Gastroparesis Drugs Market

Market Overview

The global gastroparesis drugs market size was valued at USD 5.2 billion in 2023 and is projected to reach USD 7.6 billion by 2032, registering a CAGR of 4.8% during the forecast period (2024-2032). The market expansion is significantly driven by the increasing incidence of diabetes worldwide, which is primarily caused by fast urbanization, changing lifestyles, and rising rates of frequent alcohol and tobacco intake.

Gastroparesis is a condition marked by inadequate peristaltic contractions of the stomach muscles, resulting in digestive disturbances, including nausea, vomiting, abdominal discomfort, and difficulties in regulating blood sugar levels and absorbing nutrients. Gastroparesis is a condition that primarily affects individuals with type 1 and type 2 diabetes. Medications such as erythromycin, antiemetics, and Reglan are administered to treat gastroparesis. 

The forecast year is expected to witness significant growth in the gastroparesis market due to the increasing frequency of idiopathic gastroparesis. Moreover, the rise in operations might lead to postoperative gastroparesis, which is expected to drive the expansion of the gastroparesis market. Furthermore, the increase in research and development efforts by producers to develop more sophisticated drugs for treating gastroparesis is expected to support the growth of the gastroparesis market. Furthermore, the rising prevalence of diabetes mellitus within the population will create further prospects for the expansion of the gastroparesis market in the future. 

Highlights

• Prokinetic agents generate the highest revenue share based on drug class.
• Diabetic gastroparesis accounts for the largest market share by disease type.
• Hospitals contribute significantly to the market through end-use.

Market Dynamics

Global Gastroparesis Drugs Market Drivers

Increasing Prevalence of Diabetes 

Diabetes and its linked complications have become a significant worldwide health issue. The 10th edition of the International Diabetes Federation’s (IDF) Global Diabetes Map1, published in 2021, states that diabetes is 10.5%, meaning that 1 in every ten people has diabetes. Approximately 643 million adults, accounting for 11.3% of the population, are projected to have diabetes by 2030. This number is expected to rise to 783 million adults, representing 12.2% of the population, by 2045. The global expenditure on diabetes-related healthcare is at least USD 966 billion, a 316% increase over the past 15 years.

In 2022, an article was published by NCB that between 11% to 18% of patients with diabetes experience upper gastrointestinal symptoms, with the majority of these symptoms being linked to delayed stomach emptying or gastroparesis. Gastroparesis affects around 4.8% of people with type 1 diabetes, 1% of those with type 2 diabetes, and 0.1% of people without diabetes. While there is a stronger correlation between type 1 diabetes and gastroparesis, the prevalence of gastroparesis is considerably higher in patients with type 2 diabetes. As a result, gastroparesis linked with type 2 diabetes is observed more frequently.  The increase in diabetes cases has a direct effect on the occurrence of gastroparesis, as diabetes is a prevalent factor in causing the ailment. Therefore, the growing incidence of diabetes is the main factor contributing to the market growth. 

Research and Development by Pharmaceutical Manufacturers

Pharmaceutical manufacturers’ research and development efforts have contributed to the progress of treatment options for gastroparesis. Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) is a clinical-stage pharmaceutical company actively investing in developing new and innovative drug therapies. Their current focus is on improving chemotherapeutic drugs to enhance the effectiveness and safety of cancer patients. Recently, Processa presented data on the use of PCS12852 for treating gastroparesis patients. PCS12852 is a potent and highly selective new 5-HT4 agonist ready for Phase 2b trials. The business is now seeking collaborations and considering alternative possibilities to develop the program further.

In 2023, Enterra Medical, Inc., a company specializing in treating individuals with gastroparesis, announced that the Enterra® II System has received MR Conditional approval from the United States Food and Drug Administration (FDA). The Enterra II System, consisting of the Enterra 37800 Neurostimulator and Enterra Therapy 4351-35 unipolar leads, is a sophisticated medical treatment system developed to alleviate the symptoms of gastroparesis. Gastroparesis is a complicated medical condition characterized by impaired stomach emptying, leading to symptoms of nausea and vomiting. Therefore, these advancements propel market expansion. 

Global Gastroparesis Drugs Market Restraints

Side Effects of Gastroparesis Drugs

The presence of severe adverse effects associated with gastroparesis medications is a significant obstacle that is impeding the expansion of the gastroparesis pharmaceutical industry. Prokinetics is the initial therapy option for gastroparesis, consisting of drugs that enhance gastrointestinal motility. Furthermore, Metoclopramide is a specific type of medication known as a prokinetic medicine. Notably, the US Food and Medicine Administration (FDA) has approved exclusively Metoclopramide for treating gastroparesis. It is intended to alleviate nausea and vomiting, accelerate stomach emptying, and mitigate reflux. It carries the potential for developing severe adverse effects, like Tardive Dyskinesia and Neuroleptic Malignant Syndrome. Furthermore, there is a more recent pharmaceutical called domperidone, which has a reduced incidence of adverse reactions. However, its availability is limited due to access restrictions. 

Additionally, Cisapride (Propulsid) is a medicine used to treat gastroparesis that has been prohibited in numerous countries. The product remains accessible in Canada via the Health Canada Special Access program. The medicine is subject to substantial restrictions due to the potential occurrence of infrequent yet significant cardiac events. Cisapride functions as a gastric prokinetic drug by enhancing the motility of the gastrointestinal system. The prevalent adverse effects encompass constipation, diarrhea, abdominal cramps, drowsiness, nausea, headaches, and lethargy. Hence, the adverse effects of gastroparesis medications will impede the market’s expansion over the projected timeframe.

Global Gastroparesis Drugs Market Opportunity

Rise in the Number of Surgical Procedures

The gastroparesis medicine market is expected to experience substantial expansion, primarily driven by the rising global prevalence of surgical operations. Gastroparesis, a condition marked by slow stomach emptying, typically necessitates medical intervention for appropriate symptom management. When conservative therapy is ineffective, surgical techniques, including stomach electrical stimulation (GES) and pyloroplasty, are frequently used.

Gastric Electrical Stimulation (GES), which involves the placement of electrodes in the stomach wall to regulate the movement of the stomach, has become more recognized as a feasible treatment for gastroparesis cases that do not respond to other treatments. Due to technical improvements that enhance the effectiveness and safety of GES systems, an increasing number of patients are choosing this surgical intervention. Similarly, there has been a rise in the use of pyloroplasty, a surgical treatment that aims to enlarge the pyloric sphincter to make stomach emptying easier.

Moreover, the increasing occurrence of illnesses that make persons more likely to develop gastroparesis, such as diabetes and difficulties after surgery, highlights the need for better treatment alternatives. This, in turn, creates the potential for the market to expand. 

Regional Analysis

The global gastroparesis drugs market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global gastroparesis drugs market shareholder and is estimated to grow at a CAGR of 4.6% over the forecast period.  The increase in the number of diabetes cases in this region can be mainly attributable to the high incidence of gastroparesis. Furthermore, the increasing prevalence of gastroparesis can be attributed to a significant number of individuals who are at risk of developing diabetes, as well as the presence of advantageous reimbursement policies and a rising level of awareness regarding this medical condition. The CDC’s June 2022 report indicates that around 96 million adults aged 18 and above in the United States have prediabetes, which accounts for 38.0% of the total adult population.

Moreover, the modern healthcare infrastructure and growing pharmaceutical industry in North America are crucial in facilitating the discovery, availability, and dissemination of drugs for gastroparesis. This resilient healthcare system enables prompt identification of illnesses, thorough provision of care to patients, and enhanced availability of medical interventions.

Europe is anticipated to exhibit a CAGR of 4.7% over the forecast period. Europe is expected to experience significant growth in the forecast period due to the prevalence of gastroparesis and the rapid development of drug-delivery methods in the region. These methods include innovative drug delivery systems and controlled-release formulations, which provide a more convenient and effective treatment alternative. Furthermore, the significant emphasis placed by enterprises on patient-centric care and enhancing the quality of life for gastroparesis patients is expected to contribute positively to the region's growth.

The Asia-Pacific gastroparesis drugs market is experiencing a significant increase due to various influential factors. The increasing incidence of diabetes, an important predisposing factor for gastroparesis, in countries such as India and China is driving the need for efficient therapies. Moreover, the growing prevalence of Western diets and lifestyle practices, which result in obesity and metabolic problems, also contribute to the expanding number of patients.

