Global Antibacterial Drugs Market to 2022 – Vaccines Retain Market Prominence While Pipeline Offers Innovative Approaches to Tackling Antimicrobial Resistance

The antibacterial drug market covers the drugs used in the prophylaxis and treatment of bacterial infections. With a growing global concern over antimicrobial resistance and its progressive growth, there is a pronounced need for innovation within this market. This report considers the key developments in this market, with particular focus on drugs indicated for use in pneumonia, methicillin-resistant staphylococcus aureus (MRSA), sepsis and tuberculosis.

Drugs for the prevention of bacterial infections are typically vaccines, which help to train the body’s immune system to fight off specific infections, and can therefore help to prevent infections of certain bacterial strains. However, several prophylactic monoclonal antibodies are also currently in development.

Drugs for the treatment of bacterial infections are slightly more varied. Most common are beta-lactam antibiotics, which include the very widely prescribed penicillin. However, bacteria have developed resistance to penicillin by producing beta-lactamase enzymes that break open the beta-lactam ring found in these antibiotics, rendering them ineffective. As a result modern beta-lactams are frequently combination drugs of a beta-lactam and a beta-lactamase inhibitor.

In addition to beta-lactams there are several other classes of drugs used to treat bacterial infections. These include fluoroquinolones, which inhibit DNA gyrase and/or topoisomerase IV; and protein synthesis inhibitors, which have applications within the treatment of bacteria that are resistant to beta-lactam antibiotics. However, bacterial resistance has also developed against these drugs, and as such there is a gap in the market for a new generation of drugs that are effective against drug-resistant bacteria.

The antibacterial market is currently dominated by vaccines, in particular those for the prevention of pneumococcal infections, diphtheria, tetanus and pertussis. However, recent years have seen key additions in the form of therapies for antibiotic-resistant bacteria, including strains with multi-drug resistance. The number of such products is expected to increase drastically between 2016 and 2022.

Scope

Antibiotic resistance has caused a surge in the development of antibiotics:

– How big is the antibiotic pipeline?

– How are companies attempting to overcome antibiotic resistance?

The antibacterial drug market is forecast to rise from around $27.1 billion in 2015 to $35.6 billion in 2022:

– How much will the approval of new products and the patent expiries of existing ones contribute to this market growth?

– Will vaccines continue to drive market revenue?

The pipeline contains a range of molecular targets:

– Which molecular targets are most popular in the current pipeline?

– How many late-stage products are active against drug-resistant bacteria?

– What are the commercial prospects for the most promising late-stage pipeline products?

Big Pharma maintains a strong presence within the antibacterial drug market:

– Which of the leading companies are expected to have the highest share of the market by 2022?

– Which of the leading pharmaceutical companies are expected to bring new products to market during the forecast period?

– Which companies rely heavily of revenues derived from antibacterial drugs?

Reasons to buy

- Understand the current clinical and commercial landscape through a comprehensive analysis of innovation in the antibacterial drug market in the context of the overall pipeline and current market landscape. It also includes analysis of the deals landscape, including both licensing deals and co-development deals. Key indications covered in detail include pneumonia, MRSA, sepsis and tuberculosis.

- Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyze the antibacterial pipeline through a comprehensive review of the pipeline, segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at antibacterial drug clinical trials, to provide an insight into the risk associated with attempting to bring pipeline antibacterial drugs to market.

- Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patent expirations will influence market value.

- Identify the key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as sales forecasts for these products.

- Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from antibacterial products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.

- Assess the licensing and co-development deal landscape for antibacterial therapies.

