Necrotizing Enterocolitis Market

• The total necrotizing enterocolitis market size in the 7MM will be more than USD 700 million by 2034.
• Premature infants are the most vulnerable and require extensive, specialized care to survive and grow. A 24-week gestational age infant has a 50% chance of survival despite all current neonatal intensive care measures. IBP-9414 is a pharma-grade probiotic that prevents life-threatening infant diseases.
• The risk of necrotizing enterocolitis increases with decreasing gestational age and is greatest in infants less than 28 weeks gestation. Necrotizing enterocolitis remains a significant burden with high mortality across decades, despite advances in neonatal intensive care.
• Patients with NEC Stage 1 and 2 are usually managed conservatively, while infants with Stage 3 NEC may require surgical intervention, including laparotomy or peritoneal drain placement.
• The use of probiotics to prevent NEC in very low birth weight babies (VLBWI) has become a “hot topic” in neonatal literature. Probiotics for very preterm infants Policies and practices for using probiotic supplements to prevent necrotizing enterocolitis in preterm or VLBW infants vary within and between countries. Some products currently available in the United States are categorized as dietary supplements or foods for special dietary use.
• Probiotics are widely used in Europe and Asian countries in comparison to the United States.
• Due to the unavailability of suitable medical-grade items in the United States, dietary supplement-level probiotics are recommended. Some of these have even been recalled due to contamination issues. Considering the absence of FDA-regulated pharmaceutical-grade options, mixed information on their safety and effectiveness, and the possibility of causing harm in a delicate population, the current information does not endorse the regular and widespread use of probiotics for preterm infants, especially those weighing <1,000 g at birth
• The long-term implications of giving probiotics to preterm infants and how the administration of microorganisms may permanently alter the microbiome are currently unknown.
• Studies from Japan show necrotizing enterocolitis incidence to be 1.6%, which is far lower than in Western countries like the United States, where studies have reported 7–10% high NEC incidences.
• Due to the lack of effective treatments for NEC, the research focus has shifted to testing strategies for the prevention of NEC, specifically early exposure to colostrum and mother’s milk, careful nutritional consideration, probiotics, environmental protection, skin-to-skin care (SSC), and pharmacology.

DelveInsight’s “Necrotizing Enterocolitis Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of necrotizing enterocolitis, historical and forecasted epidemiology as well as necrotizing enterocolitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The necrotizing enterocolitis market report provides current treatment and prevention practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM necrotizing enterocolitis market size from 2020 to 2034. The report also covers current necrotizing enterocolitis treatment practices/algorithms, prophylactic treatment, and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020–2034

Necrotizing Enterocolitis Disease Understanding and Treatment Algorithm

Necrotizing Enterocolitis Overview

Necrotizing Enterocolitis is a life-threatening illness almost exclusively affecting neonates. The pathophysiology of NEC is inflammation of the intestine leading to bacterial invasion causing cellular damage and death, which causes necrosis of the colon and intestine. As NEC progresses, it can lead to intestinal perforation, causing peritonitis, sepsis, and death. The signs and symptoms of NEC, poor feeding, vomiting, lethargy, and abdominal tenderness, are nonspecific, so clinicians must remain suspicious when presented with these signs and symptoms in the neonatal population. Necrotizing enterocolitis is caused by bacterial invasion into the intestinal wall, leading to inflammation and cellular destruction of the intestine wall. If unrecognized and untreated, intestinal perforation may occur, causing spillage of intestinal contents into the peritoneum and resulting in peritonitis. The specific mechanism and cause of this bacterial invasion are not yet understood. In premature neonates, gastrointestinal tract immaturity plays a role in the pathogenesis of necrotizing enterocolitis.

Necrotizing Enterocolitis Diagnosis

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.

Further details related to diagnosis are provided in the report...

Necrotizing Enterocolitis Treatment

No approved pharmaceutical treatments are specifically for necrotizing enterocolitis. Due to the lack of effective treatments for necrotizing enterocolitis, the high mortality rate research focus has shifted to testing strategies for the prevention of necrotizing enterocolitis, specifically early exposure to colostrum and mother’s milk, careful nutritional consideration, probiotics, environmental protection, skin-to-skin care (SSC), and pharmacology. Dietary supplements containing live bacteria (probiotics) are suggested to be effective in preventing NEC, but they are not subject to FDA premarket review and approval requirements for safety and effectiveness or to the manufacturing and testing standards for products regulated as drugs by FDA. A premature infant in the US NICU died in 2014 of gastrointestinal mucormycosis caused by mold from a contaminated probiotic dietary supplement.

Necrotizing Enterocolitis Epidemiology

As the market is derived using a patient-based model, the necrotizing enterocolitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of preterm infants by birth weight (≤1,500 g) and total incident cases of necrotizing enterocolitis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the United States had the highest total number of incident cases of preterm infants with a birth weight (≤1,500 g) among the 7MM. 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 2024–2034.
• The incidence of NEC is currently declining. Preterm newborns are increasingly being treated with probiotics, although the facts supporting this practice do not meet the high standards of the pharmaceutical and healthcare industries. A reduction in the number of NEC incident cases in the 7MM is expected with the introduction of pharma-grade probiotics to the market.
• The total number of incident cases of necrotizing enterocolitis in the US was ~4,000 cases in 2023 and is expected to decline during the forecast period.
• Among the EU4, Germany accounted for the highest number of incident cases of preterm infants by birth weight (≤1,500 g), followed by France, whereas Spain accounted for the lowest cases in 2023.
• The total number of incident cases of necrotizing enterocolitis in Japan was ~100 cases in 2023 and is expected to decline during the forecast period.
• According to the estimates, Japan was accounting for over 1% of total incident cases of necrotizing enterocolitis in 2023.

