PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
2.3 Upcoming Related Reports 11
3 Market Drivers and Barriers 12
3.1 Overview 12
3.2 Drivers 14
3.2.1 Driver: Increase in the Incidence of MDR Gram-Negative Bacterial Infections 14
3.2.2 Driver: Higher Pricing of Novel Antibiotics 15
3.2.3 Driver: A Rising Awareness of the Need for Novel Antibiotics 17
3.2.4 Driver: Economic Incentive Programs for Antibiotic Development 18
3.2.5 Driver: Regulatory Reform and Clinical Trial Redesign 19
3.2.6 Driver: Publically-Funded Resources or Partnerships (PPPs) 21
3.2.7 Driver: Improved Diagnostic Tools 22
3.2.8 Driver: Efforts to Decrease Overall Healthcare Costs 24
3.3 Barriers 25
3.3.1 Barrier: Low ROI Compared with Other Therapy Areas 25
3.3.2 Barrier: Difficulty Developing Truly Novel Antibiotics 26
3.3.3 Barrier: Antibiotic Stewardship 28
3.3.4 Barrier: Limited Awareness of the Threat Posed by Drug-Resistant Bacteria 29
3.3.5 Barrier: Convoluted, Shifting Regulatory Requirements 31
3.3.6 Barrier: Regulatory Bureaucracy 32
3.3.7 Barrier: Cost-Conscious Governments 34
3.3.8 Barrier: Movement Towards Preventative Care 35
3.3.9 Barrier: Competition from Cheap, Generally-Effective Generics 36
4 Unmet Needs Assessment and Opportunity Analysis 38
4.1 Unmet Needs Overview 38
4.1.1 Unmet Need: Antibiotics that Treat MDR Gram-Negative Infections 40
4.1.2 Unmet Need: Antibiotics with Novel Mechanisms of Action Targeted at Specific Pathogens 41
4.1.3 Unmet Need: Accurate, Rapid, and Inexpensive Diagnostic Tools 43
4.1.4 Unmet Need: Increase Awareness of the Threat Posed by Antibiotic Resistance 45
4.1.5 Unmet Need: Streamlined Treatment Guidelines or Global Approaches to Combat Resistance 47
4.2 Opportunities Overview 49
4.2.1 Opportunity: Screen Molecules in an Environment Similar to the Infection Site 51
4.2.2 Opportunity: Biologicals as Antibiotics 52
4.2.3 Opportunity: Leveraging Novel Diagnostics to Achieve and Maintain Commercial Success 54
4.2.4 Opportunity: Enhancing the Activity of Existing Antibiotics Against MDR Infections 55
4.2.5 Opportunity: Probiotics and Natural Flora 56
5 Incentives for Antibiotic Development 58
5.1 Overview 58
5.2 Push Incentives 61
5.2.1 Overview 61
5.2.2 Advantages 63
5.2.3 Disadvantages 63
5.3 Pull Incentives 65
5.3.1 Overview 65
5.3.2 Advantages 67
5.3.3 Disadvantages 67
5.4 Combination and Hybrid Incentives 69
5.4.1 Overview 69
5.4.2 Advantages 70
5.4.3 Disadvantages 71
6 Current Regulatory Trends 72
6.1 Overview of Regulatory Trends 72
6.1.1 Increased Pragmatism Regarding Clinical Trial Endpoints 76
6.1.2 Recognition of Preclinical-Clinical Activity Correlation (PK/PD) 78
6.1.3 Escalating Value of Microbiological Diagnostics 79
6.1.4 More Practical Risk-Benefit Assessment 80
6.1.5 Establishing an FDA-EMA Regulatory Accord for Antibiotics 82
7 The Need for an Alternative Approach to Antibiotic R&D 84
7.1 Overview 84
7.1.1 The Traditional Approach 84
7.1.2 The Partnership Approach 86
7.2 Stakeholders 89
7.2.1 The Role of Big Pharma 89
7.2.2 The Role of Academia and SMEs 91
7.2.3 The Role of Government 94
8 Appendix 97
8.1 Bibliography 97
8.2 Abbreviations 104
8.3 Physicians and Specialists Included in this Study 107
8.4 About the Authors 111
8.4.1 Authors 111
8.4.2 Reviewer 112
8.4.3 Global Head of Healthcare 112
8.5 About GlobalData 113
8.6 Disclaimer 113