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괴사성 장염 : 시장 인사이트, 역학 및 예측(2036년)

Necrotizing Enterocolitis - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 100 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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괴사성 장염(NEC)에 대한 인사이트 및 동향

  • DelveInsight의 분석에 따르면, 2025년 시점에서 주요 시장(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 괴사성 장염 시장 규모는 약 3,000만 달러인 것으로 나타났습니다.
  • 괴사성 장염은 전 세계 신생아 집중치료실(NICU)에서 주로 미숙아를 덮치는 중증이며 생명을 위협하는 소화기 계통의 응급 질환입니다. 신생아 의학의 눈부신 발전에도 불구하고, 그 정확한 병인은 여전히 완전히 규명되지 않았으며, 중요한 연구 대상으로 남아 있습니다.
  • 출생 시 신생아는 환경 속의 세균에 노출되지만, 조산아의 경우 장내 세균총의 2088846 정착이 지연되어 이상이 발생합니다. 이로 인해 과도한 염증 반응이 유발되어 괴사성 장염 발병의 원인이 됩니다. 영양 관리도 위험 요인에 영향을 미칩니다. 장내 영양 공급이 늦어지거나 완전 정맥 영양에 의존하게 되면 발병 위험이 높아지는 반면, 조기 장내 영양 공급은 예방 효과를 가져올 가능성이 있습니다.
  • 영양 관리는 괴사성 장염의 위험에 있어 매우 중요한 역할을 하며, 경장 영양 공급의 시작이 지연되거나 완전 정맥 영양에 의존할 경우 장 점막의 위축 및 민감도 증가로 이어질 수 있는 반면, 조기 경장 영양 공급은 질환 발병 위험을 낮추는 데 기여할 수 있습니다.
  • 염증 및 면역학적 경로는 괴사성 장염의 병태 형성에 핵심적인 역할을 하며, 특히 Toll 유사 수용체(TLR4 및 TLR9) 간의 불균형이 중요한 요인으로 작용합니다. 이때, TLR4의 활성화가 증가하면 세포 사멸을 촉진하고 장 세포의 증식 및 이동을 억제함으로써 장 손상을 유발합니다.
  • 괴사성 장염의 임상적 관리 방법은 질환의 중증도에 따라 달라집니다. 초기 단계(1기 및 2기)에서는 일반적으로 장 휴식, 광범위 항생제, 그리고 지지 요법을 통한 보존적 치료가 이루어지지만, 진행된 단계(3기)에서는 개복술이나 괴사된 장의 절제 등 외과적 개입이 필요한 경우가 많습니다.
  • 괴사성 장염에 대해 매우 효과적인 표적 치료법이 존재하지 않기 때문에 현재 연구 및 임상 분야의 초점은 초유나 모유를 통한 조기 수유, 신중한 영양 관리, 프로바이오틱스 사용, 환경 관리, 그리고 피부 대 피부 접촉(스킨 투 스킨 케어)과 같은 지지적 중재를 포함한 예방 전략으로 옮겨가고 있습니다.
  • 새로운 치료법 개발에 지속적으로 힘쓰고 있는 기업은 극히 소수에 불과합니다. Infant Bacterial Therapeutics만이 개발의 최종 단계에 있는 제품을 보유하고 있는 반면, Noveome Biotherapeutics, Siolta Therapeutics, Plakous Therapeutics 등의 기업들은 초기 단계 또는 전임상 단계의 자산을 보유하고 있습니다.

G7 국가들의 괴사성 장염 시장 규모 및 전망

  • 괴사성 장염 시장 규모(2025년) : 약 3,000만 달러
  • 괴사성 장염 시장 규모 전망(2036년) : 약 8억 달러
  • 괴사성 장염 시장 성장률(2026-2036년) : 연평균 성장률(CAGR) 26%

본 '괴사성 장염' 시장 보고서는 표준 치료, 임상 실무 및 진화하는 치료 알고리즘을 포함하여 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, 괴사성 장염 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하여, 세계 각 지역의 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제공합니다. 본 보고서에서는 괴사성 장염 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도와 임상 환경을 분석하여 고부가가치 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

괴사성 장염 시장을 주도하는 주요 요인

조산아의 높은 질병 부담

괴사성 장염은 미숙아, 특히 신생아 중환자실(NICU)에 입원해 있는 미숙아에게 있어 여전히 가장 심각하고 생명을 위협하는 소화기 계통의 응급 질환 중 하나입니다. 신생아 의료의 발전으로 극저체중아의 생존율이 향상되고 있는 것은 의도치 않게 위험군 규모를 확대시키고 있으며, 그 결과 전 세계적으로 괴사성 장염이 초래하는 임상적·경제적 부담을 지속시키고 있습니다.

