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PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and Market Analysis Event-Driven Update


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PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and Market Analysis Event-Driven Update

  1. 1. PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast andMarket Analysis Event-Driven UpdateReport Details:Published:November 2012No. of Pages: 127Price: Single User License – US$4995PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and Market Analysis Event-DrivenUpdateSummaryGlobalData has released its new Country report, “PharmaPoint: Rheumatoid Arthritis - Japan DrugForecast and Market Analysis Event-Driven Update”. The RA market is currently very dynamic,with the November 6, 2012 FDA approval of Pfizer’s Xeljanz (tofacitinib) and novel oral therapiesawaiting approval such as: Eli Lilly’s anti-BAFF, tabalumab and JAK1,2 inhibitor, baricitinib, andRigel/AZ’s SYK inhibitor, fostamatinib. These compounds will challenge the current biologics in theattempt to dislodge the stronghold of the TNF inhibitors, if their safety and efficacy profiles areproven once they enter the market.Japanese physicians surveyed for this report follow guidelines such as ACR or guidelines from theJapanese Rheumatology Association, but also follow their own clinical experience. However,diagnosis of mild RA in Japan begins with the PCP or other specialists, then progresses to referralto a rheumatologist. Interestingly, in Japan, internists and orthopedic surgeons may be the treatingphysicians as rheumatology is a rare specialty, though gaining more popularity (Miyasaka, 2011).Also, most people seeking treatment are 35 years and older. Within this age group, female andmale distribution is comparable.Scope- Overview of RA, including epidemiology, etiology, symptoms, diagnosis, pathology and treatmentguidelines as well as an overview on the competitive landscape.- Detailed information on the key drugs in Japan including product description, safety and efficacyprofiles as well as a SWOT analysis.- Sales forecast for the top drugs in Japan from 2011 to 2022.- Analysis of the impact of key events as well the drivers and restraints affecting the Japan
  2. 2. 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 forrheumatoid arthritis- Effectively plan your M&A and partnership strategies by identifying drugs with the most promisingsales potential- Make more informed business decisions from insightful and in-depth analysis of rheumatoidarthritis drug performance in Japan- Obtain sales forecast from 2011-2022 in the JapanGet your copy of this report @ points covered in Table of Contents of this report include1 Table of Contents1 Table of Contents 41.1 List of Tables 61.2 List of Figures 72 Introduction 82.1 Catalyst 82.2 Related Reports 93 Disease Overview 113.1 Etiology and Pathophysiology 113.1.1 Etiology 113.1.2 Pathophysiology 113.1.3 Prognosis 143.1.4 Quality of Life 143.2 Symptoms 154 Disease Management 164.1 Treatment Overview 194.2 Japan 234.2.1 Diagnosis 234.2.2 Clinical Practice 235 Competitive Assessment 255.1 Overview 255.2 Strategic Competitor Assessment 255.3 Product Profiles - Major Brands 275.3.1 Enbrel (etanercept) 275.3.2 Humira (adalimumab) 33
  3. 3. 5.3.3 Remicade (infliximab) 365.3.4 Simponi (golimumab) 405.3.5 Cimzia (certolizumab pegol) 445.3.6 Orencia (abatacept) 485.3.7 Actemra/RoActemra (tocilizumab) 525.3.8 Rituxan/MabThera (rituximab) 565.3.9 Methotrexate Sodium (numerous generic names) 595.3.10 DMARDs 626 Opportunity and Unmet Need 636.1 Overview 636.2 Unmet Needs 646.2.1 More Rheumatologists in the Field and Physician Knowledge of the Disease 646.2.2 More Cost-Effective Therapies through Oral Formulation and Biosimilars 646.2.3 The Development of Predictive Tests and Discovery of Biomarkers 646.2.4 The Discovery of Curative Therapies 656.2.5 Improved Drug Safety and Efficacy Profiles 656.3 Gap Analysis 666.4 Opportunities 676.4.1 Predictive Tools for Diagnosis and Treatment 676.4.2 Target Specificity 677 Pipeline Assessment 687.1 Overview 687.2 Promising Drugs in Clinical Development 697.2.1 Tofacitinib (CP-690550) 707.2.2 Tabalumab (LY2127399) 777.2.3 Fostamatinib (previously R788) 807.2.4 Secukinumab (AIN457) 847.2.5 Masitinib (AB101) 887.2.6 Baricitinib (formerly LY3009104/INCB28050) 927.2.7 Careram/KOLBET (iguratimod/T-614) 968 Market Outlook 998.1 Japan 998.1.1 Forecast 998.1.2 Key Events 1018.1.3 Drivers and Barriers 1029 Appendix 1049.1 Abbreviations 1049.2 Bibliography 1069.3 Methodology 1149.4 Forecasting Methodology 1149.4.1 Diagnosed Rheumatoid Arthritis Patients 1149.4.2 Percent Drug-treated Patients 115