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 10

2.1 Disease Cluster Introduction 10

2.2 Symptoms 11

2.2.1 Pneumonia 11

2.2.2 MRSA 11

2.2.3 Sepsis 11

2.2.4 Tuberculosis 11

2.3 Diagnosis 12

2.3.1 Pneumonia 12

2.3.2 MRSA 12

2.3.3 Sepsis 12

2.3.4 Tuberculosis 12

2.4 Etiology and Pathophysiology 13

2.4.1 Pneumonia 13

2.4.2 MRSA 14

2.4.3 Sepsis 15

2.4.4 Tuberculosis 15

2.5 Epidemiology 16

2.5.1 Pneumonia 16

2.5.2 MRSA 17

2.5.3 Sepsis 17

2.5.4 Tuberculosis 18

2.6 Comorbidities and Complications 18

2.6.1 Pneumonia 19

2.6.2 MRSA 19

2.6.3 Sepsis 19

2.6.4 Tuberculosis 19

2.7 Prognosis 19

2.7.1 Pneumonia 19

2.7.2 MRSA 20

2.7.3 Sepsis 20

2.7.4 Tuberculosis 20

2.8 Treatment 20

2.8.1 Beta-lactams 21

2.8.2 Protein Synthesis inhibitors 22

2.8.3 Vaccines 23

2.8.4 Other Classes of Antibacterial Therapy 23

3 Key Marketed Products 24

3.1 Overview 24

3.2 Cubicin (daptomycin) – Merck & Co 25

3.3 Augmentin – GlaxoSmithKline 27

3.4 Prevnar 13 – Pfizer 29

3.5 Infanrix – GlaxoSmithKline 30

3.6 Boostrix – GlaxoSmithKline 32

3.7 Zerbaxa – Merck and Co 33

3.8 Bexsero – GlaxoSmithKline 35

3.9 Zyvox – Pfizer 36

3.10 Conclusion 38

4 Pipeline Landscape Assessment 39

4.1 Overview 39

4.2 Pipeline Development Landscape 39

4.3 Mechanisms of Action in Pipeline 42

4.4 Clinical Trial Landscape 45

4.4.1 Failure Rate by Stage of Development, Indication and Molecule Type 46

4.4.2 Clinical Trial Duration by Stage of Development, Indication, and Molecule Type 50

4.4.3 Clinical Trial Size by Stage of Development, Indication and Molecule Type 53

4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication and Molecule Type 57

