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Frontier Pharma: Rheumatoid Arthritis - Cytokine Mediators and Kinase Inhibitors Dominate First-in-Class Product Innovation

Frontier Pharma: Rheumatoid Arthritis - Cytokine Mediators and Kinase Inhibitors Dominate First-in-Class Product Innovation

Summary

Rheumatoid Arthritis (RA) is a chronic, progressive and currently incurable auto-immune disease that affects the joints, and is characterized by synovial inflammation and hyperplasia. It occurs when a number of aberrant cell signaling events trigger chronic inflammation of the synovium - the soft tissue of the joint - leading to pain, joint stiffness, and eventually deformity and disability.

With the disease affecting 0.3-1.0% of the global population, the societal and economic costs of RA are substantial. The large target patient population and the relatively high annual cost of therapy have resulted in a crowded, highly lucrative market.

Treatment options have improved and diversified substantially over the past two decades, largely owing to the advent of biologics. Despite this, considerable unmet needs remain within RA. Consequently, opportunities for future drug developments remain significant, particularly for first-in-class innovation, which is the area most likely to produce substantial clinical advances.

Scope

Treatment options for RA have advanced over the past two decades, resulting in a crowded, competitive market landscape.

  • What is the pathophysiology of RA?
  • Which products and therapeutic strategies dominate the clinical and commercial landscapes?
  • What are the most significant unmet needs within the RA market?
Considerable diversification from current market trends is evident within the RA pipeline.
  • Which molecular targets are most prominent within the pipeline?
  • What proportion of pipeline products are first in class?
  • Which first-in-class targets are most promising?
Deal values for licensing and co-development deals vary considerably.
  • How many strategic consolidations have been completed in the past decade?
  • Which types of assets attract the largest deal values?
  • Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?
Reasons to buy

