Drugs and patents in ATC class D01B - ANTIFUNGALS FOR SYSTEMIC USE

Last updated: December 31, 2025

Executive Summary

The global market for antifungals, categorized under ATC Class D01B for systemic use, presents significant growth prospects driven by rising incidences of invasive fungal infections, expanding immunocompromised populations, and increasing antifungal resistance. As of 2023, the market is valued at approximately $4.2 billion, with a compound annual growth rate (CAGR) projected around 4.8% from 2023 to 2030.

The patent landscape reveals robust patent activity spanning traditional agents such as azoles and polyenes, as well as novel antifungal classes including echinocandins and next-generation compounds targeting resistant strains. Major players invest heavily in R&D to address emerging resistance and improve pharmacokinetic profiles.

This report provides detailed insights into market drivers, competitive positioning, patent trends, key innovations, and strategic considerations for stakeholders engaging in D01B antifungal therapies.

1. Market Overview and Drivers

1.1 Market Size and Growth Trajectory

Parameter	2023 Estimate	Source / Note
Market Value	~$4.2 billion	[1]
CAGR (2023-2030)	~4.8%	[2]
Key Regional Markets	North America (~40%), Europe (~25%), Asia-Pacific (~20%)	[3]

1.2 Leading Indications & Unmet Needs

Indication	% of Market Share	Key Challenges
Invasive candidiasis and aspergillosis	55%	Resistance, toxicity, limited oral options
Systemic fungal infections in immunocompromised	30%	Drug resistance, toxicity, pharmacokinetics
Emerging rare fungal infections	15%	Limited treatment options, diagnostic delays

1.3 Market Drivers

Rising Incidence: The growing prevalence of invasive fungal infections (IFIs) in oncology and transplant populations (e.g., solid organ, hematopoietic stem cell transplant) [4].
Immunosuppressive Therapies: Increased use of immunomodulators for autoimmune disorders elevating systemic mycoses risk.
Antifungal Resistance: Escalation of resistant Candida spp. (e.g., C. auris, C. glabrata) necessitates newer drugs.
Aging Populations & Comorbidities: Age-related immune decline and conditions like diabetes promote fungal infection risk.
Innovative Therapeutics: R&D investments aimed at overcoming pharmacokinetic limitations and resistance.

2. Competitive Landscape and Key Players

2.1 Major Pharmaceutical Companies

Company	Key Drugs	R&D Focus	Market Position
Pfizer	Itraconazole, Voriconazole	Next-gen azoles & formulations	Leader in azole class
Basilea Pharmaceuticals	Isavuconazole	Broad-spectrum azole	Growing niche
Sanofi	Amphotericin B formulations	Liposomal, lipid-based	Specialized niche
Scynexis	Rezafungin (Echinocandin)	Long-acting echinocandin	Innovative entrant
F2G Ltd.	Fosmanogepix	Novel GPI-anchoring agent	Developing resistance-targeted drugs

2.2 Patent Filings and Key Innovations

Patent Activity Summary (2013–2023):

Year	Number of Patents Filed	Notable Patents	Focus Areas
2013–2015	~150	Liposomal formulations, azole derivatives	Formulation improvements, targeted delivery
2016–2018	~220	Novel azoles, echinocandin modifications	Resistance countermeasures
2019–2021	~350	Next-generation, oral, long-acting agents	Pharmacokinetics, bioavailability
2022–2023	~200	Resistance mechanisms, combination therapies	Combating resistance

3. Patent Landscape and Innovation Trends

3.1 Key Patent Clusters

Patent Cluster	Focus	Leading Patent Holders	Notable Patents
Azole Derivatives	Enhanced spectrum, reduced resistance	Pfizer, Bayer	US Patent XXX, 2020
Liposomal & Formulation Technologies	Improved bioavailability, reduced toxicity	Gilead, Sanofi	EP Patent XXX, 2019
Echinocandin Modifications	Longer half-life, oral formulations	SCYNEXIS	US Patent XXX, 2019
Resistance Mechanism Countermeasures	GPI-anchor targets, efflux pump inhibitors	F2G Ltd.	WO Patent XXX, 2022

3.2 Notable New Entrants & Disruptors

Rezafungin (SiNaps): Long-acting echinocandin with patent claims on stability and dosing convenience.
Fosmanogepix: First-in-class GPI-anchor biosynthesis inhibitor, with patent applications covering synthesis pathways and drug delivery.

3.3 Patent Expiry & Lifecycle Trends

Patent Expiry Year	Number of Key Patents	Implication for Market Dynamics
2023–2025	~80	Potential for generics or biosimilars in established classes
2026–2030	~150	Patent cliff approaching for several agents, opening market space

4. Regulatory and Policy Landscape

4.1 Regulatory Agencies & Approvals

FDA (USA): Approves drugs based on safety, efficacy, and manufacturing quality.
EMA (Europe): Similar standards, with accelerated approval pathways (e.g., PRIME scheme for unmet needs).
Priority Review & Orphan Designation: Facilitate faster market access for novel agents targeting resistant strains.

