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

  • ID: 4496239
  • Report
  • 148 pages
  • GBI Research
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FEATURED COMPANIES

  • AbbVie
  • Amgen
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • Pfizer
  • MORE

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 TNFa 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 TNFa 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 TNFa 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.

The advent of biologic disease modifying anti-rheumatic drugs (DMARD) has boosted the rheumatoid arthritis (RA) market tremendously over the last two decades. Growth is expected to continue at a moderate pace from around $5.6 billion in 2016 to more than $9.5 billion in 2023 at a compound annual growth rate (CAGR) of over 8% in the AsiaPacific (APAC) markets of India, Australia, China, South Korea and Japan. Japan accounted for the majority of the market in 2016 with a 65.4% share, followed by China, Australia, India and South Korea with about 12.7%, 8.6%, 8.1% and 5.2% respectively.

Recently approved therapies anticipated to have a high impact include Eli Lilly and Incyte’s baricitinib and Sanofi and Regeneron’s sarilumab. Along with recently approved therapies, the entry of new therapies over the forecast period will stimulate market growth. Promising pipeline candidates include Johnson & Johnson (J&J) and GlaxoSmithKline (GSK)’s sirukumab, and Galapagos’s filgotinib. Galapagos entered into a global collaboration agreement with Gilead in 2015 to develop and commercialize filgotinib for the treatment of inflammatory indications.

The report "Rheumatoid Arthritis Therapeutics in AsiaPacific Markets to 2023  Novel JAK and IL6 Receptor Inhibitors to Stimulate Moderate Growth Despite Launch of Biosimilars of Blockbuster AntiTNFs" provides the current AsiaPacific RA market contains novel products, including sirukumab, an antiIL6 human mAb; Peficitinib, Upadacitinib and Filgotinib, which are JAK1 inhibitors; Olokizumab, an antiIL6 humanized IgG4 mAb; and RCT18, a recombinant human Blymphocyte stimulating factor (BLyS) receptor antibody fusion protein.

Scope

  • The current Asia Pacific RA market contains novel products, including sirukumab, an antiIL6 human mAb; Peficitinib, Upadacitinib and Filgotinib, which are JAK1 inhibitors; Olokizumab, an antiIL6 humanized IgG4 mAb; and RCT18, a recombinant human Blymphocyte 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 20162023 forecast period, the AsiaPacific 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 AsiaPacific 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 antiTNFs.
  • 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.
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FEATURED COMPANIES

  • AbbVie
  • Amgen
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • Pfizer
  • MORE

1 Introduction
1.1 Disease Introduction
1.2 Epidemiology
1.3 Symptoms
1.4 Etiology and Pathophysiology
1.5 Diagnosis
1.5.1 Physical Examination
1.5.2 Blood Tests
1.5.3 1987 Rheumatoid Arthritis Classification
1.5.4 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis
1.6 Prognosis
1.7 Treatment Guidelines and Options
1.7.1 Pharmacological
1.7.2 Methotrexate
1.7.3 Hydroxychloroquine
1.7.4 Leflunomide
1.7.5 Sulfasalazine
1.7.6 Cyclosporine
1.7.7 Xeljanz (tofacitinib)
1.7.8 Other Non-biologics
1.7.9 Biologic Disease-Modifying Anti-rheumatic Drugs
1.7.10 Disease Scoring Methods for Measuring Treatment Efficacy
1.8 Co-morbidities and Complications

2 Marketed Products
2.1 Overview
2.2 Small-Molecule Disease-Modifying Anti-rheumatic Drugs
2.2.1 Methotrexate-Based Products
2.2.2 Xeljanz (tofacitinib) - Pfizer
2.3 Biologic Disease-Modifying Anti-rheumatic Drugs
2.3.1 Remicade (infliximab) - Johnson & Johnson
2.3.2 Humira (adalimumab) - AbbVie
2.3.3 Enbrel (etanercept) - Amgen
2.3.4 Rituxan/MabThera (rituximab) - Biogen Idec and Genentech
2.3.5 Orencia (abatacept) - Bristol-Myers Squibb
2.3.6 Simponi (golimumab) - Johnson & Johnson, Merck
2.3.7 Cimzia (certolizumab pegol) - UCB
2.3.8 Actemra (tocilizumab) - Roche
2.3.9 Olumiant (baricitinib) - Eli Lilly
2.3.10 Kevzara (Sarilumab) - Regeneron/Sanofi
2.3.11 Prolia (denosumab) - Amgen/Daiichi Sankyo
2.4 Comparative Efficacy and Safety of Marketed Products
2.4.1 Conventional Synthetic Disease Modifying Anti-rheumatic Drugs (csDMARDs)
2.4.2 Anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs (bDMARDs)
2.4.3 Non-anti-TNF-a Biologic Disease Modifying Anti-rheumatic Drugs
2.4.4 Targeted Synthetic Disease Modifying Anti-rheumatic Drugs

