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

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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.

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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. 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.

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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?

Reasons to buy

• 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

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Executive Summary 5

2.1 Large Therapy Area Characterized by a High Degree of Pathophysiological Crossover 5

2.2 Strong Pipeline Shows High Level of Versatile Innovation 5

2.3 Substantial Deal Making Activity Observed over the Past Decade 5

3 The Case for Innovation in the Immunology Market 6

3.1 Growing Opportunities for Biologic Products 7

3.2 Diversification of Molecular Targets 7

3.3 Innovative First-in-Class Product Developments Remain Attractive 7

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8

3.5 Sustained Innovation 8

4 Introduction 9

4.1 Therapy Area Introduction 9

4.2 Symptoms 9

4.3 Etiology and Pathophysiology 9

4.3.1 Innate Immunity 9

4.3.2 Adaptive Immunity 10

4.3.3 The Role of Cytokines 11

4.3.4 Autoimmunity 11

4.3.5 Etiologic Factors for Autoimmunity and Allergies 12

4.3.6 Conclusion 12

4.4 Co-morbidities and Complications 13

4.5 Epidemiology 13

4.6 Treatment 14

4.6.1 Non-Biologic Disease-Modifying Anti-Rheumatic Drugs 15

4.6.2 Glucocorticoids 15

4.6.3 Biologics and Targeted Therapies 15

5 Pipeline Landscape Assessment 17

5.1 Overview 17

5.2 Pipeline Development Landscape 18

5.3 Molecular Targets in the Pipeline 19

5.4 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family 20

5.5 First-in-Class and Versatile Pipeline Programs 21

5.6 First-in-Class Immunology Products by Phase, Molecule Type and Molecular Target 23

5.7 Versatility of First-in-Class Pipeline Products 26

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