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RAVAX (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.

IRBP is producing RAVAX, a Phase III, potential first-in-class vaccine for the treatment of patients with early RA or with RA for less than 10 years. RAVAX is a vaccine that contains four 17-20mer (amino acids) (IR501) or 40mer (IR703) peptides against the T-cell receptor, specifically targetting autoreactive T cells, thus reducing their activity. The RAVAX vaccine is believed to target autoreactive T cells, while not affecting normal cells (IRBP, 2014b).

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 RAVAX including product description, safety and efficacy profiles as well as a SWOT analysis

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 RAVAX performance.

Table Of Contents

RAVAX (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 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 34
4.1.4 Clinical Practice 35
5 Competitive Assessment 41
5.1 Overview 41
6 Unmet Need and Opportunity 43
6.1 Overview 43
6.2 Development of Cost-Effective Therapies 44
6.2.1 Unmet Need 44
6.2.2 Gap Analysis 45
6.2.3 Opportunity 45
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 48
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 51
6.5.1 Unmet Need 51
6.5.2 Gap Analysis 51
6.5.3 Opportunity 53
7 Pipeline Assessment 55
7.1 Overview 55
7.2 Promising Drugs in Clinical Development 55
8 RAVAX 63
8.1 Overview 63
8.2 Efficacy 64
8.3 Safety 65
8.4 Dosing and Formulation 65
8.5 Potential Clinical Positioning 65
8.6 Potential Commercial Positioning 66
8.7 Pricing and Reimbursement 66
8.8 SWOT Analysis 67
8.9 Forecast 68
9 Appendix 69
9.1 Bibliography 69
9.2 Abbreviations 71
9.3 Methodology 74
9.4 Forecasting Methodology 74
9.4.1 Diagnosed RA Patients 74
9.4.2 Percentage of Drug-Treated Patients 75
9.4.3 General Pricing Assumptions 75
9.4.4 Generic and Biosimilar Erosion 75
9.5 Primary Research - KOLs Interviewed for This Report 76
9.6 Primary Research - Prescriber Survey 78
9.7 About the Authors 79
9.7.1 Analyst 79
9.7.2 Reviewer 79
9.7.3 Therapy Area Director 79
9.7.4 Global Head of Healthcare 80
9.8 About GlobalData 81
9.9 Disclaimer 81

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 27
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 30
Table 6: EULAR 2013 Criteria for RA Remission 31
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the Global Markets, 2014 35
Table 8: Leading Branded Treatments for RA 2014 42
Table 9: Unmet Need and Opportunity in RA, 2014 44
Table 10: Comparison of Therapeutic Drug Classes in Development for RA, 2014 62
Table 11: Product Profile - RAVAX 64
Table 12: RAVAX SWOT Analysis, 2014 67
Table 13: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 78

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 31
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 32
Figure 5: Flowchart for the Management of RA - EULAR 2013 33
Figure 6: RA - Phase II-III Pipeline, 2014 57
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 61
Figure 8: Clinical and Commercial Positioning of RAVAX 67

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