Last updated: February 25, 2026
What is NDC 16714-0825?
NDC 16714-0825 corresponds to Entrectinib (Rozlytrek), approved by the FDA for certain cancer treatments, including neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive solid tumors and ROS1-positive non-small cell lung cancer. The drug targets specific genetic mutations, making it suitable for personalized oncology therapies.
Market Size and Adoption
Current Market Overview
- Prevalence of Indications: NTRK fusion-positive solid tumors are rare, estimated at fewer than 1 in 3,000 cancer cases globally.
- Incidence Rates:
- NTRK gene fusions occur in approximately 0.3% of all solid tumors.
- ROS1-positive NSCLC accounts for around 1-2% of lung cancers.
Commercial Adoption
-
Market Penetration:
- Initial uptake since FDA approval in August 2019 remains limited, driven by diagnostics adoption and approval of companion tests.
- As of 2022, few large-scale clinical deployment, mainly in specialized oncology centers.
-
Competitive Landscape:
- Larotrectinib (Vitrakvi): Competes directly for NTRK fusion-positive tumors.
- Other TKIs: Crizotinib and entrectinib compete in ROS1-positive NSCLC.
- No broad-based therapies for the rare indications yet.
Market Drivers
- Growing availability and approval of companion diagnostic tests (e.g., FoundationOne CDx).
- Increased awareness among oncologists for genetic profiling.
- Broader indications as more tumor types are characterized for NTRK fusions.
Revenue Projections
| Year |
Estimated Global Sales (USD millions) |
Assumptions |
| 2023 |
150 |
Launch phase, initial access in major markets, conservative uptake |
| 2024 |
250 |
Increased diagnostics adoption, expansion into additional tumor types |
| 2025 |
400 |
Broader clinical use, added indication approvals |
| 2026 |
600 |
Steady growth, hospital and oncology center integration |
| 2027 |
850 |
Increased diagnosis rates, insurance coverage improves |
Key Factors Affecting Revenue
- Rate of diagnostic adoption.
- Expansion of approved indications.
- Competitive entries and pipeline drugs.
- Reimbursement policies.
Price Projections
Current Pricing (as of 2023)
- Average Wholesale Price (AWP): Approximately $14,000 per month, per patient.
- Annual Cost: ~$168,000.
- Wholesale Acquisition Cost (WAC): Slightly lower than AWP, around $12,500/month.
Future Price Trends
| Year |
Estimated WAC Price per Month (USD) |
Explanation |
| 2023 |
12,500 |
Current market price, no significant discounts yet |
| 2024 |
12,000 |
Competitive pressure and value-based pricing initiatives |
| 2025 |
11,500 |
QALY-based negotiations, price adjustments for expanded indications |
| 2026 |
11,000 |
Increased volume, further discounts in negotiations |
Price Factors
- Diagnostic testing costs may influence net patient expenses.
- Reimbursement policy changes can alter effective patient prices.
- Competitive drugs may drive price erosion over time.
Regulatory and Policy Impact
- Expanding approvals in additional tumor types could increase prescriber confidence.
- Adoption of value-based pricing models could reduce costs.
- Upcoming biosimilar or generics are not applicable yet as entrectinib is a small molecule.
Market Constraints
- Limited patient population due to rarity.
- High diagnostic costs may limit access.
- Long approval and reimbursement processes in certain regions.
Summary
| Aspect |
Projection & Comments |
| Global Market Value (2023) |
~$150 million, with growth expected as indications expand |
| Price Range (2023) |
$12,500-$14,000 per month (WAC/AWP) |
| Key Growth Drivers |
Diagnostic adoption, indication expansion, increased tumor profiling |
| Limitations |
Small patient population, diagnostic costs, competition |
Key Takeaways
- NDC 16714-0825 (Entrectinib) has a niche market primarily in rare tumor genetic profiles.
- The global sales forecast reaches approximately $600 million by 2026.
- Price trends suggest gradual decline, influenced by competition and value-based pricing.
- Adoption depends heavily on diagnostics, physician awareness, and reimbursement policies.
- Market growth is constrained by the rarity of target mutations but supported by expanding therapeutic applications.
FAQs
What is the primary indication for entrectinib?
Entrectinib is primarily indicated for NTRK fusion-positive solid tumors and ROS1-positive NSCLC.
How does entrectinib compare price-wise to similar drugs?
Its current monthly WAC is approximately $12,500–$14,000, comparable to other targeted oncology therapies with similar rare tumor indications.
What is the main driver of sales growth?
Expansion of indications and increased diagnostic testing adoption will be key drivers.
Are biosimilars or generics expected for entrectinib?
Not likely in the near term; as a small molecule, it may face generic competition in the future, but patents currently protect it.
What factors could slow market growth?
Limited patient population, diagnostic and treatment access barriers, and competition from other TKIs.
References
- Food and Drug Administration. (2019). Rozlytrek (entrectinib) approval announcement. https://www.fda.gov
- IQVIA. (2022). Oncology Market Overview. https://www.iqvia.com
- National Cancer Institute. (2022). NTRK and ROS1 gene fusions. https://www.cancer.gov
- EvaluatePharma. (2023). Oncology drug sales forecasts. https://www.evaluate.com
