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過敏性腸症候群(IBS)市場 - 市場の洞察、疫学、市場予測:2034年

Irritable Bowel Syndrome (IBS) - Market Insight, Epidemiology, and Market Forecast - 2034


出版日
発行
DelveInsight
ページ情報
英文 200 Pages
納期
2~10営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=143.57円
過敏性腸症候群(IBS)市場 - 市場の洞察、疫学、市場予測:2034年
出版日: 2025年04月01日
発行: DelveInsight
ページ情報: 英文 200 Pages
納期: 2~10営業日
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  • 概要
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  • 目次
概要

主なハイライト

  • 過敏性腸症候群は、運動機能障害、内臓過敏症、精神疾患合併、神経内分泌機能障害、遺伝学・エピジェネティクス、食事、免疫活性化が関与する多因子疾患であると考えられています。2023年には、主要7ヶ国で約3,200万例の過敏性腸症候群が報告されました。米国は主要7ヶ国全体の有病者の~46%を占めています。主要7ヶ国では、過敏性腸症候群は、35歳以上の年齢層と比べ、若年層(35歳未満)に多いことが観察されています。さらに、この症候群は男性に比べて女性に多いです。
  • 過敏性腸症候群と診断された症例のうち、約89%は中等度から重度に分類され、軽症の症例は~11%でした。
  • さらに、下痢優位(IBS-D)が最も多く(~35%)、混合便パターン(IBS-M)、便秘優位(IBS-C)、特定不能(IBS-U)と続きます。
  • 下剤、止瀉薬、鎮痙薬、そしてある程度の抗うつ薬が、食事療法や生活習慣の改善とともに、過敏性腸症候群の治療の柱となってきました。2023年には下剤の売上が最も高かっています。
  • 下痢や便秘を伴う過敏性腸症候群の治療薬として承認されているのは、VIBERZI(eluxadoline)、XIFAXAN(rifaximin)、LINZESS(linaclotide)、IBSRELA(tenapanor)、TRULANCE(plecanatide)などです。承認された治療薬のうち、リンゼスは約6億米ドルの売上を計上しました。
  • 米国食品医薬品局(FDA)は2023年にリンゼスを小児患者の機能性便秘治療薬として承認しており、10年後までにはブロックバスター医薬品となる可能性が高いです。
  • 治療薬には多くの種類がありますが、患者の約60%は、処方薬別有効性と安全性に不満があるため、非従来型の治療を受けています。
  • 新しい治療法としては、生物学的製剤(Blautix、Aldafermin)や低分子製剤(Rifamycin、RHB-102)があります。生物学的製剤は、過敏性腸症候群の治療薬として今後数年間は有望なクラスになると予想されます。

当レポートは、過敏性腸症候群(IBS)の疫学、市場、臨床開発に関する詳細な分析をお届けします。米国、EU4ヶ国(ドイツ、スペイン、イタリア、フランス)、英国、日本における過敏性腸症候群の市場動向に関する詳細な分析に加え、疫学および市場に関する過去および予測データを提供します。

実際の処方パターン分析、新薬評価、市場シェア、個々の治療法の取り込み/採用パターン、2020年から2034年までの過敏性腸症候群市場規模(主要7ヶ国)の過去および予測を提供します。また、過敏性腸症候群の現在の治療法/アルゴリズムやアンメットメディカルニーズも網羅し、最良の機会を発掘し、市場の潜在力を評価します。

過敏性腸症候群は、構造的または器質的な原因がないにもかかわらず、腸習慣の変化に伴う腹痛および/または不快感の症状を特徴とする慢性機能性腸疾患です。特定の時点における腸のパターンに基づいて、この疾患は4つのグループに分類されます。

  • 便秘優位型(IBS-C)
  • 下痢優位型(IBS-D)
  • 混合型(IBS-M)
  • 未分類

過敏性腸症候群の正確な原因は不明です。しかし、過敏性腸症候群の症状の病態生理には、遺伝的体質、食事、腸内細菌叢、低悪性度粘膜炎症など、いくつかの因子が関与しています。過敏性腸症候群に関連する特異的なバイオマーカーは見つかっていません。

過敏性腸症候群の診断基準のすべてに共通する特徴は、異常な腸習慣(下痢[緩く頻回の便]、便秘[硬く頻回の便]、または便秘と下痢が交互に起こる)に伴う腹痛および/または不快感です。これらの基準は、過敏性腸症候群の診断基準を満たすために、症状の一定の期間と頻度を必要とします。

過敏性腸症候群を診断するために症状の組み合わせを特定するために使用されるさまざまな基準は、Manning基準、Rome I、Rome II、Rome III、Rome IVです。

鎮痙薬、緩下剤、止瀉薬、および抗うつ薬と、食事療法および生活習慣の改善が、過敏性腸症候群の治療の中心です。

第一選択の薬物療法としては、鎮痙薬やペパーミントオイルによる腹痛治療があります。下痢や便秘の治療には、それぞれロペラミドや下剤が試されます。これらのアプローチで症状が改善しない場合は、分泌促進薬、リファキシミン、低用量三環系抗うつ薬、エルキサドリンなどの第二選択治療を行う。腹痛が持続する場合は、テガセロドやアロセトロンが推奨されます。

