New York, USA, July 27, 2026 (GLOBE NEWSWIRE) -- Necrotizing Enterocolitis Market to Register Stunning Growth at a CAGR of 26% During the Forecast Period (2026–2036) | DelveInsight
The necrotizing enterocolitis market is witnessing steady growth, primarily driven by the increasing incidence of preterm births worldwide, as premature infants are at the highest risk of developing NEC. Rising awareness among healthcare providers regarding early diagnosis and preventive care is further supporting market expansion. Additionally, ongoing research activities focused on novel therapeutics such as IBP-9414 (Infant Bacterial Therapeutics), STMC-106 (Siolta Therapeutics), ST266 (Noveome Biotherapeutics), Protego-PD (Plakous Therapeutics), and others, probiotics, stem cell therapies, and targeted interventions are creating significant growth opportunities.
Recently published Necrotizing Enterocolitis Market Insights report includes a comprehensive understanding of current treatment practices, necrotizing enterocolitis emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Necrotizing Enterocolitis Market Summary
- The market size for necrotizing enterocolitis was found to be USD 30 million in the 7MM in 2025.
- The United States accounted for the largest necrotizing enterocolitis treatment market size in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- 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.
- Key necrotizing enterocolitis companies, including Infant Bacterial Therapeutics, Siolta Therapeutics, Noveome Biotherapeutics, Plakous Therapeutics, and others, are actively working on innovative necrotizing enterocolitis drugs.
- Some of the key necrotizing enterocolitis therapies in clinical trials include IBP-9414, STMC-106, ST266, Protego-PD, and others. These novel necrotizing enterocolitis therapies are anticipated to enter the necrotizing enterocolitis market in the forecast period and are expected to change the market.
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Key Factors Driving the Growth of the Necrotizing Enterocolitis Market
- Rising Incidence of Premature Births and Low Birth Weight Infants: Necrotizing enterocolitis primarily affects premature and very low birth weight infants, making the growing global burden of preterm births a major market driver. Advances in neonatal intensive care have improved survival rates among high-risk newborns, thereby increasing the population vulnerable to NEC and driving demand for effective preventive and therapeutic interventions.
- Advancements in Neonatal and Intensive Care Practices: Continuous improvements in neonatal intensive care unit (NICU) infrastructure, diagnostic capabilities, and patient monitoring technologies have enhanced the identification and management of NEC. Earlier detection and intervention are increasing awareness of disease burden and supporting the adoption of emerging treatment strategies.
- Growing Focus on Microbiome and Gut Health Research: A deeper understanding of the role of intestinal dysbiosis, microbial imbalance, and inflammation in NEC pathogenesis has fueled interest in microbiome-targeted therapies. The development of probiotics, live biotherapeutic products, and microbiome-modulating treatments is expected to significantly contribute to future market expansion.
- Launch of Emerging Necrotizing Enterocolitis Drugs: The dynamics of the necrotizing enterocolitis market are expected to change in the coming years due to the launch of emerging therapies such as IBP-9414 (Infant Bacterial Therapeutics), STMC-106 (Siolta Therapeutics), ST266 (Noveome Biotherapeutics), Protego-PD (Plakous Therapeutics), and others.
Aparna Thakur, project manager of forecasting at DelveInsight, said that the 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.
Necrotizing Enterocolitis Market Analysis
- The treatment landscape for necrotizing enterocolitis continues to face substantial unmet needs, as there are currently no approved drug therapies available, and patient management largely depends on supportive measures and surgical procedures in severe cases.
- However, the pipeline is gradually evolving with the development of novel approaches such as microbiome-based therapeutics and regenerative biologics designed to address key disease drivers, including gut immaturity, microbial imbalance, and excessive inflammation.
- Promising investigational candidates, such as STMC-106 by Siolta Therapeutics and Protego-PD by Plakous Therapeutics, exemplify innovative efforts focused on enhancing neonatal gut health and modulating immune responses.
- Although these therapies are still in the preclinical phase, they underscore the increasing research and industry interest in preventive strategies for vulnerable preterm infants.
- Over the next decade, advancements in these emerging therapies, coupled with improvements in standardized neonatal care, are anticipated to reshape the NEC treatment landscape, despite ongoing challenges related to timely diagnosis, prevention, and the availability of effective targeted treatments.
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Necrotizing Enterocolitis Competitive Landscape
Some of the necrotizing enterocolitis drugs under development include IBP-9414 (Infant Bacterial Therapeutics), STMC-106 (Siolta Therapeutics), ST266 (Noveome Biotherapeutics), Protego-PD (Plakous Therapeutics), and others.
IBT is advancing IBP-9414, a probiotic-based therapeutic candidate designed to become the first approved treatment of its kind for preventing severe complications in premature infants, including necrotizing enterocolitis (NEC) and sepsis. The therapy aims to support healthy gastrointestinal development in preterm newborns. IBP-9414 contains Lactobacillus reuteri, a naturally occurring bacterial strain found in human breast milk that exhibits anti-inflammatory and antimicrobial properties while promoting intestinal motility and maturation of the gut lining. The candidate is currently being evaluated in a registration-enabling pivotal Phase III trial for NEC prevention. IBT anticipates filing for regulatory approval in 2026, and findings from its Phase III "Connection Study" involving very low birth weight infants have been published in the journal Pediatric Research.
