Short Bowel Syndrome Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The total market size of short bowel syndrome in the 7MM was ~USD 2.30 billion in 2023, which is expected to grow during the forecast period 2024-2034.
• Due to diminished absorptive capacity from the reduced intestinal length, conventional diet does not always adequately provide nutrition for short bowel syndrome patients. Consequently, many patients rely on total parenteral nutrition.
• In 2012, GATTEX was approved by the US FDA for the treatment of SBS. Human GLP-2 half-life is around 7 minutes and GATTEX half-life is around 2-3 h. Despite its extended duration of action, GATTEX still requires daily subcutaneous injections owing to its relatively short half-life. Furthermore, its lyophilized powder formulation involves a complicated reconstitution process prior to administration.
• Glucagon-like peptide-2 (GLP-2) agonists and, more recently, glucagon-like peptide-1 (GLP-1) agonists have been used to increase nutrient and fluid absorption and partially or wholly ameliorate the use of parenteral nutrition in short bowel syndrome patients.
• Next-generation GLP-2 agonists therapies, apraglutide and glepaglutide, have demonstrated clinically meaningful and durable responses in patients with short bowel syndrome, in STARS Nutrition and EASE-1 clinical studies, respectively. These novel therapies may address some of GATTEX's limitations, potentially delivering improved effectiveness, prolonged duration of action, simpler administration methods, and a potentially more favorable benefit profile for a broader spectrum of SBS patients.
• The total diagnosed prevalent cases of short bowel syndrome in the US was around 1,4000 in 2023.
• Among EU4 and the UK, the highest number of diagnosed prevalent cases were recorded in Germany.
• The mean age of the patients is early 50s, women are affected slightly more often than men, and the majority of patients have jejunocolic anastomosis.

This report delivers an in-depth understanding of Short Bowel Syndrome, historical and forecasted epidemiology as well as Short Bowel Syndrome market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Short Bowel Syndrome market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted the 7MM Short Bowel Syndrome market size from 2020 to 2034. The report also covers current Short Bowel Syndrome 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

Short Bowel Syndrome Disease Understanding and Treatment Algorithm

Short Bowel Syndrome Overview

Short bowel syndrome is a complex disease that occurs due to the physical loss or the loss of function of a portion of the small and/or large intestine. Consequently, individuals with short bowel syndrome often have a reduced ability to absorb nutrients such as fats, carbohydrates (sugars) vitamins, minerals, trace elements and fluids (malabsorption). The specific symptoms and severity of short bowel syndrome vary from one person to another. Diarrhea is common, often severe and can cause dehydration, which can even be life threatening. Short bowel syndrome can lead to malnutrition, unintended weight loss and additional symptoms may be due to the loss of essential vitamins and minerals. There is no cure, but the disorder usually can be treated effectively. However, in some cases, short bowel syndrome can lead to severe, disabling and life-threatening complications.

Short Bowel Syndrome Diagnosis

A diagnosis of short bowel syndrome is made based upon a detailed patient history, a thorough clinical evaluation and a variety of specialized tests including laboratory tests and X-ray studies.

A health care provider diagnoses short bowel syndrome based on a medical and family history, a physical exam, blood tests such as CBC, albumin, creatinine tests, and others. Fecal fat tests is also performed, which can show how well the small intestine is working. Imaging techniques may be used to assess individuals with short bowel syndrome. Such tests include plain abdominal X-rays to detect signs of obstruction or ileus (paralysis of intestinal muscles), computerized tomography (CT) scanning of the abdomen (abdominal CAT scan), magnetic resonance imaging (MRI) of the abdomen or an abdominal ultrasound. Upper GI series, also called a barium swallow, uses X-rays and fluoroscopy to help diagnose problems of the upper GI tract.

Short Bowel Syndrome Treatment

The treatment approach for short bowel syndrome is tailored to individual symptoms and factors such as the extent of small intestine loss, overall health, and patient preferences. A multidisciplinary team, including gastroenterologists, surgeons, dietitians, and other healthcare professionals, collaborates to create a personalized plan. Treatment options encompass total parenteral nutrition (TPN), enteral feeding, dietary adjustments, oral rehydration solutions, medications, and surgery. Intestinal adaption, a process enhancing the remaining small bowel's absorption capabilities, is a key focus, and nutritional management is vital. TPN, though associated with complications, may be required, with advances like recombinant growth hormone and glucagon-like peptide analogs offering alternatives. Medications address symptoms and may include GATTEX, anti-diarrheals, acid reducers, and growth hormones. Surgical interventions range from non-transplant procedures, such as artificially lengthening the intestines, to transplant surgeries, like small bowel transplants, considered in severe cases. The goal is to improve nutrient absorption, minimize reliance on TPN, and enhance overall quality of life for individuals with short bowel syndrome.

