Irritable Bowel Syndrome (IBS) - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Irritable bowel syndrome is believed to be a multifactorial disease involving motility dysfunction, visceral hypersensitivity, psychiatric comorbidity, neuroendocrine dysfunction, genetics and epigenetics, diet, and immune activation. Approximately 32 million cases of irritable bowel syndrome were reported in the 7MM in 2023. The United States accounted for ~46% of the total 7MM prevalent cases.
• It has been observed that irritable bowel syndrome is more prevalent in younger ages (<35 years) as compared to the older age (>=35 years) in the 7MM; additionally, the syndrome is more prevalent among women when compared to men.
• Among the diagnosed irritable bowel syndrome cases, approximately 89% are categorized under moderate-to-severe whereas ~11% of cases are mild.
• Furthermore, diarrhea-predominant (IBS-D) is the most prevalent (~35% cases) of the diagnosed patient pool, followed by mixed stool pattern (IBS-M), constipation-predominant (IBS-C), and unspecified (IBS-U).
• Laxatives, antidiarrheal, antispasmodics, and some extent antidepressants, together with dietary and lifestyle changes have for many years been the mainstay of treatment for irritable bowel syndrome. Laxatives produced the highest sales in 2023.
• The drugs approved for irritable bowel syndrome with diarrhea and constipations includes VIBERZI (eluxadoline), XIFAXAN (rifaximin), LINZESS (linaclotide), IBSRELA (tenapanor), and TRULANCE (plecanatide). Among the approved therapies, LINZESS garnered approximately USD 600 million revenue.
• As the US Food and Drug Administration (FDA) approved LINZESS in 2023 for functional constipation among pediatric patients, is likely to make a blockbuster drug by the end of the decade.
• Although the treatment armamentarium comprises a plethora of drugs, ~60% of patients still are managed non-conventional treatment, owing to dissatisfaction with the efficacy and safety shown by the available prescription drugs.
• Emerging therapies include biologics (Blautix, and Aldafermin) and small molecules (Rifamycin, and RHB-102). Biologics are anticipated to be a promising class for irritable bowel syndrome in the forthcoming years.

DelveInsight's "Irritable Bowel Syndrome (IBS) - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of Irritable Bowel Syndrome (IBS) epidemiology, market, and clinical development understanding, Addition to this report provides historical and forecasted epidemiology and market data as well as a detailed analysis on the Irritable Bowel Syndrome market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Irritable Bowel Syndrome market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Irritable Bowel Syndrome market size from 2020 to 2034 in 7MM. The report also covers current Irritable Bowel Syndrome treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Irritable Bowel Syndrome Understanding and Treatment Algorithm

Irritable Bowel Syndrome Overview and Diagnosis

Irritable bowel syndrome is a chronic functional bowel disease characterized by symptoms of abdominal pain and/or discomfort associated with altered bowel habits in the absence of a structural or organic cause. Based on bowel patterns at a particular point in time, the disorder may be categorized into four groups:

• Constipation-predominant (IBS-C)
• Diarrhea-predominant (IBS-D)
• Mixed (IBS-M)
• Unsubtyped

The precise cause of irritable bowel syndrome remains unknown. However, several factors have been implicated in the pathophysiology of irritable bowel syndrome symptoms, including genetic disposition, diet, intestinal microbiota, and low-grade mucosal inflammation. No specific biomarker related to irritable bowel syndrome has been found.

The common feature in all of the diagnostic criteria of Irritable bowel syndrome is abdominal pain and/or discomfort associated with abnormal bowel habits (diarrhea [loose and frequent stools], constipation [hard and infrequent stools], or alternating constipation and diarrhea). These criteria require a certain duration and frequency of the symptoms to fulfill the diagnostic criteria for irritable bowel syndrome.

A variety of criteria that are used to identify a combination of symptoms to diagnose irritable bowel syndrome are Manning Criteria, Rome I, Rome II, Rome III, Rome IV.

Irritable Bowel Syndrome Treatment

Antispasmodics, laxatives, antidiarrheal, and antidepressants together with dietary and lifestyle changes have for many years been the mainstay of treatment for irritable bowel syndrome.

