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PharmaPoint: Crohn’s Disease - India Drug Forecast and Market Analysis to 2022

Summary

The Crohn’s disease (CD) market is currently very dynamic, with novel biologic therapies on the horizon. These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If their promising safety and efficacy profiles translate to clinical practice once they enter the market, their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and Humira (adalimumab).The loss of patent protection of the anti-TNF marketed brands will allow for the emergence of biosimilars, such as Hospira’s Inflectra (infliximab) a Remicade biosimilar. Focusing on country dynamics, Canada and the emerging markets of China and India will also play a key role in driving growth in the long term, with each market forecast to post positive Compound Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of Remicade over the forecast period.

For the treatment of CD, 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-ASAs. GlobalData’s physician survey showed that these drugs are the mainstay of treatment for mild to moderate CD in India, as well as at earlier lines of therapy for severe disease. While Indian physicians commonly prescribe domestic generics and biosimilars, our primary research revealed that biosimilars were not readily available to those with CD.

Scope

- Overview of Crohn’s disease 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 Crohn’s disease 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 Crohn’s disease.
- 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 India.

Table Of Contents

PharmaPoint: Crohn’s Disease - India Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.2 Symptoms 16
3.3 Prognosis 17
3.4 Quality of Life 18
4 Disease Management 19
4.1 Treatment Overview 20
4.2 India 25
4.2.1 Diagnosis 25
4.2.2 Clinical Practice 25
5 Competitive Assessment 27
5.1 Overview 27
5.2 Strategic Competitor Assessment 28
5.3 Product Profiles - Major Brands 29
5.3.1 Remicade (infliximab) 29
5.3.2 Other Marketed Products 35
6 Opportunity and Unmet Need 36
6.1 Overview 36
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 37
6.3 More Therapies for Anti-TNF-Refractory Patients 38
6.4 Unmet Needs Gap Analysis 39
6.5 Targeted Therapies 40
6.6 Predictive Tools for Early Diagnosis and Treatment 41
7 Pipeline Assessment 42
7.1 Overview 42
7.2 Promising Drugs in Clinical Development 42
7.3 Other Late-Stage Pipeline Products 44
7.3.1 Cx601 44
7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 46
8 Market Outlook 51
8.1 Global Markets 51
8.1.1 Drivers and Barriers - Global Issues 51
9 India 56
9.1 Forecast 56
9.2 Key Events 58
9.3 Drivers and Barriers 59
9.3.1 Driver: Continued investment in the national healthcare system and services 59
9.3.2 Driver: Sizeable CD patient population that will increase over the coming decade 59
9.3.3 Barrier: Loose intellectual property policies present a major challenge for developers with novel drugs 60
9.3.4 Barrier: Limited access to and the high price point of CD therapies, coupled with many Indians' belief in traditional medicine, negatively impacts branded drug sales 60
9.3.5 Barrier: Downward pricing pressure limits drug sales growth 61
10 Appendix 62
10.1 Bibliography 62
10.2 Abbreviations 67
10.3 Methodology 71
10.4 Forecasting Methodology 71
10.4.1 Diagnosed CD Patients 71
10.4.2 Percent Drug-Treated Patients 72
10.4.3 Drugs Included in Each Therapeutic Class 72
10.4.4 General Pricing Assumptions 72
10.4.5 Individual Drug Assumptions 74
10.4.6 Generic Erosion 74
10.5 Physicians and Specialists Included in This Study 75
10.6 Primary Research - Prescriber Survey 76
10.7 About the Authors 77
10.7.1 Author/Reviewer 77
10.7.2 Global Head of Healthcare 77
10.8 About GlobalData 78
10.9 Disclaimer 78

1.1 List of Tables

Table 1: Symptoms of CD 17
Table 2: Treatment Guidelines for CD 21
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 23
Table 4: Leading Branded Drugs Used to Treat CD 29
Table 5: Product Profile - Remicade 31
Table 6: Remicade SWOT Analysis, 2013 34
Table 7: Summary of the Minor Therapeutic Classes in CD, 2013 35
Table 8: Overall Unmet Needs in CD - Current Level of Attainment 37
Table 9: Clinical Unmet Needs in CD - Gap Analysis, 2013 40
Table 10: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 42
Table 11: Comparison of Therapeutic Classes in Development for CD, 2013 43
Table 12: Product Profile - Cx601 45
Table 13: Cx601 SWOT Analysis, 2013 46
Table 14: Product Profile - RHB-104 48
Table 15: RHB-104 SWOT Analysis, 2013 50
Table 16: Global CD Market - Drivers and Barriers, 2012-2022 51
Table 17: Sales Forecasts ($) for CD in India, 2012-2022 57
Table 18: Key Events Impacting Sales for CD in India, 2012-2022 58
Table 19: CD Market in India - Drivers and Barriers, 2012-2022 59
Table 20: Physicians Surveyed, By Country 76

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 13
Figure 2: Potential Biologic Drug Targets for CD 16
Figure 3: Patient Care Path for CD 22
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 43
Figure 5: Sales for CD in India by Drug Class, 2012-2022 58

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