胃不全麻痺市場 - 市場の洞察、疫学、市場予測：2034年

胃不全麻痺は、胃の機械的閉塞がないにもかかわらず、固形食の胃排出が遅延し、早期満腹感、食後満腹感、悪心、嘔吐、腹鳴、腹部膨満感などの主症状を来す消化器疾患です。

胃不全麻痺は、特発性の場合もあれば、糖尿病に伴う場合もあり、医学的介入（異所性または外科的後遺症）の後に起こる場合もあり、神経学的障害の後に起こる場合もあります。また、サルモネラ胃腸炎などのウイルスまたは細菌感染の後に起こることもあります。

胃不全麻痺の診断は、胃排出遅延確認試験を行うことで行うことができます。胃運動検査で測定される胃排出率は、一般に胃不全麻痺患者の症状やQOLとの相関が低いです。その他の検査としては、シンチグラフィー、ワイヤレス運動性カプセル（WMC）、呼気炭素検査などがあります。

EU4ヶ国と英国の中で、2023年のGPLS有病者数はイタリアが最も多く、ドイツ、フランスがこれに続きます。胃不全麻痺は主に女性が罹患する疾患であり、診断された患者の68.5％が女性であるのに対し、男性は31.5％に過ぎません。

胃不全麻痺の治療は、病気の症状の重症度に基づいて行われます。糖尿病が胃不全麻痺に関連している場合は、血糖値をコントロールすることで治療を行う。胃不全麻痺の治療には、主に食事療法などの非薬理学的手段と、胃排出を促進する薬（催吐薬）、嘔吐を抑える薬（制吐薬）、痛みや腸の痙攣を抑える薬、手術などの薬理学的手段があります。

主要7ヶ国の中で、2023年のGPLS有病者数は米国が最も多いです。これらの症例は2034年までにCAGR 0.7％で増加すると予測されます。EU4ヶ国と英国では、胃不全麻痺の原因別症例数は糖尿病が最も多いことがわかっています。2023年には、T1DMで約20,000例、T2DMで約20万例が観察されました。英国では、2023年の胃不全麻痺の総治療症例数は約30,000例でした。これらの数は2034年までに増加すると予想されています。

当レポートでは、主要6ヶ国における胃不全麻痺市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 レポートのイントロダクション

第3章 胃不全麻痺のエグゼクティブサマリー

第4章 胃不全麻痺市場概要

• 市場シェア（%）2020年の主要6ヶ国における胃不全麻痺の分布、治療法別
• 市場シェア（%）2034年の主要6ヶ国における胃不全麻痺の分布、治療法別

第5章 主要な出来事

第6章 疫学と市場予測調査手法

第7章 疾患の背景と概要

• イントロダクション
• 胃不全麻痺の種類：原因別
• 胃不全麻痺の兆候と症状
• 胃不全麻痺の病態生理学
• 胃不全麻痺の病因
• 胃不全麻痺の診断
• 胃不全麻痺の治療と管理

第8章 疫学と患者数

• 主な調査結果
• 前提と根拠
• 主要6ヶ国でのGPLSの蔓延事例
• 主要6ヶ国で胃不全麻痺が蔓延していると診断された症例
• 米国
• EU4ヶ国と英国

第9章 患者動向

第10章 上市済み治療法

第11章 新しい治療法

第12章 胃不全麻痺：主要6ヶ国市場分析

• 主な調査結果
• 市場の見通し
• コンジョイント分析
• 主要な市場予測の前提条件
• 主要6ヶ国における胃不全麻痺の総市場規模
• 主要6ヶ国における胃不全麻痺の治療法別市場規模
• 米国の市場規模
• EU4ヶ国と英国の市場規模

