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시장보고서
상품코드
2082954
카바페넴 내성 장내세균목(CRE) 감염증 : 시장 인사이트, 역학 및 시장 예측(2036년)Carbapenem-resistant Enterobacteriaceae Infection - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
본 CRE 감염증 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, CRE 감염증의 환자 부담 동향, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서는 CRE 감염증 분야에서 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 상황을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
CRE 감염증 발생률 증가
특히 1-5세 소아에서 CRE 발생률이 증가하는 것이 CRE 시장 확대를 이끄는 주요 요인으로 작용하고 있습니다.
신규 CRE 감염증 치료법 분야의 기회 확대
항생제 내성의 확산과 기존 항생제의 효능 한계로 인해, CRE 감염증에 대한 새로운 표적 치료법을 개발하는 기업들에게 기회가 생기고 있습니다.
카바페넴 내성 장내세균목(CRE) 감염증 개요
카바페넴 내성 장내세균목 감염증은 카르바페넴계 항생제에 내성을 가진 장내세균과 세균에 의해 유발되는 중증이며, 종종 생명을 위협하는 세균 감염증으로, 주로 입원 환자나 면역 결핍 환자에게 영향을 미칩니다. 이러한 감염증은 일반적으로 혈류, 폐, 요로, 상처에서 발생하며, 항생제의 과다 사용, 의료 환경에의 장기간 노출, 침습적 의료 시술, 의료 현장 내 감염 전파 등의 요인에 의해 유발됩니다.
카바페넴 내성 장내세균목(CRE) 감염증의 진단
카바페넴 내성 장내세균목 감염증은 임상 평가, 미생물학적 배양 및 카르바페넴 내성균을 확인하기 위한 항생제 감수성 검사를 통해 진단됩니다. 일반적인 검체에는 혈액, 소변, 호흡기 분비물, 상처 검체 등이 포함됩니다. PCR 등의 분자진단법을 이용하여 KPC, NDM, OXA-48, VIM, IMP 등의 카바페네마제 유전자를 검출하는 경우가 있습니다. 또한, 감염원, 감염 범위, 중증도를 파악하기 위해 추가 검사나 영상 진단이 이루어지는 경우가 많습니다.
카바페넴 내성 장내세균목(CRE) 감염증의 치료
CRE 감염증 치료의 주요 목표는 내성 병원체를 근절하고, 중증 감염증을 통제하며, 사망률을 낮추고, 항생제 내성 및 감염의 추가 확산을 방지하는 것입니다. 치료는 주로 약물 요법을 통해 이루어지며, 감수성 검사 결과를 바탕으로 진행됩니다. 세프타지짐·아비박탐(AVYCAZ/ZAVICEFTA), 메로페넴·바볼박탐(VABOMERE), 이미페넴·실라스타틴·레레바크탐(RECARBRIO) 등의 신규 β-락탐/β-락타마제 억제제 병용 요법은 감수성이 있는 CRE 감염증에 대한 일반적인 1차 치료법으로 사용되고 있습니다. 메탈로-β-락타마제 생성 균주에 대해서는 아즈트레오남과 세프타지짐·아비바크탐의 병용 요법, 또는 세페핌·지데바크탐(Zaynich) 등의 신약 병용 요법이 고려될 수 있습니다. 프라조마이신(ZEMDRI), 티게사이클린, 폴리믹신 등의 추가 약제는 합병증이 있는 사례나 난치성 사례에 사용됩니다. 치료 성과를 개선하고 CRE 감염의 확산을 억제하기 위해서는 감염원 관리, 감염 예방, 항생제의 적정 사용 등의 보조 요법이 필수적입니다.
카바페넴 내성 장내세균목(CRE) 감염증의 역학 분석 및 예측에 관한 주요 조사 결과
CRE 감염증 시장은 폴리믹신, 티게사이클린, 아미노글리코사이드계 항생제 등 기존의 치료법에서 첨단 베타-락탐계 항생제와 베타-락타마제 억제제의 병용 요법 및 작용기전에 기반한 항생제로 전환되며 큰 변화를 겪고 있습니다. ZERBAXA, RECARBRIO, VABOMERE, FETROJA, XERAVA와 같은 치료법의 채택 확대는 다제내성 그람음성균에 대한 활성이 강화되고, 안전성 프로파일이 개선되었으며, 또한 오래되고 독성이 강한 치료법에 대한 의존도를 낮출 가능성을 지닌, 표적 맞춤형 항균 요법으로의 광범위한 전환을 반영하고 있습니다. 이러한 진전은 β-락타마제를 매개로 한 내성을 극복하고, 이미 확립된 항생제 계열의 유용성을 회복하는 데 대한 관심이 높아지고 있음을 보여주며, 이에 따라 CRE 치료 시장 경쟁 구도를 재편하고 있습니다.
파이프라인은 Wockhardt Ltd.사의 WCK-5222, WCK-4282, WCK-6777과 같은 신약 후보물질은 물론, 내성 장내세균목 균을 표적으로 하는 기타 차세대 항균제와의 병용 요법 등을 통해 지속적으로 발전하고 있습니다. 이러한 임상시험 중인 치료법들은 다제내성 및 카르바페넴 내성 감염증의 치료 선택지를 확대하는 동시에, 기존 항생제에 대한 의존도를 낮춤으로써 여전히 충족되지 않은 미충족 의료 수요에 대응하는 것을 목표로 하고 있습니다. 주요 7개국(7대 시장) 중 미국은 CRE 감염증 시장에서 가장 큰 규모를 차지하고 있습니다. 이는 EU4, 영국, 일본에 비해 입원율이 높고, 항생제 내성 감시 체계가 강화되어 있으며, 선진적인 항생제 치료에 대한 접근성이 용이하고, 보험 급여 환경이 양호하며, 새로 승인된 치료법의 도입이 신속하기 때문인 것으로 보입니다.
전반적으로, 차별화된 항생제의 도입, 내성 그람음성균을 대상으로 한 병용 요법의 확대, 항생제 적정 사용(ASM) 노력의 확대, 진단 능력의 향상, 그리고 병원 내 감염에 대한 인식 제고가 2022년부터 2036년에 걸쳐 주요 7개국의 CRE 감염증 시장에서 꾸준한 성장을 견인할 것으로 예상되며, 시판 중인 치료법과 개발 중인 파이프라인 후보 모두에게 큰 상업적 기회가 창출될 것으로 전망됩니다.
B-락탐계 항생제와 B-락타마제 억제제의 병용 요법, 그리고 새로운 항균 요법이 CRE 감염증 치료의 혁신을 주도하고 있습니다. 최근 승인된 의약품은 현재의 치료 기준을 향상시키고 있으며, 한편으로는 내성을 표적으로 하는 차세대 치료법이 향후 시장 성장을 견인할 것으로 기대되고 있습니다.
DelveInsight's 'Carbapenem-resistant Enterobacteriaceae (CRE) Infection- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the CRE, historical and forecasted epidemiology, as well as the CRE infection market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The CRE infection market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates CRE infection patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in CRE infection and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Carbapenem-resistant Enterobacteriaceae (CRE) Infection Market
Rising CRE Infection Incidence
The increasing incidence of CRE, particularly among children 1-5 years of age, is the primary driver of CRE market expansion.
Rising Opportunities in Novel CRE Infection Therapies
Growing antimicrobial resistance and the limited efficacy of existing antibiotics are creating opportunities for developers of novel targeted therapies for CRE infections.
