肥満外科手術後低血糖症市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 2023年、米国は7大市場内の肥満外科手術後低血糖症市場規模全体の約90％を占めています。
• 肥満外科手術後低血糖症とは、胃バイパス術やスリーブ状胃切除術などの肥満手術後に低血糖（低血糖）が開発されることです。典型的には術後数年以内に発症します。
• 急速な体重減少、消化管解剖学的構造の変化、インスリン感受性の亢進、高インスリン血症、反応性低血糖など、いくつかの危険因子が肥満後低血糖の一因となります。
• 2023年、主要7ヶ国における肥満外科手術後低血糖症（PBH）の症例数は約10万例でした。主要7ヶ国中、米国が最も症例数が多く、次いでフランスでした。
• 肥満外科手術後低血糖症には、急速な体重減少、消化管解剖学的構造の変化、インスリン感受性の亢進、高インスリン血症、反応性低血糖症など、いくつかの危険因子が関与しています。
• 肥満手術は高度肥満に対する最も効果的な治療法であることが証明されており、肥満度および肥満に関連した併存疾患の有意な改善をもたらしています。米国では年間肥満手術件数が増加しており、肥満手術患者における低血糖症状の術後有病率も増加しています。
• 肥満外科手術後低血糖症の病態生理学は複雑であり、相互に関連するいくつかの機序が関与しています。低血糖は、肥満手術後の食物摂取に対する正常なホルモンおよび代謝反応の変化に起因すると考えられています。
• 肥満外科手術後低血糖症の診断には、臨床評価、病歴聴取、血糖モニタリング、および低血糖症の他の潜在的原因の除外の組み合わせが必要です。診断の補助として、混合食負荷試験、持続血糖モニタリング、膵画像診断などの追加検査が利用されます。
• 肥満外科手術後低血糖症の管理には、少量かつ頻回な食事の摂取、高グリセミック指数食品の回避、および単純糖の制限などの食事の修正が含まれます。肥満外科手術後低血糖症アカルボース、ジアゾキシド、グルカゴン様ペプチド-1（GLP-1）受容体作動薬などの薬物が、血糖値のコントロールを助けるために処方されることがあります。重症例では、肥満手術の部分的または完全な取り消しなどの外科的介入が考慮されます。
• 現在、肥満外科手術後低血糖症の治療薬としてFDA別承認されている治療薬はありません。しかし、肥満外科手術後低血糖症の治療法として研究されているものは少ない状況です。
• 開発に関与している主な肥満外科手術後低血糖症企業は、Vogenx（ミザグリフロジン）とEiger BioPharmaceuticals（アベキシチド）です。
• 2024年4月、Vogenxは、肥満外科手術後低血糖症と診断された患者を対象にミザグリフロジンを評価する第II相臨床試験VGX-001-012の最後の患者の投与を完了したと発表しました。

肥満外科手術後低血糖症市場レポートサマリー

• 当レポートでは、疫学セグメントと予測に関する広範な知識を提供し、診断率、疾患の進行、治療ガイドラインにおける将来の潜在的成長に関する深い理解を提示します。これらの側面に関する包括的な洞察を提供し、主題の徹底的な評価を可能にします。
• さらに、現在の管理技術や新たな治療法の包括的な説明や、現在の治療状況に影響を与え、全体的な市場シフトをもたらすであろう中期段階（第II相）および著名な治療法の詳細なプロファイルは、本レポートで提供されています。
• また、疾患の包括的な分析を包含し、肥満外科手術後低血糖症の市場規模（2020年～2034年）の過去と予測に関する詳細な検討を提供します。また、治療法の市場シェア、詳細な前提条件、調査手法の根拠も記載しています。この肥満外科手術後低血糖症市場レポートには、主要7ヶ国地域の薬剤アウトリーチも含まれています。
• 肥満外科手術後低血糖症市場レポートは、主要7ヶ国の肥満外科手術後低血糖症市場の形成と推進に役立つSWOT分析と様々な病院や著名大学の専門家を含む専門家の洞察/KOLの見解、患者の旅、治療の嗜好を通して動向を理解し、事業戦略を開拓する際に強みとなる定性的洞察を含んでいます。

肥満外科手術後低血糖症症は、ルクス-エン-Y胃バイパス術（RYGB）および垂直スリーブ胃切除術（SG）後に発生する、肥満術の合併症として認識されつつあります。反応性低血糖症および後期ダンピング症候群としても知られる肥満外科手術後低血糖症症は、食後のグルコース濃度の急上昇がインスリンの高分泌を刺激し、低血糖を引き起こす代謝性合併症です。