The first-line drug therapy includes antispasmodics and peppermint oil to treat abdominal pain. Loperamide and laxatives can be tried to treat diarrhea or constipation, respectively. If these approaches fail to improve symptoms, second-line treatments, including secretagogues, rifaximin, low-dose tricyclic antidepressants, and eluxadoline, should be used. If abdominal pain persists, tegaserod and alosetron are recommended.

Over the next few years, the US Irritable Bowel Syndrome Market is expected to substantially change and experience growth. Considering that the complexity and diversity of irritable bowel syndrome presentation makes treatment difficult, which is around 30-40%, we expect the market to expand, especially as safer, satisfactory, and effective disease-modifying therapies enter the market.

Irritable Bowel Syndrome Epidemiology

The Irritable Bowel Syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of IBS, diagnosed prevalent cases of IBS, gender-specific prevalent cases of IBS, age-specific prevalent cases of IBS, severity-specific diagnosed prevalent cases of IBS, subtype-specific diagnosed prevalent cases of IBS, treated cases of IBS in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

According to the findings, irritable bowel syndrome is common and affects about 5% of the population or about 1 in 20 people in the US and the prevalence rate of irritable bowel syndrome in the US, Germany, France, Italy, Spain, and the UK, and Japan were found to be 5.3%, 3.7%, 4.2%, 5%, 4.2%, and 4%, and 2.2%, respectively, as per ROME IV criteria.

Irritable bowel syndrome is more significant in females than males. In the United States, the total gender-specific prevalent cases of irritable bowel syndrome were ~4,900,000 and ~9,700,000 in males and females, respectively, in 2023.

Approximately ~48% of diagnosed prevalent cases of irritable bowel syndrome belong to the severe category, whereas ~41% and ~11% of cases are moderate and mild, respectively.

Irritable Bowel Syndrome Recent Developments

• In January 2025, the FDA granted tentative approval to Amneal Pharmaceuticals' 550 mg rifaximin tablets, referencing Bausch Health's Xifaxan, for treating adults with irritable bowel syndrome with diarrhea (IBS-D).
• In December 2024, ANI Pharmaceuticals announced the launch of Prucalopride Tablets after receiving final approval from the FDA for its Abbreviated New Drug Application (ANDA). The tablets are the generic version of Motegrity(R).

Irritable Bowel Syndrome Drug Chapters

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

Marketed Drugs

VIBERZI/TRUBERZI (eluxadoline): Abbvie

VIBERZI (eluxadoline) is a new class of medication acting on local receptors in the gastrointestinal tract. It improves diarrhea and abdominal pain by interacting with mu- and delta opioid receptors in the intestine to slow gastrointestinal motility and reduce visceral pain. Activation of the mu-receptor reduces diarrhea, while antagonism of the delta-receptor enhances the analgesic activity and reduces the risk of constipation.

VIBERZI is currently approved for treating Irritable Bowel Syndrome. It acts locally in the enteric nervous system and decreases adverse effects on the central nervous system. The drug is available in tablet form for oral administration.

LINZESS/CONSTELLA (linaclotide): Ironwood Pharmaceuticals/ Abbvie/ Astellas Pharma

Linaclotide is a guanylate cyclase-C agonist that is thought to work in two ways based on nonclinical studies. It binds to the guanylate cyclase-C receptor locally within the intestinal epithelium. Activation of guanylate cyclase-C results in increased intestinal fluid secretion, accelerated transit, and a decrease in the activity of pain-sensing nerves in the intestine. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS to treat adults with IBS-C. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA for treating adults with moderate-to-severe IBS-C.

Emerging Drugs

BEKINDA (RHB-102): RedHill Biopharma

RHB-102 is an investigational, once-daily, bi-modal release, oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors intended to treat nausea, vomiting, and diarrhea symptoms experienced in some people suffering from acute gastroenteritis, gastritis, and irritable bowel syndrome with diarrhea (IBS-D).

The company has completed a Phase II clinical trial (NCT02757105) of RHB-102 to treat irritable bowel syndrome with predominant diarrhea (IBS-D).

