DIABETIC GASTROPARESIS TREATMENT MARKET ANALYSIS
Diabetic gastroparesis is delayed gastric emptying associated with diabetes. The condition occurs in patients suffering from both type-1 and type- 2 diabetes and is more common in female patients suffering from type-2 diabetes. The disease involves delayed emptying of the stomach leading to a series of symptoms such as nausea, vomiting, abdominal bloating, abdominal pain, weight loss, gastroesophageal reflux, spasms of the stomach wall, and heartburn.
The global diabetic gastroparesis treatment market is estimated to account for US$ 3,069.8 Mn in terms of value in 2018 and is expected to reach US$ 4,252.2 Mn by the end of 2027.
Global Diabetic Gastroparesis Treatment Market: Drivers
Increasing prevalence of diabetes is expected to propel growth of the global diabetic gastroparesis treatment market over the forecast period. For instance, according to the study, ‘Global Prevalence of Type 2 Diabetes over the Next Ten Years (2018-2028)’, published by the American Diabetes Association, 500 million people worldwide suffered from type 2 diabetes in 2018.
Moreover, easy access to off-label medicines without prescriptions is expected to boost growth of the market. Medications such as anti-emetic drugs (oandesteron) are affordable and easily accessible in emerging economies. Moreover, increasing inclination towards OTC medicines to avoid higher expenses is also leading to greater disbursement of drugs through retail pharmacies and drugstores.
North America region held dominant position in the global diabetic gastroparesis treatment market in 2018, accounting for 38.5% share in terms of value, followed by Europe.
Global Diabetic Gastroparesis Treatment Market: Restraints
Lack of clinical evidence on improvement offered by prescription drugs is expected to hinder growth of the global diabetic gastroparesis treatment market. There is very little documented clinical evidence provided for prescription drugs for the treatment of diabetic gastroparesis. Metoclopramide, domperidon, and erythromycin are used for the treatment of diabetic gastroparesis. However, approvals of these drugs are inconsistent across countries, leading to lack of availability of consistent patient improvement data due to administration of these drugs. In emerging economies, the disease remains largely untreated or often treated through non-prescription OTC drugs, which again is responsible for dearth of clinical evidence regarding improvement in quality of life for patients after consuming these drugs for the treatment of diabetic gastroparesis.
Moreover, withdrawal/termination of clinical trials is also expected to hamper growth of the market. There are very few drugs in the pipeline, which have the potential for the treatment of diabetic gastroparesis. This is due to early termination of clinical trials or failure of drugs to meet statistically significant endpoints. For instance, in August 2018, Dartmouth-Hitchcock Medical Center terminated the randomized, double-blind, placebo-controlled trial of promethazine for treatment of diabetic gastroparesis, conducted in collaboration with American College of Gastroenterology, due to lack of recruitment.
Global Diabetic Gastroparesis Treatment Market: Opportunities
Measures to support product approval and labeling claims for diabetic gastroparesis treatments is expected to offer lucrative growth opportunities for players in the global diabetic gastroparesis treatment market. For instance, in February 2019, a team of researchers affiliated with Boston Therapeutics, Inc. reported that The Diabetic Gastroparesis Symptom Severity Diary can be a reliable and valid measure that can be used to derive endpoints to evaluate treatment benefit in future diabetic gastroparesis interventional trials.
Moreover, initiatives of regulatory bodies to issue guidance for development of drugs for the treatment of diabetic gastroparesis is also expected to aid in growth of the market. For instance, in August 2019, the U.S. FDA issued guidance that addresses FDA’s current recommendations regarding clinical trial designs and clinical endpoint assessments to support the development of drugs for the treatment of idiopathic and diabetic gastroparesis.
Drugs segment in the global diabetic gastroparesis treatment market was valued at US$ 1,924.5 Mn in 2018 and is expected to reach US$ 2,646.8 Mn by 2027 at a CAGR of 3.6% during the forecast period.
Market Trends/Key Takeaways
The market is witnessing R&D in non-invasive approaches for the treatment of diabetic gastroparesis. For instance, a pilot study presented at the 2019 annual meeting of the North American Neuromodulation Society assessed the effectiveness of the gammaCore hand-held vagal nerve stimulator for the treatment of gastroparesis.
Gastric Per-Oral Endoscopic Pyloromyotomy (GPOEM) is a safe and effective therapy for refractory gastroparesis. For instance, researchers from Emory University (U.S) assessed the safety and efficacy of GPOEM and compared clinical outcomes between diabetic and non-diabetic cohorts and found that patients with predominant nausea/vomiting and short duration of diabetic gastroparesis may opt for GPOEM.
Regulations
U.S.
ICD-10-CM
- Reimbursement claims with a date of service on or after Oct 1, 2015 require the use of ICD-10-CM codes
- This is the American ICD-10-CM version of K31.84. Other international ICD-10 versions may differ
- 61 (diabetes with neurological manifestations)
- 3 (gastroparesis)
- 43 (Type 1 diabetes mellitus with diabetic autonomic [poly]neuropathy)
ICD-9-CM
- Diabetes type 1 with gastroparesis
- Diabetes type 2 with gastroparesis
- Diabetic gastroparesis
- Diabetic gastroparesis associated with type 1 diabetes mellitus
- diabetic gastroparesis associated with type 2 diabetes mellitus
- DM 1 w diabetic gastroparesis
- DM 2 W diabetic gastroparesis
- Gastroparesis due to diabetes
- Gastroparesis due to DM
- Gastroparesis syndrome
- 3 is a billable medical code that can be used to indicate a diagnosis on a reimbursement claim
- gastrica 536.8
- neurogenic 536.3
- psychogenic 306.4
- dyspepsia 536.3
- psychogenic 306.4
- stomach 536.3
- neurotic or psychogenic 306.4
- psychogenic 306.4
- Diabetic gastroparesis drugs are eligible for reimbursement in in-patient hospitalization cases, when there a proven medical necessity
- Diabetic gastroparesis treatment devices are medically necessary as these are used in severe cases of refractory gastroparesis. These are eligible for reimbursement from both public and private payers in the U.S.
Global Diabetic Gastroparesis Treatment Market[PM1] : Key Developments
Major players operating in the global diabetic gastroparesis treatment market include, Janssen Global Services, LLC, Cardinal Health, Inc., Evoke Pharma, Inc., Salix Pharmaceuticals, Inc., Alfa Wassermann SPA, Abbott Laboratories, Medtronic Plc., C. R. Bard, Inc. (Becton, Dickinson and Company), Rhythm Pharmaceuticals, Inc., Boston Scientific Corporation, Kimberly-Clark Corporation, Vanda Pharmaceuticals, Inc., and Allergan, plc.
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Global Diabetic Gastroparesis Treatment Market: Key Developments
Major players in the market are focused on approval and launch of new products to expand their product portfolio. For instance, in January 2020, Evoke Pharma, Inc., a developer of drugs for the treatment of gastrointestinal disorders and diseases, announced that the U.S. FDA accepted the company’s resubmission of its 505(b)(2) New Drug Application (NDA) for Gimoti, a nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Major players in the market are also focused on conducting clinical trials to expand their product portfolio. For instance, in December 2018, Vanda Pharmaceuticals, Inc. announced that tradipitant met the primary endpoint in a Phase II clinical study in patients with idiopathic and diabetic gastroparesis.
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