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Masitinib (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.

Masitinib is being developed in several indications, and is in Phase II or III of development for indications within cancer, central nervous system (CNS), and other inflammatory diseases. Masitinib is also currently in use in veterinary medicine for canine cancer, where it is known as Masivet or Kinavet (AB Science, 2014).

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 Masitinib including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Masitinib for the top 6 countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain and the UK.

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 Masitinib performance.
- Obtain sales forecast for Masitinib from 2013-2023 in top 6 countries (the US, France, Germany, Italy, Spain and the UK).

Table Of Contents

Masitinib (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 15
3.2 Symptoms 20
3.3 Prognosis 20
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 44
6.3.1 Unmet Need 44
6.3.2 Gap Analysis 46
6.3.3 Opportunity 47
6.4 Early Diagnosis of RA 47
6.4.1 Unmet Need 47
6.4.2 Gap Analysis 48
6.4.3 Opportunity 49
6.5 Personalized Treatment Approach 50
6.5.1 Unmet Need 50
6.5.2 Gap Analysis 50
6.5.3 Opportunity 52
7 Pipeline Assessment 54
7.1 Overview 54
7.2 Promising Drugs in Clinical Development 54
8 Masitinib 62
8.1 Overview 62
8.2 Efficacy 63
8.3 Safety 64
8.4 Dosing and Formulation 65
8.5 Potential Clinical Positioning 65
8.6 Potential Commercial Positioning 65
8.7 Pricing and Reimbursement 66
8.8 SWOT Analysis 67
8.9 Forecast 67
9 Appendix 69
9.1 Bibliography 69
9.2 Abbreviations 72
9.3 Methodology 75
9.4 Forecasting Methodology 75
9.4.1 Diagnosed RA Patients 75
9.4.2 Percentage of Drug-Treated Patients 76
9.4.3 General Pricing Assumptions 76
9.4.4 Generic and Biosimilar Erosion 77
9.4.5 Pricing of Pipeline Agents 77
9.5 Primary Research - KOLs Interviewed for This Report 78
9.6 Primary Research - Prescriber Survey 80
9.7 About the Authors 81
9.7.1 Analyst 81
9.7.2 Reviewer 81
9.7.3 Therapy Area Director 82
9.7.4 Global Head of Healthcare 82
9.8 About GlobalData 83
9.9 Disclaimer 83

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 - Masitinib 63
Table 12: ACR Response to Masitinib in RA (12 Weeks) 64
Table 13: ACR Responses for Masitinib in the Phase IIa ITT Population (12-82 Weeks) 64
Table 14: Masitinib SWOT Analysis, 2014 67
Table 15: Global Sales Forecasts ($m) for Masitinib, 2013-2023 68
Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 80

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 16
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 Masitinib 66

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