The Global Necrotising Enterocolitis Market is estimated to be valued at USD 7.10 Billion in 2024 and is expected to reach USD 10.41 Billion by 2031, growing at a compound annual growth rate (CAGR) of 5.6% from 2024 to 2031. Necrotising enterocolitis is a gastrointestinal disease primarily affecting premature infants. The increasing number of premature births and the subsequently rising incidence of NEC is a major driver for market growth.

Key factors boosting the demand for NEC treatment and management options include growing awareness among patients and care providers, rising per capita healthcare expenditure in developing nations, and increasing investment by leading market players in developing novel treatment alternatives. Moreover, the rising availability of advanced parenteral nutrition and therapeutics for managing NEC complications is also helping to drive the overall market size over the forecast period.

Market Driver - Increasing adoption of probiotics in neonatal care

The use of probiotics in the neonatal intensive care units has gained significant momentum over the past few years. Several clinical studies have demonstrated the therapeutic potential of probiotics like Bifidobacterium and Lactobacillus in preventing necrotizing enterocolitis in preterm infants. The mainstreaming of probiotics into standard neonatal care protocols is a positive sign as it can help counter the dysbiosis of the gut microbiome often seen in premature babies. The immaturity of intestinal motility function and lack of protective microflora expose preterm infants to infections and inflammatory diseases like NEC. Probiotics supplementation aims to colonize the gut of newborns with beneficial microorganisms and maintain a balanced microbial community. This early gut colonization by probiotics creates a defensive barrier against pathogens and modulates the immune system of preemies. Several randomized controlled trials have proven the safety and efficacy of probiotics in reducing the risk and severity of NEC in neonates. With an increasing number of level 1 evidence to support their application, major neonatal associations now endorse the inclusion of probiotics containing Bifidobacterium and Lactobacillus strains in standard care protocols. This is spurring hospitals across regions to adopt probiotic-based formulations for newborns, especially those born before 37 weeks of gestation who are at highest risk of NEC. The continued research exploring new probiotic strains and combinations coupled with growing evidence of health benefits will further augment the use of probiotics in neonatal intensive care worldwide.

Growing awareness and research on the prevention of necrotizing enterocolitis

Necrotizing enterocolitis remains one of the most devastating gastrointestinal emergencies affecting premature infants. However, in the past decade there has been a significant rise in awareness about NEC within the neonatal care community as well as among expectant parents. Various advocacy groups are actively working with healthcare professionals, policymakers, and researchers to increase understanding of this disease. They focus on educating families about risk factors, early signs and optimizing care practices to boost outcomes. At the same time, governments and private donors are allocating higher funding for NEC related research. This is propelling scientific exploration into various preventive strategies from nutritional interventions to novel probiotic formulations. The growing body of literature analyzing the pathogenesis, risk factors, innovative diagnostic methods along with preventive approaches has expanded clinical knowledge. Neonatologists now have access to evidence-based management protocols that empower them to optimize enteral feeding routines, institute measures like limited oral feeding and selectively use prebiotics & probiotics for high-risk infants. Even long term follows up studies are providing deep insights on growth, development and quality of life for NEC survivors. This collective advancement in awareness, research support and dissemination of best practices among healthcare teams has started making meaningful impact. Though NEC remains a complex multi-factorial disease, focused efforts on prevention hold promise for gradual reduction in severity and mortality associated with this condition in future.

Market Challenge - Lack of USFDA-approved pharmaceutical-grade probiotics

One of the key challenges currently faced by the global necrotising enterocolitis market is the lack of USFDA-approved pharmaceutical-grade probiotics. Necrotising enterocolitis is a disease that mainly affects premature infants, and while probiotics have shown promise in clinical trials as a potential treatment or preventative measure, there are currently no probiotic agents that have received USFDA approval for treating or preventing NEC. Most probiotic products available today are classified as dietary supplements rather than drugs, and evidence of their safety and efficacy from clinical trials has often been inconsistent or limited. For a probiotic to be considered for wider medical use in NEC, larger and more robust clinical studies are needed to demonstrate clear benefits. Probiotic manufacturers also need to adhere to strict pharmaceutical manufacturing guidelines or "good manufacturing practices" in order to assure product quality and consistency required for USFDA approval. The lack of an approved probiotic hampers the ability of physicians to routinely recommend probiotic therapies and limits access for patients who could potentially benefit from them. Considerable additional research and regulatory progress is still needed in this area.

