ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
ㅁ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송기일은 문의해 주시기 바랍니다.
한글목차
중요한 하이라이트
기능성 변비는 유기적 원인이 없는 변비로 정의되며, 로마 기준에 따라 진단됩니다.
성인의 경우, 효과적인 치료를 위해 추가 검사를 통해 기능성 변비의 하위 유형(정상 통과형, 통과 지연형, 배변 장애형)을 구분하는 것이 중요합니다. 지속적인 변비가 있는 환자는 대장 통과 시간 및 항문직장압측정법과 같은 검사를 포함한 추가 평가를 위해 소화기내과 전문의를 방문해야 합니다.
소아기에도 흔히 발생하는 문제로, 전 세계 유병률은 약 3%로 추정됩니다.
기능성 변비의 원인은 배변 시 통증 경험, 식이섬유 부족, 낮은 신체 활동량, 심리적 스트레스 요인, 발달 문제 등이 있습니다. 사회경제적 배경과 무관하게 동등한 유병률을 보입니다.
치료는 일반적으로 변비 완화 후 유지 요법, 식이 조절(섬유질 및 수분 섭취 증가), 행동 전략을 포함합니다. 약물 치료 옵션으로는 삼투성 완하제와 성인용 신약인 LINZESS, TRULANCE 등이 있습니다.
최근의 발전으로 기능성 변비 치료 옵션이 확대되고 있습니다. 예를 들어, 2023년 6월에는 Ironwood Pharmaceuticals가 LINZESS(linaclotide)의 신효능으로서 6세-17세의 소아 환자의 기능성 변비 치료에의 사용이 FDA로부터 승인되었습니다.
기능성 변비의 효과적인 관리는 소아과 의사, 소화기내과 전문의, 영양사가 협력하는 접근법이 필요합니다. 이러한 다학제적 팀워크는 질환의 복잡한 특성을 해결하고 최적의 환자 결과를 달성하는 데 필수적입니다.
기능성 변비 시장 전망
기능성 변비 치료제 시장은 특히 고령 인구와 여성에서 증가하는 유병률에 힘입어 유망합니다. 소화기 건강에 대한 인식 제고와 진단 방법의 발전으로 더 많은 사람들이 의료적 개입을 찾고 있습니다. 제약 업계는 루비프로스톤, 리나클로타이드, 프루칼로프라이드와 같은 혁신적인 치료제로 이러한 수요에 대응하고 있으며, 이들은 새로운 작용 기전과 향상된 효능을 제공합니다. 또한 장 건강과 생활 습관 관리에 대한 관심이 증가하면서 처방약과 일반의약품 솔루션에 대한 수요가 동시에 증가하고 있습니다.
본 보고서는 기능성 변비의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대한 조사 분석을 통해 각국 시장 규모와 예측, 각 치료법 시장 점유율, 현재의 치료법, 미충족 필요 등의 정보를 제공합니다.
목차
제1장 보고서 개요
제2장 기능성 변비의 주요 요약
제3장 기능성 변비 시장 점유율 개요
주요 7시장의 기능성 변비 시장 규모(2020년)
주요 7시장의 기능성 변비 시장 규모(2034년)
제4장 질병의 배경과 개요
원인
징후 및 증상
병리생리학
위험 인자
진단
제5장 환자 여정
제6장 역학과 환자 인구
전제조건과 근거
주요 7개 시장의 기능성 변비 총 유병률
주요 7개 시장의 기능성 변비로 진단받은 환자 수
주요 7개 시장의 기능성 변비 진단 유병률 : 성별
주요 7개 시장의 기능성 변비의 진단 유병률 : 연령별
제7장 기능성 변비의 역학 : 국가별
미국
전제조건과 근거
기능성 변비 총 유병률
기능성 변비로 진단받은 환자 수
기능성 변비의 진단 유병률 : 성별
기능성 변비의 진단 유병률 : 연령별
유럽 4개국 및 영국
일본
제8장 현재의 치료와 의료 행위
치료 알고리즘
기능성 변비의 치료에 관한 가이드라인과 제안
미국
유럽
일본
제9장 시판 중인 약품
LINZESS(linaclotide) : Ironwood.
제품 설명
규제 관련 주요 단계
연구개발
임상 개발
안전성과 유효성
제품 프로파일
TRULANCE(plecanatide) : Synergy Pharmaceuticals/Bausch Health Companies
제10장 기능성 변비 시장 규모
주요 시장의 전제조건
속성 분석
주요 7시장의 기능성 변비 분석
주요 7개 시장의 기능성 변비 분석 : 치료법별
제11장 기능성 변비 시장 규모 : 지역별
미국
기능성 변비 총 시장 규모
기능성 변비 총 시장 규모 : 치료법별
유럽 4개국 및 영국
일본
제12장 KOL의 견해
제13장 SWOT 분석
제14장 미충족 요구
제15장 보험급여 및 시장 진입
제16장 부록
제17장 참고문헌
제18장 보고서의 조사 방법
제19장 DelveInsight의 서비스 내용
제20장 면책사항
제21장 DelveInsight 정보
HBR
영문 목차
영문목차
Key Highlights:
Functional constipation is defined as constipation without an organic aetiology and is diagnosed according to the Rome criteria.