Short Bowel Syndrome Epidemiology

The short bowel syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalence of home parenteral nutrition (HPN) use, diagnosed prevalent cases of short bowel syndrome, age-specific cases of short bowel syndrome, gender-specific cases of short bowel syndrome, etiology-specific cases of short bowel syndrome in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the highest prevalent cases of short bowel syndrome were seen in the United States, followed by EU4 and the UK in 2023.
• Short bowel syndrome is more common in females as compared to males. In the United States, more than 67% of short bowel syndrome patients were female.
• In the United States, around 29% and ~24% short bowel syndrome cases were caused by surgical complications and mesenteric infarction respectively in 2023.
• In EU4 and the UK, Germany accounted for the highest prevalent cases of short bowel syndrome, while Spain accounted for the least prevalent cases in 2023.

Short Bowel Syndrome Drug Chapters

The drug chapter segment of the Short Bowel Syndrome report encloses a detailed analysis of the marketed and the late-stage (Phase III and II) pipeline drug. The marketed drugs segment encloses GATTEX/REVESTIVE (Takeda). Furthermore, the current key players for the upcoming emerging drugs include VectivBio/Ironwood (apraglutide), Zealand Pharma (glepaglutide), Hanmi Pharmaceutical (HM15912), and others. The drug chapter also helps understand the short bowel syndrome clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

GATTEX/REVESTIVE: Takeda (Shire Pharmaceuticals)

GATTEX/REVESTIVE (teduglutide) is an analog of naturally occurring human GLP-2, a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). The active ingredient in GATTEX for injection is teduglutide, which is a 33 amino acid glucagon-like peptide-2 (GLP-2) analog manufactured using a strain of Escherichia coli modified by recombinant DNA technology. In December 2012, the US FDA approved GATTEX to treat adults with short bowel syndrome who are dependent on parenteral support. In May 2019, the US FDA approved GATTEX for children 1 year of age and older with short bowel syndrome. In June 2021, Japanese Ministry of Health, Labour and Welfare (MHLW) approved REVESTIVE as a treatment for short bowel syndrome.

In April 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorization for REVESTIVE. The CHMP adopted an extension to the existing indication as teduglutide for the treatment of patients 4 months corrected gestational age and above with short bowel syndrome.

Emerging Drugs

Apraglutide: VectivBio/Ironwood

Apraglutide is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare GI diseases and is currently being evaluated as a potential once-weekly treatment for patients with short bowel syndrome with intestinal failure. Apraglutide has completed Phase II studies and is currently being evaluated in a pivotal Phase III clinical trial. The global Phase III clinical, called STARS, is evaluating the safety and efficacy of apraglutide in adults with short bowel syndrome.

In addition to the STARS trial, the company is conducting the STARS Nutrition and Open-Label Extension studies to evaluate the efficacy, safety, and tolerability of apraglutide in short bowel syndrome with intestinal failure further and to support potential submissions of marketing applications for apraglutide in the United States, European Union, and Japan. In October 2023, the company presented positive final data from the STARS Nutrition Phase II study of apraglutide in patients with short bowel syndrome with intestinal failure and colon-in-continuity (CIC).

Glepaglutide: Zealand Pharma

Glepaglutide is a long-acting GLP-2 analog that is stable in aqueous solution. Zealand is developing glepaglutide as a ready-to-use, fixed dose product designed for subcutaneous delivery via auto-injector for the potential treatment of short bowel syndrome.The Phase 3 program, named EASE, includes four clinical trials evaluating the potential for glepaglutide to reduce or eliminate the need for parenteral support in short bowel syndrome patients with intestinal failure. Efficacy and safety data from these trials formed the basis of the New Drug Application (NDA) submitted to the US FDA in December 2023. FDA has granted orphan drug designation to glepaglutide for the treatment of short bowel syndrome.

Drug Class Insights

The landscape of short bowel syndrome drug development is evolving with GLP-2 agonists such as GATTEX, glepaglutide, and apraglutide.

GLP-2 agonists: GLP-2 agonists are a class of therapeutic agents that mimic the action of GLP-2, a hormone involved in the regulation of the gastrointestinal tract. GLP-2 is known for its intestinotrophic effects, meaning it promotes growth and maintenance of the small intestine. GLP-2 agonists are primarily used in the treatment of conditions such as short bowel syndrome where there is a reduced length or function of the small intestine, leading to challenges in nutrient absorption. GATTEX, an approved GLP-2 agonist, demonstrates higher effectiveness in reducing TPN dependence for short bowel syndrome patients with stomas compared to those with catheters, holding a larger market share among stoma patients. Despite efficacy, GATTEX requires daily subcutaneous injections due to its short half-life, and its lyophilized powder formulation involves a complex reconstitution process. Glepaglutide and apraglutide are emerging therapies showing promise in addressing GATTEX limitations, potentially offering improved efficacy, longer duration of action, and easier administration.

