Diabetic Gastroparesis Treatment Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Grade 2(Compensated Gastroparesis), Grade 3(Gastric Failure), By Drug Class (Gastroprokinetic Agents, Antiemetic Agents, Antihistamines, Others), By Route of Administration (Oral, Parenteral, Nasal), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.03 Billion
CAGR (2026-2031)	3.57%
Fastest Growing Segment	Online Pharmacies
Largest Market	North America
Market Size (2031)	USD 3.74 Billion

Market Overview

The Global Diabetic Gastroparesis Treatment Market will grow from USD 3.03 Billion in 2025 to USD 3.74 Billion by 2031 at a 3.57% CAGR. The Global Diabetic Gastroparesis Treatment Market encompasses pharmacological agents, such as prokinetics and antiemetics, as well as surgical devices and procedures designed to manage delayed gastric emptying in patients with diabetes mellitus. The market is primarily propelled by the escalating global prevalence of diabetes, which directly correlates with a higher incidence of gastrointestinal complications and necessitates effective symptom management strategies. According to the International Diabetes Federation, in 2024, approximately 589 million adults were living with diabetes worldwide, representing a substantial patient pool susceptible to long-term complications.

However, market expansion faces a significant challenge due to the stringent regulatory landscape concerning drug safety and efficacy. Many existing therapies carry risks of severe adverse effects, leading regulatory bodies to impose rigorous clinical trial requirements and safety warnings on new and existing medications. This high barrier to entry prolongs product development timelines and restricts the approval of novel therapeutic agents, thereby limiting the available treatment options for clinicians and patients.

Key Market Drivers

The robust clinical pipeline and development of novel therapeutics currently serve as a primary engine for market progression, as pharmaceutical companies actively pursue safer alternatives to traditional prokinetics. Manufacturers are prioritizing the formulation of new chemical entities designed to minimize the cardiac and neurological risks associated with older agents like metoclopramide, thereby addressing long-standing regulatory safety concerns. A significant advancement in this domain occurred when CinDome Pharma announced in May 2024 that it had secured a $40 million Series B financing extension to advance the Phase 2 clinical trials of deudomperidone, a novel dopamine antagonist engineered to provide chronic symptom relief without the adverse effects of existing options. This substantial developmental investment highlights the industry’s commitment to accelerating the introduction of next-generation pharmacological solutions for gastroparesis management.

Simultaneously, the escalating global prevalence of diabetes mellitus fundamentally underpins the expanding demand for gastroparesis treatments, creating a vast and growing target patient population. As the number of individuals diagnosed with diabetes rises, the incidence of secondary gastrointestinal complications increases proportionately, necessitating sustained therapeutic intervention to manage delayed gastric emptying. According to the Centers for Disease Control and Prevention, in May 2024, approximately 38.4 million people of all ages in the United States were living with diabetes, underscoring the immense scale of the at-risk demographic in major markets. This expanding patient base directly translates into increased commercial uptake for approved therapies; for instance, Evoke Pharma reported in November 2024 that net product sales for its nasal formulation, GIMOTI, reached $2.7 million in the third quarter alone, reflecting a 70% increase compared to the prior year.

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Key Market Challenges

The stringent regulatory landscape regarding drug safety and efficacy significantly impedes the growth of the Global Diabetic Gastroparesis Treatment Market. Regulatory bodies enforce rigorous clinical trial requirements to mitigate severe risks, such as those associated with the long-term use of existing prokinetic agents. This high threshold for safety data necessitates extensive and costly development phases, often leading to product failures in late-stage trials. Consequently, the reluctance to approve new agents without overwhelming safety evidence creates a barrier to entry that stifles innovation and limits the introduction of novel therapies, leaving the market reliant on older, risk-laden medications.

This regulatory bottleneck restricts the commercial potential of the market by narrowing the range of available treatments for a clearly defined and suffering patient population. The disparity between the high burden of the disease and the scarcity of approved therapeutic options is evident in recent prevalence data. According to the American Gastroenterological Association, in 2025, gastroparesis affected approximately 21 to 24 per 100,000 persons in the United States, with women accounting for the majority of cases. This statistic highlights a substantial addressable market that remains underserved due to the slow pace of regulatory approvals, directly hampering revenue generation and overall market expansion.

Key Market Trends

The Increasing Adoption of Gastric Peroral Endoscopic Myotomy (GPOEM) represents a structural shift toward minimally invasive interventions for refractory cases. This procedure mechanically addresses pyloric spasms to facilitate gastric emptying, offering an alternative for patients unresponsive to pharmacological management. Clinicians are utilizing this technique due to its potential for durable symptom relief compared to traditional surgeries. According to Gastrointestinal Endoscopy, January 2025, in the study 'Efficacy and safety of gastric peroral endoscopic myotomy across different etiologies of gastroparesis,' a meta-analysis involving 982 patients revealed that GPOEM achieved a pooled clinical success rate of 65% specifically for diabetes related gastroparesis cases.

Simultaneously, the Expansion of Gastric Electrical Stimulation for Refractory Cases is broadening the market by targeting patients previously excluded from device based therapies. This trend involves investigating neurostimulation in individuals with chronic nausea and vomiting who maintain normal gastric emptying rates. Manufacturers are prioritizing trials to validate this wider indication. For instance, according to Enterra Medical, June 2025, in the press release 'New Hope for Chronic Nausea, Enterra Medical Begins NAVIGATE Study,' the company initiated a pivotal trial enrolling at least 148 subjects to assess safety and effectiveness in this expanding patient population.