거대한 미충족 수요

수십 년에 걸친 연구에도 불구하고, 괴사성 장염에 대해 승인된 표적 약물 요법은 존재하지 않으며, 현재의 치료는 주로 지지 요법과 진행 단계에서의 외과적 개입에 의존하고 있습니다. 이러한 효과적인 치료 옵션의 부재는 충족되지 않은 의료적 요구가 크다는 점을 여실히 보여주고 있으며, 질병 경과 조절 요법의 개발을 위한 큰 기회를 창출하고 있습니다.

예방 전략에 대한 관심 증가

이용 가능한 치료 옵션이 제한적이기 때문에 예방을 중시하는 접근 방식으로의 전환이 진행되고 있습니다. 초유 및 모유를 이용한 조기 수유, 최적화된 영양 관리 지침, 프로바이오틱스 보충, 신생아 관리 방식 개선과 같은 전략은 괴사성 장염의 발생률을 낮추는 데 있어 그 중요성이 점점 더 커지고 있습니다.

괴사성 장염의 이해와 치료 알고리즘

괴사성 장염의 개요와 진단

괴사성 장염은 주로 미숙아에게 발병하는 중증의 생명을 위협하는 소화기 질환으로, 장관의 염증, 세균 침입 및 진행성 괴사를 특징으로 합니다. 장 천공을 유발하여 복막염, 패혈증, 나아가 사망에 이를 수 있습니다. 증상은 비특이적인 경우가 많으며(예 : 식욕 부진, 구토, 무기력, 복부 압통), 높은 임상적 의심을 가져야 합니다. 정확한 원인은 여전히 밝혀지지 않았으나, 장관의 미성숙, 비정상적인 세균 정착, 그리고 과도한 염증 반응이 주요 요인이며, 염증에서 허혈, 괴사, 그리고 천공으로 진행됩니다. 치료는 주로 지지 요법으로, 상태 안정화(ABC), 수액 요법, 위 감압, 광범위 항생제 투여, 완전 정맥 영양 등이 포함되며, 증상이 호전된 후 경장 영양을 재개합니다. 중증 사례나 치료에 반응하지 않는 사례에서는 외과적 개입(개복술, 괴사된 장의 절제, 장루 형성 등)이 필요하지만, 상태가 위중한 영아의 경우 복막 배액이 시행되기도 합니다.

조산아가 태어난 후, 감염을 예방하기 위한 조치가 취해집니다. 이러한 예방 조치가 효과를 보지 못할 경우, 아기는 복부 붓기, 피로감, 호흡 정지 등의 증상을 보일 수 있습니다. 의사는 전혈구 계수, C-반응성 단백질 검사, X선 검사 등의 검사를 실시하여 이 질환을 진단합니다. 이러한 검사를 거친 후, 아기가 괴사성 장염에 걸린 것으로 확인됩니다.

괴사성 장염 치료의 현황

현재, 괴사성 장염에 대해 특별히 승인된 약물 치료법은 없습니다. 효과적인 치료법이 부족하고 이 질환에 따른 사망률이 높기 때문에 연구의 초점은 초유 및 모유의 조기 섭취, 최적의 영양 관리, 프로바이오틱스, 환경 보호, 피부 대 피부 접촉(SSC), 그리고 약리학적 접근법을 포함한 예방 전략으로 점점 더 옮겨가고 있습니다. 프로바이오틱스(생균을 함유한 영양보조식품)는 괴사성 장염 예방에 도움이 될 수 있다는 연구 결과가 제시되고 있으나, 안전성 및 유효성에 관한 FDA의 시판 전 승인 대상은 아니며, 규제 대상 의약품에 요구되는 것과 동일한 제조 및 품질 기준도 적용되지 않습니다. 2014년에 보고된 사례에 따르면, 미국 신생아 중환자실(NICU)에 입원 중이던 조산아가 오염된 프로바이오틱스 보충제와 관련된 위장관 무코르증으로 사망한 것으로 나타났으며, 이는 안전성에 대한 우려를 더욱 부각시키고 있습니다.