今後数年間で、米国の過敏性腸症候群市場は大きく変化し、成長を遂げると予想されます。過敏性腸症候群の症状が複雑で多様であることが治療を困難にしており、その割合は約30~40%であることを考慮すると、特に、より安全で満足のいく効果的な疾患修飾療法が市場に参入すれば、市場は拡大すると予想されます。

過敏性腸症候群は一般的で、米国では人口の約5%、約20人に1人が罹患しており、米国、ドイツ、フランス、イタリア、スペイン、英国、日本における過敏性腸症候群の有病率は、ROME IV基準でそれぞれ5.3%、3.7%、4.2%、5%、4.2%、2.2%であることがわかっています。

過敏性腸症候群は男性より女性の方が顕著です。米国では、2023年の過敏性腸症候群の男女別の有病者総数は、男性で~490万人、女性で~970万人でした。

過敏性腸症候群と診断された有病者の約~48%は重度のカテゴリーに属し、中等度と軽度の症例はそれぞれ~41%と~11%です。

  • 2025年1月、FDAは下痢を伴う過敏性腸症候群(IBS-D)治療薬としてAmneal Pharmaceuticalsのリファキシミン錠550mgを暫定承認しました。
  • 2024年12月、Amneal PharmaceuticalsはFDAから簡略新薬承認申請(ANDA)の最終承認を取得し、プルカロプリド錠の発売を発表しました。この錠剤はMotegrity(R)のジェネリック医薬品です。

上市済み薬剤

VIBERZI/TRUBERZI(エルキサドリン):Abbvie

VIBERZI(eluxadoline)は、消化管の局所受容体に作用する新しいクラスの薬剤です。腸内のミューおよびデルタオピオイド受容体と相互作用することにより、下痢や腹痛を改善し、消化管運動を緩慢にして内臓痛を軽減します。ミュー受容体の活性化は下痢を軽減し、デルタ受容体の拮抗作用は鎮痛作用を増強し、便秘のリスクを軽減します。

ビベルジは現在、過敏性腸症候群の治療薬として承認されています。腸神経系に局所的に作用し、中枢神経系への副作用を減少させる。経口投与用の錠剤で入手可能です。

リンゼス/コンステラ(リナクロチド):Ironwood Pharmaceuticals/Abbvie/Astellas Pharma

リナクロチドはグアニル酸シクラーゼ-C作動薬で、非臨床試験から2つの作用機序が考えられています。リナクロチドは腸管上皮の局所においてグアニル酸シクラーゼ-C受容体に結合します。グアニル酸シクラーゼ-Cが活性化されると、腸液分泌が増加し、通過が促進され、腸の痛みを感知する神経の活動が低下します。米国では、アイアンウッド社とAbbvie社が成人のIBS-C治療薬としてリンゼスを共同開発し、共同販売しています。欧州では、リナクロチドを中等度から重度のIBS-C治療薬としてCONSTELLAのブランド名で販売しています。

新薬

ベキンダ(RHB-102):RedHill Biopharma

RHB-102は、急性胃腸炎、胃炎、下痢を伴う過敏性腸症候群(IBS-D)に伴う吐き気、嘔吐、下痢の症状を治療することを目的とした、5-HT3セロトニン受容体阻害剤ファミリーの主要メンバーであるオンダンセトロンの1日1回投与の経口剤です。

同社は、下痢を主徴とする過敏性腸症候群(IBS-D)を対象としたRHB-102の第II相臨床試験(NCT02757105)を完了しました。

Blautix(MRx1234):4D pharma

Blautix(MRx1234)は、IBS-CとIBS-Dの両方の治療薬として開発されている単一株生菌製剤(LBP)であり、臨床的サブタイプに関係なく、すべての過敏性腸症候群患者に適した史上初の疾患修飾療法となる可能性があります。Blautixは、水素を消費して酢酸を産生するというユニークな代謝を持ち、微生物叢の多様性と安定性を高める細菌の相互摂食を促進します。この2つの特性は、過敏性腸症候群患者では健常対照群と比較して低下していることが実証されています。

同社は、便秘優位の過敏性腸症候群(IBS-C)または下痢優位の過敏性腸症候群(IBS-D)の治療薬として、成人を対象としたブラウティクスの第Ⅱ相臨床試験(NCT03721107)を完了しました。

過敏性腸症候群市場の展望

  • RedHill Biopharma Limited、4D pharma、Cosmo Pharmaceuticalsなどの主な企業は、それぞれ異なる臨床開発段階でリード候補を評価しています。これらの企業は、過敏性腸症候群の治療薬として自社製品を検討することを目指しています。
  • 主要7市場における過敏性腸症候群の市場規模は、2023年に約2億米ドルでした。
  • 過敏性腸症候群の市場規模は、EU4ヶ国(ドイツ、スペイン、イタリア、フランス)、英国、日本に比べて米国が最大(約1億6,000万米ドル)です。
  • 2024-2034年の予測期間中、ドイツは主要7ヶ国の中で2番目に高い市場規模を占めています。
  • EU4ヶ国と英国の中では、スペインの市場規模が最も小さいものとなっています。