Short Bowel Syndrome Market Outlook

The treatment of short bowel syndrome is individualized, taking into account the severity and specific symptoms of each patient. TPN, involving intravenous fluids with nutrient therapy, may be necessary to address potential nutrient deficiencies. While TPN can be transitioned to home care, prolonged use poses risks such as infections, blood clotting, and potential harm to the liver and kidneys. Patients often use additional medications, such as anti-diarrheals, to alleviate short bowel syndrome symptoms. Chronic intestinal failure (CIF) in short bowel syndrome is marked by the inability to achieve optimal intestinal adaptation for maintaining oral/enteral autonomy.

Surgical management is a crucial strategy for short bowel syndrome patients. Those on parenteral nutrition with rapid transit may benefit from interventions like reversing intestinal segments or interposing segments of the colon into the small bowel. Individuals with less than 60 cm of small bowel and complications from parenteral nutrition may be considered for intestinal transplantation. For patients with dilated bowel due to obstruction, treatments like intestinal tapering or strictureplasty are options based on the length of the remaining bowel. Tapering with lengthening may be considered for remnants less than 90 cm in adults or less than 30 cm in children.

The management of short bowel syndrome involves a multidisciplinary team, including gastroenterologists and nutrition specialists, due to the complexity and varied clinical implications of the condition.

• The total market size in the US for short bowel syndrome was estimated to be nearly USD 2.00 billion in 2023, which is expected to increase due to the launch of emerging therapies and label expansion of current therapies.
• GATTEX (teduglutide), the key drug in the therapeutic area, received FDA and EMA approval in 2012 for adult short bowel syndrome patients dependent on PN. Later approvals extended its use to children and infants. Patent expiry for GATTEX is in 2023, with potential generic introductions anticipated.
• Companies are actively working on developing therapies for short bowel syndrome, with drugs like glepaglutide, apraglutide, and HM15912 undergoing assessment for potential market availability in the future.
• Due to the fact glepaglutide is pre-formulated and comes in a pre-filled pen, patients can receive drug with much more ease and no need for mixing processes.
• Optimal patient care in this condition necessitates a collaborative effort among gastroenterologists, nutritionists, surgeons, and other healthcare experts, fostering a comprehensive and improved treatment approach.

Short 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, 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.

Short 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 short bowel 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 contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Neonatal and Paediatric Surgeons, Consultant Gastroenterologists, and others.

The analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as American Gastroenterological Association,USA, Lennard Jones Intestinal Failure Unit, UK, Gastroenterology and Endoscopy Unit, University of the Study of Milan, Italy, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or short bowel syndrome market trends.

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

Market Access refers to the ability of all patients to have access to a given product quickly, conveniently, and affordably. Reimbursement is the negotiation of a price between the manufacturer and payer that allows the manufacturer access to that market. It is provided to reduce the high costs and make essential drugs affordable.

OnePath product support is available to eligible patients prescribed a Takeda treatment for alpha-1 antitrypsin deficiency (Alpha-1), hereditary angioedema (HAE), Hunter syndrome (MPS II), short bowel syndrome (SBS), and type 1 Gaucher disease. The program can cover up to 100% of the patient's out-of-pocket copay costs if patients are eligible.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Short 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, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Short 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 seven majot market of Short Bowel Syndrome.

Short Bowel Syndrome Report Insights

• Patient Population
• Therapeutic Approaches
• Short Bowel Syndrome Pipeline Analysis
• Short Bowel Syndrome Market Size and Trends
• Existing and Future Market Opportunity

Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Short Bowel Syndrome Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Short Bowel Syndrome Report Assessment

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

FAQs

• What is the historical and forecasted Short Bowel Syndrome patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What was the Short Bowel Syndrome total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• Which therapy is going to be the largest contributor by 2034?
• What will be the impact of GATTEX’s expected patent expiry?
• How will GATTEX compete with apraglutide in the market for short bowel syndrome?
• How does HM15912 differentiate itself from existing GLP-2 agonists like GATTEX, and what potential advantages or innovations does it bring to the landscape of Short Bowel Syndrome treatments, considering factors such as dosing frequency, administration method, and clinical efficacy?
• 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 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 in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Short 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) and 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.