第13章 アンメットニーズ

第14章 SWOT分析

第15章 KOLの見解

第16章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 胃不全麻痺における償還シナリオ

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Gastroparesis Market and Epidemiology (2020-2034)
• Table 2: Pathogenesis and Etiology of Gastroparesis
• Table 3: Aetilogy of Gastroparesis
• Table 4: Differential Diagnosis of Gastroparesis
• Table 5: Pharmacological Treatment Options for the Management of Diabetic Gastroparesis
• Table 6: Pharmacological Treatment Options for the Management of Gastroparesis
• Table 7: Prevalent Cases of GPLS in the 7MM, in thousand (2020-2034)
• Table 8: Diagnosed Prevalent Cases of Gastroparesis in the 7MM, in thousand (2020-2034)
• Table 9: Prevalent Cases of GPLS in the United States, in thousand (2020-2034)
• Table 10: Diagnosed Prevalent Cases of Gastroparesis in the United States, in thousand (2020-2034)
• Table 11: Cause-specific Cases of Gastroparesis in the United States, in thousand (2020-2034)
• Table 12: Age-specific Cases of Gastroparesis in the United States, in thousand (2020-2034)
• Table 13: Gender-specific Cases of Gastroparesis in the United States, in thousand (2020-2034)
• Table 14: Treated Cases of Gastroparesis in the United States, in thousand (2020-2034)
• Table 15: Prevalent Cases of GPLS in EU4 and the UK, in thousand (2020-2034)
• Table 16: Diagnosed Prevalent Cases of Gastroparesis in EU4 and the UK, in thousand (2020-2034)
• Table 17: Cause-specific Cases of Gastroparesis in EU4 and the UK, in thousand (2020-2034)
• Table 18: Age-specific Cases of Gastroparesis in EU4 and the UK, in thousand (2020-2034)
• Table 19: Gender-specific Cases of Gastroparesis in EU4 and the UK, in thousand (2020-2034)
• Table 20: Treated Cases of Gastroparesis in EU4 and the UK, in thousand (2020-2034)
• Table 21: Prevalent Cases of GPLS in Japan, in thousand (2020-2034)
• Table 22: Diagnosed Prevalent Cases of Gastroparesis in Japan, in thousand (2020-2034)
• Table 23: Cause-specific Cases of Gastroparesis in Japan, in thousand (2020-2034)
• Table 24: Age-specific Cases of Gastroparesis in Japan, in thousand (2020-2034)
• Table 25: Gender-specific Cases of Gastroparesis in Japan, in thousand (2020-2034)
• Table 26: Treated Cases of Gastroparesis in Japan, in thousand (2020-2034)
• Table 27: Comparison of Marketed Drugs
• Table 28: GIMOTI (metoclopramide), Clinical Trial Description, 2024
• Table 29: Comparison of Emerging Drugs
• Table 30: VLY-686 (tradipitant), Clinical Trial Description, 2024
• Table 31: PCS12852, Clinical Trial Description, 2024
• Table 32: NG101 (metopimazine), Clinical Trial Description, 2024
• Table 33: CIN-102 (deudomperidone), Clinical Trial Description, 2024
• Table 34: Conjoint Analysis
• Table 35: Key Market Forecast Assumption of Gastroparesis in the United States
• Table 36: Key Market Forecast Assumption of Gastroparesis in EU4 and the UK
• Table 37: Key Market Forecast Assumption of Gastroparesis in the Japan
• Table 38: Total Market Size of Gastroparesis in the 7MM, in USD million (2020-2034)
• Table 39: Market Size of Gastroparesis by Therapies in the 7MM, in USD million (2020-2034)
• Table 40: Total Market Size of Gastroparesis in the US, in USD million (2020-2034)
• Table 41: Market Size of Gastroparesis by Therapies in the US, in USD million (2020-2034)