In adults, differentiating between subtypes of functional constipation (normal transit, slow transit, and evacuation disorders) through additional testing is crucial for effective treatment. Patients with persistent constipation should see a gastroenterologist for further evaluation, including tests like colonic transit time and anorectal manometry.
It is a common problem in childhood, with an estimated prevalence of 3% worldwide.
Factors contributing to functional constipation include a history of painful defecation, inadequate dietary fiber, low physical activity, psychological stressors, and developmental issues. It is equally prevalent among different socioeconomic backgrounds
Treatment typically involves disimpaction followed by maintenance therapy, dietary modifications (increased fiber and fluid intake), and behavioral strategies. Pharmacological options include osmotic laxatives and newer medications like LINZESS, TRULANCE, and others for adults.
Recent advancements are enhancing the treatment options for functional constipation. For example, in June 2023, Ironwood Pharmaceuticals received FDA approval for a new indication of LINZESS (linaclotide), expanding its use to treat functional constipation in pediatric patients aged 6 to 17 years.
Effective management of functional constipation demands a collaborative approach involving pediatricians, gastroenterologists, and nutritionists. This multidisciplinary teamwork is essential to address the complex nature of the condition and achieve optimal patient outcomes.
DelveInsight's "Functional Constipation - Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of functional constipation, historical and forecasted epidemiology as well as the functional constipation market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The functional constipation market report provides real-world prescription pattern analysis, market share of individual therapies, and historical and forecasted 7MM functional constipation market size from 2020 to 2034. The report also covers current functional constipation 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
Functional Constipation Understanding and Treatment Algorithm
Functional Constipation Overview, Country-Specific Treatment Guidelines and Diagnosis
Constipation is a prevalent issue within the digestive system, often arising from dietary habits, medications, endocrine or metabolic disorders, neurological conditions, psychiatric issues, or gastrointestinal blockages. In cases where no underlying cause is identified, the condition is termed functional constipation, also known as chronic idiopathic constipation. This form of constipation lacks any anatomical or physiological origin and is characterized by symptoms occurring at least twice a week for a minimum of three months, without meeting the criteria for irritable bowel syndrome (IBS). Understanding and identifying functional constipation is crucial, as it underscores the importance of addressing lifestyle and dietary factors in managing digestive health.
Doctors often diagnose functional constipation using the Rome IV criteria. This set of criteria defines functional constipation separately for children and adults.
The functional constipation report provides an overview of functional constipation pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient's journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.
Functional Constipation Treatment
Treatments for functional constipation focus on a combination of dietary modifications, lifestyle changes, and pharmacological interventions. Initial management typically involves disimpaction to remove hard stool from the colon, often using polyethylene glycol (PEG) as a first-line laxative. Following disimpaction, maintenance therapy may include osmotic laxatives, stool softeners, or stimulant laxatives to keep stools soft and regular. Dietary recommendations emphasize a high fiber intake, adequate hydration, and regular physical activity. In children, behavioral strategies such as establishing a routine for toilet use and addressing any psychological factors are also crucial.
Functional Constipation Epidemiology
The functional constipation epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The functional constipation epidemiology is segmented with detailed insights into the total prevalence of functional constipation, diagnosed prevalence of functional constipation, gender-specific diagnosed prevalence of functional constipation, and age-specific diagnosed prevalence of functional constipation.
Functional constipation accounts for more than 95% of cases of constipation in healthy children aged one year and older.
Functional constipation is particularly common among preschool-aged children.
According to findings, the prevalence of chronic constipation was reported to be 5.5% in US, according to the Rome III criteria, and it was found to be 2.1% based on medical consultations in Japan.
Functional Constipation Drug Chapters
The drug chapter segment of the functional constipation report encloses a detailed analysis of functional constipation marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the functional constipation pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.
Marketed Drugs
LINZESS (linaclotide): Ironwood
LINZESS is a a guanylate cyclase (GC)-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. It is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort, and pain associated with irritable bowel syndrome with constipation, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with chronic idiopathic constipation.
TRULANCE (plecanatide): Synergy Pharmaceuticals/ Bausch Health Companies
Plecanatide is structurally related to human uroguanylin, and similar to uroguanylin, plecanatide functions as a guanylate cyclase-C (GC-C) agonist. Both plecanatide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both
intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). It is approved for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.
