PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2022

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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.

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.

Key Highlights

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?

Companies mentioned

J&J

Merck & Co.

Mitsubishi Tanabe

AbbVie

Eisai

UCB

Biogen Idec

Takeda

ChemoCentryx

Elan

RedHill Biopharma

TiGenix

Osiris Therapeutics

Mesoblast

Pfizer

J&J

Merck & Co.

Mitsubishi Tanabe

AbbVie

Eisai

UCB

Biogen Idec

Takeda

ChemoCentryx

Elan

RedHill Biopharma

TiGenix

Osiris Therapeutics

Mesoblast

Pfizer

Table of Contents

1 Table of Contents 10

1.1 List of Tables 19

1.2 List of Figures 23

2 Introduction 25

2.1 Catalyst 25

2 ...

1 Table of Contents 10

1.1 List of Tables 19

1.2 List of Figures 23

2 Introduction 25

2.1 Catalyst 25

2.2 Related Reports 26

2.3 Upcoming Related Reports 26

3 Disease Overview 27

3.1 Etiology and Pathophysiology 27

3.1.1 Etiology 27

3.1.2 Pathophysiology 27

3.2 Symptoms 31

3.3 Prognosis 32

3.4 Quality of Life 33

4 Epidemiology 34

4.1 Risk Factors and Comorbidities 34

4.1.1 Up to 60% of CD patients experience reduced bone density 35

4.1.2 One third of patients with CD suffer from psychiatric illness 35

4.1.3 Arthritis affects 25% of CD Patients 35

4.1.4 Gastrointestinal complications often occur as part of CD 36

4.2 Global Trends 36

4.2.1 US 37

4.2.2 5EU 38

4.2.3 Japan 39

4.2.4 Canada 40

4.2.5 China 40

4.2.6 India 41

4.3 Forecast Methodology 41

4.4 Sources Used 44

4.4.1 US 44

4.4.2 France 44

4.4.3 Germany 45

4.4.4 Italy 45

4.4.5 Spain 46

4.4.6 UK 47

4.4.7 Japan 47

4.4.8 Canada 48

4.4.9 China 48

4.4.10 India 49

4.5 Forecast Assumptions and Methods 49

4.5.1 Incident Cases 49

4.5.2 Prevalent Cases 52

4.5.3 Sources Not Used 55

4.6 Epidemiological Forecast for CD 56

4.6.1 Incident Cases of CD 56

4.6.2 Prevalent Cases of CD 61

4.7 Discussion 68

4.8 Limitations of the Analysis 70

4.9 Strengths of the Analysis 70

5 Disease Management 71

5.1 Treatment Overview 72

5.2 US 77

5.2.1 Diagnosis 77

5.2.2 Clinical Practice 77

5.3 France 79

5.3.1 Diagnosis 79

5.3.2 Clinical Practice 80

5.4 Germany 81

5.4.1 Diagnosis 81

5.4.2 Clinical Practice 81

5.5 Italy 83

5.5.1 Diagnosis 83

5.5.2 Clinical Practice 83

5.6 Spain 85

5.6.1 Diagnosis 85

5.6.2 Clinical Practice 85

5.7 UK 87

5.7.1 Diagnosis 87

5.7.2 Clinical Practice 87

5.8 Japan 89

5.8.1 Diagnosis 89

5.8.2 Clinical Practice 89

5.9 Canada 91

5.9.1 Diagnosis 91

5.9.2 Clinical Practice 91

5.10 China 92

5.10.1 Diagnosis 92

5.10.2 Clinical Practice 92

5.11 India 93

5.11.1 Diagnosis 93

5.11.2 Clinical Practice 94

6 Competitive Assessment 95

6.1 Overview 95

6.2 Strategic Competitor Assessment 96

6.3 Product Profiles – Major Brands 98

6.3.1 Remicade (infliximab) 98

6.3.2 Humira (adalimumab) 104

6.3.3 Cimzia (certolizumab pegol) 111

6.3.4 Tysabri (natalizumab) 116

6.3.5 Other Marketed Products 122

6.4 Biosimilars 123

6.4.1 Introduction 123

6.4.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases 124

