Lialda (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.

Lialda is a patented multi-matrix (MMX)-release, coated formulation of mesalamine that can be taken once or twice daily. Clinical trials have demonstrated the efficacy of this agent over placebo for the induction and maintenance of remission in UC. Upon exposure to the alkaline pH of the colon, the MMX coating dissolves and reveals the gel suspension of mesalamine, which is concomitantly diffused within the intestinal fluid.

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 Lialda including product description, safety and efficacy profiles as well as a SWOT analysis.
– Sales forecast for Lialda for the top seven countries from 2012 to 2022.
– Sales information covered for the US, Germany, Italy, Spain, the UK, Japan and Canada.

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 Lialda performance
– Obtain sales forecast for Lialda from 2012-2022 in the top seven countries (the US, Germany, Italy, Spain, the UK, Japan and Canada)

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 8
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 13
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 Lialda (mesalamine) 29
6.1 Overview 29
6.2 Efficacy 30
6.3 Safety 30
6.4 SWOT Analysis 30
6.5 Forecast 31
7 Appendix 33
7.1 Bibliography 33
7.2 Abbreviations 35
7.3 Methodology 38
7.4 Forecasting Methodology 38
7.4.1 Diagnosed UC Patients 38
7.4.2 Percent Drug-Treated Patients 39
7.4.3 General Pricing Assumptions 39
7.4.4 Individual Drug Assumptions 40
7.4.5 Generic Erosion 40
7.5 Physicians and Specialists Included in This Study 41
7.6 Primary Research - Prescriber Survey 43
7.7 About the Authors 44
7.7.1 Author 44
7.7.2 Global Head of Healthcare 45
7.8 About GlobalData 46
7.9 Disclaimer 46

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 - Lialda 29
Table 9: Lialda SWOT Analysis, 2014 31
Table 10: Global Sales Forecasts ($m) for Lialda, 2012-2022 32
Table 11: Annual Cost of Therapy for 5-ASAs ($) 40
Table 12: Physicians Surveyed, By Country 43

1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 14
Figure 2: UC Disease Management Flowchart 25