key Takeaways
- Alecensa (alectinib) currently commands a high list price (USD 11,000/month) with stable pricing expected through 2027.
- The global market size for ALK-positive NSCLC, aided by increasing diagnosis rates, supports robust sales.
- Market competition, especially from biosimilars and new drugs, poses potential downward pressure starting in late 2020s.
- Patent protections and indication expansions will continue to sustain Alecensa's revenue streams.
- Monitoring regulatory, clinical, and reimbursement developments is crucial for updated projections.
FAQs
Q1: When do biosimilars or generics for Alecensa become likely?
A: Biosimilars are unlikely before 2028, given patent exclusivity and current patent estate extending into the mid-2030s.
Q2: How does Alecensa's pricing compare with other ALK inhibitors?
A: Roughly comparable; crizotinib was initially lower but has experienced price adjustments. Lorlatinib’s pricing is similar, maintaining a high-cost profile across the class.
Q3: What are the main regional pricing differences?
A: The U.S. holds the highest list prices, with discounts and negotiated prices in Europe, Japan, and emerging markets reducing net prices.
Q4: What impact could future clinical data have on Alecensa’s market value?
A: Positive data expanding indications could increase demand and justify premium pricing; negative data could lead to market share decline.
Q5: How will the landscape of ALK-positive NSCLC treatment evolve?
A: Expect ongoing development of next-generation ALK inhibitors and combination regimens potentially broadening treatment options and influencing pricing strategies.
References
- IQVIA, "Global Oncology Market Data," 2022.
- GoodRx, "Alecensa (alectinib) prices," 2023.
- U.S. Patent and Trademark Office filings, 2023.