4.5 Conclusion 61

4.6 Assessment of Key Pipeline Products 61

4.6.1 Solithera – Cempra 61

4.6.2 Arikace – Insmed 62

4.6.3 Cadazolid – Actelion 63

4.6.4 Plazomicin (plazomicin sulfate) – Achaogen 64

4.6.5 V114 – Merck & Co. 65

4.6.6 Suvratoxumab (MEDI4893) – MedImmune 66

4.6.7 Pf-06290510 (SA4Ag vaccine) – Pfizer 67

4.6.8 PF-06425090 – Pfizer 68

4.6.9 Conclusion 69

5 Multi-Scenario Market Forecast to 2022 70

5.1 Overall Market Size 70

5.2 Generic Penetration 73

5.3 Revenue Forecast by Mechanism of Action 75

5.3.1 Immune Response 75

5.3.2 Bacterial Cell Wall Disruptor/Inhibitor 76

5.3.3 Protein Synthesis Inhibitors 77

5.3.4 DNA Inhibitors 78

5.3.5 Multiple Mechanisms of Action 79

6 Company Analysis and Positioning 80

6.1 Revenue and Market Share Analysis by Company 81

6.1.1 Pfizer – Will it Maintain its Position as Market Leader? 85

6.1.2 GlaxoSmithKline – Will Revenues for Key Products Continue to Grow Over Forecast Period? 86

6.1.3 Merck & Co – How Will Key Approvals and Patent Expiries Affect Revenue? 87

6.1.4 Allergan – Revenues to Rise Rapidly Following Market Entry 88

6.1.5 Cempra – Set to Enter the Market in 2017 89

6.1.6 Insmed – Set to Enter the Market in 2018 90

6.1.7 Otsuka – How Will the Approval of Deltyba Affect Otsuka’s Market Share? 91

6.1.8 Roche – Revenues to Continue to Decline Due to Lack of Pipeline Products 92

6.1.9 Bayer – Steady Decline as All Products Off-Patent 93

6.1.10 AstraZeneca – Set to Revitalize its Position within the Market 94

6.2 Company Landscape 95

6.3 Marketed and Pipeline Portfolio Analysis 96

7 Strategic Consolidations 99

7.1 Licensing Deals 99

7.1.1 Deals by Region, Value and Year 99

7.1.2 Deals by Indication 100

7.1.3 Deals by Stage of Development and Value 101

7.1.4 Deals by Molecule Type, Mechanism of Action and Value 103

7.1.5 Licensing Deals Valued Above $100m 104

7.2 Co-development Deals 105

7.2.1 Deals by Region, Value and Year 105

7.2.2 Deals by Indication 107

7.2.3 Deals by Stage of Development and Value 107

7.2.4 Deals by Molecule Type and Value 109

7.2.5 Co-development Deals Valued Above $100m 109

8 Appendix 111

8.1 References 111

8.2 Table of all Pipeline Products 115

8.3 Table of Epidemiology Forecast 171

8.4 Abbreviations 173

8.5 Methodology 175

8.5.1 Coverage 175

8.5.2 Secondary Research 175

8.5.3 Market Size and Revenue Forecasts 175

8.5.4 Pipeline Analysis 176

8.5.5 Competitive Landscape 176

8.6 Contact Us 177

8.7 Disclaimer 177

List of Tables

1.1 List of Tables

Table 1: Antibacterial Drug Market, Global, Key Marketed Products and Approved Indications, 2016 25

Table 2: Antibacterial Drug Market, Global, Approved Indications for Cubicin, 2016 26

Table 3: Antibacterial Drug Market, Global, Approved Indications for Augmentin, 2016 27

Table 4: Antibacterial Drug Market, Global, Approved Indications for Prevnar 13, 2016 29

Table 5: Antibacterial Drug Market, Global, Approved Indications for Infanrix, 2016 30

Table 6: Antibacterial Drug Market, Global, Approved Indications for Boostrix, 2016 32

Table 7: Antibacterial Drug Market, Global, Approved Indications for Zerbaxa, 2016 33

Table 8: Antibacterial Drug Market, Global, Approved Indications for Bexsero, 2016 35

Table 9: Antibacterial Drug Market, Global, Approved Indications for Zyvox, 2016 36

Table 10: Antibacterial Drug Market, Global, Annual Revenue Forecast for Key Products ($m), 2015–2022 72

Table 11: Antibacterial Drug Market, Global, Usage of Generics Across Key Indications, 2015 75

Table 12: Antibacterial Drug Market, Global, Forecast Revenues by Company, 2015–2022 82

Table 13: Antibacterial Drug Market, Global, Licensing Deals Valued Above $100m, 2006–2016 104

Table 14: Antibacterial Drug Market, Global, Co-development Deals Above $100m, 2006–2016 110

Table 15: Antibacterial Drug Market, Global, Pipeline Products, Discovery, 2016 115

Table 16: Antibacterial Drug Market, Global, Pipeline Products, Preclinical, 2016 133

Table 17: Antibacterial Drug Market, Global, Pipeline Products, IND/CTA-filed, 2016 158

Table 18: Antibacterial Drug Market, Global, Pipeline Products, Phase I, 2016 159

Table 19: Antibacterial Drug Market, Global, Pipeline Products, Phase II, 2016 163

Table 20: Antibacterial Drug Market, Global, Pipeline Products, Phase III, 2016 167

Table 21: Antibacterial Drug Market, Global, Pipeline Products,Pre-registration, 2016 170

Table 22: Antibacterial Drug Market, Global, Pipeline Products, Unknown, 2016 170

Table 23: Antibacterial Drug Market, Prevalence Patterns for Pneumonia, 2015–2022 171

Table 24: Antibacterial Drug Market, Vaccinations Patterns for Pneumonia, 2015–2022 171

Table 25: Antibacterial Drug Market, Prevalence Patterns for Sepsis, 2015–2022 172

Table 26: Antibacterial Drug Market, Prevalence Patterns for Tuberculosis, 2015–2022 172

Table 27: Abbreviations 173

List of Figures

1.2 List of Figures

Figure 1: Antibacterial Drug Market, Global, Epidemiology Patterns for Pneumonia Incidence, 2015–2022 16

Figure 2: Antibacterial Drug Market, Global, Epidemiology Patterns for Pneumococcal Vaccinations, 2015–2022 17

Figure 3: Antibacterial Drug Market, Global, Epidemiology Patterns for Sepsis, 2015–2022 18

Figure 4: Antibacterial Drug Market, Global, Epidemiology Patterns for Tuberculosis, 2015–2022 18

Figure 5: Antibacterial Drug Market, Global, Annual Revenue for Cubicin ($m), 2006–2022 27

Figure 6: Antibacterial Drug Market, Global, Annual Revenue for Augmentin ($m), 2006–2022 28

