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Xeljanz (tofacitinib) (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.

Xeljanz (tofacitinib, formerly known as tasocitinib) is an oral, small-molecule inhibitor of JAK3 developed by Pfizer. Xeljanz is a first-in-class drug that was approved for the treatment of RA in the US in 2012, and in Japan in 2013. It is also in development for the treatment of psoriasis (as a topical and oral formulation), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, atopic dermatitis, and juvenile idiopathic arthritis in the seven major markets (7MM; US, 5EU, and Japan).

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 Xeljanz (tofacitinib) including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Xeljanz (tofacitinib) for the top 2 countries from 2013 to 2023.
- Sales information covered for the US and Japan.

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 Xeljanz (tofacitinib) performance.
- Obtain sales forecast for Xeljanz (tofacitinib) from 2013-2023 in top 2 countries (the US and Japan).

Table Of Contents

Xeljanz (tofacitinib) (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 14
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 40
5.1 Overview 40
6 Xeljanz (tofacitinib) 42
6.1 Overview 42
6.2 Efficacy 45
6.3 Safety 47
6.4 SWOT Analysis 48
6.5 Forecast 48
7 Appendix 50
7.1 Bibliography 50
7.2 Abbreviations 53
7.3 Methodology 56
7.4 Forecasting Methodology 56
7.4.1 Diagnosed RA Patients 56
7.4.2 Percentage of Drug-Treated Patients 57
7.4.3 General Pricing Assumptions 57
7.4.4 Individual Drug Assumptions 58
7.4.5 Generic and Biosimilar Erosion 58
7.5 Primary Research - KOLs Interviewed for This Report 59
7.6 Primary Research - Prescriber Survey 61
7.7 About the Authors 62
7.7.1 Analyst 62
7.7.2 Reviewer 62
7.7.3 Therapy Area Director 63
7.7.4 Global Head of Healthcare 63
7.8 About GlobalData 64
7.9 Disclaimer 64

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 41
Table 9: Product Profile - Xeljanz 45
Table 10: ORAL Standard ACR20 Responses for Tofacitinib vs. Humira and Placebo at Month 6 46
Table 11: ORAL Step ACR20, 50, and 70 Responses for Xeljanz vs. Placebo at Month 6 46
Table 12: Xeljanz SWOT Analysis, 2014 48
Table 13: Global Sales Forecasts ($m) for Xeljanz, 2013-2023 49
Table 14: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 61

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 15
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

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