침습성 진균 감염증 - 시장 인사이트, 역학, 시장 예측(2034년)
Invasive Fungal Infections - Market Insights, Epidemiology, and Market Forecast - 2034
상품코드 : 1855026
리서치사 : DelveInsight
발행일 : On Demand Report
페이지 정보 : 영문 157 Pages
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한글목차

주요 하이라이트

침습성 진균 감염증 시장 전망

침습성 진균 감염증의 치료는 제한된 약제군, 내성균의 증가, 안전성 문제 등으로 인해 여전히 매우 어려운 실정입니다. 현재 치료는 아졸계, 에키노칸딘계, 폴리엔계, 5 FC에 의존하고 있지만, 칸디다오리스, 칸디다 그라브라타, 아졸 내성 아스페르길루스 후미가타스 등 다제내성 균주가 이러한 치료제의 효과를 압박하고 있습니다. 진단법 개선, 고위험군 환자의 예방적 사용 확대, 항진균제 설계 및 전달의 혁신 등이 시장 성장을 촉진하는 요인으로 작용하고 있습니다. REZZAYO(rezafungin), CRESEMBA(isavuconazole) 등 최근 승인된 약제들은 진전을 보이고 있으며, fosmanogepix, ibrexafungerp, colorofim 등 후기 단계의 후보물질들은 새로운 기전, 경구용 제형, 내성 병원균에 대한 활성을 제공함으로써 내성 병원균에 대한 활성을 제공함으로써 치료법을 재구성할 수 있을 것으로 기대되고 있습니다. 이러한 추세에도 불구하고 독성, 약물 간 상호작용, 내성균의 동향은 여전히 큰 미충족 수요를 부각시키고 있으며, 침습성 진균 감염증 시장은 차세대 치료제가 매우 중요한 역할을 할 것으로 예상되는 신중한 진화의 한 분야가 되고 있습니다.

본 보고서에서는 침습성 진균 감염증의 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)의 침습성 진균 감염증 시장을 조사 분석했으며, 각 지역의 시장 규모, 현재 치료법, 미충족 수요, 신약 등의 정보를 제공합니다.

목차

제1장 중요한 인사이트

제2장 보고서 소개

제3장 주요 요약

제4장 주요 사건

제5장 역학과 시장 예측 조사 방법

제6장 침습성 진균 감염증 시장 개요

제7장 질환 배경과 개요

제8장 역학과 환자 인구

제9장 환자 여정

제10장 출시약

제11장 신약

제12장 침습성 진균 감염증 : 주요 7개 시장 분석

제13장 미충족 수요

제14장 SWOT 분석

제15장 KOL의 견해

제16장 시장 진입과 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM
영문 목차

영문목차

Key Highlights:

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

The Invasive fungal infections market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM invasive fungal infections market size from 2020 to 2034. The report also covers current invasive fungal infections treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

Study Period: 2020-2034

Invasive Fungal Infections Understanding and Treatment Algorithm

Invasive Fungal Infections Overview

Invasive fungal infections, are severe conditions characterized by the invasion of fungal pathogens into normally sterile sites, including deep tissues and vital organs, often leading to prolonged illness and life-threatening complications. They predominantly affect individuals with weakened immunity, such as patients undergoing chemotherapy, individuals with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), or organ transplant recipients receiving immunosuppressive therapy. Invasive fungal infections are most commonly caused by Candida species (especially Candida albicans, C. glabrata, C. tropicalis, among others), Aspergillus species (especially Aspergillus fumigatus), Cryptococcus species, dimorphic fungi and many more. The fungi involved are usually opportunistic pathogens that are part of the environment or normal human flora but become pathogenic when host defenses are impaired.

Invasive Fungal Infections Diagnosis

The diagnosis of invasive fungal infections relies on a combination of laboratory, imaging, and histopathological approaches, as no single method is sufficiently sensitive or specific on its own. Traditional fungal culture remains the gold standard for species identification and susceptibility testing, though it is time-consuming. Rapid diagnostic tools such as antigen detection assays (e.g., galactomannan and B-D-glucan) and molecular methods (PCR) are increasingly used for early detection and species-level identification, particularly in immunocompromised patients. Imaging modalities like high-resolution CT and MRI are critical for identifying pulmonary and systemic involvement, while direct microscopy and histopathology provide quick, though less sensitive, evidence of fungal presence in tissue or fluids.

