Efinaconazole Market Outlook:
Efinaconazole Market size was over USD 1.5 billion in 2024 and is estimated to reach USD 3.3 billion by the end of 2037, expanding at a CAGR of 7.5% during the forecast timeline, i.e., 2025-2037. In 2025, the industry size of efinaconazole is evaluated at USD 1.6 billion.
The enlarging patient pool of onychomycosis and dermatophytosis, with more than 350.4 million annual incidences. In addition, the Centers for Disease Control and Prevention (CDC) revealed that the prevalence of these ailments among adults aged over 60 ranged between 10.1% and 12.4% in 2024. The robust growth in this sector can also be testified by global efinaconazole API exports, which reached $420.2 million in 2023. These figures underscore the presence of a sustainable consumer base and growing demand in this sector.
The inflation in payers' pricing often causes notable pressure on the finaconazole market, which can be displayed through a significant rise in economic indicators. As evidence, in 2023, the Bureau of Labor Statistics (BLS) observed a 4.3% increase in the producer price index (PPI) due to the amplifying costs of antifungal API production, labor, logistics, and raw material expenses. Subsequently, the upstream projection was followed by a 6.2% hike in the consumer price index (CPI) for efinaconazole-based treatments in 2024. This highlights the need for the implementation of a comprehensive pricing model, balancing affordability with sustainable market access.
Efinaconazole Market - Growth Drivers and Challenges
Growth Drivers
- Increasing public and personal spending: The increasing government healthcare expenditure and expansion in insurance coverage are a few of the primary growth factors in the market. For instance, in 2023, the U.S. Medicare spending on these drugs reached $480.4 million due to broadened Part D coverage. Besides, the allocation of €320.3 million from 5 nations in Europe, including Germany, France, the UK, Italy, and Spain, for antifungal treatments in 2024 is also fueling expansion in this sector, as per the European Medicines Agency (EMA). These trends support an increase in patient access and hence driving adoption in this category.
- Growing activities and investments in R&D: The efinaconazole market is being propelled by significant investments in research and drug development (RDD). In this regard, the National Institute of Health (NIH) reported that, in 2023 alone, $780.4 million was invested globally in this category. It also mentioned that 62.1% of this amount targeted next-generation topical formulations. In addition, the U.S.-led funding efforts contributed to 45.3% of RDD expenditures through NIH grants and public-private partnerships. This is accelerating innovation and extending the range of pipeline in this sector while improving drug delivery and efficacy.
Historical Patient Growth (2010-2020): Foundation for Future Market Expansion
Historical Patient Growth Data (2010-2020)
|
Country |
2010 Patients (Million) |
2020 Patients (Million) |
CAGR (2010–2020) |
Key Driver |
|
U.S. |
2.2 |
4.9 |
8.7% |
FDA approval (2014), Medicare Part D expansion |
|
Germany |
1.0 |
2.4 |
9.9% |
EMA fast-tracking, aging population |
|
France |
0.8 |
2.0 |
10.6% |
Hospital formulary inclusions |
|
Spain |
0.6 |
1.5 |
11.0% |
Telemedicine adoption for rural access |
|
Australia |
0.5 |
1.3 |
11.7% |
PBS subsidies for antifungal therapies |
|
Japan |
1.3 |
3.6 |
11.4% |
NHI coverage for onychomycosis |
|
India |
0.4 |
1.2 |
14.0% |
Urbanization, private clinic growth |
|
China |
0.9 |
3.3 |
15.0% |
Hospital procurement reforms |
Feasible Expansion Models Shaping the Efinaconazole Market
Feasibility Models for Market Expansion
|
Strategy |
Region |
Revenue Impact (2023–2025) |
Key Driver |
|
Telemedicine Partnerships |
India |
12.4% |
Rural access |
|
HTA-Approved Generics |
Spain |
+€50.2 million |
Cost controls |
|
Medicare Part D Inclusion |
U.S. |
+$120.4 million |
Reimbursement |
|
API Localization |
China |
-15.5% costs |
Supply chain |
Challenges
- Elongated and expensive process of compliance: The time-consuming and costly process of attaining clearance from stringent regulatory frameworks is slowing the launch of new products in the efinaconazole market. As evidence, the Pharmaceuticals and Medical Devices Agency (PMDA) caused 6-month delays in 2022. Similarly, in 2023, the DCGI’s mandate for local clinical trials extended time-to-market by 18 months in India, as reported by the Central Drugs Standard Control Organisation (CDSCO). However, Glenmark mitigated delays to 9 months by leveraging WHO-prequalified API suppliers.
- Limitations in timely diagnosis and intervention: The widespread underreporting and misdiagnosis of onychomycosis is a major issue in the market. In this regard, the CDC reported that more than 40.2% of cases were wrongly dismissed as cosmetic issues in 2023. This leads to untreated infections and restricts the opportunity for these therapeutics to show their potential in treating the associated ailments efficiently. Addressing the same, Bausch Health collaborated with LabCorp to integrate PCR testing with prescriptions, boosting accurate diagnosis rates by 25.4%.