3 Product Pipeline
3.1 Overview
3.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty
3.3 Pipeline Distribution by Molecular Target
3.4 Promising Pipeline Candidates
3.4.1 Sirukumab - Johnson & Johnson
3.4.2 Peficitinib - Astellas
3.4.3 Upadacitinib - AbbVie
3.4.4 Filgotinib - Galapagos
3.4.5 Olokizumab - R-Pharm
3.4.6 RCT-18 - Yantai RC-Pharma
3.5 Comparative Efficacy and Safety of Pipeline Products
3.6 Product Competitiveness Framework

4 Clinical Trial Analysis
4.1 Failure Rate
4.1.1 Overall Failure Rate
4.1.2 Failure Rate by Phase and Molecule Type
4.1.3 Failure Rate by Phase and Molecular Target
4.2 Clinical Trial Duration
4.2.1 Clinical Trial Duration by Molecule Type
4.2.2 Clinical Trial Duration by Molecular Target
4.3 Clinical Trial Size
4.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development
4.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development
4.4 Summary of Clinical Trial Metrics

5 Multi-Scenario Forecast
5.1 Geographical Markets
5.2 APAC Markets
5.3 India
5.3.1 Treatment Usage Patterns
5.3.2 Annual Cost of Therapy
5.3.3 Market Size
5.4 China
5.4.1 Treatment Usage Patterns
5.4.2 Annual Cost of Therapy
5.4.3 Market Size
5.5 Australia
5.5.1 Treatment Usage Patterns
5.5.2 Annual Cost of Therapy
5.5.3 Market Size
5.6 South Korea
5.6.1 Treatment Usage Patterns
5.6.2 Annual Cost of Therapy
5.6.3 Market Size
5.7 Japan
5.7.1 Treatment Usage Patterns
5.7.2 Annual Cost of Therapy
5.7.3 Market Size

6 Market Dynamics (Drivers and Barriers) of RA Therapeutics Market
6.1 Drivers
6.1.1 Rising Prevalence in an Aging Population
6.1.2 Launch of Novel Drugs: Oral JAK Inhibitors and Novel Biologics
6.1.3 Increasing Awareness of RA
6.2 Barriers
6.2.1 Increasing Use of Complementary and Alternative Medicine
6.2.2 Launch of Cheaper Biosimilars
6.2.3 Unmet Needs for Efficacious Therapies Diminishing

7 Deals and Strategic Consolidations
7.1 Licensing Deals
7.1.1 Deals by Region and Value
7.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
7.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target
7.1.4 Maruho Enters into Licensing Agreement with 4SC for a Preclinical Compound
7.1.5 CSL Enters into Licensing Agreement with Momenta Pharmaceuticals for M230 Preclinical Product Candidate
7.1.6 Mylan Enters into Licensing Agreement with Momenta Pharmaceuticals for Biosimilar Candidates
7.1.7 Ablynx Enters into a Licensing Deal with AbbVie for the Nanobody ALX-0061
7.2 Co-development
7.2.1 Deals by Region and Value
7.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value
7.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target
7.2.4 Sanofi Enters into an Agreement with JHL Biotech
7.2.5 Gilead Sciences Enters into Co-development Agreement with Galapagos
7.2.6 Epirus Enters into an Agreement with Orygen Biotecnologia
7.2.7 Dynavax Enters into Co-development Agreement with GlaxoSmithKline

8 Appendix
8.1 All Pipeline Drugs by Stage of Development
8.1.1 Discovery
8.1.2 Preclinical
8.1.3 Investigational New Drug/Clinical Trial Authorization-Filed
8.1.4 Phase I
8.1.5 Phase II
8.1.6 Phase III
8.1.7 Pre-registration
8.2 Summary of Multi-scenario Market Forecasts to 2023
8.2.1 Asia-Pacific
8.2.2 India
8.2.3 China
8.2.4 Australia
8.2.5 South Korea
8.2.6 Japan
8.3 Bibliography
8.4 Abbreviations
8.5 Research Methodology
8.5.1 Secondary Research
8.5.2 Marketed Product Profiles
8.5.3 Late-Stage Pipeline Candidates
8.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
8.5.5 Product Competitiveness Framework
8.5.6 Pipeline Analysis
8.5.7 Clinical Trials
8.5.8 Clinical trial Endpoint Analysis
8.5.9 Forecasting Model
8.5.10 Deals Data Analysis
8.6 Contact Us
8.7 Disclaimer

List of Tables
Table 1: ACR-EULAR Classification Criteria for Rheumatoid Arthritis, 2010
Table 2: RA Therapeutics Market, Global, Licensing Deals Valued over $10m, 2006-2017
Table 3: RA Therapeutics Market, Global, Co-development Deals Valued over $10m, 2006-2017
Table 4: RA Therapeutics Market, Global, All Pipeline Products, Discovery, 2016
Table 5: RA Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016
Table 6: RA Therapeutics Market, Global, All Pipeline Products, Investigational New Drug, 2016
Table 7: RA Therapeutics Market, Global, All Pipeline Products, Phase I, 2016
Table 8: RA Therapeutics Market, Global, All Pipeline Products, Phase II, 2016
Table 9: RA Therapeutics Market, Global, All Pipeline Products, Phase III, 2016
Table 10: RA Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2016
Table 11: RA Therapeutics Market, APAC, Market Forecast, 2016-2023
Table 12: RA Therapeutics Market, India, Market Forecast, 2016-2023
Table 13: RA Therapeutics Market, China, Market Forecast, 2016-2023
Table 14: RA Therapeutics Market, Australia, Market Forecast, 2016-2023
Table 15: RA Therapeutics Market, South Korea, Market Forecast, 2016-2023
Table 16: RA Therapeutics Market, Japan, Market Forecast, 2016-2023