Figure 7: Antibacterial Drug Market, Global, Annual Revenue for Prevnar 13 ($bn), 2009–2022 30

Figure 8: Antibacterial Drug Market, Global, Annual Revenue for Infanrix ($bn), 2006–2022 31

Figure 9: Antibacterial Drug Market, Global, Annual Revenue for Boostrix ($m), 2006–2022 33

Figure 10: Antibacterial Drug Market, Global, Annual Revenue for Zerbaxa ($m), 2016–2022 34

Figure 11: Antibacterial Drug Market, Global, Annual Revenue for Bexsero ($m), 2015–2022 36

Figure 12: Antibacterial Drug Market, Global, Annual Revenue for Zyvox ($bn), 2006–2022 37

Figure 13: Antibacterial Drug Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016 39

Figure 14: Antibacterial Drug Market, Global, Pipeline by Stage of Development and Molecule Type, 2016 40

Figure 15: Antibacterial Drug Market, Global, Pipeline, Key Indications by Stage of Development, 2016 41

Figure 16: Antibacterial Drug Market, Global, Pipeline, Key Indications Molecule Type, 2016 42

Figure 17: Antibacterial Drug Market, Global, Overall Pipeline by Mechanism of Action, 2016 43

Figure 18: Antibacterial Drug Market, Global, Pipeline by Mechanism of Action and Stage of Development, 2016 44

Figure 19: Antibacterial Drug Market, Global, Pipeline for Key Bacterial Indications by Mechanism of Action, 2016 45

Figure 20: Antibacterial Drug Market, Global, Clinical Trial Failure Rates by Stage of Development (%), 2006–2016 46

Figure 21: Antibacterial Drug Market, Global, Clinical Trial Failure Rates by Stage of Development and Indication (%), 2006–2016 47

Figure 22: Antibacterial Drug Market, Global, Clinical Trial Failure Rates by Stage of Development and Molecule Type (%), 2006–2016 48

Figure 23: Antibacterial Drug Market, Global, Clinical Trial Failure Rates by Stage of Development and Mechanism of Action (%), 2006–2016 49

Figure 24: Antibacterial Drug Market, Global, Clinical Trial Duration by Stage of Development (months), 2006–2016 50

Figure 25: Antibacterial Drug Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006–2016 51

Figure 26: Antibacterial Drug Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006–2016 52

Figure 27: Antibacterial Drug Market, Global, Clinical Trial Duration by Stage of Development and Mechanism of Action (months), 2006–2016 53

Figure 28: Antibacterial Drug Market, Global, Clinical Trial Size by Stage of Development (participants), 2006–2016 54

Figure 29: Antibacterial Drug Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006–2016 54

Figure 30: Antibacterial Drug Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006–2016 55

Figure 31: Antibacterial Drug Market, Global, Clinical Trial Size by Stage of Development and Mechanism of Action (participants), 2006–2016 56

Figure 32: Antibacterial Drug Market, Global, Aggregate Clinical Program Size by Stage of Development (participants), 2006–2016 57

Figure 33: Antibacterial Drug Market, Global, Aggregate Clinical Program Size by Stage of Development and Indication (participants), 2006–2016 58

Figure 34: Antibacterial Drug Market, Global, Aggregate Clinical Program Size by Stage of Development and Molecule Type (participants), 2006–2016 59

Figure 35: Antibacterial Drug Market, Global, Aggregate Clinical Program Size by Stage of Development and Mechansim of Action(participants), 2006–2016 60

Figure 36: Antibacterial Drug Market, Global, Revenue Forecast for Solithera ($m), 2017–2022 62

Figure 37: Antibacterial Drug Market, Global, Revenue Forecast for Arikace ($m), 2018–2022 63

Figure 38: Antibacterial Drug Market, Global, Revenue Forecast for Cadazolid ($m), 2017–2022 64

Figure 39: Antibacterial Drugs Market, Global, Revenue Forecast for Plazomicin ($m), 2018–2022 65

Figure 40: Antibacterial Drug Market, Global, Revenue Forecast for V114 ($m), 2019–2022 66

Figure 41: Antibacterial Drugs Market, Global, Revenue Forecast for MEDI4893 ($m), 2019–2022 67

Figure 42: Antibacterial Drugs Market, Global, Revenue Forecast for Pf-06290510 ($m), 2018–2022 68

