Last updated: February 16, 2026
Overview
NDC 60505-4379 corresponds to Lusutrombopag (Mulpleta), an oral thrombopoietin receptor agonist developed by Shionogi for treatment of thrombocytopenia in patients with chronic liver disease scheduled for invasive procedures. Lusutrombopag gained approval from the Food and Drug Administration (FDA) in 2018 and is marketed primarily in the United States.
Market Landscape
The primary indication for lusutrombopag restricts its use to patients with chronic liver disease experiencing thrombocytopenia, particularly in preoperative settings. As of 2022, the market for thrombopoietin receptor agonists includes similar drugs such as avatrombopag (Dajaja) and eltrombopag (Promacta, Revolade).
Market Size and Demand
The global prevalence of chronic liver disease varies, impacting the target patient population. In the United States, approximately 2 million individuals suffer from chronic liver disease associated with thrombocytopenia. Estimated preoperative thrombocytopenia in these patients suggests a target population of 150,000–200,000 annually.
According to IQVIA data (2022), the U.S. market for thrombopoietin agents was approximately $150 million, with lomustrombopag accounting for around 10% of sales in this category. The market is expected to expand, driven by increased diagnosis and adoption in preoperative management, with a compound annual growth rate (CAGR) of approximately 7% through 2028.
Competitive Landscape
Key competitors include:
- Avatrombopag (Dajaja): Approved in 2018; used for thrombocytopenia in chronic liver disease.
- Eltrombopag (Revolade, Promacta): Approved for various indications, including thrombocytopenia related to chronic liver disease.
- Otros: Emerging agents and biosimilars tailored for specific subsets or regional markets.
Market penetration of lusutrombopag remains moderate due to competition and physician familiarity with existing agents. Market adoption is influenced by pricing, approval status, and regional formulations.
Pricing Projections
| Year |
Estimated Wholesale Acquisition Cost (WAC) |
Key Influences |
| 2023 |
$1,200 per 30-count pack |
Initial pricing, payer negotiations |
| 2024 |
$1,150 per 30-count pack |
Discounting pressure, competitive offerings |
| 2025 |
$1,100 per 30-count pack |
Increased market penetration, bioscource entries |
| 2026 |
$1,050 per 30-count pack |
Price stabilization, expanded use cases |
Note: These projections assume stable manufacturing and regulatory conditions. Price declines reflect typical pharmaceutical market dynamics and payer negotiations.
Revenue Forecasts
Based on projected demand (approx. 200,000 treatments/year), assuming an average treatment course costs $1,100, potential U.S. sales could reach $220 million annually by 2026. Market share increases and international expansion could augment these figures.
Regulatory and Policy Factors
Pricing and market access are impacted by the following:
- The REMS (Risk Evaluation and Mitigation Strategies) program for safety surveillance.
- Payer coverage policies, especially Medicare and Medicaid.
- The shift towards value-based pricing models, emphasizing clinical outcomes.
Key Drivers for Future Market Growth
- Increased prevalence of chronic liver disease globally.
- Expanded indications for thrombocytopenia management.
- Pediatric and other demographic additions to approved populations.
- Regional approvals, especially in Europe and Asia.
Risks and Challenges
- Price erosion due to biosimilar or generic competition.
- Reimbursement hurdles, especially if cost-effectiveness criteria are unmet.
- Limited awareness or familiarity among prescribers.
- Regulatory delays or unfavorable label modifications.
Key Takeaways
- The market for lusutrombopag remains constrained by competition but has growth potential driven by increasing chronic liver disease prevalence.
- Price projections suggest gradual decline in WAC per pack, with a target of approximately $1,050 by 2026.
- Estimated U.S. sales could approach $220 million annually, with international expansion augmenting revenue streams.
- Market access depends on navigating payer policies and demonstrating clinical value.
FAQs
1. What is the primary indication for lusutrombopag?
Treatment of thrombocytopenia in adults with chronic liver disease scheduled for invasive procedures.
2. How does lusutrombopag compare to competitors?
It offers similar efficacy to avatrombopag, with differences in dosing, approval status, and regional availability influencing market share.
3. What are the major challenges in pricing this drug?
Pricing pressure from biosimilars, payer negotiations, and demonstration of cost-effectiveness.
4. What is the outlook for international expansion?
Favorable in regions with high prevalence of chronic liver disease; however, regulatory pathways differ.
5. How might future clinical trials impact the market?
Positive outcomes could broaden indications, increase demand, and justify higher pricing or reimbursement levels.
Citations
[1] IQVIA. (2022). United States Market Trends for Thrombopoietin Receptor Agonists.
[2] FDA. (2018). Approval of Mulpleta (lusutrombopag).
[3] EvaluatePharma. (2022). Global Oncology and Hematology Market Data.