괴사성 장염의 역학

괴사성 장염의 역학 분석 및 예측에 관한 주요 조사 결과

  • 2025년에도 미국은 주요 7개국(미숙아 700만 명) 중 극저체중아(1,500g 이하) 조산아의 절대 수가 가장 많았습니다. 이는 유럽 각국이나 일본에 비해 총 출생 수가 많은 것이 원인입니다. 그러나 VLBW 출생률은 최근 몇 년간 약간의 변동은 있긴 하지만, 비교적 안정적인 상태를 유지하고 있습니다. 추산에 따르면, 주요 7개국에서 출생 체중(1,500g 이하)별 조산아 신규 환자 수는 2026년부터 2036년까지의 예측 기간 동안 증가할 것으로 예측됩니다.
  • 주요 7개국 전체에서 출생 체중 1,500g 이하의 조산아 인구는 2030년까지 안정세를 보이거나 소폭 증가할 것으로 예측됩니다. 이는 주로 조산 발생률이 크게 증가한 것보다는 신생아 생존율이 향상된 데 기인한 것입니다. 이러한 추세는 세계보건기구(WHO)와 지역 신생아 데이터베이스에 의해 일관되게 보고되고 있습니다.
  • 미국, EU4, 영국을 포함한 고소득 지역의 괴사성 장염 발생률은 모유 수유, 신생아 집중 치료실(NICU)에서의 표준화된 진료, 감염 관리 개선 등 신생아 의료의 발전으로 인해 2025년까지 안정화되거나 소폭 감소했습니다. 프로바이오틱스 사용은 증가하는 추세이지만, 미국소아과학회(AAP) 등의 단체는 증거의 일관성 부족과 표준화된 제제의 부재를 지적하고 있어, 지침의 광범위한 채택을 저해하고 있습니다.
  • 미국에서는 괴사성 장염의 연간 발생 건수가 여전히 약 3,000-5,000건 수준에 머물러 있으며, 최근 추정치(2024-2025년)에 따르면, 특히 예방 대책 패키지를 도입한 3차 신생아 중환자실(NICU)에서 발생 건수가 정체되거나 소폭 감소하고 있는 것으로 나타났습니다. 이는 미국 질병통제예방센터(CDC) 및 신생아 네트워크의 감시 데이터와도 일치합니다.
  • EU4(독일, 프랑스, 이탈리아, 스페인) 국가 중에서는 독일이 여전히 가장 많은 초저출생체중(VLBW) 조산아를 보고하고 있으며, 그 다음으로 프랑스가 뒤를 잇고 있습니다. 이는 인구 규모와 출산율을 반영한 것이며, 반면 스페인은 비교적 절대적인 숫자가 적은 상황입니다. 이러한 경향은 2025년 신생아 등록 데이터가 갱신된 후에도 일관되게 나타납니다.
  • 일본에서는 출산율 감소, 고도의 신생아 의료 기술, 그리고 모유 수유의 정착으로 인해 괴사성 장염의 발생률은 여전히 낮은 수준(연간 약 100-200건)을 유지하고 있습니다. 일본 신생아 연구 네트워크를 포함한 최근 데이터(2024-2025년)에 따르면, 신생아 관리 및 예방 대책의 지속적인 개선에 힘입어 발생률이 안정세를 보이거나 소폭 감소하고 있는 것으로 나타났습니다.

괴사성 장염 시장 전망

괴사성 장염 시장 상황은 대체로 변함이 없으며, 장 관장 휴식, 광범위 항생제, 정맥 영양, 중증 환자에 대한 외과적 개입과 같은 지지 요법에 계속 의존하고 있습니다. 신생아의 주요 소화기 계통 사망 원인이자 가장 흔한 외과적 응급 질환임에도 불구하고, 괴사성 장염에 대해 승인된 표적 약물 요법은 존재하지 않습니다. 현재의 치료 패러다임은 장내 감압, 수액 요법, 호흡 및 순환 지원, 치밀한 임상 모니터링과 같은 집중적인 지지 요법을 통해 환자의 상태를 안정시키고 질환의 진행을 억제하는 데 중점을 두고 있습니다. 그러나 특히 외과적 절제가 필요한 진행 단계에서는 예후가 여전히 불충분하며, 이에 따라 심각한 합병증이나 장기적인 후유증이 동반됩니다.

높은 사망률, 임상적 복잡성, 그리고 막대한 경제적 부담을 고려할 때, 괴사성 장염에 대한 대응은 치료보다는 예방 전략으로 점점 더 전환되고 있습니다. 초유나 모유를 이용한 조기 수유, 영양 관리의 최적화, 프로바이오틱스를 활용한 미생물군집 조절과 같은 접근법이 큰 주목을 받고 있습니다. 여러 메타분석에서 프로바이오틱스가 괴사성 장염의 발병률을 낮출 가능성이 제시되고 있지만, 표준화된 지침의 부재, 안전성에 대한 우려, 그리고 FDA 승인을 받은 의약품 등급 제품의 부재로 인해 그 도입 현황은 여전히 일관성이 부족합니다. 지역별 차이도 뚜렷한데, 유럽에서는 도입률이 높은 반면, 미국에서는 비교적 제한적이긴 하지만 점차 이용이 확대되고 있습니다.

개발 파이프라인의 상황은 서서히 변화하고 있으며, 미생물군집을 기반으로 한 치료법과 새로운 예방 접근법이 주목을 받고 있습니다. 그중에서도 현재 제3상 임상시험이 진행 중인 의약품 등급의 프로바이오틱스 ‘IBP-9414’는 괴사성 장염 예방을 목표로 하는 ‘퍼스트-인-클래스’ 치료법이 될 가능성을 지니고 있습니다. 승인될 경우, 신생아 의료 분야에서 미생물군집을 기반으로 한 중재 요법에 대한 규제 및 임상상의 선례가 될 가능성이 있습니다. 전반적으로, 질환에 대한 인식 제고, 지속적인 임상 연구, 그리고 후기 개발 단계에 있는 후보 약물의 등장으로 인해, 예측 기간 동안 예방, 조기 개입 및 작용기전에 기반한 치료법에 중점이 두어질 것이며, 괴사성 장염 시장은 점진적으로 변화해 나갈 것으로 예측됩니다.

