Last updated: August 2, 2025
Introduction
The pharmaceutical landscape for NDC 00713-0632, also known by its generic name, Daratumumab (brand name Darzalex), is characterized by its pivotal role in multiple myeloma treatment, a complex hematologic malignancy. Since its FDA approval in 2015, Daratumumab has positioned itself as a cornerstone in oncology, with an expanding indication profile and increasing adoption driven by evolving treatment paradigms. This analysis explores market dynamics, competitive landscape, pricing trends, and future projections for Daratumumab, providing essential insights for stakeholders across healthcare, investment, and policy domains.
Market Overview
Therapeutic Profile and Clinical Positioning
Daratumumab is a CD38 monoclonal antibody targeting plasma cells, approved for multiple myeloma both as a monotherapy and in combination regimens (e.g., with lenalidomide and dexamethasone). Its unique mechanism of action, including immune-mediated cytotoxicity, has demonstrated significant efficacy, translating into widespread adoption in multiple lines of therapy for relapsed/refractory and newly diagnosed patients[^1].
Market Size and Growth Drivers
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Prevalence of Multiple Myeloma: According to the American Cancer Society, approximately 35,000 new multiple myeloma cases are diagnosed annually in the U.S. alone, with the global burden projected to reach over 200,000 cases by 2030[^2].
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Expanding Indications: Recent FDA approvals extend Daratumumab’s use beyond previously refractory settings into frontline therapy, boosting market penetration.
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Increasing Adoption Rate: Oncologists favor Daratumumab due to its efficacy profile. The advent of combination therapies enhances treatment efficacy, further escalating demand.
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Market Penetration in Emerging Markets: While the U.S. and Europe dominate the current sales landscape, rising healthcare infrastructure and ongoing approval processes are expanding access in Asia and Latin America.
Competitive Landscape
Daratumumab's principal competitors include other monoclonal antibodies such as Elotuzumab (Empliciti) and Isatuximab (Sisenta), alongside emerging therapies like CAR T-cell agents (e.g., Idecabtagene vicleucel). However, Daratumumab's first-mover advantage and broad approval statuses sustain its dominant market share[^3].
Pricing Trends and Reimbursement Landscape
Historical Pricing Data
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List Price: As of 2023, the list wholesale acquisition cost (WAC) per 1,200 mg vial hovers around $6,500, with the typical treatment requiring multiple vials per dosing cycle (e.g., initial doses often involve six vials at successive intervals).
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Per-Patient Cost: Estimated annual treatment costs for Daratumumab range from $70,000 to $150,000, depending on regimen and dosage schedule[^4].
Reimbursement Dynamics
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Insurance Coverage: Medicare, Medicaid, and private insurers generally reimburse Daratumumab under risk-sharing agreements, with negotiated discounts and rebates reducing the effective cost.
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Manufacturers' Pricing Strategies: Janssen Pharmaceuticals, the manufacturer, employs tiered pricing and patient assistance programs to optimize access and market share, especially in price-sensitive regions.
Impact of Biosimilar Development
As Daratumumab's patent expiration approaches (expected around 2029-2030 in key jurisdictions), biosimilar competition anticipates significant price erosion, with projections estimating a 20-40% reduction in post-biosimilar entry^5.
Market Projections and Future Trends
Growth Outlook (2023–2028)
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Compound Annual Growth Rate (CAGR): Industry analysts project a CAGR of approximately 10-12%, driven by increased prevalence, expanded indications, and combination regimens[^6].
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Geographical Expansion: Emerging markets are expected to contribute significantly, with rapid approvals and increasing healthcare infrastructure investments.
Price Trajectory
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Short-term (Next 3-5 Years): Prices are expected to stabilize due to market saturation and reimbursement negotiations. However, ongoing price discounts and value-based agreements may moderate increases.
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Long-term (Post-Patent): Introduction of biosimilars could reduce prices by up to 50%, substantially expanding access but decreasing per-unit revenue for originators.
Regulatory and Policy Influences
Pricing modernization initiatives, such as value-based pricing and risk-sharing agreements, will influence future price settings. Additionally, global policy shifts toward drug affordability could accelerate biosimilar adoption and price declines.
Key Factors Influencing Market and Price Trends
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Clinical Efficacy and Safety Data: Ongoing trials and real-world evidence supporting superior outcomes will sustain high demand.
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Regulatory Approvals: Renewal and extensions of existing licenses, alongside new indication approvals, will impact market size.
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Biosimilar Competition: Timing and patient acceptance will dictate post-patent market pricing.
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Healthcare Policy Environment: Governments seeking cost containment through value assessments and negotiations will influence net pricing.
Key Takeaways
- Daratumumab (NDC 00713-0632) remains a vital therapeutic in multiple myeloma, with expanding indications and increasing adoption across global markets.
- The drug's pricing is currently high, reflective of its clinical benefits and market exclusivity, but is poised for significant adjustments upon biosimilar entry.
- Market growth is robust, driven by rising prevalence, enhanced treatment regimens, and emerging markets, with a projected CAGR exceeding 10% in the next five years.
- Price stabilization in the near term may give way to notable reductions post-patent expiry, emphasizing the importance of strategic planning for stakeholders.
- Future success hinges on clinical outcomes, regulatory approvals, market access efforts, and policy responses aimed at balancing innovation incentives with affordability.
FAQs
1. When is Daratumumab expected to face biosimilar competition?
Biosimilar versions of Daratumumab are anticipated around 2029-2030, contingent on patent expiry and regulatory processes, potentially leading to substantial price decreases^5.
2. How does the cost of Daratumumab compare internationally?
Prices vary globally due to differing healthcare systems, negotiation power, and reimbursement frameworks. Developed markets may have higher list prices but benefit from extensive negotiations, whereas emerging markets often see lower prices but face access challenges.
3. What are the main factors influencing Daratumumab’s future pricing?
Patents expiration, biosimilar availability, clinical efficacy data, reimbursement negotiations, and healthcare policy reforms are primary determinants.
4. Are there efforts to make Daratumumab more affordable?
Yes. Manufacturers and policymakers explore value-based pricing, tiered discounts, patient assistance programs, and biosimilar competition to improve affordability and access.
5. How does Daratumumab compare to its competitors in terms of market share?
Daratumumab leads the monoclonal antibody segment for multiple myeloma, owing to its first-mover advantage, broader indications, and extensive clinical data supporting its use[^3].
References
[^1]: Kumar, S., et al. (2020). "Efficacy and safety of Daratumumab in multiple myeloma." Blood, 135(7), 530-541.
[^2]: American Cancer Society. (2022). "Cancer Facts & Figures 2022."
[^3]: Palumbo, A., et al. (2018). "Daratumumab in multiple myeloma: clinical update." Lancet Oncology, 19(2), e79-e88.
[^4]: IQVIA Institute. (2022). "Global Oncology Trends."
[^6]: Global Data. (2022). "Multiple Myeloma Market Outlook 2022–2028."
