Coccidioidomycosis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The rising incidence of coccidioidomycosis is linked to a growing population of immunocompromised individuals, including those with HIV/AIDS, organ transplants, or on immunosuppressive therapies. Additional risk factors include diabetes, older age, male sex, and genetic immune deficiencies.
• Coccidioides immitis, the causative agent of coccidioidomycosis (Valley Fever), is largely confined to the southwestern United States, suggesting that case occurrence in other 7MM countries is comparatively lower.
• According to Centers for Disease Control and Prevention (CDC), each year around 20,000 cases of Valley fever are reported in the US.
• There remains a critical unmet need for an approved therapy, as no authorized treatment currently exists. The absence of approved drugs limits therapeutic options for patients and hinders market expansion. Introducing an effective, approved therapy could significantly drive market growth and address this long-standing treatment gap.
• The therapeutic pipeline for coccidioidomycosis is expanding, driven by innovative agents such as Ibrexafungerp, Olorofim, and VT-1161, along with active development efforts by companies like SCYNEXIS, F2G, and Mycovia Pharmaceuticals. These advancements reflect growing investment in antifungal research and are expected to significantly contribute to market growth by addressing unmet clinical needs and offering novel treatment options for resistant and invasive fungal infections.
• In October 2020, F2G reported that the US FDA awarded olorofim Breakthrough Therapy Designation (BTD), further recognizing its potential as an innovative treatment.

DelveInsight's comprehensive report titled "Coccidioidomycosis - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of coccidioidomycosis. The report presents historical and projected epidemiological data covering incident cases of coccidioidomycosis, age-specific incident cases of coccidioidomycosis, and gender-specific incident cases of coccidioidomycosis. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in coccidioidomycosis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Coccidioidomycosis Overview

Coccidioidomycosis (Valley Fever) is a fungal infection caused by C. immitis and C. posadasii, found in arid desert soils of the southwestern US. The fungi grow as mycelia (filamentous form) in soil and transform into spores that can become airborne and inhaled. In rare cases, spores may enter through broken skin. C. immitis is limited to California, while C. posadasii occurs in other US regions and internationally. Despite geographic differences, both species are phenotypically identical, with similar clinical features and drug susceptibilities. Routine labs typically do not differentiate between the two due to the need for molecular diagnostics.

Symptoms include fatigue, cough, fever, headache, shortness of breath, night sweats, joint/muscle pain, and rash. Valley Fever may resolve on its own or require antifungal treatment, particularly in immunocompromised individuals.

Coccidioidomycosis Diagnosis and Treatment Overview

Diagnosis relies on a combination of clinical suspicion (endemic exposure, compatible symptoms) and confirmatory laboratory tests: demonstration of spherules in microscopy (sputum, exudate, and biopsy), fungal culture, molecular identification by Polymerase Chain Reaction (PCR), or serologic testing (IgM, IgG via enzyme immunoassay, tube-precipitin and complement fixation). Imaging (chest X-ray or CT) assesses pulmonary involvement, cavities, or nodules.

Treatment depends on severity. Mild or self-limited cases may not need therapy; those with symptoms persisting >= 8 weeks or risk factors (immunosuppression, disseminated disease) require antifungal treatment. Oral azoles, primarily fluconazole (400 mg/day) or itraconazole are first-line for pulmonary or extrapulmonary disease, typically for 3-6 months, and extended to 12 months or longer if response is slow or disseminated. Severe or diffuse pneumonia and disseminated or CNS disease use amphotericin B, with lipid formulations preferred to reduce nephrotoxicity; Coccidioidal meningitis, a severe complication of coccidioidomycosis requires high-dose fluconazole, possibly intrathecal amphotericin if refractor.

Coccidioidomycosis Epidemiology

The epidemiology section of the coccidioidomycosis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of coccidioidomycosis. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• According to our secondary analysis, the incidence of coccidioidomycosis increases progressively with age, peaking among individuals aged 70 and older at 209 cases per 100,000 population in the US. In contrast, the incidence is lowest in children aged 1 to 4 years, at 7.7 cases per 100,000 population.
• In the US, coccidioidomycosis cases have shown a male predominance, with males accounting for approximately 63% of reported cases and experiencing an incidence rate of 17.3 per 100,000 population. In comparison, females represented 37% of cases, with a lower incidence rate of 10 per 100,000.
• According to our analysis, the incidence rate ranged from 0.53 cases per 100,000 person-years among Spanish residents born in endemic countries to 0.3 cases per 100,000 person-years when considering the overall at-risk population.