Invasive Fungal Infections Treatment

The treatment of invasive fungal infections requires timely initiation of appropriate antifungal therapy, guided by pathogen type, patient status, and resistance patterns. First-line therapy typically includes azoles (e.g., fluconazole, voriconazole, posaconazole) targeting ergosterol synthesis, echinocandins (e.g., caspofungin, micafungin) disrupting cell wall integrity, and polyenes such as liposomal amphotericin B for severe systemic infections, with pyrimidines like flucytosine used in combination for cryptococcal meningitis. If standard therapy fails or resistance emerges, combination regimens (e.g., azole plus echinocandin) or salvage therapy with liposomal amphotericin B are employed. Adjunctive management involves surgical debridement or resection in infections like mucormycosis and aspergillosis, correction of underlying risk factors (neutropenia, immunosuppression), and immune support with colony-stimulating factors. Treatment is usually prolonged, with duration continuing for at least 14 days after clearance of infection from the bloodstream, and follows a stepwise algorithm integrating first-line, salvage, and emerging therapies for optimal outcomes.

Invasive Fungal Infections Epidemiology

The epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of invasive fungal infections, total incident cases of invasive fungal infections by type, total treatment-eligible cases of invasive fungal infections, and total refractory cases of invasive fungal infections covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

Invasive Fungal Infections Drug Chapters

The drug chapter segment of the invasive fungal infections report encloses a detailed analysis of marketed and emerging drugs of late-stage (Phase III, Phase II, Phase I) pipeline drugs. It also deep dives into the invasive fungal infections pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Therapies

REZZAYO (rezafungin): Cidara Therapeutics/Mundipharma

REZZAYO is a novel once-weekly antifungal injection indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. It belongs to the echinocandin class of antifungals and works by inhibiting the synthesis of 1,3-B-D-glucan, an essential component of the fungal cell wall.

CRESEMBA (isavuconazonium sulfate): Basilea Pharmaceutica/Astellas Pharma

CRESEMBA is an azole antifungal medication used primarily for the treatment of invasive aspergillosis and invasive mucormycosis in adults. It is a prodrug of isavuconazole and is available in both oral capsules and intravenous formulations. This medication works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, thereby helping to treat severe fungal infections. Astellas Pharma and Basilea Pharmaceutica jointly developed and commercialized CRESEMBA.

Emerging Drugs

BREXAFEMME (Ibrexafungerp): GlaxoSmithKline/SCYNEXIS

Ibrexafungerp is the first agent in a novel class of structurally distinct glucan synthase inhibitors known as triterpenoids. It demonstrates broad-spectrum antifungal activity against a wide range of pathogens, including Candida, Aspergillus, Pneumocystis, dimorphic fungi, and mucorales, with efficacy even against MDR and pan-resistant species such as Candida auris. It is already approved for the treatment of Vulvovaginal Candidiasis (VVC). Currently, the company is evaluating the drug in a Phase III (NCT05178862) trial for invasive candidiasis and other refractory fungal infections.

Fosmanogepix: Basilea Pharmaceutica

Fosmanogepix is a first-in-class, broad-spectrum antifungal agent in clinical development that targets the fungal enzyme Glycosylphosphatidylinositol-anchored wall transfer Protein 1 (Gwt1), a novel pathway critical for cell wall integrity and fungal survival. Through this unique mechanism, it demonstrates potent activity against a wide array of pathogens, including Candida species (notably C. auris and azole-resistant strains), Aspergillus, Fusarium, Scedosporium, various rare molds, and endemic fungi.

Drug Class Insights

Currently, the market includes a range of therapeutic options for invasive fungal infections, such as echinocandin, azole, and polyene. Meanwhile, novel therapies like Orotomide (olorofim), Gepix (fosmanogepix), and other emerging mechanisms are under development to expand treatment choices.