List of Figures
Figure 1: RA Therapeutics Market, Australia, Age-Specific Prevalence (%), 2014-2015
Figure 2: American College of Rheumatology Treatment Guidelines, 2015
Figure 3: European League Against Rheumatism Treatment Guidelines, 2016
Figure 4: RA Therapeutics Market, Comparative Efficacy and Safety Heatmap for Conventional Synthetic Disease Modifying Anti-rheumatic Marketed Products
Figure 5: RA Therapeutics Market, Comparative Efficacy and Safety Heatmap for Anti TNF-a Biologic Disease Modifying Anti-rheumatic Marketed Products
Figure 6: RA Therapeutics Market, Comparative Efficacy and Safety Heatmap for Non-TNF-a Biologic Disease Modifying Anti-rheumatic Marketed Products
Figure 7: RA Therapeutics Market, Comparative Efficacy and Safety Heatmap for Targeted Synthetic Disease Modifying Anti-rheumatic Marketed Products
Figure 8: RA Therapeutics Market, Global, Pipeline, 2016
Figure 9: RA Therapeutics Market, Global, Pipeline by Molecular Target, 2016
Figure 10: RA Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2016
Figure 11: RA Therapeutics Market, APAC, Sirukumab Forecast ($m), 2018-2023
Figure 12: RA Therapeutics Market, APAC, Peficitinib Forecast ($m), 2019-2023
Figure 13: RA Therapeutics Market, APAC, Upadacitinib Forecast ($m), 2022-2023
Figure 14: RA Therapeutics Market, APAC, Filgotinib Forecast ($m), 2020-2023
Figure 15: RA Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products
Figure 16: RA Therapeutics Market, Competitor Matrix for RA Marketed and Pipeline Products, 2017
Figure 17: RA Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2016
Figure 18: RA Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2006-2016
Figure 19: RA Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2006-2016
Figure 20: RA Therapeutics Market, Global, Clinical Trial Size per Product by Stage of Development and Molecule Type, 2006-2016
Figure 21: RA Therapeutics Market, Global, Clinical Trial Duration by Molecular Target, 2006-2016
Figure 22: RA Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type, 2006-2016
Figure 23: RA Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target, 2006-2016
Figure 24: RA Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Type, 2006-2016
Figure 25: RA Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Target, 2006-2016
Figure 26: RA Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 27: RA Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target
Figure 28: RA Therapeutics Market, Asia Pacific, Treatment Usage Patterns (million), 2016-2023
Figure 29: RA Therapeutics Market, Asia Pacific, Market Size ($bn), 2016-2023
Figure 30: RA Therapeutics Market, India, Treatment Usage Patterns (’000), 2016-2023
Figure 31: RA Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023
Figure 32: RA Therapeutics Market, India, Market Size ($m), 2016-2023
Figure 33: RA Therapeutics Market, China, Treatment Usage Patterns (‘000), 2016-2023
Figure 34: RA Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023
Figure 35: RA Therapeutics Market, China, Market Size ($m), 2016-2023
Figure 36: RA Therapeutics Market, Australia, Treatment Usage Patterns (‘000), 2016-2023
Figure 37: RA Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023
Figure 38: RA Therapeutics Market, Australia, Market Size ($m), 2016-2023
Figure 39: RA Therapeutics Market, South Korea, Treatment Usage Patterns (‘000), 2016-2023
Figure 40: RA Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023
Figure 41: RA Therapeutics Market, South Korea, Market Size ($m), 2016-2023
Figure 42: RA Therapeutics Market, Japan, Treatment Usage Patterns (‘000), 2016-2023
Figure 43: RA Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023
Figure 44: RA Therapeutics Market, Japan, Market Size ($m), 2016-2023
Figure 45: RA Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017
Figure 46: RA Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017
Figure 47: RA Therapeutics Market, Global, Licensing Deals by Stage of Development, and Deal Value, 2006-2017
Figure 48: RA Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017
Figure 49: RA Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2017
Figure 50: RA Therapeutics Market, Global, Co-development Deals by Region and Deal Value, 2006-2017
Figure 51: RA Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017
Figure 52: RA Therapeutics Market, Global, Co-development Deals by Stage of Development, and Deal Value, 2006-2016
Figure 53: RA Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2017
Figure 54: Rheumatoid Arthritis Market, Global, Co-development Deals by Molecular Target, 2006-2017

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  • AbbVie
  • Amgen
  • Amgen
  • Daiichi Sankyo
  • Biogen Idec
  • Genentech
  • Bristol-Myers Squibb
  • Eli Lilly
  • Johnson & Johnson
  • Merck
  • Pfizer
  • Regeneron
  • Sanofi
  • Roche
  • UCB
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