Home / Pharmaceutical / Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2023 - Novel JAK and IL-6 Receptor Inhibitors to Stimulate Moderate Growth Despite Launch of Biosimilars of Blockbuster Anti-TNFs

Rheumatoid Arthritis Therapeutics in Asia-Pacific Markets to 2023 - Novel JAK and IL-6 Receptor Inhibitors to Stimulate Moderate Growth Despite Launch of Biosimilars of Blockbuster Anti-TNFs

Published: Mar 2018 | No Of Pages: 148 | Published By: GBI Research

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 Asia-Pacific RA market contains novel products, including sirukumab, an anti-IL-6 human mAb; Peficitinib, Upadacitinib and Filgotinib, which are JAK1 inhibitors; Olokizumab, an anti-IL-6 humanized IgG4 mAb; and RCT-18, a recombinant human B-lymphocyte stimulating factor (BLyS) receptor-antibody fusion protein.
  • What are the competitive advantages of the existing novel drugs?
    There are over 480 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 2016–2023 forecast period, the Asia-Pacific RA therapeutics market is expected to increase in value at a compound annual growth rate of 8.2%, from $5.6 billion to over $9.7 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 five assessed Asia-Pacific markets?
  • A 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?
  • Licensing deals are the most common form of strategic alliance in the RA therapeutics market, with deal values ranging from under $10m to over $1 billion.
  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key licensing deals?

Reasons To Buy

  • Understand the clinical context of RA by considering epidemiology, symptoms, etiology and pathophysiology, diagnosis, prognosis, treatment guidelines and options, and biologic registries.
  • 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 India, China, Australia, Japan and South Korea.
  • 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 4
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 9
2.1 Disease Introduction 9
2.2 Epidemiology 10
2.3 Symptoms 10
2.4 Etiology and 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 Prognosis 14
2.7 Treatment Guidelines and Options 14
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 20
2.8 Co-morbidities and Complications 21

3 Marketed Products 22
3.1 Overview 22
3.2 Small-Molecule Disease-Modifying Anti-rheumatic Drugs 22
3.2.1 Methotrexate-Based Products 22
3.2.2 Xeljanz (tofacitinib) – Pfizer 23
3.3 Biologic Disease-Modifying Anti-rheumatic Drugs 25
3.3.1 Remicade (infliximab) - Johnson & Johnson 25
3.3.2 Humira (adalimumab) – AbbVie 25
3.3.3 Enbrel (etanercept) - Amgen 26
3.3.4 Rituxan/MabThera (rituximab) - Biogen Idec and Genentech 27
3.3.5 Orencia (abatacept) – Bristol-Myers Squibb 28
3.3.6 Simponi (golimumab) – Johnson & Johnson, Merck 28
3.3.7 Cimzia (certolizumab pegol) – UCB 29
3.3.8 Actemra (tocilizumab) – Roche 30
3.3.9 Olumiant (baricitinib) – Eli Lilly 31
3.3.10 Kevzara (Sarilumab) – Regeneron/Sanofi 33
3.3.11 Prolia (denosumab) – Amgen/Daiichi Sankyo 35
3.4 Comparative Efficacy and Safety of Marketed Products 36
3.4.1 Conventional Synthetic Disease Modifying Anti-rheumatic Drugs (csDMARDs) 36
3.4.2 Anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs (bDMARDs) 37
3.4.3 Non-anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs 39
3.4.4 Targeted Synthetic Disease Modifying Anti-rheumatic Drugs 40

4 Product Pipeline 42
4.1 Overview 42
4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 43
4.3 Pipeline Distribution by Molecular Target 45
4.4 Promising Pipeline Candidates 48
4.4.1 Sirukumab – Johnson & Johnson 48
4.4.2 Peficitinib – Astellas 50
4.4.3 Upadacitinib – AbbVie 52
4.4.4 Filgotinib – Galapagos 55
4.4.5 Olokizumab – R-Pharm 58
4.4.6 RCT-18 – Yantai RC-Pharma 59
4.5 Comparative Efficacy and Safety of Pipeline Products 59
4.6 Product Competitiveness Framework 61

