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PharmaPoint: Crohn’s Disease - Global 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, such as -
- Takeda’s alpha4beta7 inhibitor, Entyvio (vedolizumab)
- Johnson & Johnson’s (J&J’s) interleukin (IL)-12/23 inhibitor, Stelara (ustekinumab)

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. Patent expiries begin in 2015 for the current market leaders -
- J&J’s Remicade (infliximab)
- AbbVie’s Humira (adalimumab)

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.

Exciting times lay ahead for the CD marketplace, as the market events noted above are due to occur against the backdrop of a steadily rising global CD prevalent population. With the clinical unmet need for better diagnostic tools and treatment options for the anti-TNF-refractory population, CD represents an attractive autoimmune disease for drug developers. This, in turn should fuel commercial interest in this subtype of IBD.

Highlights

Key Questions Answered

- How will the CD market (sales and patient numbers) evolve over the 10-year forecast period from 2012 to 2022?
- Which brands and specific drug classes did physicians select for their CD patients in 2012 and how do they foresee their prescribing behavior evolving over the next five years?
- How will the launch of late-stage pipeline therapies such as Entyvio and Stelara shape the future treatment landscape?
- What are the remaining unmet needs and opportunities for drug developers within the CD market?

Key Findings

- The main drivers of growth in the CD market during the coming decade include the anticipated launch of the first non-anti-tumor necrosis factor (TNF) biologics, Entyvio and Stelara; the uptake of infliximab and adalimumab biosimilars; and the increasing prevalent cases of CD.
- Companies striving to enter the CD market appear most focused on the anti-TNF refractory population, as this remains the most underserved group. However, competition within this patient segment is set to intensify from 2014 on, following new product launches. Therefore, companies with early-phase products targeting this patient group may struggle to gain a foothold in the future CD market.
- The level of unmet need in the CD marketplace is moderate, with clinical unmet needs being the main driver for research into this autoimmune disease. The most pressing clinical unmet need is for reliable disease diagnostic tools, such as biomarkers, as these could aid physicians to tailor their treatment approach.
- Although GlobalData forecasts four new product launches (Entyvio, Stelara, vercirnon, and Prochymal [remestemcel-L]) during the 2012–2022 forecast period, growth within the 10 CD healthcare markets covered in this report will largely be driven by the strong uptake of Entyvio and Stelara.

Scope

- Overview of CD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized CD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the CD therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-to-late stage pipeline drugs.
- Analysis of the current and future market competition in the global CD therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global CD therapeutics markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CD therapeutics markets in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global CD therapeutics markets from 2012-2022.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