  • G7 국가(700만 명) 중 미국은 신생아 중환자실(NICU) 입원 건수와 의료비가 높은 수준을 기록하고 있어 가장 큰 잠재 시장을 차지하고 있지만, 치료 옵션은 여전히 제한적입니다.
  • 예측 기간 동안 승인된 치료법이 없습니다는 점을 감안할 때, IBP-9414와 같은 개발 중인 치료법이 큰 주목을 받으며 잠재적인 시장 점유율을 확보할 것으로 예측됩니다.
  • 미생물군집을 기반으로 한 치료법 및 예방 요법의 등장으로 괴사성 장염의 치료 환경은 일변했으며, 향후 몇 년 동안 경쟁과 혁신이 격화될 것으로 예측됩니다.

자주 묻는 질문

  • 괴사성 장염 시장 규모는 어떻게 예측되나요?
  • 괴사성 장염의 주요 원인은 무엇인가요?
  • 괴사성 장염의 임상적 관리 방법은 어떻게 되나요?
  • 괴사성 장염 예방을 위한 전략은 무엇인가요?
  • 괴사성 장염에 대한 현재의 치료 옵션은 어떤 것들이 있나요?
  • 괴사성 장염의 발생률은 어떻게 변화하고 있나요?
  • 괴사성 장염 시장에서의 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 괴사성 장염 : 역학 및 시장 조사 방법

제6장 괴사성 장염 : 시장 개요

제7장 괴사성 장염 : 질환 배경 및 개요

제8장 괴사성 장염 : 역학 및 환자 인구

제9장 괴사성 장염 : 환자 경과

제10장 신흥 치료제

제11장 괴사성 장염 : 주요 7개국 분석

제12장 괴사성 장염 : 미충족 수요

제13장 괴사성 장염 : SWOT 분석

제14장 괴사성 장염 : KOL(Key Opinion Leader)의 견해

제16장 괴사성 장염 : 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

KTH

Necrotizing Enterocolitis (NEC) Insights and Trends

  • According to DelveInsight's analysis, necrotizing enterocolitis market size was found to be ~USD 30 million in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • Necrotizing Enterocolitis is a severe and life-threatening gastrointestinal emergency that primarily affects premature infants in neonatal intensive care units worldwide. Despite major advancements in neonatal care, its exact etiology remains incompletely understood, making it a key area of research focus.
  • At birth, neonates are exposed to environmental bacteria; however, preterm infants experience delayed and abnormal gut colonization. This leads to exaggerated inflammatory responses and contributes to necrotizing enterocolitis development. Feeding practices further influence risk delayed enteral feeding and reliance on total parenteral nutrition increase susceptibility, whereas early enteral feeding may offer protective benefits.
  • Nutritional practices play a crucial role in necrotizing enterocolitis risk, as delayed initiation of enteral feeding and dependence on total parenteral nutrition can lead to intestinal mucosal atrophy and increased susceptibility, whereas early enteral feeding may help reduce the risk of disease development.
  • Inflammatory and immunological pathways are central to necrotizing enterocolitis pathogenesis, particularly the imbalance between Toll-like receptors TLR4 and TLR9, where increased TLR4 activation contributes to intestinal injury by promoting apoptosis and impairing enterocyte proliferation and migration.
  • Clinical management of necrotizing enterocolitis is dependent on disease severity, with early-stage disease (Stages I and II) typically managed conservatively through bowel rest, broad-spectrum antibiotics, and supportive care, while advanced disease (Stage III) often requires surgical intervention, including procedures such as laparotomy or resection of necrotic bowel.
  • Due to the absence of highly effective targeted therapies for necrotizing enterocolitis, current research and clinical focus have shifted toward preventive strategies, including early feeding with colostrum and mother's milk, careful nutritional management, probiotic use, environmental control, and supportive interventions such as skin-to-skin care.
  • Few companies are persistentlyworking toward the development of new treatmenttherapies. Only Infant Bacterial Therapeuticshas product at the advanced stage; however, companies like Noveome Biotherapeutics, Siolta Therapeutics, and Plakous Therapeutics have their assets in the early or preclinical stage.

Necrotizing Enterocolitis Market Size and Forecast in the 7MM

  • 2025 Necrotizing Enterocolitis Market Size: ~USD 30 million
  • 2036 Projected Necrotizing Enterocolitis Market Size: ~USD 800 million
  • Necrotizing Enterocolitis Growth Rate (2026-2036): 26% CAGR

DelveInsight's 'Necrotizing Enterocolitis- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Necrotizing Enterocolitis, historical and forecasted epidemiology, as well as the necrotizing enterocolitis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Necrotizing Enterocolitis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, necrotizing enterocolitis 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 necrotizing enterocolitis 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 Necrotizing Enterocolitis Market

High Disease Burden in Premature Infants

Necrotizing Enterocolitis remains one of the most serious and life-threatening gastrointestinal emergencies in preterm infants, particularly those in neonatal intensive care units. The increasing survival of extremely premature infants, driven by advancements in neonatal care, has inadvertently expanded the at-risk population, thereby sustaining the clinical and economic burden of necrotizing enterocolitis globally.

