Published Date : 2022-09-10
Published Date : 2022-09-10
Updated On : 2023-09-01
Pages : 156
Thelansis’s “Irritable Bowel Syndrome (IBS) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Irritable Bowel Syndrome treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Irritable bowel syndrome (IBS) is a prevalent medical condition characterized by chronic, recurrent abdominal pain, discomfort, and altered bowel habits. This condition occurs in the absence of other organic gastrointestinal (GI) diseases, and its underlying cause is still under investigation but is believed to involve multiple factors. The factors that may trigger disruptions in GI motor and sensory function include irritation from digestive byproducts, past gastroenteritis, internal irritants, gut microbiome changes, mucosal immune responses, food intolerance, and increased mucosal permeability. These underlying disruptions give rise to symptoms such as discomfort, gut motility changes, and bowel habit alterations. Genetic factors may also contribute to the development of IBS. BS can manifest with a wide array of gastrointestinal symptoms. While abdominal pain is one of the most common complaints, individuals with IBS may also experience bloating, a feeling of incomplete bowel emptying, urgency, diarrhea, straining, and constipation. The abdominal pain in IBS is typically crampy and varies in location and intensity. This pain is often associated with bowel movements, with some patients experiencing relief after bowel movements and others having worsening pain during them. Additionally, meals and emotional stress can exacerbate abdominal pain in some patients. Functional bowel disease experts established the Rome criteria to manage patients with abdominal symptoms resembling IBS. According to this classification, IBS is categorized based on the predominant stool pattern as follows:
The differential diagnosis for IBS is extensive. A comprehensive patient history, physical examination, and a few laboratory tests can help rule out conditions such as celiac disease, inflammatory bowel disease, microscopic colitis, post-cholecystectomy bile acid diarrhea, and small intestinal bacterial overgrowth (SIBO). Patients with IBS-C may also have pelvic floor dysfunction or colonic transit disorders. If treatment fails to alleviate symptoms, further evaluation may be necessary, including a rectal examination to identify patients with dyssynergia or pelvic floor issues. Management of IBS encompasses dietary adjustments, medication options, and mind-body treatments. The United States Food and Drug Administration (FDA) has approved two agents, lubiprostone and linaclotide, specifically for IBS-C treatment.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | Tenapanor | Ardelyx | Phase 3 |
2 | ORP-101 | OrphoMed, Inc. | Phase 2 |
3 | linaclotide | Astellas Pharma Inc | Phase 3 |
4 | Eluxadoline | Allergan | Phase 2 |
5 | Bifidobacterium Longum 35624® | PrecisionBiotics Group Ltd. | Phase 2 |
6 | BOS-589 | Boston Pharmaceuticals | Phase 2 |
7 | Changkang Granule | Tasly Pharmaceutical Group Co., Ltd | Phase 2 |
8 | Plecanatide | Bausch Health Americas, Inc. | Phase 2 |
9 | ASP7147 | Seldar Pharma, Inc. | Phase 2 |
10 | Rifamycin SV | Cosmo Technologies Ltd | Phase 2 |
Continued...
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Irritable Bowel Syndrome (IBS) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Irritable Bowel Syndrome (IBS) market scenario 2022 |
1.2.2. Irritable Bowel Syndrome (IBS) market scenario 2025 |
1.2.3. Irritable Bowel Syndrome (IBS) market scenario 2032 |
2. Irritable Bowel Syndrome (IBS) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Irritable Bowel Syndrome (IBS) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Irritable Bowel Syndrome (IBS) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Irritable Bowel Syndrome (IBS) management |
2.16. Market Opportunity for Irritable Bowel Syndrome (IBS) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Irritable Bowel Syndrome (IBS) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Irritable Bowel Syndrome (IBS) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Irritable Bowel Syndrome (IBS) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Irritable Bowel Syndrome (IBS) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Irritable Bowel Syndrome (IBS) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Irritable Bowel Syndrome (IBS) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Irritable Bowel Syndrome (IBS) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Irritable Bowel Syndrome (IBS) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Irritable Bowel Syndrome (IBS) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Irritable Bowel Syndrome (IBS) Market Forecast 2022-2032 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Irritable Bowel Syndrome (IBS) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Irritable Bowel Syndrome (IBS) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Irritable Bowel Syndrome (IBS) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Irritable Bowel Syndrome (IBS) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |