PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria



Summary



Since their discovery almost a century ago, antibiotics have revolutionized the global healthcare industry by ushering in an era of significantly reduced morbidity and mortality associated with often-lethal bacterial infections. However, the increasing threat posed by multidrug-resistant (MDR) bacteria, in particular gram-negative organisms, has cast a shadow over these remarkable public health achievements. GlobalData’s primary research indicates that this high level of unmet need has generated several opportunities for firms seeking access to the market in the US or 5EU. Public and private entities have also launched initiatives to make antibiotic R&D an attractive therapy area. GlobalData anticipates that a mixture of push, pull, and hybrid mechanisms will encourage progress through all stages of antibiotic development. Increased flexibility from the FDA and EMA is also expected to decrease barriers to entry for drugs targeting MDR gram-negative bacteria. GlobalData believes that a partnership approach, involving academia, small and medium enterprises, and Big Pharma, is the best strategy for companies hoping to leverage these incentives to gain access to the market.

Highlights

Key Questions Answered

- What are the main unmet needs associated with treating drug-resistant gram-negative bacterial infections?
- What opportunities can companies exploit to gain access to the US and 5EU markets?
- What incentive mechanisms and programs can companies leverage to fund their antibiotic R&D?
- How is the changing regulatory landscape at the FDA and EMA going to affect the review of antibiotics for MDR gram-negative bacterial infections?
- What advantages does the public-private partnership approach to antibiotic R&D have over the traditional business plan for antibiotics?

Key Findings

- The escalating need for therapies against MDR gram-negative bacteria has created opportunities that can be leveraged to enter the marketplace in both the US and 5EU.
- Incentive initiatives, such as the Generating Antibiotics Incentives Now (GAIN) Act, are making antibiotics an attractive therapy area.
- The FDA and EMA have both expressed and demonstrated a willingness to increase their flexibility regarding clinical trial design and endpoints.
- The partnership approach to antibiotic R&D, which involves collaboration between academia, small and medium enterprises, and Big Pharma, is replacing the solo approach traditionally used by companies.



Scope


- Overview of incentive mechanisms and programs designed to encourage antibiotic R&D, current regulatory trends, and the role of academia, small and medium enterprises and Big Pharma in bringing next-generation antibiotics to market.
- Key topics covered include unmet needs, opportunities, and the emergence of public-private partnerships in the market for antibiotics targeting multidrug-resistant gram-negative bacteria.
- Analysis of the key industry drivers, restraints and challenges in the US and 5EU. Each trend is independently researched to provide qualitative analysis of its implications.



Reasons to buy


- Develop and design your market access strategy through a review of clinical and commercial unmet needs as well as regulatory trends related to gram-negative antibiotics.
- Develop business strategies by understanding the trends shaping and driving the gram-negative antibiotics market in the US and 5EU.
- Drive revenues by understanding the key trends and opportunities likely to impact the US and 5EU gram-negative antibiotics markets.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

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 RandD 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

List of Tables


Table 1: MDR Gram-Negative Infections - Drivers and Barriers, 2013 13
Table 2: 6MM Unmet Needs - Current Level of Attainment 39
Table 3: Push Incentives Overview 61
Table 4: Pull Incentives Overview 66
Table 5: Hybrid Incentives Overview 69
Table 6: Role of Big Pharma in Antibiotic RandD 90
Table 7: Role of Academic and SME Entities in Antibiotic RandD 92
Table 8: Role of Government Agencies in Antibiotic RandD 95

List of Figures

Figure 1: Opportunity Analysis - Clinical and Commercial Impact 50
Figure 2: Outline of Push and Pull Incentives for Antibiotic Development 59
Figure 3: Regulatory Trends in Antibiotic Drug Development 74
Figure 4: Traditional and Partnership Business Models in Antibiotic RandD 87

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