当レポートでは、主要7ヶ国における過敏性腸症候群(IBS)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 過敏性腸症候群市場概要

  • 過敏性腸症候群の薬剤クラス別市場シェア(%)、2020年
  • 過敏性腸症候群の薬剤クラス別市場シェア(%)、2034年

第4章 疫学と市場調査手法

第5章 過敏性腸症候群のエグゼクティブサマリー

第6章 疾患の背景と概要

  • リスク要因
  • 兆候と症状
  • 原因と起因
  • 病態生理学
  • 併存疾患
  • 診断
  • 診断アルゴリズム
  • 治療
  • 治療アルゴリズム
  • 治療と診断のガイドライン

第7章 疫学と患者人口

  • 主な調査結果
  • 前提と根拠:主要7ヶ国
  • 主要7ヶ国における過敏性腸症候群の総罹患数
  • 米国の疫学シナリオ
  • EU4ヶ国と英国の疫学シナリオ
  • 日本の疫学シナリオ

第8章 患者動向

第9章 過敏性腸症候群の臨床試験における主要なエンドポイント

第10章 新興の治療法

  • 主要なクロス競合-新興治療法
  • BEKINDA(RHB-102):RedHill Biopharma Limited
  • Blautix(MRx1234):4D pharma

第11章 上市済み治療法

  • 主な競合
  • VIBERZI/TRUBERZI(エルクサドリン):Abbvie
  • リンゼス/コンステラ(リナクロチド):Ironwood Pharmaceuticals/ Abbvie/ Astellas Pharma
  • IBSRELA(テナパノール):Ardelyx
  • TRULANCE(プレカナチド):Synergy Pharmaceuticals/Bausch Health
  • XIFAXAN(リファキシミン):Salix Pharmaceuticals/Bausch Health

第12章 過敏性腸症候群:主要7ヶ国分析

  • 主な調査結果
  • 市場見通し
  • コンジョイント分析
  • 主要な市場予測の前提条件
  • 主要7ヶ国における過敏性腸症候群の総市場規模
  • 米国の市場規模
  • EU4ヶ国と英国の市場規模
  • 日本の市場規模

第13章 市場アクセスと償還

  • 米国
  • EU4ヶ国と英国
  • 日本
  • 過敏性腸症候群の市場アクセスと償還

第14章 KOLの見解

第15章 SWOT分析

第16章 アンメットニーズ

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

図表

List of Tables

  • Table 1: Summary of Irritable Bowel Syndrome Market and Epidemiology (2020-2034)
  • Table 2: Risk Factors for Irritable Bowel Syndrome
  • Table 3: Differential Diagnosis for Irritable Bowel Syndrome
  • Table 4: Evidence-based Psychological Treatments
  • Table 5: Summary of Medications for Treatment of Irritable Bowel Syndrome-related Symptoms
  • Table 6: Total Prevalent Cases of Irritable Bowel Syndrome in the 7MM, in thousand (2020-2034)
  • Table 7: Total Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 8: Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 9: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 10: Age-specific Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 11: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 12: Classification-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 13: Total Treated Cases of Irritable Bowel Syndrome in the United States, in thousand (2020-2034)
  • Table 14: Total Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 15: Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 16: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 17: Age-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 18: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 19: Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 20: Total Treated Cases of Irritable Bowel Syndrome in EU4 and the UK, in thousand (2020-2034)
  • Table 21: Total Prevalent Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 22: Total Diagnosed Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 23: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 24: Age-specific Prevalent Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 25: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 26: Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 27: Total Treated Cases of Irritable Bowel Syndrome in Japan, in thousand (2020-2034)
  • Table 28: Comparison of Emerging Drugs Under Development
  • Table 29: Blautix, Clinical Trial Description, 2024
  • Table 30: Rifamycin SV MMX, Clinical Trial Description, 2024
  • Table 31: BEKINDA (RHB-102), Clinical Trial Description, 2024
  • Table 32: Aldafermin, Clinical Trial Description, 2024
  • Table 33: Comparison of Marketed Drugs
  • Table 34: Patents
  • Table 35: Efficacy Results in Randomized Clinical Trials
  • Table 36: VIBERZI/TRUBERZI (eluxadoline), Clinical Trial Description, 2024
  • Table 37: Patents
  • Table 38: Efficacy Results in two Placebo-controlled IBS-C Trials
  • Table 39: Linaclotide, Clinical Trial Description, 2024
  • Table 40: Patents
  • Table 41: Efficacy Results in two Placebo-controlled IBS-C Trials: At Least 6 out of 12 Weeks
  • Table 42: Tenapanor, Clinical Trial Description, 2024
  • Table 43: Patents
  • Table 44: Efficacy Results in two Placebo-controlled IBS-C Trials: At Least 6 out of 12 Weeks
  • Table 45: Plecanatide, Clinical Trial Description, 2024
  • Table 46: Patents
  • Table 47: Efficacy Responder Rates
  • Table 48: Percentage of Monthly Responders in Overall Improvement Rating in Irritable Bowel Syndrome Symptoms at the Final Evaluation
  • Table 49: Conjoint Analysis
  • Table 50: Total Market Size of Irritable Bowel Syndrome in the 7MM, USD million (2020-2034)
  • Table 51: Market Size of Irritable Bowel Syndrome in the US, USD million (2020-2034)
  • Table 52: Market Size of Irritable Bowel Syndrome by Therapies in the US, USD million (2020-2034)
  • Table 53: Market Size of Irritable Bowel Syndrome in EU4 and the UK, USD million (2020-2034)
  • Table 54: Market Size of Irritable Bowel Syndrome by Therapies in EU4 and the UK, USD million (2020-2034)
  • Table 55: Market Size of Irritable Bowel Syndrome in Japan, USD million (2020-2034)
  • Table 56: Market Size of Irritable Bowel Syndrome by Therapies in Japan, USD million (2020-2034)
  • Table 57: Key HTA Decisions

