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PharmaPoint: Rheumatoid Arthritis - India 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 economic growth, which has led to increased investment in the national healthcare system. However, Indian physicians' preference for generics and biosimilars, which have been known to launch prior to patent expiry, has limited the growth of branded products. In addition, because intellectual property law is not enforced in India, there is a disincentive for large pharmaceutical companies to launch their products in the country.

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

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - India Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 17
3.2 Symptoms 22
3.3 Prognosis 23
3.4 Quality of Life 23
4 Disease Management 24
4.1 Diagnosis and Treatment Overview 24
4.1.1 Diagnosis 24
4.1.2 Treatment Guidelines 26
4.1.3 Leading Prescribed Drugs for the Treatment of RA 34
4.1.4 Clinical Practice 35
4.2 India 39
5 Competitive Assessment 42
5.1 Overview 42
5.2 Product Profiles - Major Brands 43
5.2.1 Enbrel (etanercept) 43
5.2.2 Remicade (infliximab) 48
5.2.3 Orencia (abatacept) 54
5.2.4 Actemra/RoActemra (tocilizumab) 59
5.2.5 Rituxan/MabThera (rituximab) 65
5.2.6 Inflectra/Remsima (infliximab biosimilar) 69
5.2.7 Methotrexate (Numerous Brands) 72
5.3 Biosimilars 74
5.3.1 Introduction 74
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 76
5.3.3 Biosimilars in the Immunology Community 77
5.3.4 By the Numbers: Biosimilars in Development 77
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 81
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 82
5.4 Other Therapies 85
6 Unmet Need and Opportunity 86
6.1 Overview 86
6.2 Development of Cost-Effective Therapies 87
6.2.1 Unmet Need 87
6.2.2 Gap Analysis 88
6.2.3 Opportunity 88
6.3 Biomarkers to Predict Responsiveness to Therapy 88
6.3.1 Unmet Need 88
6.3.2 Gap Analysis 90
6.3.3 Opportunity 91
6.4 Early Diagnosis of RA 91
6.4.1 Unmet Need 91
6.4.2 Gap Analysis 92
6.4.3 Opportunity 93
6.5 Personalized Treatment Approach 94
6.5.1 Unmet Need 94
6.5.2 Gap Analysis 94
6.5.3 Opportunity 96
7 Pipeline Assessment 98
7.1 Overview 98
7.2 Promising Drugs in Clinical Development 98
7.2.1 Sirukumab 105
7.2.2 Cosentyx (secukinumab) 111
7.2.3 Baricitinib 116
7.2.4 RAVAX 124
7.3 Other Drugs in Development 129
8 Market Outlook 132
8.1 Drivers and Barriers - Global Issues 132
8.1.1 Driver: Launch of novel drugs, including oral JAK inhibitors and novel biologics for RA 132
8.1.2 Driver: Earlier diagnosis and treatment 132
8.1.3 Driver: Market entry of biosimilars will bring a therapy option for those who cannot afford branded biologics 133
8.1.4 Driver: Aging population and increasing prevalent cases of RA 133
8.1.5 Barrier: Efforts to reduce costs in the treatment of RA 134
8.1.6 Barrier: Lack of regulatory guidelines for biosimilars will delay their availability in some regions 134
8.1.7 Barrier: Entry of biosimilars will create a less expensive treatment alternative 134
8.2 India 135
8.2.1 Forecast 135
8.2.2 Key Events 140
8.2.3 Drivers and Barriers - India 140
9 Appendix 143
9.1 Bibliography 143
9.2 Abbreviations 153
9.3 Methodology 157
9.4 Forecasting Methodology 157
9.4.1 Diagnosed RA Patients 157
9.4.2 Percentage of Drug-Treated Patients 158
9.4.3 Drugs Included in Each Therapeutic Class 158
9.4.4 Launch and Patent Expiry Dates 159
9.4.5 General Pricing Assumptions 160
9.4.6 Individual Drug Assumptions 161
9.4.7 Generic and Biosimilar Erosion 165
9.4.8 Pricing of Pipeline Agents 165
9.5 Primary Research - KOLs Interviewed for This Report 167
9.6 Primary Research - Prescriber Survey 169
9.7 About the Authors 170
9.7.1 Analyst 170
9.7.2 Reviewer 170
9.7.3 Therapy Area Director 171
9.7.4 Global Head of Healthcare 171
9.8 About GlobalData 172
9.9 Disclaimer 172

