Amphotericin B Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Sales Channel (Direct, Indirect), By End Use (Systemic Fungal Infections, Candidiasis, Aspergillosis, Mucormycosis, Leishmaniasis, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 561.05 Million
CAGR (2026-2031)	4.56%
Fastest Growing Segment	Systemic Fungal Infections
Largest Market	North America
Market Size (2031)	USD 733.15 Million

Market Overview

The Global Amphotericin B Market will grow from USD 561.05 Million in 2025 to USD 733.15 Million by 2031 at a 4.56% CAGR. Amphotericin B is a broad-spectrum polyene antifungal antibiotic administered intravenously to treat severe, life-threatening systemic fungal infections such as mucormycosis and cryptococcal meningitis. The market is primarily driven by the escalating global prevalence of invasive mycoses among immunocompromised populations, including organ transplant recipients and oncology patients undergoing chemotherapy. Furthermore, increasing resistance to azole-based therapies necessitates the continued reliance on this potent agent as a critical treatment option. According to the Global Action Fund for Fungal Infections, in 2024, approximately 6.5 million individuals were estimated to be affected annually by life-threatening fungal diseases, underscoring the urgent demand for effective antifungal pharmacotherapies.

However, market expansion is significantly impeded by the severe nephrotoxicity associated with conventional deoxycholate formulations. This dose-limiting side effect often necessitates the use of lipid-based formulations, which are considerably safer but present a substantial cost barrier. Consequently, the high price of these less toxic alternatives restricts accessibility and adoption in low-to-middle-income healthcare systems where the fungal disease burden is often most acute, thereby limiting the overall market potential in these high-need regions.

Key Market Drivers

The rising incidence of invasive fungal infections, particularly those caused by multi-drug resistant strains, is a primary catalyst propelling the demand for Amphotericin B. As pathogens like Candida auris increasingly exhibit resistance to first-line azole and echinocandin therapies, healthcare providers are reverting to Amphotericin B for its broad fungicidal activity and low resistance rates. This trend is intensified by the growing prevalence of hospital-acquired infections among immunocompromised groups. According to the Centers for Disease Control and Prevention, December 2024, clinical cases of the multi-drug resistant Candida auris in the U.S. reached 4,514 in 2023, highlighting the critical need for potent salvage therapies. Additionally, the market is sustained by the sheer volume of specific fungal pathologies; according to the International Society for Infectious Diseases, in 2024, over 2.1 million people globally were estimated to develop invasive aspergillosis annually, creating a sustained baseline demand for effective fungicidal agents.

Concurrently, advancements in lipid-based drug delivery systems are reshaping the market by directly addressing the nephrotoxicity limitations of conventional formulations. Pharmaceutical developers are actively engineering novel oral and lipid-nanocrystal mechanisms to maintain the drug's efficacy while significantly improving its safety profile and patient compliance. These innovations are crucial for expanding the drug's utility beyond acute hospital settings into step-down therapies. For instance, according to Matinas BioPharma, June 2024, in the 'Compassionate/Expanded Use Access Program' for its oral lipid-nanocrystal formulation, 24 patients with severe invasive fungal infections had been treated, demonstrating the clinical viability of this technology. These technological progressions are vital for unlocking new market segments, as they promise to reduce the heavy economic burden associated with the hospitalization required for traditional intravenous administration.

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Key Market Challenges

The prohibitive cost of lipid-based formulations represents a critical economic barrier that severely constrains the Global Amphotericin B Market, particularly in high-burden, low-to-middle-income countries. While lipid complex and liposomal variants offer a necessary clinical alternative to the nephrotoxic conventional deoxycholate, their premium pricing structure restricts widespread adoption in the regions where invasive fungal infections are most endemic. This price disparity creates a bifurcated market where the safer, higher-value products are financially inaccessible to the public healthcare systems that require them the most, effectively capping revenue growth by limiting the addressable market to wealthy developed nations.

Consequently, the gap between clinical necessity and economic feasibility prevents the market from capitalizing on the rising volume of cases in developing economies. This lack of accessibility directly correlates with adverse patient outcomes and lost commercial opportunity. According to the World Health Organization, in 2025, invasive fungal diseases resulted in approximately 3.8 million deaths globally, a mortality burden heavily concentrated in resource-limited settings where access to less toxic, high-grade antifungal pharmacotherapies remains inconsistent due to acquisition costs. This inability to penetrate high-need markets due to pricing pressures remains a primary drag on global industry momentum.

Key Market Trends

Following the patent expiration of major branded liposomal products, the market is experiencing a surge in the approval and commercialization of cost-effective generic versions, significantly altering the competitive landscape. This expansion of generic and biosimilar therapeutics is rapidly increasing accessibility in cost-sensitive regions, allowing healthcare systems to transition away from nephrotoxic conventional formulations without incurring the prohibitive costs of originator brands. According to Sun Pharmaceutical Industries, May 2024, in the 'Q4 and Full Year Results for FY24' report, the company's US formulation sales—underpinned by its robust portfolio of complex generics including Amphotericin B liposome injection—reached US$ 1,854 million, reflecting a 10.1% year-over-year growth that underscores the rising market penetration and commercial viability of these non-branded alternatives.

