Postoperative Ileus - Market Insight, Epidemiology and Market Forecast -2034

Key Highlights:

• Abdominal surgery is said to be the most common cause of postoperative ileus. In the United States in all inpatient gastrointestinal (GI) surgeries, about 6 out of 100 (5.8%-6.3%) developed diagnosed postoperative ileus.
• Despite the integration of enhanced recovery protocols, the prevalence of postoperative ileus remains variable based on the specific surgical procedure, ranging from 7% to 27%, after colorectal surgery, demonstrating peak occurrence.
• Current supportive and preventive measures mainly include maintaining adequate intravenous fluids, correcting electrolyte imbalances (particularly low potassium and sodium), ensuring proper dietary management, and using non-opioid analgesics where possible.
• FDA-approved therapies for postoperative ileus include metoclopramide (REGLAN), neostigmine (PROSTIGMIN), and alvimopan (ENTEREG), all of which face generic competition; alvimopan lost exclusivity in 2024.
• The postoperative ileus pipeline remains limited, with only a few mid-stage candidates such as ORE-001 (lidocaine) and TU-100 (Daikenchuto/TJ-100) in Phase II trials, emphasizing slow progress and a constrained innovation landscape.
• The total market size of postoperative ileus in the United States was approximately USD 3,500 million in 2024 and is projected to increase during the forecast period (2025-2034).
• In 2024, incident cases of postoperative ileus accounted for approximately 379,500 cases in the United States.

DelveInsight's "Postoperative Ileus - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of postoperative ileus, historical and forecasted epidemiology, as well as postoperative ileus market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

Postoperative ileus market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM postoperative ileus market size from 2020 to 2034. The report also covers current postoperative ileus treatment practices/algorithms 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

Postoperative Ileus Understanding and Treatment Algorithm

Postoperative Ileus Overview

Postoperative ileus, also referred to as Postoperative Gastrointestinal Dysfunction (POGD) or paralytic ileus, is a transient impairment of gastrointestinal motility that commonly arises following surgical procedures, particularly abdominal operations. It manifests as abdominal distension and intolerance to oral intake, resulting from impaired gastrointestinal propulsion in the absence of mechanical obstruction. The fungi involved are usually opportunistic pathogens that are part of the environment or normal human flora but become pathogenic when host defenses are impaired. It is most commonly caused by abdominal or pelvic surgery and the use of opioid analgesics or anesthesia.

Further details are provided in the final report...

Postoperative Ileus Diagnosis

The diagnosis of postoperative ileus is based on clinical evaluation, supportive imaging, and laboratory tests. Physical examination typically reveals a distended, tympanic abdomen with absent or reduced bowel sounds. It is crucial to differentiate ileus from mechanical bowel obstruction, which generally presents with more acute symptoms and a definitive transition point on imaging. Abdominal X-rays and CT scans usually show diffuse bowel distension without a clear obstruction point of obstruction in ileus. Laboratory tests, including electrolytes, complete blood count, and inflammatory markers, help identify reversible causes and exclude other complications like infection or ischemia.

Further details are provided in the final report...

Postoperative Ileus Treatment

The treatment of postoperative ileus primarily involves supportive and preventive measures by ensuring adequate intravenous fluids and electrolyte balance, promoting early ambulation, and minimizing opioid use through non-opioid analgesics. Chewing gum may be used as an adjunct to promote gastrointestinal activity, and early resumption of oral intake is encouraged to support mucosal health. Nasogastric tube decompression is reserved for patients with severe vomiting or abdominal distension. Pharmacologic agents like alvimopan, intravenous lidocaine, and NSAIDs aid by blocking opioid effects, reducing inflammation, and providing analgesia, respectively, forming a multimodal approach to accelerate gastrointestinal recovery.

Further details are provided in the final report...

Postoperative Ileus Epidemiology

The epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total gastrointestinal/abdominal procedures (at-risk population for postoperative Ileus), total incident cases of postoperative ileus, severity-specific cases of postoperative ileus, and postoperative ileus prevention and treatment eligible patient population covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Gastrointestinal/Abdominal Procedures accounted for approximately 5.68 million cases in 2024, representing a higher number than non-abdominal procedures in the at-risk population for postoperative ileus.
• The total number of incident cases of postoperative ileus in the 7MM was nearly 771,600 in 2024.
• In EU4 and the UK, Germany has the highest number of incident cases of postoperative ileus, with approximately 152,200 cases in 2024.
• In Japan, severe postoperative ileus accounted for about 32,000 cases in 2024.

Postoperative Ileus Drug Chapters

The drug chapter segment of the postoperative ileus report encloses a detailed analysis of marketed and emerging late-stage (Phase II) pipeline drugs. It also deep dives into postoperative ileus pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Discontinued Marketed Therapies

Alvimopan (ENTEREG): Merck

Alvimopan is a peripherally acting µ-opioid receptor antagonist (PAMORA) approved for short-term, in-hospital use to accelerate gastrointestinal recovery following bowel resection surgery with primary anastomosis. By blocking the adverse effects of opioids on the gut without affecting central pain relief it helps reduce the duration of postoperative ileus, allowing patients to tolerate solid food and have bowel movements sooner.

• In February 2024, Hikma Pharmaceuticals announced that they have launched alvimopan capsules, 12 mg, in the US.
• In December 2014, Merck announced its plans to acquire Cubist Pharmaceuticals and subsequently completed the tender offer to finalize the acquisition in January 2015.
• In May 2008, Adolor Corporation and GSK announced that the US FDA had approved alvimopan capsules for accelerating the recovery of gastrointestinal function in patients after bowel resection surgery.