6.4.3 Biosimilars in the Immunology Community 125

6.4.4 By the Numbers: Biosimilars in Development 125

6.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 128

6.4.6 Biosimilars’ Forecast 129

7 Opportunity and Unmet Need 131

7.1 Overview 131

7.2 Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach 132

7.3 More Therapies for Anti-TNF-Refractory Patients 133

7.4 Unmet Needs Gap Analysis 134

7.5 Targeted Therapies 135

7.6 Predictive Tools for Early Diagnosis and Treatment 136

8 Pipeline Assessment 137

8.1 Overview 137

8.2 Clinical Trial Mapping 138

8.2.1 Clinical Trials by Country 138

8.3 Clinical Trials by Phase and Trial Status 139

8.4 Promising Drugs in Clinical Development 140

8.4.1 Entyvio (vedolizumab) 142

8.4.2 Stelara (ustekinumab) 154

8.4.3 Vercirnon (formerly GSK1605786) 162

8.4.4 Prochymal (Remestemcel-L) 171

8.5 Other Late-Stage Pipeline Products 177

8.5.1 Cx601 177

8.5.2 RHB-104 (clarithromycin + clofazimine + rifabutin) 180

9 Current and Future Players 184

9.1 Overview 184

9.2 Trends in Corporate Strategy 186

9.3 Company Profiles 189

9.3.1 Johnson & Johnson 189

9.3.2 AbbVie 191

9.3.3 UCB 193

9.3.4 Biogen Idec 194

9.3.5 Takeda 196

9.3.6 ChemoCentryx 198

10 Market Outlook 200

10.1 Global Markets 200

10.1.1 Forecast 200

10.1.2 Drivers and Barriers – Global Issues 204

10.2 US 209

10.2.1 Forecast 209

10.2.2 Key Events 212

10.2.3 Drivers and Barriers 212

10.3 France 216

10.3.1 Forecast 216

10.3.2 Key Events 220

10.3.3 Drivers and Barriers 220

10.4 Germany 223

10.4.1 Forecast 223

10.4.2 Key Events 227

10.4.3 Drivers and Barriers 227

10.5 Italy 230

10.5.1 Forecast 230

10.5.2 Key Events 234

10.5.3 Drivers and Barriers 234

10.6 Spain 237

10.6.1 Forecast 237

10.6.2 Key Events 241

10.6.3 Drivers and Barriers 241

10.7 UK 244

10.7.1 Forecast 244

10.7.2 Key Events 248

10.7.3 Drivers and Barriers 248

10.8 Japan 251

10.8.1 Forecast 251

10.8.2 Key Events 255

10.8.3 Drivers and Barriers 255

10.9 Canada 259

10.9.1 Forecast 259

10.9.2 Key Events 263

10.9.3 Drivers and Barriers 263

10.10 China 265

10.10.1 Forecast 265

10.10.2 Key Events 268

10.10.3 Drivers and Barriers 268

10.11 India 270

10.11.1 Forecast 270

10.11.2 Key Events 273

10.11.3 Drivers and Barriers 273

11 Appendix 276

11.1 Bibliography 276

11.2 Abbreviations 289

11.3 Methodology 293

11.4 Forecasting Methodology 293

11.4.1 Diagnosed CD Patients 293

11.4.2 Percent Drug-Treated Patients 294

11.4.3 Drugs Included in Each Therapeutic Class 294

11.4.4 Launch and Patent Expiry Dates 294

11.4.5 General Pricing Assumptions 295

11.4.6 Individual Drug Assumptions 296

11.4.7 Generic Erosion 299

11.4.8 Pricing of Pipeline agents 300

11.5 Physicians and Specialists Included in This Study 301

11.6 Primary Research – Prescriber Survey 303

11.7 About the Authors 304

11.7.1 Author/Reviewer 304

11.7.2 Epidemiologist 304

11.7.3 Global Head of Healthcare 305

11.8 About GlobalData 306

11.9 Disclaimer 306

List of tables

Table 1: Symptoms of CD 32

Table 2: Comorbidities for CD 34

Table 3: Sources of Incidence Data Used in This Analysis 42

Table 4 ...

