Last updated: February 21, 2026
What is the Product Corresponding to NDC 16571-0853?
The National Drug Code (NDC) 16571-0853 corresponds to Alecensa (alectinib) capsules, 150 mg. It is marketed by Roche and approved for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).
Market Overview
Approved Indications
- ALK-positive metastatic NSCLC
- Use as a first-line therapy and for patients with progressed disease after chemotherapy
Competitive Landscape
- Key competitors include:
- Xalkori (crizotinib) by Pfizer
- Zykadia (ceritinib) by Novartis
- Lorbrena (lorlatinib) by Pfizer
Market Size and Trends
| Parameter |
2022 |
Estimated 2027 |
CAGR (2022-2027) |
| U.S. NSCLC patients eligible for ALK inhibitors |
25,000 |
30,000 |
3.7% |
| Estimated ALK+ NSCLC treatment market value |
$2.2B |
$2.8B |
4.4% |
- Increasing prevalence of NSCLC globally prompts growth.
- ALK mutations present in approximately 3-5% of NSCLC cases.
- Approval expansions and label updates for Alecensa broaden the eligible patient pool.
Market Penetration and Adoption
- Initial adoption limited due to competition from first-in-class agents.
- Steady increase in market share with extended label usage and clinician familiarity.
- Estimated current global sales of Alecensa approximate $600 million (2022).
Patent and Regulatory Exclusivity
- Patents protect Alecensa until at least 2030.
- Orphan drug designation secures additional market exclusivity periods.
Pricing Analysis
Current List Price
- U.S. retail price: approximately $9,480 per 150 mg capsule.
- Cost per treatment cycle (assuming 300 mg daily over 21 days): ~$63,400.
Reimbursement and Pricing Dynamics
- Net prices often lower due to rebates and discounts.
- Insurance coverage and patient assistance programs influence ultimate patient costs.
International Pricing
- Prices vary significantly:
- Canada: ~$8,200 per cycle.
- European Union: prices range from €6,000-€8,500 (~$6,500-$9,200).
- Emerging markets: substantially lower, around $2,000-$4,000 per cycle.
Factors Impacting Future Pricing
- Expansion to earlier line settings or combination therapies.
- Price negotiations with healthcare systems.
- Potential biosimilar or generic development delays due to patent protections.
Price Projection Outlook
| Year |
Estimated Average Price |
Rationale |
| 2023 |
$9,500 |
Static prices amid steady demand |
| 2024 |
$9,300 |
Slight discounting due to increased market competition |
| 2025 |
$9,100 |
Price pressure from biosimilar developments unlikely; value-based pricing increases |
| 2026 |
$8,900 |
Potential for negotiated rebates as utilization scales |
| 2027 |
$8,700 |
Market saturation and increased competition from next-generation ALK inhibitors |
Risks and Opportunities
Risks
- Entry of biosimilars or generics after patent expiration.
- Market saturation driven by new therapies.
- Pricing pressure from payers.
Opportunities
- Expansion to combination regimens.
- Use in earlier-stage NSCLC.
- Geographic expansion into emerging markets.
Key Takeaways
- Alecensa's market is driven by NSCLC prevalence and mutation-specific therapies.
- The current price remains high, supported by patent exclusivity and clinical value.
- Price declines are projected but are tempered by demand and lack of immediate generic competition.
- The global market offers growth potential, especially if label expansions occur.
- Competitive pressures and regulatory decisions will influence future pricing strategies.
FAQs
1. What factors most influence Alecensa’s market share?
Price, clinical efficacy, label expansions, and the availability of competitor drugs.
2. How does Alecensa's pricing compare with other ALK inhibitors?
It is generally priced higher than older drugs like crizotinib but comparable to newer agents like lorlatinib.
3. When are biosimilars or generics likely to impact the Alecensa market?
Not before 2030, given patent protections, but development of biosimilars could influence pricing after patent expiry.
4. How are reimbursement policies affecting Alecensa's market?
Reimbursement rates, formulary placements, and patient assistance programs significantly shape net prices.
5. What market strategies could extend Alecensa’s profitability?
Label expansion, dose optimization, geographic expansion, and partnership with payers.
References
- U.S. Food and Drug Administration. (2017). Alecensa (alectinib) summary review.
- IQVIA. (2022). Oncology market report.
- European Medicines Agency. (2019). Alecensa approval details.
- CPI. (2023). Drug price database.
- Novartis. (2022). Zykadia (ceritinib) product profile.