肥満外科手術後低血糖症の診断には、臨床評価、病歴の検討、血糖モニタリング、および低血糖症の他の潜在的原因の除外の組み合わせが必要です。診断の補助として、混合食負荷試験、持続血糖モニタリング、膵画像診断などの追加検査が利用されます。

第一選択治療としてアカルボースが使用されていますが、有害な消化器症状がこの選択肢を制限しています。ジアゾキシドおよびオクトレオチドも使用されており、その結果はまちまちですが、副作用および患者の非服薬性によりその有用性は制限されています。興味深いことに、外因性GLP-1受容体作動薬もPBHの改善を示しています。おそらく、低血糖状態において、B細胞からのインスリン分泌を抑制し、A細胞からのグルカゴン分泌を増加させることが原因とみられています。歴史的には、外科的治療として胃瘻造設術、胃バイパス術、膵遠位端切除術が推奨されてきました。CCB、ニフェジピン、またはベラパミルを使用して、栄養療法と外科療法の間の治療ギャップを埋めることは価値があります。

• 2023年、主要7ヶ国における肥満外科手術後低血糖症例の合計は約11万例と推定され、2034年までに増加します。
• 2023年には、米国が肥満外科手術後低血糖症例の約80％を占め、最も多いです。
• 2023年、米国ではスリーブ状胃切除術の症例で肥満後低血糖の症例が多く、次いでRoux-en-Y胃バイパス術の症例、その他の症例でした。
• 肥満後低血糖の重症度については、米国では2023年に軽度から中等度のカテゴリーに90％以上の症例となっています。
• 米国では、2023年に肥満外科手術後低血糖症の治療症例が5万例近くとなっています。

肥満外科手術後低血糖症市場

Vogenx、Eiger BioPharmaceuticalsなど、さまざまな主要企業が肥満外科手術後低血糖症（PBH）の治療状況をリードしています。国別および治療法別の市場規模の詳細は以下の通りです。

• 2023年、主要7ヶ国における肥満外科手術後低血糖症市場規模は約2億米ドルであり、肥満外科手術後低血糖症症例の増加と新しい治療法の発売により、2034年までに増加すると予測されます。
• 主要7ヶ国の中で、2023年の肥満外科手術後低血糖症市場規模は米国が最も大きく、次いでフランス、イタリアとなっています。
• 新興治療薬の中では、Eiger BioPharmaceuticalsのAVEXITIDEが予測期間（2024年～2034年）中に最も高い肥満外科手術後低血糖症市場規模を獲得すると予想されます。

当レポートでは、主要7ヶ国における肥満外科手術後低血糖症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 報告書のイントロダクション

第3章 肥満後低血糖（PBH）市場概要

• 2020年の肥満後低血糖（PBH）の国別市場シェア（％）分布
• 2034年の肥満後低血糖（PBH）の国別市場シェア（％）分布
• 2020年の肥満後低血糖（PBH）の治療薬クラス別市場シェア（％）分布
• 2034年の肥満後低血糖（PBH）の治療薬クラス別市場シェア（％）分布

第4章 肥満治療後低血糖症のエグゼクティブサマリー

第5章 疾患の背景と概要

• イントロダクション
• 胃バイパス手術後の低血糖
• PBHの病因
• 低血糖の危険因子
• PBHの病態生理学
• 診断評価
• 鑑別診断
• 診断ガイドライン

第6章 調査手法

第7章 肥満外科手術後低血糖症の疫学と患者人口

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国における肥満後低血糖（PBH）症例の総数
• 米国
• EU4ヶ国と英国
• 日本

第8章 肥満外科手術後低血糖症の患者動向

第9章 肥満外科手術後低血糖症治療の新たな展開

• キークロス
• ミザグリフロジン：Vogenx
• アベキシタイド（エキセンディン9-39）：Eiger BioPharmaceuticals

第10章 肥満後低血糖（PBH）市場：主要7ヶ国市場分析

• 主な調査結果
• 肥満治療後低血糖市場の展望
• 肥満治療後低血糖市場予測の前提条件
• コンジョイント分析
• 主要7ヶ国における肥満治療後低血糖症市場規模
• 肥満治療後低血糖市場規模（主要7ヶ国）
• 米国：肥満治療後低血糖市場規模
• EU4ヶ国および英国：肥満外科手術後低血糖症市場規模
• 日本：肥満外科手術後低血糖症市場規模

