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Clazakizumab (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023

Summary

Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation and deformity of the joints . It affects over seven million individuals in the 10MM covered in this report (US, France, Germany, Italy, Spain, UK, Japan, Australia, China, and India) and the prevalence is expected to grow to just over 8.5 million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of RA and inhibiting progression to erosive bone disease. However, the landscape is quickly changing with the introduction of biosimilars, novel biologics, and a class of oral therapies known as JAK inhibitors, all of which will change the market dynamics between 2013 and 2023. With the anti-TNFs as extremely effective therapies for RA, the market is extremely competitive for new entrants and will undergo further pressure as biosimilars are approved and launch.

Clazakizumab is a humanized mAb directed against IL-6 that is in Phase IIb of development by Alder Biopharmaceuticals for the treatment of moderate to severe RA. It is expected to be used as an SC injection, in combination with MTX, but is also under investigation for use as a monotherapy. Clazakizumab blocks IL-6 and therefore reduces inflammation, as well as swelling, pain, and joint destruction, associated with RA.

Scope

- Overview of Rheumatoid Arthritis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Clazakizumab including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Clazakizumab for the top seven countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan.

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 Rheumatoid Arthritis.
- 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 Clazakizumab performance.
- Obtain sales forecast for Clazakizumab from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan).

Table Of Contents

Clazakizumab (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 16
3.2 Symptoms 20
3.3 Prognosis 21
3.4 Quality of Life 21
4 Disease Management 22
4.1 Diagnosis and Treatment Overview 22
4.1.1 Diagnosis 22
4.1.2 Treatment Guidelines 24
4.1.3 Leading Prescribed Drugs for the Treatment of RA 33
4.1.4 Clinical Practice 34
5 Competitive Assessment 40
5.1 Overview 40
6 Unmet Need and Opportunity 42
6.1 Overview 42
6.2 Development of Cost-Effective Therapies 43
6.2.1 Unmet Need 43
6.2.2 Gap Analysis 44
6.2.3 Opportunity 44
6.3 Biomarkers to Predict Responsiveness to Therapy 45
6.3.1 Unmet Need 45
6.3.2 Gap Analysis 47
6.3.3 Opportunity 47
6.4 Early Diagnosis of RA 48
6.4.1 Unmet Need 48
6.4.2 Gap Analysis 49
6.4.3 Opportunity 50
6.5 Personalized Treatment Approach 50
6.5.1 Unmet Need 50
6.5.2 Gap Analysis 51
6.5.3 Opportunity 53
7 Pipeline Assessment 54
7.1 Overview 54
7.2 Promising Drugs in Clinical Development 54
8 Clazakizumab 62
8.1 Overview 62
8.2 Efficacy 63
8.3 Safety 65
8.4 Dosing and Formulation 65
8.5 Potential Clinical Positioning 66
8.6 Potential Commercial Positioning 66
8.7 Pricing and Reimbursement 66
8.8 SWOT Analysis 68
8.9 Forecast 68
9 Appendix 70
9.1 Bibliography 70
9.2 Abbreviations 73
9.3 Methodology 76
9.4 Forecasting Methodology 76
9.4.1 Diagnosed RA Patients 76
9.4.2 Percentage of Drug-Treated Patients 77
9.4.3 General Pricing Assumptions 77
9.4.4 Generic and Biosimilar Erosion 78
9.4.5 Pricing of Pipeline Agents 78
9.5 Primary Research - KOLs Interviewed for This Report 79
9.6 Primary Research - Prescriber Survey 81
9.7 About the Authors 82
9.7.1 Analyst 82
9.7.2 Reviewer 82
9.7.3 Therapy Area Director 83
9.7.4 Global Head of Healthcare 83
9.8 About GlobalData 84
9.9 Disclaimer 84

1.1 List of Tables

Table 1: Symptoms of RA 20
Table 2: 1987 ACR Diagnostic Criteria for RA 23
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 24
Table 4: Treatment Guidelines for RA Used by Each Country in the 10MM 26
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 29
Table 6: EULAR 2013 Criteria for RA Remission 30
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the Global Markets, 2014 34
Table 8: Leading Branded Treatments for RA 2014 41
Table 9: Unmet Need and Opportunity in RA, 2014 43
Table 10: Comparison of Therapeutic Drug Classes in Development for RA, 2014 61
Table 11: Product Profile - Clazakizumab 63
Table 12: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks 64
Table 13: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks 64
Table 14: Clazakizumab SWOT Analysis, 2014 68
Table 15: Global Sales Forecasts ($m) for Clazakizumab, 2013-2023 69
Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 81

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 17
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 19
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 30
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 31
Figure 5: Flowchart for the Management of RA - EULAR 2013 32
Figure 6: RA - Phase II-III Pipeline, 2014 56
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 60
Figure 8: Clinical and Commercial Positioning of Clazakizumab 67

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