Clinical treatment protocols are increasingly moving toward single high-dose or short-course regimens, particularly for Cryptococcal Meningitis and Visceral Leishmaniasis, to reduce hospitalization time and cumulative toxicity. This evolution in standard of care is reshaping volume demand and packaging requirements, driving a shift from prolonged daily infusions to concentrated, high-value dosing schedules. However, widespread implementation faces inertia as providers slowly adapt to these updated guidelines. According to Infectious Disease Advisor, April 2024, in a review of recent clinical management practices, a survey revealed that only 14% of infectious disease physicians had fully adopted the specific single-dose liposomal Amphotericin B regimen (AMBITION-cm protocol), indicating a significant opportunity for market development as professional consensus consolidates around these efficient delivery models.

Segmental Insights

The systemic fungal infections segment represents the fastest-growing category within the global amphotericin B market. This accelerated expansion is primarily driven by the rising prevalence of invasive mycoses, such as candidiasis and aspergillosis, among immunocompromised patient populations. Increasing cases of drug-resistant fungal strains have prompted healthcare providers to rely on amphotericin B as a critical therapeutic intervention. Furthermore, organizations like the World Health Organization have highlighted the escalating threat of these priority pathogens, necessitating effective antifungal treatments and thereby sustaining demand for this specific application.

Regional Insights

North America maintains a leading position in the Global Amphotericin B Market due to the extensive presence of major pharmaceutical manufacturers and a highly developed healthcare infrastructure. The rising incidence of invasive fungal infections drives the consistent demand for effective therapeutic interventions in the region. Additionally, favorable regulatory frameworks established by the U.S. Food and Drug Administration facilitate the swift approval and commercialization of new formulations. Strong reimbursement policies and continuous investment in clinical research further reinforce the market dominance of North America in this sector.

Recent Developments

• In October 2024, the Competition Commission of India approved the acquisition of Bharat Serums and Vaccines Limited by Mankind Pharma. This strategic consolidation brought together Mankind Pharma's extensive market reach with Bharat Serums and Vaccines' specialized portfolio in critical care and women's health. Bharat Serums and Vaccines is a prominent manufacturer of complex injectable formulations, including liposomal amphotericin B, and played a vital role in the supply chain during recent global fungal outbreaks. The acquisition was positioned to strengthen the combined entity's capabilities in developing and distributing essential specialty medicines in both domestic and international markets.
• In June 2024, Elion Therapeutics secured $81 million in a Series B funding round to advance the development of SF001, a novel analog of amphotericin B. The financing was led by Deerfield Management and the AMR Action Fund, with participation from additional investors. The company stated that the capital would be utilized to progress the clinical trials of SF001, which has been rationally designed to mitigate the systemic toxicities, particularly nephrotoxicity, typically associated with traditional amphotericin B treatments. This significant investment highlighted the industry's continued commitment to improving the safety profile of polyene antifungals for patients with life-threatening invasive fungal infections.
• In April 2024, Gilead Sciences launched the CARING 2024 Program, a collaborative research initiative focused on addressing invasive fungal infections in China. Following the 2023 approval of AmBisome (liposomal amphotericin B) in the region, the company initiated this request for proposals to support investigator-sponsored research regarding the incidence, identification, and management of fungal diseases. The program aimed to award up to $1,000,000 in total funding to academic institutions and clinical investigators. The initiative sought to generate critical scientific data on the safety and efficacy of liposomal amphotericin B in treating high-risk patient populations, such as those with hematologic malignancies.
• In March 2024, Matinas BioPharma reported positive clinical outcomes from its Compassionate/Expanded Use Access Program for MAT2203, an investigational oral formulation of amphotericin B. The company announced a complete clinical response in three patients treating serious invasive fusarium infections, a condition often resistant to standard therapies. These patients, including a renal transplant recipient and a burn victim, had previously failed other treatments or experienced significant toxicity. This development demonstrated the potential efficacy of the company's proprietary lipid nanocrystal platform in delivering amphotericin B orally, potentially offering a safer alternative to conventional intravenous administration.

Key Market Players

• Gilead Sciences, Inc.
• Bristol‑Myers Squibb Company
• Sun Pharmaceutical Industries Ltd.
• Cipla Limited
• Mylan N.V.
• Xellia Pharmaceuticals ApS
• Fresenius Kabi AG
• Pfizer Inc.
• Teva Pharmaceutical Industries Ltd.
• Astellas Pharma Inc.

By Sales Channel	By End Use	By Region
Direct Indirect	Systemic Fungal Infections Candidiasis Aspergillosis Mucormycosis Leishmaniasis Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Amphotericin B Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Amphotericin B Market, By Sales Channel:

• Direct
• Indirect

• Amphotericin B Market, By End Use:

• Systemic Fungal Infections
• Candidiasis
• Aspergillosis
• Mucormycosis
• Leishmaniasis
• Others

• Amphotericin B Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE