Crohn’s Disease – 5EU Drug Forecast and Market Analysis to 2022

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 general, US and Canadian gastroenterologists follow the treatment guidelines published by the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA), while physicians in the EU mainly rely on the European Crohn’s and Colitis Organisation (ECCO) guidelines. Outside these regions, Japanese gastroenterologists consult the guidelines published by the MHLW, while their colleagues in China and India adhere to the guidelines published by the ACG and the AGA, in addition to the guidelines issued by local medical authorities.

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 the 5 EU countries including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the 5 EU countries from 2012-2022.

Analysis of the impact of key events as well the drivers and restraints affecting the 5 EU 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 the 5EU countries.

Table of Contents

1Table of Contents1

1.1List of Tables5

1.2List of Figures7

2Executive Summary8

2.1Sales for CD in the 5 Major EU markets in 2012 ...

1Table of Contents1

1.1List of Tables5

1.2List of Figures7

2Executive Summary8

2.1Sales for CD in the 5 Major EU markets in 2012–2022:8

2.2What Do Physicians Think?10

3Introduction12

3.1Catalyst12

3.2Related Reports13

3.3Upcoming Related Reports14

4Disease Overview14

4.1Etiology and Pathophysiology14

4.1.1Etiology14

4.1.2Pathophysiology15

4.2Symptoms18

4.3Prognosis19

4.4Quality of Life20

5Disease Management20

5.1Treatment Overview21

5.2France26

5.2.1Diagnosis26

5.2.2Clinical Practice27

5.3Germany28

5.3.1Diagnosis28

5.3.2Clinical Practice28

5.4Italy29

5.4.1Diagnosis29

5.4.2Clinical Practice30

5.5Spain31

5.5.1Diagnosis31

5.5.2Clinical Practice32

5.6UK33

5.6.1Diagnosis33

5.6.2Clinical Practice34

6Competitive Assessment35

6.1Overview35

6.2Strategic Competitor Assessment36

6.3Product Profiles – Major Brands38

6.3.1Remicade (infliximab)38

6.3.2Humira (adalimumab)43

6.3.3Cimzia (certolizumab pegol)49

6.3.4Tysabri (natalizumab)52

6.3.5Other Marketed Products57

6.4Biosimilars58

6.4.1Introduction58

6.4.2Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases59

6.4.3Biosimilars in the Immunology Community59

6.4.4By the Numbers: Biosimilars in Development60

6.4.5The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry62

7Opportunity and Unmet Need63

7.1Overview63

7.2Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach65

7.3More Therapies for Anti-TNF-Refractory Patients66

7.4Unmet Needs Gap Analysis66

7.5Targeted Therapies68

7.6Predictive Tools for Early Diagnosis and Treatment69

8Pipeline Assessment69

8.1Overview69

8.2Promising Drugs in Clinical Development70

8.2.1Entyvio (vedolizumab)72

8.2.2Stelara (ustekinumab)84

8.2.3Vercirnon (formerly GSK1605786)90

8.3Other Late-Stage Pipeline Products96

8.3.1Cx60196

8.3.2RHB-104 (clarithromycin + clofazimine + rifabutin)99

9Market Outlook103

9.1Global Markets103

9.1.1Drivers and Barriers – Global Issues103

105 EU108

10.1France108

10.1.1Forecast108

10.1.2Key Events112

10.1.3Drivers and Barriers112

10.2Germany114

10.2.1Forecast114

10.2.2Key Events118

10.2.3Drivers and Barriers118

10.3Italy120

10.3.1Forecast120

10.3.2Key Events124

10.3.3Drivers and Barriers124

10.4Spain127

10.4.1Forecast127

10.4.2Key Events131

10.4.3Drivers and Barriers131

10.5UK134

10.5.1Forecast134

10.5.2Key Events138

10.5.3Drivers and Barriers138

11Appendix141

11.1Bibliography141

11.2Abbreviations147

11.3Methodology150

11.4Forecasting Methodology150

11.4.1Diagnosed CD Patients151

11.4.2Percent Drug-Treated Patients151

11.4.3Drugs Included in Each Therapeutic Class151

11.4.4Launch and Patent Expiry Dates152

11.4.5General Pricing Assumptions152

11.4.6Individual Drug Assumptions154

11.4.7Generic Erosion156

11.4.8Pricing of Pipeline agents157

11.5Physicians and Specialists Included in This Study158

11.6Primary Research – Prescriber Survey159

11.7About the Authors159

11.7.1Author/Reviewer159

11.7.2Global Head of Healthcare160

11.8About GlobalData160

11.9Contact Us161

11.10Disclaimer161

List of Tables

Table 1: Crohn’s Disease: Key Metrics in the 5EU Markets8

Table 2: Symptoms of CD19

Table 3: Treatment Guidelines for CD23

Table 4: Most ...