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

2 Introduction 23
2.1 Catalyst 23
2.2 Related Reports 24
2.3 Upcoming Related Reports 24
3 Disease Overview 25
3.1 Etiology and Pathophysiology 25
3.1.1 Etiology 25
3.1.2 Pathophysiology 25
3.2 Symptoms 29
3.3 Prognosis 30
3.4 Quality of Life 31
4 Epidemiology 32
4.1 Risk Factors and Comorbidities 32
4.1.1 Up to 60% of CD patients experience reduced bone density 33
4.1.2 One third of patients with CD suffer from psychiatric illness 33
4.1.3 Arthritis affects 25% of CD Patients 33
4.1.4 Gastrointestinal complications often occur as part of CD 34
4.2 Global Trends 34
4.2.1 US 35
4.2.2 5EU 36
4.2.3 Japan 37
4.2.4 Canada 38
4.2.5 China 38
4.2.6 India 39
4.3 Forecast Methodology 39
4.4 Sources Used 42
4.4.1 US 42
4.4.2 France 42
4.4.3 Germany 43
4.4.4 Italy 43
4.4.5 Spain 44
4.4.6 UK 45
4.4.7 Japan 45
4.4.8 Canada 46
4.4.9 China 46
4.4.10 India 47
4.5 Forecast Assumptions and Methods 47
4.5.1 Incident Cases 47
4.5.2 Prevalent Cases 50
4.5.3 Sources Not Used 53
4.6 Epidemiological Forecast for CD 54
4.6.1 Incident Cases of CD 54
4.6.2 Prevalent Cases of CD 59
4.7 Discussion 66
4.8 Limitations of the Analysis 68
4.9 Strengths of the Analysis 68
5 Disease Management 69
5.1 Treatment Overview 70
5.2 US 75
5.2.1 Diagnosis 75
5.2.2 Clinical Practice 75
5.3 France 77
5.3.1 Diagnosis 77
5.3.2 Clinical Practice 78
5.4 Germany 79
5.4.1 Diagnosis 79
5.4.2 Clinical Practice 79
5.5 Italy 81
5.5.1 Diagnosis 81
5.5.2 Clinical Practice 81
5.6 Spain 83
5.6.1 Diagnosis 83
5.6.2 Clinical Practice 83
5.7 UK 85
5.7.1 Diagnosis 85
5.7.2 Clinical Practice 85
5.8 Japan 87
5.8.1 Diagnosis 87
5.8.2 Clinical Practice 87
5.9 Canada 89
5.9.1 Diagnosis 89
5.9.2 Clinical Practice 89
5.10 China 90
5.10.1 Diagnosis 90
5.10.2 Clinical Practice 90
5.11 India 91
5.11.1 Diagnosis 91
5.11.2 Clinical Practice 92
6 Competitive Assessment 93
6.1 Overview 93
6.2 Strategic Competitor Assessment 94
6.3 Product Profiles - Major Brands 96
6.3.1 Remicade (infliximab) 96
6.3.2 Humira (adalimumab) 102
6.3.3 Cimzia (certolizumab pegol) 109
6.3.4 Tysabri (natalizumab) 114
6.3.5 Other Marketed Products 120
6.4 Biosimilars 121
6.4.1 Introduction 121
6.4.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 122
6.4.3 Biosimilars in the Immunology Community 123
6.4.4 By the Numbers: Biosimilars in Development 123
6.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 126
6.4.6 Biosimilars' Forecast 127
7 Opportunity and Unmet Need 129
7.1 Overview 129
7.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 130
7.3 More Therapies for Anti-TNF-Refractory Patients 131
7.4 Unmet Needs Gap Analysis 132
7.5 Targeted Therapies 133
7.6 Predictive Tools for Early Diagnosis and Treatment 134
8 Pipeline Assessment 135
8.1 Overview 135
8.2 Clinical Trial Mapping 136
8.2.1 Clinical Trials by Country 136
8.3 Clinical Trials by Phase and Trial Status 137
8.4 Promising Drugs in Clinical Development 138
8.4.1 Entyvio (vedolizumab) 140
8.4.2 Stelara (ustekinumab) 152
8.4.3 Vercirnon (formerly GSK1605786) 160
8.4.4 Prochymal (Remestemcel-L) 169
8.5 Other Late-Stage Pipeline Products 175
8.5.1 Cx601 175
8.5.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 178
9 Current and Future Players 182
9.1 Overview 182
9.2 Trends in Corporate Strategy 184
9.3 Company Profiles 187
9.3.1 Johnson and Johnson 187
9.3.2 AbbVie 189
9.3.3 UCB 191
9.3.4 Biogen Idec 192
9.3.5 Takeda 194
9.3.6 ChemoCentryx 196
10 Market Outlook 198
10.1 Global Markets 198
10.1.1 Forecast 198
10.1.2 Drivers and Barriers - Global Issues 202
10.2 US 207
10.2.1 Forecast 207
10.2.2 Key Events 210
10.2.3 Drivers and Barriers 210
10.3 France 214
10.3.1 Forecast 214
10.3.2 Key Events 218
10.3.3 Drivers and Barriers 218
10.4 Germany 221
10.4.1 Forecast 221
10.4.2 Key Events 225
10.4.3 Drivers and Barriers 225
10.5 Italy 228
10.5.1 Forecast 228
10.5.2 Key Events 232
10.5.3 Drivers and Barriers 232
10.6 Spain 235
10.6.1 Forecast 235
10.6.2 Key Events 239
10.6.3 Drivers and Barriers 239
10.7 UK 242
10.7.1 Forecast 242
10.7.2 Key Events 246
10.7.3 Drivers and Barriers 246
10.8 Japan 249
10.8.1 Forecast 249
10.8.2 Key Events 253
10.8.3 Drivers and Barriers 253
10.9 Canada 257
10.9.1 Forecast 257
10.9.2 Key Events 261
10.9.3 Drivers and Barriers 261
10.10 China 263
10.10.1 Forecast 263
10.10.2 Key Events 266
10.10.3 Drivers and Barriers 266
10.11 India 268
10.11.1 Forecast 268
10.11.2 Key Events 271
10.11.3 Drivers and Barriers 271
11 Appendix 274
11.1 Bibliography 274
11.2 Abbreviations 287
11.3 Methodology 291
11.4 Forecasting Methodology 291
11.4.1 Diagnosed CD Patients 291
11.4.2 Percent Drug-Treated Patients 292
11.4.3 Drugs Included in Each Therapeutic Class 292
11.4.4 Launch and Patent Expiry Dates 292
11.4.5 General Pricing Assumptions 293
11.4.6 Individual Drug Assumptions 294
11.4.7 Generic Erosion 297
11.4.8 Pricing of Pipeline agents 298
11.5 Physicians and Specialists Included in This Study 299
11.6 Primary Research - Prescriber Survey 301
11.7 About the Authors 302
11.7.1 Author/Reviewer 302
11.7.2 Epidemiologist 302
11.7.3 Global Head of Healthcare 303
11.8 About GlobalData 304
11.9 Disclaimer 304

