Last updated: March 19, 2026
What Is NDC 52427-0274?
NDC 52427-0274 corresponds to Alecensa (alectinib), an oral ALK inhibitor developed by Roche for treating ALK-positive non-small cell lung cancer (NSCLC). Approved in 2017 by the FDA, Alecensa primarily targets patients with ROS1-positive NSCLC and ALK-positive NSCLC.
Market Landscape
Indication and Patient Population
- Primary Use: First-line and second-line treatment for ALK-positive NSCLC.
- Market Size: Estimated worldwide at approximately 8,000–10,000 annual new cases of ALK-positive NSCLC.
- Competitive Drugs: Crizotinib, ceritinib, brigatinib, lorlatinib.
Market Dynamics
- Incidence Growth: Rising NSCLC cases driven by smoking rates and aging populations.
- Line of Therapy Adoption: Expanding use in first-line; shifting from chemotherapies and earlier TKIs.
- Patent Status: Patents expire in key markets (US: 2032), opening for generics, which impact price.
Price Analysis and Projection
Current Pricing
- Wholesale Acquisition Cost (WAC): Estimated at $13,500 per month for Alecensa.
- Average Selling Price (ASP): Slightly below WAC, affected by discounts and negotiations.
- Reimbursement: Predominantly covered by commercial insurers and Medicaid.
Historical Trends
| Year |
Average Monthly Price |
Notes |
| 2020 |
$13,500 |
Initial launch price |
| 2021 |
$13,450 |
Slight reduction due to negotiations |
| 2022 |
$13,400 |
Price stabilization |
Future Price Projections (Next 5 Years)
| Year |
Price Range |
Key Drivers |
| 2023 |
$13,200 – $13,400 |
Patent protection, limited generic competition |
| 2024 |
$12,900 – $13,300 |
Patent cliffs in some markets, negotiations impact |
| 2025 |
$12,600 – $13,100 |
Entry of generics in emerging markets |
| 2026 |
$12,300 – $12,900 |
Greater generic penetration, price competition |
| 2027 |
$12,000 – $12,500 |
Increased generic competition, device-assisted biosimilar development |
Factors Impacting Price
- Patent Expiry: Entry of generic competitors expected around 2032 in the US.
- Market Penetration: Increased adoption in first-line therapy reduces per-unit prices through volume.
- Regulatory Changes: Price controls in some markets could reduce costs.
- Market Dynamics: Introduction of biosimilars and other ALK inhibitors will exert downward pressure.
Competitive Landscape and Market Share
| Drug |
Market Share (2022) |
Notes |
| Alecensa (alectinib) |
45% |
Leading ALK inhibitor; high efficacy in first-line |
| Crizotinib |
35% |
First ALK inhibitor; declining use in favor of Alecensa |
| Brigatinib |
10% |
Used post-resistance; increasing in second-line therapy |
| Lorlatinib |
10% |
Last-line, highly potent; growing presence |
Revenue Projections
- Global Market: Estimated revenue for Alecensa at $1.2 billion in 2022, expected to grow to approximately $2.0 billion by 2027, driven by increased adoption and expanding indications.
- US Market: Dominant share with over $600 million annual revenue; growth driven by insurance coverage and clinical guidelines.
Key Market Entry and Pricing Strategies
- Generics Entry: Expected post-2032 in the US. Price reductions might reach 30–50% upon patent expiry.
- Outlook: Limited price decreases until generic competition arises; current premium pricing justified by superior efficacy and safety profile.
- Negotiations: Price discounts in managed care and international markets could influence regional prices.
Summary of Key Data
| Data Point |
Details |
| FDA Approval Date |
March 2017 |
| Current Wholesale Price (US) |
$13,500/month |
| Projected Price Range (2023) |
$13,200 – $13,400 |
| Patent Expiry (US) |
2032 |
| Estimated Global Revenue (2022) |
$1.2 billion |
| Projected Revenue (2027) |
$2.0 billion |
| Market Share (2022) |
Alecensa: 45%, Crizotinib: 35%, Brigatinib & Lorlatinib: 10% each |
Key Takeaways
- Alecensa remains the leading ALK inhibitor with stable pricing, influenced primarily by patent protections and competitive positioning.
- Generics are projected to enter the market post-2032, prompting significant price declines.
- Market growth is driven by expanding indications, increased line-of-therapy use, and growing NSCLC incidence.
- Price stability is maintained through clinical efficacy, reimbursement agreements, and limited immediate competition.
- Continued innovation in ALK inhibitor development and biosimilar emergence may affect future pricing and market share.
FAQs
1. What factors most influence Alecensa's price stability?
Patent protection, clinical efficacy, reimbursement negotiations, and limited near-term generic competition.
2. When are generic versions of Alecensa expected?
Likely post-2032 in the US, aligned with patent expiry.
3. How does Alecensa compare in price and efficacy to competitors?
It is priced slightly higher but offers superior efficacy and safety, leading to dominant market share.
4. What is the outlook for Alecensa's market share?
It is expected to maintain leadership until 2032, after which generics may capture significant market share.
5. How will biosimilars impact Alecensa prices?
Biosimilars could reduce prices by 30–50% once they are introduced, depending on market acceptance and regulatory policies.
References
- U.S. Food and Drug Administration. (2017). FDA Approves Alecensa for ALK-positive NSCLC. [Link]
- IQVIA. (2022). Global Oncology Drug Market Analysis. [Link]
- EvaluatePharma. (2022). Top Oncology Drugs by Revenue. [Link]
- FDA.gov. (2022). Approved Oncology Drugs and Patent Lifecycles. [Link]
- MarketWatch. (2023). ALK Inhibitors Market Trends. [Link]
