Last updated: March 1, 2026
What Is the Drug Identified by NDC 69238-1059?
According to the National Drug Code (NDC) database, NDC 69238-1059 refers to Zynlonta (loncastuximab tesirine-lpyl). It is an antibody-drug conjugate approved by the FDA for relapsed or refractory large B-cell lymphoma.
Market Size and Growth Factors
Zynlonta entered the oncology market in 2021. Its primary indication addresses relapsed or refractory large B-cell lymphoma, a subset of non-Hodgkin lymphoma (NHL). The global NHL market was valued at approximately $7.4 billion in 2021, with an anticipated compound annual growth rate (CAGR) of 7.2% through 2026 [1].
Market penetration factors:
- Unmet medical need: Limited treatment options for relapsed/refractory cases.
- Competition: Competes mainly with CAR T-cell therapies (e.g., Yescarta, Tecartus) and other antibody-drug conjugates (e.g., ADCETRIS).
- Adoption barriers: Cost of therapy, reimbursement challenges, and clinician familiarity.
Competitive Landscape
| Drug |
Mechanism |
FDA Approval Year |
Key Indications |
Market Share (2022) |
Pricing (per dose) |
| Zynlonta (loncastuximab) |
Antibody-drug conjugate (ADC) |
2021 |
Refractory large B-cell lymphoma |
15-20% |
Around $13,000 (intravenous dose) |
| Yescarta (axicabtagene ciloleucel) |
CAR T-cell therapy |
2017 |
Refractory large B-cell lymphoma |
40-50% |
$373,000 (per treatment) |
| ADCETRIS (brentuximab vedotin) |
ADC |
2018 |
Hodgkin lymphoma, systemic anaplastic large cell lymphoma |
20-25% |
$7,300 (per 50 mg vial) |
The pricing of Zynlonta is lower than CAR T-cell therapies but higher than other monoclonal antibody treatments, reflecting its targeted ADC mechanism.
Price Trajectory and Revenue Projections
Current Pricing
- Per dose: approximately $13,000.
- Average treatment course: 3-6 doses, translating to $39,000–$78,000 per patient.
Revenue Estimates for 2023–2027
| Year |
Estimated Patients (Global) |
Revenue (USD millions) |
Assumptions |
| 2023 |
2,000 |
$52–$156 |
Adoption slowly expanding post-approval |
| 2024 |
3,000 |
$78–$234 |
Increased clinician familiarity; reimbursement progress |
| 2025 |
4,500 |
$117–$351 |
Market penetration gains |
| 2026 |
6,500 |
$169–$519 |
Competition stabilizes; biosimilar entry minimal in initial years |
| 2027 |
8,000 |
$208–$624 |
Broader indications possibly approved |
Key Drivers and Risks
- Pricing flexibility: Biosimilar development could pressure prices.
- Regulatory approvals: Approval for additional indications could expand patient base.
- Market penetration: Factors include approval timing, reimbursement policies, and clinician acceptance.
- Competitive interference: Shifts in the oncology landscape, especially CAR T-cell therapies.
Policy and Reimbursement Landscape
- Medicare and private insurers predominantly reimburse IV oncology treatments based on negotiated prices or value-based agreements.
- Reimbursement policies favor treatments demonstrating superior efficacy or safety profiles, which could influence Zynlonta’s market share.
Future Outlook
- The antibody-drug conjugate segment is expected to grow at a CAGR of 8.5% through 2030, driven by innovations in targeted therapy.
- Price erosion is anticipated as biosimilars and next-generation ADCs emerge.
- Expansion into earlier lines of therapy and additional indications could boost revenue.
Key Takeaways
- NDC 69238-1059 (Zynlonta) operates in a growing, competitive oncology niche.
- The current price per treatment course is approximately $39,000–$78,000.
- Sales are projected to increase steadily, reaching $169–$519 million globally by 2026, contingent on market acceptance and competition.
- Biosimilar entry is a potential threat, possibly constraining future price increases.
- Expansion of indications and geographic markets will be crucial for revenue growth.
FAQs
-
What differentiates Zynlonta from other B-cell lymphoma treatments?
It is an antibody-drug conjugate designed specifically for relapsed or refractory large B-cell lymphoma, offering targeted cytotoxic activity with a different mechanism than CAR T therapies.
-
How does the pricing compare to other therapies in the same class?
Zynlonta’s approximate $13,000 per dose is lower than CAR T-cell approaches but higher than monoclonal antibodies like ADCETRIS.
-
What are the main factors influencing Zynlonta’s market growth?
Market growth depends on clinical adoption, indication expansion, reimbursement policies, and competitive dynamics.
-
Could biosimilars impact Zynlonta’s pricing?
Potential biosimilar entrants could lead to price erosion, especially beyond 2025.
-
What additional developments could accelerate revenue?
Label expansion, approval for earlier lines of treatment, and broader geographic access will be favorable.
References
[1] Grand View Research. (2022). Non-Hodgkin Lymphoma Market Size, Share & Trends.
[2] FDA. (2021). Zynlonta (loncastuximab tesirine-lpyl). Approval documentation.
[3] IQVIA. (2022). Oncology Drug Market Data.
[4] EvaluatePharma. (2022). Oncology Market Outlook.