Azole

Azole antifungals, such as fluconazole, itraconazole, voriconazole, and posaconazole, help manage invasive fungal infections by disrupting fungal cell membrane synthesis. In fungi, the enzyme lanosterol 14a-demethylase (CYP51) converts lanosterol into ergosterol, a key component that maintains membrane structure and function. By inhibiting this enzyme, azoles block ergosterol production, leading to defective cell membranes, leakage of cellular contents, and fungal death. Voriconazole is highly effective against Aspergillus, fluconazole is commonly used for Candida, and posaconazole and isavuconazole provide broader coverage, including resistant strains. Their broad spectrum, oral and IV availability, and safer profile compared to amphotericin B make azoles the cornerstone of IFI treatment.

Invasive Fungal Infections Market Outlook

The treatment of invasive fungal infections remains highly challenging due to limited drug classes, rising resistance, and safety concerns. Current therapy relies on azoles, echinocandins, polyenes, and 5-FC, but multidrug-resistant strains such as Candida auris, Candida glabrata, and azole-resistant Aspergillus fumigatus are straining the effectiveness of these options. Market growth is driven by improved diagnostics, expanding prophylaxis use in high-risk patients, and innovation in antifungal design and delivery. Recently approved drugs like REZZAYO (rezafungin) and CRESEMBA (isavuconazole) highlight progress, while late-stage candidates such as fosmanogepix, ibrexafungerp, and olorofim promise to reshape treatment by offering novel mechanisms, oral formulations, and activity against resistant pathogens. Despite this momentum, toxicity, drug-drug interactions, and resistance trends continue to highlight major unmet needs, making the invasive fungal infection market one of cautious evolution where next-generation therapies are expected to play a pivotal role.

The Invasive fungal infections treatment landscape is evolving as new therapies advance through development. Companies like Glaxosmithkline/SCYNEXIS (BREXAFEMME), Basilea Pharmaceutica (fosmanogepix), Shionogi/F2G (Olorofim), Pulmocide (Opelconazole), and others are actively exploring candidates to address symptoms and improve disease management across the 7MM.

Key updates

Invasive Fungal Infections Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake. In the emerging landscape, BREXAFEMME is poised to maintain first-mover advantage in IFIs despite fosmanogepix addressing a broader patient population, owing to its launch in 2026, while opelconazole represents the first inhalation-based antifungal, with the potential to enhance patient compliance compared with conventional oral or IV therapies.

Invasive Fungal Infections Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, II, and I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for invasive fungal infections emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including MDs, PhD, Senior Researcher, and others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of Southern California, University of North Carolina at Chapel Hill, University of Santo Tomas, Medicine and Surgery, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or invasive fungal infections market trends.

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 gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, 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.

Market Access and Reimbursement

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

REZZAYO

Melinta Therapeutics announced expanded reimbursement and access for REZZAYO (rezafungin for injection). CMS assigned a permanent product-specific J-Code (J0349) effective October 1, 2023, and also granted NTAP for eligible hospitals treating Medicare patients in the inpatient acute care setting.

REZZAYO has a dedicated J-Code for use across all outpatient settings. Beginning October 2023, it also qualifies for NTAP, allowing hospitals to receive an additional payment on top of the standard MS-DRG for inpatient Medicare cases. The NTAP covers lesser of 75% of REZZAYO's cost or 75% of the cost above the MS-DRG, capped at USD 4,387.50 per case.

Co-pay assistance

Eligible patients with commercial insurance may receive

NOTE: Further Details are provided in the final report

Scope of the Report:

Invasive Fungal Infections Report Insights

Invasive Fungal Infections Report Key Strengths

Invasive Fungal Infections Report Assessment

FAQs:

Reasons to buy:

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Invasive fungal infections Market Overview at a Glance

7. Disease Background and Overview

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Drugs

11. Emerging Drugs

12. Invasive fungal infections: 7MM Analysis

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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