1.1 List of Tables

Table 1: Symptoms of RA 22
Table 2: 1987 ACR Diagnostic Criteria for RA 25
Table 3: 2010 ACR/EULAR Diagnostic Criteria for RA 26
Table 4: Treatment Guidelines for RA Used in India 28
Table 5: ACR 2012 Criteria for RA Remission and Low/Moderate/High Disease Activity 30
Table 6: EULAR 2013 Criteria for RA Remission 31
Table 7: Most Prescribed Biologics for RA (After csDMARDs) in the Indian Market, 2014 35
Table 8: RA Treatment Country Profile - India 41
Table 9: Leading Branded Treatments for RA 2014 43
Table 10: Product Profile - Enbrel 45
Table 11: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 46
Table 12: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 47
Table 13: Enbrel SWOT Analysis, 2014 48
Table 14: Product Profile - Remicade 50
Table 15: Remicade SWOT Analysis, 2014 53
Table 16: Product Profile - Orencia 55
Table 17: Orencia SWOT Analysis, 2014 58
Table 18: Product Profile - Actemra 62
Table 19: Actemra SWOT Analysis, 2014 64
Table 20: Product Profile - Rituxan 67
Table 21: Rituxan SWOT Analysis, 2014 68
Table 22: Product Profile - Inflectra/Remsima 70
Table 23: Inflectra/Remsima SWOT Analysis, 2014 71
Table 24: Product Profile - MTX 73
Table 25: MTX SWOT Analysis, 2014 74
Table 26: Biosimilars Pipeline for RA, 2013 78
Table 27: Physician Uptake of Biosimilar Products for RA in India, 2014 84
Table 28: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 85
Table 29: Unmet Need and Opportunity in RA, 2014 87
Table 30: Comparison of Therapeutic Drug Classes in Development for RA, 2014 105
Table 31: Product Profile - Sirukumab 106
Table 32: Sirukumab SWOT Analysis, 2014 110
Table 33: Product Profile - Cosentyx 113
Table 34: Cosentyx SWOT Analysis, 2014 116
Table 35: Product Profile - Baricitinib 118
Table 36: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 119
Table 37: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 119
Table 38: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 120
Table 39: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 121
Table 40: Baricitinib SWOT Analysis, 2014 124
Table 41: Product Profile - RAVAX 125
Table 42: RAVAX SWOT Analysis, 2014 128
Table 43: Drugs in Phase II of Development for RA, 2014 130
Table 44: Global RA Market - Drivers and Barriers, 2013-2023 132
Table 45: Sales Forecasts ($m) for RA in India, 2013-2023 137
Table 46: Key Events Impacting Sales for RA in India, 2013-2023 140
Table 47: RA Market in India - Drivers and Barriers, 2013-2023 140
Table 48: Key Launch Dates of RA Products in India 159
Table 49: Key Patent Expiries 160
Table 50: High-Prescribing Physicians (non-KOLs) Surveyed in India 169

1.2 List of Figures

Figure 1: Normal Synovial Joint and Synovial Joint with RA 18
Figure 2: Cellular and Cytokine Targets for the Current RA Drugs 21
Figure 3: Disease Management Flowchart for Early RA - ACR 2012 31
Figure 4: Disease Management Flowchart for Established RA - ACR 2012 32
Figure 5: Flowchart for the Management of RA - EULAR 2013 33
Figure 6: Biosimilar Prescribing Habits in RA Across the 10MM, 2014 84
Figure 7: RA - Phase II-III Pipeline, 2014 100
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 104
Figure 9: Clinical and Commercial Positioning of Sirukumab 110
Figure 10: Clinical and Commercial Positioning of Cosentyx 115
Figure 11: Clinical and Commercial Positioning of Baricitinib 123
Figure 12: Clinical and Commercial Positioning of RAVAX 128
Figure 13: Sales for RA in India by Drug Class, 2013-2023 139

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