Last updated: August 2, 2025
Introduction
The drug identified by NDC 00113-0194 pertains to a specific pharmaceutical product, and comprehensively analyzing its market landscape and pricing trajectory requires understanding its therapeutic category, competitor landscape, regulatory environment, and market dynamics. This report synthesizes current data on therapeutic applications, market demand, competitive positioning, and pricing trends to inform strategic decisions for stakeholders.
Product Overview and Therapeutic Indications
NDC 00113-0194 corresponds to Daratumumab (Darzalex), a monoclonal antibody indicated primarily for multiple myeloma treatment. Approved by the FDA in 2015, Daratumumab has established itself as an essential agent within hematologic oncology, notably in multiple myeloma, either as a monotherapy or in combination regimens. The drug's mechanism involves targeting CD38-expressing myeloma cells, leading to immune-mediated destruction.
Market Landscape
Market Size and Growth Drivers
The global multiple myeloma market is projected to reach approximately $30 billion by 2027, growing at a CAGR of about 8-10% through 2027 (Source: Grand View Research). Advancements in targeted therapies, increased diagnosis rates, and longer patient survival contribute to this expansion.
Daratumumab forms a significant component of this market, with sales driven by:
- Increasing prevalence of multiple myeloma, especially among aging populations.
- Expanding line of therapeutic combinations, improving efficacy outcomes.
- Regulatory approvals for indications beyond initial approval, including newly approved combination regimens.
- Rising adoption in outpatient settings due to convenience and improved administration protocols.
Competitive Landscape
Daratumumab faces competition from several agents within the multiple myeloma space:
- Elotuzumab (Empliciti): Another anti-CD38 monoclonal antibody.
- Isatuximab (Sarclisa): Approved for relapsed/refractory multiple myeloma.
- Proteasome inhibitors (e.g., Bortezomib, Carfilzomib)
- Immunomodulatory drugs (e.g., Lenalidomide, Pomalidomide)
Despite competition, Daratumumab's pioneering position supports significant market share, with continued growth driven by expanding indications.
Regulatory and Reimbursement Factors
Multiple FDA approvals have solidified Daratumumab’s position. Reimbursement considerations are largely favorable, with payers recognizing its clinical benefits. However, high acquisition costs influence pricing policies, prompting payers to negotiate value-based pricing or rebates.
Pricing Trends and Projections
Current Pricing Landscape
As of 2023, the wholesale acquisition cost (WAC) for Daratumumab is approximately $6,300 to $7,200 per vial, with treatment courses often requiring multiple doses, leading to total treatment costs ranging from $100,000 to $150,000 per patient annually. These prices reflect the drug's monoclonal antibody manufacturing complexity and clinical value.
Historical Price Trends
Since FDA approval, Daratumumab’s list prices have remained relatively stable but have seen slight adjustments attributable to cost-of-living inflation, manufacturing efficiencies, and competitive pressures. Notably, biosimilar development in the space, although delayed for Daratumumab, could influence pricing in the mid or long term.
Future Price Projections (Next 5 Years)
- Stability in List Price: Given strong brand dominance, US list prices are anticipated to hover around current levels, with minor annual increases (~2-3%) aligned with inflation.
- Impact of Biosimilars: Entry of biosimilars, potentially by 2025-2026, could impose significant downward pressure, possibly reducing prices by 20-40% over the long term.
- Rebates and Negotiated Discounts: Payer negotiations and outcome-based agreements are expected to further reduce net prices by 10-25%, particularly within managed care and alternative payment models.
Market Dynamics Influencing Price
- Patent Exclusivity: The expiration of key patents could enable biosimilar entry, reducing prices.
- Manufacturing costs: High complexity sustains premium pricing, but advancements could lower costs over time.
- Regulatory developments: Orphan drug designation and additional indications may expand revenue; conversely, biosimilar approvals may prompt price discounts.
- Market penetration: Increased utilization, especially in early lines of therapy, could sustain higher overall revenues despite single-product pricing stability.
Strategic Considerations
Stakeholders must monitor biosimilar development pathways and patent landscapes. Payers and providers will focus on real-world evidence to justify reimbursement and negotiate discounts. Manufacturers might explore value-based pricing models to maintain profitability amid biosimilar competition.
Key Takeaways
- Market expansion for Daratumumab is driven by increasing multiple myeloma prevalence and expanding indications.
- Current pricing remains high, with annual treatment costs often exceeding $120,000.
- Potential biosimilar entry by 2025-2026 could reduce prices substantially, impacting future revenue streams.
- Reimbursement dynamics favor continued use given clinical benefits, but cost containment pressures necessitate adaptable pricing strategies.
- Innovation and clinical advances will influence future market share and pricing, emphasizing the need for ongoing competitive intelligence.
FAQs
1. When are biosimilars for Daratumumab expected to enter the market?
Regulatory approval timelines suggest biosimilars could enter the US market between 2025 and 2026, contingent on clinical trial outcomes and patent litigation.
2. How do current prices compare internationally?
European and other markets often see lower list prices due to different pricing and reimbursement policies, with prices typically 20-30% lower than US levels.
3. What impact will combination therapies have on Daratumumab pricing?
Combination regimens often increase total treatment costs but can improve efficacy, which may justify maintaining or slightly increasing the per-unit price for Daratumumab, especially if it remains a component of preferred regimens.
4. How might reimbursement policies change over the next five years?
Payers are increasingly favoring outcomes-based reimbursement, potentially leading to negotiated discounts, risk-sharing arrangements, and formulary prioritization for early-line therapy with Daratumumab.
5. What are the main barriers to price reductions for Daratumumab?
High manufacturing complexity, lack of immediate biosimilar competition, and the drug’s pivotal role in treatment resistance limit aggressive price reductions in the short term.
References:
- Grand View Research, "Multiple Myeloma Market Analysis," 2022.
- FDA Drug Approvals Database, Daratumumab (Darzalex), 2015.
- IQVIA, "Hospital and Retail Price Trends," 2023.
- Market Intelligence Reports, "Biopharmaceuticals and Biosimilars," 2022.
