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PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2025

Summary

Ulcerative Colitis (UC) is a type of chronic IBD that causes inflammation and ulcers in the innermost lining of the colon and rectum. As a result, the colon’s ability to absorb water is decreased, which leads to progressive loosening of the stool, bloody stool, and sometimes cramping or abdominal pain, with urgency for bowel movement. Other associated symptoms of UC include loss of appetite, weight loss, fatigue, and anaemia in cases of severe bleeding.

It is estimated that the 2015 Ulcerative Colitis (UC) drug sales to be $5.64B across the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) covered in this report. By the end of the forecast period in 2025, sales will increase to over $6.58B at a Compound Annual Growth Rate (CAGR) of 1.6%, which is driven by approval/launch of nine pipeline therapies and anti-tumor necrosis factor (TNF) biosimilars.

In general, companies that are striving to enter the UC market are targeting all mild, moderate and severe UC patients. However, majority of late pipeline products are targeting UC patients refractory to steroids and anti-TNF therapies as well as anti-TNF naïve patients, as this population remains the most underserved group, with limited therapeutic options and high clinical unmet need.

Johnson & Johnson’s (J&J’s) Remicade was market leader in 2015 with $1.4B in sales for UC. However, the brand will be experiencing significant erosion from biosimilars across 7MM throughout the 10 year forecast period. To mitigate brand erosion in France, J&J has reduced Remicade price in the country and is available at a same price as its biosimilars, leaving the market more competitive.

The report “PharmaPoint: Ulcerative Colitis - Global Drug Forecast and Market Analysis to 2025” provides an overview of UC, including epidemiology, aetiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

In particular, it provides the following -

  • Annualized UC therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Provides strategic competitor assessment, market characterization, unmet needs, and implications for the UC therapeutics market.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global UC therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Companies mentioned this report: Johnson & Johnson, AbbVie, Takeda Pharmaceuticals, Salix Pharmaceuticals, Pfizer, Roche, InDeX Pharmaceuticals, Lipid Therapeutics, Celgene, EA Pharma, Ferring, Tillotts Pharma

