PUBLISHER: DelveInsight | PRODUCT CODE: 2082897
PUBLISHER: DelveInsight | PRODUCT CODE: 2082897
Gastroparesis Market Size and Forecast in the US
DelveInsight's 'Gastroparesis - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the gastroparesis, historical and forecasted epidemiology, as well as the gastroparesis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The gastroparesis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates gastroparesis patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in gastroparesis and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Gastroparesis Market
Rising Prevalence of Diabetes
Gastroparesis is strongly linked to diabetes, particularly long-standing cases. As diabetes rates increase globally, the number of gastroparesis patients grows, boosting demand for diagnosis and treatment.
Aging Population
Older adults are more prone to gastrointestinal disorders, including gastroparesis. The growing elderly population contributes significantly to rising case numbers and healthcare demand.
Unmet Medical Needs
Current treatments often provide limited relief and may have side effects. The need for more effective and safer therapies continues to drive innovation and market interest.
Gastroparesis Overview and Diagnosis
Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying without any mechanical obstruction. It commonly occurs in people with long-standing diabetes but can also arise from post-surgical complications, medications, or idiopathic causes. Patients typically experience nausea, vomiting, early satiety, bloating, and abdominal pain, which can significantly impact nutrition and quality of life. The condition can lead to complications such as malnutrition, dehydration, and erratic blood glucose levels, particularly in diabetic patients. Its chronic and relapsing nature often requires long-term management and monitoring.
Diagnosis involves ruling out mechanical obstruction and confirming delayed gastric emptying. Common tools include gastric emptying scintigraphy (the gold standard), breath tests, and upper endoscopy. Physicians also assess underlying causes such as diabetes and review medications that may impair gastric motility, ensuring a comprehensive evaluation before confirming gastroparesis. Additional tests like wireless motility capsules and imaging studies may be used in complex cases. Accurate diagnosis is crucial to differentiate gastroparesis from other functional gastrointestinal disorders with similar symptoms.
Current Gastroparesis Treatment Landscape
Treatment focuses on symptom management, dietary modifications, and improving gastric motility. Patients are advised to consume small, low-fat, low-fiber meals. Pharmacologic therapy includes prokinetic and antiemetic agents such as Metoclopramide (GIMOTI), the only FDA-approved drug specifically indicated for gastroparesis, and Erythromycin, used off-label. Other supportive medications, like antiemetics, may help control nausea and vomiting. In severe or refractory cases, options such as gastric electrical stimulation, jejunostomy feeding tubes, or surgical interventions may be considered to maintain nutrition and improve quality of life. Continuous monitoring and individualized treatment plans are essential due to variability in patient response.
Gastroparesis Unmet Needs
The section "unmet needs of gastroparesis" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Key Findings from Gastroparesis Epidemiological Analysis and Forecast
Gastroparesis Drug Analysis & Competitive Landscape
The gastroparesis drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the gastroparesis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the gastroparesis therapeutics market.
Approved Therapies for Gastroparesis
Metoclopramide (GIMOTI): EVOKE Pharma/EVERSANA
GIMOTI nasal spray is the first and only FDA-approved non-oral treatment for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide hydrochloride is the active ingredient in GIMOTI. It is a dopamine antagonist, 5-HT3 antagonist, and 5-HT4 agonist with promotility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. In June 2020, the US FDA approved metoclopramide (GIMOTI) nasal spray. In January 2020, EVOKE Pharma entered into a commercial services agreement with Eversana Life Sciences Services for the commercialization of GIMOTI. According to the Eversana Agreement, Eversana will commercialize and distribute GIMOTI in the US.
Gastroparesis Pipeline Analysis
Naronapride (ATI-7505): Renexxion
Naronapride is an investigational gastrointestinal prokinetic drug. It is designed to treat disorders of gut motility, including gastroparesis. Naronapride works through a differentiated dual mechanism of action- 5-HT4 receptor agonism and dopamine D2 receptor antagonism. Inhibiting D2 receptors removes the "brakes" on the motility of the gut. The high 5-HT4 receptor selectivity minimizes the potential for off-target pharmacological effects. Its dual mechanism of action, minimal systemic bioavailability, and differentiated pharmaceutical and pharmacokinetic profile are designed to deliver targeted activity within the GI tract while limiting systemic exposure. In October 2021, Renexxion Ireland announced that it had entered into a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH to jointly develop and commercialize Naronapride, a unique late-stage GI prokinetic, initially for gastroparesis.
