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Filgotinib (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.

Filgotinib is a selective JAK1 inhibitor that is currently in Phase IIb of development by Galapagos. It is expected to be used to treat adults with moderate to severe RA who have active disease. In clinical trials, the use of filgotinib is under investigation both as a monotherapy and in combination with MTX. Like other JAK inhibitors, it will be available as an oral tablet, most likely in 50mg, 100mg, or 200mg strengths, and taken once daily. Alternatively, clinical trials have used twice-daily administration.

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 Filgotinib including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Filgotinib for the top 7 countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Australia.

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 Filgotinib performance.
- Obtain sales forecast for Filgotinib from 2013-2023 in top 7 countries (the US, France, Germany, Italy, Spain, the UK and Australia).

Table Of Contents

Filgotinib (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 21
3.3 Prognosis 22
3.4 Quality of Life 22
4 Disease Management 23
4.1 Diagnosis and Treatment Overview 23
4.1.1 Diagnosis 23
4.1.2 Treatment Guidelines 25
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 Filgotinib 63
8.1 Overview 63
8.2 Efficacy 64
8.3 Safety 64
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 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 21
Table 2: 1987 ACR Diagnostic Criteria for RA 24
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 25
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 - Filgotinib 64
Table 12: Filgotinib SWOT Analysis, 2014 68
Table 13: Global Sales Forecasts ($m) for Filgotinib, 2013-2023 69
Table 14: 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 20
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 Filgotinib 67

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