Scope
  • Overview of UC, including epidemiology, aetiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized UC therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the UC therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global UC therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global UC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global UC therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global UC therapeutics market from 2015-2025.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or Staging Systems
3.3 Symptoms
3.4 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.3.1 Incidence
4.3.2 Prevalence
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for UC (2015-2025)
4.5.1 Diagnosed Incident Cases of UC
4.5.2 Diagnosed Prevalent Cases of UC
4.5.3 Undiagnosed Prevalent Cases of UC
4.5.4 Total Prevalent Cases of UC
4.5.5 Diagnosed Incident Cases of IC
4.5.6 Diagnosed Prevalent Cases of IC
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
4.6.4 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.1.1 Diagnosis
5.1.2 Treatment Guidelines and Leading Prescribed Drugs
5.1.3 Clinical Practice
5.2 US
5.3 5EU
5.4 Japan
6 Competitive Assessment
6.1 Overview
6.2 Product Profiles - Ulcerative Colitis
6.2.1 5-ASAs
6.2.2 Steroids
6.2.3 Thiopurines
6.2.4 Other Immunomodulators
6.2.5 Anti-TNFα drugs (Remicade, Humira, Simponi)
6.2.6 Anti-integrins (Entyvio)
6.2.7 Biosimilars
7 Unmet Needs Assessment and Opportunity Analysis
7.1 Overview
7.2 Inadequacy of current anti-TNF- α drug treatment
7.2.1 Unmet need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Patient Adherence
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Lack of safe, efficacious and less costly treatment alternatives
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Need for novel oral therapies
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 Ustekinumab (Stelara, Suterara, CNTO-1275)
8.2.2 Etrolizumab
8.2.3 LT-02 (phosphatidylcholine)
8.2.4 Kappaproct
8.2.5 Xeljanz (Tofacitinib, Cp-690,550)
8.2.6 Ozanimod hydrochloride
8.2.7 Carotegrast (AJM300)
8.2.8 Mesalamine (TP-05)
8.2.9 AJG511
8.3 Biosimilars
8.3.1 Overview
8.3.2 Infliximab biosimilars
8.3.3 Adalimumab biosimilars
8.3.4 Forecast
9 Current and Future Players
9.1 Overview
9.2 Trends in Corporate Strategy
9.3 Company Profiles
9.3.1 Johnson & Johnson (J&J)
9.3.2 AbbVie
9.3.3 Takeda Pharmaceuticals
9.3.4 Salix Pharmaceuticals
9.3.5 Pfizer Inc.
9.3.6 F. Hoffmann-La Roche Ltd.
9.3.7 InDex Pharmaceuticals
9.3.8 Lipid Therapeutics GmbH
9.3.9 Celgene Corporation
9.3.10 EA Pharma
9.3.11 Ferring International
9.3.12 Tillotts Pharma
10 Market Outlook
10.1 Global Markets
10.1.1 Forecast
10.1.2 Drivers and Barriers - Global Issues
10.2 US
10.2.1 Forecast
10.2.2 Key Events
10.2.3 Drivers and Barriers
10.3 France
10.3.1 Forecast
10.3.2 Key Events
10.3.3 Drivers and Barriers
10.4 Germany
10.4.1 Forecast
10.4.2 Key Events
10.4.3 Drivers and Barriers
10.5 Italy
10.5.1 Forecast
10.5.2 Key Events
10.5.3 Drivers and Barriers
10.6 Spain
10.6.1 Forecast
10.6.2 Key Events
10.6.3 Drivers and Barriers
10.7 United Kingdom
10.7.1 Forecast
10.7.2 Key Events
10.7.3 Drivers and Barriers
10.8 Japan
10.8.1 Forecast
10.8.2 Key Events
10.8.3 Drivers and Barriers
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Diagnosed Prevalent Patients
11.4.2 Percent Drug-Treated Patients
11.4.3 Drugs Included in Each Therapeutic Class
11.4.4 Launch and Patent Expiry Dates
11.4.5 General Pricing Assumptions
11.4.6 Individual Drug Assumptions
11.4.7 Generic Erosion
11.4.8 Pricing of Pipeline Agents
11.5 Primary Research - KOLs Interviewed for this Report
11.6 Primary Research - Prescriber Survey
11.7 About the Authors
11.7.1 Analyst
11.7.2 Analyst
11.7.3 Reviewer
11.7.4 Therapy Area Director
11.7.5 Epidemiologist
11.7.6 Managing Epidemiologist
11.7.7 Global Director of Therapy Analysis and Epidemiology
11.8 About GlobalData
11.9 Disclaimer
1.1 List of Tables
Table 1: Genetic factors implicated in UC causation
Table 2: Truelove and Witts categorization of disease severity and clinical parameters
Table 3: Pediatric Ulcerative Colitis Activity Index
Table 4: Typical Symptoms of UC
Table 5: Risk Factors and Comorbidities for UC and IBD
Table 6: Incidence of UC in the 5EU
Table 7: Prevalence of UC in Italy, Spain, and the UK
Table 8: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC
Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of UC
Table 10: 7MM, Sources Used to Forecast Undiagnosed Prevalent Cases of UC
Table 11: 7MM, Sources Used to Forecast the Total Prevalent Cases of UC
Table 12: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of UC by Stage at Diagnosis
Table 13: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Incident/Prevalent Cases of UC by Severity
Table 14: 7MM, Sources of Epidemiological Data used to Forecast Mortality Due to CRC and TMC Among the Diagnosed Prevalent Cases of UC
Table 15: 7MM, Sources Used to Forecast Autoimmune Comorbidities Among the Diagnosed Prevalent Cases of UC
Table 16: 7MM, Sources Used to Forecast UC Cases Requiring Colectomy Among the Diagnosed Prevalent Cases of UC Due to Failure of Medical Management
