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Baricitinib (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.

Eli Lilly and Incyte are jointly developing baricitinib, an oral JAK inhibitor, for the treatment of patients with moderate to severe RA. Baricitinib has roughly equal affinity for JAK1 and JAK2, preventing the intracellular signaling cascades that lead to the production of IL-6 and IL-23, thereby reducing inflammation.

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 Baricitinib including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Baricitinib for the top 10 countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Australia, China and India.

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 Baricitinib performance.
- Obtain sales forecast for Baricitinib from 2013-2023 in top 10 countries (the US, France, Germany, Italy, Spain, the UK and Japan, Australia, China and India).

Table Of Contents

Baricitinib (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 19
3.3 Prognosis 20
3.4 Quality of Life 20
4 Disease Management 21
4.1 Diagnosis and Treatment Overview 21
4.1.1 Diagnosis 21
4.1.2 Treatment Guidelines 23
4.1.3 Leading Prescribed Drugs for the Treatment of RA 33
4.1.4 Clinical Practice 34
5 Competitive Assessment 39
5.1 Overview 39
6 Unmet Need and Opportunity 41
6.1 Overview 41
6.2 Development of Cost-Effective Therapies 42
6.2.1 Unmet Need 42
6.2.2 Gap Analysis 43
6.2.3 Opportunity 43
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 46
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 49
6.5.1 Unmet Need 49
6.5.2 Gap Analysis 50
6.5.3 Opportunity 51
7 Pipeline Assessment 53
7.1 Overview 53
7.2 Promising Drugs in Clinical Development 53
8 Baricitinib 61
8.1 Overview 61
8.2 Efficacy 63
8.3 Safety 64
8.4 Dosing and Formulation 66
8.5 Potential Clinical Positioning 67
8.6 Potential Commercial Positioning 67
8.7 Pricing and Reimbursement 67
8.8 SWOT Analysis 69
8.9 Forecast 69
9 Appendix 71
9.1 Bibliography 71
9.2 Abbreviations 75
9.3 Methodology 79
9.4 Forecasting Methodology 79
9.4.1 Diagnosed RA Patients 79
9.4.2 Percentage of Drug-Treated Patients 80
9.4.3 General Pricing Assumptions 80
9.4.4 Generic and Biosimilar Erosion 81
9.4.5 Pricing of Pipeline Agents 81
9.5 Primary Research - KOLs Interviewed for This Report 82
9.6 Primary Research - Prescriber Survey 84
9.7 About the Authors 85
9.7.1 Analyst 85
9.7.2 Reviewer 85
9.7.3 Therapy Area Director 86
9.7.4 Global Head of Healthcare 86
9.8 About GlobalData 87
9.9 Disclaimer 87

1.1 List of Tables

Table 1: Symptoms of RA 19
Table 2: 1987 ACR Diagnostic Criteria for RA 22
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 23
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 40
Table 9: Unmet Need and Opportunity in RA, 2014 42
Table 10: Comparison of Therapeutic Drug Classes in Development for RA, 2014 60
Table 11: Product Profile - Baricitinib 63
Table 12: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 64
Table 13: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 64
Table 14: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 65
Table 15: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 66
Table 16: Baricitinib SWOT Analysis, 2014 69
Table 17: Global Sales Forecasts ($m) for Baricitinib, 2013-2023 70
Table 18: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 84

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 18
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 55
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 59
Figure 8: Clinical and Commercial Positioning of Baricitinib 68

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