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한글목차
주요 하이라이트
과민성대장증후군은 운동 기능 장애, 내장 과민성, 정신 질환 합병증, 신경 내분비 기능 장애, 유전학 및 후생유전학, 식습관, 면역 활성화가 관여하는 다인자 질환으로 여겨지고 있으며, 2023년 주요 7개국에서 약 3,200만 건의 과민성대장증후군이 보고되었습니다. 미국은 주요 7개국 전체 환자의 약 46%를 차지합니다. 주요 7개국에서 과민성대장증후군은 35세 이상 연령층에 비해 젊은 연령층(35세 미만)에서 더 많이 발생하는 것으로 나타났습니다. 또한, 이 증후군은 남성에 비해 여성에게 더 많이 발생합니다.
과민성대장증후군으로 진단된 사례 중 약 89%는 중등도-중증으로 분류되며, 경증은 -11%였습니다.
또한, 설사 우세(IBS-D)가 가장 많고(-35%), 혼합변 패턴(IBS-M), 변비 우세(IBS-C), 불명확(IBS-U)이 그 뒤를 이었습니다.
완하제, 지사제, 진경제, 항경련제, 그리고 어느 정도의 항우울제가 식이요법과 생활습관 개선과 함께 과민성 대장증후군 치료의 주축을 이루고 있으며, 2023년에는 완하제가 가장 높은 판매량을 기록했습니다.
설사와 변비를 동반한 과민성대장증후군 치료제로 승인된 약물은 VIBERZI(eluxadoline), XIFAXAN(rifaximin), LINZESS(linaclotide), IBSRELA(tenapanor), TRULANCE(plecanatide) 등이 있습니다. plecanatide) 등이 있습니다. 승인된 치료제 중 린제스는 약 6억 달러의 매출을 기록했습니다.
미국 식품의약국(FDA)은 2023년 린제스를 소아 환자의 기능성 변비 치료제로 승인했으며, 10년 후에는 블록버스터 의약품이 될 가능성이 높습니다.
많은 종류의 치료제가 있지만, 환자의 약 60%는 처방약별 효과와 안전성에 불만이 있어 비재래식 치료를 받고 있습니다.
새로운 치료법으로는 생물학적 제제(Blautix, Aldafermin)와 저분자 제제(Rifamycin, RHB-102)가 있습니다. 생물학적 제제는 과민성대장증후군 치료제로서 향후 몇 년 동안 유망한 계열이 될 것으로 예상됩니다.
본 보고서는 과민성대장증후군(IBS)의 역학, 시장, 임상 개발에 대한 상세한 분석을 제공합니다. 미국, EU 4개국(독일, 스페인, 이탈리아, 프랑스), 영국, 일본의 과민성대장증후군 시장 동향에 대한 상세한 분석과 함께 역학 및 시장 관련 과거 및 예측 데이터를 제공합니다.
실제 처방 패턴 분석, 신약 평가, 시장 점유율, 개별 치료법 채택/사용 패턴, 2020년에서 2034년까지 과민성대장증후군 시장 규모(주요 7개국)의 과거 및 예측을 제공합니다. 또한, 과민성대장증후군의 현재 치료법/알고리즘과 미충족 의료 수요를 다루며, 최적의 기회를 발굴하고 시장 잠재력을 평가합니다.
과민성대장증후군은 구조적 또는 기질적 원인이 없음에도 불구하고 장 습관의 변화에 따른 복통 및/또는 불편감을 특징으로 하는 만성 기능성 장 질환입니다. 특정 시점의 장 패턴에 따라 이 질환은 네 가지 그룹으로 분류됩니다.
변비 우세형(IBS-C)
설사 우세형(IBS-D)
혼합형(IBS-M)
미분류
과민성대장증후군의 정확한 원인은 밝혀지지 않았습니다. 그러나 과민성 대장증후군 증상의 병태생리에는 유전적 체질, 식습관, 장내 세균총, 저악성 점막 염증 등 여러 가지 요인이 관여하고 있습니다. 과민성대장증후군과 관련된 특이적인 바이오마커는 아직 발견되지 않았습니다.
