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카바페넴 내성 장내세균목(CRE) 감염증 : 시장 인사이트, 역학 및 시장 예측(2036년)

Carbapenem-resistant Enterobacteriaceae Infection - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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카바페넴 내성 장내세균목(CRE) 감염증에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 기준 주요 시장(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 CRE 감염증 시장 규모는 약 3억 달러인 것으로 나타났습니다.
  • CRE 감염의 상당 부분은 특히 중증 상태의 입원 환자에서 당뇨병, 만성 신장 질환, 암, 면역 억제 상태 등의 동반 질환과 관련이 있으며, 사망률을 낮추고 내성 확산을 억제하기 위해서는 조기 진단, 감염 관리, 항생제의 적정 사용, 그리고 표적 치료 전략이 필요하다는 점이 부각되고 있습니다.
  • 주요 7개국(G7)의 CRE 감염증 시장에서 ZERBAXA, RECARBRIO, VABOMERE 등 첨단 베타-락탐계 항생제/베타-락타마제 억제제의 병용 요법은 다제내성 그람음성균 감염증 치료에서의 사용 확대에 힘입어 치료 시장에서 큰 점유율을 차지하고 있습니다.
  • 현재 CRE 감염증 치료 시장은 폴리믹신, 티게사이클린, 아미노글리코사이드, 카르바페넴 계열 병용 요법과 같은 기존의 저비용 약물에 대한 의존이 지속되고 있는 한편, 중증 CRE 감염증에서의 유효성 향상, 내성 발생 감소, 안전성 개선이라는 요구에 힘입어, FETROJA, XACDURO, ZAYNICH와 같은 고부가가치 신규 항균제로의 전환이 진행되고 있다는 점이 특징입니다.
  • CRE 감염증의 치료 동향은 확립된 항균 요법과 새로운 항균 요법의 병용에 의해 주도되고 있으며, ‘RECARBRIO’, ‘VABOMERE’, ‘ZAYNICH’와 같은 제품들은 카르바페넴 내성 극복, 환자 예후 개선, 그리고 항균제 적정 사용 촉진을 목표로 한 지속적인 혁신을 반영하고 있습니다.
  • CRE 감염증 치료제 파이프라인은 여전히 비교적 제한적이지만, 지데박탐/세페핌, 세페핌/타조박탐, 지데박탐/엘타페넴 등 몇 가지 새로운 항감염 후보 약물이 임상 개발 단계에 있습니다. 이러한 치료법은 카르바페넴 내성 병원체에 대한 활성을 높이고, 폴리믹신 계열 치료에 대한 의존도를 낮춤으로써, 다제내성 장내세균과 세균 감염증 분야에서 해결되지 않은 중대한 의료적 요구를 충족시키는 것을 목표로 하고 있습니다.

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.

카바페넴 내성 장내세균목(CRE) 감염증 시장을 주도하는 주요 요인

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) 감염증의 이해와 치료 알고리즘

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

카바페넴 내성 장내세균목(CRE) 감염증의 역학 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 2025년 주요 7개국에서 발생한 CRE 감염증 신규 환자 수는 총 약 2만 3,000건이었습니다.
  • 2025년, 미국 내 CRE 감염증의 신규 환자 수는 약 1만 4,000건을 차지하고 있으며, 2036년까지 증가할 것으로 예측됩니다.
  • EU4 국가 중 2025년 CRE 감염증 신규 환자 수가 가장 많았던 곳은 이탈리아였고, 그 다음은 프랑스였으며, 독일은 가장 적었습니다.
  • 2025년, 일본 내 CRE 감염증의 신규 환자 수는 약 350건이었으나, 2036년까지 증가할 것으로 예측됩니다.
  • 보고된 CRE 감염증 전체 사례 중 남성이 약 60%를 차지하고 있습니다.

카바페넴 내성 장내세균목(CRE) 감염증 시장 전망

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.

  • 추산에 따르면, 2025년에는 미국이 CRE 감염증 시장에서 가장 큰 점유율을 차지했습니다. 주요 7개국 전체 시장 규모는 약 3억 달러이며, 2036년까지 더욱 확대될 것으로 전망됩니다.
  • CRE 감염증 시장은 치료 전략이 기존 방식에서 첨단 β-락탐계 항생제/β-락타마제 억제제의 병용 요법으로 전환됨에 따라 변화하고 있으며, ZERBAXA, RECARBRIO, VABOMERE 등의 신약이 다제내성 그람음성균에 대한 활성 향상, 임상 결과 개선, 그리고 기존 치료법에 비해 신독성이 낮아짐에 따라 시장 채택을 주도하고 있습니다.
  • 미국은 항생제 내성으로 인한 부담이 크고, 신규 항생제의 도입이 신속하며, 보험 환급 환경이 양호하다는 점에서 CRE 시장을 주도하고 있습니다. 한편, EU와 일본에서는 감시 체계 강화, 항생제 적정 사용 노력, 그리고 새로운 CRE 치료법의 도입 확대에 힘입어 꾸준한 성장이 나타나고 있습니다.
  • 기존의 항생제 치료: 콜리스틴, 폴리믹신 B, 티게사이클린, 아미노글리코사이드계 항생제 등의 약제는 특히 중증의 병원 내 감염에서 CRE 감염증에 대한 중요한 구제 치료 옵션으로 계속 사용되고 있으나, 그 사용은 신독성, 신경독성 및 내성 증가로 인해 종종 제한되고 있습니다.
  • β-락탐/β-락타마제 억제제의 병용 요법: AVYCAZ, RECARBRIO, VABOMERE, XACDURO 등의 치료법은 카르바페네마제 및 기타 β-락타마제를 억제함으로써 내성 그람음성균에 대한 항균 활성을 회복시켜 CRE 관리를 대폭 개선했습니다. 이러한 약제들은 현재 표적 맞춤형 CRE 치료 분야에서 큰 진전을 이루고 있습니다.
  • 신규 및 차세대 항균 요법: WCK 5222, WCK 4282, WCK 6777 등의 새로운 후보 약물이 β-락타마제 억제 작용 강화 및 항균력 향상을 통해 다제내성 및 광범위 내성 그람음성균 감염증을 치료하기 위해 개발되고 있습니다.
  • 지지 요법 및 병용 요법 접근법: 치료 성과를 최적화하고, 내성 발생을 억제하며, CRE와 관련된 발병률 및 사망률을 낮추기 위해서는 항생제 병용 요법, 감염 관리 전략, 신속 진단 도구 및 항생제 적정 사용 프로그램이 여전히 필수적입니다.

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.

자주 묻는 질문

  • 2025년 카바페넴 내성 장내세균목(CRE) 감염증 시장 규모는 어떻게 되나요?
  • CRE 감염증의 주요 치료법은 무엇인가요?
  • CRE 감염증의 발생률은 어떤 추세를 보이고 있나요?
  • CRE 감염증의 진단 방법은 무엇인가요?
  • CRE 감염증 치료제 파이프라인에는 어떤 후보 약물이 있나요?
  • CRE 감염증의 주요 시장 참여 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 역학 및 시장 예측 조사 방법

제6장 카바페넴 내성 장내세균목 : 시장 개요

제7장 카바페넴 내성 장내세균목 : 질환 배경과 개요

제8장 카르바페넴 내성 장내 세균눈세균(CRE) 감염증 치료

제9장 카바페넴 내성 장내세균목 : 역학 및 환자 인구

제10장 카바페넴 내성 장내세균목 : 환자 경과

제11장 시판 치료제

제12장 신흥 치료제

제13장 카바페넴 내성 장내세균목 : 주요 7개국 분석

제14장 카바페넴 내성 장내세균목 : 미충족 요구

제15장 카바페넴 내성 장내세균목 : SWOT 분석

제16장 카바페넴 내성 장내세균목 : KOL(Key Opinion Leader)의 견해

제17장 카바페넴 내성 장내세균목 : 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

LSH 26.07.27

Carbapenem-resistant Enterobacteriaceae (CRE) Infection Insights and Trends

  • According to DelveInsight's analysis, the CRE infection market size was found to be ~USD 300 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • A significant proportion of CRE infections is linked to comorbidities such as diabetes, chronic kidney disease, cancer, and immunosuppressive conditions, particularly among critically ill hospitalized patients, highlighting the need for early diagnosis, infection control, antimicrobial stewardship, and targeted treatment strategies to reduce mortality and limit resistance spread.
  • In the CRE infection market across the 7MM, advanced B-lactam/B-lactamase inhibitor combinations such as ZERBAXA, RECARBRIO, and VABOMERE hold a substantial share of the treatment landscape, supported by their growing use in managing multidrug-resistant Gram-negative infections.
  • The current CRE infection treatment market is characterized by continued reliance on older low-cost agents such as polymyxins, tigecycline, aminoglycosides, and carbapenem-based combination regimens, alongside a growing shift toward premium novel antibiotics including FETROJA, XACDURO, and ZAYNICH, driven by the need for improved efficacy, reduced resistance development, and better safety outcomes in severe CRE infections.
  • The CRE infection treatment landscape is driven by a mix of established and novel antibacterial therapies, with products such as RECARBRIO, VABOMERE, and ZAYNICH reflecting continued innovation aimed at overcoming carbapenem resistance, improving patient outcomes, and advancing antimicrobial stewardship.
  • While the CRE infection pipeline remains relatively limited, several novel anti-infective candidates, including Zidebactam/Cefepime, Cefepime/Tazobactam, and Zidebactam/Ertapenem, are in clinical development. These therapies aim to address the significant unmet need in multidrug-resistant Enterobacteriaceae infections by enhancing activity against carbapenem-resistant pathogens and reducing reliance on polymyxin-based treatments.

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 Understanding and Treatment Algorithm

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.

1. Limited availability of effective antibiotics against multidrug-resistant CRE strains

2. Rising antimicrobial resistance leading to reduced treatment success rates

3. Need for rapid and accurate diagnostic tools for early detection

4. High mortality and recurrence rates, especially in critically ill patients, and others.....

Comprehensive unmet needs insights in Carbapenem-resistant Enterobacteriaceae (CRE) Infection and their strategic implications are provided in the full report.

Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Epidemiology

Key Findings from Carbapenem-resistant Enterobacteriaceae (CRE) Infection Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the total incident cases of CRE infection in the 7MM were approximately 23,000 in 2025.
  • The US, in 2025, accounted for around 14,000 incident cases of CRE infection, which will increase by the year 2036.
  • Among the EU4, Italy accounted for the highest number of incident cases of CRE infection, followed by France, whereas Germany accounted for the lowest number of cases in 2025.
  • In 2025, there were approximately 350 cases of CRE infections in Japan, which will increase by 2036.
  • Males represent approximately 60% of all reported CRE Infection cases.

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

  • Deerfield Management Company
  • Cipla
  • Merck
  • Wockhardt, and others

Carbapenem-resistant Enterobacteriaceae (CRE) Infection Drug Updates

  • In March 2026, Wockhardt received a favourable recommendation from CDSCO's Subject Expert Committee for marketing approval of Zidebactam/Cefepime (Zaynich) in Gram-negative infections, advancing the novel antibiotic toward DCGI approval for tackling MDR and XDR-resistant infections.
  • In September 2025, Deerfield Management Company announced the sale of its portfolio company, Melinta Therapeutics, to CorMedix, Inc. Deerfield had acquired full private ownership of Melinta in 2020 through a financial restructuring and supported the company's growth by leveraging its operational, business development, data analytics, and market research capabilities to expand Melinta's anti-infective product portfolio.
  • In May 2025, Cipla launched Plazomicin (ZEMDRI) in India for the treatment of cUTIs, including pyelonephritis, strengthening its anti-microbial resistance (AMR) portfolio and addressing rising multidrug-resistant and CRE infections.

Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Market Outlook

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.

  • According to the estimates, the United States accounted for the largest share of the CRE Infection market in 2025. The total market size across the 7MM was approximately USD 300 million and is projected to grow further through 2036.
  • The CRE infection market is evolving as treatment strategies shift from conventional toward advanced B-lactam/B-lactamase inhibitor combinations, with newer agents such as ZERBAXA, RECARBRIO, and VABOMERE, driving adoption due to enhanced activity against multidrug-resistant Gram-negative pathogens, improved clinical outcomes, and reduced nephrotoxicity compared with older therapies.
  • The US leads the CRE market due to its high antimicrobial resistance burden, rapid adoption of novel antibiotics, and favorable reimbursement environment, while the EU and Japan are experiencing steady growth supported by enhanced surveillance, antimicrobial stewardship efforts, and increasing uptake of new anti-CRE therapies.

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.

  • Conventional antibiotic therapies: Agents such as colistin, polymyxin B, tigecycline, and aminoglycosides remain important salvage treatment options for CRE infections, particularly in severe hospital-acquired infections, although their use is often limited by nephrotoxicity, neurotoxicity, and rising resistance.
  • B-lactam/B-lactamase inhibitor combinations: Therapies such as AVYCAZ, RECARBRIO, VABOMERE, and XACDURO have significantly improved CRE management by restoring antibacterial activity against resistant Gram-negative pathogens through inhibition of carbapenemases and other B-lactamases. These agents now represent a major advancement in targeted CRE treatment.
  • Novel and next-generation antibacterial therapies: Emerging candidates such as WCK 5222, WCK 4282, and WCK 6777 are being developed to address multidrug-resistant and extensively drug-resistant Gram-negative infections through enhanced B-lactamase inhibition and improved antibacterial potency.
  • Supportive and combination treatment approaches: Combination antibiotic regimens, infection-control strategies, rapid diagnostic tools, and antimicrobial stewardship programs remain essential for optimizing treatment outcomes, limiting resistance development, and reducing CRE-associated morbidity and mortality.

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of CRE infection, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the CRE infection market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The 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 in shaping and driving the 7MM CRE infection market.