Emerging CRE Infection Competitive Landscape
Emerging therapies such as WCK 5222, WCK 4282, and WCK 6777 aim to address critical unmet needs in CRE by offering improved activity against carbapenem-resistant pathogens, reducing reliance on toxic legacy antibiotics, and expanding treatment options for multidrug-resistant infections.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Overview
Carbapenem-Resistant Enterobacteriaceae Infection is a serious and often life-threatening bacterial infection caused by Enterobacteriaceae resistant to carbapenem antibiotics, primarily affecting hospitalized and immunocompromised patients. These infections commonly involve the bloodstream, lungs, urinary tract, and wounds, and are driven by factors such as antibiotic overuse, prolonged healthcare exposure, invasive medical procedures, and transmission within healthcare settings.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Diagnosis
Carbapenem-Resistant Enterobacteriaceae Infection is diagnosed through clinical assessment, microbiological culture, and antimicrobial susceptibility testing to identify carbapenem-resistant organisms. Common specimens include blood, urine, respiratory secretions, and wound samples. Molecular diagnostic methods, such as PCR, may be used to detect carbapenemase genes, including KPC, NDM, OXA-48, VIM, and IMP. Additional laboratory and imaging studies are often performed to determine the source, extent, and severity of infection.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Treatment
The primary goals of CRE infection treatment are to eradicate resistant pathogens, control severe infections, reduce mortality, and prevent further antimicrobial resistance and transmission. Management is mainly pharmacologic and guided by susceptibility testing. Novel B-lactam/B-lactamase inhibitor combinations such as ceftazidime-avibactam (AVYCAZ/ZAVICEFTA), meropenem-vaborbactam (VABOMERE), and imipenem-cilastatin-relebactam (RECARBRIO) are commonly used first-line therapies for susceptible CRE infections. In metallo-B-lactamase-producing strains, combination therapies such as aztreonam with ceftazidime-avibactam or newer agents like cefepime-zidebactam (Zaynich) may be considered. Additional agents, including plazomicin (ZEMDRI), tigecycline, and polymyxins, are used in complicated or refractory cases. Supportive strategies such as source control, infection prevention, and antimicrobial stewardship are essential to improve outcomes and limit the spread of CRE infections.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Unmet Needs
The section "unmet needs of CRE Infection" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Comprehensive unmet needs insights in Carbapenem-resistant Enterobacteriaceae (CRE) Infection and their strategic implications are provided in the full report.
Key Findings from Carbapenem-resistant Enterobacteriaceae (CRE) Infection Epidemiological Analysis and Forecast
Carbapenem-resistant Enterobacteriaceae (CRE) Infection Drug Chapters & Competitive Analysis
The CRE infection drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the CRE infection treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the CRE infection therapeutics market.
Approved Therapies for Carbapenem-resistant Enterobacteriaceae (CRE) Infection
Meropenem/Vaborbactam (VABOMERE): Deerfield Management Company
VABOMERE is an intravenous combination therapy comprising the carbapenem antibiotic meropenem and the novel B-lactamase inhibitor vaborbactam. Approved by the US FDA in 2017, it is indicated for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. VABOMERE has demonstrated strong activity against CRE, particularly Klebsiella pneumoniae carbapenemase (KPC)-producing strains. By inhibiting serine carbapenemases, vaborbactam restores the antibacterial activity of meropenem against resistant Gram-negative pathogens. Its development represents a significant advancement in addressing the growing threat of multidrug-resistant bacterial infections and the need for novel antimicrobial treatment options.
Plazomicin (ZEMDRI): Cipla
ZEMDRI is a next-generation intravenous aminoglycoside antibiotic developed for the treatment of multidrug-resistant Gram-negative infections, particularly CRE. Originally developed by Achaogen, Inc., it received US FDA approval in 2018 for cUTIs in adults with limited treatment options. Designed to overcome common aminoglycoside resistance mechanisms, plazomicin demonstrates strong activity against resistant pathogens such as Klebsiella pneumoniae and Escherichia coli, supporting its role in addressing critical antimicrobial resistance challenges.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Pipeline Analysis
Zidebactam/Cefepime (WCK-5222): Wockhardt
WCK 5222, developed by Wockhardt Ltd., is an investigational intravenous antibiotic combination comprising cefepime and the novel B-lactamase inhibitor zidebactam. The therapy is being developed for the treatment of multidrug-resistant Gram-negative infections, including CRE Infection. By enhancing cefepime activity against resistant pathogens, WCK 5222 aims to provide a carbapenem-sparing treatment option for severe hospital-acquired infections and address the growing challenge of antimicrobial resistance.
Cefepime/Tazobactam (WCK-4282): Wockhardt
WCK-4282, developed by Wockhardt Ltd., is an investigational intravenous B-lactam/B-lactamase inhibitor combination comprising cefepime and tazobactam. The therapy is being developed for the treatment of multidrug-resistant Gram-negative bacterial infections, including infections caused by ESBL-producing Enterobacterales and select carbapenem-resistant pathogens. By combining the broad-spectrum antibacterial activity of cefepime with the B-lactamase inhibitory activity of tazobactam, WCK 4282 aims to enhance coverage against resistant organisms and provide an additional treatment option for severe hospital-acquired and complicated infections.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Key Players, Market Leaders, and Emerging Companies
Carbapenem-resistant Enterobacteriaceae (CRE) Infection Drug Updates
The CRE Infection market is undergoing a significant transformation, moving beyond conventional therapies such as polymyxins, tigecycline, and aminoglycosides toward advanced B-lactam/B-lactamase inhibitor combinations and mechanism-driven antibacterial agents. The growing adoption of therapies such as ZERBAXA, RECARBRIO, VABOMERE, FETROJA, and XERAVA reflects a broader shift toward targeted antimicrobial therapies with enhanced activity against multidrug-resistant Gram-negative pathogens, improved safety profiles, and the potential to reduce reliance on older, more toxic treatment options. These advances underscore the increasing focus on overcoming B-lactamase-mediated resistance and restoring the utility of established antibiotic classes, thereby reshaping the competitive landscape of CRE treatment.
