膵外分泌不全治療の世界市場：2024～2031年

概要

世界の膵外分泌不全治療市場は、2023年に33億米ドルに達し、2031年には53億7,000万米ドルに達すると予測され、予測期間2024年CAGRは6.4%で成長する見込みです。

外分泌膵機能不全（EPI）は、外分泌膵酵素欠乏を特徴とする病態であり、そ結果、脂肪、糖、タンパク質適切な分解に必要な消化酵素を膵臓が産生できなくなります。こ状態は、急性膵炎、慢性膵炎（CP）、膵がん、嚢胞性線維症など、ほとんど膵疾患から生じる可能性があります。

慢性膵炎や嚢胞性線維症有病率上昇、膵外分泌不全症例増加、高度な治療薬やドラッグデリバリーシステム改善に対する需要など要因が市場を牽引しています。

市場力学

促進要因

慢性膵炎（CP）および嚢胞性線維症（CF）の有病率の上昇

世界の膵外分泌不全治療市場の需要は、複数の要因によって牽引されています。膵外分泌不全治療は慢性膵炎の重篤な後遺症であり、嚢胞性線維症を含む他の症候群に起因することもあります。慢性膵炎の子どもの約3分の1が外分泌膵不全です。

嚢胞性線維症は、肺を厚い粘液で詰まらせることによって、呼吸の問題を引き起こします。この粘液は膵臓も詰まらせ、消化酵素の分泌を妨げます。その結果、小腸は食物を完全に消化することができなくなり、消化管は未消化の食物を部分的に通過させなければならなくなります。これは外分泌膵不全治療（EPI）と呼ばれる状態です。

2023年8月に発表されたWorld Journal of Gastroenterology誌の調査によると、CPの有病率は100,000人当たり13.5～163例、発症率は100,000人年当たり5～31.7例です。

さらに、業界の大手企業は研究開発に注力しており、治療における技術革新がこの市場の成長を後押ししています。例えば、2024年4月にノートンヘルスケアが嚢胞性線維症に対する広域酵素補充療法のフェーズ1試験を開始しました。この新しいクラスの酵素補充療法は、脂肪用のリパーゼ、タンパク質用のプロテアーゼ、炭水化物用のアミラーゼという幅広いスペクトラムの組成で、比類のない性能を発揮するように設計されています。

同様に、2023年9月、アナグラム・セラピューティクス社は、CFに関連した外分泌膵不全の成人患者を対象に、ANG003の経口投与の忍容性と安全性を評価する無作為化多施設共同並行研究試験において、最初の参加者に投与が完了したことを報告しました。ANG003は、吸収不良および膵外分泌機能不全の治療に経口で使用される革新的な広域酵素補充療法です。

抑制要因

高額な治療費、厳しい政府規制、限られた利用可能性と治療の複雑さ、人々の認識と診断の欠如、資金とヘルスケアインフラの欠如、研究開発の高コストなどの要因が市場の妨げになると予想されます。

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
    • 慢性膵炎（CP）および嚢胞性線維症（CF）の有病率の上昇
    • 膵外分泌不全例の増加
    • 先進治療薬とドラッグデリバリーシステムの改善に対する需要
  • 抑制要因
    • 治療費の高騰
    • 政府の厳しい規制
  • 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 治療別

• 薬剤タイプ
  • クレオン
  • ゼンペップ
  • パンクリーゼ
  • ウルトラ
  • ビオケース
  • その他
• 栄養管理（栄養補助食品）
• 膵酵素補充療法

第7章 用途別

• クローン病
• 潰瘍性大腸炎
• 胃食道逆流症
• 過敏性腸症候群
• 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

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地域
• 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

• AbbVie
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Codexis Inc
• Nestle
• Alcresta Therapeutics, Inc
• First Wave BioPharma
• Eli Lilly and Company
• Cilian AG
• Synspira Therapeutics
• Perseo Pharma
• Vivus LLC

第12章 付録

Overview

The global exocrine pancreatic insufficiency treatment market reached US$ 3.30 billion in 2023 and is expected to reach US$ 5.37 billion by 2031, growing at a CAGR of 6.4% during the forecast period 2024-2031.

Exocrine pancreatic insufficiency (EPI) is a condition characterized by the deficiency of exocrine pancreatic enzymes, resulting in the inability of the pancreas to produce the digestive enzymes required for the proper breakdown of fats, sugars, and proteins. This condition can arise from most pancreatic diseases, including acute pancreatitis, chronic pancreatitis (CP), pancreatic cancer, and cystic fibrosis.

The market is driven by factors such as the rise in the prevalence of chronic pancreatitis & cystic fibrosis, increasing cases of exocrine pancreatic insufficiency, and demands for advanced therapeutics & improved drug delivery systems.

Market Dynamics

Drivers

Rise in the Prevalence of Chronic Pancreatitis (CP) & Cystic Fibrosis (CF)

The demand for the global exocrine pancreatic insufficiency treatment market is driven by multiple factors. exocrine pancreatic insufficiency treatment is a serious sequela of chronic pancreatitis and can also result from other syndromes including cystic fibrosis. Approximately one-third of children with chronic pancreatitis have exocrine pancreatic insufficiency.

Cystic fibrosis causes breathing issues by clogging the lungs with thick mucus. This mucus also clogs the pancreas and hampers the release of digestive enzymes. Over time, this can result in the small intestine becoming unable to digest food completely, meaning the digestive tract has to pass partially undigested food through it. This is a condition called exocrine pancreatic insufficiency treatment(EPI).

According to the World Journal of Gastroenterology, a research publication in August 2023, states that the prevalence of CP ranges from 13.5 to 163 cases per 100000 individuals, and the incidence of CP ranges from 5 to 31.7 new cases per 100000 person-years.

Moreover, major players in the industry focus on research & development, and technological innovations in the treatment propel this market growth. For instance, in April 2024, Norton Healthcare's Phase 1 trial for a broad-spectrum enzyme replacement therapy for cystic fibrosis. This new class of enzyme replacement therapy is designed to provide unparalleled performance with a broad-spectrum composition, lipase for fat, protease for protein, and amylase for carbohydrates.

Similarly, in September 2023, Anagram Therapeutics Inc. reported that the first participants had been dosed in a randomized, multicenter, parallel research study to assess the tolerability and safety of orally administered ANG003 in adult individuals with CF-related exocrine pancreatic insufficiency. ANG003 is an innovative broad-spectrum enzyme replacement therapy used orally to treat malabsorption and exocrine pancreatic insufficiency.

Restraints

Factors such are the high cost of treatment, stringent government regulations, limited availability & complexity of treatment, lack of awareness & diagnosis among people, lack of funding & healthcare infrastructure, and high cost of research & development, are expected to hamper the market.

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Segment Analysis

The global exocrine pancreatic insufficiency treatment market is segmented based on treatment, application, distribution channel and region.

The pancreatic enzyme replacement therapy segment accounted for approximately 36.5% of the global exocrine pancreatic insufficiency treatment share

The pancreatic enzyme replacement therapy segment is expected to hold the largest market share over the forecast period. Pancreatic enzyme replacement therapy is safe and effective at treating pancreatic exocrine insufficiency a debilitating condition of the GI tract that is caused by conditions that impair pancreatic function such as pancreatitis, pancreatic cancer, Crohn's disease, celiac disease, and cystic fibrosis.

Moreover, in February 2022, investigators at the University of Miami surveyed patients about their experience using pancreatic enzyme replacement therapy (PERT) and found education about this treatment is lacking.

In addition, key player's strategies such as partnerships & collaborations, and innovations in research & development help to drive this segment's growth. For instance, in December 2023, Codexis, Inc. announced it had entered into a purchase agreement with Nestle Health Science, a globally recognized leader in the field of nutritional science, for CDX-7108, an investigational therapy for the potential treatment of exocrine pancreatic insufficiency treatment(EPI).

Under the terms of the agreement, Codexis will receive up to $45M in potential milestone payments, including a $5M upfront payment, as well as single-digit net-sales-based royalties. Codexis will receive up to an additional $5M if Nestle Health Science exercises an option to purchase two additional early-stage enzymes being developed for EPI.

Also, in February 2023, Codexis, Inc. announced interim results from a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing pancreatic enzyme replacement therapy (PERT).

Geographical Analysis

North America accounted for approximately 42.3% of the global exocrine pancreatic insufficiency treatment market share

North America region is expected to hold the largest market share over the forecast period owing to the higher prevalence of conditions linked to EPI, such as cystic fibrosis and chronic pancreatitis. The region has a well-established healthcare infrastructure, advanced diagnostic capabilities, and high levels of awareness about EPI, which contribute to early detection and effective management.

Furthermore, major pharmaceutical companies and research institutions that focus on EPI and related disorders are present in North America, further boosting its position in the market.

This region's proactive approach to healthcare and substantial investments in research and development underlines its dominance in addressing EPI and driving advancements in its treatment. For instance, in December 2022, First Wave BioPharma got approval from the U.S. Food and Drug Administration (FDA) for permission to start a Phase 2 clinical trial that would test the company's new formulation of adrulipase in people with cystic fibrosis (CF) who have exocrine pancreatic insufficiency.

Also, in April 2022, Alcresta Therapeutics, Inc., announced a series of commercial milestone achievements. Alcresta announced its first profitable year in 2021, the completion of royalty payments to the Cystic Fibrosis Foundation (CFF), and a doubling of its sales force to expand the promotion of RELiZORB, a first-of-its-kind digestive enzyme cartridge used in enteral feeding designed to mimic the function of pancreatic lipase. RELiZORB is the only enzyme product cleared by the FDA.

Market Segmentation

By Treatment

• Drug Type
  • Creon
  • Zenpep
  • Pancreaze
  • Ultra
  • Viokace
  • Others
• Nutritional management (Dietary Supplements)
• Pancreatic Enzyme Replacement Therapy

By Application

• Crohn's Disease
• Ulcerative Colitis
• GERD
• IBS
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

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 global players in the exocrine pancreatic insufficiency treatment market include AbbVie, Codexis Inc., Nestle, Alcresta Therapeutics, Inc., First Wave BioPharma, Eli Lilly and Company, Cilian AG, Synspira Therapeutics, Perseo Pharma, and Vivus LLC among others.

Key Developments

• In May 2024, Alcresta Therapeutics, Inc., announced the commercial availability of the next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge. The next-generation RELiZORB device was cleared by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).
• In December 2023, Alcresta Therapeutics, Inc., announced 510(k) clearance of its next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The next-generation RELiZORB device was developed to address the enteral nutrition needs of a wider population of patients living with rare diseases.
• In July 2023, First Wave BioPharma, Inc. disclosed that it had received topline results from its Phase 2 SPAN clinical trial, which is investigating an enhanced enteric micro granule delivery formulation of adrulipase for treating exocrine pancreatic insufficiency treatment in cystic fibrosis (CF) patients.

Why Purchase the Report?

• To visualize the global exocrine pancreatic insufficiency treatment market segmentation based on treatment, application 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 global exocrine pancreatic insufficiency treatment market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global exocrine pancreatic insufficiency treatment market report would provide approximately 62 tables, 60 figures, and 182 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 Treatment
• 3.2. Snippet by Application
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rise in the Prevalence of Chronic Pancreatitis (CP) & Cystic Fibrosis (CF)
    • 4.1.1.2. Increasing Cases of Exocrine Pancreatic Insufficiency
    • 4.1.1.3. Demands for Advanced Therapeutics and Improved Drug Delivery System
  • 4.1.2. Restraints
    • 4.1.2.1. The High Cost of Treatment
    • 4.1.2.2. Stringent Government Regulations
  • 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 Treatment

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 6.1.2. Market Attractiveness Index, By Treatment
• 6.2. Drug Type*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.2.3. Creon
  • 6.2.4. Zenpep
  • 6.2.5. Pancreaze
  • 6.2.6. Ultra
  • 6.2.7. Viokace
  • 6.2.8. Others
• 6.3. Nutritional management (Dietary Supplements)
• 6.4. Pancreatic Enzyme Replacement Therapy

7. By Application

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 7.1.2. Market Attractiveness Index, By Application
• 7.2. Crohn's Disease *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Ulcerative Colitis
• 7.4. GERD
• 7.5. IBS
• 7.6. 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 Pharmacies *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacies
• 8.4. Online Pharmacies

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 Treatment
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 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. 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 Treatment
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. UK
    • 9.3.6.3. France
    • 9.3.6.4. Italy
    • 9.3.6.5. Spain
    • 9.3.6.6. 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 Treatment
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. 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 Treatment
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. 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 Treatment
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 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. AbbVie *
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio & Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Codexis Inc
• 11.3. Nestle
• 11.4. Alcresta Therapeutics, Inc
• 11.5. First Wave BioPharma
• 11.6. Eli Lilly and Company
• 11.7. Cilian AG
• 11.8. Synspira Therapeutics
• 11.9. Perseo Pharma
• 11.10. Vivus LLC

LIST NOT EXHAUSTIVE

12. Appendix

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