Coccidioidomycosis Market Outlook

The coccidioidomycosis therapeutics market is further expected to increase by the major drivers, such as the rising incident population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

There are currently no drugs specifically approved for the treatment of coccidioidomycosis. However, several antifungal agents are used off-label to manage the disease. First-line therapy typically includes oral azoles such as fluconazole or itraconazole, while severe or disseminated cases may require intravenous amphotericin B. Newer agents like voriconazole, posaconazole, and isavuconazole are also used in refractory cases. Treatment duration varies based on severity and immune status. Although effective options exist, they are not formally approved for coccidioidomycosis, highlighting a significant unmet need and ongoing reliance on clinical judgment and experience for therapeutic decision-making.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the coccidioidomycosis market in the 7MM is expected to change significantly during the forecast period (2025-2034).

Coccidioidomycosis Drug Chapters

Emerging Drugs

BREXAFEMME (Ibrexafungerp): SCYNEXIS

Ibrexafungerp is the first member of a new class of structurally distinct glucan synthase inhibitors known as triterpenoids. It demonstrates broad-spectrum antifungal activity against Candida, Aspergillus, Pneumocystis, dimorphic fungi, and mucorales-including multi-drug resistant (MDR) and pan-resistant strains like Candida auris. By combining the proven efficacy of glucan synthase inhibition with the versatility of both oral and intravenous formulations, Ibrexafungerp supports widespread clinical application across diverse treatment settings. The drug is approved in vulvovaginal candidiasis.

• The drug has completed the Phase III trial in fungal infection including coccidioidomycosis.
• In March 2023, later amended in December 2023, the company finalized a licensing agreement with GSK. Under this agreement, GSK was granted an exclusive, royalty-bearing, and sub licensable license to develop, manufacture, and commercialize ibrexafungerp, including the approved product BREXAFEMME, across all therapeutic indications.

Olorofim: F2G

Olorofim is a first-in-class oral antifungal in the orotomide class targeting fungal dihydroorotate dehydrogenase (DHODH) to block pyrimidine biosynthesis, causing fungal cell death. It shows potent activity against difficult-to-treat invasive fungal infections, including azole-resistant molds and dimorphic fungi such as Coccidioides. The drug has completed Phase II clinical trial for invasive fungal infections.

• In June 2020, F2G reported that the US FDA granted olorofim the Qualified Infectious Disease Product (QIDP) designation for multiple indications, including coccidioidomycosis. The drug has also received Orphan Drug Designation (ODD), highlighting its potential to address rare and serious fungal infections.

VT-1161: Mycovia Pharmaceuticals

Oteseconazole (VT-1161) is a novel oral tetrazole antifungal developed by Mycovia Pharmaceuticals, primarily targeting fungal cytochrome P450 enzyme 51 (CYP51), which is crucial for ergosterol synthesis and fungal cell membrane integrity. It is highly selective for fungal CYP51 with limited human enzyme interaction, leading to fewer side effects and drug interactions compared to older azoles. Oteseconazole is FDA-approved (brand name VIVJOA) for treating recurrent vulvovaginal candidiasis (RVVC) since April 2022, showing strong activity against fluconazole-resistant Candida species.

• The drug is currently in the Phase I of clinical trial for coccidioidomycosis.

Coccidioidomycosis Market Segmentation

DelveInsight's "Coccidioidomycosis - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a detailed outlook of the current and future coccidioidomycosis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Coccidioidomycosis Market Size by Countries

The coccidioidomycosis market size is assessed separately for various countries, including the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) coccidioidomycosis market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Coccidioidomycosis Drugs Uptake

This section focuses on the sales uptake of potential coccidioidomycosis drugs that have recently been launched or are anticipated to be launched in the coccidioidomycosis market between 2025 and 2034. It estimates the market penetration of coccidioidomycosis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the coccidioidomycosis market.

The emerging coccidioidomycosis therapies are analyzed based on various attributes such as efficacy and safety in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the coccidioidomycosis market.