List of Figures

  • Figure 1: Epidemiology and Market Methodology
  • Figure 2: Overview of Irritable Bowel Syndrome
  • Figure 3: Three Symptoms Subcategories of Irritable Bowel Syndrome
  • Figure 4: Signs and Symptoms of Irritable Bowel Syndrome.
  • Figure 5: Possible Causes of Irritable Bowel Syndrome
  • Figure 6: Elements in the Pathophysiology of Irritable Bowel Syndrome
  • Figure 7: Overview of the Pathophysiology of Irritable Bowel Syndrome
  • Figure 8: Common Extra-intestinal Comorbidities of Irritable Bowel Syndrome
  • Figure 9: Diagnostic Algorithm for Positive Diagnosis of Irritable Bowel Syndrome
  • Figure 10: Treatment Options in Irritable Bowel Syndrome
  • Figure 11: Treatment Options for irritable bowel syndrome Based on the Symptoms
  • Figure 12: Treatment Algorithm of Irritable Bowel Syndrome
  • Figure 13: Total Prevalent Cases of Irritable Bowel Syndrome in the 7MM (2020-2034)
  • Figure 14: Total Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 15: Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 16: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 17: Age-specific Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 18: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 19: Classification-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 20: Total Treated Cases of Irritable Bowel Syndrome in the United States (2020-2034)
  • Figure 21: Total Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 22: Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 23: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 24: Age-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 25: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 26: Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 27: Total Treated Cases of Irritable Bowel Syndrome in EU4 and the UK (2020-2034)
  • Figure 28: Total Prevalent Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 29: Total Diagnosed Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 30: Gender-specific Prevalent Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 31: Age-specific Prevalent Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 32: Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 33: Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 34: Total Treated Cases of Irritable Bowel Syndrome in Japan (2020-2034)
  • Figure 35: Total Market Size of Irritable Bowel Syndrome in the 7MM, USD million (2020-2034)
  • Figure 36: Market Size of Irritable Bowel Syndrome in the US, USD million (2020-2034)
  • Figure 37: Market Size of Irritable Bowel Syndrome by Therapies in the US, USD million (2020-2034)
  • Figure 38: Market Size of Irritable Bowel Syndrome in EU4 and the UK, USD million (2020-2034)
  • Figure 39: Market Size of Irritable Bowel Syndrome by Therapies in EU4 and the UK, USD million (2020-2034)
  • Figure 40: Market Size of Irritable Bowel Syndrome in Japan, USD million (2020-2034)
  • Figure 41: Market Size of Irritable Bowel Syndrome by Therapies in Japan, USD million (2020-2034)
  • Figure 42: Health Technology Assessment
  • Figure 43: Reimbursement Process in Germany
  • Figure 44: Reimbursement Process in France
  • Figure 45: Reimbursement Process in Italy
  • Figure 46: Reimbursement Process in Spain
  • Figure 47: Reimbursement Process in the United Kingdom
  • Figure 48: Reimbursement Process in Japan
目次
Product Code: DIMI0305

Key Highlights:

  • Irritable bowel syndrome is believed to be a multifactorial disease involving motility dysfunction, visceral hypersensitivity, psychiatric comorbidity, neuroendocrine dysfunction, genetics and epigenetics, diet, and immune activation. Approximately 32 million cases of irritable bowel syndrome were reported in the 7MM in 2023. The United States accounted for ~46% of the total 7MM prevalent cases.
  • It has been observed that irritable bowel syndrome is more prevalent in younger ages (<35 years) as compared to the older age (>=35 years) in the 7MM; additionally, the syndrome is more prevalent among women when compared to men.
  • Among the diagnosed irritable bowel syndrome cases, approximately 89% are categorized under moderate-to-severe whereas ~11% of cases are mild.
  • Furthermore, diarrhea-predominant (IBS-D) is the most prevalent (~35% cases) of the diagnosed patient pool, followed by mixed stool pattern (IBS-M), constipation-predominant (IBS-C), and unspecified (IBS-U).
  • Laxatives, antidiarrheal, antispasmodics, and some extent antidepressants, together with dietary and lifestyle changes have for many years been the mainstay of treatment for irritable bowel syndrome. Laxatives produced the highest sales in 2023.
  • The drugs approved for irritable bowel syndrome with diarrhea and constipations includes VIBERZI (eluxadoline), XIFAXAN (rifaximin), LINZESS (linaclotide), IBSRELA (tenapanor), and TRULANCE (plecanatide). Among the approved therapies, LINZESS garnered approximately USD 600 million revenue.
  • As the US Food and Drug Administration (FDA) approved LINZESS in 2023 for functional constipation among pediatric patients, is likely to make a blockbuster drug by the end of the decade.
  • Although the treatment armamentarium comprises a plethora of drugs, ~60% of patients still are managed non-conventional treatment, owing to dissatisfaction with the efficacy and safety shown by the available prescription drugs.
  • Emerging therapies include biologics (Blautix, and Aldafermin) and small molecules (Rifamycin, and RHB-102). Biologics are anticipated to be a promising class for irritable bowel syndrome in the forthcoming years.

DelveInsight's "Irritable Bowel Syndrome (IBS) - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of Irritable Bowel Syndrome (IBS) epidemiology, market, and clinical development understanding, Addition to this report provides historical and forecasted epidemiology and market data as well as a detailed analysis on the Irritable Bowel Syndrome market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Irritable Bowel Syndrome market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Irritable Bowel Syndrome market size from 2020 to 2034 in 7MM. The report also covers current Irritable Bowel Syndrome treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Irritable Bowel Syndrome Understanding and Treatment Algorithm

Irritable Bowel Syndrome Overview and Diagnosis

Irritable bowel syndrome is a chronic functional bowel disease characterized by symptoms of abdominal pain and/or discomfort associated with altered bowel habits in the absence of a structural or organic cause. Based on bowel patterns at a particular point in time, the disorder may be categorized into four groups:

  • Constipation-predominant (IBS-C)
  • Diarrhea-predominant (IBS-D)
  • Mixed (IBS-M)
  • Unsubtyped

The precise cause of irritable bowel syndrome remains unknown. However, several factors have been implicated in the pathophysiology of irritable bowel syndrome symptoms, including genetic disposition, diet, intestinal microbiota, and low-grade mucosal inflammation. No specific biomarker related to irritable bowel syndrome has been found.

The common feature in all of the diagnostic criteria of Irritable bowel syndrome is abdominal pain and/or discomfort associated with abnormal bowel habits (diarrhea [loose and frequent stools], constipation [hard and infrequent stools], or alternating constipation and diarrhea). These criteria require a certain duration and frequency of the symptoms to fulfill the diagnostic criteria for irritable bowel syndrome.

A variety of criteria that are used to identify a combination of symptoms to diagnose irritable bowel syndrome are Manning Criteria, Rome I, Rome II, Rome III, Rome IV.

Irritable Bowel Syndrome Treatment

Antispasmodics, laxatives, antidiarrheal, and antidepressants together with dietary and lifestyle changes have for many years been the mainstay of treatment for irritable bowel syndrome.

The first-line drug therapy includes antispasmodics and peppermint oil to treat abdominal pain. Loperamide and laxatives can be tried to treat diarrhea or constipation, respectively. If these approaches fail to improve symptoms, second-line treatments, including secretagogues, rifaximin, low-dose tricyclic antidepressants, and eluxadoline, should be used. If abdominal pain persists, tegaserod and alosetron are recommended.

Over the next few years, the US Irritable Bowel Syndrome Market is expected to substantially change and experience growth. Considering that the complexity and diversity of irritable bowel syndrome presentation makes treatment difficult, which is around 30-40%, we expect the market to expand, especially as safer, satisfactory, and effective disease-modifying therapies enter the market.

Irritable Bowel Syndrome Epidemiology

The Irritable Bowel Syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of IBS, diagnosed prevalent cases of IBS, gender-specific prevalent cases of IBS, age-specific prevalent cases of IBS, severity-specific diagnosed prevalent cases of IBS, subtype-specific diagnosed prevalent cases of IBS, treated cases of IBS in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

According to the findings, irritable bowel syndrome is common and affects about 5% of the population or about 1 in 20 people in the US and the prevalence rate of irritable bowel syndrome in the US, Germany, France, Italy, Spain, and the UK, and Japan were found to be 5.3%, 3.7%, 4.2%, 5%, 4.2%, and 4%, and 2.2%, respectively, as per ROME IV criteria.

Irritable bowel syndrome is more significant in females than males. In the United States, the total gender-specific prevalent cases of irritable bowel syndrome were ~4,900,000 and ~9,700,000 in males and females, respectively, in 2023.

Approximately ~48% of diagnosed prevalent cases of irritable bowel syndrome belong to the severe category, whereas ~41% and ~11% of cases are moderate and mild, respectively.

