Bridging the gap: Novel antifungal agents and the challenge of equitable access in low– and middle–income countries

Abstract

Invasive fungal infections are a major, yet under-recognized, global health threat, accounting for an estimated 1.6–1.7 million deaths annually–on par with tuberculosis and surpassing many neglected tropical diseases. The disproportionate burden in low- and middle-income countries (LMICs) is compounded by poor diagnostic capacity, outdated treatment options, and lack of access to novel antifungals. This review provides a critical analysis of newly approved and late-stage antifungal agents, evaluates their clinical profiles and regulatory progress, and explores the systemic barriers to affordability and accessibility in LMICs. A narrative review approach was employed, drawing on literature from PubMed, Scopus, Web of Science, and policy databases between 2018 and 2025. The review integrates clinical trial data, pharmacoeconomic assessments, and global access policies, with a focus on seven agents: ibrexafungerp, rezafungin, fosmanogepix, olorofim, oteseconazole, opelconazole, and MAT2203. While these agents represent significant therapeutic advances–targeting drug–resistant Candida auris, azole–resistant Aspergillus, and rare molds–barriers remain formidable. High prices driven by orphan drug status, patent protections, limited registration in LMICs, inadequate fungal diagnostics, and supply chain inequities obstruct access. Strategic interventions are needed, including tiered pricing, pooled procurement, inclusion of antifungals on the WHO Essential Medicines List, and public–private models with access clauses. Furthermore, decentralized trials, local manufacturing, and diagnostic innovation will be essential to align antifungal R&D with global health equity goals. Novel antifungal agents offer transformative potential for managing invasive fungal infections, but without coordinated policy, financing, and access initiatives, LMICs will continue to face unacceptable treatment gaps. Bridging innovation and implementation must become a core global health priority.

Keywords

Antifungal resistance / Emerging antifungals / Drug access in LMICs / Invasive fungal infections / Essential medicines policy

Conflict of interest statement

The authors claim there is no conflict of interest.

Funding

The study received no extramural funding.

Data availability statement

The data supporting the findings of this study are available from the corresponding author upon request.

Authors’ contributions

Samajdar SS and Chatterjee R contributed in study conceptualization and data acquisition. Chatterjee R and Mukherjee S contributed in manuscript writing. All authors read and approved the final manuscript.

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