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市場調査レポート
商品コード
1705101
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 |
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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 |
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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主なハイライト
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。
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。
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。
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。
Key Highlights:
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.
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:
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.
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
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).
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.