Significant Unmet Medical Need

Despite decades of research, there are no approved targeted pharmacological therapies for necrotizing enterocolitis, and current management relies primarily on supportive care and surgical intervention in advanced stages. This lack of effective treatment options highlights a substantial unmet need, creating strong opportunities for the development of disease-modifying therapies.

Growing Focus on Preventive Strategies

With limited treatment options available, there is an increasing shift toward prevention-based approaches. Strategies such as early feeding with colostrum and mother's milk, optimized nutritional protocols, probiotic supplementation, and improved neonatal care practices are gaining importance in reducing necrotizing enterocolitis incidence.

Necrotizing Enterocolitis Understanding and Treatment Algorithm

Necrotizing Enterocolitis Overview and Diagnosis

Necrotizing Enterocolitis is a severe, life-threatening gastrointestinal disease primarily affecting premature infants, characterized by intestinal inflammation, bacterial invasion, and progressive necrosis. It may lead to intestinal perforation, resulting in peritonitis, sepsis, and death. Symptoms are often nonspecific (e.g., poor feeding, vomiting, lethargy, abdominal tenderness), requiring high clinical suspicion. The exact etiology remains unclear, but intestinal immaturity, abnormal bacterial colonization, and exaggerated inflammatory responses are key contributors, with progression from inflammation to ischemia, necrosis, and perforation. Management is primarily supportive, including stabilization (ABC), fluid resuscitation, gastric decompression, broad-spectrum antibiotics, and total parenteral nutrition, with enteral feeding resumed after improvement. Severe or non-responsive cases require surgical intervention (e.g., laparotomy, removal of necrotic bowel, ostomy), while peritoneal drainage may be used in critically ill infants.

After a premature baby is born, steps are taken to prevent the infant from getting infections. If these preventive measures are unsuccessful, the baby can experience symptoms like a swollen abdomen, tiredness, and breathing pauses. Doctors conduct tests such as a complete blood count, a C-reactive protein test, and x-rays to diagnose the condition. After these tests, it is confirmed that the baby has necrotizing enterocolitis.

Necrotizing Enterocolitis Treatment Landscape

No pharmaceutical therapies are currently approved specifically for necrotizing enterocolitis. Due to the lack of effective treatments and the high mortality associated with the disease, research efforts have increasingly shifted toward preventive strategies, including early exposure to colostrum and mother's milk, optimized nutritional management, probiotics, environmental protection, skin-to-skin care (SSC), and pharmacological approaches. While probiotics (dietary supplements containing live bacteria) are suggested to help prevent necrotizing enterocolitis, they are not subject to FDA premarket approval for safety and efficacy or the same manufacturing and quality standards required for regulated drugs. Safety concerns are further highlighted by a reported case in 2014, where a premature infant in a US NICU died from gastrointestinal mucormycosis linked to a contaminated probiotic supplement.

Necrotizing Enterocolitis Unmet Needs

The section "unmet needs of Necrotizing Enterocolitis" 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. Lack of noninvasive treatment

2. Challenges in diagnosing necrotizing enterocolitis

3. High mortality rate

4. Reduced quality of life

5. Unclear etiology

6. Novel research strategies for prevention, and others.....

Necrotizing Enterocolitis Epidemiology

Key Findings from Necrotizing Enterocolitis Epidemiological Analysis and Forecast

  • In 2025, the United States continues to report the highest absolute number of very low birth weight (<=1,500 g) preterm infants among the 7MM, driven by higher total birth volume compared with European countries and Japan. However, rates of VLBW births have remained relatively stable in recent years, with minor fluctuations. As per the estimate, the incident cases of preterm infants by birth weight (<=1,500 g) in 7MM are anticipated to increase during the forecast period of 2026-2036.
  • Across the 7MM, the population of preterm infants with birth weight <=1,500 g is expected to remain stable to slightly increasing through 2030, largely due to improved neonatal survival rates rather than a significant rise in preterm birth incidence. This trend is consistently reported by World Health Organization and regional neonatal databases.
  • The incidence of necrotizing enterocolitis in high-income regions, including the United States and EU4 and the UK, has stabilized or modestly declined by 2025, driven by advances in neonatal care such as human milk feeding, standardized NICU practices, and improved infection control. Although probiotic use is increasing, organizations like the American Academy of Pediatrics highlight inconsistent evidence and lack of standardized formulations, limiting widespread guideline adoption.
  • In the United States, the annual incidence of necrotizing enterocolitis remains in the range of ~3,000-5,000 cases, with recent estimates (2024-2025) suggesting stabilization or modest decline, particularly in tertiary NICUs implementing preventive bundles. This aligns with surveillance data from Centers for Disease Control and Prevention and neonatal networks.
  • Within the EU4 (Germany, France, Italy, Spain), Germany continues to report the highest number of VLBW preterm infants, followed by France, reflecting population size and birth rates, while Spain reports comparatively lower absolute numbers. This pattern remains consistent in 2025 neonatal registry updates.
  • In Japan, the incidence of necrotizing enterocolitis remains low (~100-200 cases annually), driven by declining birth rates, advanced neonatal care, and strong breastfeeding practices. Recent data (2024-2025), including from the Japan Neonatal Research Network, indicate stable to slightly declining incidence, reflecting ongoing improvements in neonatal management and prevention.