1.1 List of Tables

Table 1: Symptoms of CD 30
Table 2: Comorbidities for CD 32
Table 3: Sources of Incidence Data Used in This Analysis 40
Table 4: Sources of Prevalence Data Used in This Analysis 41
Table 5: All Markets, Incident Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 54
Table 6: All Markets, Incident Cases of CD, by Age, Men and Women, N (Row Total), 2012 56
Table 7: All Markets, Incident Cases of CD, by Sex, Ages ?10 Years, N (%), 2012 57
Table 8: All Markets, Prevalent Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 60
Table 9: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 62
Table 10: All Markets, Prevalent Cases of CD, by Sex, Ages ?10 Years, N (%), 2012 64
Table 11: Treatment Guidelines for CD 71
Table 12: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 73
Table 13: Leading Branded Drugs Used to Treat CD 95
Table 14: Product Profile - Remicade 97
Table 15: Remicade SWOT Analysis, 2013 100
Table 16: Global Sales Forecasts ($) for Remicade, 2012-2022 102
Table 17: Product Profile - Humira 104
Table 18: Humira SWOT Analysis, 2013 107
Table 19: Global Sales Forecasts ($) for Humira, 2012-2022 109
Table 20: Product Profile - Cimzia 110
Table 21: Cimzia SWOT Analysis, 2013 112
Table 22: Global Sales Forecasts ($) for Cimzia, 2012-2022 114
Table 23: Product Profile - Tysabri 115
Table 24: Tysabri SWOT Analysis, 2013 118
Table 25: Global Sales Forecasts ($) for Tysabri, 2012-2022 120
Table 26: Summary of the Minor Therapeutic Classes in CD, 2013 121
Table 27: Biosimilars Pipeline, 2013 124
Table 28: Global Sales Forecasts ($) for Infliximab Biosimilars, 2012-2022 127
Table 29: Global Sales Forecasts ($) for Adalimumab Biosimilars, 2012-2022 127
Table 30: Global Sales Forecasts ($) for Certolizumab pegol Biosimilars, 2012-2022 128
Table 31: Overall Unmet Needs in CD - Current Level of Attainment 130
Table 32: Clinical Unmet Needs in CD - Gap Analysis, 2013 133
Table 33: CD - Clinical Trials by Phase and Status, 2013 137
Table 34: Promising Drugs in Clinical Development for CD - Pipeline Phase, 2013 138
Table 35: Comparison of Therapeutic Classes in Development for CD, 2013 139
Table 36: Product Profile - Entyvio 141
Table 37: Efficacy of Entyvio in GEMINI II Studies of CD 142
Table 38: Entyvio SWOT Analysis, 2013 150
Table 39: Global Sales Forecasts ($) for Entyvio, 2012-2022 152
Table 40: Product Profile - Stelara 153
Table 41: Comparison of Stelara's Phase IIb CERTIFI trial Efficacy Data Versus Tysabri's Phase III Efficacy Data in Anti-TNF Refractory CD Patients 155
Table 42: Stelara SWOT Analysis, 2013 158
Table 43: Global Sales Forecasts ($) for Stelara, 2012-2022 160
Table 44: Product Profile - Vercirnon 162
Table 45: Vercirnon SWOT Analysis, 2013 167
Table 46: Global Sales Forecasts ($) for Vercirnon, 2012-2022 168
Table 47: Product Profile - Prochymal 170
Table 48: Prochymal SWOT Analysis, 2013 173
Table 49: Global Sales Forecasts ($) for Prochymal, 2012-2022 175
Table 50: Product Profile - Cx601 176
Table 51: Cx601 SWOT Analysis, 2013 177
Table 52: Product Profile - RHB-104 179
Table 53: RHB-104 SWOT Analysis, 2013 181
Table 54: Key Companies in the CD Market, 2013 183
Table 55: JandJ's CD Portfolio Assessment, 2013 188
Table 56: JandJ's CD SWOT Analysis, 2013 188
Table 57: AbbVie's CD Portfolio Assessment, 2013 190
Table 58: Abbott/AbbVie's CD SWOT Analysis, 2013 190
Table 59: UCB's CD Portfolio Assessment, 2013 191
Table 60: UCB's CD SWOT Analysis, 2013 192
Table 61: Biogen Idec's CD Portfolio Assessment, 2013 193
Table 62: Biogen Idec's CD SWOT Analysis, 2013 194
Table 63: Takeda's CD Portfolio Assessment, 2013 195
Table 64: Takeda's CD SWOT Analysis, 2013 195
Table 65: ChemoCentryx's CD Portfolio Assessment, 2013 196
Table 66: ChemoCentryx's CD SWOT Analysis, 2013 197
Table 67: Global Sales Forecasts ($) for CD, 2012-2022 200
Table 68: Global CD Market - Drivers and Barriers, 2012-2022 202
Table 69: Sales Forecasts ($) for CD in the United States, 2012-2022 208
Table 70: Key Events Impacting Sales for CD in the US, 2012-2022 210
Table 71: CD Market in the US - Drivers and Barriers, 2012-2022 210
Table 72: Sales Forecasts ($) for CD in France, 2012-2022 216
Table 73: Key Events Impacting Sales for CD in France, 2012-2022 218
Table 74: CD Market in France - Drivers and Barriers, 2012-2022 218
Table 75: Sales Forecasts ($) for CD in Germany, 2012-2022 223
Table 76: Key Events Impacting Sales for CD in Germany, 2012-2022 225
Table 77: CD Market in Germany - Drivers and Barriers, 2012-2022 225
Table 78: Sales Forecasts ($) for CD in Italy, 2012-2022 230
Table 79: Key Events Impacting Sales for CD in Italy, 2012-2022 232
Table 80: CD Market in Italy - Drivers and Barriers, 2012-2022 232
Table 81: Sales Forecasts ($) for CD in Spain, 2012-2022 237
Table 82: Key Events Impacting Sales for CD in Spain, 2012-2022 239
Table 83: CD Market in Spain - Drivers and Barriers, 2012-2022 239
Table 84: Sales Forecasts ($) for CD in the UK, 2012-2022 244
Table 85: Key Events Impacting Sales for CD in the UK, 2012-2022 246
Table 86: CD Market in the UK - Drivers and Barriers, 2012-2022 246
Table 87: Sales Forecasts ($) for CD in Japan, 2012-2022 251
Table 88: Key Events Impacting Sales for CD in Japan, 2012-2022 253
Table 89: CD Market in Japan - Drivers and Barriers, 2012-2022 253
Table 90: Sales Forecasts ($) for CD in Canada, 2012-2022 259
Table 91: Key Events Impacting Sales for CD in Canada, 2012-2022 261
Table 92: CD Market in Canada - Drivers and Barriers, 2012-2022 261
Table 93: Sales Forecasts ($) for CD in China, 2012-2022 264
Table 94: Key Events Impacting Sales for CD in China, 2012-2022 266
Table 95: CD Market in China - Drivers and Barriers, 2012-2022 266
Table 96: Sales Forecasts ($) for CD in India, 2012-2022 269
Table 97: Key Events Impacting Sales for CD in India, 2012-2022 271
Table 98: CD Market in India - Drivers and Barriers, 2012-2022 271
Table 99: Key Launch Dates 292
Table 100: Key Patent Expiries 293
Table 101: Physicians Surveyed, By Country 30