第11章 KOLの見解

第12章 肥満外科手術後低血糖症のSWOT分析

第13章 肥満外科手術後低血糖症のアンメットニーズ

第14章 肥満外科手術後低血糖症：市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第15章 付録

第16章 DelveInsightのサービス内容

第17章 免責事項

List of Tables

• Table 1: Summary of Postbariatric Hypoglycemia, Market and Epidemiology (2020-2034)
• Table 2: Summarized Diagnostic Evaluation for Differentiating Etiologies of Hypoglycemia
• Table 3: Total Postbariatric Hypoglycemia (PBH) Cases in the 7MM (2020-2034)
• Table 4: Type-specific Bariatric Surgery Cases in the United States (2020-2034)
• Table 5: Total Postbariatric Hypoglycemia (PBH) Cases in the United States (2020-2034)
• Table 6: Postbariatric Hypoglycemia (PBH) Cases in Types of Bariatric Surgeries in the United States (2020-2034)
• Table 7: Severity-specific Postbariatric Hypoglycemia (PBH) Cases in the United States (2020-2034)
• Table 8: Total Treated cases of Postbariatric Hypoglycemia (PBH) in the United States (2019-2032)
• Table 9: Type-specific Bariatric Surgery Cases in EU4 and the UK (2020-2034)
• Table 10: Total Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK (2020-2034)
• Table 11: Postbariatric Hypoglycemia (PBH) Cases in Types of Bariatric Surgeries in EU4 and the UK (2020-2034)
• Table 12: Severity-specific Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK (2020-2034)
• Table 13: Total Treated Cases of Postbariatric Hypoglycemia (PBH) in EU4 and the UK (2020-2034)
• Table 14: Type-specific Bariatric Surgery Cases in Japan (2020-2034)
• Table 15: Total Postbariatric Hypoglycemia (PBH) Cases in Japan (2020-2034)
• Table 16: Postbariatric Hypoglycemia (PBH) Cases in Types of Bariatric Surgeries in Japan (2020-2034)
• Table 17: Severity-specific Postbariatric Hypoglycemia (PBH) Cases in Japan (2020-2034)
• Table 18: Total Treated Cases of Postbariatric Hypoglycemia (PBH) in Japan (2019-2032)
• Table 19: Comparison of Emerging Drugs
• Table 20: Mizagliflozin, Clinical Trial Description, 2023
• Table 21: AVEXITIDE (exendin 9-39), Clinical Trial Description, 2023
• Table 22: Key Market Forecast Assumptions for mizagliflozin
• Table 23: Key Market Forecast Assumptions for Avexitide (exendin 9-39)
• Table 24: Total Post-Bariatric hypoglycemia Market Size in the 7MM in USD million (2020-2034)
• Table 25: Post-Bariatric hypoglycemia Market Size by Therapies in the 7MM in USD million (2020-2034)
• Table 26: Total Post-Bariatric hypoglycemia Market Size in the United States in USD million (2020-2034)
• Table 27: Post-Bariatric hypoglycemia Market Size by Therapies in the United States in USD million (2020-2034)
• Table 28: Total Post-Bariatric hypoglycemia Market Size in EU4 and the UK in USD million (2020-2034)
• Table 29: Post-Bariatric hypoglycemia Market Size by Therapies in EU4 and the UK in USD million (2020-2034)
• Table 30: Total Post-Bariatric hypoglycemia Market Size in Japan in USD million (2020-2034)
• Table 31: Post-Bariatric hypoglycemia Market Size by Therapies in Japan in USD million (2020-2034)

The List of Tables is not exhaustive, will be provided in the final report.

List of Figures

• Figure 1:Mechanisms of Hypoglycemia After Upper Gastrointestinal Surgery
• Figure 2: Potential Contributors to the Pathophysiology of PBH
• Figure 3: Schematic of Suggested Approach to Evaluation
• Figure 4: Management of Postbariatric Hypoglycemia
• Figure 5: Total Postbariatric Hypoglycemia (PBH) Cases in the 7MM (2020-2034)
• Figure 6: Type-specific Bariatric Surgery Cases in the United States (2020-2034)
• Figure 7: Total Postbariatric Hypoglycemia (PBH) Cases in the United States (2020-2034)
• Figure 8: Postbariatric Hypoglycemia (PBH) Cases in types of Bariatric Surgeries in the United States (2020-2034)
• Figure 9: Severity-specific Post Bariatric Hypoglycemia (PBH) Cases in the United States (2020-2034)
• Figure 10: Total Treated cases of Postbariatric Hypoglycemia (PBH) in the United States (2020-2034)
• Figure 11: Type-specific Bariatric Surgery Cases in EU4 and the UK (2020-2034)
• Figure 12: Total Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK (2020-2034)
• Figure 13: Postbariatric Hypoglycemia (PBH) Cases in types of Bariatric Surgeries in EU4 and the UK (2020-2034)
• Figure 14: Severity-specific Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK (2020-2034)
• Figure 15: Total Treated Cases of Postbariatric Hypoglycemia (PBH) in EU4 and the UK (2020-2034)
• Figure 16: Type-specific Bariatric Surgery Cases in Japan (2020-2034)
• Figure 17: Total Postbariatric Hypoglycemia (PBH) Cases in Japan (2020-2034)
• Figure 18: Postbariatric Hypoglycemia (PBH) Cases in types of Bariatric Surgeries in Japan (2020-2034)
• Figure 19: Severity-specific Post Bariatric Hypoglycemia (PBH) Cases in Japan (2020-2034)
• Figure 20: Total Treated cases of Postbariatric Hypoglycemia (PBH) in Japan (2020-2034)
• Figure 21: Total Post-Bariatric hypoglycemia Market Size in the 7MM (2020-2034)
• Figure 22: Post-Bariatric hypoglycemia Market Size by Therapies in the 7MM (2020-2034)
• Figure 23: Total Post-Bariatric hypoglycemia Market Size in the United States in USD million (2020-2034)
• Figure 24: Post-Bariatric hypoglycemia Market Size by Therapies in the United States in USD million (2020-2034)
• Figure 25: Total Post-Bariatric hypoglycemia Market Size in EU4 and the UK in USD million (2020-2034)
• Figure 26: Post-Bariatric hypoglycemia Market Size by Therapies in EU4 and the UK in USD million (2020-2034)
• Figure 27: Total Post-Bariatric hypoglycemia Market Size in Japan (2020-2034)
• Figure 28: Post-Bariatric hypoglycemia Market Size by Therapies in Japan (2020-2034)
• Figure 29: Unmet Needs
• Figure 30: Health Technology Assessment
• Figure 31: Reimbursement Process in Germany
• Figure 32: Reimbursement process in France
• Figure 33: Reimbursement process in Italy
• Figure 34: Reimbursement process in Spain
• Figure 35: Reimbursement process in the United Kingdom
• Figure 36: Reimbursement process in Japan

The List of Figures is not exhaustive, will be provided in the final report.

Key Highlights:

• In 2023, the United States accounted for approximately 90% of the total Post-Bariatric hypoglycemia market size within the seven major markets.
• Post-Bariatric 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 Post-Bariatric hypoglycemia, including rapid weight loss, altered gastrointestinal anatomy, increased insulin sensitivity, hyperinsulinemia, and reactive hypoglycemia.
• In 2023, there were approximately 100,000 cases of Post-Bariatric hypoglycemia (PBH) Cases in the 7MM. Among the 7MM, the United States accounted for the highest number of cases, which was followed by France.
• Several risk factors contribute to Post-Bariatric hypoglycemia, including rapid weight loss, altered gastrointestinal anatomy, increased insulin sensitivity, hyperinsulinemia, and reactive hypoglycemia.
• Bariatric surgery has proven to be the most effective treatment for severe obesity, leading to significant improvements in body mass index and obesity-related co-morbidities. With increasing bariatric surgery procedures performed per year in the United States, postoperative prevalence of hypoglycemia symptoms in bariatric surgery patients is also increasing.
• The pathophysiology of Post-Bariatric hypoglycemia is complex and involves several inter-related mechanisms. It is believed to result from alterations in the normal hormonal and metabolic response to food intake following bariatric surgery.
• Diagnosis of Post-Bariatric 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 Post-Bariatric hypoglycemia involves dietary modifications, such as consuming small and frequent meals, avoiding high-glycemic index foods, and restricting simple sugars. Post-Bariatric hypoglycemia 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.
• There are currently no therapeutics approved by the FDA for the treatment of Post-Bariatric hypoglycemia. However, few therapies are being investigated for the treatment of Post-Bariatric hypoglycemia.
• Some key Post-Bariatric hypoglycemia companies involved in the development are Vogenx (mizagliflozin) and Eiger BioPharmaceuticals (avexitide).
• In April 2024, Vogenx announced that it has completed dosing of the last patient in its Phase II clinical study VGX-001-012 evaluating mizagliflozin in patients diagnosed with post-bariatric hypoglycemia.

Post-Bariatric hypoglycemia Market Report Summary

• The Post-Bariatric hypoglycemia market 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 mid-stage (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 Post-Bariatric hypoglycemia market report also encompasses a comprehensive analysis of the disease, providing an in-depth examination of its historical and projected Post-Bariatric hypoglycemia market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The Post-Bariatric hypoglycemia market report also includes drug outreach coverage in the 7MM region.
• The Post-Bariatric hypoglycemia market 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 Post-Bariatric hypoglycemia market.

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

Post-Bariatric hypoglycemia Treatment Market

Post-Bariatric hypoglycemia Overview

Post-Bariatric hypoglycemia is an increasingly recognized complication of bariatric surgery, occurring after roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (SG). Postbariatric surgery hypoglycemia, also known as reactive hypoglycemia and late dumping syndrome, is a metabolic complication in which a spike in glucose levels after eating a meal stimulates a high insulin secretion, leading to low blood sugar.

Post-Bariatric hypoglycemia Diagnosis

Diagnosis of Post-Bariatric 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.

Post-Bariatric hypoglycemia Treatment

Acarbose has been used as first-line treatment, although adverse gastrointestinal symptoms limit this option. Diazoxide and octreotide have been used with mixed results, but side effects and patient nonadherence limit their utility. Interestingly, exogenous GLP-1 receptor agonists have also demonstrated improvement in PBH, possibly through downregulation of insulin secretion from B-cells and increased secretion of glucagon from a-cells during conditions of hypoglycemia. Historically, surgical treatments were recommended more commonly, gastrostomy tube placement, reversal of gastric bypass anatomy, and distal pancreatectomy. It is worth using CCBs, nifedipine, or verapamil to bridge the treatment gap between nutrition and surgical therapy.

Post-Bariatric hypoglycemia Epidemiology

The Post-Bariatric hypoglycemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Type-specific Bariatric Surgery Cases, Total Post-Bariatric hypoglycemia Cases, Post-Bariatric hypoglycemia Cases in types of Bariatric Surgeries, Severity-specific Post-Bariatric hypoglycemia Cases, and Total Treated cases of Post-Bariatric hypoglycemia in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the total Post-Bariatric hypoglycemia cases in the 7MM were estimated to be approximately 110,000 cases which, as per DelveInsight's estimates, will increase by 2034.
• In 2023, the US accounted for the highest cases of Post-Bariatric hypoglycemia with approximately 80% cases.
• As per DelveInsight's analysis, in 2023, there were higher cases of Post-Bariatric hypoglycemia in sleeve gastrectomy cases, which was followed by Roux-en-Y gastric bypass cases, and cases in others in the US.
• As per severity of Post-Bariatric hypoglycemia, there were more than 90% cases in the mild to moderate category in 2023, in the United States.
• There were nearly 50,000 treated cases of Post-Bariatric hypoglycemia in 2023 in the United States.

Post-Bariatric hypoglycemia Market

Various key players are leading the treatment landscape of Post-Bariatric hypoglycemia (PBH), such as Vogenx, Eiger BioPharmaceuticals, and others. The details of the country-wise and therapy-wise market size have been provided below.

• In 2023, the Post-Bariatric hypoglycemia market size in the 7MM was nearly 200 USD million and it is expected to increase by 2034, driven by an increase in the cases of Post-Bariatric hypoglycemia and the launch of new therapies.
• Among the 7MM, the United States accounted for the highest Post-Bariatric hypoglycemia market size, followed by France and Italy, in 2023.
• Among the emerging therapies, Eiger BioPharmaceuticals' AVEXITIDE is expected to garner the highest Post-Bariatric hypoglycemia market size during the forecast period (2024-2034).

Post-Bariatric hypoglycemia Drug Chapters

The section dedicated to drugs in the Post-Bariatric hypoglycemia market report provides an in-depth evaluation of mid-stage pipeline drugs (Phase II) related to Post-Bariatric hypoglycemia.

The drug chapters section provides valuable information on various aspects related to clinical trials of Post-Bariatric 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 Post-Bariatric hypoglycemia.

Post-Bariatric hypoglycemia Emerging Therapies

Mizagliflozin: Vogenx

Mizagliflozin follows an oral route of administration and minimally absorb the inhibitor of Sodium-glucose transporter 1 (SGLT1). Post-Bariatric hypoglycemia patients have elevated SGLT1 levels in the gut. This elevated blood glucose stimulates uncontrolled insulin secretion in Post-Bariatric hypoglycemia patients. In February 2024, Vogenx announced completion of patient enrollment of a mid-Phase II clinical dose ranging study (VGX-001-012) evaluating mizagliflozin in patients diagnosed with post-bariatric 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. In June 2023, the company announced that the US FDA has granted breakthrough therapy designation to AVEXITIDE for the treatment of Post-Bariatric hypoglycemia.

Note: Detailed assessment will be provided in the final report of Post-Bariatric hypoglycemia...

Post-Bariatric hypoglycemia Market Outlook

Most of the therapies are based on case series or reports and extrapolated from their use in other conditions that cause hypoglycemia. Acarbose has been used as first-line treatment, although adverse gastrointestinal symptoms limit this option. Diazoxide and octreotide have been used with mixed results, but side effects and patient nonadherence limit their utility. Interestingly, exogenous GLP-1 receptor agonists have also demonstrated improvement in PBH, possibly through down regulation of insulin secretion from B-cells and increased secretion of glucagon from a-cells during conditions of hypoglycemia.

Several drugs are being investigated to treat Post-Bariatric hypoglycemia, including mizagliflozin and exendin 9-39. Both drugs have demonstrated significant improvements in PBH patients with well-tolerated safety profiles.

As no approved therapies are available in the Post-Bariatric hypoglycemia market, there is a huge opportunity for pharmaceutical firms to develop targeted and effective therapies for treating Post-Bariatric hypoglycemia.

Post-Bariatric hypoglycemia KOL Views

To stay abreast of the latest trends in the Post-Bariatric hypoglycemia 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 Post-Bariatric 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 10 KOLs across the 7MM. We contacted institutions such as the King's College London, University of Valencia, Arden University, Stanford University, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Post-Bariatric 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:

Post-Bariatric hypoglycemia 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 Post-Bariatric hypoglycemia 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 Post-Bariatric hypoglycemia, one of the most important primary endpoints was change from baseline mean 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.

Post-Bariatric hypoglycemia 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 Post-Bariatric hypoglycemia market 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.

Post-Bariatric hypoglycemia Market Report Insights

• Post-Bariatric hypoglycemia Patient Population
• Post-Bariatric hypoglycemia Therapeutic Approaches
• Post-Bariatric hypoglycemia Market Size
• Post-Bariatric hypoglycemia Market Trends
• Existing Post-Bariatric hypoglycemia Market Opportunity

Post-Bariatric hypoglycemia Market Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Post-Bariatric hypoglycemia Epidemiology Segmentation
• Patient-based Post-Bariatric hypoglycemia Market Forecasting
• Key Cross Competition

Post-Bariatric hypoglycemia Market Report Assessment

• Current Treatment Practices
• Reimbursements
• Post-Bariatric hypoglycemia 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 Post-Bariatric hypoglycemia management recommendations?
• Would research and development advances pave the way for future tests and therapies for Post-Bariatric hypoglycemia?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Post-Bariatric hypoglycemia?
• What kind of uptake will the new therapies witness in coming years in Post-Bariatric hypoglycemia patients and what is the expected launch date of AVEXITIDE?

Table of Contents

1. Key Insights

2. Report Introduction

3. Postbariatric Hypoglycemia (PBH) Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Postbariatric Hypoglycemia (PBH) by Countries in 2020
• 3.2. Market Share (%) Distribution of Postbariatric Hypoglycemia (PBH) by Countries in 2034
• 3.3. Market Share (%) Distribution by Class of Postbariatric Hypoglycemia (PBH) Therapies in 2020
• 3.4. Market Share (%) Distribution by Class of Postbariatric Hypoglycemia (PBH) Therapies in 2034

4. Executive Summary of Postbariatric Hypoglycemia

5. Disease Background and Overview

• 5.1. Introduction
• 5.2. Hypoglycemia After Gastric Bypass Surgery
• 5.3. Etiology of PBH
• 5.4. Risk Factors for Hypoglycemia
• 5.5. Pathophysiology of PBH
• 5.6. Diagnostic Evaluation
• 5.7. Differential Diagnosis
• 5.8. Diagnostic Guidelines

6. Methodology

7. Post-Bariatric hypoglycemia Epidemiology and Patient Population

• 7.1. Key Findings
• 7.2. Assumptions and Rationale
• 7.3. Total Postbariatric Hypoglycemia (PBH) Cases in the 7MM
• 7.4. The United States
  • 7.4.1. Type-specific Bariatric Surgery Cases in the United States
  • 7.4.2. Total Postbariatric Hypoglycemia (PBH) Cases in the United States
  • 7.4.3. Postbariatric Hypoglycemia (PBH) Cases in types of Bariatric Surgeries in the United States
  • 7.4.4. Severity-specific Postbariatric Hypoglycemia (PBH) Cases in the United States
  • 7.4.5. Total Treated cases of Postbariatric Hypoglycemia (PBH) in the United States
• 7.5. EU4 and the UK
  • 7.5.1. Type-specific Bariatric Surgery Cases in EU4 and the UK
  • 7.5.2. Total Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK
  • 7.5.3. Postbariatric Hypoglycemia (PBH) Cases in Types of Bariatric Surgeries in EU4 and the UK
  • 7.5.4. Severity-specific Postbariatric Hypoglycemia (PBH) Cases in EU4 and the UK
  • 7.5.5. Total Treated Cases of Postbariatric Hypoglycemia (PBH) in EU4 and the UK
• 7.6. Japan
  • 7.6.1. Type-specific Bariatric Surgery Cases in Japan
  • 7.6.2. Total Postbariatric Hypoglycemia (PBH) Cases in Japan
  • 7.6.3. Postbariatric Hypoglycemia (PBH) Cases in types of Bariatric Surgeries in Japan
  • 7.6.4. Severity-specific Postbariatric Hypoglycemia (PBH) Cases in Japan
  • 7.6.5. Total Treated cases of Postbariatric Hypoglycemia (PBH) in Japan

8. Post-Bariatric hypoglycemia Patient Journey

9. Emerging Post-Bariatric hypoglycemia Therapies

• 9.1. Key Cross
• 9.2. Mizagliflozin: Vogenx
  • 9.2.1. Product Description
  • 9.2.2. Clinical Developmental Activities
  • 9.2.3. Safety and Efficacy
• 9.3. AVEXITIDE (exendin 9-39): Eiger BioPharmaceuticals
  • 9.3.1. Product Description
  • 9.3.2. Other Developmental Activities
  • 9.3.3. Clinical Developmental Activities
  • 9.3.4. Safety and Efficacy

10. Postbariatric Hypoglycemia (PBH) Market: Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Post-Bariatric hypoglycemia Market Outlook
• 10.3. Key Post-Bariatric hypoglycemia Market Forecast Assumptions
• 10.4. Conjoint Analysis
• 10.5. Total Post-Bariatric hypoglycemia Market Size in the 7MM
• 10.6. Post-Bariatric hypoglycemia Market Size by Therapies in the 7MM
• 10.7. United States: Post-Bariatric hypoglycemia Market Size
  • 10.7.1. Total Post-Bariatric hypoglycemia Market Size in the United States
  • 10.7.2. Post-Bariatric hypoglycemia Market Size by Therapies in the United States
• 10.8. EU4 and the UK: Post-Bariatric hypoglycemia Market Size
  • 10.8.1. Total Post-Bariatric hypoglycemia Market Size in EU4 and the UK
  • 10.8.2. Post-Bariatric hypoglycemia Market Size by Therapies in EU4 and the UK
• 10.9. Japan: Post-Bariatric hypoglycemia Market Size
  • 10.9.1. Total Post-Bariatric hypoglycemia Market Size in Japan
  • 10.9.2. Post-Bariatric hypoglycemia Market Size by Therapies in Japan

11. KOL Views

12. Post-Bariatric hypoglycemia SWOT Analysis

13. Post-Bariatric hypoglycemia Unmet Needs

14. Post-Bariatric hypoglycemia Market Access and Reimbursement

• 14.1. The United States
  • 14.1.1. Centre for Medicare and Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. The United Kingdom
• 14.3. Japan
• 14.4. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. DelveInsight Capabilities

17. Disclaimer

The Table of Contents is not exhaustive, will be provided in the final report.