Antibacterial Therapeutics – High levels of Pipeline Innovation Focused on the Increasing Unmet Need Associated with Antibiotic Resistance

Antibacterial resistance is currently believed to be responsible for over 700,000 deaths each year. As antibiotic resistance increases, due to the overuse and misuse of antibiotics, the number of avoidable deaths is expected to increase, with one study predicting there will be 10 million deaths caused by bacteria resistant to antibiotics in 2050.

There are several techniques being utilized to combat the spread of antibiotic resistance, which range from combining antibiotics to increase efficacy to reducing the use antibiotics in both humans and livestock.

However, significantly reducing the number of deaths caused by antibacterial resistance will require the development of new antibacterials that target infections caused by the most deadly and antibiotic resistant bacteria while acting on targets not currently utilized by marketed products in order to avoid cross resistance.

Without the development of innovate antibacterial products the emergence and spread of antibiotic resistance will not only increase the number of avoidable deaths caused by the infection itself, it also has the potential to increase the risks associated with surgery, while putting additional pressure on already stretched healthcare providers, as treating drug-resistant infections is considerably more expensive than treating drug-susceptible infections.

This report examines the entire antibacterial therapy area with a particular focus on four key indications, methicillin resistant staphylococcus aureus (MRSA), sepsis, pneumonia and tuberculosis, which were selected due to their pipeline size, prevalence and level of unmet need.

Scope

– The antibacterial pipeline is large, with 1,634 products in active development. Does current pipeline innovation hold the potential to affect the future antibacterial market?

– The four key indications in the antibacterial pipeline are tuberculosis, pneumonia, MRSA and sepsis. How does the composition of each pipeline compare both in terms of first-in-class and non-first-in-class innovation.

– There are 234 first-in-class products in the antibacterial pipeline. Which of these possess the greatest potential to improve disease outcome and be commercially successful, based on their target?

– Analysis of strategic consolidations and deals revealed a high level of activity between 2006 and 2017.

– A significant number of first-in-class products have been identified with no prior involvement in deals. How does deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy

- Appreciate the current clinical and commercial landscapes by considering disease symptoms, pathogenesis, etiology, co-morbidities and complications, epidemiology, diagnosis, prognosis and treatment options.

- Visualize the composition of the antibacterial therapeutics market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.

- Analyze the antibacterial pipeline and stratify by stage of development, molecule type and molecular target.

- Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, human first-in-class targets have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.

- Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals, which may represent potential investment opportunities.

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 Robust Pipeline Aims to Address Unmet Needs 5

2.2 High level of Innovation in the Sepsis and Tuberculosis Pipelines. 5

2.3 Opportunities to obtain innovative first-in-class products remain. 5

3 The Case for Innovation 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

3.6 Report Guidance 9

4 Clinical and Commercial Landscape 10

4.1 Therapy Area Overview 10

4.2 Symptoms 10

4.2.1 Pneumonia 10

4.2.2 MRSA 11

4.2.3 Sepsis 11

4.2.4 Tuberculosis 11

4.3 Diagnosis 11

4.4 Pathophysiology 15

4.5 Prognosis 17

4.5.1 Tuberculosis 17

4.5.2 Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections 17

4.5.3 Pneumonia 17

4.5.4 Sepsis 17

4.6 Treatment Options 18

4.6.1 Cell-Wall Synthesis Inhibitors 18

4.7 Overview of Marketed Products within Antibacterial Therapies 20

5 Assessment of Pipeline Product Innovation 21

5.1 Overview 21

5.2 Antibacterial Pipeline by Phase, Molecule Type and Molecular Target 21

5.2.1 Antibacterial Pipeline Overall 21

5.2.2 Key Antibacterial Indications 22

5.3 Pipeline by Molecular Target 24

5.3.1 Antibacterial Disease Overall 24

5.3.2 Key Antibacterial Indications 25

5.4 Comparative Distribution of Programs between the Antibacterial Therapeutics Market and Pipeline by Therapeutic Target Family 27

