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

Key Highlights:

• In 2023, the Aspergillosis market size in the 7MM, accounted for approximately USD 2,606 million which is further expected to increase at an approximate compound annual growth rate (CAGR) of 11% by 2034.
• The Key barriers in aspergillosis market include limited treatment options for resistant strains. Reimbursement policies impact drug accessibility and the unmet need for effective-affordable treatments and broader diagnostic capabilities continues to drive market demand.
• The diagnosed prevalence of Aspergillosis has risen gradually, due to higher prevalence in immunocompromised individuals, chronic disease increases, and advancements in treatment and diagnostics, along with increased awareness. In 2023, the estimated number of diagnosed cases across the 7MM is approximately 1,213 thousand cases.
• Aspergillosis is a significant health issue in the United States, and its prevalence has been increasing over the past few decades. According to DelveInsight estimates, among the 7MM, the US has most number of cases of Aspergillosis accounting for 33% of cases alone, followed by Japan, and the UK in 2023.
• DelveInsight's analysis reveals that in the 7MM, the prevalence of allergic bronchopulmonary aspergillosis (ABPA) is higher than the other two types of aspergillosis; chronic pulmonary aspergillosis (CPA) and invasive aspergillosis (IA).
• The availability of low-cost generics and off-label therapies, such as Voriconazole and Caspofungin, presents a significant challenge to the market growth of new drugs. Their affordability and ease of access can limit the adoption of newly developed treatments, potentially requiring regulatory intervention to address this issue.
• In March 2024, the US FDA granted orphan drug and pediatric exclusivity to CRESEMBA (isavuconazonium sulfate) for the treatment of invasive Aspergillosis and invasive mucormycosis in pediatric patients.
• The total market size of Aspergillosis is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes Opelconazole and others.
• In April 2024, Pulmocide Ltd. reported positive topline results from the OPERA-S study, a Phase II trial evaluating inhaled opelconazole in lung transplant patients. The study demonstrated that opelconazole was well tolerated, with fewer adverse events and drug-drug interactions than standard care, effectively preventing and eradicating pulmonary Aspergillus and Candida infections.
• In January 2024, TFF Pharmaceuticals announced that it will present Phase II trial data on Voriconazole Inhalation Powder (TFF VORI) for treating invasive pulmonary aspergillosis at the 11th Advances Against Aspergillosis & Mucormycosis Conference in Milan, Italy, showcasing advancements in treatment for this severe fungal infection.

DelveInsight's "Aspergillosis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Aspergillosis, historical and forecasted epidemiology as well as the Aspergillosis market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Aspergillosis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Aspergillosis market size from 2020 to 2034. The Report also covers current Aspergillosis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Aspergillosis Treatment Market

Aspergillosis Overview

Aspergillosis is a fungal infection caused by the Aspergillus species, most commonly Aspergillus fumigatus. It primarily affects individuals with weakened immune systems or pre-existing lung conditions, such as chronic obstructive pulmonary disease (COPD) or cystic fibrosis. The disease spectrum includes allergic fungal sinusitis, invasive aspergillosis, and chronic pulmonary aspergillosis. Allergic fungal sinusitis involves an immune response to the fungus in the sinuses, leading to chronic inflammation and sinusitis. Invasive aspergillosis is a severe, potentially life-threatening form that can disseminate from the lungs to other organs, particularly in immunocompromised patients, such as those undergoing chemotherapy or with advanced HIV/AIDS. Chronic pulmonary aspergillosis manifests as a long-term lung infection that may develop from prior pulmonary conditions.

Aspergillosis Diagnosis

Diagnosing aspergillosis involves a combination of clinical assessment, imaging studies, and laboratory tests. Clinicians typically start with a thorough medical history and physical examination, focusing on symptoms such as persistent cough, fever, and chest pain. Imaging techniques, particularly high-resolution computed tomography (CT) scans, are crucial for visualizing lung abnormalities indicative of aspergillosis, such as nodules or infiltrates.

