Post-Bariatric Hypoglycemia (PBH) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Post-Bariatric Hypoglycemia (PBH) Market Outlook

Thelansis’s “Post-Bariatric Hypoglycemia (PBH) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Post-Bariatric Hypoglycemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Post-Bariatric Hypoglycemia (PBH) Overview

Post-bariatric hypoglycemia (PBH) is when patients undergoing various bariatric procedures experience low blood glucose levels following meals. PBH is recognized as a metabolic complication associated with different types of bariatric surgery (BS). While BS is currently considered the most effective and relatively safe treatment for obesity and its related complications, the development of PBH can significantly impact patients' quality of life. PBH is characterized by postprandial hypoglycemic symptoms, typically occurring between one and four hours after a meal, with a higher frequency observed one-year post-surgery. These symptoms are accompanied by low blood glucose levels, often confirmed through provocative testing. The prevalence of PBH varies depending on the diagnostic tools employed. Recent studies have reported prevalence rates of up to 88% using a mixed meal tolerance test (MMTT) and up to 75% using continuous glucose monitoring (CGM). PBH can present with a range of autonomic symptoms, such as tremors, palpitations, and anxiety, as well as neuroglycopenic symptoms, including dizziness, confusion, and even loss of consciousness. However, a significant proportion of PBH patients remain asymptomatic, complicating the diagnosis of this condition. Although the long-term effects of asymptomatic PBH are currently unknown, individuals with symptomatic PBH are known to experience a reduced quality of life as assessed through questionnaires. The diagnosis of PBH is challenging for several reasons. Firstly, PBH, often referred to as "late dumping syndrome," must be distinguished from "early dumping syndrome," which typically occurs within the first 30 minutes after a meal and the first few months post-surgery. Early dumping syndrome is caused by the rapid passage of nutrients into the small intestine, where the bolus's hyperosmolarity triggers a fluid shift from the intravascular component to the intestinal lumen. This leads to gastrointestinal symptoms such as abdominal pain, bloating, increased bowel sounds, nausea, diarrhea, and vasomotor symptoms, including fatigue, flushing, palpitations, tachycardia, hypotension, and, rarely, syncope. The diagnosis of PBH is further complicated by the unique glycemic variability observed in patients who have undergone Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). This variability is characterized by earlier blood glucose peaks and lower nadirs, presenting a challenge for the biochemical diagnosis of PBH during standardized dynamic testing. Nutritional therapy is generally considered the cornerstone of PBH treatment. Nutritional therapy aims to prevent initial postprandial glycemic peaks by restricting carbohydrate intake, avoiding high glycemic index (GI) foods and simple sugars, increasing meal frequency, and reducing meal size. High GI foods provoke greater insulin peaks and pose a higher risk of PBH. Despite the empirical recommendation of low GI foods for treating PBH, these dietary modifications are essential for managing the condition effectively.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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