Irritable Bowel Syndrome Recent Developments

  • In January 2025, the FDA granted tentative approval to Amneal Pharmaceuticals' 550 mg rifaximin tablets, referencing Bausch Health's Xifaxan, for treating adults with irritable bowel syndrome with diarrhea (IBS-D).
  • In December 2024, ANI Pharmaceuticals announced the launch of Prucalopride Tablets after receiving final approval from the FDA for its Abbreviated New Drug Application (ANDA). The tablets are the generic version of Motegrity(R).

Irritable Bowel Syndrome Drug Chapters

The drug chapter segment of the Irritable Bowel Syndrome report encloses a detailed analysis of Irritable Bowel Syndrome marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Irritable Bowel Syndrome pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

VIBERZI/TRUBERZI (eluxadoline): Abbvie

VIBERZI (eluxadoline) is a new class of medication acting on local receptors in the gastrointestinal tract. It improves diarrhea and abdominal pain by interacting with mu- and delta opioid receptors in the intestine to slow gastrointestinal motility and reduce visceral pain. Activation of the mu-receptor reduces diarrhea, while antagonism of the delta-receptor enhances the analgesic activity and reduces the risk of constipation.

VIBERZI is currently approved for treating Irritable Bowel Syndrome. It acts locally in the enteric nervous system and decreases adverse effects on the central nervous system. The drug is available in tablet form for oral administration.

LINZESS/CONSTELLA (linaclotide): Ironwood Pharmaceuticals/ Abbvie/ Astellas Pharma

Linaclotide is a guanylate cyclase-C agonist that is thought to work in two ways based on nonclinical studies. It binds to the guanylate cyclase-C receptor locally within the intestinal epithelium. Activation of guanylate cyclase-C results in increased intestinal fluid secretion, accelerated transit, and a decrease in the activity of pain-sensing nerves in the intestine. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS to treat adults with IBS-C. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA for treating adults with moderate-to-severe IBS-C.

Emerging Drugs

BEKINDA (RHB-102): RedHill Biopharma

RHB-102 is an investigational, once-daily, bi-modal release, oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors intended to treat nausea, vomiting, and diarrhea symptoms experienced in some people suffering from acute gastroenteritis, gastritis, and irritable bowel syndrome with diarrhea (IBS-D).

The company has completed a Phase II clinical trial (NCT02757105) of RHB-102 to treat irritable bowel syndrome with predominant diarrhea (IBS-D).

Blautix (MRx1234): 4D pharma

Blautix (MRx1234) is a single-strain live biotherapeutic product (LBP), being developed as a treatment for both IBS-C and IBS-D and has the potential to become the first-ever disease-modifying therapy suitable for all irritable bowel syndrome patients regardless of clinical subtype. Blautix has a unique metabolism, consuming hydrogen and producing acetate, which promotes bacterial cross-feeding of the microbiota increasing diversity and stability, two attributes that have been demonstrated to be decreased in patients with irritable bowel syndrome compared to healthy controls.

The company has completed a Phase II clinical trial (NCT03721107) of blautix in adults for the treatment of irritable bowel syndrome with predominant constipation (IBS-C) or diarrhea (IBS-D).

Irritable Bowel Syndrome Market Outlook

  • Key players, such as RedHill Biopharma Limited, 4D pharma, Cosmo Pharmaceuticals, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Irritable Bowel Syndrome.
  • The market size of Irritable Bowel Syndrome in the seven major markets was around USD 2000 million in 2023.
  • The United States accounts for the largest market size (around USD 1600 million) of Irritable Bowel Syndrome, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
  • Germany accounts for the second highest market size in the 7MM during the forecast period 2024-2034.
  • Among EU4 and the UK, Spain had the smallest market size.

Irritable Bowel Syndrome Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Irritable Bowel Syndrome Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Irritable Bowel Syndrome Syndrome emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Irritable Bowel Syndrome. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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 gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, 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 event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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

There are five drugs approved for irritable bowel syndrome in the United States, namely VIBERZI (eluxadoline), LINZESS (linaclotide), IBSRELA (tenapanor), TRULANCE (plecanatide), and XIFAXAN (rifaximin). Market access and reimbursement options can differ depending on regulatory status, the size of the target population, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.

At a policy level, irritable bowel syndrome prescription drug coverage remains just as necessary in the appropriate management of irritable bowel syndrome as in other chronic medical conditions. Irritable bowel syndrome prescription drug prices at a policy level would improve treatment satisfaction and adherence, recognizing that prior authorization restrictions and other insurance barriers directly cause over 1/3 of treatment discontinuations among IBS-C patients who can successfully start prescription drug therapy. Factors driving treatment preference based on cost-effectiveness differed between patients and payers in a sensitivity analysis. Drug prices and costs of associated irritable bowel syndrome care largely drove the treatment preferences of payers; this contrasted with the patient's perspective. Payer preference toward SSRI is primarily driven by the comparatively low cost of citalopram (USD 0.03/pill) compared to per-pill costs of linaclotide (USD 13.57), plecanatide (USD 13.20) and lubiprostone (USD 5.92). Even the most expensive SSRI evaluated in an IBS-C trial (paroxetine; USD 1.90/pill) resulted in only 14-16% of the cost of an annual supply of on-label drugs exceeding USD 4,000 annually. Consistent with denials of coverage, prior authorizations, and formulary restrictions which gastroenterologists face in daily practice, it is suggested that physicians who use SSRIs in IBS-C may find them more cost-effective than on-label drugs at their current prices.