Gastroparesis Key Players, Market Leaders, and Emerging Companies
Gastroparesis Drug Updates
The treatment landscape for gastroparesis has historically relied on symptomatic management, including dietary modifications, antiemetics, and prokinetic agents. A key milestone in therapy is the approval of metoclopramide (GIMOTI), which enhances gastric motility through dopamine receptor antagonism. Despite its effectiveness, long-term use is limited by safety concerns, highlighting the need for better-tolerated and more durable therapies.
The gastroparesis pipeline is gradually evolving, with investigational agents targeting gastrointestinal motility and symptom control through novel mechanisms. Naronapride (ATI-7505), a selective 5-HT4 receptor agonist, is being developed to enhance gastric emptying with improved cardiac safety versus earlier agents. CIN-102 (deudomperidone) aims to deliver prokinetic effects with fewer central nervous system side effects. NG101 (metopimazine) is also under investigation for its antiemetic action, potentially relieving persistent nausea and vomiting associated with gastroparesis.
Overall, the emergence of safer and more targeted therapies, along with improvements in diagnostic capabilities and increasing disease awareness, is projected to propel steady market growth across the 7MM from 2022 to 2036, yielding significant commercial opportunities for existing products and pipeline candidates.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Gastroparesis (2022-2036 Forecast)
The gastroparesis market (2022-2036 forecast) is shifting toward mechanism-based therapies that aim to improve gastric motility and control core symptoms such as nausea and vomiting, rather than relying solely on general supportive care.
Overall, innovation in gastroparesis is driven by approved and investigational small-molecule therapies targeting complementary mechanisms, including prokinetic and antiemetic effects. As pipeline candidates advance, they are expected to broaden treatment options beyond metoclopramide, address key unmet needs, and support steady market growth across major regions.
Gastroparesis Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the gastroparesis drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
During the forecast period, the currently FDA-approved therapy Metoclopramide (GIMOTI) is expected to maintain baseline utilization as the first-line pharmacologic option. However, its uptake is likely to plateau due to safety concerns such as extrapyramidal side effects and limitations on long-term use. It will continue to be widely used in acute and short-term management, particularly in newly diagnosed patients and in settings where newer therapies are not yet accessible.
Among pipeline agents, Naronapride (ATI-7505) is expected to see gradual uptake as a next-generation 5-HT4 agonist, driven by its potential to improve gastric motility with a more favorable cardiovascular safety profile. CIN-102 (domperidone) is expected to follow a moderate adoption curve, particularly in regions where domperidone use is established, benefiting from improved pharmacokinetic stability and reduced CNS penetration. Its uptake will likely be driven by chronic symptom management needs. NG101 (metopimazine) is expected to achieve faster early adoption in select patient segments due to its strong antiemetic effect, positioning it as an add-on therapy for refractory nausea and vomiting. Overall uptake will depend on clinical efficacy, safety outcomes, and positioning alongside standard of care therapies.
Gastroparesis Therapies Price Scenario & Trends
Pricing and analogue assessment of gastroparesis therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market gastroparesis, adherence, and long-term uptake.
The recommended dosage of GIMOTI for adults with acute and recurrent diabetic gastroparesis is one spray (15 mg) administered into one nostril, 30 minutes before each meal and at bedtime, up to a maximum of four times daily. Treatment duration ranges from 2 to 8 weeks, based on the patient's symptomatic response. A single bottle provides sufficient medication for 28 days of use at the maximum recommended frequency. The cost per bottle is approximately USD 2,276.03, resulting in an estimated total therapy cost of around USD 4,552 for an 8-week course.
Industry Experts and Physician Views for Gastroparesis
To keep up with the gastroparesis market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions 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 Gastroparesis emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in gastroparesis, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as the Duke Molecular Physiology Institute, Department of Nephrology, Hospital Universitario Fundacion Alcorcon, and Nippon Medical School, etc. were contacted. Their opinion helps understand and validate current and emerging gastroparesis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in gastroparesis.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of gastroparesis, 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.
Conjoint analysis analyzes 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.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.
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