This report will allow you to -
  • Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, diagnosis, and treatment options.
  • Visualize the composition of the RA landscape, including key unmet needs, in order to gain a competitive understanding of gaps in the current market.
  • Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, all first-in-class targets in the RA pipeline have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
  • Identify first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 A Crowded, Competitive Market, with Significant Unmet Needs Remaining
2.2 Early-Stage Pipeline Offers Greatest Promise for First-in-Class Innovation
2.3 Cytokine and Cytokine Receptors, as well as Protein Kinases, Largely Dominate First-in-Class Pipeline Products
3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Development Remains Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance
4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Disease Symptoms
4.3 Epidemiology
4.4 Etiology
4.5 Pathophysiology
4.6 Co-morbidities and Complications
4.7 Diagnosis
4.7.1 Blood Tests
4.7.2 1987 Rheumatoid Arthritis Classification
4.7.3 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis
4.8 Disease Progression
4.9 Treatment Options and Treatment Algorithm
4.10 Overview of Marketed Products in Rheumatoid Arthritis
4.10.1 Molecule Type and Molecular Target Analysis
5 Assessment of Pipeline Product Innovation
5.1 Rheumatoid Arthritis Pipeline by Stage of Development, Molecule Type and Molecular Target
5.2 Comparative Distribution of Programs between the Rheumatoid Arthritis Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Programs Targeting Novel Molecular Targets
6 Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks in Rheumatoid Arthritis
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment
7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5 (CD40)
7.2 Pipeline Programs Targeting Non-Receptor Tyrosine-Protein Kinase TYK2 (TYK2)
7.3 Pipeline Programs Targeting IL-10 and IL-18
7.4 Pipeline Programs Targeting 72 kDa Type IV Collagenase (MMP2)
7.5 Pipeline Programs Targeting P2X Purinoceptor 7 (P2RX7)
7.6 Pipeline Programs Targeting Protein Kinase C Theta Type (PRKCQ)
7.7 Pipeline Programs Targeting C-C Motif Chemokine 4 (CCL4) and C-C Motif Chemokine 5 (CCL5)
7.8 Pipeline Programs Targeting C-X-C Motif Chemokine 10 (CXCL10) and C-X-C Motif Chemokine 13 (CXCL13)
8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.3 Co-development Deals
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals
9 Appendix
9.1 References
9.2 Abbreviations
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-Development Deals
9.5 Contact Us
9.6 Disclaimer
1.1 List of Tables
Table 1: 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis, 2010
Table 2: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of Tumor Necrosis Factor Receptor Superfamily Member 5 (CD40), 2016
Table 3: Rheumatoid Arthritis, Global, Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5 (CD40), 2016
Table 4: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of Tyrosine-Protein Kinase TYK2 (TYK2), 2016
Table 5: Rheumatoid Arthritis, Global, Pipeline Programs Targeting Tyrosine-Protein Kinase TYK2 (TYK2), 2016
Table 6: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of Interleukin 18, 2016
Table 7: Rheumatoid Arthritis, Global, Pipeline Programs Targeting Interleukin 18, 2016
Table 8: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of Interleukin 10, 2016
Table 9: Rheumatoid Arthritis, Global, Pipeline Programs Targeting Interleukin 10, 2016
Table 10: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of 72 kDa type IV collagenase (MMP2), 2016
Table 11: Rheumatoid Arthritis, Global, Pipeline Programs Targeting 72 kDa type IV collagenase (MMP2), 2016
Table 12: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of P2X Purinoceptor 7 (P2RX7), 2016
Table 13: Rheumatoid Arthritis, Global, Pipeline Programs Targeting P2X Purinoceptor 7 (P2RX7), 2016
Table 14: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of Protein Kinase C Theta Type (PRKCQ), 2016
Table 15: Rheumatoid Arthritis, Global, Rheumatoid Arthritis, Global, Pipeline Programs Targeting Protein Kinase C Theta Type (PRKCQ), 2016
Table 16: Rheumatoid Arthritis, Global, Rheumatoid Arthritis, Global, Pipeline Programs Targeting C-C Motif Chemokine 4 (CCL4), 2016
Table 17: Rheumatoid Arthritis, Global, Rheumatoid Arthritis, Global, Pipeline Programs Targeting C-C Motif Chemokine 5 (CCL5), 2016
Table 18: Rheumatoid Arthritis, Global, Rheumatoid Arthritis, Global, Pipeline Programs Targeting C-C Motif Chemokine 4 (CCL4) and C-C Motif Chemokine 5 (CCL5), 2016
Table 19: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of C-X-C Motif Chemokine 10, 2016
Table 20: Rheumatoid Arthritis, Global, Pipeline Programs Targeting C-X-C Motif Chemokine 10, 2016
Table 21: Rheumatoid Arthritis, Global, Key Features and Pipeline Activity of C-X-C Motif Chemokine 13, 2016
Table 22: Rheumatoid Arthritis, Global, Pipeline Programs Targeting C-X-C Motif Chemokine 13 (CXCL13), 201
1.2 List of Figures
Figure 1: Rheumatoid Arthritis, US, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Product Approvals, 1987-2012 7
Figure 2: Rheumatoid Arthritis, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013 8
Figure 3: Rheumatoid Arthritis, Global, Marketed Products by Molecule Type and Molecular Target, 2016
Figure 4: Rheumatoid Arthritis, Global, Pipeline by Stage of Development and Molecule Type, 2016
Figure 5: Rheumatoid Arthritis, Global, Pipeline by Molecular Target and Stage of Development, 2016
Figure 6: Rheumatoid Arthritis, Global, Pipeline by Key Molecular Target Groups, 2016
Figure 7: Rheumatoid Arthritis, Global, Distribution of Molecular Targets Across Pipeline and Marketed Products, 2016
Figure 8: Rheumatoid Arthritis, Global, Distribution of Pipeline First-in-Class and Established Molecular Targets, 2016
Figure 9: Rheumatoid Arthritis, Global, Percentage Distribution of First-in-Class and Established Pipeline Products by Stage of Development (%), 2016
Figure 10: Rheumatoid Arthritis, Global, Percentage Distribution of First-in-Class and Established Pipeline Products by Molecular Target (%), 2016
Figure 11: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 1)
Figure 12: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 2)
Figure 13: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 3)
Figure 14: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 4)
Figure 15: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 5)
Figure 16: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 6)
Figure 17: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 7)
Figure 18: Rheumatoid Arthritis, Global, Pipeline Products, 2016 (part 8)
Figure 19: Rheumatoid Arthritis, Global, First-in-Class Molecular Target Matrix Assessment, 2016 (part 1)
Figure 20: Rheumatoid Arthritis, Global, First-in-Class Molecular Target Matrix Assessment, 2016 (part 2)
Figure 21: Rheumatoid Arthritis, Global, First-in-Class Molecular Target Matrix Assessment, 2016 (part 3)
Figure 22: Rheumatoid Arthritis, Global, Industry-Wide Deals by Stage of Development, 2006-2014
Figure 23: Rheumatoid Arthritis, Global, Industry-Wide Licensing Deals by Deal Value ($m), Upfront Payment Value ($m) and Stage of Development, 2006-2014
Figure 24: Rheumatoid Arthritis, Global, Licensing Deals by Region and Deal Value ($m), 2006-2016
Figure 25: Rheumatoid Arthritis, Global, Disclosed and Undisclosed Licensing Deals by Year, Total Disclosed Deal Value ($m) and Total Upfront Payment Value ($m), 2006-2015
Figure 26: Rheumatoid Arthritis, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016
Figure 27: Rheumatoid Arthritis, Frequency and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target, Global, 2006-2016
Figure 28: Rheumatoid Arthritis, Global, Co-development Deals by Region and Deal Value ($m), 2006-2016
Figure 29: Rheumatoid Arthritis, Global, Disclosed and Undisclosed Co-development Deals by Year, Total Disclosed Deal Value ($m) and Total Upfront Payment Value ($m), 2006-2015
Figure 30: Rheumatoid Arthritis, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016
Figure 31: Rheumatoid Arthritis, Global, Frequency and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target, 2006-2016
Figure 32: Rheumatoid Arthritis, Global, First-in-Class Programs with No Recorded Prior Deal Involvement, 2016 (part 1)
Figure 33: Rheumatoid Arthritis, Global, First-in-Class Programs with No Recorded Prior Deal Involvement, 2016 (part 2)

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