6 Signaling Pathways, and First-in-Class Molecular Target Integration. 36

6.1 The Complexity of Signaling Networks in Antibacterial therapies 36

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 36

6.3 First-in-Class Target Matrix Assessment 36

6.3.1 Sepsis 37

6.3.2 MRSA 38

6.3.3 Pneumonia 38

6.3.4 Tuberculosis 39

7 First-in-Class Target and Pipeline Program Evaluation 40

7.1 Pipeline Programs that Target Monocyte Differentiation Antigen CD14 40

7.2 Pipeline Programs that Target Toll-Like Receptor 3 41

7.3 Pipeline Programs that Target Gelsolin 42

7.4 Pipeline Programs that Target NACHT LRR and PYD Domains Containing Protein 3 44

7.5 Pipeline Programs that Target Low-affinity immunoglobulin gamma Fc region receptor IIa (CD32a) 45

7.6 Pipeline Programs that Target Triggering Receptor Expressed on Myeloid Cells 1 46

7.7 Pipeline Programs that Target Furin 48

7.8 Pipeline Programs that Target Angiopoietin 2 49

8 Deals and Strategic Consolidations 51

8.1 Industry-Wide First-in-Class Deals 51

8.2 Licensing Deals 52

8.2.1 Deals by Region, Value and Year 52

8.2.2 Deals by Stage of Development and Value 53

8.2.3 Deals by Molecule Type, Molecular Target and Value 54

8.2.4 Table for Licensing Deals with a Disclosed Value 55

8.3 Co-development Deals 56

8.4 List of First-in-Class Pipeline Products with and without Prior Deal Involvement 60

9 Appendix 66

9.1 References 66

9.2 Abbreviations 69

9.3 Disease List 70

9.3.1 Tuberculosis: 70

9.3.2 Pneumonia 70

9.3.3 MRSA 70

9.3.4 Sepsis: 70

9.4 Research Methodology 70

9.4.1 Data integrity 71

9.4.2 Innovative and meaningful analytical techniques and frameworks: 71

9.4.3 Evidence based analysis and insight: 71

9.5 Secondary Research 71

9.5.1 Market Analysis 71

9.5.2 Pipeline Analysis 71

9.5.3 First-in-Class Matrix Assessment 71

9.5.4 First-in-Class Target Profiles 72

9.5.5 Licensing and Co-Development Deals 72

9.6 Contact Us 73

9.7 Disclaimer 73

List of Tables

1.1 List of Tables

Table 1: Antibacterial Therapeutics, Quick-Sequential Oran Failure Assessment Test Criteria 12

Table 2: Antibacterial Therapeutics, Glasgow Coma Scale 12

Table 3: Antibacterial Therapeutics, Sequential Organ Failure Assessment score 13

Table 4: Antibacterial Therapeutics, Monocyte Differentiation Antigen CD14 as a Therapeutic Target, 2017 41

Table 5: Pipeline Programs Targeting Monocyte Differentiation Antigen CD14 41

Table 6: Antibacterial Therapeutics, Toll-Like Receptor 3 as a Therapeutic Target, 2017 42

Table 7: Pipeline Programs Targeting Toll-Like Receptor 3 42

Table 8: Antibacterial Therapeutics, Gelsolin as a Therapeutic Target, 2017 43

Table 9: Pipeline Programs Targeting Gelsolin 43

Table 10: Antibacterial Therapeutics NACHT LRR and PYD Domains Containing Protein 3 as a Therapeutic Target, 2017 45

Table 11: Pipeline Programs Targeting NACHT LRR and PYD Domains Containing Protein 3 45

Table 12: Antibacterial Therapeutics, Low-affinity immunoglobulin gamma Fc region receptor IIa as a Therapeutic Target, 2017 46

Table 13: Pipeline Programs Targeting Low-affinity immunoglobulin gamma Fc region receptor IIa 46

Table 14: Antibacterial Therapeutics, Triggering Receptor Expressed on Myeloid Cells 1s as a Therapeutic Target, 2017 47

Table 15:Pipeline Programs Targeting Triggering Receptor Expressed on Myeloid Cells 1 48

Table 16: Antibacterial Therapeutics, Furin as a Therapeutic Target, 2017 48

Table 17: Pipeline Programs Targeting Furin 49

Table 18: Antibacterial Therapeutics, Angiopoietin 2as a Therapeutic Target, 2017 50

Table 19: Pipeline Programs Targeting Angiopoietin 2 50

List of Figures

1.2 List of Figures

Figure 1: Antibacterial Therapeutics, US, Innovation Trends in Product Approvals, 1987-2014 6