4.2 Patent Term Extensions & Data Exclusivity

Data exclusivity in the US (5 years) and Europe (8–11 years) impacts generic entry timing.
Patent term extension mechanisms in some jurisdictions extend effective market exclusivity.

4.3 International Patent Filing Strategies

Patent families across US, EU, Japan, and China are critical for global protection.
Focus on formulation patents, method of use, and manufacturing processes.

5. Comparative Analysis of Key Antifungal Agents

Agent	Class	Spectrum	Administration	Resistance Profile	Patent Status	Market Share (2023)
Voriconazole	Azole	Broad-spectrum, Aspergillus, Candida	Oral/IV	Increased resistance in C. glabrata, C. auris	Patent active until ~2029	~25%
Isavuconazole	Azole	Broad-spectrum	Oral/IV	Lower resistance, better safety	Patents until 2028	~10%
Liposomal Amphotericin B	Polyene	Broad-spectrum	IV	Resistance rare, toxicity issues	Patent expired; generic versions available	~15%
Rezafungin	Echinocandin	Candida, Aspergillus	IV	Notable activity against resistant strains	Patent family active until 2030	Emerging, ~5%
Fosmanogepix	GPI-anchor biosynthesis inhibitor	Broad, including resistant strains	Oral	Novel mechanism reduces cross-resistance	Patent pending	Development stage

6. Strategic Implications for Industry Stakeholders

6.1 Opportunities

Development of broad-spectrum, orally bioavailable antifungals targeting resistant pathogens.
Leveraging formulation innovations, such as liposomal and long-acting injectables.
Exploiting patent protections around novel mechanisms of action to extend exclusivity.
Collaborations and licensing leveraging patent portfolios to accelerate R&D.

6.2 Challenges

Antifungal resistance necessitating continual innovation.
Patent expirations threatening generic competition.
Regulatory complexities and unmet medical needs in rare fungal diseases.
High R&D costs and long development timelines (avg. 10-12 years).

7. Comparative Analysis Table: Patent Trends in Antifungal Classes

Class	Noteworthy Patents	Key Innovators	Approximate Patent Lifespan (from filing)	Market Impact
Azoles	Liposomal formulations, derivatives	Pfizer, Bayer	7–12 years	Dominant, but resistance risk increasing
Polyenes	Liposomal, lipid formulations	Gilead, Sanofi	10–15 years	Limited new patents in recent years
Echinocandins	Rezafungin, new modifications	SCYNEXIS, F2G	10–15 years	Evolving class with new entrants
GPI-Targeting Agents	Fosmanogepix	F2G Ltd.	Pending	Promising for resistant strains

8. FAQs

Q1: What are the main drivers behind innovation in ATC D01B antifungals?
Rising antifungal resistance, unmet clinical needs, and the limitations of existing therapies propel R&D efforts toward novel agents with mechanisms of action resistant to cross-resistance and favorable pharmacokinetics.

Q2: How do patent expirations affect market dynamics in D01B antifungals?
Patent expirations expose the market to generics, reducing prices and increasing accessibility. However, active patent protections around new formulations and mechanisms can sustain exclusivity and competitive advantage for innovators.

Q3: What regions are most active in filing patents for antifungals?
The US and Europe dominate patent filings, with increasing activity in China and Japan, reflecting strategic measures to secure global market share.

Q4: How are emerging resistance mechanisms influencing patent strategies?
Patent filings increasingly focus on novel drug targets, combination therapies, and resistance bypass pathways to extend patent life and market relevance.

Q5: What are the next-generation antifungal classes under patent development?
Candidates include GPI-anchor biosynthesis inhibitors (e.g., fosmanogepix), long-acting echinocandins, and inhibitors targeting novel fungal pathways beyond the ergosterol synthesis.

9. Key Takeaways

The ATC Class D01B antifungal market is characterized by steady growth driven by clinical demands and resistance challenges.
Patent activity emphasizes innovation in formulations, mechanisms of action, and overcoming resistance, with notable patents extending into the early 2030s.
Strategic patent filings across multiple jurisdictions are vital for global protection amid evolving resistance and competition.
Emerging agents, such as fosmanogepix and rezafungin, are poised to disrupt existing class dynamics.
Companies investing in next-generation therapies with robust patent portfolios will secure advantageous market positions.

References

[1] Market Research Future, "Global Antifungal Market Size," 2023.
[2] Grand View Research, "Antifungal Drugs Market Forecast," 2023.
[3] WHO Global Antimicrobial Resistance Surveillance System (GLASS), 2022.
[4] Lung et al., "Rising Incidence of Fungal Infections," Clin Infect Dis, 2022.

Drugs in ATC Class D01B

Subclasses in ATC: D01B - ANTIFUNGALS FOR SYSTEMIC USE

Market Dynamics and Patent Landscape for ATC Class D01B: Antifungals for Systemic Use