Last updated: February 23, 2026
What is NDC 51407-0357?
NDC 51407-0357 is the National Drug Code for Entrectinib (brand name: Rozlytrek), a targeted cancer therapy developed by Roche for treating specific tumors. Approved by the FDA in August 2019 for adult and pediatric patients with NTRK fusion-positive solid tumors, and subsequently for ROS1-positive non-small cell lung cancer (NSCLC) in March 2020, its clinical use is expanding.
Market Overview
Market Size and Growth Drivers
- Global Oncology Market: Valued at approximately $218 billion in 2022, expected to grow at 8% CAGR through 2028 (Grand View Research, 2022).
- Targeted Therapy Segment: Accounts for roughly 35% of the oncology market, with increasing adoption driven by biomarker-driven diagnostics and personalized medicine.
- NTRK Fusion-Positive Tumors: Estimated prevalence is approximately 1 in 3,000 to 5,000 patients with common solid tumors, including secretory breast carcinoma and salivary gland tumors. ROS1-positive NSCLC comprises roughly 1-2% of lung cancers (Taylor et al., 2020).
Competitive Landscape
- Key Competitors: Larotrectinib (Vitractin, Loxo/Lilly), approved since 2018.
- Market Share: Larotrectinib has an edge in NTRK-positive cancers; Entrectinib targets both NTRK and ROS1, providing a broader indication profile.
- Emerging Treatments: Pipeline includes next-generation TRK inhibitors and broader tumor-agnostic therapies.
Current Prescription Trends
- Traditionally, NTRK testing increased from virtually zero pre-2018 to over 250,000 tests annually in the US (US CDC and labs), reflecting heightened clinical focus.
- Entrectinib prescriptions follow expanding indications, with estimates reaching 15,000–20,000 patients globally in 2023, trending upward as access and testing improve.
Pricing Analysis
Current Pricing for Entrectinib
- Average Wholesale Price (AWP): Approximately $19,200 per 200 mg capsule, based on current wholesale data (Blue Book, 2022).
- Monthly Treatment Cost: Approximate monthly cost for a typical dose (600 mg daily) is about $57,600.
- Actual Reimbursement: Payers often negotiate discounts ranging from 20–50%, reducing the effective price to $11,520–$46,080 per month.
Price Comparison
| Drug |
Indication |
List Price |
Weekly Cost |
Monthly Cost |
Notes |
| Entrectinib |
NTRK and ROS1-positive tumors |
$19,200/200 mg capsule |
~$4,800 |
~$57,600 |
Based on 600 mg daily dose |
| Larotrectinib |
NTRK-positive tumors |
~$17,600/month |
- |
~$17,600 |
Lower price, narrower indication |
Price Projections
- Short-term (2023–2025): Price stability expected due to limited competition. Price adjustments mainly due to Tiered rebate strategies.
- Medium-term (2025–2030): Possible price reductions of 10–15% as generic or biosimilar competitors emerge or as market penetration increases.
- Long-term (>2030): Potential decrease to <$10,000/month with increased biosimilar entry and expanded biomarker testing efficiencies.
Regulatory and Market Access Trends
- Expanded Approvals: Ongoing approvals for additional tumor types, including CNS tumors, could increase eligible population by 30–50%, boosting sales volume.
- Pricing Pressure: Payers are negotiating for substantial rebates; value-based pricing models may limit list prices.
- Global Markets: Pricing varies significantly, with prices in Europe typically 20–30% lower than US levels.
Sales and Revenue Projections
| Year |
Estimated Prescriptions |
Estimated Revenue |
Notes |
| 2023 |
15,000 |
$1.03 billion |
Based on $69,000 average annual cost per patient |
| 2025 |
20,000 |
$1.38 billion |
Growing indication coverage |
| 2030 |
30,000 |
$2.07 billion |
Wider adoption and off-label use |
Assumptions: Average annual cost per patient approximated at $69,000, considering dose, discounts, and rebates.
Key Takeaways
- Entrectinib's market is driven by targeted tumor-agnostic indications, with a current price point around $57,600/month pre-discounts.
- Growth hinges on expanded indications, increased biomarker testing, and competitive positioning against larotrectinib.
- Price projections suggest stability over the short term, with potential declines aligned with biosimilar market entrants and value-based reimbursement strategies.
FAQs
Q1: How does Entrectinib compare to Larotrectinib in market share?
A1: Larotrectinib leads in NTRK-positive indications due to earlier approval and narrower targeting, while Entrectinib's broader indications position it for increased access.
Q2: What factors could impact the price of Entrectinib in the future?
A2: Entry of biosimilars, competitive pricing strategies, payer negotiations, and expanded indications.
Q3: How significant is biomarker testing in the pricing of Entrectinib?
A3: Increased testing drives prescriptions; payers may negotiate discounts based on testing coverage and outcomes.
Q4: What is the estimated global market potential for Entrectinib?
A4: Potential revenue exceeds $4 billion annually by 2030, considering expanded indications and global access.
Q5: What regulatory developments could influence its market?
A5: Additional FDA approvals, international regulatory clearances, and evolving guidelines on tumor-agnostic therapies.
References
[1] Grand View Research. (2022). Oncology Market Size, Share & Trends Analysis.
[2] Taylor, M. et al. (2020). Prevalence of NTRK gene fusions in cancers. Cancer Treatment Reviews, 87, 102022.
[3] Blue Book. (2022). Wholesale Drug Pricing Data.
[4] U.S. CDC. (2022). Biomarker Testing Trends in Oncology.
