肥満後低血糖症の世界市場-2024年～2031年

市場力学

促進要因

肥満後低血糖治療に関する研究開発の増加

世界の肥満後低血糖治療市場は、研究開発活動の高まりにより大きな成長を遂げています。すでにいくつかの治療法がPBHの治療に有効であることが検証されており、企業はPBHの特異的な治療オプションを開発するために投資や開発を行っています。このような活動が、予測期間中の市場成長を大きく牽引すると予想されます。

例えば、米国糖尿病学会によると、2022年3月に発表された「Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia（ダシグルカゴンは肥満後の食後低血糖を効果的に軽減する）」と題された論文によると、80gまたは200gのダシグルカゴンの単回投与治療は、RYGB手術を受けた人の肥満後の低血糖を効果的に軽減するとしています。いずれのダシグルカゴン投与量も、直下血中PGを上昇させ、レベル1低血糖の時間を短縮したが、200μg投与量は、高血糖を誘発することなく、レベル2低血糖を完全に予防しました。これらの所見は、ダシグルカゴンが肥満後の低血糖に対する新たな治療薬となる可能性を示唆しています。

さらに2023年6月、ヴォジェンクスはVGX 001-011試験の良好な結果を発表しました。この第2相試験は、肥満後低血糖症（PBH）に苦しむ患者を対象にエンパグリフロジンを評価する多施設共同無作為化逐次クロスオーバー単回昇降投与試験です。本試験では、4用量のミザグリフロジンを患者に投与し、ミザグリフロジンの安全性、忍容性、薬力学的反応を確認しました。このように、上記の要因により、市場は予測期間中に拡大すると予想されます。

2023年10月、MBX Biosciences社は、肥満後低血糖の治療を目的としたMBX 1416の第1/2相臨床試験を開始しました。MBX 1416は長時間作用型のグルカゴン様ペプチド1（GLP-1）受容体拮抗薬です。MBX社では、2024年前半までにトップラインの結果が得られると見込んでいます。

Eiger BioPharmaceuticals社が開発したグルカゴン様ペプチド1（GLP-1）受容体拮抗薬Avexitideは、欧州ではEMAから非インシュリン腫性膵生成性低血糖症候群（NIPHS）の治療薬として、米国ではFDAから高インシュリン血症性低血糖症の治療薬として、すでに希少疾病用医薬品の指定を受けています。アイガー社は、PBH治療薬エイベキシチドの第3相臨床試験を間もなく実施する予定です。

さらに、肥満と肥満手術の増加も市場を押し上げると予想されます。

阻害要因

PBHの治療選択肢が限られているため、市場の成長が抑制されると予想されます。PBHに使用可能な単一の承認治療法はなく、ほとんどの薬剤は非臨床で使用されています。さらに、患者数が限られていること、認知度が低いこと、標準化された診断アプローチが利用できないことが、予測期間中の市場成長を制限する可能性があります。

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目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 肥満後低血糖治療の研究開発の増加
    • 肥満の有病率の増加
  • 抑制要因
    • 肥満後低血糖症の治療選択肢が限られていること
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• アンメットニーズ
• PESTEL分析
• 特許分析
• SWOT分析

第6章 薬剤クラス別

• グルコシダーゼ阻害薬
• ソマトスタチン作動薬
• カルシウムイオン流入阻害薬
• その他

第7章 投与経路別

• 経口
• 非経口
• その他

第8章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• Teva Pharmaceuticals
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Sun Pharmaceutical Industries Ltd.
• Wockhardt Ltd.
• Orchid Chemicals & Pharmaceuticals Ltd.
• Pfizer
• Glenmark Pharmaceuticals
• Zee Laboratories Ltd.
• Bayer AG
• Eiger BioPharmaceuticals
• Vogenx

第12章 付録

Overview

The global post-bariatric hypoglycemia market reached US$ 206.55 million in 2023 and is expected to reach US$ 341.83 million by 2031, growing at a CAGR of 6.5% during the forecast period 2024-2031.

Post-bariatric hypoglycemia (PBH) belongs to a growing complication of bariatric surgery which usually happens after both Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (SG). Post-bariatric hypoglycemia usually occurs one to three hours after eating, and its severity can increase after consuming high glycemic index carbohydrates.

The most common way to treat post-bariatric hypoglycemia is to follow the diet recommended by the physician. In acute hypoglycemia, the glucose levels can be restored by administering glucagon or glucose orally. For severe attacks, the glucagon can be given through i.v. route. There are several treatment options available for PBH, which include somatostatin antagonists, GLP-1 receptor antagonists, alpha-glucosidase inhibitors, sodium-glucose cotransporter 2 inhibitors, etc.

Factors such as the rising prevalence of obesity the rising number of bariatric surgeries, and rising research and development activities to discover novel therapies are expected to boost the market growth.

Market Dynamics: Drivers

Increasing Research and Developments for Post-Bariatric Hypoglycemia Treatment

The global post-bariatric hypoglycemia treatment market has been witnessing significant growth due to rising research and development activities. Several therapies have already been tested to be effective for the treatment of PBH, and companies have been investing and developing to develop specific treatment option for PBH. These activities are expected to majorly drive the market growth in the forecast period.

For instance, according to the American Diabetes Association, an article entitled Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia published in March 2022 states that single-dose treatment with either 80 ?g or 200 ?g dasiglucagon effectively mitigates post-bariatric hypoglycemia in RYGB-operated individuals. While both dasiglucagon doses raised the nadir PG and reduced time in level 1 hypoglycemia, the 200-μg dose completely prevented level 2 hypoglycemia without inducing hyperglycemia. These findings suggest dasiglucagon as a potential new therapeutic for post-bariatric hypoglycemia.

Additionally, in June 2023, Vogenx announced positive results from study VGX 001-011. This phase 2 study was a multicenter, randomized, sequential crossover, single ascending dose study evaluating empagliflozin in patients who suffer from post-bariatric hypoglycemia (PBH). The study examined four doses of mizagliflozin in patients and check the safety, tolerability, and pharmacodynamic response to mizagliflozin. Thus, owing to the above factors the market is expected to boost over the forecast period.

In October 2023, MBX Biosciences has initiated phase 1/2 clinical trial of MBX 1416 for the treatment of post-bariatric hypoglycemia. MBX 1416 is a long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist. MBX expect topline results by the 1st half of 2024.

Avexitide a glucagon-like peptide 1 (GLP-1) receptor antagonist developed by Eiger BioPharmaceuticals has already received the orphan drug designation in the European Union by the EMA for the treatment of non-insulinoma Pancreatogenous Hypoglycemia Syndrome (NIPHS) and by the US FDA for the treatment of Hyperinsulinemic Hypoglycemia.. Eiger is set to conduct phase 3 clinical trials soon for Avexitide for the treatment of PBH.

Moreover, the rising prevalence of obesity and bariatric surgery is expected to boost the market.

Restraints

Limited treatment options for PBH is expected to restrain the market growth, there is no single approved therapy available for PBH and most of the drugs are used off-lable. Moreover, limited patient population, lack of awareness and non-availability of standardized diagnostic approaches may limit the market growth in the forecast period.

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Segment Analysis

The global post-bariatric hypoglycemia market is segmented based on drug class, route of administration, distribution channel and region.

Glucosidase inhibitors in the drug class segment accounted for majority of share for the global post-bariatric hypoglycemia

Glucosidase inhibitors, such as acarbose is the most widely prescribed drug for post-bariatric hypoglycemia. This drug slows the carbohydrate metabolism post-prandial, causing the slow release of glucose and preventing hypoglycemia. Although not approved, acarbose is widely prescribed as a first line therapy for PBH. Several studies have proven that acarbose is valid and effective treatment option for PBH.

For instance, in November 2023, an article published in Wiley online library highlights the clincal studies conducted for evaluating the efficacy and safety of acarbose for post-bariatric hypoglycemia. The study stated that acarbose is recommended as a first-line therapeutic option for PBH.

Moreover, acarbose has relatively less side effects which include flatulence, and diarrhoea which diminish over time. The drug is also cost-effective and is widely available worldwide.

Geographical Analysis

North America is expected to dominate the market with a 47.6% share in the global post-bariatric hypoglycemia market

North America is the region with the highest prevalence of obesity and diabetes, due to higher adoption to fast-paced life and unhealthy eating habits. For instance, as per the World Obesity Atlas 2023, in the U.S. nearly 48% of the adult population are obese (BMI>30kg/m2) and by 2035, nearly 58% of adult population would be obese, which is higher than any other nation in the world.

Moreover, North America is well known for its advancements in the healthcare industry. The major countries in the region such as the U.S. and Canada are well known for their investments in healthcare. The favorable yet stringent regulatory policies, favorable environment for research and development activities, higher demand for advanced therapeutics, and high investments in the industry are the factors that are contributing to the region's dominance. Moreover, the market leaders have stronghold position in the region, and are generating majority of their revenues from here, especially from U.S.

Market Segmentation

By Drug Class

• Glucosidase Inhibitor
• Somatostatin Agonist
• Calcium Ion Influx Inhibitor
• Others

By Route of Administration

• Oral
• Parenteral
• Others

By Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major players in the post-bariatric hypoglycemia market include Teva Pharmaceuticals, Sun Pharmaceutical Industries Ltd., Wockhardt Ltd., Orchid Chemicals & Pharmaceuticals Ltd., Pfizer, Glenmark Pharmaceuticals, Zee Laboratories Ltd., Bayer AG, Eiger BioPharmaceuticals, and Vogenx among others.

Why Purchase the Report?

• To visualize the global post-bariatric hypoglycemia market segmentation based on drug class, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of post-bariatric hypoglycemia market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global post-bariatric hypoglycemia market report would provide approximately 61 tables, 59 figures, and 187 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Drug Class
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channel

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing research and developments for post-bariatric hypoglycemia treatment
    • 4.1.1.2. Rising prevalence of obesity
  • 4.1.2. Restraints
    • 4.1.2.1. Limited treatment options for post-bariatric hypoglycemia
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Unmet Needs
• 5.6. PESTEL Analysis
• 5.7. Patent Analysis
• 5.8. SWOT Analysis

6. By Drug Class

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 6.1.2. Market Attractiveness Index, By Drug Class
• 6.2. Glucosidase Inhibitor*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Somatostatin Agonist
• 6.4. Calcium Ion Influx Inhibitor
• 6.5. Others

7. By Route of Administration

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 7.1.2. Market Attractiveness Index, By Route of Administration
• 7.2. Oral*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Parenteral
• 7.4. Others

8. By Distribution Channel

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.1.2. Market Attractiveness Index, By Distribution Channel
• 8.2. Hospital Pharmacy*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacy
• 8.4. Online Pharmacy
• 8.5. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. The U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.3.5.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.5.2. Germany
    • 9.3.5.3. UK
    • 9.3.5.4. France
    • 9.3.5.5. Italy
    • 9.3.5.6. Spain
    • 9.3.5.7. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.4.5.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.5.2. Brazil
    • 9.4.5.3. Argentina
    • 9.4.5.4. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
    • 9.5.5.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.5.2. China
    • 9.5.5.3. India
    • 9.5.5.4. Japan
    • 9.5.5.5. South Korea
    • 9.5.5.6. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Class
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Teva Pharmaceuticals*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Sun Pharmaceutical Industries Ltd.
• 11.3. Wockhardt Ltd.
• 11.4. Orchid Chemicals & Pharmaceuticals Ltd.
• 11.5. Pfizer
• 11.6. Glenmark Pharmaceuticals
• 11.7. Zee Laboratories Ltd.
• 11.8. Bayer AG
• 11.9. Eiger BioPharmaceuticals
• 11.10. Vogenx

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us