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PharmaPoint: Ulcerative Colitis - India Drug 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.

It is worth noting that in India, the local drug companies produce their own biosimilars, without many regulatory guidelines or any regard for the patent protection of the marketed products. For the treatment of UC, Indian physicians rely heavily on non-pharmacological methods, such as dietary recommendations, and for pharmacologic therapy, they use generic products within the corticosteroids and 5-ASA classes. GlobalData’s physician survey showed that these drugs are the mainstay of treatment for mild to moderate UC in India, as well as at earlier lines of therapy for severe disease.

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 the key drugs in India including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in India from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the India Ulcerative Colitis market.

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 drug performance
- Obtain sales forecast for drugs from 2012-2022 in Ulcerative Colitis.

Table Of Contents

PharmaPoint: Ulcerative Colitis - India Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 10
2.3 Upcoming Related Reports 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 15
3.2 Symptoms 17
3.2.1 Quality of Life 17
4 Disease Management 19
4.1 Diagnosis and Treatment Overview 19
4.1.1 Diagnosis 19
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 23
4.1.3 Clinical Practice 24
4.2 India 28
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 31
5.3 Product Profiles - Major Brands 32
5.3.1 Remicade (infliximab) 32
5.3.2 Apriso (mesalamine) 39
5.3.3 Asacol HD (mesalamine) 43
5.3.4 Pentasa (mesalamine) 47
5.3.5 Other Drug Classes Used in the Treatment of UC 50
5.4 Biosimilars 51
5.4.1 Introduction 51
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 52
5.4.3 Biosimilars in the Immunology Community 52
5.4.4 By the Numbers: Biosimilars in Development 53
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 56
6 Opportunity and Unmet Need 57
6.1 Overview 57
6.2 Unmet Needs 58
6.2.1 Curative Therapy for Severe UC Patients 58
6.2.2 Diagnostic Markers for Disease Severity 58
6.2.3 Personalized Therapy 58
6.2.4 A Replacement for Steroids 59
6.2.5 Novel Oral Drug Formulations 60
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk 61
6.2.7 Improved Management of Infectious Adverse Events 61
6.3 Unmet Needs Gap Analysis 62
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools 63
6.5 Predictors of Medically-Refractory Disease 64
7 Pipeline Assessment 65
7.1 Overview 65
7.2 Promising Drugs in Clinical Development 65
8 Market Outlook 67
8.1 India 67
8.1.1 Forecast 67
8.1.2 Key Events 71
8.1.3 Drivers and Barriers 71
9 Appendix 74
9.1 Bibliography 74
9.2 Abbreviations 78
9.3 Methodology 82
9.4 Forecasting Methodology 82
9.4.1 Diagnosed UC Patients 82
9.4.2 Percent Drug-Treated Patients 83
9.4.3 Drugs Included in Each Therapeutic Class 83
9.4.4 Launch and Patent Expiry Dates 83
9.4.5 General Pricing Assumptions 84
9.4.6 Individual Drug Assumptions 84
9.4.7 Generic Erosion 85
9.5 Physicians and Specialists Included in This Study 86
9.6 Primary Research - Prescriber Survey 87
9.7 About the Authors 88
9.7.1 Author 88
9.7.2 Global Head of Healthcare 89
9.8 About GlobalData 90
9.9 Disclaimer 90

1.1 List of Tables

Table 1: Genetic Factors That Confer a Predisposition to UC 15
Table 2: Typical Symptoms of UC 17
Table 3: Truelove and Witts UC Severity Index 21
Table 4: UCDAI 22
Table 5: Treatment Guidelines for UC Used in the 10MM 23
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 24
Table 7: UC Management Country Profile - India 29
Table 8: Leading Treatments for UC, 2014 32
Table 9: Product Profile - Remicade 34
Table 10: Remicade SWOT Analysis, 2014 38
Table 11: Product Profile - Apriso 40
Table 12: Apriso SWOT Analysis, 2014 42
Table 13: Product Profile - Asacol HD 44
Table 14: Asacol HD SWOT Analysis, 2014 47
Table 15: Product Profile - Pentasa 48
Table 16: Pentasa SWOT Analysis, 2014 50
Table 17: Summary of Other Immunomodulators for UC, 2013 51
Table 18: Biosimilars Pipeline, 2013 54
Table 19: Overall Unmet Needs - Current Level of Attainment 57
Table 20: Corticosteroid Long-Term Side Effects 60
Table 21: Clinical Unmet Needs in UC - Gap Analysis, 2013 63
Table 22: Prognostic Markers in UC 64
Table 23: UC - Pre-Registration and Phase III Pipeline, 2014 65
Table 24: Comparison of Therapeutic Classes in Development for UC, 2014 66
Table 25: Sales Forecasts ($) for UC in India, 2012-2022 68
Table 26: Key Events Impacting Sales for UC in India, 2012-2022 71
Table 27: UC Market in India - Drivers and Barriers, 2012-2022 71
Table 28: Key launches for Ulcerative Colitis , 2012-2022 83
Table 29: Key Patent Expiries 84
Table 30: Annual Cost of Therapy for 5-ASAs ($) 85
Table 31: Physicians Surveyed, By Country 87

1.2 List of Figures

Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC 16
Figure 2: UC Disease Management Flowchart 27
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012-2022 66
Figure 4: Sales for UC in India by Drug Class, 2012-2022 70

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