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Biosimilars (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.

With the cost of biologic therapies being very high, at an annual cost of at least $25,000, global healthcare systems need a reprieve from the expense. On September 9, 2013, Hospira’s Inflectra and Celltrion’s Remsima, which are both biosimilars of J&J’s Remicade, were approved by the European Commission (EC) for marketing in the EU for multiple autoimmune diseases, including RA, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis. Remsima and Inflectra have been rolled out in selected European markets, although their launch in the 5EU is still pending due to potential intellectual property protections in these healthcare markets. The US-based generics company, Hospira, will market Inflectra in the EU, while the South Korean biotechnology company, Celltrion, the original developer of the infliximab biosimilar, will do so as well, but under the brand name Remsima, based on a collaboration forged between the two companies in 2009.

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

Table Of Contents

Biosimilars (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 Inflectra/Remsima (infliximab biosimilar) 41
6.1 Overview 41
6.2 Efficacy 42
6.3 Safety 42
6.4 SWOT Analysis 43
6.5 Forecast 43
7 Biosimilars 44
7.1 Introduction 44
7.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 45
7.3 Biosimilars in the Immunology Community 46
7.4 By the Numbers: Biosimilars in Development 47
7.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 51
7.6 Uptake of Biosimilars for RA is Expected to Vary by Market 52
7.7 Biosimilars' Forecast 55
7.7.1 Etanercept Biosimilars 55
7.7.2 Adalimumab Biosimilars 56
7.7.3 Infliximab Biosimilars 58
7.7.4 Certolizumab Pegol Biosimilars 59
7.7.5 Abatacept Biosimilars 60
7.7.6 Tocilizumab Biosimilars 61
7.7.7 Rituximab Biosimilars 62
8 Appendix 64
8.1 Bibliography 64
8.2 Abbreviations 68
8.3 Methodology 71
8.4 Forecasting Methodology 71
8.4.1 Diagnosed RA Patients 71
8.4.2 Patent Expiry Dates 72
8.4.3 General Pricing Assumptions 72
8.4.4 Individual Drug Assumptions 74
8.4.5 Generic and Biosimilar Erosion 75
8.5 Primary Research - KOLs Interviewed for This Report 76
8.6 Primary Research - Prescriber Survey 78
8.7 About the Authors 79
8.7.1 Analyst 79
8.7.2 Reviewer 79
8.7.3 Therapy Area Director 80
8.7.4 Global Head of Healthcare 80
8.8 About GlobalData 81
8.9 Disclaimer 81

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: Product Profile - Inflectra/Remsima 42
Table 10: Inflectra/Remsima SWOT Analysis, 2014 43
Table 11: Biosimilars Pipeline for RA, 2013 48
Table 12: Physician Uptake of Biosimilar Products for RA Across the 10MM, 2014 54
Table 13: Global Sales Forecasts ($m) for Etanercept Biosimilars, 2013-2023 55
Table 14: Global Sales Forecasts ($m) for Adalimumab Biosimilars, 2013-2023 56
Table 15: Global Sales Forecasts ($m) for Infliximab Biosimilars, 2013-2023 58
Table 16: Global Sales Forecasts ($m) for Certolizumab Pegol Biosimilars, 2013-2023 59
Table 17: Global Sales Forecasts ($m) for Abatacept Biosimilars, 2013-2023 60
Table 18: Global Sales Forecasts ($m) for Tocilizumab Biosimilars, 2013-2023 61
Table 19: Global Sales Forecasts ($m) for Rituximab Biosimilars, 2013-2023 62
Table 20: Key Patent Expiries 72
Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 78

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: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 53
Figure 7: Global Sales Forecasts ($m) for Enbrel vs. Etanercept Biosimilars, 2013-2023 55
Figure 8: Global Sales Forecasts ($m) for Humira vs. Adalimumab Biosimilars, 2013-2023 57
Figure 9: Global Sales Forecasts ($m) for Remicade vs. Infliximab Biosimilars, 2013-2023 58
Figure 10: Global Sales Forecasts ($m) for Cimzia vs. Certolizumab Pegol Biosimilars, 2013-2023 60
Figure 11: Global Sales of Orencia vs. Abatacept (IV) Biosimilars, 2013-2023 61
Figure 12: Global Sales of Actemra vs. Tocilizumab (IV) Biosimilars, 2013-2023 62
Figure 13: Global Sales of Rituxan vs. Rituximab Biosimilars, 2013-2023 63

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