• Table 42: Total Market Size of Gastroparesis in EU4 and the UK, in USD million (2020-2034)
• Table 43: Market Size of Gastroparesis by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 44: Total Market Size of Gastroparesis in Japan, in USD million (2020-2034)
• Table 45: Market Size of Gastroparesis by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Difference Between Normal Gastric Function and Gastroparesis
• Figure 2:Types of Gastroparesis Based on Causes
• Figure 3: Etiologies of Gastroparesis
• Figure 4: Symptoms of Gastroparesis
• Figure 5: Interaction of Interstitial Cells of Cajal (ICC) Cells and Neuronal Nitric Oxide Synthase (nNOS) Signaling for Normal Gastric Emptying
• Figure 6: Summary of the Effect of Neural Inputs on Gastric Emptying
• Figure 7: Diagnosis of Gastroparesis
• Figure 8: Diagnosis Algorithm of Gastroparesis
• Figure 9: Treatment Algorithm of Gastroparesis
• Figure 10: Treatment Algorithm of Diabetic Gastroparesis
• Figure 11: Prevalent Cases of GPLS in the 7MM (2020-2034)
• Figure 12: Diagnosed Prevalent Cases of Gastroparesis in the 7MM (2020-2034)
• Figure 13: Prevalent Cases of GPLS in the United States (2020-2034)
• Figure 14: Diagnosed Prevalent Cases of Gastroparesis in the United States (2020-2034)
• Figure 15: Cause-specific Cases of Gastroparesis in the United States (2020-2034)
• Figure 16: Age-specific Cases of Gastroparesis in the United States (2020-2034)
• Figure 17: Gender-specific Cases of Gastroparesis in the United States (2020-2034)
• Figure 18: Treated Cases of Gastroparesis in the United States (2020-2034)
• Figure 19: Prevalent Cases of GPLS in EU4 and the UK (2020-2034)
• Figure 20: Diagnosed Prevalent Cases of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 21: Cause-specific Cases of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 22: Age-specific Cases of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 23: Gender-specific Cases of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 24: Treated Cases of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 25: Prevalent Cases of GPLS in Japan (2020-2034)
• Figure 26: Diagnosed Prevalent Cases of Gastroparesis in Japan (2020-2034)
• Figure 27: Cause-specific Cases of Gastroparesis in Japan (2020-2034)
• Figure 28: Age-specific Cases of Gastroparesis in Japan (2020-2034)
• Figure 29: Gender-specific Cases of Gastroparesis in Japan (2020-2034)
• Figure 30: Treated Cases of Gastroparesis in Japan (2020-2034)
• Figure 31: Total Market Size of Gastroparesis in the 7MM (2020-2034)
• Figure 32: Market Size of Gastroparesis by Therapies in the 7MM (2020-2034)
• Figure 33: Total Market Size of Gastroparesis in the US (2020-2034)
• Figure 34: Market Size of Gastroparesis by Therapies in the US (2020-2034)
• Figure 35: Total Market Size of Gastroparesis in EU4 and the UK (2020-2034)
• Figure 36: Market Size of Gastroparesis by Therapies in EU4 and the UK (2020-2034)
• Figure 37: Total Market Size of Gastroparesis in Japan (2020-2034)
• Figure 38: Market Size of Gastroparesis by Therapies in Japan (2020-2034)
• Figure 39: Health Technology Assessment
• Figure 40: Reimbursement Process in Germany
• Figure 41: Reimbursement Process in France
• Figure 42: Reimbursement Process in Italy
• Figure 43: Reimbursement Process in Spain
• Figure 44: Reimbursement Process in the United Kingdom
• Figure 45: Reimbursement Process in Japan