Report Insights

  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Patient Population Forecast
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Therapeutics Market Size
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Pipeline Analysis
  • Carbapenem-resistant Enterobacteriaceae (CRE) Infection Market Size and Trends
  • Carbapenem-resistant Enterobacteriaceae (CRE) Infection Market Opportunity (Current and Forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year Forecast
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Treatment Addressable Market (TAM)
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Competitive Landscape
  • Carbapenem-resistant Enterobacteriaceae (CRE) Infection Major Companies Insights
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Price Trends and Analogue Assessment
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Therapies Drug Adoption/Uptake
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Therapies Peak Patient Share Analysis

Report Assessment

  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Current Treatment Practices
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Unmet Needs
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Clinical Development Analysis
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Emerging Drugs Product Profiles
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Market Attractiveness
  • Carbapenem-resistant Enterobacteriaceae (CRE) Infection Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the CRE Infection market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of CRE Infection?
  • What are the disease risks, burdens, and unmet needs of CRE Infection? What will be the growth opportunities across the 7MM concerning the patient population with Carbapenem-resistant Enterobacteriaceae CRE Infection?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of CRE Infection? What are the current guidelines for treating CRE Infection in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the CRE Infection market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • 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.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. Carbapenem-Resistant Enterobacteriaceae (CRE) Infection Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of CRE infection by Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of CRE infection by Therapies in the 7MM, in 2036

7. Disease Background and Overview of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

  • 7.1. Introduction
  • 7.2. Enterobacteriaceae
  • 7.3. Classification of Carbapenem-resistant Enterobacteriaceae
  • 7.4. Risk and Spread of CRE Infection
  • 7.5. Mechanism of Drug Resistance
  • 7.6. Symptoms
  • 7.7. Diagnosis of CRE
  • 7.8. Guidelines

8. Treatment for Carbapenem-resistant Enterobacteriaceae (CRE) Infections

  • 8.1. Guidelines

9. Epidemiology and Patient Population of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Incident Cases of CRE infection in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in the US
    • 9.4.2. Type-specific Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in the US
    • 9.4.3. Age-specific Incident cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in the US
    • 9.4.4. Total treated Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in the US
  • 9.5. EU4 and the UK
    • 9.5.1. Total Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in EU4 and the UK
    • 9.5.2. Type-Specific Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in EU4 and the UK
    • 9.5.3. Age-specific Incident cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in EU4 and the UK
    • 9.5.4. Total treated Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in Japan
    • 9.6.2. Type-specific Incident Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in Japan
    • 9.6.3. Age-specific Incident cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in Japan
    • 9.6.4. Total treated Cases of Carbapenem-resistant Enterobacteriaceae (CRE) Infection in Japan

10. Patient Journey of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

11. Marketed Therapies

  • 11.1. Marketed Competitive Landscape of Carbapenem-resistant Enterobacteriaceae (CRE) Infection
  • 11.2. Meropenem/Vaborbactam (Vabomere): Deerfield Management Company
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
      • 11.2.5.1. Clinical Trial Information
    • 11.2.6. Analyst's Views
  • 11.3. Plazomicin (Zemdri): Cipla
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
      • 11.3.5.1. Clinical Trial Information
    • 11.3.6. Analyst's Views

12. Emerging Drugs

  • 12.1. Emerging Competitive Landscape of Carbapenem-resistant Enterobacteriaceae (CRE) Infection
  • 12.2. Zidebactam/Cefepime (WCK 5222): Wockhardt
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst's Views
  • 12.3. Cefepime/Tazobactam (WCK 4282): Wockhardt
    • 12.3.1. Drug Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trials Information
    • 12.3.4. Analyst's Views

13. Carbapenem-resistant Enterobacteriaceae (CRE) Infection: 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Carbapenem-resistant Enterobacteriaceae (CRE) Infection
  • 13.3. Key Market Forecast Assumptions
    • 13.3.1. Cost Assumptions
    • 13.3.2. Pricing Trends
    • 13.3.3. Analogue Assessment
    • 13.3.4. Launch Year and Therapy Uptakes
  • 13.4. Conjoint Analysis of Carbapenem-resistant Enterobacteriaceae (CRE) Infection
  • 13.5. Total Market Size of CRE Infection in the 7MM
  • 13.6. Total Market Size of CRE Infection by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of CRE Infection in the United States
    • 13.7.2. Total Market Size of CRE Infection by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of CRE Infection in EU4 and the UK
    • 13.8.2. Total Market Size of CRE Infection by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of CRE Infection in Japan
    • 13.9.2. Total Market Size of CRE Infection by Therapies in Japan

14. Unmet Needs of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

15. SWOT Analysis of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

16. KOL Views of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

17. Market Access and Reimbursement of Carbapenem-resistant Enterobacteriaceae (CRE) Infection

  • 17.1. The United States
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of CRE Infection Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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