1. Market Research
  2. > Pharmaceutical
  3. > Therapy Market Trends
  4. > PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and Market Analysis to 2023

PharmaPoint: Rheumatoid Arthritis - Japan 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 sales in this market include the aging population and the increasing prevalence of RA, as well as the universal healthcare system, which provides ease of access to physicians and specialists. Barriers to the growth of this market include the approval process for drugs in Japan, which requires trials to be conducted in Japanese populations, and the lag time between the approval and launch of drugs. Biosimilars are expected to launch in the RA market in Japan during the forecast period.

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

Table Of Contents

PharmaPoint: Rheumatoid Arthritis - Japan 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 Japan 40
5 Competitive Assessment 43
5.1 Overview 43
5.2 Product Profiles - Major Brands 44
5.2.1 Enbrel (etanercept) 44
5.2.2 Humira (adalimumab) 50
5.2.3 Remicade (infliximab) 53
5.2.4 Simponi (golimumab) 58
5.2.5 Cimzia (certolizumab pegol) 63
5.2.6 Orencia (abatacept) 67
5.2.7 Actemra/RoActemra (tocilizumab) 72
5.2.8 Inflectra/Remsima (infliximab biosimilar) 78
5.2.9 Xeljanz (tofacitinib) 81
5.2.10 Iguratimod/T-614 87
5.2.11 Methotrexate (Numerous Brands) 90
5.3 Biosimilars 93
5.3.1 Introduction 93
5.3.2 Hospira's Inflectra Versus JandJ's Remicade in Key Autoimmune Diseases 94
5.3.3 Biosimilars in the Immunology Community 95
5.3.4 By the Numbers: Biosimilars in Development 95
5.3.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry 100
5.3.6 Uptake of Biosimilars for RA is Expected to Vary by Market 101
5.4 Other Therapies 104
6 Unmet Need and Opportunity 105
6.1 Overview 105
6.2 Development of Cost-Effective Therapies 106
6.2.1 Unmet Need 106
6.2.2 Gap Analysis 107
6.2.3 Opportunity 107
6.3 Biomarkers to Predict Responsiveness to Therapy 107
6.3.1 Unmet Need 107
6.3.2 Gap Analysis 109
6.3.3 Opportunity 110
6.4 Early Diagnosis of RA 110
6.4.1 Unmet Need 110
6.4.2 Gap Analysis 111
6.4.3 Opportunity 112
6.5 Personalized Treatment Approach 113
6.5.1 Unmet Need 113
6.5.2 Gap Analysis 113
6.5.3 Opportunity 115
7 Pipeline Assessment 117
7.1 Overview 117
7.2 Promising Drugs in Clinical Development 117
7.2.1 Sarilumab 124
7.2.2 Sirukumab 131
7.2.3 Clazakizumab 137
7.2.4 Cosentyx (secukinumab) 143
7.2.5 Denosumab (Prolia/Xgeva) 148
7.2.6 Baricitinib 154
7.2.7 Peficitinib 162
7.2.8 RAVAX 167
7.3 Other Drugs in Development 171
8 Market Outlook 174
8.1 Drivers and Barriers - Global Issues 174
8.1.1 Driver: Launch of novel drugs, including oral JAK inhibitors and novel biologics for RA 174
8.1.2 Driver: Earlier diagnosis and treatment 175
8.1.3 Driver: Market entry of biosimilars will bring a therapy option for those who cannot afford branded biologics 175
8.1.4 Driver: Aging population and increasing prevalent cases of RA 175
8.1.5 Barrier: Efforts to reduce costs in the treatment of RA 176
8.1.6 Barrier: Lack of regulatory guidelines for biosimilars will delay their availability in some regions 176
8.1.7 Barrier: Entry of biosimilars will create a less expensive treatment alternative 176
8.2 Japan 177
8.2.1 Forecast 177
8.2.2 Key Events 182
8.2.3 Drivers and Barriers - Japan 182
9 Appendix 186
9.1 Bibliography 186
9.2 Abbreviations 199
9.3 Methodology 204
9.4 Forecasting Methodology 204
9.4.1 Diagnosed RA Patients 204
9.4.2 Percentage of Drug-Treated Patients 205
9.4.3 Drugs Included in Each Therapeutic Class 205
9.4.4 Launch and Patent Expiry Dates 206
9.4.5 General Pricing Assumptions 207
9.4.6 Individual Drug Assumptions 208
9.4.7 Generic and Biosimilar Erosion 215
9.4.8 Pricing of Pipeline Agents 216
9.5 Primary Research - KOLs Interviewed for This Report 217
9.6 Primary Research - Prescriber Survey 219
9.7 About the Authors 220
9.7.1 Analyst 220
9.7.2 Reviewer 220
9.7.3 Therapy Area Director 221
9.7.4 Global Head of Healthcare 221
9.8 About GlobalData 222
9.9 Disclaimer 222

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 Japan 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 Japan, 2014 36
Table 8: RA Treatment Country Profile - Japan 42
Table 9: Leading Branded Treatments for RA 2014 44
Table 10: Product Profile - Enbrel 46
Table 11: 10-Year, Open-Label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 Years for Completers 47
Table 12: 10-year, Open-Label Safety and Efficacy Trial of Enbrel: Overall Safety Results 48
Table 13: Enbrel SWOT Analysis, 2014 49
Table 14: Product Profile - Humira 51
Table 15: Humira SWOT Analysis, 2014 53
Table 16: Product Profile - Remicade 55
Table 17: Remicade SWOT Analysis, 2014 58
Table 18: Product Profile - Simponi 60
Table 19: Simponi SWOT Analysis, 2014 62
Table 20: Product Profile - Cimzia 64
Table 21: Cimzia SWOT Analysis, 2014 66
Table 22: Product Profile - Orencia 68
Table 23: Orencia SWOT Analysis, 2014 71
Table 24: Product Profile - Actemra 75
Table 25: Actemra SWOT Analysis, 2014 77
Table 26: Product Profile - Inflectra/Remsima 79
Table 27: Inflectra/Remsima SWOT Analysis, 2014 80
Table 28: Product Profile - Xeljanz 84
Table 29: ORAL Standard ACR20 Responses for Tofacitinib vs. Humira and Placebo at Month 6 85
Table 30: ORAL Step ACR20, 50, and 70 Responses for Xeljanz vs. Placebo at Month 6 85
Table 31: Xeljanz SWOT Analysis, 2014 87
Table 32: Product Profile - Iguratimod 88
Table 33: Iguratimod SWOT Analysis, 2014 90
Table 34: Product Profile - MTX 91
Table 35: MTX SWOT Analysis, 2014 92
Table 36: Biosimilars Pipeline for RA, 2013 97
Table 37: Physician Uptake of Biosimilar Products for RA in Japan, 2014 103
Table 38: Summary of Minor Therapeutic Drug Classes Used to Treat RA, 2014 104
Table 39: Unmet Need and Opportunity in RA, 2014 106
Table 40: Comparison of Therapeutic Drug Classes in Development for RA, 2014 124
Table 41: Product Profile - Sarilumab 126
Table 42: MOBILITY Study Part, A, Results for Sarilumab at Week 12 127
Table 43: MOBILITY Study, Part B, Results for Sarilumab at Week 52 127
Table 44: Sarilumab SWOT Analysis, 2014 131
Table 45: Product Profile - Sirukumab 132
Table 46: Sirukumab SWOT Analysis, 2014 136
Table 47: Product Profile - Clazakizumab 138
Table 48: Phase IIb Study of Clazakizumab: ACR Responses After 12 Weeks 139
Table 49: Phase IIb Study of Clazakizumab: ACR Responses After 24 Weeks 139
Table 50: Clazakizumab SWOT Analysis, 2014 142
Table 51: Product Profile - Cosentyx 145
Table 52: Cosentyx SWOT Analysis, 2014 148
Table 53: Product Profile - Denosumab 150
Table 54: Denosumab SWOT Analysis, 2014 153
Table 55: Product Profile - Baricitinib 156
Table 56: Baricitinib Phase IIb Trial, Part A: ACR Responses at Week 12 157
Table 57: Baricitinib Phase IIb Trial, Part B: ACR Responses at Weeks 24 and 52 157
Table 58: Baricitinib Phase IIb Trial, Part A: Safety at Week 12 158
Table 59: Baricitinib Phase IIb Trial, Part A, Laboratory Values at Week 12 159
Table 60: Baricitinib SWOT Analysis, 2014 162
Table 61: Product Profile - Peficitinib 163
Table 62: Peficitinib SWOT Analysis, 2014 166
Table 63: Product Profile - RAVAX 168
Table 64: RAVAX SWOT Analysis, 2014 171
Table 65: Drugs in Phase II of Development for RA, 2014 172
Table 66: Global RA Market - Drivers and Barriers, 2013-2023 174
Table 67: Sales Forecasts ($m) for RA in Japan, 2013-2023 179
Table 68: Key Events Impacting Sales for RA in Japan, 2013-2023 182
Table 69: RA Market in Japan - Drivers and Barriers, 2013-2023 182
Table 70: Key Launch Dates of RA Products in Japan 206
Table 71: Key Patent Expiries 207
Table 72: High-Prescribing Physicians (non-KOLs) Surveyed in Japan 219

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 103
Figure 7: RA - Phase II-III Pipeline, 2014 119
Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2013-2023 123
Figure 9: Clinical and Commercial Positioning of Sarilumab 130
Figure 10: Clinical and Commercial Positioning of Sirukumab 136
Figure 11: Clinical and Commercial Positioning of Clazakizumab 142
Figure 12: Clinical and Commercial Positioning of Cosentyx 147
Figure 13: Clinical and Commercial Positioning of denosumab in RA 153
Figure 14: Clinical and Commercial Positioning of Baricitinib 161
Figure 15: Clinical and Commercial Positioning of Peficitinib 166
Figure 16: Clinical and Commercial Positioning of RAVAX 170
Figure 17: Sales for RA in Japan by Drug Class, 2013-2023 181

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Ahmad

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers
PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025

PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025

  • $ 10995
  • Industry report
  • November 2016
  • by GlobalData

PharmaPoint: Non-Small Cell Lung Cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025 Summary Lung cancer is currently is the most common cause of death from cancer worldwide. Of total lung ...

OpportunityAnalyzer: Myelofibrosis - Opportunity Analysis and Forecasts to 2025

OpportunityAnalyzer: Myelofibrosis - Opportunity Analysis and Forecasts to 2025

  • $ 10995
  • Industry report
  • November 2016
  • by GlobalData

OpportunityAnalyzer: Myelofibrosis - Opportunity Analysis and Forecasts to 2025 Summary Myelofibrosis (MF) is a rare blood disorder, which is characterized by bone marrow fibrosis. Currently, there is ...

OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025

OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025

  • $ 10995
  • Industry report
  • November 2016
  • by GlobalData

OpportunityAnalyzer: Endometriosis - Opportunity Analysis and Forecast to 2025 Summary Endometriosis is an estrogen-dependent, chronic, inflammatory disease characterized by the appearance and growth of ...


ref:plp2014

Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.