Moreover, enhancements in healthcare infrastructure and the availability of medical services in nations around the area enable more accurate diagnosis and effective treatment of gastroparesis. Pharmaceutical companies acknowledge the unexplored market opportunity and allocate resources to research and develop innovative therapies for the Asian population. Furthermore, the increasing knowledge among medical practitioners and individuals on the ailment and its treatment is fueling the need for gastroparesis medications. Hence, these factors propelled the regional market growth.

Segmental Analysis

The global gastroparesis drugs market is segmented based on drug class, disease type, and end-use.

Based on drug class, the market is segmented into Antiemetic Agents, Prokinetic Agents, and Botulinum Toxin Injections.

The prokinetic agents segment dominated the market in 2023. Prokinetic medicines are a class of medications that enhance the contractions of the stomach muscles, hence improving gastric motility. They are commonly recommended to people suffering from gastroparesis, a condition that leads to symptoms such as nausea and vomiting while impeding digestion. Prokinetic medicines are essential in treating gastroparesis because they effectively target the root cause of the illness. Aside from their use in treating gastroparesis, these medications have also been examined for their efficacy and safety in critically ill patients receiving enteral nourishment. The studies have demonstrated favorable outcomes in lowering feeding intolerance in these patients.

Based on disease type, the market is segmented into Diabetic Gastroparesis, Post-Surgical Gastroparesis, Idiopathic Gastroparesis, and Other Disease Types.

The diabetic gastroparesis segment held the largest share in 2023. The increase can be ascribed to the widespread occurrence of diabetes globally. Diabetic gastroparesis is a form of gastroparesis that arises as a consequence of diabetes, having a more pronounced impact on patients with diabetes. The Institute for Health Metrics and Evaluation (IHME) has announced a rise in worldwide diabetes diagnoses, projected to escalate from 529 million to 1.3 billion by 2050. Currently, diabetes has a worldwide prevalence rate of 6.1%, making it one of the top 10 leading causes of death and disability.

Additionally, an increase in the prevalence of diabetes can result in the development of diabetic gastroparesis. Pharmaceutical companies and researchers are currently prioritizing the development of medications that specifically target this form of gastroparesis, further contributing to the expansion of the diabetic gastroparesis segment in the market. In April 2022, Processa Pharmaceuticals commenced its Phase 2A trial for PCS12852, a promising therapeutic candidate for gastroparesis.

Postoperative gastroparesis, which is defined as a delay in the emptying of the stomach after abdominal surgery, presents considerable clinical difficulty. Postoperative gastroparesis, sometimes linked to treatments involving manipulation of the stomach or other organs, can result in extended hospital admissions, nutritional deficits, and reduced quality of life. The cause of this condition is either the interruption of neuronal connections or injury to the stomach muscles. Management generally entails conservative interventions, such as dietary adjustments and the use of prokinetic medications. If the condition is severe, surgical procedures like pyloroplasty may be considered. Prompt identification and care are crucial in minimizing complications and maximizing patient outcomes in cases of post-surgical gastroparesis.

The market is segmented into Hospitals, Clinics, and Pharmacies based on end users.

The hospital segment dominated the market in 2023. Hospitals possess the essential resources and medical proficiency to manage gastroparesis patients' intricate and diverse requirements, encompassing extreme instances that may necessitate surgical or specialized treatment. The comprehensive strategy and capacity to provide synchronized healthcare contribute to the hospital sector’s popularity.

The pharmacies segment is the fastest growing. The growth of the segment can be attributed to the convenient availability of pharmacies for patients buying gastroparesis pharmaceuticals and other relevant treatment medications, the ongoing expansion of retail pharmacy chains, and their emphasis on establishing an online presence.

Recent Developments

• December 2023 – Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced that the FDA has accepted the filing of Vanda’s New Drug Application (NDA) for precipitant. Tradipitant is intended to be used for treating symptoms of gastroparesis.
• March 2024 – Renexxion Ireland Limited (Renexxion), a private biopharmaceutical company focused on developing groundbreaking medications for patients suffering from gastrointestinal (GI) disorders, and its European partner, Dr. Falk Pharma GmbH (Dr. Falk Pharma), is pleased to announce that FDA has granted clearance for the Investigational New Drug (IND) application for naronapride, a treatment for patients with gastroparesis.