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. The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, descriptive overview of Irritable Bowel Syndrome, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the Irritable Bowel Syndrome market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Irritable Bowel Syndrome market.

Irritable Bowel Syndrome Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Irritable Bowel Syndrome Pipeline Analysis
  • Irritable Bowel Syndrome Market Size and Trends
  • Existing and future Market Opportunity

Irritable Bowel Syndrome Report Key Strengths

  • Ten Years Forecast
  • 7MM Coverage
  • Irritable Bowel Syndrome Epidemiology Segmentation
  • Inclusion of Country specific treatment guidelines
  • KOL's feedback on approved and emerging therapies
  • Key Cross Competition
  • Conjoint analysis
  • Drugs Uptake and Key Market Forecast Assumptions

Irritable Bowel Syndrome Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

  • What is the growth rate of the 7MM Irritable Bowel Syndrome treatment market?
  • What was the Irritable Bowel Syndrome total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
  • Is there any unexplored patient setting that can open the window for growth in the future?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
  • What are the current and emerging options for the treatment of Irritable Bowel Syndrome?
  • How many companies are developing therapies for the treatment of Irritable Bowel Syndrome?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Irritable Bowel Syndrome Market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1 Key Insights

2 Report Introduction

3 Irritable Bowel Syndrome Market Overview at a Glance

  • 3.1 Market Share (%) Distribution of Irritable Bowel Syndrome by Drug-class in 2020
  • 3.2 Market Share (%) Distribution of Irritable Bowel Syndrome by Drug-class in 2034

4 Epidemiology and Market Methodology

5 Executive Summary of Irritable Bowel Syndrome

  • 5.1 Key Events

6 Disease Background and Overview

  • 6.1 Risk Factors
  • 6.2 Signs and Symptoms
  • 6.3 Causes and Triggers
  • 6.4 Pathophysiology
  • 6.5 Comorbidities
  • 6.6 Diagnosis
    • 6.6.1 Symptom-based Diagnostic Criteria
      • 6.6.1.1 Manning Criteria
      • 6.6.1.2 Rome I
      • 6.6.1.3 Rome II
      • 6.6.1.4 Rome III
      • 6.6.1.5 Rome IV
    • 6.6.2 Differential Diagnosis
  • 6.7 Diagnostic Algorithm
  • 6.8 Treatment
    • 6.8.1 Dietary Therapy
    • 6.8.2 Psychotherapy
    • 6.8.3 Microbial Manipulation
    • 6.8.4 Pharmacotherapy
      • 6.8.4.1 IBS-C (Irritable Bowel Syndrome With Constipation)
      • 6.8.4.1.1 Fibers
      • 6.8.4.1.2 Prokinetics
      • 6.8.4.1.3 Anticholinergics
      • 6.8.4.1.4 Dopamine Antagonists
      • 6.8.4.1.5 Serotonergic Agonists
      • 6.8.4.1.6 Antibiotics
      • 6.8.4.1.7 Laxatives
      • 6.8.4.2 IBS-D (Irritable bowel syndrome with diarrhea)
      • 6.8.4.2.1 Antispasmodics
      • 6.8.4.2.2 Antidiarrheal drugs
      • 6.8.4.2.3 Antidepressants
    • 6.8.5 Alternative Treatment
      • 6.8.5.1 Peppermint Oil
      • 6.8.5.2 Turmeric Extract
      • 6.8.5.3 Chamomile Drops
  • 6.9 Treatment Algorithm
  • 6.10 Treatment and Diagnostic Guidelines
    • 6.10.1 Italian Guidelines for the Management of Irritable Bowel Syndrome (2022)
    • 6.10.2 British Society of Gastroenterology Guidelines on the Management of Irritable Bowel Syndrome (2021)
    • 6.10.3 Japanese Society of Gastroenterology: Evidence-based Clinical Practice Guidelines for Irritable Bowel Syndrome (2021)
    • 6.10.4 The American College of Gastroenterology: Clinical Guideline on Management of Irritable Bowel Syndrome (2020)

7 Epidemiology and Patient Population

  • 7.1 Key Findings
  • 7.2 Assumptions and Rationale: The 7MM
  • 7.3 Total Prevalent Cases of Irritable Bowel Syndrome in the 7MM
  • 7.4 Epidemiology Scenario in the United States
    • 7.4.1 Total Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.2 Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.3 Gender-specific Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.4 Age-specific Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.5 Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.6 Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in the United States
    • 7.4.7 Total Treated Cases of Irritable Bowel Syndrome in the United States
  • 7.5 Epidemiology Scenario in EU4 and the UK
    • 7.5.1 Total Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.2 Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.3 Gender-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.4 Age-specific Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.5 Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.6 Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in EU4 and the UK
    • 7.5.7 Total Treated Cases of Irritable Bowel Syndrome in EU4 and the UK
  • 7.6 Epidemiology Scenario in Japan
    • 7.6.1 Total Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.2 Total Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.3 Gender-specific Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.4 Age-specific Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.5 Severity-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.6 Subtype-specific Diagnosed Prevalent Cases of Irritable Bowel Syndrome in Japan
    • 7.6.7 Total Treated Cases of Irritable Bowel Syndrome in Japan

8 Patient Journey

9 Key Endpoints in Irritable Bowel Syndrome Clinical Trials

10 Emerging Therapies

  • 10.1 Key Cross Competition - Emerging Therapies
  • 10.4 BEKINDA (RHB-102): RedHill Biopharma Limited
    • 10.4.1 Product Description
    • 10.4.2 Other Developmental Activities
    • 10.4.3 Clinical Developmental Activities
      • 10.4.3.1 Clinical Trial Information
    • 10.4.4 Safety and Efficacy
  • 10.5 Blautix (MRx1234): 4D pharma
    • 10.5.1 Product Description
    • 10.5.2 Clinical Developmental Activities
      • 10.5.2.1 Clinical Trial Information
    • 10.5.3 Safety and Efficacy

11 Marketed Therapies

  • 11.1 Key Competitors
  • 11.2 VIBERZI/TRUBERZI (eluxadoline): Abbvie
    • 11.2.1 Product Description
    • 11.2.2 Regulatory Milestones
    • 11.2.3 Other Developmental Activities
    • 11.2.4 Pivotal Clinical Trial
      • 11.2.4.1 Summary of Pivotal Clinical Trial
    • 11.2.5 Ongoing Pipeline Activity
      • 11.2.5.1 Clinical Trials Information
  • 11.3 LINZESS/CONSTELLA (linaclotide): Ironwood Pharmaceuticals/ Abbvie/ Astellas Pharma
    • 11.3.1 Product Description
    • 11.3.2 Regulatory Milestones
    • 11.3.3 Other Developmental Activities
    • 11.3.4 Pivotal Clinical Trial
      • 11.3.4.1 Summary of Pivotal Clinical Trial
    • 11.3.5 Ongoing Pipeline Activity
      • 11.3.5.1 Clinical Trials Information
  • 11.4 IBSRELA (tenapanor): Ardelyx
    • 11.4.1 Product Description
    • 11.4.2 Regulatory Milestones
    • 11.4.3 Other Developmental Activities
    • 11.4.4 Pivotal Clinical Trial
      • 11.4.4.1 Summary of Pivotal Clinical Trial
    • 11.4.5 Ongoing Pipeline Activity
      • 11.4.5.1 Clinical Trials Information
  • 11.5 TRULANCE (plecanatide): Synergy Pharmaceuticals/Bausch Health
    • 11.5.1 Product Description
    • 11.5.2 Regulatory Milestones
    • 11.5.3 Other Developmental Activities
    • 11.5.4 Pivotal Clinical Trial
      • 11.5.4.1 Summary of Pivotal Clinical Trial
    • 11.5.5 Ongoing Pipeline Activity
      • 11.5.5.1 Clinical Trials Information
  • 11.6 XIFAXAN (rifaximin): Salix Pharmaceuticals/Bausch Health
    • 11.6.1 Product Description
    • 11.6.2 Regulatory Milestones
    • 11.6.3 Other Developmental Activities
    • 11.6.4 Pivotal Clinical Trial
      • 11.6.4.1 Summary of pivotal clinical trial

12 Irritable Bowel Syndrome: The 7MM Analysis

  • 12.1 Key Findings
  • 12.2 Market Outlook
  • 12.3 Conjoint Analysis
  • 12.4 Key Market Forecast Assumptions
  • 12.5 Total Market Size of Irritable Bowel Syndrome in the 7MM
  • 12.6 The United States Market Size
    • 12.6.1 Total market size of Irritable Bowel Syndrome in the US
    • 12.6.2 Market size of Irritable Bowel Syndrome by therapies in the US
  • 12.7 EU4 and the UK Market Size
    • 12.7.1 Total market size of Irritable Bowel Syndrome in EU4 and the UK
    • 12.7.2 Market size of Irritable Bowel Syndrome by therapies in EU4 and the UK
  • 12.8 Japan Market Size
    • 12.8.1 Total Market Size of Irritable Bowel Syndrome in Japan
    • 12.8.2 Market size of Irritable Bowel Syndrome by therapies in Japan

13 Market Access and Reimbursement

  • 13.1 The United States
    • 13.1.1 Centre for Medicare and Medicaid Services (CMS)
  • 13.2 In EU4 and the UK
    • 13.2.1 Germany
    • 13.2.2 France
    • 13.2.3 Italy
    • 13.2.4 Spain
    • 13.2.5 United Kingdom
  • 13.3 Japan
    • 13.3.1 MHLW
  • 13.4 Market Access and Reimbursement of Irritable Bowel Syndrome
    • 13.4.1 Key HTA Decisions
    • 13.4.2 Patient Access Programs

14 KOL Views

15 SWOT Analysis

16 Unmet Needs

17 Appendix

  • 17.1 Bibliography
  • 17.2 Report Methodology

18 DelveInsight Capabilities

19 Disclaimer