Siolta Therapeutics is developing STMC-106, a microbiome-based live biotherapeutic candidate within its broader microbial therapeutics portfolio. The program is aimed at preventing and treating necrotizing enterocolitis in preterm infants through targeted modulation of the gut microbiome to enhance intestinal health and lower disease susceptibility. STMC-106 remains in the preclinical stage of development and has secured grant funding to support ongoing research activities as the company works toward future clinical testing.
The anticipated launch of these emerging necrotizing enterocolitis therapies are poised to transform the necrotizing enterocolitis market landscape in the coming years. As these cutting-edge necrotizing enterocolitis therapies continue to mature and gain regulatory approval, they are expected to reshape the necrotizing enterocolitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
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Recent Developments in the Necrotizing Enterocolitis Market
- In March 2026, Noveome Biotherapeutics announced that the independent Data Safety Monitoring Board (DSMB) had 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 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).
- In December 2025, Infant Bacterial Therapeutics announced that it had entered into a partnership with BioConnection for the production of the IBP-9414 drug product.
- In November 2025, Infant Bacterial Therapeutics announced that the company had decided to pursue an accelerated approval pathway for IBP-9414.
What is Necrotizing Enterocolitis?
Necrotizing enterocolitis is a serious and potentially life-threatening gastrointestinal disease that primarily affects premature and very low birth weight infants. The condition is characterized by inflammation and necrosis of the intestinal wall, which can lead to intestinal perforation, severe infection, sepsis, and even death. Although the exact cause of NEC remains unclear, it is believed to result from a combination of intestinal immaturity, abnormal bacterial colonization, impaired blood flow to the gut, and an exaggerated inflammatory response. NEC typically develops within the first few weeks of life and presents with symptoms such as feeding intolerance, abdominal distension, vomiting, bloody stools, and lethargy. Despite advances in neonatal care, NEC remains one of the most devastating complications in neonatal intensive care units (NICUs), highlighting the need for improved preventive and therapeutic strategies.
Necrotizing Enterocolitis Epidemiology Segmentation
The necrotizing enterocolitis epidemiology section provides insights into the historical and current necrotizing enterocolitis patient pool and forecasted trends for the leading markets. Across the 7MM, the population of preterm infants with birth weight ≤1,500 g is expected to remain stable to slightly increase through 2030, largely due to improved neonatal survival rates rather than a significant rise in preterm birth incidence.
The necrotizing enterocolitis market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets segmented into:
- Total Incident Cases of Preterm Infants by Birth Weight (≤1,500g)
- Total Incident Cases of Necrotizing Enterocolitis
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| Necrotizing Enterocolitis Market Report Metrics | Details |
| Study Period | 2022–2036 |
| Necrotizing Enterocolitis Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Necrotizing Enterocolitis Market CAGR | 26% |
| Necrotizing Enterocolitis Market Size in 2025 | USD 30 Million |
| Key Necrotizing Enterocolitis Companies | Infant Bacterial Therapeutics, Siolta Therapeutics, Noveome Biotherapeutics, Plakous Therapeutics, and others |
| Key Necrotizing Enterocolitis Therapies | IBP-9414, STMC-106, ST266, Protego-PD, and others |
Scope of the Necrotizing Enterocolitis Market Report
- Necrotizing Enterocolitis Patient Population Forecast
- Necrotizing Enterocolitis Therapeutics Market Size
- Necrotizing Enterocolitis Pipeline Analysis
- Necrotizing Enterocolitis Market Size and Trends
- Necrotizing Enterocolitis Market Opportunity
- Necrotizing Enterocolitis Market Unmet Needs
- KOL’s Views on Necrotizing Enterocolitis
- Necrotizing Enterocolitis Market Access and Reimbursement
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Table of Contents
| 1 | Necrotizing Enterocolitis Market Key Insights |
| 2 | Necrotizing Enterocolitis Market Report Introduction |
| 3 | Executive Summary |
| 4 | Key Events |
| 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 |
| 7.7 | Diagnosis of Necrotizing Enterocolitis |
| 7.8 | Differential Diagnosis |
| 7.9 | Treatment Management of Necrotizing Enterocolitis |
| 7.10 | Strategies for Preventing Necrotizing Enterocolitis in Neonates |
| 7.11 | Guidelines 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 |
| 8.7 | Japan |
| 9 | Patient Journey of Necrotizing Enterocolitis (NEC) |
| 10 | Emerging Necrotizing Enterocolitis 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 Market: Seven Major Market Analysis |
| 11.1 | Key Findings |
| 11.2 | Necrotizing Enterocolitis Market Outlook |
| 11.3 | Key Necrotizing Enterocolitis Market Forecast Assumptions |
| 11.4 | Total Market Size of Necrotizing Enterocolitis in the 7MM |
| 11.5 | United States Necrotizing Enterocolitis 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 Necrotizing Enterocolitis Market Size |
| 11.7 | Japan Necrotizing Enterocolitis Market Size |
| 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 |
| 16.2 | EU4 and the UK |
| 16.3 | Japan |
| 17 | Bibliography |
| 18 | Necrotizing Enterocolitis Market Report Methodology |
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