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Market Analysis and Price Projections for NDC 49884-0768
Last updated: February 17, 2026
Overview
NDC 49884-0768 corresponds to the drug Crizotinib, marketed as Rozlytrek by Genentech. It is approved for specific tumor types with target genetic alterations, notably ROS1-positive non-small cell lung cancer (NSCLC) and certain other solid tumors. The drug entered the oncology market in 2019, targeting a niche but growing segment of precision medicine.
Market Size and Growth Drivers
Indication Expansion: Initially approved for ROS1-positive NSCLC, Rozlytrek received approvals for tumor agnostic indications, including NTRK gene fusion-positive solid tumors in August 2019, and later for specific pediatric indications.
Prevalence of Targeted Mutations: Approximately 1-2% of NSCLC patients harbor ROS1 rearrangements, equating to roughly 15,000-30,000 eligible US patients annually.
Market Penetration: As of 2023, estimated penetration stands at roughly 30% among eligible patients, with potential growth due to increased testing and awareness.
Competitive Landscape
Primary Competitors: Crizotinib (Xalkori) for ROS1 NSCLC; Entrectinib (Rozlytrek for NTRK fusions); Larotrectinib (Vitrakvi) for NTRK-fusion tumors.
Market Share: Crizotinib holds about 60%, while Entrectinib and Larotrectinib account for 25% and 15%, respectively. Rozlytrek's share is estimated at 10-15%, expected to grow as testing expands.
Pricing Data and Cost Analysis
Wholesale Acquisition Cost (WAC): Approximately $13,700 per 250 mg capsule. The standard dose for NSCLC is 600 mg daily (2 x 300 mg capsules), equating to roughly $32,880 monthly, or about $394,560 annually.
Indication-Specific Pricing: For tumor-agnostic indications, dosing and duration can vary, influencing overall costs.
Pricing Trends: Since launch, price adjustments have been minor, maintaining stability amid expanded indications.
Reimbursement and Market Forces
Insurance Coverage: Coverage is generally comprehensive under private insurers, Medicare, and Medicaid, with prior authorization required.
Cost-Effectiveness: Clinical benefits in targeted populations support reimbursement decisions. However, high costs limit uptake versus off-label and generic alternatives.
Price Projections (2023-2030)
Year
Estimated WAC Price per Year
Notes
2023
$394,560
Current pricing with stable trend
2024
$400,000
Slight increase reflecting inflation and value adjustments
2025
$405,000
Expected stabilization with potential for minor hikes
2026
$410,000
Market stabilization, with no significant price pressure
2027
$415,000
Slight growth projected
2028
$420,000
No major patent expiry or regulatory change anticipated
2029
$420,000
Price remains steady
2030
$425,000
Marginal increase likely influenced by inflation
Market and Price Influences
Regulatory Changes: Approval for additional indications could elevate demand, potentially allowing price increases.
Biosimilar and Generic Entry: No biosimilars anticipated before 2030 due to orphan drug protections and complex manufacturing.
Pricing Pressure: Likely limited due to the targeted nature of treatment and lack of substitutes.
Key Takeaways
The drug's niche positioning in personalized oncology maintains its premium pricing.
Market growth depends on expanded testing and indication approvals.
Price stability is projected through 2030, with minimal inflation adjustments.
Reimbursement policies favor continued access but may influence pricing strategies.
Competition from other targeted therapies remains a significant market factor.
FAQs
What is the main clinical use of NDC 49884-0768?
It treats ROS1-positive NSCLC and NTRK fusion-positive tumors.
How does the pricing compare to similar therapies?
Rozlytrek’s annual cost (~$395,000) aligns with other targeted cancer therapies like Larotrectinib (~$330,000) and Entrectinib (~$180,000), reflecting its targeted, precision medicine status.
What factors could influence future price changes?
Regulatory approval of additional indications, market competition, and inflation.
Is reimbursement widely available?
Yes, coverage is generally broad but requires prior authorization due to high costs.
When could biosimilars or generics enter the market?
Likely after patent expiry, projected post-2030, considering orphan drug protections and manufacturing complexity.
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