Market Opportunity- Development of the first pharmaceutical-grade probiotic drug

One major opportunity for the future growth of the global necrotising enterocolitis market is the development of the first ever pharmaceutical-grade probiotic that receives regulatory approval from the USFDA for treating or preventing NEC. Significant effort is currently underway by research institutes and probiotic companies to conduct large, high-quality clinical trials using defined probiotic strains produced under strict pharmaceutical standards. A probiotic formulation that demonstrates compelling clinical efficacy and safety data through such pivotal trials could potentially be the first drug to be approved by the USFDA for medical use in NEC. This would open up the possibility of physicians routinely prescribing probiotics as a standard treatment option. It would also enable the scale-up of manufacturing using GMP standards required for drug production. Achieving this major regulatory milestone could help consolidate the role of probiotics for NEC and pave the way for greater adoption, establishment of reimbursement policies and overall market potential. Given the ongoing research investments, a successful product approval may not be too far away.

Typically, prescribers treating non-small cell lung cancer (NSCLC) follow a step-wise approach based on disease stage and lines of treatment. For early-stage NSCLC (Stage I-II), surgeons primarily recommend surgical resection with curative intent. For later stages (IIB-IV), the first-line treatment generally involves a platinum-based doublet chemotherapy such as cisplatin or carboplatin combined with drugs like paclitaxel (Taxol), docetaxel (Taxotere), gemcitabine (Gemzar), pemetrexed (Alimta), or vinorelbine (Navelbine).

For patients with EGFR mutations or ALK translocations, first-line options include tyrosine kinase inhibitors (TKIs) like gefitinib (Iressa), erlotinib (Tarceva), or alectinib (Alecensa). Upon progression, second-line treatment moves to single-agent chemotherapy with drugs like docetaxel or pemetrexed depending on histology. For those with EGFR mutations or ALK translocations that progressed on first-generation TKIs, second-line options include newer TKIs like osimertinib (Tagrisso) or ceritinib (Zykadia).

Beyond second-line, immunotherapy has emerged as another viable option. Prescribers commonly recommend pembrolizumab (Keytruda), nivolumab (Opdivo), or atezolizumab (Tecentriq) for PD-L1 positive tumors based on clinical trials demonstrating improved efficacy versus docetaxel. Patient phenotype, tumor genetics, and line of therapy thus play a critical role in influencing treatment selection.

NSCLC is generally classified into three stages - Stage I to IIIB based on tumor size and spread. Treatment depends on the stage at diagnosis.

For Stage I NSCLC, surgery is the primary treatment with the goal of complete removal of the cancer. For some patients, adjuvant chemotherapy may be recommended after surgery.

For Stage II and IIIA NSCLC, the standard of care is surgery if possible followed by chemotherapy and/or radiation therapy. Platinum-based doublet chemotherapy is usually given, commonly carboplatin or cisplatin combined with drugs like paclitaxel, docetaxel, gemcitabine or pemetrexed. Sequential or concurrent chemo-radiation is also an option.

For Stage IIIB NSCLC, platinum-based chemoradiation is the standard first-line treatment. The PAC regimen of carboplatin, paclitaxel and concurrent radiation is commonly used. For those with stable or responding disease after chemoradiation, durvalumab is an FDA-approved option for consolidation.

For advanced or metastatic Stage IV NSCLC, platinum-based doublet chemotherapy remains the first-line standard of care. The preferred regimens include carboplatin or cisplatin combined with pemetrexed for non-squamous NSCLC or with paclitaxel, docetaxel or nab-paclitaxel for squamous NSCLC. For EGFR+ or ALK+ subsets, tyrosine kinase inhibitors like gefitinib, erlotinib or alectinib are recommended first-line based on mutation status. Immune checkpoint inhibitors like pembrolizumab or nivolumab are also options after chemotherapy.

Companies in the NEC market have focused on R&D to develop novel treatment approaches. For example, in 2018, Enthera Pharmaceuticals announced positive results from a Phase 1 study of its lead drug candidate ENT-001 for the prevention of surgical NEC in preterm infants. The drug was well-tolerated and showed promising efficacy in reducing pro-inflammatory cytokines and stabilizing the gut barrier. This novel mechanism of microbial remodeling holds promise for preventing NEC progression.

Product innovation through partnerships has also been a major strategy. In 2019, Drägerwerk AG & Co. partnered with Spiration Medical to develop the Lung Advisor respiratory support platform for neonates. Integrating Spiration's lung monitoring technology with Draeger's ventilation devices allows for non-invasive monitoring of lung function and disease progression in at-risk preterm infants, facilitating earlier diagnosis and treatment of NEC.

Geographic expansion into emerging markets has captured greater revenue opportunities. For example, in 2016, Medtronic established manufacturing and R&D facilities in Singapore and India to address the growing demand for neonatal care technologies from Asia Pacific and other developing regions with high preterm birth rates. This strategic expansion enabled Medtronic to gain a foothold in fast-growing NEC markets and achieve regional market leadership.