  4. 4. 9.4.3 Drugs Included in Each Therapeutic Class 1159.4.4 Launch and Patent Expiry Dates 1169.4.5 General Pricing Assumptions 1169.4.6 Individual Drug Assumptions 1179.4.7 Generic Erosion 1239.4.8 Pricing of Pipeline agents 1239.5 Physicians and Specialists Included in this Study 1249.6 Primary Research - Prescriber Survey 1249.7 About the Authors 1259.7.1 Analysts 1259.7.2 Global Head of Healthcare 1269.8 About GlobalData 1279.9 Contact Us 1279.10 Disclaimer 1271.1 List of TablesTable 1: Symptoms of Rheumatoid Arthritis 15Table 2: Treatment Guidelines for Rheumatoid Arthritis 19Table 3: Top Three Biologics Prescribed for Moderate-Severe Rheumatoid Arthritis by Market 22Table 4: Treatment Guidelines for Rheumatoid Arthritis 26Table 5: Product Profile - Enbrel 28Table 6: 10 year Open-label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 years forCompleters 29Table 7: 10 year Open-label Safety and Efficacy Trial of Enbrel: Safety Results Overall 30Table 8: Enbrel SWOT Analysis, 2012 32Table 9: Product Profile - Humira 33Table 10: Humira SWOT Analysis, 2012 35Table 11: Product Profile - Remicade 37Table 12: Remicade SWOT Analysis, 2012 39Table 13: Product Profile - Simponi 41Table 14: Simponi SWOT Analysis, 2012 43Table 15: Product Profile - Cimzia 45Table 16: Cimzia SWOT Analysis, 2012 47Table 17: Product Profile - Orencia 49Table 18: Orencia SWOT Analysis, 2012 51Table 19: Product Profile - Actemra/RoActemra 53Table 20: Actemra/RoActemra SWOT Analysis, 2012 55Table 21: Product Profile - Rituxan 57Table 22: Rituxan SWOT Analysis, 2012 58Table 23: Product Profile - Methotrexate 60Table 24: Methotrexate SWOT Analysis, 2012 61Table 25: Summary of Minor Therapeutic Classes, 2012 62
  5. 5. Table 26: Overall Unmet Needs - Current Level of Attainment 63Table 27: Clinical Unmet Needs - Gap Analysis, 2012 66Table 28: Rheumatoid Arthritis - Phase Pipeline, 2012 69Table 29: Comparison of Therapeutic Classes in Development for RA, 2012 70Table 30: Product Profile - Tofacitinib 71Table 31: Clinical Trial Locations by Country for Tofacitinib 71Table 32: ORAL Standard ACR 20 Responses for Tofacitinib vs. Placebo vs. Humira at Month 672Table 33: ORAL Step ACR 20, 50, 70 Responses for Tofacitinib vs. Placebo at Month Six 72Table 34: Efficacy Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 73Table 35: Safety Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 73Table 36: Tofacitinib Clinical Trial Mortalities as of September 29, 2011 74Table 37: Tofacitinib SWOT Analysis, 2012 76Table 38: Product Profile - Tabalumab 77Table 39: ACR Responses and DAS28 Scores for Tabalumab vs. Placebo at Week 16 78Table 40: Tabalumab SWOT Analysis, 2012 79Table 41: Product Profile - Fostamatinib 80Table 42: ACR Responses and DAS28 Scores for Fostamatinib vs. Placebo at Month Three 81Table 43: Fostamatinib SWOT Analysis, 2012 83Table 44: Product Profile - Secukinumab 84Table 45: Secondary Endpoint Results for Secukinumab vs. Placebo at Weeks 24 and 52 85Table 46: Secukinumab SWOT Analysis, 2012 87Table 47: Product Profile - Masitinib 88Table 48: ACR Responses for Masitinib in the ITT Population (12 Weeks) 89Table 49: ACR Responses for Masitinib in the ITT Population (12-82 Weeks) 89Table 50: Masitinib SWOT Analysis, 2012 91Table 51: Product Profile - Baricitinib 92Table 52: ACR Responses for Baricitinib + MTX vs. Placebo + MTX at Week 12 93Table 53: Safety of 4 and 8mg Baricitinib at Week 12 94Table 54: Laboratory Values of 4 and 8mg Baricitinib at Week 12 94Table 55: Baricitinib SWOT Analysis, 2012 95Table 56: Product Profile - Careram 96Table 57: Careram SWOT Analysis, 2012 98Table 58: Sales Forecasts ($m) for Rheumatoid Arthritis in Japan 100Table 59: Key Events Impacting Sales for Rheumatoid Arthritis in Japan, 2012 101Table 60: Rheumatoid Arthritis Market - Drivers and Barriers in Japan, 2012 102Table 61: Key Launch Dates 116Table 62: Key Patent Expiries 116Table 63: Physicians Surveyed, By Country 1241.2 List of FiguresFigure 1: Healthy and Arthritic Joint with Rheumatoid Arthritis 11
  6. 6. Figure 2: Rheumatoid Arthritis Biologic Drug Targets 13Figure 3: Diagnosis Criteria for Rheumatoid Arthritis Based on 2010 ACR/EULAR Criteria PointSystem 18Figure 4: Severity of Rheumatoid Arthritis 18Figure 5: Biologic Treatment Flow Based on Updated 2012 ACR Treatment Recommendations*21Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2012-2022 69Figure 7: Sales for Rheumatoid Arthritis in Japan by Drug Class 101Contact: for more information.