과민성대장증후군의 모든 진단 기준의 공통적인 특징은 비정상적인 배변 습관(설사[느슨하고 잦은 배변], 변비[딱딱하고 잦은 배변], 또는 변비와 설사가 번갈아 나타나는 경우)에 따른 복통 및/또는 불편감입니다. 이러한 기준은 과민성대장증후군의 진단 기준을 충족하기 위해 일정한 기간과 빈도의 증상을 필요로 합니다.
과민성대장증후군을 진단하기 위해 증상의 조합을 식별하는 데 사용되는 다양한 기준은 Manning 기준, Rome I, Rome II, Rome III, Rome IV입니다.
일차적인 약물요법으로는 진경제와 페퍼민트 오일을 이용한 복통치료가 있습니다. 설사나 변비 치료에는 각각 로페라미드나 완하제를 사용해 볼 수 있습니다. 이러한 방법으로 증상이 개선되지 않으면 분비 촉진제, 리팍시민, 저용량 삼환계 항우울제, 엘록사드린과 같은 2차 선택적 치료를 시행합니다. 복통이 지속되는 경우, 테가세로드나 알로세트론이 권장됩니다.
향후 몇 년 동안 미국 과민성대장증후군 시장은 크게 변화하고 성장할 것으로 예상됩니다. 과민성대장증후군의 증상이 복잡하고 다양하여 치료가 어렵고, 그 비율이 약 30-40%인 점을 감안할 때, 특히 보다 안전하고 만족스럽고 효과적인 질환 조절 요법이 시장에 진입하면 시장이 확대될 것으로 예상됩니다.
과민성대장증후군은 흔한 질환으로 미국에서는 인구의 약 5%, 약 20명 중 1명이 앓고 있으며, 미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본에서의 과민성대장증후군의 유병률은 ROME IV 기준으로 각각 5.3%, 3.7%, 4.2%, 5%, 4.2%, 2.2%인 것으로 알려져 있습니다. 알고 있습니다.
과민성대장증후군은 남성보다 여성에게 더 많이 발생합니다. 미국에서는 2023년 남녀별 과민성대장증후군 유병자 수가 남성은 490만 명, 여성은 970만 명에 달했습니다.
과민성대장증후군 진단을 받은 환자의 약 48%는 중증에 속하며, 중등도 및 경증은 각각 41%와 11%입니다.
2024년 12월, Amneal Pharmaceuticals는 FDA로부터 신약허가신청(ANDA)의 최종 승인을 받아 풀칼로퓨리드 정제의 출시를 발표하였습니다. 이 정제는 Motegrity(R)의 제네릭 의약품입니다.
시판 중인 약품
VIBERZI/TRUBERZI(엘록사드린) : Abbvie
VIBERZI(eluxadoline)는 소화관의 국소 수용체에 작용하는 새로운 계열의 약물입니다. 장내 뮤 및 델타 오피오이드 수용체와 상호작용하여 설사 및 복통을 개선하고, 소화관 운동을 느리게 하여 내장 통증을 감소시킵니다. 뮤 수용체 활성화는 설사를 완화하고, 델타 수용체 길항 작용은 진통 작용을 강화하고 변비 위험을 줄입니다.
비벨지는 현재 과민성대장증후군 치료제로 승인되었습니다. 장 신경계에 국소적으로 작용하여 중추신경계에 대한 부작용을 감소시킵니다. 경구 투여용 정제로 제공됩니다.
리나클로티드는 구아닐산시클라아제-C 작용제이며, 비임상시험을 통해 두 가지 작용기전이 추정되고 있습니다. 리나클로티드는 장 상피의 국소 부위에서 구아닐산시클라아제-C 수용체에 결합합니다. 구아닐산시클라아제-C가 활성화되면 장액 분비가 증가하고, 통과가 촉진되며, 장의 통증을 감지하는 신경의 활동이 감소합니다. 미국에서는 아이언우드사와 Abbvie사가 성인 IBS-C 치료제로 린제스를 공동 개발하여 공동 판매하고 있습니다. 유럽에서는 리나크로티드를 중등도에서 중증의 IBS-C 치료제로 CONSTELLA라는 브랜드명으로 판매하고 있습니다.
신약
베킨다(RHB-102) : RedHill Biopharma
RHB-102는 5-HT3 세로토닌 수용체 억제제 계열의 주요 성분인 온단세트론의 1일 1회 경구제이며, 급성 위장염, 위염, 설사를 동반한 과민성대장증후군(IBS-D)에 수반되는 메스꺼움, 구토, 설사 증상을 치료하기 위한 치료제입니다.
설사를 주 증상으로 하는 과민성대장증후군(IBS-D)을 대상으로 한 RHB-102의 임상 2상(NCT02757105)을 완료했습니다.
Blautix（MRx1234） : 4D pharma
Blautix(MRx1234)는 IBS-C와 IBS-D 치료제로 개발 중인 단일 균주 생균제(LBP)로, 임상적 아형에 관계없이 모든 과민성대장증후군 환자에게 적합한 최초의 질환 개선 치료제가 될 수 있습니다. 아세트산을 생성하는 독특한 대사를 가지고 있으며, 미생물총의 다양성과 안정성을 향상시키는 박테리아의 상호섭취를 촉진합니다. 이 두 가지 특성은 과민성대장증후군 환자에서 정상 대조군에 비해 감소된 것으로 입증되었습니다.
회사는 성인 대상 변비 우세형 과민성대장증후군(IBS-C) 또는 설사 우세형 과민성대장증후군(IBS-D) 치료제로서 브라우탁스의 성인 대상 임상 2상(NCT03721107)을 완료했습니다.
과민성대장증후군 시장 전망
RedHill Biopharma Limited, 4D pharma, Cosmo Pharmaceuticals 등 주요 기업들은 각기 다른 임상 개발 단계에서 주요 후보물질을 평가하고 있습니다. 이들 기업은 과민성대장증후군 치료제로 자사 제품을 검토하는 것을 목표로 하고 있습니다.
주요 7개 시장의 과민성대장증후군 시장 규모는 2023년 약 2억 달러에 달했습니다.
과민성대장증후군의 시장 규모는 EU 4개국(독일, 스페인, 이탈리아, 프랑스), 영국, 일본에 비해 미국이 가장 큰 시장(약 1억 6,000만 달러)을 형성하고 있습니다.
2024-2034년 예측 기간 동안 독일은 주요 7개국 중 두 번째로 높은 시장 규모를 차지하고 있습니다.
EU 4개국과 영국 중 스페인의 시장 규모가 가장 작은 것으로 나타났습니다.
세계 주요 7개국 과민성대장증후군(IBS) 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등의 정보를 정리하여 전해드립니다.
TRULANCE(plecanatide) : Synergy Pharmaceuticals/Bausch Health
XIFAXAN(rifaximin) : Salix Pharmaceuticals/Bausch Health
제12장 과민성대장증후군 : 주요 7개국 분석
주요 조사 결과
시장 전망
컨조인트 분석
주요 시장 예측 가정
주요 7개국의 과민성대장증후군 전체 시장 규모
미국의 시장 규모
EU 4개국과 영국의 시장 규모
일본의 시장 규모
제13장 시장 접근과 상환
미국
EU 4개국과 영국
일본
과민성대장증후군 시장 접근과 상환
제14장 KOL의 견해
제15장 SWOT 분석
제16장 미충족 수요
제17장 부록
제18장 DelveInsight의 서비스 내용
제19장 면책사항
ksm
영문 목차
영문목차
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.
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.
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
