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.

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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.

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