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PharmaPoint: Rheumatoid Arthritis - Australia Drug 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.

The drivers of growth in this market include the increasing RA patient population and the universal healthcare system, as well as the use of technology to connect patients with physicians and speed the process of diagnosis and treatment. Barriers to the growth of the market include government measures to cut healthcare spending, similar to the austerity measures implemented in the 5EU. In the RA market in Australia, there are a number of different treatment options available, similar to the 7MM.

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 the key drugs in the Australia including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the Australia from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Australia Rheumatoid arthritis market.

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 drug performance
- Obtain sales forecast for drugs from 2013-2023 in the Australia.

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - Australia Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 18
3.2 Symptoms 23
3.3 Prognosis 24
3.4 Quality of Life 24
4 Disease Management 25
4.1 Diagnosis and Treatment Overview 25
4.1.1 Diagnosis 25
4.1.2 Treatment Guidelines 27
4.1.3 Leading Prescribed Drugs for the Treatment of RA 35
4.1.4 Clinical Practice 36
4.2 Australia 41
5 Competitive Assessment 42
5.1 Overview 42
5.2 Product Profiles - Major Brands 43
5.2.1 Enbrel (etanercept) 43
5.2.2 Humira (adalimumab) 49
5.2.3 Remicade (infliximab) 52
5.2.4 Simponi (golimumab) 57
5.2.5 Cimzia (certolizumab pegol) 61
5.2.6 Orencia (abatacept) 66
5.2.7 Actemra/RoActemra (tocilizumab) 71
5.2.8 Rituxan/MabThera (rituximab) 77
5.2.9 Inflectra/Remsima (infliximab biosimilar) 81
5.2.10 Methotrexate (Numerous Brands) 84
5.3 Biosimilars 86
5.3.1 Introduction 86
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 88
5.3.3 Biosimilars in the Immunology Community 89
5.3.4 By the Numbers: Biosimilars in Development 89
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 94
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 94
5.4 Other Therapies 97
6 Unmet Need and Opportunity 98
6.1 Overview 98
6.2 Development of Cost-Effective Therapies 99
6.2.1 Unmet Need 99
6.2.2 Gap Analysis 100
6.2.3 Opportunity 100
6.3 Biomarkers to Predict Responsiveness to Therapy 100
6.3.1 Unmet Need 100
6.3.2 Gap Analysis 102
6.3.3 Opportunity 103
6.4 Early Diagnosis of RA 103
6.4.1 Unmet Need 103
6.4.2 Gap Analysis 104
6.4.3 Opportunity 105
6.5 Personalized Treatment Approach 106
6.5.1 Unmet Need 106
6.5.2 Gap Analysis 106
6.5.3 Opportunity 108
7 Pipeline Assessment 110
7.1 Overview 110
7.2 Promising Drugs in Clinical Development 110
7.2.1 Sarilumab 117
7.2.2 Sirukumab 124
7.2.3 Baricitinib 130
7.2.4 Filgotinib 138
7.2.5 RAVAX 143
7.3 Other Drugs in Development 148
8 Market Outlook 151
8.1 Drivers and Barriers - Global Issues 151
8.1.1 Driver: Launch of novel drugs, including oral JAK inhibitors and novel biologics for RA 151
8.1.2 Driver: Earlier diagnosis and treatment 151
8.1.3 Driver: Market entry of biosimilars will bring a therapy option for those who cannot afford branded biologics 152
8.1.4 Driver: Aging population and increasing prevalent cases of RA 152
8.1.5 Barrier: Efforts to reduce costs in the treatment of RA 153
8.1.6 Barrier: Lack of regulatory guidelines for biosimilars will delay their availability in some regions 153
8.1.7 Barrier: Entry of biosimilars will create a less expensive treatment alternative 153
8.2 Australia 154
8.2.1 Forecast 154
8.2.2 Key Events 158
8.2.3 Drivers and Barriers 158
9 Appendix 160
9.1 Bibliography 160
9.2 Abbreviations 171
9.3 Methodology 175
9.4 Forecasting Methodology 175
9.4.1 Diagnosed RA Patients 175
9.4.2 Percentage of Drug-Treated Patients 176
9.4.3 Drugs Included in Each Therapeutic Class 176
9.4.4 Launch and Patent Expiry Dates 177
9.4.5 General Pricing Assumptions 178
9.4.6 Individual Drug Assumptions 179
9.4.7 Generic and Biosimilar Erosion 185
9.4.8 Pricing of Pipeline Agents 185
9.5 Primary Research - KOLs Interviewed for This Report 187
9.6 Primary Research - Prescriber Survey 189
9.7 About the Authors 190
9.7.1 Analyst 190
9.7.2 Reviewer 190
9.7.3 Therapy Area Director 191
9.7.4 Global Head of Healthcare 191
9.8 About GlobalData 192
9.9 Disclaimer 192

1.1 List of Tables

Table 1: Symptoms of RA 23
Table 2: 1987 ACR Diagnostic Criteria for RA 26
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 27
Table 4: Treatment Guidelines for RA Used in Australia 29
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 31
Table 6: EULAR 2013 Criteria for RA Remission 32
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the Australia Market, 2014 36
Table 8: Leading Branded Treatments for RA 2014 43
Table 9: Product Profile - Enbrel 45
Table 10: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 46
Table 11: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 47
Table 12: Enbrel SWOT Analysis, 2014 48
Table 13: Product Profile - Humira 50
Table 14: Humira SWOT Analysis, 2014 52
Table 15: Product Profile - Remicade 54
Table 16: Remicade SWOT Analysis, 2014 57
Table 17: Product Profile - Simponi 59
Table 18: Simponi SWOT Analysis, 2014 61
Table 19: Product Profile - Cimzia 63
Table 20: Cimzia SWOT Analysis, 2014 65
Table 21: Product Profile - Orencia 67
Table 22: Orencia SWOT Analysis, 2014 70
Table 23: Product Profile - Actemra 74
Table 24: Actemra SWOT Analysis, 2014 76
Table 25: Product Profile - Rituxan 79
Table 26: Rituxan SWOT Analysis, 2014 80
Table 27: Product Profile - Inflectra/Remsima 82
Table 28: Inflectra/Remsima SWOT Analysis, 2014 83
Table 29: Product Profile - MTX 85
Table 30: MTX SWOT Analysis, 2014 86
Table 31: Biosimilars Pipeline for RA, 2013 90
Table 32: Physician Uptake of Biosimilar Products for RA in Australia, 2014 96
Table 33: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 97
Table 34: Unmet Need and Opportunity in RA, 2014 99
Table 35: Comparison of Therapeutic Drug Classes in Development for RA, 2014 117
Table 36: Product Profile - Sarilumab 119
Table 37: MOBILITY Study Part, A, Results for Sarilumab at Week 12 120
Table 38: MOBILITY Study, Part B, Results for Sarilumab at Week 52 120
Table 39: Sarilumab SWOT Analysis, 2014 124
Table 40: Product Profile - Sirukumab 125
Table 41: Sirukumab SWOT Analysis, 2014 129
Table 42: Product Profile - Baricitinib 132
Table 43: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 133
Table 44: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 133
Table 45: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 134
Table 46: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 135
Table 47: Baricitinib SWOT Analysis, 2014 138
Table 48: Product Profile - Filgotinib 139
Table 49: Filgotinib SWOT Analysis, 2014 143
Table 50: Product Profile - RAVAX 145
Table 51: RAVAX SWOT Analysis, 2014 148
Table 52: Drugs in Phase II of Development for RA, 2014 149
Table 53: Global RA Market - Drivers and Barriers, 2013-2023 151
Table 54: Sales Forecasts ($m) for RA in Australia, 2013-2023 155
Table 55: Key Events Impacting Sales for RA in Australia, 2013-2023 158
Table 56: RA Market in Australia - Drivers and Barriers, 2013-2023 158
Table 57: Key Launch Dates of RA Products in Australia 177
Table 58: Key Patent Expiries 178
Table 59: High-Prescribing Physicians (non-KOLs) Surveyed in Australia 189

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 19
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 22
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 32
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 33
Figure 5: Flowchart for the Management of RA - EULAR 2013 34
Figure 6: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 96
Figure 7: RA - Phase II-III Pipeline, 2014 112
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 116
Figure 9: Clinical and Commercial Positioning of Sarilumab 123
Figure 10: Clinical and Commercial Positioning of Sirukumab 129
Figure 11: Clinical and Commercial Positioning of Baricitinib 137
Figure 12: Clinical and Commercial Positioning of Filgotinib 142
Figure 13: Clinical and Commercial Positioning of RAVAX 147
Figure 14: Sales for RA in Australia by Drug Class, 2013-2023 157

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