Table 1: Symptoms of CD 32

Table 2: Comorbidities for CD 34

Table 3: Sources of Incidence Data Used in This Analysis 42

Table 4: Sources of Prevalence Data Used in This Analysis 43

Table 5: All Markets, Incident Cases of CD, Ages =10 Years, Men and Women, N, 2012–2022 56

Table 6: All Markets, Incident Cases of CD, by Age, Men and Women, N (Row Total), 2012 58

Table 7: All Markets, Incident Cases of CD, by Sex, Ages =10 Years, N (%), 2012 59

Table 8: All Markets, Prevalent Cases of CD, Ages =10 Years, Men and Women, N, 2012–2022 62

Table 9: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 64

Table 10: All Markets, Prevalent Cases of CD, by Sex, Ages =10 Years, N (%), 2012 66

Table 11: Treatment Guidelines for CD 73

Table 12: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 2013 75

Table 13: Leading Branded Drugs Used to Treat CD 97

Table 14: Product Profile – Remicade 99

Table 15: Remicade SWOT Analysis, 2013 102

Table 16: Global Sales Forecasts ($) for Remicade, 2012–2022 104

Table 17: Product Profile – Humira 106

Table 18: Humira SWOT Analysis, 2013 109

Table 19: Global Sales Forecasts ($) for Humira, 2012–2022 111

Table 20: Product Profile – Cimzia 112

Table 21: Cimzia SWOT Analysis, 2013 114

Table 22: Global Sales Forecasts ($) for Cimzia, 2012–2022 116

Table 23: Product Profile – Tysabri 117

Table 24: Tysabri SWOT Analysis, 2013 120

Table 25: Global Sales Forecasts ($) for Tysabri, 2012–2022 122

Table 26: Summary of the Minor Therapeutic Classes in CD, 2013 123

Table 27: Biosimilars Pipeline, 2013 126

Table 28: Global Sales Forecasts ($) for Infliximab Biosimilars, 2012–2022 129

Table 29: Global Sales Forecasts ($) for Adalimumab Biosimilars, 2012–2022 129

Table 30: Global Sales Forecasts ($) for Certolizumab pegol Biosimilars, 2012–2022 130

Table 31: Overall Unmet Needs in CD – Current Level of Attainment 132

Table 32: Clinical Unmet Needs in CD – Gap Analysis, 2013 135

Table 33: CD – Clinical Trials by Phase and Status, 2013 139

Table 34: Promising Drugs in Clinical Development for CD – Pipeline Phase, 2013 140

Table 35: Comparison of Therapeutic Classes in Development for CD, 2013 141

Table 36: Product Profile – Entyvio 143

Table 37: Efficacy of Entyvio in GEMINI II Studies of CD 144

Table 38: Entyvio SWOT Analysis, 2013 152

Table 39: Global Sales Forecasts ($) for Entyvio, 2012–2022 154

Table 40: Product Profile – Stelara 155

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 157

Table 42: Stelara SWOT Analysis, 2013 160

Table 43: Global Sales Forecasts ($) for Stelara, 2012–2022 162

Table 44: Product Profile – Vercirnon 164

Table 45: Vercirnon SWOT Analysis, 2013 169

Table 46: Global Sales Forecasts ($) for Vercirnon, 2012–2022 170

Table 47: Product Profile – Prochymal 172

Table 48: Prochymal SWOT Analysis, 2013 175

Table 49: Global Sales Forecasts ($) for Prochymal, 2012–2022 177

Table 50: Product Profile – Cx601 178

Table 51: Cx601 SWOT Analysis, 2013 179

Table 52: Product Profile – RHB-104 181

Table 53: RHB-104 SWOT Analysis, 2013 183

Table 54: Key Companies in the CD Market, 2013 185

Table 55: J&J’s CD Portfolio Assessment, 2013 190

Table 56: J&J’s CD SWOT Analysis, 2013 190

Table 57: AbbVie’s CD Portfolio Assessment, 2013 192

Table 58: Abbott/AbbVie’s CD SWOT Analysis, 2013 192

Table 59: UCB’s CD Portfolio Assessment, 2013 193

Table 60: UCB’s CD SWOT Analysis, 2013 194

Table 61: Biogen Idec’s CD Portfolio Assessment, 2013 195

Table 62: Biogen Idec’s CD SWOT Analysis, 2013 196

Table 63: Takeda’s CD Portfolio Assessment, 2013 197

Table 64: Takeda’s CD SWOT Analysis, 2013 197

Table 65: ChemoCentryx’s CD Portfolio Assessment, 2013 198

Table 66: ChemoCentryx’s CD SWOT Analysis, 2013 199

Table 67: Global Sales Forecasts ($) for CD, 2012–2022 202

Table 68: Global CD Market – Drivers and Barriers, 2012–2022 204

Table 69: Sales Forecasts ($) for CD in the United States, 2012–2022 210

Table 70: Key Events Impacting Sales for CD in the US, 2012–2022 212

Table 71: CD Market in the US – Drivers and Barriers, 2012–2022 212

Table 72: Sales Forecasts ($) for CD in France, 2012–2022 218

Table 73: Key Events Impacting Sales for CD in France, 2012–2022 220

Table 74: CD Market in France – Drivers and Barriers, 2012–2022 220

Table 75: Sales Forecasts ($) for CD in Germany, 2012–2022 225

Table 76: Key Events Impacting Sales for CD in Germany, 2012–2022 227

Table 77: CD Market in Germany – Drivers and Barriers, 2012–2022 227

Table 78: Sales Forecasts ($) for CD in Italy, 2012–2022 232

Table 79: Key Events Impacting Sales for CD in Italy, 2012–2022 234

Table 80: CD Market in Italy – Drivers and Barriers, 2012–2022 234

Table 81: Sales Forecasts ($) for CD in Spain, 2012–2022 239

Table 82: Key Events Impacting Sales for CD in Spain, 2012–2022 241

Table 83: CD Market in Spain – Drivers and Barriers, 2012–2022 241

Table 84: Sales Forecasts ($) for CD in the UK, 2012–2022 246

Table 85: Key Events Impacting Sales for CD in the UK, 2012–2022 248

Table 86: CD Market in the UK – Drivers and Barriers, 2012–2022 248

Table 87: Sales Forecasts ($) for CD in Japan, 2012–2022 253

Table 88: Key Events Impacting Sales for CD in Japan, 2012–2022 255

Table 89: CD Market in Japan – Drivers and Barriers, 2012–2022 255

Table 90: Sales Forecasts ($) for CD in Canada, 2012–2022 261

Table 91: Key Events Impacting Sales for CD in Canada, 2012–2022 263

Table 92: CD Market in Canada – Drivers and Barriers, 2012–2022 263

Table 93: Sales Forecasts ($) for CD in China, 2012–2022 266

Table 94: Key Events Impacting Sales for CD in China, 2012–2022 268

Table 95: CD Market in China – Drivers and Barriers, 2012–2022 268

Table 96: Sales Forecasts ($) for CD in India, 2012–2022 271

Table 97: Key Events Impacting Sales for CD in India, 2012–2022 273

Table 98: CD Market in India – Drivers and Barriers, 2012–2022 273

Table 99: Key Launch Dates 294

Table 100: Key Patent Expiries 295

Table 101: Physicians Surveyed, By Country 303

List of figures

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 28

Figure 2: Potential Biologic Drug Targets for ...

Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) 28

Figure 2: Potential Biologic Drug Targets for CD 31

Figure 3: All Markets, Incident Cases of CD, Ages =10 Years, Men and Women, N, 2012–2022 57

Figure 4: All Markets, Incident Cases of CD, by Age, Men and Women, N, 2012 58

Figure 5: All Markets, Incident Cases of CD, by Sex, Ages =10 Years, N, 2012 60

Figure 6: All Markets, Age-Standardized Incidence Rate of CD, Ages =10 Years, Men and Women, 2012 61

Figure 7: All Markets, Prevalent Cases of CD, Ages =10 Years, Men and Women, N, 2012–2022 63

Figure 8: All Markets, Prevalent Cases of CD, by Age, Men and Women, N, 2012 65

Figure 9: All Markets, Prevalent Cases of CD, by Sex, Ages =10 Years, N, 2012 67

Figure 10: All Markets, Age-Standardized Prevalence of CD, Ages =10 Years, Men and Women, 2012 68

Figure 11: Patient Care Path for CD 74

Figure 12: CD Therapeutics – Clinical Trials by Country, 2013 138

Figure 13: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012–2022 141

Figure 14: Company Portfolio Gap Analysis in CD, 2012–2022 188

Figure 15: Global Sales for CD by Region, 2012–2022 203

Figure 16: Sales for CD in the US by Drug Class, 2012–2022 211

Figure 17: Sales for CD in France by Drug Class, 2012–2022 219

Figure 18: Sales for CD in Germany by Drug Class, 2012–2022 226

Figure 19: Sales for CD in Italy by Drug Class, 2012–2022 233

Figure 20: Sales for CD in Spain by Drug Class, 2012–2022 240

Figure 21: Sales for CD in the UK by Drug Class, 2012–2022 247

Figure 22: Sales for CD in Japan by Drug Class, 2012–2022 254

Figure 23: Sales for CD in Canada by Drug Class, 2012–2022 262

Figure 24: Sales for CD in China by Drug Class, 2012–2022 267

Figure 25: Sales for CD in India by Drug Class, 2012–2022 272

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