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PharmaPoint: Crohn’s Disease - Japan 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.

In contrast to the 7MM, but akin to Canada, Remicade will remain on patent in the Japanese CD market for a significant portion of the 10-year forecast period, with biosimilar erosion predicted from 2021 on. This, in turn, will lead to the brand experiencing year-on-year growth through to its peak-year sales in 2022.

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

Table Of Contents

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

2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 14
3.2 Symptoms 18
3.3 Prognosis 19
3.4 Quality of Life 20
4 Disease Management 21
4.1 Treatment Overview 22
4.2 Japan 27
4.2.1 Diagnosis 27
4.2.2 Clinical Practice 27
5 Competitive Assessment 29
5.1 Overview 29
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles - Major Brands 31
5.3.1 Remicade (infliximab) 31
5.3.2 Humira (adalimumab) 37
5.3.3 Other Marketed Products 41
5.4 Biosimilars 42
5.4.1 Introduction 42
5.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 43
5.4.3 Biosimilars in the Immunology Community 44
5.4.4 By the Numbers: Biosimilars in Development 44
5.4.5 The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry 46
6 Opportunity and Unmet Need 48
6.1 Overview 48
6.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 49
6.3 More Therapies for Anti-TNF-Refractory Patients 50
6.4 Unmet Needs Gap Analysis 51
6.5 Targeted Therapies 52
6.6 Predictive Tools for Early Diagnosis and Treatment 53
7 Pipeline Assessment 54
7.1 Overview 54
7.2 Promising Drugs in Clinical Development 54
7.2.1 Entyvio (vedolizumab) 56
7.2.2 Stelara (ustekinumab) 68
7.3 Other Late-Stage Pipeline Products 75
7.3.1 Cx601 75
7.3.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 77
8 Market Outlook 82
8.1 Global Markets 82
8.1.1 Drivers and Barriers - Global Issues 82
9 Japan 87
9.1 Forecast 87
9.2 Key Events 89
9.3 Drivers and Barriers 90
9.3.1 Driver: Pathways for biosimilar approval are already in place 90
9.3.2 Driver: Increasing number of prevalent cases of CD 90
9.3.3 Driver: Continued uptake of TNF inhibitors, particularly Remicade 91
9.3.4 Driver: Launch of the first non-anti-TNF during the mid-forecast 91
9.3.5 Driver: The well-developed universal healthcare system ensures insurance coverage for patients with chronic diseases 92
9.3.6 Barrier: Biennial pricing system may limit long-term revenues for companies operating in this market 92
9.3.7 Barrier: Time lag between drug approval and launch, due to the process required for listing a drug on the NHI 92
9.3.8 Barrier: Regulatory approval is often contingent upon companies presenting domestic and/or Japanese-specific clinical trial data 93
10 Appendix 94
10.1 Bibliography 94
10.2 Abbreviations 99
10.3 Methodology 102
10.4 Forecasting Methodology 102
10.4.1 Diagnosed CD Patients 102
10.4.2 Percent Drug-Treated Patients 103
10.4.3 Drugs Included in Each Therapeutic Class 103
10.4.4 Launch and Patent Expiry Dates 104
10.4.5 General Pricing Assumptions 104
10.4.6 Individual Drug Assumptions 105
10.4.7 Generic Erosion 107
10.4.8 Pricing of Pipeline agents 107
10.5 Physicians and Specialists Included in This Study 108
10.6 Primary Research - Prescriber Survey 110
10.7 About the Authors 111
10.7.1 Author/Reviewer 111
10.7.2 Global Head of Healthcare 111
10.8 About GlobalData 112
10.9 Disclaimer 112

1.1 List of Tables

Table 1: Symptoms of CD 19
Table 2: Treatment Guidelines for CD 23
Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 25
Table 4: Leading Branded Drugs Used to Treat CD 31
Table 5: Product Profile - Remicade 33
Table 6: Remicade SWOT Analysis, 2013 36
Table 7: Product Profile - Humira 38
Table 8: Humira SWOT Analysis, 2013 41
Table 9: Summary of the Minor Therapeutic Classes in CD, 2013 42
Table 10: Biosimilars Pipeline, 2013 45
Table 11: Overall Unmet Needs in CD - Current Level of Attainment 49
Table 12: Clinical Unmet Needs in CD - Gap Analysis, 2013 52
Table 13: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 55
Table 14: Comparison of Therapeutic Classes in Development for CD, 2013 56
Table 15: Product Profile - Entyvio 58
Table 16: Efficacy of Entyvio in GEMINI II Studies of CD 59
Table 17: Entyvio SWOT Analysis, 2013 67
Table 18: Product Profile - Stelara 69
Table 19: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 71
Table 20: Stelara SWOT Analysis, 2013 74
Table 21: Product Profile - Cx601 76
Table 22: Cx601 SWOT Analysis, 2013 77
Table 23: Product Profile - RHB-104 79
Table 24: RHB-104 SWOT Analysis, 2013 81
Table 25: Global CD Market - Drivers and Barriers, 2012-2022 82
Table 26: Sales Forecasts ($) for CD in Japan, 2012-2022 88
Table 27: Key Events Impacting Sales for CD in Japan, 2012-2022 89
Table 28: CD Market in Japan - Drivers and Barriers, 2012-2022 90
Table 29: Key Launch Dates 104
Table 30: Key Patent Expiries 104
Table 31: Physicians Surveyed, By Country 110

1.2 List of Figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 15
Figure 2: Potential Biologic Drug Targets for CD 18
Figure 3: Patient Care Path for CD 24
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 55
Figure 5: Sales for CD in Japan by Drug Class, 2012-2022 89

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