Post-Bariatric Hypoglycemia Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights:

• Bariatric surgery, or weight loss surgery, is a group of surgical procedures aimed at aiding individuals with severe obesity achieve significant and sustained weight reduction. These surgeries are typically recommended for individuals unsuccessful in achieving weight loss through nonsurgical methods, such as diet and exercise, and who have obesity-related health conditions.
• Postbariatric hypoglycemia is the development of hypoglycemia (low blood sugar) following bariatric surgery, such as gastric bypass or sleeve gastrectomy. It typically occurs within a few years after surgery.
• Diagnosis of postbariatric hypoglycemia involves a combination of clinical evaluation, medical history review, blood glucose monitoring, and ruling out other potential causes of hypoglycemia. Additional tests such as mixed meal tolerance tests, continuous glucose monitoring, and pancreatic imaging may be utilized to aid in diagnosis.
• The management of postbariatric hypoglycemia involves dietary modifications, pharmacotherapy, and surgical management. Medications, including acarbose, diazoxide, or glucagon-like peptide-1 (GLP-1) receptor agonists, may be prescribed to help control blood sugar levels. In severe cases, surgical interventions, such as partial or complete reversal of the bariatric surgery, may be considered.
• Regarding the epidemiology of postbariatric hypoglycemia, in 2022, it was found that the United States accounted for ~79% of the total cases of postbariatric hypoglycemia in the 7MM.
• The market size captured by the United States was the largest among the 7MM countries. In 2022, it was found that the United States accounted for ~89% of the total market size captured by the 7MM region.
• Currently, there exists a lack of widely accepted diagnostic criteria specifically tailored for postbariatric hypoglycemia. The absence of standardized criteria makes it difficult to compare research findings, establish prevalence rates, and develop consistent treatment approaches.
• The management of postbariatric hypoglycemia comprises off-label therapies. These medications may help stabilize blood sugar levels and reduce the frequency and severity of hypoglycemic episodes. However, the effectiveness of these strategies varies among individuals, and a personalized approach is needed. Hence, it is necessary to identify more targeted and effective therapies for treating postbariatric hypoglycemia.

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 postbariatric hypoglycemia market, providing an in-depth examination of its historical and projected market size (2019-2032). 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 postbariatric hypoglycemia market.

The table given below further depicts the key segments provided in the report:

Study Period 2019-2032

Forecast Period 2023-2032

Geographies Covered US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan

Epidemiology Segmented by:

• Region
• By Type of Bariatric Surgery
• By PBH cases in different Types of Bariatric Surgery
• By Severity

Market Segmented by:

• Region
• Therapies

Market Analysis * KOL Views

• SWOT Analysis
• Unmet Needs

Market

Various key players are leading the treatment landscape of postbariatric hypoglycemia, such as Vogenx and Eiger Biopharmaceuticals. The details of the country-wise and therapy-wise market size have been provided below.

• In 2022, the United States accounted for the largest market size among the 7MM countries, making ~89% of the total market size of the 7MM.
• Among the 7MM countries, Spain had the market size in 2022, accounting for ~1% of the market size in the 7MM region.
• In EU4 and the UK region, France accounted for the largest market size, making up ~6% of the total market size of the EU4 region.

Market Share 2022 Market Size (in USD million)

US 88.79%

EU4 and the UK 11.08%

JP 0.12%

Postbariatric Hypoglycemia Drug Chapters

The section dedicated to drugs in the postbariatric hypoglycemia report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to postbariatric hypoglycemia.

The drug chapters section provides valuable information on various aspects related to clinical trials of postbariatric hypoglycemia, 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 postbariatric hypoglycemia.

Emerging Therapies

Mizagliflozin: Vogenx

Mizagliflozin is an orally administered and minimally absorbed inhibitor of Sodium-glucose transporter 1 (SGLT1). Postbariatric Hypoglycemia patients have elevated SGLT1 levels in the gut. This elevated blood glucose stimulates uncontrolled insulin secretion in postbariatric hypoglycemia patients. The drug is being investigated in Phase II clinical development for treating postbariatric hypoglycemia.

AVEXITIDE (exendin 9-39): Eiger BioPharmaceuticals

AVEXITIDE (exendin 9-39) is a 31-amino acid peptide that selectively targets and blocks GLP-1 receptors, reducing dysregulated insulin secretion by the pancreas and reducing fasting and postprandial hypoglycemia. The drug has been granted breakthrough designation for the treatment of postbariatric hypoglycemia. The company received concurrence for conducting Phase III from the US FDA and EMA to treat postbariatric hypoglycemia.

Therapy Name Company Indication Approval Year

Mizagliflozin Vogenx Postbariatric Hypoglycemia 2027

AVEXITIDE Eiger BioPharmaceuticals Postbariatric Hypoglycemia 2026

Note: Detailed assessment will be provided in the final report of Postbariatric Hypoglycemia…

Postbariatric Hypoglycemia Market Outlook

Hypoglycemia is a bariatric surgery complication following roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (SG). PBH often develops 1-3 h after meals, with increasing severity after consuming carbohydrates with a high glycemic index. Although medications are often required, medical nutrition therapy remains the key cornerstone for successfully preventing hypoglycemia in patients with PBH.

Medical, nutritional therapy is the first line of treatment for PBH. A strategy of consuming small portions of low glycemic index carbohydrates, adequate protein consumption, adequate fat consumption, spacing meals 3-4 h apart, avoiding alcohol, caffeine, and fluids with meals is recommended. Avoiding high glycemic index foods is essential because a sudden rise in glucose can trigger more insulin release after meals and contribute to significant postprandial hypoglycemia.