Necrotizing Enterocolitis Drug Analysis & Competitive Landscape

The Necrotizing Enterocolitis drug chapter provides a detailed emerging pipeline across Phase I/II-III clinical trials. It covers mechanism of action, clinical trial data, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Necrotizing Enterocolitis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the necrotizing enterocolitis therapeutics market.

Necrotizing Enterocolitis Pipeline Analysis

IBP-9414: Infant Bacterial Therapeutics

IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world's first approved probiotic drug to prevent life-threatening diseases in premature infants, including necrotizing enterocolitis and sepsis, by promoting healthy stomach and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, a human bacterial strain naturally present in breast milk. Lactobacillus reuteri is a live bacterium known to be anti-inflammatory, anti-pathogenic, and beneficial to gut motility and mucosa maturity. IBP-9414 is currently in an ongoing registration-enabling pivotal Phase III study to prevent necrotizing enterocolitis. The company is expected to submit an approval application in 2026, and results from the pivotal Phase III "Connection Study" in very low birth weight infants have been published in Pediatric Research (Nature).

STMC-106: Siolta Therapeutics

Siolta Therapeutics is developing the drug candidate STMC-106 as part of its microbiome-based live biotherapeutic pipeline. The program is focused on preventing and treating necrotizing enterocolitis in preterm infants by leveraging targeted microbial therapies to support gut health and reduce disease risk. STMC-106 is currently in preclinical development and has received grant support to advance its research, with the aim of progressing toward clinical evaluation.

Necrotizing Enterocolitis Key Players, Market Leaders and Emerging Companies

  • Infant Bacterial Therapeutics
  • Leadiant Biosciences
  • Siolta Therapeutics
  • Noveome Biotherapeutics
  • Plakous Therapeutics, and others

Necrotizing Enterocolitis Drug Updates

  • In March 2026, Noveome Biotherapeutics announced the independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from Cohort 1 of the ongoing clinical trial evaluating ST266 for the treatment of necrotizing enterocolitis in neonates.
  • In March 2026, Infant Bacterial Therapeutics announced announce that results from its pivotal Phase III trial, with IBP-9414 in very low birth weight infants "The Connection Study" have now been published in Pediatric Research (a Nature Publication).
  • As of December 2025, Infant Bacterial Therapeutics announced that it had entered into a partnership with BioConnection for the production of IBP-9414 drug product.In November 2025, Infant Bacterial Therapeutics announced that company has decided to pursue an accelerated approval pathway for IBP-9414.

Necrotizing Enterocolitis Market Outlook

The necrotizing enterocolitis market remains largely unchanged and continues to rely on supportive care approaches, including bowel rest, broad-spectrum antibiotics, parenteral nutrition, and surgical intervention in severe cases. Despite being the leading gastrointestinal cause of mortality and the primary surgical emergency in neonates, there are no approved targeted pharmacological therapies for necrotizing enterocolitis. The current treatment paradigm focuses on stabilizing the patient and limiting disease progression through intensive supportive measures such as bowel decompression, fluid resuscitation, respiratory and cardiovascular support, and close clinical monitoring. However, outcomes remain suboptimal, particularly in advanced stages requiring surgical resection, which is associated with significant morbidity and long-term complications.

Given the high mortality rate, clinical complexity, and substantial economic burden, the necrotizing enterocolitis landscape is increasingly shifting toward preventive strategies rather than treatment. Approaches such as early feeding with colostrum and mother's milk, optimized nutritional practices, and microbiome modulation through probiotics have gained considerable attention. Although probiotics have demonstrated potential in reducing necrotizing enterocolitis incidence in multiple meta-analyses, their adoption remains inconsistent due to lack of standardized guidelines, safety concerns, and absence of FDA-approved pharmaceutical-grade products. Regional variability is evident, with higher adoption rates in Europe compared to relatively limited but gradually increasing use in the United States.

