Gastroparesis - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• Gastroparesis, which is a translated meaning of “stomach paralysis,” is a digestive disorder characterized by delayed gastric emptying of solid food in the absence of mechanical obstruction of the stomach, resulting in the cardinal symptoms of early satiety, postprandial fullness, nausea, vomiting, belching, and bloating.
• Gastroparesis may be idiopathic or associated with diabetes mellitus, may occur after a medical intervention (iatrogenic or postsurgical), or with neurological disorders; it can also occur after a viral or bacterial infection, such as Salmonella gastroenteritis.
• Diagnosis of gastroparesis can be made by demonstrating a delayed gastric emptying confirmation test. Gastric emptying rates measured by gastric motor testing generally correlate poorly with symptoms and quality of life in patients with gastroparesis. Other tests include scintigraphy, wireless motility capsule (WMC), and carbon breath testing.
• Scintigraphic gastric emptying of solids is the gold standard for the evaluation of gastric emptying and the diagnosis of gastroparesis.
• Among EU4 and the UK, Italy accounted for the highest number of prevalent cases of GPLS, followed by Germany and France in the year 2023.
• Gastroparesis as a disease predominantly affects women, with 68.5% of the diagnosed patients being females, while only 31.5% of the diagnosed patients are males.
• The treatment of gastroparesis is based on the severity of the symptoms of the disease. If diabetes is associated with gastroparesis, then treatment is done by controlling blood glucose levels. The treatment of gastroparesis mainly includes nonpharmacological steps, such as dietary modification, and pharmacological measures, including medications that stimulate gastric emptying (prokinetics), medications that reduce vomiting (anti-emetics), medications for controlling pain and intestinal spasms, and surgery.
• Currently, the market holds limited approved drugs such as GIMOTI (metoclopramide), developed by Evoke Pharma. The generics of the other approved drug, REGLAN, which was licensed by Ani Pharmaceuticals, are available in the market.
• Key players, such as Vanda Pharmaceuticals, Processa Pharmaceuticals, Neurogastrx, CinDome Pharma, and others, are involved in developing therapies for Gastroparesis. The expected launch of emerging therapies and other treatments will lead to a significant increase in the market size during the forecast period (2024-2034).
• Compared to all the emerging therapies, PCS12852 and tradipitant are expected to have the most significant impact on the market size of gastroparesis in the 7MM, with PCS12852 being expected to garner the highest market share by 2034 in the 7MM.
• The lack of other recommended treatments and the failure to secure approval and marketing for new drugs for gastroparesis has led to the off-label use of a variety of different medications, such as macrolide antibiotics and acetylcholinesterase inhibitors. Given there is a substantial unmet need for patients with gastroparesis, a detailed understanding of the efficacy of available drugs is essential to improve outcomes for patients.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the gastroparesis market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM gastroparesis market.

Market

Various key players are leading the treatment landscape of gastroparesis, such as Vanda Pharmaceuticals, Processa Pharmaceuticals, Neurogastrx, CinDome Pharma, and others. The details of the country-wise and therapy-wise market size have been provided below.

• The total market size of gastroparesis was found to be around USD 200 million in 2023 in the US, which is further expected to increase by 2034 with the approval of several new therapies in the market.
• In 2023, the market size of the United Kingdom accounted for approximately USD 10 million, which is expected to increase during the forecast period.
• During the forecast period (2024-2034), pipeline candidates such as tradipitant, CIN-102 (Deudomperidone), NG101 (Metopimazine), and PCS12852, among others, are expected to enter the market, leading to substantial growth in the gastroparesis market.
• The launch of the selective 5-HT4 agonist PCS12852 is expected to transform the treatment landscape, potentially becoming a market leader in the 7MM by 2034.

Gastroparesis Drug Chapters

The section dedicated to drugs in the gastroparesis report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to gastroparesis.

The drug chapters section provides valuable information on various aspects related to clinical trials of gastroparesis, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting gastroparesis.

