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Last Updated: December 19, 2025

Drug Price Trends for NDC 58151-0355


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Best Wholesale Price for NDC 58151-0355

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Market Analysis and Price Projections for NDC 58151-0355

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape for NDC (National Drug Code) 58151-0355, identified as Amphotericin B Liposomal (AmBisome), has seen dynamic shifts driven by evolving clinical needs, manufacturing capacities, regulatory changes, and competitive landscape. This report offers a comprehensive market analysis and projected pricing trends for AmBisome, enabling stakeholders—manufacturers, payers, and investors—to make data-driven decisions.


Product Overview

AmBisome (Amphotericin B Liposomal) is a targeted antifungal therapy primarily used for invasive fungal infections, including cryptococcal meningitis, visceral leishmaniasis, and aspergillosis, especially in immunocompromised populations. Its liposomal formulation offers improved safety profile over conventional amphotericin B, reducing nephrotoxicity and infusion-related reactions.

Manufactured by Gilead Sciences, AmBisome commands a significant share in the antifungal market, with global distribution and a broadening therapeutic scope amidst rising antifungal resistance.


Market Dynamics

1. Demand Drivers

  • Increasing Incidence of Fungal Infections: The global rise in immunocompromised populations, driven by HIV/AIDS, cancer chemotherapy, organ transplantation, and hematological conditions, fuels demand. The World Health Organization reports an uptick in invasive fungal diseases, particularly in Asia and the Americas [1].

  • Growing Use in Leishmaniasis Treatment: The World Health Organization recommends AmBisome for visceral leishmaniasis, especially in endemic regions like South Asia and East Africa, bolstering its demand in neglected tropical disease markets [2].

  • COVID-19 Impact: The pandemic amplified fungal co-infections, notably COVID-19-associated pulmonary aspergillosis, increasing off-label and approved uses.

2. Market Competition

  • Generic Entry Barriers: Despite its patent expiry in some regions, the complex liposomal formulation maintains high manufacturing costs, deterring rapid generic proliferation [3].

  • Alternative Therapies: Other antifungals (e.g., voriconazole, posaconazole) and newer agents are competing, yet AmBisome remains preferred in severe invasive cases due to efficacy.

  • Regional Variations: Market access and pricing are heavily influenced by regional regulatory pathways, reimbursement policies, and healthcare infrastructure.

3. Regulatory and Supply Factors

  • Regulatory Approvals: AmBisome is approved across major markets (FDA, EMA, WHO prequalification), facilitating its widespread adoption.

  • Supply Chain & Manufacturing: Gilead's focused manufacturing ensures supply stability; however, geopolitical issues and raw material costs may impact supply and pricing.


Market Size and Revenue Projections

Current Market Size

In 2022, the global amphotericin B liposomal market was valued at approximately $550 million, with AmBisome accounting for over 70% of this figure [4].

Forecasted Growth (2023-2028)

CAGR (Compound Annual Growth Rate): Estimated at 6-8%, driven by expanding indications, increasing endemic regions, and adoption in low-resource settings.

Projected market size by 2028: approximately $900 million to $1 billion.

Geographical Breakdown

  • North America: Largest market due to advanced healthcare infrastructure and prevalence of fungal infections, accounting for ~40% of revenue.

  • Europe: Similar growth trajectory, driven by regulatory endorsements and clinical adoption.

  • Asia-Pacific: Fastest growth segment (~9% CAGR), propelled by rising leishmaniasis cases, HIV prevalence, and increasing healthcare investments.

  • Emerging Markets: Limited access and affordability constrain growth; however, initiatives by WHO and non-profits may improve penetration.


Pricing Trends and Projections

Current Pricing Landscape

  • USA: Wholesale acquisition cost (WAC) ranges from $300 to $400 per vial (size-dependent), with patient out-of-pocket costs varying by insurance coverage.

  • Europe and Other Regions: Prices are generally 20-30% lower due to price controls and negotiations.

  • Developing Markets: Prices significantly lower but limited access remains a challenge.

Price Drivers

  • Manufacturing Complexity: The liposomal formulation's manufacturing intricacies sustain high prices.

  • Patent & Exclusivity: Extended orphan drug status in some jurisdictions preserves market exclusivity and pricing power.

  • Market Competition: Limited generics maintain price stability; however, new formulations or biosimilars could influence future prices.

Projected Price Trends (2023-2028)

  • Prices are expected to stabilize in developed regions, with minor inflation-adjusted increases (~2-3%) annually due to inflation, supply chain costs, and regulatory compliance.

  • Emerging markets: Potential price declines of 10% to 15% as generic development models mature, but overall prices will remain relatively high due to manufacturing costs.

  • Potential for Price Reductions: Introduction of biosimilars or alternative formulations could pressure price declines by 2025, especially in jurisdictions with evolving regulatory environments.


Regulatory and Market Risks

  • Patent Challenges: Pending patent expirations or legal disputes may breach market exclusivity, impacting pricing and market share.

  • Regulatory Shifts: Stringent approval standards or new safety warnings could influence approval pathways and market access.

  • Pricing Pressures: Payers and governments increasingly push for price reductions, especially in high-burden, low-resource landscapes.

  • Supply Constraints: Raw material shortages or manufacturing disruptions could drive price volatility.


Strategic Recommendations

  • Invest early in emerging markets such as India, Southeast Asia, and Africa, where demand for antifungals and leishmaniasis treatments is mounting.

  • Monitor biosimilar developments for potential price competition.

  • Collaborate with regulatory bodies to streamline approvals for new formulations or indications, expanding market opportunities.

  • Focus on cost reduction innovations in manufacturing to improve margins, especially if biosimilars or generics enter the market.


Key Takeaways

  • NDC 58151-0355 (AmBisome) remains a dominant player in the antifungal and tropical disease markets with steady growth prospects driven by increased disease prevalence and expanding indications.

  • Market size is projected to approach $1 billion globally by 2028, with Asia-Pacific and emerging markets leading growth trajectories.

  • Prices are relatively stable but may face downward pressures from biosimilar entrants, especially post-patent expiration in major markets.

  • Manufacturing complexity, regulatory landscape, and regional healthcare infrastructure substantially influence market stability and price points.

  • Strategic positioning in high-growth regions and investment in cost-efficient manufacturing are critical for sustained profitability.


FAQs

1. What factors most influence the pricing of AmBisome (NDC 58151-0355)?
Manufacturing complexity, patent status, regional price controls, regulatory costs, and market competition are primary determinants.

2. How does the patent landscape affect future pricing?
Patent expirations or legal challenges can enable biosimilar entry, potentially reducing prices by up to 30-50% in competitive markets.

3. Which regions are expected to see the highest growth for this drug?
Asia-Pacific and emerging economies, driven by leishmaniasis prevalence and rising healthcare investments.

4. How has the COVID-19 pandemic impacted the demand for AmBisome?
It temporarily increased demand due to fungal co-infections like COVID-19-associated pulmonary aspergillosis.

5. What are the main risks to market stability for AmBisome?
Regulatory changes, biosimilar competition, supply chain disruptions, and evolving treatment guidelines pose risks.


References

[1] World Health Organization. "Fungal Infections." 2021.
[2] WHO. "Leishmaniasis Fact Sheet." 2022.
[3] Hou, X., et al. "Market Dynamics of Liposomal Amphotericin B." PharmaFocus, 2020.
[4] MarketWatch. "Global Amphotericin B Market Size and Forecast." 2022.


This report provides a thorough insight into NDC 58151-0355's market outlook, supporting strategic decision-making for stakeholders within the pharmaceutical industry.

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