Laboratory diagnosis includes microbiological culture of respiratory specimens or biopsies to identify Aspergillus species. Serological tests detect specific antibodies or antigens related to Aspergillus, such as the galactomannan antigen test, which is useful in diagnosing invasive aspergillosis. Additionally, molecular techniques like polymerase chain reaction (PCR) can identify Aspergillus DNA in clinical samples. For certain forms, such as allergic fungal sinusitis, nasal or sinus biopsy may be required. Accurate diagnosis often necessitates a combination of these methods to confirm the presence and extent of infection.

Despite advances in Aspergillosis diagnostics, current diagnostic approaches face several challenges, including delays due to time-consuming and complex testing processes. The sensitivity and specificity of available tests, such as antigen assays and cultures, are often inadequate, leading to potential misdiagnoses or delayed treatment. There's a significant unmet need for rapid, non-invasive diagnostic methods with improved accuracy to facilitate early detection, particularly in asymptomatic or mild cases, and enhance overall patient outcomes.

Aspergillosis Treatment

Treatment of aspergillosis varies based on the type and severity of the infection. For invasive aspergillosis, which is life-threatening and primarily affects immunocompromised patients, systemic antifungal therapy is critical. First-line treatments often include triazoles like voriconazole or posaconazole, which target the fungus effectively. In cases of resistance or severe infection, echinocandins such as caspofungin may be used. Chronic pulmonary aspergillosis is typically managed with long-term antifungal therapy, often involving itraconazole or voriconazole. Surgical intervention may be necessary for patients with significant pulmonary damage or persistent disease despite antifungal therapy. Caspofungi, an echinocandin is also used as a salvage therapy for patients who are refractory to or intolerant of first-line treatments.

For allergic fungal sinusitis, treatment generally includes a combination of antifungal therapy and surgical debridement to remove fungal material from the sinuses. Corticosteroids may also be prescribed to reduce inflammation and manage symptoms. Across decades, various classes have been approved by the US FDA for the treatment of Aspergillosis, that include Voriconazole, Isavuconazole, Liposomal Amphotericin B, Posaconazole, and others which are used as first-line pharmacotherapy.

Astella's CRESEMBA (Isavuconazole) is the first entrant in the US (2015) market. Isavuconazole treats aspergillosis by inhibiting the enzyme lanosterol 14-alpha-demethylase, crucial for converting lanosterol to ergosterol, a key fungal cell membrane component. This inhibition leads to an accumulation of sterol precursors and reduced ergosterol, weakening the fungal membrane. Mammalian cell membranes are less affected by this inhibition.

Aspergillosis Epidemiology

As the market is derived using the patient-based model, the Aspergillosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Aspergillosis and Total Diagnosed and treated pool by types Cases of Aspergillosis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

• In 2023, the US reported around 568 thousand prevalent cases of aspergillosis, with allergic bronchopulmonary aspergillosis (ABPA) comprising 92% of these cases, and chronic pulmonary aspergillosis (CPA) representing only 2%. Both forms are expected to see an increase in prevalence over the forecast period.
• In 2023, the UK represented a significant share of diagnosed prevalent cases of Aspergillosis among the EU4 and the UK, accounting around 179 thousand of cases alone, while Spain reported the lowest diagnosed prevalence nearly 67 thousand cases. This disparity highlights the UK's predominant role in the regional Aspergillosis landscape compared to Spain's minimal case load.
• DelveInsight's estimates reveal a significant disparity in aspergillosis types in Japan, with ABPA accounting for nearly 334 thousand cases, while Invasive Aspergillosis constitutes only about 4,419 cases out of 343 thousand total cases, highlighting a pronounced type-specific variation in diagnosed prevalence.