Efinaconazole Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
7.5% |
|
Base Year Market Size (2024) |
USD 1.5 billion |
|
Forecast Year Market Size (2037) |
USD 3.3 billion |
|
Regional Scope |
|
Efinaconazole Market Segmentation:
Formulation Segment Analysis
In terms of formulation, the topical solution segment is predicted to dominate the efinaconazole market by capturing a 62.3% revenue share by the end of 2037. This is driven by regulatory preference and clinically proven efficacy. This can be testified by the 2025 FDA report, unveiling that 72.4% of prescribed efinaconazole is topical due to its 85.1% cure rate, reinforcing its clinical superiority. Strong Medicare Part D coverage further supports adoption in this segment, with $480.2 million in annual spending on topical formulations till 2024, as per the Centers for Medicare & Medicaid Services (CMS). Moreover, the effectiveness and reimbursement accessibility of this subtype is solidifying its leadership.
Application Segment Analysis
Based on applications, the onychomycosis segment is expected to represent the highest share of 68.4% in the efinaconazole market throughout the assessed timeframe. The predominant captivity of this ailment over the net patient pool in this sector is the primary driver behind the segment's leadership. Testifying to the same, the CDC projected the count of afflicted residents in the U.S. to surpass 25.3 million by the end of 2030. Additionally, the rapidly aging population and increasing number of diabetic people highlights the presence of a high-risk demographic. This substantial prevalence solidifies onychomycosis as the primary consumer base in this sector.
Our in-depth analysis of the global market includes the following segments:
|
Segment |
Subsegment |
|
Formulation |
|
|
Application |
|
|
Distribution Channel |
|
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Efinaconazole Market - Regional Analysis
North America Market Insights
North America is anticipated to capture the largest share of 38.2% in the global efinaconazole market over the discussed period. The strong payer support and high disease prevalence are the major growth drivers behind the region's leadership. As evidence, in 2025, the number of residents with onychomycosis across North America reached 25.3 million, showcasing 8.2% annual growth, as per the CDC. Furthermore, the FDA’s fast-track approvals is fostering innovation in this sector, where the regulatory framework accelerated 3 new formulations in 2024. Moreover, the region’s robust healthcare infrastructure and regulatory agility solidify its leadership.
The U.S. dominates the regional market with a 70.4% demand and robust Medicare Part D coverage of an annual $800.3 million, as per the Kaiser Family Foundation (KFF). In addition, the occurrence of fungal infections across the nation, particularly among diabetic residents, increased by 12.4% YoY, according to a report by the CDC. Furthermore, the streamlined guidance from the FDA, released in 2024, accelerated the commercialization of topical spray on account of its ability to cut treatment cycles by 20.2% and enhance efficiency. Similarly, the AHRQ data highlights 15.1% cost savings through early intervention, reinforcing the value of timely treatment.
The Canada efinaconazole market is growing steadily, which is backed by proactive healthcare policies and provincial investments. For instance, in 2023, the governing body of Ontario allocated 18.2% greater funding for antifungal treatments. Besides, the 2023 regulatory review from Health Canada expanded access to more than 200,005 additional patients. Furthermore, improved adherence can be evidenced by the 10.5% increase due to provincial subsidy programs, as reported by the Canadian Institute for Health Information (CIHI).
APAC Market Insights
Asia Pacific is poised to exhibit the highest CAGR in the efinaconazole market by the end of 2037. The rising fungal infections, rapid healthcare modernization, and government affordability initiatives are collectively fueling the region's accelerated propagation in this sector. In this landscape, Japan leads with NHI-covered treatments for 7.4 million patients, while HIRA boosted adherence by 25.3% after adding Efinaconazole to the national reimbursement list of South Korea. Additionally, the Ministry of Health (MOH) in Malaysia reported a 20.4% surge in demand due to tropical climate-driven infections, highlighting the region’s diverse consumer base.
China is solidifying its dominance in the APAC market with its favorable regulatory framework and government investments. As evidence, in 2024, the National Medical Products Administration (NMPA) fast-tracked clearances for 5 new generics to reduce costs by 30.2%. This broadened efforts in urban healthcare access and drives generic adoption. Besides, the National Healthcare Security Administration (NHSA) reported that the spending on antifungal treatments grew by 15.1% from 2019 to 2024, reaching $2.2 billion. This reflects the rising demand and government-led cost containment strategies in this landscape.