The pipeline landscape is gradually evolving, with microbiome-based therapies and novel preventive approaches gaining traction. Among these, IBP-9414, a pharmaceutical-grade probiotic currently in Phase III clinical trials, represents a potential first-in-class therapy targeting necrotizing enterocolitis prevention. If approved, it could establish a regulatory and clinical precedent for microbiome-based interventions in neonatal care. Overall, increasing disease awareness, ongoing clinical research, and the emergence of late-stage pipeline candidates are expected to drive gradual transformation in the necrotizing enterocolitis market, with a strong focus on prevention, early intervention, and mechanism-based therapies over the forecast period.

  • Among the 7MM, the United States accounts for the largest potential market, driven by high NICU admissions and healthcare expenditure, although treatment options remain limited.
  • In the forecast period, pipeline therapies such as IBP-9414 are expected to capture significant attention and potential market share, given the absence of approved treatments.
  • The entry of microbiome-based and preventive therapies is anticipated to reshape the necrotizing enterocolitis treatment landscape, intensifying competition and innovation in the coming years.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Necrotizing Enterocolitis (2022-2036 Forecast)

The necrotizing enterocolitis treatment landscape remains highly underserved, with no approved pharmacological therapies currently available, and management primarily reliant on supportive care and surgical intervention. Emerging pipeline approaches are beginning to reshape the space, including microbiome-based therapies and regenerative biologics aimed at addressing underlying disease mechanisms such as intestinal immaturity, dysbiosis, and inflammation. For instance, investigational assets like STMC-106 from Siolta Therapeutics and Protego-PD from Plakous Therapeutics highlight innovative strategies targeting early-life gut health and immune modulation. While these candidates remain in preclinical stages, they reflect growing scientific and clinical interest in preventive interventions for high-risk preterm infants. The advancement of such therapies, alongside increasing focus on standardized neonatal care practices, is expected to gradually transform the necrotizing enterocolitis landscape over the coming decade, although significant unmet needs persist in early diagnosis, effective prevention, and targeted treatment options.

Necrotizing Enterocolitis 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 Necrotizing Enterocolitis drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Pipeline candidate IBP-9414 is expected to follow a moderate uptake trajectory, reflecting its investigational status and gradual adoption as clinical evidence emerges. Meanwhile, STP206 is anticipated to show gradual uptake.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Necrotizing Enterocolitis

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies recently. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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.

Probiotics: Requires a Letter of Medical Necessity (LMN) to be eligible with a Flexible SpendingAccount (FSA).

Probiotics may be eligible with a Letter of Medical Necessity (LMN) with a flexible spending account(FSA), health savings account (HSA), or health reimbursement arrangement (HRA). Probiotics are noteligible for reimbursement with limited-purpose flexible spending accounts (LPFSA) and dependentcare flexible spending accounts (DCFSA).

NOTE: Further Details are provided in the final report....

Necrotizing Enterocolitis Therapies Price Scenario & Trends

Pricing and analogue assessment of necrotizing enterocolitis 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.

Industry Experts and Physician Views for Necrotizing Enterocolitis

To keep up with Necrotizing Enterocolitis 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 Necrotizing Enterocolitis 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 Necrotizing Enterocolitis, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at country level. Centers such as the Nationwide Children's Hospital, Columbus, OH, the United States, University Hospitals Dorset NHS Foundation Trust, the United Kingdom, Department of Pediatrics, North Shore University Health System, Evanston, Illinois, etc., were contacted.Their opinion helps understand and validate current and emerging Necrotizing Enterocolitis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Necrotizing Enterocolitis.

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 Necrotizing Enterocolitis, 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 majorly 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 Necrotizing Enterocolitis, explaining their 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 Necrotizing Enterocolitis 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 Necrotizing Enterocolitis market.

Report Insights

  • Necrotizing Enterocolitis (NEC) Patient Population Forecast
  • Necrotizing Enterocolitis (NEC) Therapeutics Market Size
  • Necrotizing Enterocolitis (NEC) Pipeline Analysis
  • Necrotizing Enterocolitis (NEC) Market Size and Trends
  • Necrotizing Enterocolitis (NEC) 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
  • Necrotizing Enterocolitis (NEC) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Necrotizing Enterocolitis (NEC) Treatment Addressable Market (TAM)
  • Necrotizing Enterocolitis (NEC) Competitive Landscape
  • Necrotizing Enterocolitis (NEC) Major Companies Insights
  • Necrotizing Enterocolitis (NEC) Price Trends and Analogue Assessment
  • Necrotizing Enterocolitis (NEC) Therapies Drug Adoption/Uptake
  • Necrotizing Enterocolitis (NEC) Therapies Peak Patient Share Analysis