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.

Note: Detailed assessment will be provided in the final report of gastroparesis.

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.

Further details are provided in the report.

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.

Further details are provided in the report.

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.

Further details related to country-based variations are provided in the report.

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.

Further details related to treatment and management are provided in the report.

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 at Delveinsight 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?

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Gastroparesis

4. Gastroparesis Market Overview at a Glance

• 4.1. Market Share by Therapies (%) Distribution of Gastroparesis in 2020 in the 6MM
• 4.2. Market Share by Therapies (%) Distribution of Gastroparesis in 2034 in the 6MM

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types of Gastroparesis: Based on Causes
  • 7.2.1. Idiopathic Gastroparesis
  • 7.2.2. Diabetic Gastroparesis (DGp)
  • 7.2.3. Iatrogenic and Postsurgical Gastroparesis
• 7.3. Signs and Symptoms of Gastroparesis
• 7.4. Pathophysiology of Gastroparesis
• 7.5. Aetiology of Gastroparesis
• 7.6. Diagnosis of Gastroparesis
  • 7.6.1. Differential Diagnosis of Gastroparesis
  • 7.6.2. Diagnosis Guidelines
    • 7.6.2.1. Consensus Guidelines for Diagnosis of Diabetic Gastroparesis
    • 7.6.2.2. Official Practice Recommendations of the American College of Gastroenterology (ACG) for Diagnosis of Gastroparesis
  • 7.6.3. Diagnosis Algorithm
• 7.7. Treatment and Management of Gastroparesis
  • 7.7.1. Dietary Modifications
  • 7.7.2. Pharmacological Treatment
  • 7.7.3. Pyloric Intervention
  • 7.7.4. Gastric Electrical Stimulation
  • 7.7.5. Treatment Guidelines
    • 7.7.5.1. Official Practice Recommendations of the American College of Gastroenterology (ACG) for Management and Treatment of Gastroparesis
    • 7.7.5.2. Consensus Guidelines for Management of Diabetic Gastroparesis
  • 7.7.6. Treatment Algorithm

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale
• 8.3. Prevalent Cases of GPLS in the 6MM
• 8.4. Diagnosed Prevalent Cases of Gastroparesis in the 6MM
• 8.5. The United States
  • 8.5.1. Prevalent Cases of GPLS in the United States
  • 8.5.2. Diagnosed Prevalent Cases of Gastroparesis in the United States
  • 8.5.3. Cause-specific Cases of Gastroparesis in the United States
  • 8.5.4. Age-specific Cases of Gastroparesis in the United States
  • 8.5.5. Gender-specific Cases of Gastroparesis in the United States
  • 8.5.6. Treated Cases of Gastroparesis in the United States
• 8.6. EU4 and the UK
  • 8.6.1. Prevalent Cases of GPLS in EU4 and the UK
  • 8.6.2. Diagnosed Prevalent Cases of Gastroparesis in EU4 and the UK
  • 8.6.3. Cause-specific Cases of Gastroparesis in EU4 and the UK
  • 8.6.4. Age-specific Cases of Gastroparesis in EU4 and the UK
  • 8.6.5. Gender-specific Cases of Gastroparesis in EU4 and the UK
  • 8.6.6. Treated Cases of Gastroparesis in EU4 and the UK

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross of Marketed Therapies
• 10.2. GIMOTI (metoclopramide) Nasal Spray: Evoke Pharma
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Developmental Activities
  • 10.2.4. Clinical Development
  • 10.2.5. Safety and Efficacy

11. Emerging Therapies

• 11.1. Key Cross of Emerging Therapies
• 11.2. VLY-686 (tradipitant): Vanda Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Other Developmental Activities
  • 11.2.3. Clinical Development
  • 11.2.4. Clinical Trial Information
  • 11.2.5. Safety and Efficacy
• 11.3. PCS12852: Processa Pharmaceuticals
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activities
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trial Information
  • 11.3.5. Safety and Efficacy
• 11.4. NG101 (metopimazine): Neurogastrx
  • 11.4.1. Product Description
  • 11.4.2. Other Developmental Activities
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trial Information
• 11.5. CIN-102 (deudomperidone): CinDome Pharma
  • 11.5.1. Product Description
  • 11.5.2. Other Developmental Activities
  • 11.5.3. Clinical Development
  • 11.5.4. Clinical Trial Information
  • 11.5.5. Safety and Efficacy

12. Gastroparesis: Six Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
• 12.5. Total Market Size of Gastroparesis in the 6MM
• 12.6. Market Size of Gastroparesis by Therapies in the 6MM
• 12.7. The United States Market Size
  • 12.7.1. Total Market Size of Gastroparesis in the United States
  • 12.7.2. Market Size of Gastroparesis by Therapies in the United States
• 12.8. EU4 and the UK Market Size
  • 12.8.1. Total Market Size of Gastroparesis in EU4 and the UK
  • 12.8.2. Market Size of Gastroparesis by Therapies in EU4 and the UK

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

• 16.1. United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Reimbursement Scenario in Gastroparesis
  • 16.3.1. Patient Access Programs

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight