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

  • ID: 3822826
  • Report
  • Region: Global
  • 66 pages
  • GBI Research
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Unmet needs in rheumatoid arthritis treatment could be addressed by first-in-class pipeline
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.

In particular, the diversification in pharmaceutical therapeutics has led to a transformation in both the clinical and commercial landscape, with the advent of biologic agents. These therapies have greatly improved treatment options for a large proportion of patients who respond inadequately, are intolerant or have contraindications to first-line treatments such as methotrexate (MTX).

Tumor necrosis factor (TNF)-a targeting biologics have proved to be particularly lucrative. Humira (adalimumab), Enbrel and Remicade (infliximab) are all well-established mega-blockbusters, and in 2015 generated global revenue of $14.4 Billion, $9.3 Billion and $9.2 Billion, respectively.

The RA pipeline is relatively large, containing 454 products. The proportion of first-in-class products in the pipeline is marginally lower than the industry average, but despite this it contains many promising first-in-class targets that have the potential to lead to therapeutic advances. In particular, there is a higher proportion and diversity of first-in-class molecular targets in the early development stages than in the clinical trial development stages.

While the RA pipeline largely constitutes developmental therapeutics with established molecular targets, a range of highly innovative developments have also emerged, with molecular targets that have not been reported for any marketed product across any indication in the industry. This reflects a growing understanding of the signaling pathways underlying RA pathophysiology.

The report “Frontier Pharma: Rheumatoid Arthritis - Cytokine Mediators and Kinase Inhibitors Dominate First-in-Class Product Innovation” provides you to identify the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, diagnosis, and treatment options. Additionally, this report Visualize the composition of the RA landscape, including key unmet needs, in order to gain a competitive understanding of gaps in the current market and helps you to recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.

Companies mentioned in this report: Boehringer Ingelheim, Novartis, Sareum, Portola Pharmaceuticals, AB2 Bio, Pfizer, Xalud Therapeutics, Weizmann Institute of Science, Medestea Research & Production, Astellas, Radikal Therapeutics, Metabolab, Jyant Technologies, Vaccinex.
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1 Table of Contents
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 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), 2016

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
Figure 2: Rheumatoid Arthritis, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval ($m), 2006-2013
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) 58
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Unmet needs in rheumatoid arthritis treatment could be addressed by first-in-class pipeline.

The rheumatoid arthritis market is highly lucrative and significant advances in the understanding of the disease have greatly improved treatment options for a large number of patients over the past two decades. However, serious unmet needs remain, and there are still many opportunities for future drug developments, particularly for first-in-class innovation, according to the publisher.

The company’s latest report states that rheumatoid arthritis remains an incurable condition with no therapeutics that directly act to restore bone content and reduce cartilage degradation. Safety, often concerning elevated infection as a result of immunosuppression, remains a concern, while many patients respond inadequately or eventually develop resistance to first- and second-line therapies. In addition, biologics require either intravenous or subcutaneous administration, which is often inconvenient and painful for patients.

One of our analysts explains: “The current disease pipeline is relatively large, containing 454 products. While the proportion of first-in-class products in the pipeline is marginally lower than the industry average, it contains many first-in-class targets that have the potential to lead to therapeutic advances. In particular, there is a higher proportion and diversity of first-in-class molecular targets in the early development stages than in the clinical trial development stages.

“This is an encouraging trend, revealing sustained research and development in rheumatoid arthritis. Nonetheless, limited first-in-class innovation at the later development stages suggests that the therapeutic landscape will continue to be dominated by currently marketed products in the near future.”

Our report also states that in terms of types of first-in-class products in the pipeline, cytokine and cytokine receptors, as well as protein kinases, largely dominate. Most first-in-class products targeting cytokines and their receptors are biologic therapies, and target a range of mediators that underlie inflammatory and adaptive immune responses in rheumatoid arthritis.
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