Emerging Drugs

ORE-001 (lidocaine): Orexa BV

ORE-001 is an oral lidocaine formulation developed by Orexa BV, designed to stimulate food intake and improve recovery in conditions such as postoperative ileus, anorexia, and malnutrition in the elderly patient. Currently, the company is evaluating the drug in a Phase II (NCT05923086) trial for the prevention of postoperative ileus.

• In January 2024, Orexa BV announced the dosing of the first patient in its Phase II clinical trial of ORE-001 for the prevention of postoperative ileus.
• In June 2023, Orexa BV announced that it had collaborated with Clinical Research Organization QPS to run its Phase IIa clinical trial focused on prevention.

TU-100 (Daikenchuto/TJ-100): Tsumura USA

TU-100 is a traditional Japanese herbal medicine actively investigated for promoting recovery from postoperative ileus after abdominal surgery. Its mechanism involves stimulating intestinal motility through neural pathways, specifically by enhancing acetylcholine release via serotonergic receptor activation, and providing anti-inflammatory effects by suppressing neutrophil and macrophage infiltration, as well as increasing intestinal blood flow.

• In July 2024, Tsumura announced that patient enrollment for the late Phase II clinical trial, involving 402 subjects, had been completed.
• In March 2024, the drug completed Phase II (NCT04742907) trial for the treatment of postoperative ileus.

Drug Class Insights

The current treatment landscape for postoperative ileus combines supportive care, such as intravenous fluids, electrolyte correction, early mobilization, and opioid-sparing analgesia with pharmacological agents like alvimopan, intravenous lidocaine, and NSAIDs to reduce inflammation and speed recovery. Meanwhile, novel therapies like ORE-001 and TU-100 are under development to expand treatment choices.

Opioid Receptor Agonists

Opioid receptor agonists bind to G protein-coupled opioid receptors, primarily the mu-opioid receptor (MOR), leading to inhibition of adenylate cyclase, decreased cAMP production, and the opening of potassium channels with concurrent closing of calcium channels. This results in neuronal hyperpolarization and reduced neurotransmitter release, ultimately decreasing pain signal transmission and producing analgesia. However, activation of peripheral opioid receptors in the gastrointestinal tract inhibits acetylcholine release from enteric neurons, reducing gut motility and contributing to postoperative ileus by slowing intestinal transit and causing bowel dysfunction.

Postoperative Ileus Market Outlook

The management of postoperative ileus has not seen meaningful innovation in the last two decades. Historically, alvimopan (ENTEREG), a peripherally acting µ-opioid receptor antagonist (PAMORA), was the only FDA-approved drug for accelerating gastrointestinal recovery following bowel resection. However, the branded product has now been discontinued, leaving the market dependent on a combination of generic agents and standard of care interventions. Current therapy relies on prokinetic agents like metoclopramide, which have limited use due to side effects; NSAIDs; opioids; centrally acting opioid antagonists like naloxone are limited by reversing analgesia; peripheral opioid antagonists (PAMORAs) such as alvimopan and methylnaltrexone target opioid effects on the gut, with alvimopan showing clinical efficacy but limited availability. Antiemetics address nausea but not ileus resolution; laxatives offer nonspecific symptomatic relief; intravenous lidocaine reduces opioid use and may support bowel recovery adjunctively.

With no branded therapies currently available for postoperative ileus, the treatment pipeline remains limited but strategically oriented toward addressing core drivers such as impaired motility and opioid-induced dysfunction. Two Phase II candidates, ORE-001 (Orexa BV) and TU-100 (Tsumura), are advancing in development, aiming to alleviate symptoms and enhance disease management across the 7MM.

• The total market size of Postoperative Ileus in the 7MM was approximately USD 3,700 million in 2024 and is projected to increase during the forecast period (2025-2034).
• As per DelveInsight's analysis, by 2034, among the therapies, the highest revenue is expected to be generated by anti-emetic in the 7MM.

Key updates

• In September 2024, the US FDA withdrew approval of the New Drug Application (NDA) for alvimopan 12 mg capsules, previously held by Cubist Pharmaceuticals, following the company's request to discontinue marketing the product.
• In July 2024, Tsumura announced that patient enrollment for the late Phase II clinical trial, involving 402 subjects, had been completed.

Postoperative Ileus Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Postoperative Ileus Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, II, and I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for postoperative ileus emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders 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 evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including MDs, PhD, Senior Researchers, and others.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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.

Market Access and Reimbursement

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

Postoperative ileus represents a major source of financial burden due to increased morbidity and prolonged hospitalization. It is associated with a 50-100% rise in total hospital costs per patient, driven by greater use of staffing, imaging, pharmacy, and laboratory services. Importantly, inaccurate recognition and coding of postoperative ileus further compound this burden by limiting reimbursement.

Further Details are provided in the final report

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of postoperative ileus, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the postoperative ileus 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 postoperative ileus.

Postoperative Ileus Report Insights

• Patient Population
• Therapeutic Approaches
• Postoperative Ileus Pipeline Analysis
• Postoperative Ileus Market Size And Trends
• Existing And Future Market Opportunities

Postoperative Ileus Report Key Strengths

• Ten-Year Forecast
• The 7MM Coverage
• Postoperative Ileus Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Postoperative Ileus Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Analyst Views
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the historical and forecasted postoperative ileus patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What was the total postoperative ileus market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for treating postoperative ileus?
• How many companies are developing therapies to treat postoperative ileus?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the postoperative ileus Market.
• Insights on patient burden/disease prevalence, 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.
• Highlights of access and reimbursement policies of approved 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.