Rheumatoid Arthritis Therapeutics in South-East Asia Markets to 2022 - Novel JAK and IL-6 Receptor Inhibitors to Stimulate Moderate Growth Despite Launch of Biosimilars of Blockbuster Anti-TNFs

Summary

Rheumatoid Arthritis (RA) is a chronic, progressive and currently incurable autoimmune disease that primarily affects the joints. It is characterized by synovial inflammation and gradual bone erosion over many years. Disease progression results in stiffness and pain, especially in the hands and feet, which hinders mobility. Without treatment, the disease leads to joint destruction and disability.

The chronic nature of the disease, which requires ongoing treatment, and the relatively high annual cost of therapy (ACoT) have made RA treatment a highly lucrative market.

The RA therapeutic market has become very competitive due to the high number of new drug approvals. Competition is fierce, particularly among TNF-α inhibitors, which dominate the treatment market for RA patients who are refractory to traditional disease-modifying anti-rheumatic drugs (DMARD). Despite this, 30% of RA patients fail to attain a clinical response when treated with TNF-α inhibitors. However, other targeted programs, as well as newly marketed small-molecule DMARDs such as the Janus kinase (JAK) inhibitor Xeljanz (tofacitinib), have the potential to replace ineffective TNF-α inhibitors. Recently published study results of Xeljanz have shown a significant reduction in the risk of developing cardiac diseases such as heart attack and stroke in patients with RA.

Despite the superior efficacy of recently marketed therapies over traditional DMARD therapies, there is a need to improve safety in the therapeutic landscape. Elevated rates of infection are a frequent consequence of the immunosuppression involved in treatments, but this is required to suppress the autoimmune responses responsible for the symptoms of the condition. As a result, these biological therapies are not recommended to patients who are susceptible to infection.

In addition, there is a need to create biologics with more convenient and less invasive drug-delivery methods, as all existing therapies are administered subcutaneously or intravenously. These routes of administration are frequently associated with pain, rash, and allergic reactions at the injection or infusion site, and in the case of infusion flu-like illness, fever, chills, nausea, and headache. Therefore convenient and safe administration without significant compromise of therapy efficacy remains an unmet need.

Although the recently approved drug Xeljanz is an orally administered small-molecule drug, indicated as a second-line treatment for RA patients who have not shown an adequate response to methotrexate, and as a third-line therapy for patients who have not responded sufficiently to biologics, it carries a black-box warning in the US due to the safety issues of serious infections and malignancy.

Scope

The current South-East Asia RA market contains novel products, including Xeljanz, a JAK inhibitor; and Actemra (tocilizumab), an IL-6 receptor inhibitor.

- What are the competitive advantages of the existing novel drugs?

There are over 450 active pipeline molecules, and most of the late-stage investigational drug candidates feature improved dosing regimens and administration routes in comparison to currently marketed products and combination therapies.

- Which classes of novel drugs are most prominent in the pipeline?
- What is the potential for pipeline products to address unmet needs in the RA market?

Analysis of clinical trials since 2006 identified that the failure rates of RA molecules were highest in Phase II, at 72.6%, with the overall attrition rate for RA standing at 94.6%.

- How do failure rates vary by stage of development, molecule type, and molecular target?
- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?

Over the 2015-2022 forecast period, the South-East Asia RA therapeutics market is expected to increase in value at a CAGR of 4.7%, from $1.04 billion to over $1.4 billion.

- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the eight assessed South-East Asia markets?

Rising RA prevalence population and the uptake of newer therapies will lead to significant market growth over the forecast period, despite the launch of biosimilars of blockbuster anti-TNFs.

- Will the launch of biosimilars or emerging pipeline molecules threaten the commercial success of existing drugs?

Reasons to buy

This report will enable you to -

- Understand the clinical context of RA by considering epidemiology, symptoms, etiology and pathophysiology, diagnosis, prognosis and treatment guidelines and options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in terms of molecule type, administration route, molecular target, and novelty.
- Consider market opportunities and potential risks by examining trends in RA clinical trial size, duration, and failure rate by stage of development, molecule type, and molecular target.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in RA by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam, and Indonesia.
- Discover trends in licensing and co-development deals concerning RA products and identify the major strategic consolidations that have shaped the commercial landscape.

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 Epidemiology 11
2.3 Symptoms 11
2.4 Etiology and Pathophysiology 11
2.5 Diagnosis 13
2.5.1 Physical Examination 13
2.5.2 Blood Tests 13
2.5.3 1987 Rheumatoid Arthritis Classification 14
2.5.4 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis 14
2.6 Prognosis 14
2.7 Treatment Guidelines and Options 15
2.7.1 Pharmacological 16
2.7.2 Methotrexate 16
2.7.3 Hydroxychloroquine 17
2.7.4 Leflunomide 17
2.7.5 Sulfasalazine 17
2.7.6 Cyclosporine 17
2.7.7 Xeljanz (tofacitinib) 17
2.7.8 Other Non-biologics 18
2.7.9 Biologic Disease-Modifying Anti-rheumatic Drugs 18
2.7.10 Disease Scoring Methods for Measuring Treatment Efficacy 19
2.8 Co-infection or Co-morbidities 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 Infliximab 23
3.3.2 Humira (adalimumab) - AbbVie 24
3.3.3 Etanercept 24
3.3.4 Rituximab 25
3.3.5 Orencia (abatacept) - Bristol-Myers Squibb 26
3.3.6 Simponi (golimumab) - Johnson & Johnson, Merck 26
3.3.7 Cimzia (certolizumab pegol) - UCB 27
3.3.8 Actemra (tocilizumab) - Roche 27
3.4 Comparative Efficacy and Safety of Marketed Products 28

4 Pipeline Analysis 34

4.1 Overview 34
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 34
4.3 Pipeline by Molecular Target 36
4.4 Promising Pipeline Candidates 39
4.4.1 Baricitinib - Eli Lilly 39
4.4.2 Sarilumab - Regeneron/Sanofi 41
4.4.3 Sirukumab - Johnson & Johnson 43
4.4.4 Peficitinib - Astellas 44
4.4.5 Upadacitinib - AbbVie 46
4.4.6 Filgotinib - Galapagos 47
4.5 Comparative Efficacy and Safety of Pipeline Products 48
4.6 Product Competitiveness Framework 50

5 Clinical Trial Analysis 52

5.1 Failure Rate 52
5.1.1 Overall Failure Rate 52
5.1.2 Failure Rate by Phase and Molecule Type 54
5.1.3 Failure Rate by Phase and Molecular Target 55
5.2 Clinical Trial Duration 55
5.2.1 Trial Duration by Stage of Development and Molecule Type 55
5.2.2 Trial Duration by Stage of Development and Molecular Target 56
5.3 Clinical Trial Size 57
5.3.1 Patient Enrollment per Product by Stage of Development and Molecule Type/Molecular Target 57
5.3.2 Patient Enrollment per Trial by Stage of Development and Molecule Type/Molecular Target 59
5.4 Summary of Clinical Trial Metrics 61

6 Multi-Scenario Forecast 63

6.1 Geographical Markets 63
6.2 South-East Asia Markets 63
6.3 South Korea 66
6.3.1 Treatment Usage Patterns 66
6.3.2 Annual Cost of Therapy 66
6.3.3 Market Size 67
6.4 Singapore 68
6.4.1 Treatment Usage Patterns 68
6.4.2 Annual Cost of Therapy 69
6.4.3 Market Size 69
6.5 Taiwan 70
6.5.1 Treatment Usage Patterns 70
6.5.2 Annual Cost of Therapy 71
6.5.3 Market Size 72
6.6 Malaysia 73
6.6.1 Treatment Usage Patterns 73
6.6.2 Annual Cost of Therapy 74
6.6.3 Market Size 75
6.7 Philippines 76
6.7.1 Treatment Usage Patterns 76
6.7.2 Annual Cost of Therapy 77
6.7.3 Market Size 78
6.8 Thailand 79
6.8.1 Treatment Usage Patterns 79
6.8.2 Annual Cost of Therapy 80
6.8.3 Market Size 81
6.9 Vietnam 82
6.9.1 Treatment Usage Patterns 82
6.9.2 Annual Cost of Therapy 83
6.9.3 Market Size 84
6.10 Indonesia 85
6.10.1 Treatment Usage Patterns 85
6.10.2 Annual Cost of Therapy 86
6.10.3 Market Size 87
6.11 Market Dynamics (Drivers and Barriers) 88
6.11.1 Drivers 88
6.11.2 Barriers 89

7 Deals and Strategic Consolidations 90

7.1 Licensing Deals 90
7.1.1 Deals by Region and Value 90
7.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 92
7.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 92
7.1.4 Mylan Enters into Licensing Agreement with Momenta Pharmaceuticals for Biosimilar Candidates 95
7.1.5 Roche Enters into Licensing Agreement with Proximagen for VAP-1 Inhibitor 95
7.1.6 Alder Biopharmaceuticals Enters into Licensing Deal with Bristol-Myers Squibb and Alder Biopharmaceuticals for Clazakizumab 96
7.1.7 Ablynx Enters into a Licensing Deal with AbbVie for the Nanobody ALX-0061 96
7.2 Co-development 97
7.2.1 Deals by Region and Value 97
7.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 98
7.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 99
7.2.4 Gilead Sciences Enters into Co-development Agreement with Galapagos 102
7.2.5 Nextera Enters into Research Agreement with Janssen Biotech 103
7.2.6 GlaxoSmithKline Enters into Global Agreement with Archemix 103
7.2.7 Chroma Therapeutics Enters into Co-development Agreement with GlaxoSmithKline 103

8 Appendix 105

8.1 All Pipeline Drugs by Stage of Development 105
8.1.1 Discovery 105
8.1.2 Preclinical 108
8.1.3 IND/CTA-filed 117
8.1.4 Phase I 118
8.1.5 Phase II 120
8.1.6 Phase III 122
8.1.7 Pre-registration 123
8.2 Summary of Multi-Scenario Market Forecasts to 2022 123
8.3 Abbreviations 127
8.4 References 129
8.5 Research Methodology 136
8.5.1 Secondary Research 137
8.5.2 Marketed Product Profiles 137
8.5.3 Late-Stage Pipeline Candidates 137
8.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products 137
8.5.5 Pipeline Analysis 138
8.5.6 Forecasting Model 139
8.5.7 Deals Data Analysis 140
8.6 Contact Us 140
8.7 Disclaimer 140

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