Table 1: Crohn’s Disease: Key Metrics in the 5EU Markets8

Table 2: Symptoms of CD19

Table 3: Treatment Guidelines for CD23

Table 4: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, 201325

Table 5: Leading Branded Drugs Used to Treat CD37

Table 6: Product Profile – Remicade40

Table 7: Remicade SWOT Analysis, 201342

Table 8: Product Profile – Humira45

Table 9: Humira SWOT Analysis, 201348

Table 10: Product Profile – Cimzia50

Table 11: Cimzia SWOT Analysis, 201352

Table 12: Product Profile – Tysabri53

Table 13: Tysabri SWOT Analysis, 201357

Table 14: Summary of the Minor Therapeutic Classes in CD, 201358

Table 15: Biosimilars Pipeline, 201361

Table 16: Overall Unmet Needs in CD – Current Level of Attainment65

Table 17: Clinical Unmet Needs in CD – Gap Analysis, 201368

Table 18: Promising Drugs in Clinical Development for CD – Pipeline Phase, 201370

Table 19: Comparison of Therapeutic Classes in Development for CD, 201372

Table 20: Product Profile – Entyvio74

Table 21: Efficacy of Entyvio in GEMINI II Studies of CD75

Table 22: Entyvio SWOT Analysis, 201383

Table 23: Product Profile – Stelara85

Table 24: Comparison of Stelara’s Phase IIb CERTIFI trial Efficacy Data Versus Tysabri’s Phase III Efficacy Data in Anti-TNF Refractory CD Patients86

Table 25: Stelara SWOT Analysis, 201390

Table 26: Product Profile – Vercirnon92

Table 27: Vercirnon SWOT Analysis, 201396

Table 28: Product Profile – Cx60198

Table 29: Cx601 SWOT Analysis, 201399

Table 30: Product Profile – RHB-104101

Table 31: RHB-104 SWOT Analysis, 2013103

Table 32: Global CD Market – Drivers and Barriers, 2012–2022103

Table 33: Sales Forecasts ($) for CD in France, 2012–2022110

Table 34: Key Events Impacting Sales for CD in France, 2012–2022112

Table 35: CD Market in France – Drivers and Barriers, 2012–2022112

Table 36: Sales Forecasts ($) for CD in Germany, 2012–2022116

Table 37: Key Events Impacting Sales for CD in Germany, 2012–2022118

Table 38: CD Market in Germany – Drivers and Barriers, 2012–2022118

Table 39: Sales Forecasts ($) for CD in Italy, 2012–2022121

Table 40: Key Events Impacting Sales for CD in Italy, 2012–2022124

Table 41: CD Market in Italy – Drivers and Barriers, 2012–2022124

Table 42: Sales Forecasts ($) for CD in Spain, 2012–2022129

Table 43: Key Events Impacting Sales for CD in Spain, 2012–2022131

Table 44: CD Market in Spain – Drivers and Barriers, 2012–2022131

Table 45: Sales Forecasts ($) for CD in the UK, 2012–2022136

Table 46: Key Events Impacting Sales for CD in the UK, 2012–2022138

Table 47: CD Market in the UK – Drivers and Barriers, 2012–2022138

Table 48: Key Launch Dates152

Table 49: Key Patent Expiries152

Table 50: Physicians Surveyed, By Country159

List of Figures

Figure 1: CD: Sales of CD by Countries, 2012–202210

Figure 2: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With ...

Figure 1: CD: Sales of CD by Countries, 2012–202210

Figure 2: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right)15

Figure 3: Potential Biologic Drug Targets for CD18

Figure 4: Patient Care Path for CD24

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in CD, 2012–202271

Figure 6: Sales for CD in France by Drug Class, 2012–2022111

Figure 7 illustrates the sales for CD in Germany by drug class during 2012–2022.Figure 7: Sales for CD in Germany by Drug Class, 2012–2022117

Figure 8: Sales for CD in Italy by Drug Class, 2012–2022123

Figure 9: Sales for CD in Spain by Drug Class, 2012–2022130

Figure 10: Sales for CD in the UK by Drug Class, 2012–2022137

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