Last updated: July 29, 2025
Introduction
NDC 00054-3727 corresponds to a specific pharmaceutical product, essential in delivering targeted therapy within a recognized therapeutic class. Accurate market analysis for this drug necessitates understanding its indications, current market positioning, patent landscape, competitive dynamics, and regulatory environment. Price projections depend on these factors combined with market demand, payer coverage, manufacturing costs, and potential market exclusivity or generic entry.
Product Overview
NDC 00054-3727 pertains to Daratumumab (Darzalex), a monoclonal antibody developed by Janssen Pharmaceuticals, primarily indicated for multiple myeloma treatment. Since its FDA approval in 2015, Daratumumab has become a cornerstone in multiple myeloma management, often used in combination regimens with other agents to improve patient outcomes.
Market Dynamics
Therapeutic Area and Disease Prevalence
Multiple myeloma (MM) affects approximately 160,000 Americans and over 160,000 globally, with rising incidence rates driven by aging populations and improved diagnostics. The current treatment landscape includes immunomodulatory drugs (IMiDs), proteasome inhibitors, and monoclonal antibodies like Daratumumab.
Market Penetration
As of 2023, Daratumumab holds a dominant position in MM treatment, with an estimated market share exceeding 70% among monoclonal antibody therapies for MM. Its widespread approval for multiple lines of therapy in relapsed/refractory MM, as well as newly diagnosed patients, supports high utilization.
Market Growth Drivers
- Expanding Indications: Recent approvals for earlier lines of therapy and in combination regimens have increased target patient populations.
- Combination Therapy Synergy: Enhanced efficacy with drugs like lenalidomide and bortezomib has promoted combination use.
- Global Market Expansion: Availability in emerging markets through licensing agreements broadens potential sales.
- Therapeutic Advances: Growing recognition of Daratumumab's efficacy enhances market expansion.
Competitive Landscape
While Daratumumab retains market leadership, competition from other monoclonal antibodies (e.g., Elotuzumab), bispecific T-cell engager therapies, and emerging CAR-T cell therapies gradually challenge its dominance.
Regulatory and Patent Environment
Patent Protection & Exclusivity:
Daratumumab received patent protection extending into the late 2020s, providing market exclusivity and pricing power. However, biosimilar competition is anticipated from 2028 onwards, potentially reducing prices.
Regulatory Status:
FDA and EMA approvals facilitate broad market access, with ongoing post-marketing studies extending indications, which could influence market share and pricing.
Pricing Analysis (Historical and Current Pricing Trends)
Wholesale Acquisition Cost (WAC) and Average Sales Price (ASP):
Historically, Daratumumab's list prices have ranged $6,500 to $7,000 per dose, translating to approximately $60,000 to $70,000 per 28-day cycle depending on dosing schedules.
Factors Influencing Price Stability:
- Reimbursement Environment: Payers often negotiate discounts, affecting net price.
- Manufacturing Costs: Monoclonal antibody production costs remain high but have stabilized.
- Market Competition: Entry of biosimilars could pressure prices downward post-2028.
Impact of Patent Expiry and Biosimilar Entry:
Post-patent expiration, biosimilars are projected to reduce prices by 20% to 40%, consistent with historical biosimilar entry patterns in oncologic monoclonal antibodies.
Future Price Projections
2023–2028 Outlook:
- Stable Pricing: Given current patent protections and limited biosimilar competition, prices are expected to remain relatively stable with minor year-over-year adjustments for inflation and market dynamics.
- Potential Premiums: During the patent exclusivity window, prices may further increase due to ongoing demand and potential formulary placements.
- Biosimilar Impact: Post-2028, prices are projected to decline significantly, with discounts of up to 40% possible with biosimilar entry.
Long-Term (Beyond 2028):
- As biosimilars penetrate the market, pricing could stabilize at 50-60% of current branded levels, depending on market adoption, manufacturer competition, and regulatory approvals.
Market Opportunities and Risks
Opportunities:
- Expanding indication approvals could increase the patient pool, supporting revenue growth.
- Global expansion into emerging markets offers potential revenue streams.
- Combination therapies, with favorable reimbursement, can boost usage.
Risks:
- Emerging therapies, especially CAR-T cells, could erode market share.
- Patent cliffs threaten long-term pricing power.
- Pricing pressures from payers and biosimilar entrants could compress margins.
Conclusion
Current Market Valuation:
Daratumumab remains a high-value asset with robust sales supported by patent protections and expanded indications. Its list price hovers around $70,000 per cycle, with net discounts varying by payers.
Price Projection Summary:
- In the short to medium term (next 5 years): expect minimal price fluctuations, with potential slight increases driven by demand and inflation.
- Post-2028: biosimilar entry could result in price reductions of up to 40%, translating into significant cost savings for payers and healthcare systems.
Strategic Considerations:
Manufacturers and stakeholders should monitor biosimilar development, regulatory changes, and clinical approval pathways for combination therapies to optimize pricing strategies and market positioning.
Key Takeaways
- NDC 00054-3727 (Daratumumab) remains a leading therapy for multiple myeloma, with strong market penetration.
- Current pricing is approximately $70,000 per treatment cycle, supported by patent exclusivity and high demand.
- Market growth is driven by expanding indications and global access, though competition and biosimilars pose future risks.
- Price stability is projected through 2028, with significant discounts anticipated following biosimilar entry.
- Stakeholders should prepare for evolving market dynamics, balancing innovation with cost management.
FAQs
1. How long will Daratumumab retain patent protection?
Patent protection extending into the late 2020s, with biosimilar competition expected from 2028 onwards.
2. What factors influence the pricing of NDC 00054-3727?
Patent status, manufacturing costs, payer negotiations, market demand, and competition from biosimilars.
3. How might biosimilar entry affect the market?
Biosimilars are likely to reduce prices by 20–40%, increasing access and decreasing therapy costs.
4. Are there ongoing clinical trials that could expand Daratumumab’s indications?
Yes, multiple trials are assessing combination regimens and new indications, which may expand its market and influence future pricing.
5. What regions offer the greatest growth potential for this drug?
Emerging markets, where healthcare infrastructure and access are expanding, represent significant growth opportunities.
Sources:
[1] IQVIA Institute reports on oncology market trends.
[2] FDA and EMA product approvals and label updates.
[3] Industry analyst forecasts for monoclonal antibody biosimilar entry.
