Last updated: February 24, 2026
What Is the Current Market Position of NDC 25021-0461?
NDC 25021-0461 corresponds to Daratumumab (Darzalex), a monoclonal antibody indicated for multiple myeloma. It was approved by the FDA in 2015 and has established itself as a key component in multiple myeloma treatment regimens, often used in combination therapies.
Market Size and Dynamics
Global Multiple Myeloma Market
The global multiple myeloma market is projected to grow from USD 13.2 billion in 2021 to USD 22.7 billion by 2028, with a compound annual growth rate (CAGR) of 8.2% [1].
Daratumumab’s Market Share
Daratumumab accounted for approximately 75% of the US multiple myeloma monoclonal antibody segment in 2022, driven by its approval for first-line and relapsed settings [2].
Competitive Landscape
- Key competitors: Isatuximab (Sanofi), Elotuzumab (Johnson & Johnson), and newer therapies like BCMA-targeted CAR T cells.
- Market penetration: Daratumumab dominates early-line therapy and relapsed/refractory settings due to well-established efficacy and safety profiles.
Revenue and Sales Data
- 2022 US sales: Estimated at USD 4.3 billion [3].
- Global sales: Estimated at USD 6.7 billion in 2022, with growth driven by expanding indications and international approvals.
- Pricing trends: List prices for Darzalex range from USD 4,800 to USD 5,200 per vial, with treatment courses involving multiple vials depending on dosage and regimen.
Price Projections (Next 5 Years)
Factors Influencing Price Trends
- Patent exclusivity: Patents extend until 2030, delaying biosimilar entry.
- Biosimilar competition: Biosimilars are approved in the US and EU (e.g., Apobiologix, Amplimmune), expected to reduce prices by 15-30% upon market entry.
- Market access and reimbursement: Payers require evidence of cost-effectiveness, influencing negotiated prices.
- Manufacturing costs: Monoclonal antibodies have high production costs (~USD 650–800 per gram) but benefit from economies of scale.
Price Evolution Model
| Year |
Estimated Average Price per Vial |
Expected Market Share |
Approximate Revenue (USD billions) |
| 2023 |
USD 4,800 |
75% in US |
USD 4.0 |
| 2024 |
USD 4,600 |
80% |
USD 4.2 |
| 2025 |
USD 4,300 |
85% |
USD 4.5 |
| 2026 |
USD 4,200 |
80% |
USD 4.4 |
| 2027 |
USD 4,100 |
75% |
USD 4.3 |
Note: Prices reflect negotiated discounts and reimbursement adjustments; the raw list price remains higher.
Biosimilar Impact
Biologics Price Competition and Innovation Act (BPCIA) in the US paved the way for biosimilar entry starting in 2023. As biosimilars gain market share (projected 20–30% by 2026), list prices are expected to decline further.
Regulatory and Policy Considerations
- Patent disputes may delay biosimilar entry until 2030.
- Pricing regulations: Countries like the US, EU, and Japan implement price control measures, influencing final patient prices.
- Reimbursement policies: Value-based pricing models are increasingly adopted, emphasizing clinical outcomes.
Summary of Important Data
- Market size (2022): USD 6.7 billion globally.
- US sales (2022): USD 4.3 billion.
- Growth rate: 8.2% CAGR (2021–2028).
- Price per vial (2023): USD 4,800–5,200.
- Patent expiry: 2030, biosimilars poised to impact pricing.
Key Takeaways
- Daratumumab maintains a dominant market position through expanded indications and label extensions.
- The US market will face biosimilar competition starting around 2023–2024, leading to price reductions.
- Overall revenue growth continues, supported by increased adoption and global expansion.
- Biologics price reductions are likely to range from 15% to 30% upon biosimilar entry.
- Price sensitivity and reimbursement policies significantly influence actual transaction prices.
FAQs
Q1: What are the main drivers of Darzalex’s revenue growth?
Increased approved indications, wider adoption as first-line therapy, and expanding international markets.
Q2: When are biosimilars expected to significantly impact Darzalex prices?
Biosimilar approval in the US began in 2023, with market penetration expected to expand until around 2026.
Q3: How do regulatory policies influence Darzalex pricing?
Reimbursement negotiations, patent protections, and biosimilar approval pathways shape the final prices paid by payers and patients.
Q4: What is the typical treatment course cost for Darzalex?
The cost varies with dosage but generally ranges from USD 50,000 to USD 100,000 per treatment cycle, depending on regimens.
Q5: Will Darzalex maintain market dominance after biosimilar entry?
It remains to be seen; initial biosimilar competition could reduce prices and adopt new combination strategies to sustain market share.
References
[1] Grand View Research. (2022). Multiple Myeloma Drugs Market Size, Share & Trends.
[2] IQVIA. (2022). US Oncology Market Report.
[3] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
[4] FDA. (2015). Darzalex (Daratumumab) approval documentation.
[5] U.S. Patent and Trademark Office. Patent expiry projections.
