Frontier Pharma: Versatile Innovation in Immunology - Large Therapy Area Pipeline with a High Degree of Repositioning Potential

  • ID: 4061450
  • Report
  • Region: Global
  • 80 Pages
  • GBI Research
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This Disease Area has a Total of 2,145 Products in Active Development, Trailing Only Oncology, Infectious Diseases and Central Nervous System Disorders in Terms of Pipeline Size
Immunology is one of the largest therapy areas, with a total of 2,145 products in active development, trailing only oncology, infectious diseases and central nervous system disorders in terms of pipeline size. There are a total of 539 immunology pipeline products that act on a first-in-class molecular target, representing 40% of the total immunology pipeline for which the molecular target was disclosed.

Immunology is a therapy area characterized by disorders of the immune system, specifically an aberrant immune response against healthy tissues present in the body, leading to chronic or acute inflammation. Depending on the specific site affected, this can lead to various types of chronic pain and loss of mobility, and have a negative impact on quality of life.

The immune system is highly complex and has a high degree of functional redundancy. For example, the functions of cytokines and chemokines, which serve as endogenous systemic chemical messengers for the immune system, are overlapping and often incompletely characterized. While this presents numerous molecular targets for potential pharmaceutical intervention across multiple diseases, it also creates difficulty in selecting the appropriate target or combination of targets for these drugs.

There are a total of 253 distinct first-in-class molecular targets in development, of which 65 were found to be in development across multiple indications. Cytokines and intracellular signal transducers were strongly represented amongst the most promising versatile first-in-class molecular targets.

Between 2006 and 2016, a total of 497 licensing deals and 433 co-development deals in the immunology therapy area were identified as having been completed, with a combined aggregate value of US$46 billion. This high level of deal-making activity is indicative of a strong willingness on the part of pharmaceutical companies to engage in strategic consolidations in order to mitigate some of the risks associated with drug development in the immunology therapy area.

The report “Frontier Pharma: Versatile Innovation in Immunology - Large Therapy Area Pipeline with a High Degree of Repositioning Potential” helps you to understand the current standard of treatment across these markets, and what lessons can be learned by companies seeking to innovate and build on these products, also helps to identify current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options and leading products and companies within the market, as well as key unmet needs, in order to gain a competitive understanding of gaps in the market.

Additionally, it will insights to review key pipeline trends by analyzing therapies by stage of development, molecule type and molecular target, and identify key trends regarding innovation within each segment and identify promising first-in-class pipeline assets that have had no prior involvement in licensing or co-development deals, and are therefore potentially suitable for in-licensing.
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1 Table of Contents

2 Executive Summary
2.1 Large Therapy Area Characterized by a High Degree of Pathophysiological Crossover
2.2 Strong Pipeline Shows High Level of Versatile Innovation
2.3 Substantial Deal Making Activity Observed over the Past Decade

3 The Case for Innovation in the Immunology Market
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation

4 Introduction
4.1 Therapy Area Introduction
4.2 Symptoms
4.3 Etiology and Pathophysiology
4.3.1 Innate Immunity
4.3.2 Adaptive Immunity
4.3.3 The Role of Cytokines
4.3.4 Autoimmunity
4.3.5 Etiologic Factors for Autoimmunity and Allergies
4.3.6 Conclusion
4.4 Co-morbidities and Complications
4.5 Epidemiology
4.6 Treatment
4.6.1 Non-Biologic Disease-Modifying Anti-Rheumatic Drugs
4.6.2 Glucocorticoids
4.6.3 Biologics and Targeted Therapies

5 Pipeline Landscape Assessment
5.1 Overview
5.2 Pipeline Development Landscape
5.3 Molecular Targets in the Pipeline
5.4 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family
5.5 First-in-Class and Versatile Pipeline Programs
5.6 First-in-Class Immunology Products by Phase, Molecule Type and Molecular Target
5.7 Versatility of First-in-Class Pipeline Products

6 Immunology Signaling Network, Disease Causation and Innovation Alignment
6.1 Complexity of Signaling Networks
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Matrix Assessment

7 First-in-Class Target and Pipeline Program Evaluation
7.1 Pipeline Programs Targeting Toll-Like Receptors 3, 6 and 8
7.2 Pipeline Programs Targeting Spleen Tyrosine Kinase
7.3 Pipeline Programs Targeting IL-7R
7.4 Pipeline Programs Targeting C-C Chemokine Receptor Type 6
7.5 Pipeline Programs Targeting P2RX7
7.6 Pipeline Programs Targeting ITK
7.7 Pipeline Programs Targeting IRAK4
7.8 Pipeline Programs Targeting Orai1
7.9 Pipeline Programs Targeting Tumor Necrosis Factor Receptor Superfamily Member 5
7.10 Conclusion

8 Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.2.1 Deals by Region, Year and Value
8.2.2 Deals by Stage of Development and Value
8.2.3 Deals by Molecule Type and Value
8.2.4 Deals by Molecular Target and Value
8.3 Co-development Deals
8.3.1 Deals by Region, Year and Value
8.3.2 Deals by Stage of Development and Value
8.3.3 Deals by Molecule Type and Value
8.3.4 Deals by Molecular Target and Value
8.4 List of First-in-Class Pipeline Products with and Without Prior Deal Involvement

9 Appendix
9.1 Abbreviations
9.2 References
9.3 Research Methodology
9.3.1 Data integrity
9.3.2 Innovative and meaningful analytical techniques and frameworks
9.3.3 Evidence based analysis and insight
9.4 Secondary Research
9.4.1 Market Analysis
9.4.2 Pipeline Analysis
9.4.3 Licensing and Co-development Deals

List of Tables

Table 1: Versatile Innovation in Immunology, Global, Epidemiology of Inflammatory Immunological Disorders, 2015
Table 2: Versatile Innovation in Immunology, Global, Toll-Like Receptors and their Known Ligands, 2016
Table 3: Versatile Innovation in Immunology, Global, Key Features of TLR3, 2016
Table 4: Versatile Innovation in Immunology, Global, Key Features of TLR6, 2016
Table 5: Versatile Innovation in Immunology, Global, Key Features of TLR8, 2016
Table 6: Versatile Innovation in Immunology, Global, Key Features of Syk, 2016
Table 7: Versatile Innovation in Immunology, Global, Key Features of IL-7R, 2016
Table 8: Versatile Innovation in Immunology, Global, Key Features of C-C Chemokine Receptor Type 6, 2016
Table 9: Versatile Innovation in Immunology, Global, Key Features of P2RX7, 2016
Table 10: Versatile Innovation in Immunology, Global, Key Features of ITK, 2016
Table 11: Versatile Innovation in Immunology, Global, Key Features of IRAK4, 2016
Table 12: Versatile Innovation in Immunology, Global, Key Features of Orai1, 2016
Table 13: Versatile Innovation in Immunology, Global, Key Features of Tumor Necrosis Factor Receptor Superfamily Member 5 , 2016

List of Figures

Figure 1: Versatile Innovation in Immunology, US, Innovation Trends in Product Approvals, 1987-2014
Figure 2: Versatile Innovation in Immunology, US, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013
Figure 3: Versatile Innovation in Immunology, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area and Breakdown of Immunology Pipeline by Indication, 2016
Figure 4: Versatile Innovation in Immunology, Global, Pipeline for Immunology by Stage of Development and Molecule Type, 2016
Figure 5: Versatile Innovation in Immunology, Global, Pipeline for Immunology by Molecular Target, 2016
Figure 6: Versatile Innovation in Immunology, Global, Pipeline and Marketed Products for Immunology by Molecular Target Category, 2016
Figure 7: Versatile Innovation in Immunology, Global, Overall Pharmaceutical Industry First-in-Class Pipeline by Therapy Area and Breakdown of Immunology First-in-Class Pipeline by Indication, 2016
Figure 8: Versatile Innovation in Immunology Therapeutics Market, Global, First-in-Class Pipeline for Immunology by Stage of Development and Molecule Type, 2016
Figure 9: Versatile Innovation in Immunology, Global, First-in-Class Pipeline for Immunology by Molecular Target, 2016
Figure 10: Versatile Innovation in Immunology, Global, Pipeline for Immunology by First-in-Class Status and Molecular Target Class, 2016
Figure 11: Versatile Innovation in Immunology, Global, Distribution of First-in-Class and Established Products by Stage of Development (%), 2016
Figure 12: Versatile Innovation in Immunology, Global, Distribution of First-in-Class and Established Products by Molecular Target Class (%), 2016
Figure 13: Versatile Innovation in Immunology, Global, First-in-Class Immunology Pipeline Products by Number of Indications, 2016
Figure 14: Versatile Innovation in Immunology, Global, Pipeline for Key Immunology Indications by Molecular Target, 2016
Figure 15: Versatile Innovation in Immunology, Global, Versatile Pipeline for Immunology by Stage of Development and Molecule Type, 2016
Figure 16: Versatile Innovation in Immunology, Global, Versatile First-in-Class Pipeline Immunology by Molecular Target, 2015
Figure 17: Versatile Innovation in Immunology, Global, First-in-Class Pipeline for Immunology by Versatile Status and Molecular Target Class, 2016
Figure 18: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 1), 2016
Figure 19: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 2), 2016
Figure 20: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 3), 2016
Figure 21: Versatile Innovation in Immunology, Global, First-in-class Pipeline for Immunology Indications (Part 4), 2016
Figure 22: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 1)
Figure 23: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 2)
Figure 24: Versatile Innovation in Immunology, Global, First-in-Class Matrix, 2016 (part 3)
Figure 25: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR3, 2016
Figure 26: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR6, 2016
Figure 27: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting TLR8, 2016
Figure 28: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Syk, 2016
Figure 29: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting IL-7R, 2016
Figure 30: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting C-C Chemokine Receptor Type 6, 2016
Figure 31: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting P2RX7, 2016
Figure 32: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting ITK, 2016
Figure 33: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting IRAK4, 2016
Figure 34: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Orai1, 2016
Figure 35: Versatile Innovation in Immunology, Global, Pipeline Programs Targeting Tumor necrosis factor receptor superfamily member 5 , 2016
Figure 36: Versatile Innovation in Immunology, Global, Licensing Deals by Stage of Development, 2006-2015
Figure 37: Versatile Innovation in Immunology, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of Development and First-in-Class Status ($m), 2006-2015
Figure 38: Versatile Innovation in Immunology, Global, Licensing Deals by Region, Value and Year, 2006-2016
Figure 39: Versatile Innovation immunology, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
Figure 40: Versatile Innovation in Immunology, Global, Licensing Deals by Molecule Type, 2006-2016
Figure 41: Immunology, Global, Licensing Deals by Molecular Target, 2006-2016
Figure 42: Versatile Innovation in Immunology, Global, Licensing Deals Valued Above $100m, 2006-2016
Figure 43: Versatile Innovation in Immunology, Global, Co-development Deals by Region, Value and Year, 2006-2016
Figure 44: Immunology, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2016
Figure 45: Versatile Innovation in Immunology, Global, Co-development Deals by Molecule Type, 2006-2016
Figure 46: Versatile Innovation in Immunology, Global, Co-development Deals by Molecular Target, 2006-2016
Figure 47: Versatile Innovation in Immunology, Global, Co-development Deals Valued Above $100m, 2006-2016
Figure 48: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016
Figure 49: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016
Figure 50: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement, 2016
Figure 51: Versatile Innovation in Immunology, Global, List of First-in-Class Pipeline Products with and Without Prior Deal Involvement,

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