Figure 2: Antibacterial Therapeutics. US. Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 8

Figure 3 : Antibacterial Therapeutics, Global, Molecule Types and Molecular Targets of Marketed Products, 2017 20

Figure 4: Antibacterial Therapeutics, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area 2017 21

Figure 5:Antibacterial Therapeutics, Global, Pipeline Products by Stage of Development and Molecule Type, 2017 22

Figure 6: Tuberculosis, Pneumonia, MRSA, and Sepsis, Global, Pipelines by Stage of Development, 2017 23

Figure 7: Tuberculosis, Pneumonia, MRSA, and Sepsis, Global, Pipelines by Molecule Type, 2017 24

Figure 8: Antibacterial Therapeutics, Global, Pipeline by Molecular Target, 2017 25

Figure 9: Tuberculosis, Pneumonia, MRSA, Sepsis, Global, Pipelines by Molecular Target, 2017 26

Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products, 2017 27

Figure 11: Antibacterial Therapeutics, Global, Pipeline by Molecular Target Class, First-in-Class Status and Stage of Development, 2017 28

Figure 12: Antibacterial Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Stage of Development (%), 2017 28

Figure 13: Antibacterial Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecule Type (%), 2017 29

Figure 14: Antibacterial Therapeutics Market, Global, Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Products by Molecular Target (%), 2017 29

Figure 15: Antibacterial Therapeutics Market, Global, Ratio of First-in-Class Products to First-in-Class Targets by Stage of Development and Molecular Target, 2017 30

Figure 16: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 1), 2017 31

Figure 17: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 2), 2017 32

Figure 18: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 3), 2017 33

Figure 19: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 4), 2017 33

Figure 20: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 5), 2017 34

Figure 21: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 6), 2017 34

Figure 22: Antibacterial Therapeutics, Global, First-in-Class Products in Pipeline (Part 7), 2017 35

Figure 23: Antibacterial Therapeutics, Global, First-in-class Human Targets, 2017 37

Figure 24: Sepsis, Global, First-in-class Targets, 2017 37

Figure 25: MRSA, Global, First-in-class Targets, 2017 38

Figure 26: Pneumonia, Global, First-in-class Targets, 2017 38

Figure 27: Tuberculosis, Global, First-in-class targets, 2017 39

Figure 28: Antibacterial Therapeutics, Global, Licensing Deals by Stage of Development, 2006-2015 51

Figure 29 :Pharmaceutical Industry, Global, Industry-Wide Licensing Deals by Deal Value, Upfront Payment Value, Stage of 52

Figure 30: Antibacterial Therapeutics, Global, Licensing Deals by Region and Value, 2006-2017 53

Figure 31: Antibacterial Therapeutics, Global, Licensing Deals by Stage and Value, 2006-2017 54

Figure 32: Antibacterial Therapeutics, Global, Licensing Deals by Molecular Target, 2006-2017 54

Figure 33: Antibacterial Therapeutics, Licensing Deals with Disclosed Values, 2006-2017, Part 1 55

Figure 34: Antibacterial Therapeutics, Licensing Deals with Disclosed Values, 2006-2017, Part 2 55

Figure 35: Antibacterial Therapeutics, Licensing Deals with Disclosed Values, 2006-2017, Part 3 56

Figure 36: Antibacterial Therapeutics, Global, Co-development Deals by Region and Value, 2006-2017 57

Figure 37: Antibacterial Therapeutics, Global, Co-development Deals by Stage and Value, 2006-2017 58

Figure 38: Antibacterial Therapeutics, Global, Co-development Deals by Molecule Type, 2006-2017 59

Figure 39: Antibacterial Therapeutics, Global, Co-development Deals with Disclosed Values, 2006-2017 60

Figure 40: Antibacterial Therapeutics, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 1) 61

Figure 41 :Antibacterial Therapeutics, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 2) 62

Figure 42: Antibacterial Therapeutics, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 3) 63

Figure 43: Antibacterial Therapeutics, Global, First-in-class Programs in Active Development Without Recorded Prior Deal Involvement, 2017 (Part 4) 64

Figure 44: Antibacterial Therapeutics, Global, First-in-class Programs in Active Development With Recorded Prior Deal Involvement, 2017 65

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