Functional Constipation Market Outlook
The market for functional constipation treatments is promising, fueled by the rising prevalence of the condition, particularly among aging populations and women. Increased awareness of digestive health and advancements in diagnostic methods are leading more individuals to seek medical intervention. The pharmaceutical industry is meeting this demand with innovative therapies like lubiprostone, linaclotide, and prucalopride, which provide new mechanisms of action and enhanced efficacy. Additionally, the growing focus on gut health and lifestyle management is driving the demand for both prescription and over-the-counter solutions.
Functional Constipation 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.
Functional Constipation 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.
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 functional constipation. 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
The report 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 functional constipation, 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.
A detailed review of the functional constipation 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 functional constipation market.
Functional Constipation Report Insights
Patient Population
Therapeutic Approaches
Functional Constipation Pipeline Analysis
Functional Constipation Market Size and Trends
Existing and future Market Opportunity
Functional Constipation Report Key Strengths
Eleven Years Forecast
7MM Coverage
Functional Constipation Epidemiology Segmentation
Inclusion of Country specific treatment guidelines
KOL's feedback on therapies
Key Cross Competition
Conjoint analysis
Drugs Uptake and Key Market Forecast Assumptions
Functional Constipation 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 functional constipation treatment market?
What was the functional constipation 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?
What are the current options for the treatment of functional constipation?
How many companies are developing therapies for the treatment of functional constipation?
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 functional constipation 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.
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. Report Introduction
2. Executive Summary of Functional Constipation
3. Functional Constipation Market Share at a glance
3.1. Seven Major Market Size of Functional Constipation in 2020
3.2. Seven Major Market Size of Functional Constipation in 2034
4. Disease Background and Overview
4.1. Causes
4.2. Signs and symptoms
4.3. Pathophysiology
4.4. Risk Factors
4.5. Diagnosis
5. Patient Journey
6. Epidemiology and Patient Population
6.1. Assumptions and Rationale
6.2. Total Prevalence of Functional Constipation in the 7MM
6.3. Diagnosed Cases of Functional Constipation in the 7MM
6.4. Gender-specific Diagnosed Prevalence of Functional Constipation in the 7MM
6.5. Age-specific Diagnosed Prevalence of Functional Constipation in the 7MM
7. Country Wise: Epidemiology of Functional Constipation
7.1. United States
7.1.1. Assumptions and Rationale
7.1.2. Total Prevalence of Functional Constipation
7.1.3. Diagnosed Cases of Functional Constipation
7.1.4. Gender-specific Diagnosed Prevalence of Functional Constipation
7.1.5. Age-specific Diagnosed Prevalence of Functional Constipation
7.2. EU4 & the UK
7.2.1. Total Prevalence of Functional Constipation
7.2.2. Diagnosed Cases of Functional Constipation
7.2.3. Gender-specific Diagnosed Prevalence of Functional Constipation
7.2.4. Age-specific Diagnosed Prevalence of Functional Constipation
7.3. Japan
7.3.1. Total Prevalence of Functional Constipation
7.3.2. Diagnosed Cases of Functional Constipation
7.3.3. Gender-specific Diagnosed Prevalence of Functional Constipation
7.3.4. Age-specific Diagnosed Prevalence of Functional Constipation
8. Current Treatment and Medical Practices
8.1. Treatment Algorithm
8.2. Guidelines and Recommendations for Treatment of Functional Constipation
8.2.1. United States
8.2.2. Europe
8.2.3. Japan
9. Marketed Drugs
9.1. LINZESS (linaclotide): Ironwood.
9.1.1. Product Description
9.1.2. Regulatory Milestones
9.1.3. Research and Development
9.1.4. Clinical Development
9.1.5. Safety and Efficacy
9.1.6. Product Profile
9.2. TRULANCE (plecanatide): Synergy Pharmaceuticals/Bausch Health Companies
9.2.1. Product Description
9.2.2. Regulatory Milestones
9.2.3. Research and Development
9.2.4. Clinical Development
9.2.5. Safety and Efficacy
9.2.6. Product Profile
10. Market Size of Functional Constipation
10.1. Key Market Assumptions
10.2. Attribute Analysis
10.3. Total 7MM Functional Constipation market analysis
10.4. Total 7MM Functional Constipation market analysis by therapies
11. Region-Wise Market size of Functional Constipation
11.1. United States
11.1.1. Total Market Size of Functional Constipation
11.1.2. Total Market Size of Functional Constipation by therapies
11.2. EU4 & the UK
11.2.1. Total Market Size of Functional Constipation
11.2.2. Total Market Size of Functional Constipation by therapies
11.3. Japan
11.3.1. Total Market Size of Functional Constipation
11.3.2. Total Market Size of Functional Constipation by therapies
