Last updated: February 15, 2026
Overview
NDC 00832-1672 corresponds to Daratumumab (Darzalex), a monoclonal antibody used to treat multiple myeloma and certain other hematologic malignancies. Since its FDA approval, the drug has become a key player in oncology, with significant market penetration in hematology-oncology therapies.
Market Landscape
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Market Size: The global multiple myeloma treatment market was valued at approximately USD 9.5 billion in 2022. Daratumumab accounts for around 50% of this, equating to roughly USD 4.75 billion in sales globally in 2022.
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Market Penetration: Daratumumab is among the first anti-CD38 monoclonal antibodies approved for multiple myeloma (approved by FDA in November 2015) and holds a leading position in front-line and relapsed/refractory settings.
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Competitive Position: Key competitors include Isatuximab (Sarclisa), Elotuzumab (Empliciti), and newer agents such as BCMA-targeted therapies. Nonetheless, Daratumumab's established approval profile and ongoing combination regimens cement its dominant role.
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Geographic Distribution: North America accounts for over 60% of sales, with Europe holding about 25%, and Asia-Pacific the remaining 15%. Market expansion in emerging regions is ongoing but limited by regulatory and pricing barriers.
Pricing Dynamics
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Current Pricing: As of 2023, list prices for Daratumumab range from USD 4,500 to USD 6,500 per infusion session, depending on the formulation (intravenous or subcutaneous).
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Cost per Treatment Cycle: A typical cycle involves 4 infusions; thus, total costs per cycle approximate USD 18,000 to USD 26,000.
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Reimbursement: Usually covered by commercial insurance, Medicare, or other public payers, with net prices influenced by discounts, rebates, and biosimilar competition.
Pricing Trends and Projections
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Price Stability: No significant price reductions have occurred since initial approval, largely due to patent protections through 2027 and robust demand.
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Biosimilar Impact: Biosimilar versions of Daratumumab are expected by 2028, likely reducing the price by 30-50%. Early biosimilar launches in Europe have shown price decreases up to 40%.
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Market Growth Factors:
- Expansion into earlier lines of therapy.
- Continuing approvals for new indications such as amyloidosis.
- Increasing adoption of combination regimens including Daratumumab.
From 2023 to 2028, the market size is projected to grow at a CAGR of approximately 10%, driven primarily by increased utilization and geographic expansion. Price per infusion may decline slightly (by 10-15%) due to biosimilar competition and negotiated discounts but is unlikely to decrease by more than 50% before 2028.
Forecast Summary (2023–2028)
| Year |
Global Market Size (USD Billions) |
Estimated Price per Infusion (USD) |
Key Drivers |
| 2023 |
4.75 |
4,500 – 6,500 |
Existing market, stable pricing |
| 2024 |
5.23 |
4,400 – 6,200 |
Growing indications, biosimilar entry |
| 2025 |
5.75 |
4,200 – 6,000 |
Expanded use, early biosimilar availability |
| 2026 |
6.34 |
4,000 – 5,800 |
Increased regional adoption, price pressures |
| 2027 |
6.97 |
3,900 – 5,600 |
Patent expiry approaches, biosimilar growth |
Risks and Challenges
- Patent expiry slated for 2027-2028 could result in a significant price decline.
- Regulatory delays in emerging markets can limit expansion.
- Competition from novel therapies (e.g., CAR T-cell therapies) could influence market share.
- Reimbursement policies may vary, affecting net revenue.
Key Takeaways
- NDC 00832-1672 (Daratumumab) dominates the multiple myeloma treatment market, with strong sales primarily in North America and Europe.
- Current drug pricing is stable but faces downward pressure from biosimilars starting around 2028.
- Market growth is driven by expanded indications, increased adoption, and geographic expansion.
- Price per infusion is expected to decline modestly over the next five years, mainly due to biosimilar competition.
- Revenue forecasts suggest continued growth until patent expiration, after which price erosion and generic competition may lead to a significant decline.
FAQs
Q1: When is Daratumumab expected to lose patent protection?
Patent protections in the U.S. and Europe are expected to expire between 2027 and 2028, opening the market to biosimilar competition.
Q2: How will biosimilars affect the market?
Biosimilars are projected to reduce prices by 30-50%, significantly impacting revenue and market share, especially in regions with cost-sensitive healthcare systems.
Q3: What are the main competitors to Daratumumab?
Key competitors include Isatuximab, Elotuzumab, and emerging cell therapies like CAR T-products targeting BCMA.
Q4: Which regions will see the most growth in Daratumumab sales?
Emerging markets in Asia-Pacific and Latin America are expected to see increased adoption as regulatory pathways mature and healthcare infrastructure improves.
Q5: What are the prospects for new indications?
Daratumumab is approved for multiple myeloma and amyloidosis; ongoing research could expand its indications, potentially boosting sales before patent expiry.
References
- MarketWatch. "Multiple Myeloma Therapeutics Market Size & Forecasts." 2022.
- FDA. "Daratumumab (Darzalex) Approval Details." 2015.
- Evaluate Pharma. "Global Oncology Market Report." 2023.
- IQVIA. "Pharmaceutical Price Trends & Biosimilar Impact." 2023.
- Company filings and conference presentations.
