|By PR Newswire||
|February 26, 2014 12:36 PM EST||
LONDON, Feb. 26, 2014 /PRNewswire/ -- Reportbuyer.com just published a new market research report:
PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria
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.
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?
- 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.
- 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.
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
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 R&D 90
Table 7: Role of Academic and SME Entities in Antibiotic R&D 92
Table 8: Role of Government Agencies in Antibiotic R&D 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 R&D 87
Read the full report:
PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Dec. 1, 2015 11:45 AM EST Reads: 471
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Dec. 1, 2015 11:45 AM EST Reads: 368
Actifio is powering new application development and testing services from Net3 Technologies (N3T), a managed cloud services provider. N3T's new Symmetry DevOps™ service builds on its existing Palmetto Virtual Data Center (PvDC) Cloud services for data backup and disaster recovery (DR) based on the Actifio Copy Data Virtualization platform. Previously, N3T's data protection and DR services were challenged by overlapping and inefficient legacy hardware and software platforms from multiple vendo...
Dec. 1, 2015 11:30 AM EST
Most of the IoT Gateway scenarios involve collecting data from machines/processing and pushing data upstream to cloud for further analytics. The gateway hardware varies from Raspberry Pi to Industrial PCs. The document states the process of allowing deploying polyglot data pipelining software with the clear notion of supporting immutability. In his session at @ThingsExpo, Shashank Jain, a development architect for SAP Labs, discussed the objective, which is to automate the IoT deployment proces...
Dec. 1, 2015 11:00 AM EST Reads: 138
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Dec. 1, 2015 11:00 AM EST Reads: 513
Countless business models have spawned from the IaaS industry – resell Web hosting, blogs, public cloud, and on and on. With the overwhelming amount of tools available to us, it's sometimes easy to overlook that many of them are just new skins of resources we've had for a long time. In his general session at 17th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, an IBM Company, broke down what we have to work with, discussed the benefits and pitfalls and how we can best use them ...
Dec. 1, 2015 10:45 AM EST Reads: 129
In demand-intensive mobile and web applications, an emerging pattern is to host the Systems of Engagement in the cloud (for maximum responsiveness) but keep the Systems of Record with the other important business systems in the company datacenter, often on a tightly secured mainframe. But what about the space in between? In this IBM Redpaper publication, we show that the IBM Bluemix cloud platform offers technologies that make it easy for cloud-based SoEs to securely connect to on-premises IBM...
Dec. 1, 2015 10:19 AM EST
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Dec. 1, 2015 10:00 AM EST Reads: 577
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
Dec. 1, 2015 09:00 AM EST Reads: 481
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at Built.io, examined how Docker has evolved into a highly effective tool for application del...
Dec. 1, 2015 08:00 AM EST Reads: 397
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Dec. 1, 2015 08:00 AM EST Reads: 251
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Dec. 1, 2015 08:00 AM EST Reads: 396
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound...
Dec. 1, 2015 06:30 AM EST Reads: 515
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
Dec. 1, 2015 06:00 AM EST Reads: 273
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, San...
Dec. 1, 2015 05:00 AM EST Reads: 622