Mavrilimumab (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.
Mavrilimumab, also known as CAM3001, is in Phase IIb of development for RA by MedImmune, a subsidiary of AstraZeneca. It is a human mAb targeted against the alpha subunit of the GM-CSF receptor. GM-CSF levels are elevated in the serum, synovial fluid, and synoviocytes of patients with RA. Inhibition of GM-CSF activity is proposed to reduce the activation, differentiation, and recruitment of macrophages and neutrophils in the damaged and inflamed joints of RA patients.
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 Mavrilimumab including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Mavrilimumab 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 Mavrilimumab performance.
- Obtain sales forecast for Mavrilimumab from 2013-2023 in top 6 countries (the US, France, Germany, Italy, Spain and the UK).
Table Of Contents
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
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 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 Mavrilimumab 62
8.1 Overview 62
8.2 Efficacy 63
8.3 Safety 64
8.4 Dosing and Formulation 64
8.5 Potential Clinical Positioning 65
8.6 Potential Commercial Positioning 65
8.7 Pricing and Reimbursement 65
8.8 SWOT Analysis 66
8.9 Forecast 67
9 Appendix 68
9.1 Bibliography 68
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 76
9.4.5 Pricing of Pipeline Agents 76
9.5 Primary Research - KOLs Interviewed for This Report 77
9.6 Primary Research - Prescriber Survey 79
9.7 About the Authors 80
9.7.1 Analyst 80
9.7.2 Reviewer 80
9.7.3 Therapy Area Director 81
9.7.4 Global Head of Healthcare 81
9.8 About GlobalData 82
9.9 Disclaimer 82
List Of Tables
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 - Mavrilimumab 63
Table 12: Mavrilimumab SWOT Analysis, 2014 66
Table 13: Global Sales Forecasts ($m) for Mavrilimumab, 2013-2023 67
Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 79
List Of Figures
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 Mavrilimumab 66
