Last updated: February 24, 2026
What is NDC 70677-1273?
NDC 70677-1273 refers to the drug Lusutrombopag, marketed under the brand name Mulpleta. It is a thrombopoietin receptor agonist indicated for patients with chronic liver disease who have thrombocytopenia and are scheduled for invasive procedures. Approved by the U.S. Food and Drug Administration (FDA) in August 2018, it is administered orally.
Market Overview
Market Size and Growth
The global thrombopoietin receptor agonists (TPO-RAs) market was valued at approximately USD 1.2 billion in 2022. It is projected to reach USD 2.3 billion by 2030, at a compound annual growth rate (CAGR) of 8.4% (Fortune Business Insights, 2023).
Key Drivers
- Increasing prevalence of chronic liver diseases, especially hepatitis C and cirrhosis.
- Growing need for minimally invasive procedures in patients with thrombocytopenia.
- Advancements in TPO-RA development and increased awareness.
Market Segmentation
- By drug class: Romiplostim, Eltrombopag, Lusutrombopag.
- By end-user: Hospitals, clinics, specialty care centers.
- By region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
North America holds the largest market share (~42%) due to higher diagnosis rates, better healthcare infrastructure, and regulatory approvals of newer therapies.
Competitive Landscape
Approved TPO-RAs
| Drug Name |
Manufacturer |
Approval Year |
Indication |
Estimated Market Share (2022) |
| Lusutrombopag |
Shionogi/Other |
2018 |
Thrombocytopenia in liver disease patients |
20% |
| Eltrombopag |
GlaxoSmithKline (Promacta) |
2008 |
Thrombocytopenia from hepatitis C, ITP |
45% |
| Romiplostim |
Amgen |
2008 |
Chronic immune thrombocytopenia (ITP) |
35% |
Pricing Benchmarks
- Eltrombopag (brand: Promacta): USD 9,800 per month (average wholesale price, 2022).
- Romiplostim (brand: Nplate): USD 10,500 per month.
- Lusutrombopag (Mulpleta): USD 5,700 for a one-week treatment course (not FDA-based, estimates from market sources, 2022).
Price Trends
Prices for TPO-RAs vary significantly based on usage, region, and healthcare setting. Lusutrombopag tends to be priced lower than others, attributed to its oral administration and specific indication.
Reimbursement and Pricing Policies
In the U.S., Medicare and private payers reimburse for TPO-RAs based on coverage policies. Coverage for Mulpleta is generally aligned with traditional criteria for liver disease and thrombocytopenia. Pricing pressures are higher in Europe and Asia, where negotiations and healthcare budgets influence drug pricing.
Price Projection (2023-2027)
Assumptions
- Incidence of severe thrombocytopenia in chronic liver disease patients grows at 2.5% annually.
- Market share of Lusutrombopag increases gradually due to favorable pricing and emerging clinical data.
- Entry of biosimilars or generics is unlikely within this period for Lusutrombopag due to patent protections.
| Year |
Projected Market Penetration of Lusutrombopag |
Estimated Price (USD) |
Expected Revenue (USD million) |
| 2023 |
22% |
5,700 |
150 |
| 2024 |
25% |
5,700 |
180 |
| 2025 |
28% |
5,700 |
210 |
| 2026 |
30% |
5,500 (slight discount) |
210 |
| 2027 |
33% |
5,500 |
250 |
Prices are slightly discounted over time to reflect payer pressures.
Revenue Drivers
- Increase in procedures requiring thrombocytopenia management.
- Expanded label indications for Lusutrombopag.
- Growth in adoption within hospital outpatient settings.
Risks
- Price erosion due to payer pressure.
- Clinical data limitations impacting market adoption.
- Competition from alternatives or biosimilars.
- Regulatory challenges in markets outside the U.S.
Key Market Challenges
- Limited global penetration due to regional regulatory approvals.
- Price sensitivity in emerging markets reduces margins.
- Dependence on clinical pathway acceptance by healthcare providers.
Summary
Lusutrombopag remains a niche but growing asset in the thrombopoietin receptor agonist space, with a moderate market share and competitive pricing. Its revenue outlook for 2023-2027 hinges on the expansion of indications and procedural volume, with pricing expected to stabilize around USD 5,500–USD 5,700 per course.
Key Takeaways
- Lusutrombopag’s global market is projected to grow at a CAGR of approximately 8.4%.
- Its current price for a treatment course averages USD 5,700, lower than competitors.
- Increased procedural demand in chronic liver disease cases will drive revenue growth.
- Competitive pressures and payer policies may moderate future pricing increases.
- Market entry barriers and regulatory limitations constrain rapid global expansion.
FAQs
1. How does Lusutrombopag differentiate from other TPO-RAs?
It is an oral medication approved specifically for thrombocytopenia in chronic liver disease patients, targeting procedural settings where injectable options are less convenient.
2. What are the primary factors influencing its price?
Clinical efficacy, manufacturing costs, payer negotiations, competition, and region-specific healthcare policies.
3. Are there biosimilar versions of Lusutrombopag available?
As of 2023, patents protect Lusutrombopag, and no biosimilars are on the market. Biosimilar development remains unlikely shortly due to chemical complexity.
4. How does regulatory approval impact its market?
FDA approval facilitates access in the U.S. and influences expansion into other markets. Lack of approval in certain regions limits sales growth.
5. What potential market expansion strategies could increase revenue?
Expanding approved indications, increasing clinical adoption, entering new regional markets, and optimizing pricing strategies.
References
[1] Fortune Business Insights. (2023). Thrombopoietin Receptor Agonists Market Size and Forecast.
[2] U.S. Food and Drug Administration. (2018). Mulpleta (Lusutrombopag) approval information.
[3] National Cancer Institute. (2022). Thrombocytopenia management guidelines.
[4] GoodRx. (2022). Drug pricing information for thrombopoietin receptor agonists.
[5] MarketWatch. (2023). Biotech forecast and industry trends report.
