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Enbrel (etanercept) (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.

Amgen’s Enbrel (etanercept) is a soluble TNF inhibitor used for the treatment of moderate-to-severe active RA patients who are unresponsive to one or more csDMARDs. Enbrel is a leading biologic agent and is approved for multiple immunological indications, including psoriasis and ankylosing spondylitis. It is a fusion protein made by recombinant DNA technology, where the TNF receptor is combined with the Fc portion of human immunoglobulin G1 (IgG1). Enbrel binds to and neutralizes both lymphotoxin and TNFa, thus preventing synovial inflammation (DrugBank, 2012; Scott, 2012).

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 Enbrel (Etanercept) including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Enbrel (Etanercept) 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 Enbrel (Etanercept) performance.
- Obtain sales forecast for Enbrel (Etanercept) from 2013-2023 in top 10 countries (the US, France, Germany, Italy, Spain, the UK and Japan, Australia, China and India).

Table Of Contents

Enbrel (etanercept) (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 33
4.1.4 Clinical Practice 34
5 Competitive Assessment 40
5.1 Overview 40
6 Enbrel (etanercept) 42
6.1 Overview 42
6.2 Efficacy 44
6.3 Safety 45
6.4 SWOT Analysis 46
6.5 Forecast 47
7 Appendix 48
7.1 Bibliography 48
7.2 Abbreviations 52
7.3 Methodology 55
7.4 Forecasting Methodology 55
7.4.1 Diagnosed RA Patients 55
7.4.2 Percentage of Drug-Treated Patients 56
7.4.3 General Pricing Assumptions 56
7.4.4 Individual Drug Assumptions 57
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 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: Product Profile - Enbrel 43
Table 10: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 44
Table 11: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 45
Table 12: Enbrel SWOT Analysis, 2014 46
Table 13: Global Sales Forecasts ($m) for Enbrel, 2013-2023 47
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 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

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