Segmental Insights

According to recent industry analysis, the Online Pharmacies segment constitutes the fastest-growing distribution channel in the Global Diabetic Gastroparesis Treatment Market. This robust growth is principally driven by the widespread adoption of digital healthcare solutions and the convenience of home delivery services. Since diabetic gastroparesis requires long-term management, patients increasingly value the accessibility and ease of procuring medications online, particularly those with limited mobility. Additionally, the availability of competitive pricing and the expansion of secure e-commerce infrastructure continue to accelerate the consumer shift away from traditional brick-and-mortar retail outlets.

Regional Insights

North America dominates the global diabetic gastroparesis treatment market primarily due to the high prevalence of diabetes and its associated complications across the region. This leadership is supported by a well-established healthcare infrastructure that ensures early diagnosis and consistent patient management. Furthermore, the availability of favorable reimbursement frameworks enhances patient access to necessary therapeutic options. The market position is strengthened by continuous clinical research and regulatory developments overseen by the U.S. Food and Drug Administration, which fosters a stable environment for pharmaceutical availability. These factors collectively secure North America’s primary standing in the industry.

Recent Developments

• In September 2025, CinDome Pharma, a portfolio company of CinRx Pharma, announced the completion of patient enrollment in its envision3D Phase 2 clinical trial. This study was designed to evaluate the safety and efficacy of deudomperidone (CIN-102), a novel formulation of a dopamine D2/D3 antagonist, in adults with diabetic gastroparesis. The company positioned the investigational drug as a potential chronic treatment option, aiming to address the limitations of existing therapies that are often restricted by safety concerns. The successful enrollment marked a critical milestone in the development program, with the company anticipating topline results to follow, which would determine the subsequent regulatory pathway and potential registration strategies for the medication in the global market.
• In June 2025, Processa Pharmaceuticals, Inc. entered into an exclusive licensing agreement with Intact Therapeutics, Inc. for the development and commercialization of PCS12852, a novel 5-HT4 receptor agonist. Under the terms of the agreement, Processa Pharmaceuticals granted Intact Therapeutics the rights to advance the drug candidate for the treatment of gastroparesis and other gastrointestinal motility disorders. The deal structure included potential milestone payments totaling $452.5 million, along with royalties on future net sales and an equity stake in the partner company. This collaboration aimed to leverage Intact Therapeutics' specialized delivery platform to potentially enhance the therapeutic profile of PCS12852, which had previously demonstrated a favorable safety and efficacy profile in Phase 2a clinical trials for patients suffering from gastric emptying delays.
• In October 2024, Evoke Pharma, Inc., in collaboration with EVERSANA, presented new real-world data at the American College of Gastroenterology (ACG) Annual Meeting regarding the use of GIMOTI (metoclopramide) nasal spray. The presented study focused on patients with diabetic gastroparesis who were concurrently using GLP-1 receptor agonists, a class of drugs often associated with delayed gastric emptying. The findings demonstrated that patients treated with the nasal spray formulation experienced statistically significant improvements in clinical outcomes compared to those using oral metoclopramide. This development was particularly relevant for the market as it highlighted a potential therapeutic advantage for GIMOTI in managing symptoms among the growing population of patients utilizing GLP-1 therapies for diabetes and weight management.
• In September 2024, Vanda Pharmaceuticals Inc. provided an update on the regulatory status of tradipitant, a neurokinin-1 receptor antagonist intended for the treatment of gastroparesis symptoms. The company announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA), effectively declining the approval of the therapy at that time. The regulatory agency suggested that additional studies with specific designs and durations would be necessary to support the application. Vanda Pharmaceuticals expressed strong disagreement with the decision, noting that the application included substantial evidence of efficacy from placebo-controlled studies and real-world data, highlighting the significant unmet need in the diabetic gastroparesis treatment market.

Key Market Players

• ANI Pharmaceuticals, Inc.
• Evoke Pharma
• Janssen Pharmaceutica N.V
• Teva Pharmaceuticals Inc.
• Pfizer Inc.
• Salix Pharmaceuticals, Inc.
• Allergan Plc.
• Novartis AG
• SCHWITZ BIOTECH
• Wellona Pharmaceutical Private Limited

By Type	By Drug Class	By Route of Administration	By Distribution Channel	By Region
Grade 2(Compensated Gastroparesis) Grade 3(Gastric Failure)	Gastroprokinetic Agents Antiemetic Agents Antihistamines Others	Oral Parenteral Nasal	Hospital Pharmacies Retail Pharmacies Online Pharmacies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Diabetic Gastroparesis Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Diabetic Gastroparesis Treatment Market, By Type:

• Grade 2(Compensated Gastroparesis)
• Grade 3(Gastric Failure)

• Diabetic Gastroparesis Treatment Market, By Drug Class:

• Gastroprokinetic Agents
• Antiemetic Agents
• Antihistamines
• Others

• Diabetic Gastroparesis Treatment Market, By Route of Administration:

• Oral
• Parenteral
• Nasal

• Diabetic Gastroparesis Treatment Market, By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

• Diabetic Gastroparesis Treatment Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE