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PharmaPoint: Rheumatoid Arthritis - China 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, along with economic growth and government initiatives to increase access to healthcare. However, Chinese physicians’ preference for generics and biosimilars over the originator products has limited the growth of branded products, and the launch of generics/biosimilars has been known to occur prior to patent expiry. Because intellectual property laws are not enforced in China, 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 China including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the China from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the China 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 China.

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - China 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 China 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 Humira (adalimumab) 49
5.2.3 Remicade (infliximab) 52
5.2.4 Cimzia (certolizumab pegol) 57
5.2.5 Actemra/RoActemra (tocilizumab) 61
5.2.6 Rituxan/MabThera (rituximab) 67
5.2.7 Inflectra/Remsima (infliximab biosimilar) 71
5.2.8 Iguratimod/T-614 74
5.2.9 Methotrexate (Numerous Brands) 76
5.3 Biosimilars 79
5.3.1 Introduction 79
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 80
5.3.3 Biosimilars in the Immunology Community 81
5.3.4 By the Numbers: Biosimilars in Development 81
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 86
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 87
5.4 Other Therapies 90
6 Unmet Need and Opportunity 91
6.1 Overview 91
6.2 Development of Cost-Effective Therapies 92
6.2.1 Unmet Need 92
6.2.2 Gap Analysis 93
6.2.3 Opportunity 93
6.3 Biomarkers to Predict Responsiveness to Therapy 93
6.3.1 Unmet Need 93
6.3.2 Gap Analysis 95
6.3.3 Opportunity 96
6.4 Early Diagnosis of RA 96
6.4.1 Unmet Need 96
6.4.2 Gap Analysis 97
6.4.3 Opportunity 98
6.5 Personalized Treatment Approach 99
6.5.1 Unmet Need 99
6.5.2 Gap Analysis 99
6.5.3 Opportunity 101
7 Pipeline Assessment 103
7.1 Overview 103
7.2 Promising Drugs in Clinical Development 103
7.2.1 Sirukumab 110
7.2.2 Baricitinib 116
7.2.3 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 China 135
8.2.1 Forecast 135
8.2.2 Key Events 140
8.2.3 Drivers and Barriers 140
9 Appendix 143
9.1 Bibliography 143
9.2 Abbreviations 152
9.3 Methodology 156
9.4 Forecasting Methodology 156
9.4.1 Diagnosed RA Patients 156
9.4.2 Percentage of Drug-Treated Patients 157
9.4.3 Drugs Included in Each Therapeutic Class 157
9.4.4 Launch and Patent Expiry Dates 158
9.4.5 General Pricing Assumptions 159
9.4.6 Individual Drug Assumptions 160
9.4.7 Generic and Biosimilar Erosion 164
9.4.8 Pricing of Pipeline Agents 164
9.5 Primary Research - KOLs Interviewed for This Report 165
9.6 Primary Research - Prescriber Survey 167
9.7 About the Authors 168
9.7.1 Analyst 168
9.7.2 Reviewer 168
9.7.3 Therapy Area Director 169
9.7.4 Global Head of Healthcare 169
9.8 About GlobalData 170
9.9 Disclaimer 170

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 China 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 China Market, 2014 35
Table 8: RA Treatment Country Profile - China 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 - Humira 50
Table 15: Humira SWOT Analysis, 2014 52
Table 16: Product Profile - Remicade 54
Table 17: Remicade SWOT Analysis, 2014 57
Table 18: Product Profile - Cimzia 59
Table 19: Cimzia SWOT Analysis, 2014 60
Table 20: Product Profile - Actemra 64
Table 21: Actemra SWOT Analysis, 2014 66
Table 22: Product Profile - Rituxan 69
Table 23: Rituxan SWOT Analysis, 2014 70
Table 24: Product Profile - Inflectra/Remsima 72
Table 25: Inflectra/Remsima SWOT Analysis, 2014 73
Table 26: Product Profile - Iguratimod 75
Table 27: Iguratimod SWOT Analysis, 2014 76
Table 28: Product Profile - MTX 77
Table 29: MTX SWOT Analysis, 2014 78
Table 30: Biosimilars Pipeline for RA, 2013 83
Table 31: Physician Uptake of Biosimilar Products for RA in China, 2014 89
Table 32: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 90
Table 33: Unmet Need and Opportunity in RA, 2014 92
Table 34: Comparison of Therapeutic Drug Classes in Development for RA, 2014 110
Table 35: Product Profile - Sirukumab 111
Table 36: Sirukumab SWOT Analysis, 2014 115
Table 37: Product Profile - Baricitinib 118
Table 38: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 119
Table 39: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 119
Table 40: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 120
Table 41: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 121
Table 42: Baricitinib SWOT Analysis, 2014 124
Table 43: Product Profile - RAVAX 125
Table 44: RAVAX SWOT Analysis, 2014 128
Table 45: Drugs in Phase II of Development for RA, 2014 130
Table 46: Global RA Market - Drivers and Barriers, 2013-2023 132
Table 47: Sales Forecasts ($) for RA in China, 2013-2023 137
Table 48: Key Events Impacting Sales for RA in China, 2013-2023 140
Table 49: RA Market in China - Drivers and Barriers, 2013-2023 140
Table 50: Key Launch Dates of RA Products in China 158
Table 51: Key Patent Expiries 159
Table 52: High-Prescribing Physicians (non-KOLs) Surveyed in China 167

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 89
Figure 7: RA - Phase II-III Pipeline, 2014 105
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 109
Figure 9: Clinical and Commercial Positioning of Sirukumab 115
Figure 10: Clinical and Commercial Positioning of Baricitinib 123
Figure 11: Clinical and Commercial Positioning of RAVAX 128
Figure 12: Sales for RA in China by Drug Class, 2013-2023 139

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