sfRowasa (Ulcerative Colitis) – Forecast and Market Analysis to 2022

Summary

During the forecast period from 2012-2022, the growth of the UC market will be driven largely by the entry of Johnson & Johnson’s (J&J’s) Simponi and Takeda’s Entyvio, which will lead to an increase in the overall number of patients being treated with biologics in the US, 5EU, Japan, and Canada. Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.

Each sfRowasa unit is a 60mL rectal suspension that delivers up to 4g of mesalamine to the left side of the colon. sfRowasa sulfite-free (sf) formulation is the first sulfite-free rectal suspension available for the treatment of UC. The results of a study published in the American Journal of Gastroenterology in 1998 showed that products containing sulfites may be the cause of a possible flare in UC patients (Levine et al, 1998, Year). Hydrogen sulfide is a luminally-acting, bacterially-derived molecule that is harmful to cells and has been implicated in UC.

Scope

– Overview of Ulcerative Colitis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
– Detailed information on SfRowasa including product description, safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for SfRowasa from 2012 to 2022.
– Sales information covered for the US

Reasons to buy

– Understand and capitalize by identifying products that are most likely to ensure a robust return
– Stay ahead of the competition by understanding the changing competitive landscape for Ulcerative Colitis
– Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
– Make more informed business decisions from insightful and in-depth analysis of SfRowasa performance
– Obtain sales forecast for SfRowasa from 2012-2022 in the US

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
2.3 Upcoming Related Reports 10
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 14
3.2 Symptoms 15
3.2.1 Quality of Life 16
4 Disease Management 17
4.1 Diagnosis and Treatment Overview 17
4.1.1 Diagnosis 17
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 20
4.1.3 Clinical Practice 22
5 Competitive Assessment 26
5.1 Overview 26
5.2 Strategic Competitor Assessment 27
6 sfRowasa (mesalamine) 29
6.1 Overview 29
6.2 Efficacy 29
6.3 Safety 30
6.4 SWOT Analysis 30
6.5 Forecast 31
7 Appendix 32
7.1 Bibliography 32
7.2 Abbreviations 33
7.3 Methodology 36
7.4 Forecasting Methodology 36
7.4.1 Diagnosed UC Patients 36
7.4.2 Percent Drug-Treated Patients 37
7.4.3 General Pricing Assumptions 37
7.4.4 Individual Drug Assumptions 38
7.4.5 Generic Erosion 38
7.5 Physicians and Specialists Included in This Study 39
7.6 Primary Research - Prescriber Survey 40
7.7 About the Authors 41
7.7.1 Author 41
7.7.2 Global Head of Healthcare 42
7.8 About GlobalData 43
7.9 Disclaimer 43

1.1 List of Tables
Table 1: Genetic Factors That Confer a Predisposition to UC 13
Table 2: Typical Symptoms of UC 15
Table 3: Truelove and Witts UC Severity Index 19
Table 4: UCDAI 20
Table 5: Treatment Guidelines for UC Used in the 10MM 21
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 22
Table 7: Leading Treatments for UC, 2014 28
Table 8: Product Profile - sfRowasa 29
Table 9: sfRowasa SWOT Analysis, 2014 30
Table 10: Global Sales Forecasts ($m) for sfRowasa, 2012-2022 31
Table 11: Annual Cost of Therapy for 5-ASAs ($) 38
Table 12: Physicians Surveyed, By Country 40

1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 15
Figure 2: UC Disease Management Flowchart 25