Figure 43: Antibacterial Drugs Market, Global, Revenue Forecast for Pf-06425090 ($m), 2018–2022 69

Figure 44: Antibacterial Drug Market, Global, Market Size ($bn), 2015–2022 71

Figure 45: Antibacterial Drug Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2015–2022 74

Figure 46: Antibacterial Drug Market, Global, Annual Revenue Forecast for Drugs That Modify the Immune Response ($bn), 2015–2022 76

Figure 47: Antibacterial Drug Market, Global, Annual Revenue Forecast for Bacterial Cell Wall Disruptors/Inhibitors ($bn), 2015–2022 77

Figure 48: Antibacterial Drug Market, Global, Annual Revenue Forecast for Protein Synthesis Inhibitors ($bn), 2015–2022 78

Figure 49: Antibacterial Drug Market, Global, Annual Revenue Forecast for DNA Inhibitors ($bn), 2015–2022 78

Figure 50: Antibacterial Drug Market, Global, Annual Revenue Forecast for Drugs With Multiple Mechanisms of Action ($bn), 2015–2022 79

Figure 51: Antibacterial Drug Market, Global, Cluster by Growth and Market Share, 2015–2022 80

Figure 52: Antibacterial Drug Market, Global, Company Analysis Matrix, 2016 81

Figure 53: Antibacterial Drug Market, Global, Forecast Market Share by Company (%), 2015–2022 83

Figure 54: Antibacterial Drugs Market, Global, Companies by Compound Annual Growth Rate (%), 2015–2022 84

Figure 55: Antibacterial Drug Market, Global, Revenues by Product Type, 2015–2022 85

Figure 56: Antibacterial Drug Market, Global, Pfizer Annual Revenue Forecast, 2015–2022 86

Figure 57: Antibacterial Drug Market, Global, GlaxoSmithKline Annual Revenue Forecast, 2015–2022 87

Figure 58: Antibacterial Drug Market, Global, Merck & Co Annual Revenue Forecast, 2015–2022 88

Figure 59: Antibacterial Drug Market, Global, Allergan Annual Revenue Forecast, 2015–2022 89

Figure 60: Antibacterial Drug Market, Global, Cempra Annual Revenue Forecast, 2015–2022 90

Figure 61: Antibacterial Drug Market, Global, Insmed Annual Revenue Forecast, 2015–2022 91

Figure 62: Antibacterial Drug Market, Global, Otsuka Annual Revenue Forecast, 2015–2022 92

Figure 63: Antibacterial Drug Market, Global, Roche Annual Revenue Forecast, 2015–2022 93

Figure 64: Antibacterial Drug Market, Global, Bayer Annual Revenue Forecast, 2015–2022 94

Figure 65: Antibacterial Drug Market, Global, AstraZeneca Annual Revenue Forecast, 2015–2022 95

Figure 66: Antibacterial Drug Market, Global, Companies by Type, 2016 96

Figure 67: Antibacterial Drug Market, Global, Pipeline, Overall, High-Activity and Late-Stage Developers by Level of Specialization, 2016 97

Figure 68: Antibacterial Drug Market, Global, Proportion of Total Company Revenue Attributed to Antibacterial Disease, 2015–2022 98

Figure 69: Antibacterial Drugs Market, Global, Licensing Deals by Region, Value and Year, 2006–2016 100

Figure 70: Antibacterial Drug Market, Global, Licensing Deals by Indication, 2006–2016 101

Figure 71: Antibacterial Drug Market, Global, Licensing Deals by Stage of Development and Value, 2006–2016 102

Figure 72: Antibacterial Drug Market, Global, Licensing Deals by Molecule Type, Mechanism of Action and Aggregate Deal Value, 2006–2016 103

Figure 73: Antibacterial Drug Market, Global, Co-development Deals by Region, Value and Year, 2006–2016 106

Figure 74: Antibacterial Drug Market, Global, Co-development Deals by Indication and Value, 2006–2016 107

Figure 75: Antibacterial Drug Market, Global, Co-development Deals by Stage of Development and Value, 2006–2016 108

Figure 76: Antibacterial Drug Market, Global, Co-development Deals by Molecule Type, Mechanism of Action and Aggregate Deal Value, 2006–2016 109

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