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Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2021

Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2021


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Executive Summary

Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2021-Novel IL-6 and JAK Inhibitors to Stimulate Moderate Growth Despite Brand Erosion of Blockbuster Anti-TNFs

GBI Research, the leading business intelligence provider, has released its latest research, "Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2021-Novel IL-6 and JAK Inhibitors to Stimulate Moderate Growth Despite Brand Erosion of Blockbuster Anti-TNFs", which provides in-depth analysis of Rheumatoid Arthritis (RA) market within the Asia-Pacific (APAC) market covering the four countries of Australia, China, India and Japan. The report provides an estimation of market size for 2014, along with market forecast until 2021. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of the pipeline, and deal analysis.

The value of the RA market in the APAC region amounted to an estimated USD 5.6 billion in 2014 and is expected to register a Compound Annual Growth Rate (CAGR) of 3.3% to reach USD 6.9 billion by 2021. The key drivers for growth in the APAC market include: the increasing prevalent population and the anticipated market launch of promising pipeline candidates. The late-stage pipeline which has a potential to stimulate growth during the forecast period include interleukin (IL)-6 inhibitors Sanofi/Regeneron's sarilumab, Johnson & Johnson/GlaxoSmithKline's [J&J/GSK's] sirukumab, small molecules (four janus kinase [JAK] inhibitors: Eli Lilly/Incyte's baricitinib, Loss of patent exclusitivity of major second-line biologic anti-TNF during such as Enbrel, Remicade and Humira by the end of the forecast period is the major barrier for growth in the RA market size in the APAC markets. Preference for less expensive alternatives to branded medicines, such as biosimilars and other alternate therapies is another major barrier in cost-conscious APAC markets, India and China.

Scope

The report analyzes treatment usage patterns, drug types available and pipeline and market forecasts for RA. It covers and includes

A brief introduction to RA, including the disease's pathophysiology, risk factors, diagnosis and an overview of pharmacotherapy and treatment algorithms.

In-depth analysis of the drug combinations used in the treatment of RA, including analyses of their safety, efficacy, and place in the disease treatment algorithm, as well as a heat map comparing the drug combinations in terms of safety and efficacy

A comprehensive review of the pipeline for OC therapies, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market in the forecast period; the pipeline is analyzed on the basis of phase distribution, molecule type and molecular target, and route of administration

Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, and trial duration, and program failure rate analyses for each molecule type and mechanism of action

Multi-scenario forecast market data to 2021, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and the changes in disease epidemiology across the APAC markets

Discussion of the drivers and barriers for market growth

In-depth analysis of licensing and co-development deals involving drugs indicated in RA, including an outline of the key deals

Reasons To Buy

Primarily, the report will allow clients to gain a strong understanding of RA, helping to identify and clarify market opportunities and the competitive environment. It will also allow you to

Understand the RA pipeline and the key trends in the current product development landscape

Observe detailed profiles for the promising pipeline products, including revenue forecasts, and gain an insight into how they are likely to compete in the market, and what their main competitors will be

Follow the trends in RA clinical trial size and duration in relation to industry averages and assess the potential risk of future developmental programs for RA therapeutics, depending on the mechanism of action, by considering the recorded clinical trial failure rates

Observe the potential growth patterns expected for the RA market over the forecast period, and identify which countries are expected to make the biggest contribution to this growth.

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 8

1.2 List of Figures 8

2 Introduction 10

2.1 Disease Introduction 10

2.2 Symptoms 11

2.3 Etiology 11

2.4 Pathophysiology 11

2.5 Diagnosis 12

2.5.1 Physical Examination 12

2.5.2 Blood Tests 12

2.5.3 1987 Rheumatoid Arthritis Classification 13

2.5.4 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis 13

2.6 Epidemiology 14

2.7 Co-morbidities and Complications 14

2.8 Disease Progression 15

2.9 Pharmacotherapy Algorithm 15

2.10 Treatment Options 16

2.10.1 Pharmacological 17

2.10.2 Methotrexate 17

2.10.3 Hydroxychloroquine 17

2.10.4 Leflunomide 17

2.10.5 Sulfasalazine 17

2.10.6 Cyclosporine 18

2.10.7 Prograf (tacrolimus) 18

2.10.8 Xeljanz (tofacitinib) 18

2.11 Other Non-biologics 18

2.11.1 Non-steroidal Anti-inflammatory Drugs 18

2.11.2 Painkillers 18

2.11.3 Glucocorticoids 18

2.12 Biologic Disease-Modifying Anti-rheumatic Drugs 19

2.12.1 Tumor Necrosis Factor Alpha Inhibitors 19

2.12.2 Interleukin Inhibitors 19

2.12.3 Other Biologics that Target B- and T-Cell Antigens 19

2.13 Disease Scoring Methods for Measuring Treatment Efficacy 20

2.13.1 Radiographic Progression 20

2.13.2 Clinical Disease Activity Index and Simplified Disease Activity Index 20

2.13.3 Disease Activity Score-28 20

2.13.4 American College of Rheumatology 20

2.13.5 Health Assessment Questionnaire 20

3 Marketed Products 21

3.1 Overview 21

3.2 Small-Molecule Disease-Modifying Anti-rheumatic Drugs 21

3.2.1 Methotrexate-Based Products 21

3.2.2 Xeljanz (tofacitinib)-Pfizer 22

3.3 Biologic Disease-Modifying Anti-rheumatic Drugs 23

3.3.1 Remicade (infliximab)-Johnson & Johnson, Merck 23

3.3.2 Humira (adalimumab)-AbbVie 24

3.3.3 Enbrel (etanercept)-Amgen, Pfizer and Takeda Pharmaceutical 25

3.3.4 Rituxan (rituximab)-Genentech, Biogen IDEC 27

3.3.5 Orencia (abatacept)-Bristol-Myers Squibb 28

3.3.6 Simponi (golimumab)-Johnson & Johnson, Merck 29

3.3.7 Cimzia (certolizumab pegol)-UCB 30

3.3.8 Kineret (anakinra)-Swedish Orphan Biovitrum 31

3.3.9 Actemra (tocilizumab)-Roche 32

3.3.10 Comparative Safety and Efficacy 33

3.4 Unmet Need 36

4 Product Pipeline 37

4.1 Overview 37

4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 37

4.3 Pipeline Distribution by Mechanism of Action 39

4.3.1 Cytokine Inhibitors 41

4.3.2 B- and T-cells 42

4.3.3 Intracellular Kinases 43

4.4 Clinical Trial Analysis 44

4.4.1 Overall Attrition Rate 44

4.4.2 Attrition Rate by Phase, Molecule Type and Target 45

4.4.3 Average Clinical Trial Size by Molecule Type 46

4.4.4 Average Clinical Trial Size by Mechanism of Action 49

4.4.5 Average Clinical Trial Duration per Molecule Type by Product 50

4.4.6 Average Clinical Trial Duration per Mechanism of Action by Product 52

4.4.7 Primary and Secondary Endpoints 53

4.4.8 Summary 54

4.5 Promising Pipeline Drugs 54

4.5.1 Baricitinib-Eli Lilly 54

4.5.2 Sarilumab-Regeneron Pharmaceuticals/Sanofi 55

4.5.3 Sirukumab-Johnson & Johnson 56

4.5.4 Decernotinib-Vertex Pharmaceuticals 56

4.5.5 Masitinib 57

4.5.6 Denosumab 57

4.6 Comparative Heat Map 58

5 Market Forecasts 61

5.1 Asia-Pacific 61

5.1.1 Treatment Usage Patterns 61

5.1.2 Market Size 62

5.2 India 63

5.2.1 Treatment Usage Patterns 63

5.2.2 Annual Cost of Therapy 64

5.2.3 Market Size 65

5.3 China 65

5.3.1 Treatment Usage Patterns 65

5.3.2 Annual Cost of Therapy 66

5.3.3 Market Size 67

5.4 Australia 67

5.4.1 Treatment Usage Patterns 67

5.4.2 Annual Cost of Therapy 68

5.4.3 Market Size 69

5.5 Japan 69

5.5.1 Treatment Usage Patterns 69

5.5.2 Annual Cost of Therapy 70

5.5.3 Market Size 71

5.6 Drivers and Barriers of Rheumatoid Arthritis Therapeutics Market 71

5.6.1 Drivers 71

5.6.2 Barriers 72

6 Deals 74

6.1 Licensing Agreements 74

6.1.1 Deal Values by Therapeutic Molecule Type 76

6.1.2 Deal Values by Therapeutic Mechanism of Action 78

6.1.3 AstraZeneca Enters into Licensing Agreement with Rigel Pharma for Fostamatinib Disodium 80

6.1.4 Alder Biopharmaceuticals Enters into Licensing Deal with Bristol-Myers Squibb and Alder Biopharmaceuticals for Clazakizumab 80

6.1.5 Janssen Biotech Enters into a Licensing Deal with Astellas Pharma for Peficitinib 80

6.1.6 Ablynx Enters into a Licensing Deal with AbbVie for the Nanobody ALX-006 80

6.2 Co-development 81

6.2.1 Deal Values by Therapeutic Molecule Type and Phase 82

6.2.2 Deal Values by Therapeutic Mechanism of Action and Phase 84

6.2.3 GlaxoSmithKline enters into Global Agreement with Archemix 86

6.2.4 Abbott Laboratories Enters into Global Collaboration with Galapagos for filgotinib 86

6.2.5 Chroma Therapeutics Enters into a Co-development Agreement with GlaxoSmithKline 86

7 Appendix 87

7.1 All Pipeline Drugs by Phase of Development 87

7.1.1 Discovery 87

7.1.2 Preclinical 92

7.1.3 IND-CTA Filed 101

7.1.4 Phase I 102

7.1.5 Phase II 104

7.1.6 Phase III 106

7.2 Market Forecasts to 2021 108

7.3 Abbreviations 110

7.4 Bibliography 112

7.4.1 References for Figure 10 118

7.4.2 References for Figure 26 120

7.5 Research Methodology 121

7.5.1 Coverage 122

7.5.2 Secondary Research 122

7.5.3 Primary Research 122

7.5.4 Therapeutic Landscape 123

7.5.5 Geographical Landscape 126

7.5.6 Pipeline Analysis 126

7.6 Expert Panel Validation 126

7.7 Contact Us 126

7.8 Disclaimer 126

1.1 List of Tables

Table 1: ACR-EULAR Classification Criteria for Rheumatoid Arthritis, 2010 14

Table 2: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Discovery, 2014 87

Table 3: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 92

Table 4: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, IND/CTA-Filed, 2014 101

Table 5: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase I, 2014 102

Table 6: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase II, 2014 104

Table 7: Rheumatoid Arthritis, Therapeutics, Global, All Pipeline Products, Phase III, 2014 106

Table 8: Rheumatoid Arthritis, Therapeutics Market, Asia-Pacific, Market Forecast, 2014-2021 108

Table 9: Rheumatoid Arthritis, Therapeutics Market, India, Market Forecast, 2014-2021 108

Table 10: Rheumatoid Arthritis, Therapeutics Market, China, Market Forecast, 2014-2021 108

Table 11: Rheumatoid Arthritis, Therapeutics Market, Australia, Market Forecast, 2014-2021 109

Table 12: Rheumatoid Arthritis, Therapeutics Market, Japan, Market Forecast, 2014-2021 109

Table 13: Abbreviations 110

1.2 List of Figures

Figure 1: American College of Rheumatology Treatment Guidelines, 2012 16

Figure 2: Rheumatoid Arthritis Market, Global, Annual Sales of Remicade (USD bn), 2008-2014 24

Figure 3: Rheumatoid Arthritis Market, Global, Annual Sales of Humira (USD bn), 2008-2014 25

Figure 4: Rheumatoid Arthritis Market, Global, Annual Sales of Enbrel (USD bn), 2008-2014 26

Figure 5: Rheumatoid Arthritis Market, Global, Annual Sales of Rituxan (USD bn), 2008-2014 27

Figure 6: Rheumatoid Arthritis Market, Global, Annual Sales of Orencia (USD m), 2008-2014 29

Figure 7: Rheumatoid Arthritis Market, Global, Annual Sales of Simponi (USD m), 2009-2014 30

Figure 8: Rheumatoid Arthritis Market, Global, Annual Sales of Cimzia (USD m), 2008-2014 31

Figure 9: Rheumatoid Arthritis Market, Global, Annual Sales of Actemra (USD m), 2008-2014 33

Figure 10: Comparative Efficacy and Safety of Marketed Products 35

Figure 11: Rheumatoid Arthritis Market, Global, Pipeline, 2014 38

Figure 12: Rheumatoid Arthritis Market, Global, Pipeline by Mechanism of Action, 2014 40

Figure 13: Rheumatoid Arthritis Market, Global, Pipeline, Cytokine Inhibitors, 2014 42

Figure 14: Rheumatoid Arthritis Market, Global, Pipeline, Inhibitors of B and T Cells, 2014 43

Figure 15: Rheumatoid Arthritis Market, Global, Pipeline, Intracellular Kinase Inhibitors, 2014 44

Figure 16: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate (%), 2006-2014 44

Figure 17: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate (%), 2006-2014 45

Figure 18: Rheumatoid Arthritis, Global, Clinical Trial Failure Rate (%), 2006-2014 46

Figure 19: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Size by Molecule Type by Product, 2006-2014 47

Figure 20: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Size by Molecule Type by Trial, 2006-2014 48

Figure 21: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Size by Mechanism of Action by Product, 2006-2014 49

Figure 22: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Size by Mechanism of Action by Trial, 2006-2014 50

Figure 23: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Duration by Molecule Type by Product (months), 2006-2014 51

Figure 24: Rheumatoid Arthritis Market, Global, Pipeline, Clinical Trial Duration by Mechanism of Action by Product (months), 2006-2014 52

Figure 25: Rheumatoid Arthritis Market, Global, Frequency of Primary Endpoints Measured in Clinical Trials, 2006-2014 53

Figure 26: Comparative Efficacy and Safety of Pipeline Programs 60

Figure 27: Rheumatoid Market, Asia-Pacific, Treatment Usage Patterns (million), 2014-2021 62

Figure 28: Rheumatoid Market, Asia-Pacific, Market Size (USD bn), 2014-2021 63

Figure 29: Rheumatoid Market, India, Treatment Usage Patterns (million), 2014-2021 64

Figure 30: Rheumatoid Market, India, Annual Cost of Therapy (USD ), 2014-2021 64

Figure 31: Rheumatoid Market, India, Market Size (USD m), 2014-2021 65

Figure 32: Rheumatoid Market, China, Treatment Usage Patterns (million), 2014-2021 66

Figure 33: Rheumatoid Market, China, Annual Cost of Therapy (USD ), 2014-2021 66

Figure 34: Rheumatoid Market, China, Market Size (USD m), 2014-2021 67

Figure 35: Rheumatoid Market, Australia, Treatment Usage Patterns ('000), 2014-2021 68

Figure 36: Rheumatoid Market, Australia, Annual Cost of Therapy (USD ), 2014-2021 68

Figure 37: Rheumatoid Market, Australia, Market Size (USD m), 2014-2021 69

Figure 38: Rheumatoid Market, Japan, Treatment Usage Patterns ('000), 2014-2021 70

Figure 39: Rheumatoid Market, Japan, Annual Cost of Therapy (USD ), 2014-2021 70

Figure 40: Rheumatoid Market, Japan, Market Size (USD bn), 2014-2021 71

Figure 41: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014 75

Figure 42: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014 77

Figure 43: Rheumatoid Arthritis Market, Global, Licensing Deals, 2006-2014 79

Figure 44: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014 81

Figure 45: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014 83

Figure 46: Rheumatoid Arthritis Market, Global, Co-development Deals, 2006-2014 85

Figure 47: GBI Research Market Forecasting Model 125

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