Table 17: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IC
Table 18: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IC
Table 19: 7MM, Sources Not Used in Epidemiological Analysis of UC
Table 20: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, Selected Years 2015-2025
Table 21: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, N (Row %), 2015
Table 22: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N (Row %), 2015
Table 23: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015-2025
Table 24: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015
Table 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015
Table 26: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, Select Years, 2015-2025
Table 27: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N (Row %), 2015
Table 28: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N (Row %), 2015
Table 29: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, N, Selected Years, 2015-2025
Table 30: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N (Row %), 2015
Table 31: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N (Row %), 2015
Table 32: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015-2025
Table 33: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, N, Selected Years, 2015-2025
Table 34: Diagnostic features of UC
Table 35: Truelove and Witts categorization of disease severity and clinical parameters
Table 36: UCDAI
Table 37: Pediatric Ulcerative Colitis Activity Index
Table 38: Treatment Guidelines for Ulcerative Colitis
Table 39: Most Prescribed Drugs for Ulcerative Colitis by Class in the Global Markets, 2015
Table 40: Different 5-ASAs used for managing UC
Table 41: Different corticosteroids used for managing UC
Table 42: Country Profile - US
Table 43: Region Profile - 5EU
Table 44: Country Profile - Japan
Table 45: Leading Treatments for UC, 2015
Table 46: Product Profile - Lialda
Table 47: Efficacy of different drugs in 5-ASA class in inducing remission in UC patients
Table 48: Efficacy of different drugs in 5-ASA class in preventing disease relapse in UC patients
Table 49: Percentage of patients experiencing adverse events with 5-ASAs
Table 50: 5-ASA SWOT Analysis, 2015
Table 51: Product Profile -Steroids
Table 52: Efficacy of Uceris
Table 53: Safety of Uceris
Table 54: Uceris SWOT Analysis, 2016
Table 55: Product Profile -Azathioprine
Table 56: Percentage of patients experiencing adverse events with AZA and 6-MP therapy
Table 57: Azathioprine SWOT Analysis, 2015
Table 58: Product Profile -MTX
Table 59: MTX SWOT Analysis, 2015
Table 60: Product Profile -Remicade
Table 61: Efficacy data for ACT 1 and ACT 2 trials
Table 62: Safety of Remicade
Table 63: SWOT Analysis, Remicade 2016
Table 64: Product Profile -Humira
Table 65: Efficacy of Humira - Primary and Secondary Endpoints-ULTRA 2 Phase III Program
Table 66: SWOT Analysis, Humira 2016
Table 67: Product Profile -Simponi
Table 68: Efficacy of Simponi
Table 69: Safety of Simponi
Table 70: Simponi SWOT Analysis, 2016
Table 71: Product Profile - Entyvio
Table 72: Efficacy of Entyvio
Table 73: Efficacy of Entyvio
Table 74: Safety of Entyvio
Table 75: Entyvio SWOT Analysis
Table 76: Infliximab Biosimilars for UC Treatment
Table 77: Product Profile -Infliximab biosimilar
Table 78: Percentage of patients experiencing adverse events with infliximab biosimilars
Table 79: Biosimilars SWOT Analysis, 2015
Table 80: Unmet Need and Opportunity in UC, 2015
Table 81: Late stage development drugs for UC, 2015-2025
Table 82: Product Profile - Ustekinumab
Table 83: Ustekinumab SWOT Analysis, 2015
Table 84: Product Profile - Etrolizumab
Table 85: Efficacy of Etrolizumab
Table 86:Safety of Etrolizumab
Table 87 : Pipeline Drug Etrolizumab SWOT Analysis, 2016
Table 88: Product Profile - LT-02
Table 89: Efficacy Analysis for LT-02
Table 90: Efficacy Analysis for Different Doses of LT-02
Table 91: LT-02 SWOT Analysis, 2015
Table 92: Product Profile - Kappaproct
Table 93: Safety of Kappaproct
Table 94: Kappaproct SWOT Analysis, 2016
Table 95: Product Profile - Xeljanz
Table 96: Patient reported outcomes for Xeljanz compared to placebo
Table 97: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups
Table 98: Mean change from baseline in partial Mayo score in Xeljanz and placebo groups
Table 99: Rates of various adverse events experienced in Xeljanz and placebo groups
Table 100: Xeljanz SWOT Analysis, 2015
Table 101: Product Profile - Ozanimod hydrochloride
Table 102: Efficacy analysis of Ozanimod
Table 103: Safety of Ozanimod
Table 104: Pipeline Drug Ozanimod SWOT Analysis, 2015
Table 105: Product Profile - Carotegrast
Table 106: Efficacy analysis in carotegrast and placebo groups
Table 107: Safety analysis of carotegrast
Table 108: Carotegrast SWOT Analysis, 2015
Table 109: Product Profile - Mesalamine (TP-05)
Table 110: Pipeline Drug TP-05 SWOT Analysis, 2016
Table 111: Product Profile - AJG511
Table 112: Efficacy analysis of AJG511
Table 113: Carotegrast SWOT Analysis, 2015
Table 114: Product Profile - Infliximab biosimilars
Table 115: Infliximab biosimilars SWOT Analysis, 2015