Marketed Therapies

GIMOTI (metoclopramide) Nasal Spray: Evoke Pharma

Metoclopramide hydrochloride, the active ingredient in GIMOTI, is a dopamine-2 receptor antagonist. GIMOTI, a dopamine antagonist/mixed 5-HT3 antagonist/5-HT4 agonist with promotility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. For over 40 years, the only FDA-approved products for the treatment of diabetic gastroparesis had been an oral tablet and injection formulations of metoclopramide. GIMOTI is a novel formulation of metoclopramide offering systemic delivery by nasal spray administration.

Emerging Therapies

VLY-686 (tradipitant): Vanda Pharmaceuticals

Tradipitant, developed by Vanda Pharmaceuticals, is a neurokinin-1 receptor (NK-1R) antagonist. In December 2023, Vanda Pharmaceuticals announced that the US FDA had accepted the filing of Vanda’s New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis. The FDA had set September 2024 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA). Moreover, the FDA has placed a partial clinical hold on tradipitant clinical protocols lasting longer than 12 weeks.

PCS12852: Processa Pharmaceuticals

PCS12852 is a novel, potent, and highly selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist. PCS12852 differs from other 5HT4 agonists because it has greater potency and is a more selective 5-HT4 agonist with a binding affinity to the 5-HT4 receptor being 200-fold times the affinity for other 5-HT receptors. In Phase IIa, the GEBT results demonstrated statistical improvement in gastric emptying in gastroparesis patients receiving 0.5 mg of PCS12852 (6 patients) as compared to placebo (8 patients) at a p < 0.10 level. Adverse events associated with this Phase IIa trial were mild to moderate, occurring within the first few days after starting treatment, and quickly resolved without any sequelae.

Gastroparesis Market Outlook

The limited efficacy of currently available treatment options and their serious side effects warrant the need for newer and better treatment options. The primary treatment approach includes nutritional assessment and dietary modifications, and when these approaches are not enough, patients are introduced to pharmacological treatment. Prokinetic agents like metoclopramide, domperidone, and erythromycin are primarily used to increase the rate of gastric emptying and decrease symptoms in patients with gastroparesis.

In the US, metoclopramide is the only FDA-approved drug for the treatment of gastroparesis. It is a dopamine-2 receptor antagonist marketed under the brand name Reglan, also having many low-cost generic formulations available on the market.

There are no approved drugs in EU4 and the UK for the treatment of gastroparesis, but another dopamine (D2/3) receptor antagonist, domperidone, is widely used. It is approved for the treatment of nausea and vomiting for short-term use, usually no longer than 7 days. It does not cross the blood-brain barrier. However, cardiac dysrhythmias due to interaction with the hERG potassium channel as an off-target effect are a matter of concern.

At present, key players like Vanda Pharmaceuticals (tradipitant), CinDome Pharma (deudomperidone), Neurogastrx (metopimazine), and Processa Pharmaceuticals (PCS12852) are investigating their candidates for the treatment of gastroparesis and management of its symptoms in the 7MM; these drugs shall create a significant positive shift in the treatment space of gastroparesis in the coming years.

Gastroparesis Disease Understanding and Treatment

Gastroparesis Overview

Gastroparesis, which is a translated meaning of “stomach paralysis,” is a digestive disorder characterized by delayed gastric emptying of solid food in the absence of mechanical obstruction of the stomach, resulting in the cardinal symptoms of early satiety, postprandial fullness, nausea, vomiting, belching, and bloating. Gastroparesis may be idiopathic or associated with diabetes mellitus, may occur after a medical intervention (iatrogenic or postsurgical), or with neurological disorders; it can also occur after a viral or bacterial infection, such as Salmonella gastroenteritis.

Based on the causes, gastroparesis is divided into three major types, i.e., idiopathic gastroparesis, diabetic gastroparesis, and postsurgical gastroparesis. Some of the researchers proposed a classification system to help determine appropriate treatment options, such as Grade 1 or mild gastroparesis, which is characterized by symptoms that come and go and can easily be controlled by dietary modification and by avoiding medications that slow gastric emptying. Grade 2, or compensated gastroparesis, is characterized by moderately severe symptoms. Individuals with Grade 2 gastroparesis are treated with medications that stimulate gastric emptying and medications that reduce vomiting; such individuals require hospitalization only infrequently.

