Last updated: March 9, 2026
What is NDC 58657-0120?
NDC 58657-0120 corresponds to Daratumumab (Darzalex), a monoclonal antibody developed by Janssen Pharmaceuticals. It is approved for multiple myeloma treatment in relapsed or refractory cases.
Market Overview
Current Market Size
The global multiple myeloma treatment market totaled approximately $20 billion in 2022, with monoclonal antibody therapies constituting roughly 40% of sales. Daratumumab holds a significant share within this segment, estimated at 50% of monoclonal antibody sales for multiple myeloma globally.
Key Competitors
Major competitors include:
- Elotuzumab (Empliciti): Another monoclonal antibody approved for multiple myeloma.
- Venetoclax (Venclexta): A BCL-2 inhibitor used in combination therapies.
- Carfilzomib (Kyprolis): Proteasome inhibitor.
Regulatory Status
Daratumumab received FDA approval in 2015 for multiple myeloma. Its approval expanded to include both monotherapy and combination therapy settings.
Sales Trends
- 2022 global sales approximate $4.5 billion.
- Janssen projects compound annual growth rate (CAGR) of roughly 8-10% through 2027**, driven by expanding indications and combination regimens.
Patent and Patent Expiry
The primary patent protections are expected to extend until 2030, with biosimilar competition anticipated post-expiry, impacting pricing and market share.
Price Analysis
Current Pricing
The wholesale acquisition cost (WAC) for Daratumumab varies by formulation:
| Formulation |
Price per vial |
Dosage |
Estimated per-treatment cost |
| 20 mg/mL solution, IV |
~$2,000 |
16 mg/kg (average 1,200 mg) |
~$40,000 |
| Subcutaneous formulation |
~$2,750 per dose |
1800 mg per dose |
~$37,000 per treatment cycle |
Pricing varies by country, with US list prices being the highest.
Price Trends and Projections
- 2023–2027 growth rate: 4-6%, driven by increased adoption and expanded indications.
- Biosimilar entry anticipated from 2029, likely leading to 20-30% price reduction.
Biosimilar Impact
Post-2030, biosimilars could reduce Daratumumab’s price by 35-50%, similar to patterns seen with other monoclonal antibodies like trastuzumab and rituximab.
Market Drivers and Constraints
Drivers
- Growing prevalence of multiple myeloma.
- New combination regimens showing improved outcomes.
- Longer treatment durations.
Constraints
- High treatment costs.
- Competition from biosimilars.
- Reimbursement limitations in certain markets.
Price Forecast Summary (2023–2030)
| Year |
Estimated Price Range (per treatment) |
Market Share |
Comments |
| 2023 |
$37,000–$40,000 |
70% growth |
Slight increases expected annually |
| 2025 |
$39,000–$42,000 |
75% |
Continued expansion, no biosas full entry yet |
| 2027 |
$40,000–$44,000 |
80% |
Biosimilar threat looming |
| 2029 |
$30,000–$35,000 |
60%–70% |
Biosimilar entries expected |
| 2030+ |
$20,000–$25,000 |
Market penetration |
Biosimilar market develops |
Key Takeaways
- NDC 58657-0120 (Daratumumab) remains a leading monoclonal antibody in multiple myeloma therapy.
- Market size continues to expand at a CAGR of 8-10% until 2027.
- Current US treatment costs are approximately $37,000 to $40,000 per treatment cycle.
- Biosimilar competition is projected to significantly lower prices after 2029, with discounts of up to 50% likely.
- Ongoing clinical trials and label expansions could sustain or boost Daratumumab’s market share.
FAQs
1. What factors influence Daratumumab pricing?
Market demand, treatment duration, competition from biosimilars, and reimbursement policies.
2. How does biosimilar entry affect pricing?
Biosimilars typically reduce prices by 35-50%, increasing market competition and affordability.
3. What is the expected market size by 2030?
Potentially exceeding $9 billion, assuming continued growth and expanded indications.
4. How do different formulations impact cost?
Subcutaneous formulations are priced slightly higher per dose but may reduce treatment administration costs.
5. Are there upcoming approvals that could impact market dynamics?
Yes, ongoing clinical trials for new combination therapies and expanded indications could further influence demand and pricing.
References
- American Cancer Society. (2022). Multiple Myeloma Statistics. https://cancerstatisticscenter.cancer.org
- IQVIA. (2022). Global Oncology Market Insights. IQVIA Institute.
- FDA. (2015). Daratumumab approval letter. U.S. Food and Drug Administration.
- Janssen Pharmaceuticals. (2022). Daratumumab product information and sales data. Janssen Reports.
