Frontier Pharma: Versatile Innovation in Immunology - Large Therapy Area Pipeline with a High Degree of Repositioning Potential
Summary
Immunology is a large 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.
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. There are a total of 529 immunology pipeline products that act on first-in-class molecular targets, representing approximately 40% of the total immunology pipeline for which the molecular target was disclosed.
Due to a degree of crossover between immunology indications in terms of their underlying pathophysiology, it is not uncommon for products being developed for this therapy area to have developmental programs testing them across multiple indications.
Approximately one-fifth of first-in-class pipeline products are in development for two or more indications within the therapy area. This presents an opportunity for companies to develop innovative products across multiple immune disorders, and therefore reach a larger pool of patients than products developed for single indications.
Scope
- What are the key points of overlap in the pathophysiology of immune disorders?
- What is the current standard of treatment across these markets, and what lessons can be learned by companies seeking to innovate and build on these products?
- Which molecule types and molecular targets are most prominent within the pipeline?
- Which first-in-class targets are most promising?
- Do immunology products attract high deal values, and which specific product types are able to attract the highest values?
- Which molecule types and molecular targets dominate the deals landscape?
- Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, co-morbidities and complications, and treatment options.
- Identify 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. 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.
- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, all first-in-class targets in the immunology pipeline have been assessed and ranked according to clinical potential, and the most promising early-stage targets have been further reviewed in greater detail.
- 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.
- 1 Table of Contents
- 1.1 List of Tables
- 1.2 List of Figures
- 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
- 9.5 Contact Us
- 9.6 Disclaimer
- 1.1 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
- 1.2 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, 2016
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