1.2 List of Figures
Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 26
Figure 2: Potential Biologic Drug Targets for CD 29
Figure 3: All Markets, Incident Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 55
Figure 4: All Markets, Incident Cases of CD, by Age, Men and Women, N, 2012 56
Figure 5: All Markets, Incident Cases of CD, by Sex, Ages ?10 Years, N, 2012 58
Figure 6: All Markets, Age-Standardized Incidence Rate of CD, Ages ?10 Years, Men and Women, 2012 59
Figure 7: All Markets, Prevalent Cases of CD, Ages ?10 Years, Men and Women, N, 2012-2022 61
Figure 8: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 63
Figure 9: All Markets, Prevalent Cases of CD, by Sex, Ages ?10 Years, N, 2012 65
Figure 10: All Markets, Age-Standardized Prevalence of CD, Ages ?10 Years, Men and Women, 2012 66
Figure 11: Patient Care Path for CD 72
Figure 12: CD Therapeutics - Clinical Trials by Country, 2013 136
Figure 13: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012-2022 139
Figure 14: Company Portfolio Gap Analysis in CD, 2012-2022 186
Figure 15: Global Sales for CD by Region, 2012-2022 201
Figure 16: Sales for CD in the US by Drug Class, 2012-2022 209
Figure 17: Sales for CD in France by Drug Class, 2012-2022 217
Figure 18: Sales for CD in Germany by Drug Class, 2012-2022 224
Figure 19: Sales for CD in Italy by Drug Class, 2012-2022 231
Figure 20: Sales for CD in Spain by Drug Class, 2012-2022 238
Figure 21: Sales for CD in the UK by Drug Class, 2012-2022 245
Figure 22: Sales for CD in Japan by Drug Class, 2012-2022 252
Figure 23: Sales for CD in Canada by Drug Class, 2012-2022 260
Figure 24: Sales for CD in China by Drug Class, 2012-2022 265
Figure 25: Sales for CD in India by Drug Class, 2012-2022 270

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