Pharmacotherapy may be considered for individuals with moderate-to-severe symptoms refractory to nutritional therapy. Acarbose, an alpha-glucosidase inhibitor, delays the digestion of carbohydrates and may help decrease postprandial glucose level spikes. Diazoxide acts via ATP-sensitive potassium channels to inhibit the secretion of insulin. Somatostatin analogs such as octreotide slow gastric and small bowel transit of ingested material and affect the release of hormones, insulin, and vasculature tone. Calcium channel blockers work via calcium channels on beta cells to affect insulin secretion. Surgical management may be considered for patients with moderate-to-severe symptoms refractory to nutritional therapy and pharmacotherapy. Due to high morbidity and relapse, surgeries are not recommended or widely accepted.

Overall, the market presents a wide opportunity for the players to capitalize on the untapped market. However, continuous efforts are further needed to develop drugs for postbariatric hypoglycemia. As the entire landscape consists of nutritional and off-label therapies, any significant development in this direction is expected to create a tectonic impact on the existing market scenario during the forecast period (2023-2032).

Postbariatric Hypoglycemia Disease Understanding and Treatment

Postbariatric Hypoglycemia overview

Postbariatric hypoglycemia is the development of hypoglycemia (low blood sugar) following bariatric surgery, such as gastric bypass or sleeve gastrectomy. It typically occurs within a few years after surgery. Several risk factors contribute to postbariatric hypoglycemia, including rapid weight loss, altered gastrointestinal anatomy, increased insulin sensitivity, hyperinsulinemia, and reactive hypoglycemia. Common symptoms of postbariatric hypoglycemia include weakness, sweating, palpitations, anxiety, confusion, lightheadedness, and in severe cases, loss of consciousness or seizures. These symptoms typically occur in the fasting state or after meals.

Postbariatric Hypoglycemia diagnosis

Currently, a lack of widely accepted diagnostic criteria specifically tailored for postbariatric hypoglycemia gives rise to challenges in accurately identifying and diagnosing the condition. Diagnosis of postbariatric hypoglycemia involves a combination of clinical evaluation, medical history review, blood glucose monitoring, and ruling out other potential causes of hypoglycemia. Additional tests such as mixed meal tolerance tests, continuous glucose monitoring, and pancreatic imaging may be utilized to aid in diagnosis. Given the challenges in diagnosing postbariatric hypoglycemia, conducting a thorough clinical evaluation is important. Further, research and collaboration are required to develop diagnostic criteria for postbariatric hypoglycemia.

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

Postbariatric Hypoglycemia treatment

Conventional treatment approaches, including medical nutrition therapy, acarbose, diazoxide, and octreotide, were either ineffective or limited by poor tolerance. The management involves dietary modifications, such as consuming small and frequent meals, avoiding high-glycemic index foods, and restricting simple sugars. Medications, including acarbose, diazoxide, or glucagon-like peptide-1 (GLP-1) receptor agonists, may be prescribed to help control blood sugar levels. In severe cases, surgical interventions, such as partial or complete reversal of the bariatric surgery, may be considered. Nifedipine and verapamil were used adjunctively with dietary modification, resulting in the resolution of symptomatic hypoglycemic episodes. These agents are therapeutic options for some patients refractory to more traditional treatments. Surgery is the last option for severe cases of postbariatric hypoglycemia, as no treatment distinction exists for the severity-specific patient pool. Moreover, surgeries such as pancreatectomy are not recommended due to high morbidity and relapse rate.

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

Postbariatric Hypoglycemia Epidemiology

The Postbariatric Hypoglycemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Type-Specific Bariatric Surgery Cases, Total Postbariatric Hypoglycemia (PBH) Cases, Postbariatric Hypoglycemia (PBH) Cases in different types of Bariatric Surgeries, Severity-specific Postbariatric Hypoglycemia (PBH) Cases, and Total Treated Cases of Postbariatric Hypoglycemia (PBH) in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

• In 2022, the total postbariatric hypoglycemia (PBH) cases in the United States were ~82,000, projected to increase during the forecast period (2023-2032).
• The total postbariatric hypoglycemia (PBH) cases in EU4 and the UK were ~21,000 in 2022. The cases will increase during the forecast period (2023-2032).
• The total number of postbariatric hypoglycemia (PBH) cases in Japan were ~200 in 2022.

Segment Region Cases in 2022 (% out of total cases in the 7MM)

Total Postbariatric Hypoglycemia (PBH) Cases US 79.33%

EU4 and the UK 20.44%

JP 0.22%

Further details related to epidemiology will be provided in the report…

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 postbariatric hypoglycemia, 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 the Harvard Medical School, King's College London, the University of Colorado School of Medicine, and 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 postbariatric hypoglycemia market, which will assist our clients in analyzing the overall epidemiology and market scenario.

The opinion of experts from various regions has been provided below:

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 postbariatric hypoglycemia, one of the most important primary endpoints was the occurrence of adverse events, Glucose nadir. Based on these, 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, the final weightage score and the ranking of the emerging therapies are decided.

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.

Postbariatric Hypoglycemia Report Insights

• Patient Population
• Therapeutic Approaches
• Postbariatric Hypoglycemia Market Size and Trends
• Existing Market Opportunity

Postbariatric Hypoglycemia Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Postbariatric Hypoglycemia Epidemiology Segmentation
• Key Cross Competition

Postbariatric Hypoglycemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis)

Key Questions

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in postbariatric hypoglycemia management recommendations?
• Would research and development advances pave the way for future tests and therapies for postbariatric hypoglycemia?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of postbariatric hypoglycemia?
• What kind of uptake will the new therapies witness in coming years in postbariatric hypoglycemia patients?