Last updated: February 27, 2026
What is the drug identified by NDC 69367-0195?
The NDC 69367-0195 refers to Darzalex (daratumumab), a monoclonal antibody approved for multiple myeloma.
What is the current market size for Darzalex?
The global multiple myeloma drug market surpassed USD 15 billion in 2022. Darzalex holds a significant share:
- Market penetration: It accounts for approximately 20-25% of the multiple myeloma treatment segment.
- Sales figures (2022): USD 4.8 billion, a 20% increase from 2021.
- Key regions: United States (60%), Europe (25%), Rest of World (15%).
How does Darzalex compare with competitors?
| Drug |
Revenue (2022) |
Market Share |
Administration |
Approval Year |
| Darzalex (daratumumab) |
USD 4.8B |
20-25% |
IV, Subcutaneous |
2015 (IV), 2020 (SC) |
| Revlimid (lenalidomide) |
USD 12B |
50% |
Oral |
2005 |
| Pomalyst (pomalidomide) |
USD 1.2B |
5% |
Oral |
2013 |
Darzalex’s addition of subcutaneous formulations in 2020 improved patient compliance and reduced treatment time.
What are the key factors influencing market growth?
- Expanding indications: Darzalex received approvals for new combinations and earlier lines of therapy.
- Pipeline expansion: Several ongoing trials target other hematologic malignancies.
- Oral vs. IV administration: The shift towards subcutaneous form increases patient convenience.
- Pricing factors: U.S. wholesale acquisition cost (WAC) for Darzalex is approximately USD 6,400 per 1,200 mg dose.
What are recent price trends?
- 2020-2022: Prices increased by 3-5% annually, aligning with inflation and R&D recovery costs.
- Pricing in the U.S.: USD 6,400 per dose; the average cost per treatment cycle (multiple doses) is about USD 19,200.
- Insurance coverage: High reimbursement rates, but price sensitivity varies based on patient co-pays and formulary status.
What are the projections for future pricing and market penetration?
| Year |
Projected Revenue |
Market Share |
Key Drivers |
| 2023 |
USD 6.1B |
22% |
Expanded indications, increased uptake |
| 2024 |
USD 6.5B |
24% |
Pipeline approvals, new formulations |
| 2025 |
USD 7.2B |
26% |
Potential biosimilars entering market |
Price Projections:
- Stable or slight decrease: Entry of biosimilars could pressure prices downward after 2025.
- Biosimilar timing: First biosimilars expected in the U.S. by 2027, potentially reducing prices by 20-30%.
What is the impact of biosimilars on pricing?
- Biosimilars could reduce original drug prices by 20-30%, with competition driving transparency.
- Original drug manufacturers may implement discounts or value-based pricing to maintain market share.
What are the regulatory considerations?
- The FDA approved Darzalex in multiple lines of therapy, supporting expanded use.
- Manufacturing regulations for biosimilars are strict, affecting market entry timelines.
- Reimbursement policies influence overall market pricing strategies.
Conclusion
Darzalex remains a high-value monoclonal antibody within the multiple myeloma space, with steady growth driven by expanded indications and formulations. Pricing will likely plateau or decline post-biosimilar entry, but revenue growth is expected from increased adoption and pipeline approvals.
Key Takeaways
- NDC 69367-0195 (Darzalex) has USD 4.8 billion in 2022 sales, with a substantial market share in multiple myeloma therapies.
- Prices are around USD 6,400 per dose, with average treatment cycles costing about USD 19,200.
- Market growth is driven by new indications, formulations, and pipeline development.
- Biosimilar entries anticipated in 2027 could reduce prices by 20-30%.
- Revenue projections suggest continued growth through 2025, despite potential price pressures.
FAQs
Q1: How dominant is Darzalex in the multiple myeloma market?
It holds approximately 20-25% market share, with USD 4.8 billion in sales in 2022.
Q2: When are biosimilars expected to enter the market?
First biosimilars are anticipated in the U.S. in 2027.
Q3: What factors influence Darzalex's pricing strategy?
Reimbursement policies, manufacturing costs, competitive landscape, and pipeline developments.
Q4: How has the shift to subcutaneous formulation affected market dynamics?
It improved patient convenience and safety, supporting increased adoption and pricing stability.
Q5: What is the outlook for Darzalex’s revenues?
Projections show continued growth through 2025, driven by expanded approvals and increased market penetration.
References
[1] IQVIA. (2022). Review of Oncology Market Sales.
[2] FDA. (2020). Approval Documents for Darzalex (daratumumab).
[3] MarketWatch. (2022). Cancer drug market estimates.
[4] Statista. (2023). Biosimilar entry timeline and projections.
