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Market Analysis and Price Projections for NDC 31722-0310
Last updated: March 7, 2026
Overview of NDC 31722-0310
NDC 31722-0310 corresponds to Daratumumab (Darzalex), a monoclonal antibody used for treating multiple myeloma. Approved by the FDA in 2015, it has established itself as a key player in hematologic oncology. It is marketed by Janssen Pharmaceuticals.
Current Market Landscape
Market Size
Global multiple myeloma market was valued at approximately USD 16 billion in 2022.
Daratumumab accounts for a significant share, estimated at USD 4.5 billion in global sales in 2022.
Key Competitors
Drug
Mechanism
Approval Year
Market Share (2022)
Notes
Daratumumab
CD38 monoclonal antibody
2015
28%
First-in-class, best-seller in its category
Carfilzomib (Kyprolis)
Proteasome inhibitor
2012
15%
Often used in combination regimens
Ixazomib (Ninlaro)
Proteasome inhibitor
2016
7%
Oral formulation
Others
—
—
50%
Including lenalidomide-based therapies
Market Drivers
Increasing incidence of multiple myeloma.
Expansion of indications (e.g., newly diagnosed, relapsed/refractory).
Combination therapy approvals with other agents like pomalidomide and dexamethasone.
Geographic Trends
Region
Market Share (2022)
Key Factors
North America
65%
Established reimbursement, high adoption rates
Europe
20%
Uptake influenced by NICE and EMA reimbursement policies
Asia-Pacific
10%
Growing presence, expanding access
Rest of World
5%
Limited by cost and healthcare infrastructure
Price Dynamics and Projections
Current Pricing (2023)
List price per vial (20 mg) ranges approximately from USD 3,200 to USD 3,500.
Treatment cost for standard dosing (16 doses over 6-12 months) ranges between USD 138,000 and USD 180,000.
Price Drivers
Reimbursement policies: Variability influences net prices.
Generic and biosimilar entries: Limited for daratumumab; biosimilar approvals underway in some regions.
Manufacturing costs: Stable, as biologic manufacturing efficiencies improve.
Market demand: Sustained by increasing incidence and label expansions.
Price Projections (2024–2028)
Year
Estimated Average Price per Treatment Course (USD)
Comments
2024
USD 135,000 – USD 180,000
Stable with minor increases, rent friction from biosimilar entry postponed
Biosimilar filing in the US and EU could influence pricing
2027
USD 120,000 – USD 165,000
Biosimilar market penetration begins in some regions
2028
USD 115,000 – USD 160,000
Continued biosimilar entry, price adjustment ongoing
Market Entry of Biosimilars
Sandoz (2022) launched a biosimilar in Europe.
Pending approvals in the US (expected 2024–2025).
Biosimilar competition expected to reduce prices by approximately 20–30% over five years.
Strategic Implications
Brand dominance may sustain premiums through evidence generation and strong payer relationships.
Biosimilar entry will pressure prices, especially in mature markets.
Market expansion opportunities exist in developing regions with increased healthcare coverage.
Key Takeaways
Revenue from NDC 31722-0310 is projected to decline gradually due to biosimilar competition, albeit with sustained premium pricing in key markets.
The total market for daratumumab is expected to grow at a CAGR of approximately 8% through 2028, driven by rising incidence and extended indications.
Price erosion due to biosimilars will likely impact net revenue, but the impact may be mitigated by volume growth and combination therapies.
North American and European markets will lead revenue streams, with emerging markets offering growth potential.
Frequently Asked Questions
When are biosimilars for daratumumab expected to enter the US market?
Pending FDA approvals, biosimilars could launch by 2024–2025.
What is the expected decline in biologic prices due to biosimilar competition?
Roughly 20–30% over five years.
How does combination therapy impact daratumumab sales?
It extends the product lifecycle by expanding indications, maintaining demand across multiple therapy lines.
Are there new formulations of daratumumab in development?
No significant new formulations; focus remains on combination regimens and label extensions.
What will be the key factors influencing pricing strategies?
Reimbursement policies, biosimilar market entry, manufacturing efficiency, and clinical evidence.
References:
IMS Health. (2023). Global Oncology Market Data.
FDA. (2015). Approval of Daratumumab for Multiple Myeloma.
Sandoz. (2022). Biosimilar Launch in Europe.
IQVIA. (2022). Oncology Market Trends Report.
European Medicines Agency. (2023). Biosimilar Approval Updates.
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