5 Clinical Trial Analysis 63
5.1 Failure Rate 63
5.1.1 Overall Failure Rate 63
5.1.2 Failure Rate by Phase and Molecule Type 65
5.1.3 Failure Rate by Phase and Molecular Target 66
5.2 Clinical Trial Duration 67
5.2.1 Clinical Trial Duration by Molecule Type 67
5.2.2 Clinical Trial Duration by Molecular Target 68
5.3 Clinical Trial Size 69
5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 69
5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 70
5.4 Summary of Clinical Trial Metrics 72

6 Multi-Scenario Forecast 74
6.1 Geographical Markets 74
6.2 APAC Markets 74
6.3 India 77
6.3.1 Treatment Usage Patterns 77
6.3.2 Annual Cost of Therapy 77
6.3.3 Market Size 78
6.4 China 79
6.4.1 Treatment Usage Patterns 79
6.4.2 Annual Cost of Therapy 80
6.4.3 Market Size 81
6.5 Australia 82
6.5.1 Treatment Usage Patterns 82
6.5.2 Annual Cost of Therapy 83
6.5.3 Market Size 84
6.6 South Korea 85
6.6.1 Treatment Usage Patterns 85
6.6.2 Annual Cost of Therapy 86
6.6.3 Market Size 87
6.7 Japan 88
6.7.1 Treatment Usage Patterns 88
6.7.2 Annual Cost of Therapy 89
6.7.3 Market Size 90

7 Market Dynamics (Drivers and Barriers) of RA Therapeutics Market 92
7.1 Drivers 92
7.1.1 Rising Prevalence in an Aging Population 92
7.1.2 Launch of Novel Drugs: Oral JAK Inhibitors and Novel Biologics 92
7.1.3 Increasing Awareness of RA 92
7.2 Barriers 93
7.2.1 Increasing Use of Complementary and Alternative Medicine 93
7.2.2 Launch of Cheaper Biosimilars 93
7.2.3 Unmet Needs for Efficacious Therapies Diminishing 93

8 Deals and Strategic Consolidations 94
8.1 Licensing Deals 94
8.1.1 Deals by Region and Value 94
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 96
8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 97
8.1.4 Maruho Enters into Licensing Agreement with 4SC for a Preclinical Compound 99
8.1.5 CSL Enters into Licensing Agreement with Momenta Pharmaceuticals for M230 Preclinical Product Candidate 100
8.1.6 Mylan Enters into Licensing Agreement with Momenta Pharmaceuticals for Biosimilar Candidates 100
8.1.7 Ablynx Enters into a Licensing Deal with AbbVie for the Nanobody ALX-0061 100
8.2 Co-development 103
8.2.1 Deals by Region and Value 103
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 105
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 106
8.2.4 Sanofi Enters into an Agreement with JHL Biotech 109
8.2.5 Gilead Sciences Enters into Co-development Agreement with Galapagos 109
8.2.6 Epirus Enters into an Agreement with Orygen Biotecnologia 109
8.2.7 Dynavax Enters into Co-development Agreement with GlaxoSmithKline 110

9 Appendix 112
9.1 All Pipeline Drugs by Stage of Development 112
9.1.1 Discovery 112
9.1.2 Preclinical 115
9.1.3 Investigational New Drug/Clinical Trial Authorization-Filed 125
9.1.4 Phase I 125
9.1.5 Phase II 128
9.1.6 Phase III 130
9.1.7 Pre-registration 131
9.2 Summary of Multi-scenario Market Forecasts to 2023 131
9.2.1 Asia-Pacific 131
9.2.2 India 132
9.2.3 China 132
9.2.4 Australia 132
9.2.5 South Korea 133
9.2.6 Japan 133
9.3 Bibliography 133
9.4 Abbreviations 141
9.5 Research Methodology 144
9.5.1 Secondary Research 144
9.5.2 Marketed Product Profiles 145
9.5.3 Late-Stage Pipeline Candidates 145
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 145
9.5.5 Product Competitiveness Framework 145
9.5.6 Pipeline Analysis 146
9.5.7 Clinical Trials 146
9.5.8 Clinical trial Endpoint Analysis 146
9.5.9 Forecasting Model 147
9.5.10 Deals Data Analysis 148
9.6 Contact Us 148
9.7 Disclaimer 148

 

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