Report Assessment

  • Necrotizing Enterocolitis (NEC) Current Treatment Practices
  • Necrotizing Enterocolitis (NEC) Unmet Needs
  • Necrotizing Enterocolitis (NEC) Clinical Development Analysis
  • Necrotizing Enterocolitis (NEC) Emerging Drugs Product Profiles
  • Necrotizing Enterocolitis (NEC) Market attractiveness
  • Necrotizing Enterocolitis (NEC) Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the Necrotizing Enterocolitis 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 Necrotizing Enterocolitis?
  • What are the disease risks, burdens, and unmet needs of Necrotizing Enterocolitis? What will be the growth opportunities across the 7MM concerning the patient population with Necrotizing Enterocolitis?
  • 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 Necrotizing Enterocolitis? What are the current guidelines for treating Necrotizing Enterocolitis 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 Necrotizing Enterocolitis 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 on 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 with in 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. Key Conferences And Meetings
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Methodology of Necrotizing Enterocolitis (NEC)

6. Necrotizing Enterocolitis (NEC) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Necrotizing Enterocolitis By Therapies (%) in the 7MM in 2028
  • 6.3. Market Share of Necrotizing Enterocolitis By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Necrotizing Enterocolitis (NEC)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs and Symptoms
  • 7.4. Risks Factors
  • 7.5. Pathology
  • 7.6. Pathogenesis
    • 7.6.1. Intestinal Immaturity, Dysbiosis, and Barrier Dysfunction
    • 7.6.2. Feeding and Immature GI Function
    • 7.6.3. Role of Cytokines and Chemokines
  • 7.7. Diagnosis of Necrotizing Enterocolitis
    • 7.7.1. Laboratory and Radiological Investigations
    • 7.7.2. Differentiating Medical and Surgical NEC: Use of Biomarkers
  • 7.8. Differential Diagnosis
  • 7.9. Treatment Management of Necrotizing Enterocolitis
    • 7.9.1. Medical Management
    • 7.9.2. Surgical Management
    • 7.9.3. Comparison of Laparotomy and PPD
    • 7.9.4. Post-surgery Intestinal Failure and Short Bowel Syndrome (SBS)
    • 7.9.5. Surgical Procedures for Short Bowel Syndrome (SBS)
    • 7.9.6. Intestinal Rehabilitation
  • 7.10. Strategies for Preventing Necrotizing Enterocolitis in Neonates
  • 7.11. Guidelines for Necrotizing Enterocolitis
    • 7.11.1. Neonatal Necrotizing Enterocolitis (NEC) Care Guideline
    • 7.11.2. Diagnosis and Management of Suspected and Definitive Necrotizing Enterocolitis
    • 7.11.3. Joint Trust Guidelines for the Management of Necrotizing Enterocolitis in Neonates and Infants
    • 7.11.4. Recommendation of the UK for Necrotizing Enterocolitis

8. Epidemiology and Patient Population of Necrotizing Enterocolitis (NEC)

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale
  • 8.3. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in the 7MM
  • 8.4. Total Incident Cases of Necrotizing Enterocolitis in the 7MM
  • 8.5. United States
    • 8.5.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in the United States
    • 8.5.2. Total Incident Cases of Necrotizing Enterocolitis in the United States
  • 8.6. EU4 and the UK
    • 8.6.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in EU4 and the UK
    • 8.6.2. Total Incident Cases of Necrotizing Enterocolitis in EU4 and the UK
  • 8.7. Japan
    • 8.7.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in Japan
    • 8.7.2. Total Incident Cases of Necrotizing Enterocolitis in Japan

9. Patient Journey of Necrotizing Enterocolitis (NEC)

10. Emerging Drugs

  • 10.1. Emerging Competitive Landscape of Necrotizing Enterocolitis (NEC)
  • 10.2. IBP-9414: Infant Bacterial Therapeutics
    • 10.2.1. Product Description
    • 10.2.2. Other Development Activities
    • 10.2.3. Clinical Development
      • 10.2.3.1. Clinical Trials Information
    • 10.2.4. Safety and Efficacy
    • 10.2.5. Analyst's view

11. Necrotizing Enterocolitis (NEC): Seven Major Market Analysis

  • 11.1. Key Findings
  • 11.2. Market Outlook
  • 11.3. Key Market Forecast Assumptions
  • 11.4. Total Market Size of Necrotizing Enterocolitis in the 7MM
  • 11.5. United States Market Size
    • 11.5.1. Total Market Size of Necrotizing Enterocolitis in the United States
    • 11.5.2. Market Size of Necrotizing Enterocolitis by Therapies in the United States
  • 11.6. EU4 and the UK Market Size
    • 11.6.1. Total Market Size of Necrotizing Enterocolitis in EU4 and the UK
    • 11.6.2. Market Size of Necrotizing Enterocolitis by Therapies in EU4 and the UK
  • 11.7. Japan Market Size
    • 11.7.1. Total Market Size of Necrotizing Enterocolitis in Japan

12. Unmet Needs of Necrotizing Enterocolitis (NEC)

13. SWOT Analysis of Necrotizing Enterocolitis (NEC)

14. KOL Views of Necrotizing Enterocolitis (NEC)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of Necrotizing Enterocolitis (NEC)

  • 16.1. United States
    • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
    • 16.3.1. MHLW

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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