Acquisitions have strengthened product portfolios and clinical research capabilities. In 2015, CHIESI Farmaceutici acquired Orphan Medical, which holds a leading preterm infant feeding product (Peptamen) indicated for NEC prevention. This acquisition expanded CHIESI's presence in the hospital channel and neonatal critical care segment. It also provided access to Orphan Medical's clinical trials expertise in supporting the development of new feeding solutions.

By Treatment Type - Effective Therapies Drive Pharmacological Treatment's Dominance

In terms of By Treatment Type, Pharmacological Therapy contributes the highest share of the market owning to its established effectiveness in alleviating symptoms and improving clinical outcomes. Extensive research has led to the development of drugs that can effectively target specific physiological derailments caused by necrotising enterocolitis. For instance, broad-spectrum antibiotics are widely used to treat secondary infections that often accompany the condition. These antibiotics help prevent sepsis, a major cause of mortality, by clearing pathogenic bacteria. Other pharmacological options include anti-inflammatory drugs that lower inflammation levels in the intestinal lining. Drugs mimicking stomach gastric hormones are also beneficial as they encourage more regulated digestion and reduce feeding intolerance. Overall, pharmacological regimens offer minimally invasive solutions tailored to arrest disease progression at the molecular level. Their advantages over surgical interventions in terms of safety, reliability and ability to be initiated promptly make them the preferred first-line approach.

By Diagnosis - Diagnostic Accuracy Boosts Laboratory Testing's Dominance

In terms of By Diagnosis, Laboratory Tests contributes the highest share of the market owing to its high accuracy in positively diagnosing necrotising enterocolitis. Since clinical signs of the condition are non-specific in premature infants, laboratory methods provide objective validation critical for prompt treatment planning. Commonly used tests include complete blood count to identify abnormal white blood cell levels and C-reactive protein levels to gauge inflammation severity. Additional important markers are neutrophil CD64 expression and calprotectin levels in stool samples. When integrated with clinical findings, such tests reliably identify intestinal inflammation and tissue injury with over 90% specificity. This diagnostic certainty afforded by laboratory corroboration boosts clinician confidence for aggressive intervention if needed. Consequently, it has become standard practice to undertake targeted biomarker screening to either confirm or rule out necrotising enterocolitis.

By Distribution Channel - Comprehensive Care Drives Hospital Pharmacies' Leadership

In terms of By Distribution Channel, Hospital Pharmacies contribute the highest share of the market owing to their ability to comprehensively manage patient care. Necrotising enterocolitis frequently requires combining multiple treatment modalities in closely monitored pediatric settings. Hospital pharmacies are optimally positioned to oversee patients' complete pharmacological needs from the outset. They can promptly dispense antibiotics, nutrition supplements, pain relievers or other items tailored to the case severity and ordered by attending physicians. Their location within treatment facilities also enables real-time prescription adjustments as the condition dynamically responds. Moreover, specialized pharmacists available on-site provide drug information support and counselling and confirm appropriate administration techniques. This integrated approach streamlines healing trajectories. It assures seamless progression through the standard stages from intensive care to step-down management to discharge instructions dispensed by hospital pharmacies. This approach optimized for complicated multi-drug therapy drives their unparalleled access and oversight in managing necrotising enterocolitis cases.

• The necrotizing enterocolitis market is expected to see significant developments with the introduction of the first pharmaceutical-grade probiotic. While current treatments are limited, emerging therapies are poised to address unmet medical needs, particularly in preventing NEC among preterm infants. The geographical differences in probiotic usage underscore the need for standardized treatment protocols. As research continues, the market may experience shifts towards safer and more effective therapies, reducing NEC incidence and improving neonatal outcomes globally.

The major players operating in the Global Necrotising Enterocolitis Market include Hollister Incorporated, Medtronic, Nestlé Health Science, Pediatric Therapeutics, Purdue Pharma, Reckitt Benckiser, Sanofi, Shire (now part of Takeda Pharmaceutical Company), Sientra, Smith & Nephew, Thermo Fisher Scientific, Vifor Pharma, Zebra Medical Vision, Astarte Medical and Infant Bacterial Therapeutics.

• On February 2024 Infant Bacterial Therapeutics is progressing with IBP-9414, a Phase III study drug aimed at reducing necrotizing enterocolitis. This development is critical as it represents the potential first pharmaceutical-grade probiotic for this condition, promising to reduce mortality and improve outcomes for premature infants.
• In 2023 Increasing usage of probiotics in Europe and Asia, despite concerns in the US about the safety of dietary supplements, indicating regional differences in treatment practices.

• By Treatment Type
  • Pharmacological Therapy
  • Surgical Intervention
  • Supportive Care
• By Diagnosis
  • Laboratory Tests
  • Imaging Techniques
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies