Last updated: July 29, 2025
Introduction
The pharmaceutical industry operates within a dynamic landscape driven by innovation, regulatory changes, market demand, and pricing strategies. This report offers an in-depth analysis of the market environment and pricing trends associated with the drug identified by NDC 45802-0736. Precise understanding of these factors is crucial for stakeholders, including manufacturers, payers, and investors, to optimize decision-making processes.
Drug Profile and Therapeutic Context
NDC 45802-0736 refers to Daratumumab (Darzalex), a monoclonal antibody developed by Janssen Pharmaceuticals, approved for treating multiple myeloma. Its therapeutic efficacy has established it as a cornerstone in hematologic oncology, expanding indications over time. Daratumumab targets CD38 antigens on malignant plasma cells, demonstrating significant clinical benefits in both relapsed/refractory and newly diagnosed multiple myeloma cases.
Understanding its therapeutic niche offers insights into the market size, competitive positioning, and growth prospects.
Market Size and Demand Dynamics
Global Market Scope
The multiple myeloma market is projected to reach approximately $20 billion globally by 2027, driven by increasing prevalence, innovation, and expanded indications (source: Grand View Research). Daratumumab’s contribution is estimated to represent a significant share within this market due to its efficacy and approval for multiple lines of therapy.
Prevalence and Incidence
The American Cancer Society estimates approximately 35,000 new cases of multiple myeloma annually in the U.S. alone. The aging population and improved survival rates have contributed to a growing patient pool. As newer, more effective formulations emerge, demand is expected to sustain or increase.
Market Competitors
Daratumumab faces competition from other monoclonal antibodies, such as elotuzumab (Empliciti) and isatuximab (Reyll), as well as novel small molecules and CAR-T therapies. Nevertheless, its established efficacy credibility secures its market position, especially when combined with other agents.
Pricing Trends and Market Dynamics
Historical Pricing Data
In the U.S., Daratumumab’s list price has hovered around $6,900 per vial, with treatment courses involving multiple vials depending on dosing regimens. The initial wholesale acquisition cost (WAC) has remained relatively stable, but actual prices after discounts and rebates are often lower.
Pricing Strategies and Payer Influence
Manufacturers employ a combination of list prices, discounts, and patient assistance programs to navigate payer negotiations. As biosimilars or generics are not yet approved or available, the price trend is expected to remain relatively stable unless significant biosimilar competition arises.
Regulatory and Policy Impact
Pricing is also influenced by formulary placements, prior authorization requirements, and value-based pricing negotiations fueled by real-world evidence of clinical benefits. Policy shifts toward value-based care could incentivize price adjustments aligned with outcomes.
Market Penetration and Reimbursement
Reimbursement through Medicare and private insurers depends on the drug’s perceived value, cost-effectiveness, and clinical benefit. Donor reimbursement levels and policy incentives will influence net prices, impacting revenue projections.
Future Price Projections
Factors Contributing to Price Stability
- Absence of biosimilar competition in the near-term.
- High demand driven by multiple myeloma prevalence.
- Established clinical efficacy and preferential positioning in treatment guidelines.
Potential Price Trends
In the next 3-5 years, prices are expected to remain stable or experience modest increases, aligned with inflation, and adjustments for market access negotiations. Significant price reductions are unlikely unless biosimilar entry or regulatory interventions disrupt the current market.
Impact of Biosimilars and Market Entry
Potential biosimilar versions could induce price competition, leading to possible reductions of 20-30% or more. Market entry could occur within the next 5-7 years, contingent on regulatory approvals and patent litigation outcomes.
Conclusion
Daratumumab (NDC 45802-0736) operates within a lucrative and expanding markets for multiple myeloma therapies. Its entrenched clinical efficacy and current lack of biosimilar competition support a stable pricing environment over the near term. While pricing may see incremental growth influenced by inflation and market dynamics, potential biosimilar entrants pose a significant long-term price divergence risk. Stakeholders must monitor regulatory developments, patent landscapes, and market entry timelines to refine strategic planning.
Key Takeaways
- The multiple myeloma market is expanding, with daratumumab commanding a substantial share due to clinical efficacy.
- Current pricing for Daratumumab remains stable, generally around $6,900 per vial, with discounts affecting net revenues.
- Market demand driven by increasing prevalence sustains pricing stability; however, biosimilar competition is anticipated within 5-7 years.
- Payer strategies, policy reforms, and value-based models influence net price and adoption levels.
- Stakeholders should prepare for potential price reductions upon biosimilar entry, influencing long-term revenue projections.
FAQs
1. What is the current market size for Daratumumab (NDC 45802-0736)?
The global multiple myeloma therapeutic market is projected to reach approximately $20 billion by 2027, with Daratumumab representing a significant portion driven by its widespread use and expanding indications.
2. How does Daratumumab's pricing compare to other monoclonal antibodies in oncology?
Its list price (~$6,900 per vial) is comparable to other monoclonal antibodies in oncology. Market positioning and negotiated discounts significantly influence actual costs borne by payers and patients.
3. What factors could influence future price trends for Daratumumab?
Key factors include biosimilar competition, regulatory changes, healthcare policy reforms, and evolving value-based pricing models.
4. When are biosimilars for Daratumumab expected to enter the market?
Biosimilar versions could enter within 5-7 years, depending on regulatory approvals, patent litigation, and market dynamics.
5. How can stakeholders prepare for upcoming market changes?
Regular monitoring of patent landscapes, competitor developments, and policy trends will enable proactive adjustments in pricing, partnership strategies, and market positioning.
Sources
[1] Grand View Research, "Multiple Myeloma Drugs Market," 2022.
[2] American Cancer Society, "Cancer Facts & Figures," 2022.
[3] FDA Drug Approval Database, "Daratumumab (Darzalex) Approval Details," 2015.
