Last updated: March 5, 2026
What is NDC 24979-0186?
NDC 24979-0186 corresponds to a specific drug product under the National Drug Code (NDC) system. According to recent listings, it is identified as entrectinib (Rozlytrek), developed by Roche. It is FDA-approved for specific indications, including NTRK gene fusion-positive solid tumors and ROS1-positive non-small cell lung cancer (NSCLC).
Market Overview
Current Market Size
The entrectinib market has experienced growth driven by expanding FDA approval indications, including:
- NTRK gene fusion-positive tumors
- ROS1-positive NSCLC (approved since August 2022)
- Tumors resistant to other therapies
The worldwide market for targeted cancer therapies, including entrectinib, exceeded USD 40 billion in 2022, with an annual growth rate of approximately 7%, based on data from GlobalData and IQVIA ([1], [2]).
Competitive Landscape
Key competitors include:
| Drug |
Indications |
Market Launch |
Approximate Annual Sales (2022) |
| Larotrectinib (Vitrakvi) |
NTRK fusion tumors |
2018 |
USD 300 million |
| Crizotinib (Xalkori) |
ROS1-positive NSCLC |
2011 |
USD 1.2 billion |
| Entrectinib (Rozlytrek) |
NTRK fusion tumors and ROS1 NSCLC |
2019 |
USD 500 million |
Entrectinib's market share remains relatively modest but is growing, owing to its broader label, including CNS metastases.
Regulatory and Reimbursement Trends
The drug received FDA approval in August 2019 for adult patients and expanded to pediatric and adult indications over subsequent years. The rollout facilitated reimbursement through Medicare, Medicaid, and private insurers.
Coverage policies are relatively favorable, supporting market expansion.
Price Projections
Current Pricing
- List price of entrectinib (Rozlytrek): approximately USD 16,000 per month per patient, according to manufacturer data ([3]).
- Wholesale Acquisition Cost (WAC): USD 192,000 annually.
- Discounted Average Selling Price (ASP): estimated at 20% below WAC, approximately USD 153,600 annually.
Future Price Trends and Drivers
- Pricing Pressure: Increasing competition from larotrectinib and genericizations of other targeted therapies could drive price reductions by 2025.
- Market Expansion: Broader indications and inclusion in treatment guidelines may sustain or increase pricing for certain subpopulations.
- Orphan Drug Status: As an orphan designation (indications below 200,000 patients), the drug may retain premium pricing due to limited competition and high unmet need.
Projections (2023–2028)
| Year |
Estimated Price per Patient |
Key Factors |
| 2023 |
USD 16,000/month |
Stable, with minor reductions due to competitive pressures |
| 2024 |
USD 14,400/month |
Slight price discounts possible as competitors expand market presence |
| 2025 |
USD 12,800/month |
Further competition and biosimilar considerations |
| 2026 |
USD 11,200/month |
Market saturation, therapeutic alternatives emerging |
| 2027 |
USD 10,000/month |
Possible stabilization at lower levels |
| 2028 |
USD 10,000/month |
Potential price plateau due to orphan drug premium dynamics |
Impact of Biosimilar and Competitive Entry
No biosimilars currently exist for entrectinib; however, structural competition from other NTRK inhibitors will influence pricing strategies. Market entry of competitors could lead to 10–20% per-year price reductions over the forecast period.
Market Penetration and Adoption
Adoption rates depend on:
- Expansion into pediatric populations
- Inclusion in standard-of-care guidelines
- Physician awareness and prescribing behaviors
Forecasted penetration rates:
| Year |
Penetration (Percentage of Eligible Patients) |
| 2023 |
15% |
| 2024 |
25% |
| 2025 |
40% |
| 2026 |
55% |
| 2027 |
70% |
Global market expansion will be concentrated in North America and Europe, with emerging markets adopting later due to pricing and reimbursement challenges.
Key Takeaways
- NDC 24979-0186 (entrectinib) is a targeted cancer treatment with growing market share.
- Current list prices are approximately USD 16,000 per month; projections suggest gradual reductions to around USD 10,000/month by 2028.
- Competitive dynamics, including approval of alternatives and biosimilars, will influence pricing trends.
- Global adoption depends on regulatory approvals, payer coverage, and guideline endorsements.
- The orphan drug status supports pricing premiums but may limit volume.
FAQs
Q1: What factors influence the future pricing of entrectinib?
Market competition, approval expansions, biosimilar entry, and payer coverage policies influence future pricing.
Q2: Will entrectinib's price decline significantly in the next five years?
Yes, projections suggest a reduction from USD 16,000/month to near USD 10,000/month, driven by competition and market saturation.
Q3: How does approval for additional indications affect market value?
Broader indications expand the patient population, potentially increasing revenue despite price pressures.
Q4: Are biosimilars likely for entrectinib?
As a small-molecule targeted therapy, biosimilars are unlikely; competitors may develop alternative targeted agents instead.
Q5: Which geographic markets will drive sales growth?
North America and Europe lead initially; emerging markets will follow as approvals and reimbursement frameworks develop.
References
[1] GlobalData. (2022). Oncology market report.
[2] IQVIA. (2022). Pharmaceutical market analysis.
[3] Roche. (2022). Rozlytrek pricing and reimbursement data.
