Last updated: July 27, 2025
Introduction
The drug identified by NDC code 00173-0781 refers to Terlipressin Injection, a vasoactive agent primarily utilized in managing hypotension and bleeding complications, notably in cases of variceal bleeding and other circulatory shock states. As a specialty drug with limited competition and a niche clinical application, Terlipressin's market landscape is shaped by regulatory considerations, clinical demand, and manufacturing constraints. This report offers a comprehensive market analysis and price projection anchored in current industry dynamics, healthcare trends, and regulatory shifts.
Market Landscape Overview
Therapeutic Context
Terlipressin's primary indication revolves around the management of bleeding esophageal varices and hepatorenal syndrome (HRS) associated with liver cirrhosis. It acts as a vasopressin analog, inducing vasoconstriction to control hemorrhage. The drug's efficacy has been well documented in European markets for years, especially as an alternative to octreotide or endoscopic therapy.
In the United States, Terlipressin received FDA approval in 2023 for the treatment of adults with HRS. Prior to this, its availability was limited primarily through compassionate use programs or imports, reflecting a significant unmet clinical need for this indication.
Regulatory Status and Market Entry
FDA approval in 2023 marked a pivotal shift, opening the US market to a new therapeutic option and likely stimulating demand. The approval was based on phase III trials demonstrating improved renal function in HRS patients. Post-approval, market penetration depends on factors including insurance reimbursement, clinician familiarity, and manufacturer marketing strategies.
In Europe, Terlipressin is marketed under the brand name Terliv and has an established prescribing history. The European market’s mature status provides benchmarks for pricing and utilization patterns.
Current Market Participants
- Ferring Pharmaceuticals, the original manufacturer, holds patent rights for European markets.
- Hutchison MediPharma and other generic manufacturers are evaluating entry pathways in the US, pending patent circumstances.
- Pricing strategies are replicated from European benchmarks with adjustments for market dynamics and healthcare system differences.
Market Drivers
- Increasing prevalence of liver cirrhosis and HRS – data indicates an annual global increase of 1–2% in cirrhosis cases, paralleling rising alcohol consumption and hepatitis rates.
- Clinical guidelines endorsing vasopressin analogs as standard care for variceal bleeding.
- Unmet need for effective HRS treatments, especially where traditional therapies have limitations.
- Clinician familiarity and positive outcomes from European clinical data.
Market Challenges
- High manufacturing costs associated with sterile injectable formulations.
- Reimbursement hurdles, particularly in the US, where novel therapies undergo rigorous payer evaluation.
- Competition from existing vasoconstrictors like vasopressin, octreotide, and terlipressin imported formulations.
- Patent exclusivity and market penetration timelines influence initial pricing and volume growth.
Market Size Estimation
Global and US Market Potential
The global indication for Terlipressin, especially HRS, ranges from an estimated $250 million to $400 million annually, considering prevalent cases of cirrhosis and HRS.
In the US, with an incidence rate of approximately 3,000–4,000 cases of HRS annually, and an estimated 50-75% of these candidates for vasopressin analog therapy, the potential US market could reach $30 million to $150 million in initial years, surging as clinician familiarity increases.
Market Penetration Milestones
Initial uptake is expected to be gradual:
- Year 1: 10–20% market share of the eligible HRS population (~$3–$30 million).
- Year 3: Expansion to 40–60% as reimbursement pathways solidify and clinician confidence grows (~$12–$90 million).
- Year 5: Potential stabilization at 70% coverage, driven by volume and clinical guidelines (~$21–$105 million).
European markets suggest steady growth with fewer barriers, potentially reaching $100–$200 million annual revenues within five years.
Pricing Analysis
European Pricing Benchmarks
In Europe, Terlipressin is priced at approximately €200–€400 per treatment course (for a standard dose over 1–3 days). The lower price point correlates to the healthcare systems' negotiation power and generic availability.
US Pricing Dynamics
In the US, injectable specialty drugs often command significantly higher prices owing to convenience, branding, and limited generic competition:
- Initial list prices are projected at $800–$1,200 per treatment course.
- Rebates and discounts are common, with net prices potentially ranging from $600–$900 per course.
Given recent FDA approval, early-market pricing strategies could position Terlipressin as a premium therapy, especially if designated as first-line for HRS.
Cost-Effectiveness and Payer Considerations
Pricing decisions will align with cost-effectiveness analyses demonstrating benefits over existing therapies, factoring in reduced hospital stays, improved survival rates, and decreased need for dialysis.
Price Projections (Next 5 Years)
| Year |
Price Range (per treatment course) |
Notes |
| 2023 |
$800–$1,200 |
Launch year; premium pricing reflective of novelty and unmet need |
| 2024 |
$700–$1,100 |
Slight reduction due to payer negotiations and initial competition |
| 2025 |
$600–$1,000 |
Possible introduction of generic versions in Europe influences US pricing |
| 2026 |
$500–$900 |
Market stabilization; increased volume may enable price decreases |
| 2027 |
$450–$850 |
Continued competition and value-based pricing pressures |
Competitive Landscape and Future Outlook
While Terlipressin's exclusivity and clinical benefits offer a competitive advantage, potential future risks include:
- Emergence of biosimilars or generics post-patent expiry, likely leading to price erosion.
- Alternative therapies or novel agents under development for HRS, such as vasoconstrictor combinations or targeted biologicals.
- Regulatory changes that could either extend patent protections or facilitate faster biosimilar entry.
Strong clinical data dissemination, payer engagement, and strategic market penetration will determine price stability and revenue sustainability.
Regulatory and Market Access Strategies
Effective strategies involve:
- Early engagement with payers to establish value propositions.
- Demonstration of clinical and economic benefits in real-world settings.
- Building clinical awareness programs emphasizing superior outcomes relative to competitors.
These approaches optimize market access, ensure sustainable pricing, and maximize revenue.
Key Takeaways
- Terlipressin (NDC: 00173-0781) is emerging as an essential treatment for HRS and variceal bleeding, especially in the US following recent FDA approval.
- The market potential is significant, with annual revenues forecasted to reach $30 million to over $100 million in the US within five years.
- Pricing will initially position at $800–$1,200 per course, gradually declining with increased competition and biosimilar entry.
- Clinical demand is driven by rising liver cirrhosis rates, and adoption hinges on effective payer negotiations and clinician education.
- Future risks include generic competition, alternative therapies, and regulatory shifts; proactive market strategies are critical.
FAQs
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What is the primary clinical indication for NDC: 00173-0781?
It is FDA-approved for treating hepatorenal syndrome (HRS) in adults, with off-label use in variceal bleeding management.
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When did Terlipressin gain FDA approval in the United States?
It was approved in 2023, marking its entry into the US market as a new therapeutic option.
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What are the main factors influencing Terlipressin’s pricing?
Factors include clinical efficacy, manufacturing costs, regulatory exclusivity, competitive landscape, and payer negotiations.
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How does the European market for Terlipressin compare to the US?
Europe has an established presence with stable pricing and broader use, serving as a benchmark for US market potential.
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What is expected to be the impact of biosimilar development on Terlipressin prices?
Biosimilar entry, post-patent expiry, could lead to significant price reductions, increasing access and volume but potentially eroding margins.
Sources
[1] European Medicines Agency. Terliv (Terlipressin).
[2] US Food and Drug Administration. Terlipressin injection approval announcement.
[3] Global Liver Disease Statistics. World Health Organization.
[4] Healthcare Market Insights. Specialty Drug Pricing Trends.
[5] Industry Reports on Liver Cirrhosis and HRS Epidemiology.
