PUBLISHER: DelveInsight | PRODUCT CODE: 1855029
PUBLISHER: DelveInsight | PRODUCT CODE: 1855029
DelveInsight's "Short Bowel Syndrome (SBS) - Market Insights, Epidemiology, and Market Forecast - 2034" 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 Short Bowel Syndrome market size from 2020 to 2034 in the 7MM. 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.
Study Period: 2020-2034
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 can usually 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 are 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 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 TPN, enteral feeding, dietary adjustments, oral rehydration solutions, medications, and surgery. Intestinal adaptation, 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.
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 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
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 drugs. 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 is a novel, recombinant analogue of human GLP-2, a naturally occurring protein involved in the rehabilitation of the intestinal lining. It has been developed to reduce dependence on parenteral nutrition in adult patients with SBS. Teduglutide has received ODD for the treatment of SBS from the EMA and the US FDA.
GATTEX was first approved by the FDA in December 2012 for adults with SBS on parenteral support, with its indication expanded in May 2019 to include pediatric patients aged 1 year and older.
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 an investigational, next-generation, long-acting synthetic GLP-2 analog being evaluated as a potential once-weekly treatment for patients with SBS-IF.
Glepaglutide: Zealand Pharma
Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for SBS. Glepaglutide is being developed as a liquid product in an autoinjector designed for subcutaneous administration, aimed to reduce or eliminate the need for parenteral support in people living with SBS. The US FDA has granted ODD for glepaglutide for the treatment of SBS.
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.
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.
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 Pipeline Activities
The report provides insights into different therapeutic candidates in the 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 therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Neonatal and Paediatric Surgeons, Consultant Gastroenterologists, and others.
Delveinsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the 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.
In the base scenario, teduglutide costs USD 949,910/QALY gained. In one-way sensitivity analyses, only reducing teduglutide cost decreased the cost/QALY gained to below the typical threshold of USD 100,000/QALY gained. Specifically, the cost of teduglutide would need to be reduced by >65% for it to reach the threshold value. Probabilistic sensitivity analysis favored no teduglutide use in 80% of iterations at a USD 100,000/QALY threshold. However, teduglutide therapy was cost-saving in 13% of model iterations.
Takeda Patient Support
Eligible patients may pay as little as USD 0 for each GATTEX prescription, subject to meeting all eligibility requirements.