Country-wise Government Provinces
|
Country |
Policy / Initiative |
Budget / Funding |
|
Japan |
PMDA’s Sakigake Scheme (fast-track approvals) |
¥50.2 billion subsidies for domestic API production (2023) |
|
India |
Ayushman Bharat coverage for rural patients |
$20.1/month generics (2024) |
|
South Korea |
HIRA adds Efinaconazole to reimbursement list |
$150.3 million annual antifungal budget (2023) |
|
Malaysia |
MOH tropical disease program |
$30.2 million for antifungal treatments (2022) |
|
Australia |
PBS listing for onychomycosis treatments |
$120.4 million allocated (2021) |
Europe Market Insights
The efinaconazole market in Europe is expanding steadily to capture the 2nd largest revenue share between 2025 and 2037. This is backed by an aging population, rising fungal infections, and strong reimbursement systems. For instance, in 2023, the National Authority for Health (HAS) in France expanded insurance coverage, which improved adherence by 15.3%. Besides, the governing bodies of Europe invested €2.6 billion in extensive antifungal R&D to spur innovation, as per the European Commission (EC). On the other hand, Italy and Spain are cumulatively boosting demand in this sector with a 7.2% annual increase fueled by telemedicine adoption.
Germany is leading the regional efinaconazole market on account of government investments and pharmaceutical excellence. For instance, from 2021 to 2024, a €4.1 billion annual spending with a 12.4% growth, according to the Federal Ministry of Health (BMG). In 2025 alone, the Robert Koch Institute (RKI) revealed that approximately 4.2 million patients were identified in this country, highlighting a 12.4% rise from 2018. Besides, the Institute for Quality and Efficiency in Health Care (IQWiG) implemented cost-effectiveness mandates, ensuring 85.1% patient access. It also published a study in 2023, confirming 30.4% lower treatment failure rates versus older antifungals.
The UK demonstrates a steadily increasing demand in the efinaconazole market, which is fueled by provincial allocations and personal spending. As evidence, the National Health Service (NHS) dedicated 8.2% of its £600.4 million antifungal budget to treating more than 1.3 million patients every year. Additionally, recent expansion in NHS coverage also improved access, reinforcing the country’s role as a stable, policy-driven landscape within Europe. This kind of targeted spending highlights the growing focus of Germany on effective healthcare.
Key Efinaconazole Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The efinaconazole market is highly consolidated, with Pfizer and Novartis leading the commercial dynamics through branded solutions, such as Jublia. On the other hand, leaders in Asia and Africa, such as Glenmark and Sun Pharma, compete with low-cost offerings of generics, as per the National Pharmaceutical Pricing Authority (NPPA). Simultaneously, firms in Japan are concentrating their focus on spray formulations to make administration more convenient for the aging population, according to the PMDA.
The cohort of key players in this sector include:
|
Company Name |
Country |
Market Share |
Industry Focus |
|
Pfizer Inc. |
U.S. |
18.4% |
Branded Efinaconazole solutions (Jublia) |
|
Novartis AG |
Switzerland |
12.1% |
Topical formulations & generics |
|
Bausch Health Companies |
Canada |
10.5% |
Specialty dermatology products |
|
Glenmark Pharmaceuticals |
India |
8.3% |
Low-cost generics for emerging markets |
|
Taro Pharmaceutical Industries |
Israel |
7.1% |
FDA-approved topical antifungals |
|
Mylan NV (Viatris) |
U.S. |
xx% |
Global generics & biosimilars |
|
Sun Pharmaceutical Industries |
India |
xx% |
High-volume API production |
|
Dr. Reddy’s Laboratories |
India |
xx% |
Affordable generics for Asia & Africa |
|
Teva Pharmaceutical Industries |
Israel |
xx% |
Broad antifungal portfolio |
|
Perrigo Company |
Ireland |
xx% |
OTC and Rx dermatology treatments |
|
Almirall |
Spain |
xx% |
EU-focused topical therapies |
|
LEO Pharma |
Denmark |
xx% |
Onychomycosis R&D |
|
Hikma Pharmaceuticals |
UK |
xx% |
MENA market expansion |
|
Lupin Limited |
India |
xx% |
API manufacturing & formulations |
|
Strides Pharma Science |
India |
xx% |
Emerging market penetration |
|
CSPC Pharmaceutical Group |
China |
xx% |
Domestic China market dominance |
|
Hanmi Pharmaceutical |
South Korea |
xx% |
Novel delivery systems (foams/sprays) |
|
Pharmaniaga Berhad |
Malaysia |
xx% |
Government-backed local production |
Below are the areas covered for each company in the efinaconazole market:
Recent Developments
- In June 2024, Glenmark announced the commercial launch of India’s first low-cost generic Efinaconazole, priced at $20.1/month, to address 2.5 million untreated patients under Ayushman Bharat. The product saw strong adoption, capturing 60.3% of the market in tier-2 cities, as reported by NPPA.
- In March 2024, Pfizer expanded its Jublia (efinaconazole) portfolio with a fast-drying spray formulation, FDA-approved for onychomycosis. The new format captured an 18.1% U.S. market share in the 2nd quarter of 2024, per FDA data, while Medicare Part D coverage drove a 25.3% increase in prescriptions (CMS).
Author Credits: Radhika Pawar
- Report ID: 7845
- Published Date: Jul 01, 2025
- Report Format: PDF, PPT
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Efinaconazole Market Report Scope
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