The pipeline continues to evolve with emerging therapies such as WCK-5222, WCK-4282, and WCK-6777 from Wockhardt Ltd., alongside other next-generation antimicrobial combinations targeting resistant Enterobacterales. These investigational therapies aim to address persistent unmet needs by expanding treatment options for multidrug-resistant and carbapenem-resistant infections while reducing dependence on legacy antibiotics. Among the 7MM, the United States represents the largest CRE infection market, driven by higher hospitalization rates, increasing antimicrobial resistance surveillance, greater access to advanced antibacterial therapies, favorable reimbursement environments, and more rapid adoption of newly approved treatments compared with the EU4, the United Kingdom, and Japan.
Overall, the introduction of differentiated antibacterial agents, expansion of combination therapies targeting resistant Gram-negative organisms, growing antimicrobial stewardship initiatives, improved diagnostic capabilities, and rising awareness regarding hospital-acquired infections are expected to drive steady growth in the 7MM CRE infection market from 2022-2036, creating significant commercial opportunities for both marketed therapies and emerging pipeline candidates.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Carbapenem-resistant Enterobacteriaceae (CRE) Infection (2022-2036 Forecast)
The CRE infection market comprises polymyxins, B-lactam/B-lactamase inhibitor combinations, aminoglycosides, tetracycline derivatives, and emerging next-generation antibacterial therapies, each targeting distinct resistance mechanisms associated with CRE infections.
B-lactam/B-lactamase inhibitor combinations and emerging antibacterial therapies together define the core innovation landscape in CRE infections, with recently approved agents improving current treatment standards, while next-generation resistance-targeting therapies are expected to drive future market growth.
Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the CRE infection market's uptake by drugs, patient uptake by therapy, and sales of each drug.
The uptake of therapies in CRE infections is expected to vary across conventional polymyxin- and aminoglycoside-based regimens, B-lactam/B-lactamase inhibitor combinations, and emerging next-generation antibacterial agents. Recently approved or increasingly adopted therapies such as ceftazidime-avibactam, meropenem-vaborbactam, and imipenem-cilastatin-relebactam are anticipated to demonstrate moderate to high uptake, while newer agents, including cefiderocol and investigational anti-CRE therapies, are expected to witness progressive uptake, supported by improved efficacy against multidrug-resistant Gram-negative pathogens, reduced toxicity, and broader activity against carbapenemase-producing organisms. Their adoption is likely to be driven by the limitations of older treatment options, including nephrotoxicity associated with polymyxins, limited clinical efficacy, and rising antimicrobial resistance. In comparison, other novel antimicrobial combinations, bacteriophage-based therapies, and pathogen-targeted approaches are expected to experience gradual but steady uptake as clinical evidence expands, and these therapies become increasingly incorporated into antimicrobial stewardship programs and treatment guidelines for severe CRE infections across hospital and critical care settings.
Market Access and Reimbursement of CRE Infection
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.
Further details are provided in the final report....
Carbapenem-resistant Enterobacteriaceae (CRE) Infection Therapies Price Scenario & Trends
Pricing and analogue assessment of CRE Infection therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Further details are provided in the final report....
Industry Experts and Physician Views for Carbapenem-resistant Enterobacteriaceae (CRE) Infection
To keep up with CRE market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions 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 CRE infection emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in CRE, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the Harvard Medical School, University of Nottingham, and Japanese Red Cross Central Blood Institute, etc. were contacted. Their opinion helps understand and validate current and emerging CRE infection therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in IDA.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of CRE infection, 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.
Conjoint analysis analyzes emerging 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.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.
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