Functional Constipation - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Functional constipation is defined as constipation without an organic aetiology and is diagnosed according to the Rome criteria.
• In adults, differentiating between subtypes of functional constipation (normal transit, slow transit, and evacuation disorders) through additional testing is crucial for effective treatment. Patients with persistent constipation should see a gastroenterologist for further evaluation, including tests like colonic transit time and anorectal manometry.
• It is a common problem in childhood, with an estimated prevalence of 3% worldwide.
• Factors contributing to functional constipation include a history of painful defecation, inadequate dietary fiber, low physical activity, psychological stressors, and developmental issues. It is equally prevalent among different socioeconomic backgrounds
• Treatment typically involves disimpaction followed by maintenance therapy, dietary modifications (increased fiber and fluid intake), and behavioral strategies. Pharmacological options include osmotic laxatives and newer medications like LINZESS, TRULANCE, and others for adults.
• Recent advancements are enhancing the treatment options for functional constipation. For example, in June 2023, Ironwood Pharmaceuticals received FDA approval for a new indication of LINZESS (linaclotide), expanding its use to treat functional constipation in pediatric patients aged 6 to 17 years.
• Effective management of functional constipation demands a collaborative approach involving pediatricians, gastroenterologists, and nutritionists. This multidisciplinary teamwork is essential to address the complex nature of the condition and achieve optimal patient outcomes.

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

The functional constipation market report provides real-world prescription pattern analysis, market share of individual therapies, and historical and forecasted 7MM functional constipation market size from 2020 to 2034. The report also covers current functional constipation 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

Functional Constipation Understanding and Treatment Algorithm

Functional Constipation Overview, Country-Specific Treatment Guidelines and Diagnosis

Constipation is a prevalent issue within the digestive system, often arising from dietary habits, medications, endocrine or metabolic disorders, neurological conditions, psychiatric issues, or gastrointestinal blockages. In cases where no underlying cause is identified, the condition is termed functional constipation, also known as chronic idiopathic constipation. This form of constipation lacks any anatomical or physiological origin and is characterized by symptoms occurring at least twice a week for a minimum of three months, without meeting the criteria for irritable bowel syndrome (IBS). Understanding and identifying functional constipation is crucial, as it underscores the importance of addressing lifestyle and dietary factors in managing digestive health.

Doctors often diagnose functional constipation using the Rome IV criteria. This set of criteria defines functional constipation separately for children and adults.

The functional constipation report provides an overview of functional constipation pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient's journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Functional Constipation Treatment

Treatments for functional constipation focus on a combination of dietary modifications, lifestyle changes, and pharmacological interventions. Initial management typically involves disimpaction to remove hard stool from the colon, often using polyethylene glycol (PEG) as a first-line laxative. Following disimpaction, maintenance therapy may include osmotic laxatives, stool softeners, or stimulant laxatives to keep stools soft and regular. Dietary recommendations emphasize a high fiber intake, adequate hydration, and regular physical activity. In children, behavioral strategies such as establishing a routine for toilet use and addressing any psychological factors are also crucial.

Functional Constipation Epidemiology

The functional constipation epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The functional constipation epidemiology is segmented with detailed insights into the total prevalence of functional constipation, diagnosed prevalence of functional constipation, gender-specific diagnosed prevalence of functional constipation, and age-specific diagnosed prevalence of functional constipation.

• Functional constipation accounts for more than 95% of cases of constipation in healthy children aged one year and older.
• Functional constipation is particularly common among preschool-aged children.
• According to findings, the prevalence of chronic constipation was reported to be 5.5% in US, according to the Rome III criteria, and it was found to be 2.1% based on medical consultations in Japan.

Functional Constipation Drug Chapters

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

Marketed Drugs

LINZESS (linaclotide): Ironwood

LINZESS is a a guanylate cyclase (GC)-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. It is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort, and pain associated with irritable bowel syndrome with constipation, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with chronic idiopathic constipation.

TRULANCE (plecanatide): Synergy Pharmaceuticals/ Bausch Health Companies

Plecanatide is structurally related to human uroguanylin, and similar to uroguanylin, plecanatide functions as a guanylate cyclase-C (GC-C) agonist. Both plecanatide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both

intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). It is approved for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

Functional Constipation Market Outlook

The market for functional constipation treatments is promising, fueled by the rising prevalence of the condition, particularly among aging populations and women. Increased awareness of digestive health and advancements in diagnostic methods are leading more individuals to seek medical intervention. The pharmaceutical industry is meeting this demand with innovative therapies like lubiprostone, linaclotide, and prucalopride, which provide new mechanisms of action and enhanced efficacy. Additionally, the growing focus on gut health and lifestyle management is driving the demand for both prescription and over-the-counter solutions.

Functional Constipation 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.

Functional Constipation 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.

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 functional constipation. 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

The report 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 functional constipation, 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.
• A detailed review of the functional constipation 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 functional constipation market.

Functional Constipation Report Insights

• Patient Population
• Therapeutic Approaches
• Functional Constipation Pipeline Analysis
• Functional Constipation Market Size and Trends
• Existing and future Market Opportunity

Functional Constipation Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Functional Constipation Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL's feedback on therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Functional Constipation 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 functional constipation treatment market?
• What was the functional constipation 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?
• What are the current options for the treatment of functional constipation?
• How many companies are developing therapies for the treatment of functional constipation?
• 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 functional constipation 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.