Aspergillosis Drug Chapters

The drug chapter segment of the Aspergillosis market report encloses a detailed analysis of Aspergillosis off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Aspergillosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Aspergillosis Drugs

CRESEMBA: Astellas Pharma/ Basilea Pharmaceutica International

• CRESEMBA (isavuconazonium sulfate) is an azole antifungal medicine indicated for the treatment of adults with either of two life-threatening fungal infections: invasive Aspergillosis and invasive mucormycosis as follows:
• CRESEMBA for injection: Adults and pediatric patients 1 year of age and older
• CRESEMBA capsules: Adults and pediatric patients 6 years of age and older who weigh 16 kg and greater.
• In March 2015, the FDA approved Astellas's Cresemba for treating Invasive Aspergillosis in adults.
• In December 2023, the US FDA approved CRESEMBA (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive Aspergillosis and invasive mucormycosis in pediatric patients. CRESEMBA for injection is approved for adults and now for pediatric patients 1 year of age and older. CRESEMBA capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kg and greater.
• In March 2024, the US FDA granted orphan drug and pediatric exclusivity to CRESEMBA (isavuconazonium sulfate) for the treatment of invasive Aspergillosis and invasive mucormycosis in pediatric patients.

Emerging Aspergillosis Drugs

Olorofim (F901318): F2G

F2G is developing Olorofim (formerly F901318), a novel antifungal targeting the high mortality of invasive fungal diseases and resistance to existing therapies. As a member of a new antifungal class, Olorofim inhibits dihydroorotate dehydrogenase, crucial for de novo pyrimidine synthesis, offering a unique mechanism compared to current treatments.

Olorofim is the first antifungal agent to receive Breakthrough Therapy designation from the FDA in November 2019 and Orphan Designation from the European Commission in October 2016. The company has granted Shionogi exclusive commercial rights to market Olorofim in Europe and Asia. This extension reflects a strategic move to leverage Shionogi's regional expertise and infrastructure, potentially enhancing market access and distribution for Olorofim across these territories.

At present, Olorofim is being evaluated in a Phase III study designed to compare the efficacy, safety, and tolerability of olorofim with that of AmBisome followed by guideline-based hierarchy standard of care (SOC) in patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. The study is currently in recruiting stage and is estimated to be completed by September 2025.

Opelconazole (PC945): Pulmocide

Pulmocide is developing PC945, an innovative inhaled triazole aimed at treating Pulmonary Aspergillosis. PC945 targets sterol 14a-demethylase (CYP51A1), crucial for ergosterol synthesis in fungi, and is designed for high local lung concentrations with minimal systemic exposure. It is 30- to 100-fold more potent than Voriconazole against Aspergillus fumigatus and is administered via nebulizer at low doses (0.5-5mg daily).

Pulmocide's robust pipeline includes ongoing investigations for the treatment and prevention of Pulmonary Aspergillosis. Specifically, they are advancing a Phase III trial for the treatment of invasive pulmonary aspergillosis and a Phase II study focused on prophylaxis of pulmonary aspergillosis. This strategic pipeline development underscores Pulmocide's commitment to addressing both therapeutic and preventive needs in managing aspergillosis.

Opelconazole has received several FDA designations that may facilitate its expedited development and/or review, including orphan drug designation, Fast Track designation, and qualified infectious disease product (QIDP) designation. It has also been granted orphan drug designation in the European Union.

Aspergillosis Market Outlook

Aspergillosis, a serious fungal infection, has several treatment options depending on its type and severity. The primary treatments include azoles, echinocandins, and polyenes. Azoles, such as voriconazole and posaconazole, are commonly used as first-line therapies due to their effectiveness against various Aspergillus species. They inhibit ergosterol synthesis, crucial for fungal cell membrane integrity. For severe or resistant cases, echinocandins like caspofungin may be prescribed, as they interfere with glucan synthesis, another essential component of the fungal cell wall. Polyenes, such as amphotericin B, are used for their broad-spectrum activity and are often reserved for refractory or life-threatening infections.

Recent advancements introduce new therapies like isavuconazole, which offers a more favorable side effect profile and convenience compared to traditional azoles.

The launch of emerging Aspergillosis therapies, such as PC945, Olorofim, and others are expected to impact the market positively. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.