Blautix (MRx1234): 4D pharma

Blautix (MRx1234) is a single-strain live biotherapeutic product (LBP), being developed as a treatment for both IBS-C and IBS-D and has the potential to become the first-ever disease-modifying therapy suitable for all irritable bowel syndrome patients regardless of clinical subtype. Blautix has a unique metabolism, consuming hydrogen and producing acetate, which promotes bacterial cross-feeding of the microbiota increasing diversity and stability, two attributes that have been demonstrated to be decreased in patients with irritable bowel syndrome compared to healthy controls.

The company has completed a Phase II clinical trial (NCT03721107) of blautix in adults for the treatment of irritable bowel syndrome with predominant constipation (IBS-C) or diarrhea (IBS-D).

Irritable Bowel Syndrome Market Outlook

• Key players, such as RedHill Biopharma Limited, 4D pharma, Cosmo Pharmaceuticals, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Irritable Bowel Syndrome.
• The market size of Irritable Bowel Syndrome in the seven major markets was around USD 2000 million in 2023.
• The United States accounts for the largest market size (around USD 1600 million) of Irritable Bowel Syndrome, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Germany accounts for the second highest market size in the 7MM during the forecast period 2024-2034.
• Among EU4 and the UK, Spain had the smallest market size.

Irritable Bowel Syndrome Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with 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.

Irritable Bowel Syndrome Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. 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 Irritable Bowel Syndrome Syndrome 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.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Irritable Bowel Syndrome. This will support the clients in potential upcoming novel 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 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, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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

There are five drugs approved for irritable bowel syndrome in the United States, namely VIBERZI (eluxadoline), LINZESS (linaclotide), IBSRELA (tenapanor), TRULANCE (plecanatide), and XIFAXAN (rifaximin). Market access and reimbursement options can differ depending on regulatory status, the size of the target population, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

At a policy level, irritable bowel syndrome prescription drug coverage remains just as necessary in the appropriate management of irritable bowel syndrome as in other chronic medical conditions. Irritable bowel syndrome prescription drug prices at a policy level would improve treatment satisfaction and adherence, recognizing that prior authorization restrictions and other insurance barriers directly cause over 1/3 of treatment discontinuations among IBS-C patients who can successfully start prescription drug therapy. Factors driving treatment preference based on cost-effectiveness differed between patients and payers in a sensitivity analysis. Drug prices and costs of associated irritable bowel syndrome care largely drove the treatment preferences of payers; this contrasted with the patient's perspective. Payer preference toward SSRI is primarily driven by the comparatively low cost of citalopram (USD 0.03/pill) compared to per-pill costs of linaclotide (USD 13.57), plecanatide (USD 13.20) and lubiprostone (USD 5.92). Even the most expensive SSRI evaluated in an IBS-C trial (paroxetine; USD 1.90/pill) resulted in only 14-16% of the cost of an annual supply of on-label drugs exceeding USD 4,000 annually. Consistent with denials of coverage, prior authorizations, and formulary restrictions which gastroenterologists face in daily practice, it is suggested that physicians who use SSRIs in IBS-C may find them more cost-effective than on-label drugs at their current prices.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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. 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 a segment of key events, an executive summary, descriptive overview of Irritable Bowel Syndrome, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, 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 Irritable Bowel Syndrome 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 Irritable Bowel Syndrome market.

Irritable Bowel Syndrome Report Insights

• Patient Population
• Therapeutic Approaches
• Irritable Bowel Syndrome Pipeline Analysis
• Irritable Bowel Syndrome Market Size and Trends
• Existing and future Market Opportunity

Irritable Bowel Syndrome Report Key Strengths

• Ten Years Forecast
• 7MM Coverage
• Irritable Bowel Syndrome Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL's feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Irritable Bowel Syndrome Report Assessment

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

FAQs:

• What is the growth rate of the 7MM Irritable Bowel Syndrome treatment market?
• What was the Irritable Bowel Syndrome total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• 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? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Irritable Bowel Syndrome?
• How many companies are developing therapies for the treatment of Irritable Bowel Syndrome?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician 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 in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Irritable Bowel Syndrome 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.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• 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.