Table 116: Product Profile - Amjevita
Table 117: Amjevita SWOT Analysis, 2016
Table 118: Key Companies in the Ulcerative Colitis Market in the 7MM, 2015
Table 119: J&J’s UC Portfolio Assessment, 2015
Table 120: AbbVie’s UC Portfolio Assessment, 2015
Table 121: Takeda’s UC Portfolio Assessment, 2015
Table 122: Salix Pharmaceuticals’ UC Portfolio Assessment, 2015
Table 123: Pfizer’s UC Portfolio Assessment, 2015
Table 124: Roches UC Portfolio Assessment, 2015
Table 125: InDex Pharmaceutical’s UC Portfolio Assessment, 2015
Table 126: Lipid Therapeutics’ UC Portfolio Assessment, 2015
Table 127: Celgene’s UC Portfolio Assessment, 2015
Table 128: EA Pharma’s UC Portfolio Assessment, 2015
Table 129: Ferring Pharmaceuticals’ UC Portfolio Assessment, 2015
Table 130: Tillotts Pharma’s UC Portfolio Assessment, 2015
Table 131:Ulcerative Colitis Market - Global Drivers and Barriers, 2015‒2025
Table 132: Key Events Impacting Sales for Ulcerative Colitis in the US, 2015-2025
Table 133: Ulcerative Colitis Market - Drivers and Barriers in the US, 2015‒2025
Table 134: Key Events Impacting Sales for Ulcerative Colitis in France, 2015-2025
Table 135: Ulcerative Colitis Market - Drivers and Barriers in France, 2015‒2025
Table 136: Key Events Impacting Sales for Ulcerative Colitis in Germany, 2015-2025
Table 137: Ulcerative Colitis Market - Drivers and Barriers in Germany, 2015‒2025
Table 138: Key Events Impacting Sales for Ulcerative Colitis in Italy, 2015-2025
Table 139: Ulcerative Colitis Market - Drivers and Barriers in Italy, 2015‒2025
Table 140: Key Events Impacting Sales for Ulcerative Colitis in Spain, 2015-2025
Table 141: Ulcerative Colitis Market - Drivers and Barriers in Spain, 2015‒2025
Table 142: Key Events Impacting Sales for Ulcerative Colitis in the UK, 2015-2025
Table 143: Ulcerative Colitis Market - Drivers and Barriers in UK, 2015‒2025
Table 144: Key Events Impacting Sales for Ulcerative Colitis in Japan, 2015-2025
Table 145: Ulcerative Colitis Market - Drivers and Barriers in Japan, 2015‒2025
Table 146: Key Projected Launch Dates for UC
Table 147: Key Historical and Projected Patent Expiry Dates for UC
Table 148: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC Figure 2: 7MM, Diagnosed Incident Cases of UC, Both Sexes, All Ages, Selected Years, 2015-2025 Figure 3: 7MM, Age-Specific Diagnosed Incident Cases of UC, Both Sexes, All Ages, N, 2015 Figure 4: 7MM, Sex-Specific Diagnosed Incident Cases of UC, All Ages, N, 2015 Figure 5: 7MM, Age-Standardized Diagnosed Incidence of UC (Cases per 100,000 Population), All Ages, Both Sexes, N, 2015 Figure 6: 7MM, Diagnosed Incident Cases of UC Segmented by Stage at Diagnosis, Both Sexes, All Ages, N, 2015 Figure 7: 7MM, Diagnosed Incident Cases of UC Segmented by Severity, Both Sexes, All ages, N, 2015 Figure 8: 7MM, Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, 2015-2025 Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of UC, Both Sexes, N, 2015 Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of UC, All Ages, N, 2015 Figure 11:7MM, Age-Standardized Diagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015 Figure 12: 7MM, Diagnosed Prevalent Cases of UC Segmented by Severity, Both Cases, All Ages, N, 2015 Figure 13: 7MM, Mortality Due to Complications Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 Figure 14: 7MM, Colectomy Due to Failure of Medical Management Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 Figure 15: 7MM. Comorbidities Among the Diagnosed Prevalent Cases of UC, Both Sexes, All Ages, N, 2015 Figure 16: 7MM, Undiagnosed Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015-2025 Figure 17: 7MM, Age-Specific Undiagnosed Prevalent Cases of UC, Both Sexes, N, 2015 Figure 18: 7MM, Sex-Specific Undiagnosed Prevalent Cases of UC, All Ages, N, 2015 Figure 19: 7MM, Age-Standardized Undiagnosed Prevalence of UC, All Ages, Both Sexes, %, 2015 Figure 20: 7MM, Total Prevalent Cases of UC, Both Sexes, All Ages, Selected Years, N, 2015-2025 Figure 21: 7MM, Age-Specific Total Prevalent Cases of UC, Both Sexes, N, 2015 Figure 22: 7MM, Sex-Specific Total Prevalent Cases of UC, All Ages, N, 2015 Figure 23: 7MM, Age-Standardized Total Prevalence of UC, All Ages, Both Sexes, %, 2015 Figure 24: 7MM, Diagnosed Incident Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015-2025 Figure 25: 7MM, Diagnosed Prevalent Cases of IC, Both Sexes, All Ages, Selected Years, N, 2015-2025 Figure 26 : Ulcerative Colitis Treatment Algorithm Figure 27: Global Sales for Ulcerative Colitis by Drug Class, 2015 and 2025 Figure 28: Sales for Ulcerative Colitis by Drug Class in the US, 2015 and 2025 Figure 29: Sales for Ulcerative Colitis by Drug Class in France, 2015 and 2025 Figure 30: Sales for Ulcerative Colitis by Drug Class in Germany, 2015 and 2025 Figure 31: Sales for Ulcerative Colitis by Drug Class in Italy, 2015 and 2025 Figure 32: Sales for Ulcerative Colitis by Drug Class in Spain, 2015 and 2025 Figure 33: Sales for Ulcerative Colitis by Drug Class in the UK, 2015 and 2025 Figure 34: Sales for Ulcerative Colitis by Drug Class in Japan, 2015 and 2025

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