Necrotizing Enterocolitis Recent Developments

• In May 2025, Infinant Health announced that the FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to its investigational drug candidate, INF108, for the prevention of necrotizing enterocolitis in preterm infants.

Necrotizing Enterocolitis Drug Chapters

The drug chapter segment of the necrotizing enterocolitis report encloses a detailed analysis of the late-stage (Phase III) pipeline drug. It also helps understand the clinical trial details, expressive pharmacological action, agreements and collaborations, advantages and disadvantages of each included drug, and the latest news and press releases. Currently, there are no approved therapies for necrotizing enterocolitis. IBP-9414 stands as the sole medication under development aimed at reducing or preventing the incidence of NEC in premature babies (≤1,500 grams).

Emerging Drug

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.

Note: Detailed emerging therapies assessment will be provided in the final report...

Necrotizing Enterocolitis Market Outlook

Necrotizing enterocolitis is the primary surgical emergency in newborns and the leading cause of gastrointestinal mortality among this vulnerable group. Due to its high mortality rate, challenging treatment, substantial financial impact on society, and long-term complications for survivors, there is an urgent requirement to develop innovative preventive strategies to eliminate necrotizing enterocolitis.

One potential preventative strategy for necrotizing enterocolitis is the use of probiotics. Although there has been significant interest in probiotics in neonatal care for decades, no clear guidelines exist regarding which probiotic to use or for which patients, and no FDA-approved products exist for necrotizing enterocolitis. In addition, there is a lack of agreement regarding the benefits of probiotics in neonates and some concerns about the safety and efficacy of available products.

Several recent meta-analyses have evaluated the effects of probiotics to prevent NEC (Bell Stage 2 or 3), late-onset sepsis, and death in preterm infants (typically very low birth weight infants). In the past 5 years, there have been numerous published systematic reviews. Despite significant heterogeneity among studies, the cumulative pooled risk ratio (RR) for NEC (including more than 10,000 infants) strongly favors treatment with probiotics to prevent NEC.

• The total market size of necrotizing enterocolitis in the US will be more than USD 600 million by 2034.
• Among EU4, Germany accounts for the maximum market size in 2023, while Spain occupies the bottom of the ladder.
• Considering the substantial volume of literature advocating for the utilization of probiotics to prevent NEC, the rise in probiotic usage is to be expected, despite the inherent drawbacks of the current dietary supplement-grade products accessible in the United States.

Necrotizing Enterocolitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034. No other company is developing an advanced preventive treatment for necrotizing enterocolitis in the late stage except for Infant Bacterial Therapeutics. We estimate that the market uptake of IBP-9414 will be fairly quick, as it would be the first probiotic product with pharmaceutical quality to be approved for this condition.

Further detailed analysis of emerging therapies drug uptake in the report…

Necrotizing Enterocolitis Pipeline Development Activities

The report provides insights into therapeutic candidates in the different stages. It also analyzes key players involved in developing targeted therapeutics.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the necrotizing enterocolitis evolving preventive treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility, including pulmonologists, HCPs, physicians, and others.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as 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 therapy treatment patterns or necrotizing enterocolitis market trends. This will support the clients in potential upcoming novel prophylactic treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, 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. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

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.

Scope of the Report

• The report covers key events, an executive summary, and a descriptive overview of necrotizing enterocolitis, explaining its causes, signs and symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact 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 shape and drive the 7MM necrotizing enterocolitis market.

Necrotizing Enterocolitis Report Insights

• Patient population
• Therapeutic approaches
• Necrotizing enterocolitis pipeline analysis
• Necrotizing enterocolitis market size and trends
• Existing and future market opportunities

Necrotizing Enterocolitis Report Key Strengths

• 11 years forecast
• The 7MM coverage
• Necrotizing enterocolitis epidemiology segmentation
• Key cross competition
• Drugs uptake and key market forecast assumptions

Necrotizing Enterocolitis Report Assessment

• Current prophylactic treatment practices
• Unmet needs
• Pipeline product profiles
• Market attractiveness
• Qualitative analysis (SWOT and Analyst Views)

FAQs

• What was the necrotizing enterocolitis total market size, the market size by therapies, and market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What will be the impact of IBP-9414's expected approval by 2025?
• What are the pricing variations among different geographies for probiotics?
• 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?
• Why are incident cases of preterm infants by birth weight (≤1,500 g) declining in Germany?
• Why are incident cases of necrotizing enterocolitis declining in the 7MM?
• What are the current guidelines for treating and preventing necrotizing enterocolitis in the US, Europe, and Japan?
• What key designations have been granted for the emerging therapies for necrotizing enterocolitis?
• What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the necrotizing enterocolitis market.
• 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.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• 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 Analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around 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.