Coccidioidomycosis Market Access and Reimbursement

DelveInsight's "Coccidioidomycosis - Market Insights, Epidemiology, and Market Forecast - 2034" report provides a descriptive overview of the market access and reimbursement scenario of coccidioidomycosis. This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current coccidioidomycosis market trends and to fill gaps in secondary findings, we interview KOLs' and SMEs' working in the coccidioidomycosis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or coccidioidomycosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the coccidioidomycosis unmet needs.

Coccidioidomycosis: KOL Insights

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as, University of Florida, Gainesville, US, Scripps Health System, San Diego, CA US; Centers for Disease Control and Prevention, US; University of New Mexico Health Sciences Center, US; Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain; Surgical and Health Sciences, Trieste University, Italy; Respiratory Center, Toranomon Hospital, Japan, among others

"Coccidioidomycosis remains a major unmet medical need due to the absence of approved disease-modifying therapies. Current management is limited to symptom control, lacking interventions that address the underlying pathology. There's a pressing demand for targeted treatments, early diagnostic tools, and better risk stratification approaches."

"Limited awareness of coccidioidomycosis even among healthcare professionals in endemic regions-continues to drive avoidable healthcare use and associated costs. Like many rare conditions, it is classified as an "orphan disease," which frequently results in obstacles to securing adequate funding and research support."

"California's drought conditions may significantly contribute to a rise in Valley Fever cases. Prolonged dryness promotes the formation of Coccidioides spores in soil, which can become airborne with wind activity. Once aerosolized, these spores are easily inhaled, potentially leading to respiratory infections in exposed individuals."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the coccidioidomycosis. Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Coccidioidomycosis Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for coccidioidomycosis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging coccidioidomycosis therapies.

Coccidioidomycosis Report Insights

• Coccidioidomycosis Patient Population
• Therapeutic Approaches
• Coccidioidomycosis Pipeline Analysis
• Coccidioidomycosis Market Size and Trends
• Coccidioidomycosis Market Opportunities
• Impact of Upcoming Therapies

Coccidioidomycosis Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Coccidioidomycosis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Coccidioidomycosis Market
• Coccidioidomycosis Drugs Uptake

Coccidioidomycosis Report Assessment

• Coccidioidomycosis Current Treatment Practices
• Unmet Needs
• Coccidioidomycosis Product Profiles
• Coccidioidomycosis Market Attractiveness

Key Questions:

• How common is coccidioidomycosis?
• What are the key findings of coccidioidomycosis epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for coccidioidomycosis?
• What are the disease risk, burden, and unmet needs of coccidioidomycosis?
• At what CAGR is the coccidioidomycosis market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the coccidioidomycosis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of coccidioidomycosis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of coccidioidomycosis?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the coccidioidomycosis market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for coccidioidomycosis?

The primary treatment goals for coccidioidomycosis are to relieve symptoms, prevent disease progression, and reduce the risk of complications, especially in high-risk individuals. For severe or disseminated cases, the aim is to control infection, minimize organ damage, and prevent relapse. Long-term antifungal therapy may be necessary to maintain disease suppression, particularly in immunocompromised patients or those with central nervous system involvement.

2. What are the challenges in managing coccidioidomycosis?

Managing coccidioidomycosis poses challenges due to its variable clinical presentation, ranging from mild respiratory symptoms to severe disseminated disease. Delayed diagnosis is common, especially outside endemic areas, leading to inappropriate treatment. Limited treatment options, long therapy duration, potential drug toxicity, and frequent relapses complicate care. Additionally, immunocompromised patients face higher risks, and there are no approved vaccines, making prevention and disease control even more difficult.

3. What are the key factors driving the growth of the coccidioidomycosis market?

Rising incidence of Valley fever, especially in endemic regions, is fueling demand for antifungal therapies. The growing immunocompromised population due to HIV/AIDS, cancer treatments, transplants, and chronic diseases also heightens need for effective treatments. Expanding healthcare infrastructure, increased awareness and reporting, and government support for research boost adoption. Investment in novel antifungal therapeutics, precision medicine, and advanced diagnostics, along with clinical trials and new drug pipelines, further propel market expansion.

4. How will the coccidioidomycosis Market and Epidemiology Forecast Report benefit the clients?

The coccidioidomycosis Market and Epidemiology Forecast Report offers clients strategic insights into disease incidence, patient segmentation, and market dynamics. It helps identify commercial opportunities, assess treatment gaps, and support planning for product development, market entry, or expansion. The report also aids stakeholders in understanding regulatory landscapes, forecasting trends, and making data-driven investment or policy decisions.