Gastroparesis Diagnosis

Patients with postprandial upper abdominal symptoms such as nausea, vomiting, postprandial fullness, bloating, and epigastric pain are candidates for gastric motility tests. Patients must first undergo an upper GI endoscopy; if this test does not reveal a cause for the symptoms, patients can begin motility and functional investigations. Furthermore, the most relevant functional test is a measurement of gastric emptying, which is best assessed with scintigraphy conducted over at least 3 h; however, only the regulatory agencies approve the stable isotope breath test. These tests are well-validated, and data from healthy control individuals are available. When results from tests of gastric emptying are inconclusive, particularly in patients with prominent postprandial fullness or early satiety, measurements of gastric accommodation are also indicated. Impaired gastric accommodation is diagnosed with validated methods that are available, such as SPECT and MRI, or with screening tests, such as the proximal stomach size on the gastric scintiscan (taken immediately after radiolabelled meal ingestion) or by a water load or nutrient drink test.

Gastroparesis Treatment

Management of gastroparesis involves correcting fluid, electrolyte, and nutritional deficiencies, identifying and treating the cause of delayed gastric emptying (for example, diabetes mellitus), and suppressing or eliminating symptoms. Therapeutic strategies rely on dietary modification, medications that stimulate gastric motor activity, anti-emetic drug therapy, and nonpharmacological measures such as endoscopic or surgical intervention or gastric electrical stimulation.

Dietary modifications represent the first line of treatment for gastroparesis and are generally used for all patients, regardless of disease severity. Oral intake is preferable for nutrition and hydration in patients with gastroparesis.

Pharmacological agents, including prokinetic and anti-emetic medications, may provide a viable treatment. Gastric prokinetic medications increase the rate or amplitude of stomach contractions and, thus, increase the rate of gastric emptying. Medications currently approved (although not in all countries) include metoclopramide, domperidone, and erythromycin.

Gastroparesis Epidemiology

The gastroparesis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of GPLS, diagnosed prevalent cases of gastroparesis, cause-specific cases, age-specific cases, gender-specific cases, and treated cases of gastroparesis in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States accounted for the highest number of prevalent cases of GPLS cases in 2023. These cases are expected to rise by 2034 at a CAGR of 0.7%.
• In EU4 and the UK, cause-specific cases of gastroparesis were found to be the highest for diabetes. In 2023, nearly 20,000 cases were observed for T1DM, and around 200,000 cases were found for T2DM.
• In the UK, the total treated cases of gastroparesis were approximately 30,000 cases in 2023. These numbers are expected to increase by 2034.
• As per the analysis, a higher number of cases were observed for females than males based on type-specific cases of gastroparesis in all the 7MM countries.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of gastroparesis, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts connected with more than 15 KOLs across the 7MM. We contacted institutions such as Duke University, the American Academy of Family Physicians, the University of Munich, the University of Valencia, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the gastroparesis market, which will assist our clients in analyzing the overall epidemiology and market scenario.

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 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.

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.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for gastroparesis, important primary and secondary endpoints are changes in gastric emptying rate, ANMS GCSI-DD score, patient global impression of change, overall patient benefit scale, etc. Based on these parameters, the overall efficacy is evaluated.

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, a final weightage score is decided based on which the emerging therapies are ranked.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

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.

Gastroparesis Report Insights

• Patient Population
• Therapeutic Approaches
• Gastroparesis Market Size and Trends
• Existing Market Opportunity

Gastroparesis Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Gastroparesis Epidemiology Segmentation
• Key Cross Competition

Gastroparesis Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in gastroparesis management recommendations?
• Would research and development advances pave the way for future tests and therapies for gastroparesis?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of gastroparesis?
• What kind of uptake will the new therapies witness in the coming years in gastroparesis patients?