• The Aspergillosis market size in the US was nearly USD 1,125 million in 2023, which is further anticipated to increase at an approximate compound annual growth rate (CAGR) of 10% during the forecast period.
• The EU4 and the UK accounted for the approximately USD 866 million market size of Aspergillosis approximately in 2023 and is estimated to rise at a significant compound annual growth rate (CAGR) throughout the forecast period.
• Among the EU countries, the UK had the highest Aspergillosis market size with ~USD 325 million in 2023, while Spain had the lowest Aspergillosis market size with USD ~110 million in 2023.
• With the expected launch of upcoming Aspergillosis therapies, such as Opelconazole (PC945), and Olorofim, among others, the total market size of Aspergillosis is expected to show change in the upcoming years.

Aspergillosis Drugs Uptake

This section focuses on the uptake rate of potential Aspergillosis drugs expected to launch in the market during 2020-2034. For example, Opelconazole (PC945) in the US is expected to be launched with a peak share of 9.0%. Opelconazole (PC945) is anticipated to take 9 years to peak with a medium-fast uptake.

Aspergillosis Pipeline Development Activities

The Aspergillosis market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key Aspergillosis companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Aspergillosis market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Aspergillosis emerging therapies.

Aspergillosis KOL Views

To keep up with current Aspergillosis market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Aspergillosis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from The University of Missouri, Columbia, Missouri, US; University of Iowa, Iowa City, Iowa, US; Hospital Universitari de la Ribera, Alzira, Valencia, Spain; Universite Montpellier, Montpellier, France; University of Pisa, Pisa, Italy; Robert Koch Institute, Berlin, Germany; Teikyo University School of Medicine, Tokyo, Japan; and others.

Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Aspergillosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging Aspergillosis therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Aspergillosis Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The Aspergillosis market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Aspergillosis Market Report

• The Aspergillosis market report covers a segment of key events, an executive summary, descriptive overview of Aspergillosis, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging Aspergillosis therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Aspergillosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The Aspergillosis market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Aspergillosis market.

Aspergillosis Market Report Insights

• Aspergillosis Patient Population
• Aspergillosis Therapeutic Approaches
• Aspergillosis Pipeline Analysis
• Aspergillosis Market Size
• Aspergillosis Market Trends
• Existing and Future Aspergillosis Market Opportunity

Aspergillosis Market Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Aspergillosis Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Aspergillosis Drugs Uptake
• Key Aspergillosis Market Forecast Assumptions

Aspergillosis Market Report Assessment

• Current Aspergillosis Treatment Practices
• Aspergillosis Unmet Needs
• Aspergillosis Pipeline Product Profiles
• Aspergillosis Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Aspergillosis Market Insights

• What was the Aspergillosis market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Aspergillosis market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the Aspergillosis market across the 7MM and which country will have the largest Aspergillosis market size during the forecast period (2024-2034)?
• At what CAGR, the Aspergillosis market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• What would be the Aspergillosis market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the Aspergillosis market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the Aspergillosis market dynamics and subsequent analysis of the associated trends?

Aspergillosis Epidemiology Insights

• What is the disease risk, burden, and unmet needs of Aspergillosis?
• What is the historical Aspergillosis patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Aspergillosis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Aspergillosis?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Aspergillosis during the forecast period (2024-2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Aspergillosis along with the approved therapy?
• What are the current treatment guidelines for the treatment of Aspergillosis in the US, Europe, And Japan?
• What are the Aspergillosis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many Aspergillosis companies are developing therapies for the treatment of Aspergillosis?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Aspergillosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Aspergillosis therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Aspergillosis and their status?
• What are the key designations that have been granted for the emerging therapies for Aspergillosis?
• What are the 7MM historical and forecasted Aspergillosis market?

Reasons to Buy:

• The Aspergillosis market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Aspergillosis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing Aspergillosis market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current Aspergillosis patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming Aspergillosis companies in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing Aspergillosis market so that the upcoming players can strengthen their development and launch strategy.