Last updated: February 27, 2026
What is NDC 70677-1001?
NDC 70677-1001 refers to Alecensa (alectinib), a targeted therapy used to treat non-small cell lung cancer (NSCLC) with ALK gene rearrangements. This drug is marketed by Roche and approved by the FDA since 2017. It is indicated for patients with ALK-positive metastatic NSCLC, including those with brain metastases.
Market Overview
Indication and Demand
- Patient Population: Estimated 200,000 NSCLC cases annually in the U.S. with ALK mutations, representing approximately 3-5% of NSCLC cases.
- Treatment Landscape:
- First-line: Crizotinib (Pfizer)
- Second-line and beyond: Alectinib (Roche), Ceritinib (Lilly), Brigatinib (Takeda)
- Market Penetration:
- Alectinib captures approximately 50% of ALK-positive NSCLC treatment, with increasing adoption due to efficacy and CNS penetration.
Competitive Environment
- Main competitors include Pfizer’s Xalkori (crizotinib), which was first approved in 2011, and other next-generation ALK inhibitors like brigatinib and lorlatinib.
- Alectinib's superior blood-brain barrier penetration has increased its preference among oncologists.
Market Size and Trends
- The global NSCLC drug market exceeds USD 8 billion, with targeted therapies accounting for a growing share.
- The ALK inhibitor segment is projected to grow at a Compound Annual Growth Rate (CAGR) of 7–9% over the next five years (MarketResearch.com, 2022).
- COVID-19 temporarily impacted growth in early 2020 but recovered quickly due to continued drug demand.
Pricing Analysis
Current Price Landscape
| Drug |
Average Wholesale Price (AWP) per 30-day supply |
Approval Year |
Notes |
| Alecensa (alectinib) |
USD 12,500 |
2017 |
Premium pricing due to targeted therapy status |
| Xalkori (crizotinib) |
USD 11,200 |
2011 |
Lower but decreasing relative market share |
| Brigatinib |
USD 13,000 |
2017 |
Launching at similar price points |
Prices are approximate, based on recent Medicare and wholesale listings.
Price Trends
- Since market entry, Alecensa’s price has increased modestly, aligning with inflation and R&D costs.
- Competition has maintained prices in the USD 11,000–13,000 range per 30-day supply.
- No significant price reductions expected in the short term given the drug’s market exclusivity and clinical advantages.
Reimbursement and Access
- Managed care coverage is available, with payers increasingly favoring targeted therapies due to improved outcomes.
- Out-of-pocket costs for patients are typically USD 50–USD 150 per month with insurance.
Revenue Projections
Short-term (Next 2 Years)
- Sales are projected to grow at 10-15% annually, driven by increased adoption in first-line therapy.
- Estimated global sales in 2023: USD 1.2–1.5 billion.
Mid-term (Next 5 Years)
- Market penetration reaching above 70% for ALK-positive NSCLC patients.
- Uptake in emerging markets could add USD 300–500 million annually.
- Assumes continued exclusivity and no competitive price erosion.
Long-term (Next 10 Years)
- Patent expiration anticipated around 2029–2030, risking generic entry.
- Price erosion of 30-50% could occur after patent loss, reducing revenues accordingly.
Risk Factors Impacting Price and Market
- Patent expiry: Loss of exclusivity will force price reductions.
- Regulatory decisions: New approvals or restrictions can influence demand.
- Competitive launches: More effective or cost-efficient drugs entering market.
- Reimbursement policies: Payer negotiations could impact net pricing.
Key Takeaways
- Alecensa maintains a premium price point of approximately USD 12,500 per 30-day supply.
- The therapy captures a significant share of the ALK-positive NSCLC segment, with market growth driven by increased adoption.
- Revenue projections indicate steady growth, but patent expiration around 2029-2030 poses a risk of price erosion.
- Market dynamics are influenced by competitive pressures, reimbursement policies, and regulatory developments.
FAQs
1. How does Alecensa’s pricing compare internationally?
Prices vary globally; European countries often negotiate lower prices through health authorities, with premiums higher in the U.S. due to market dynamics.
2. What is the expected impact of biosimilars or generics?
Patent expiration could lead to biosimilars or generics entering markets, reducing prices by 30-50% and affecting revenues.
3. Are there any upcoming regulatory challenges?
No major approvals or restrictions are anticipated in the near term; however, regulatory agencies may require post-marketing data impacting pricing.
4. How does Alecensa’s efficacy influence its market uptake?
Higher efficacy in CNS metastases and better safety profile compared to earlier options have accelerated its adoption.
5. What emerging markets present growth opportunities?
China, India, and Brazil are key emerging markets with increasing healthcare access and adoption of targeted therapies.
Citations
[1] MarketResearch.com. (2022). Global NSCLC targeted therapy market report.
[2] FDA. (2017). Approval letter for Alecensa.
[3] IQVIA. (2022). Market dashboard for ALK inhibitors in oncology.
