GlobalData report explores antibiotics market opportunity
By Mia Burns
The rising demand for antibiotics to counter increasing cases of drug-resistant infections, combined with decreasing R&D costs, is presenting an ideal opportunity for pharma manufacturers to launch novel products into the marketplace, according to a new report from GlobalData. Analysts state in the report that during the upcoming years, the growing level of threat from multidrug-resistant bacteria, particularly gram-negative organisms, will be a key driver behind the growth of the antibiotics market in the United States, France, Italy, Germany, Spain, and the United Kingdom.
GlobalData analysts say that a stagnant antibiotic pipeline has escalated medical concerns caused by multidrug-resistant bacteria in these countries, and a significant unmet need exists for novel antibiotics to counter the problem. However, low returns on investment, primarily caused by expensive R&D processes and convoluted regulatory requirements have been deterring drug manufacturers from developing new products.
Public-private partnerships represent an alternative business model that effectively aligns clinical and commercial needs, according to the company. As a result, regulators, pharma companies and physicians are now working more closely than ever to remove a number of obstacles for keen developers.
“According to GlobalData, the traditional R&D ‘blockbuster’ pathway is no longer a realistic approach to developing novel antibiotics, as it does not effectively align clinical unmet need with commercial viability,” Christopher Pace, Ph.D., GlobalData’s healthcare analyst covering infectious disease told Med Ad News Daily. “Public-private partnerships will allow firms to maximize return on investment by distributing financial risk among multiple stakeholders. For example, big pharma will rely on academic labs and small and medium enterprises to conduct early-stage R&D (discovery and preclinical studies) while leveraging its clinical development expertise to more efficiently bring drugs to market. Financial backing from governments also represents an important aspect of the public-private partnerships model and is expected to play a key role in all stages of the R&D process. GlobalData expects that these partnerships, which should help to minimize the risk associated with antibacterial R&D, will lead to the development of antibiotics targeted towards niche patient populations with the greatest clinical unmet need, such as multidrug-resistant gram-negative infections.”
Among the examples of small and medium enterprises are Cubist Pharmaceuticals, which larger than a typical small and medium enterprise, but is still what most are striving for in terms of pipeline; Trius Therapeutics and Optimer Pharmaceuticals, which Cubist has acquired; Paratek Pharmaceuticals; Sequella; ActiveBiotics Pharma; and Tetraphase Pharmaceuticals, Brad Tebbets, Ph.D., GlobalData’s healthcare analyst covering infectious disease told Med Ad News Daily.
The analysts say that they anticipate a mixture of push, pull, and hybrid mechanisms will encourage progress through all stages of antibiotic development. “Various push incentives have been implemented to subsidize the upfront costs associated with early-stage antibiotic research and development,” says Dr. Tebbets. “Various push incentives have been implemented to subsidize the up-front costs associated with early-stage antibiotic research and development. GlaxoSmithKline’s Discovery Fast Track Competition, Wellcome Trust, and the Innovative Medicines Initiative are all examples of public-private programs designed to encourage antibiotic research and development. Pull mechanisms are outcome-based incentives that reward companies for the regulatory approval of a drug. Exclusivity extensions, patent vouchers, monetary prizes, and differential pricing are all examples of pull incentives. The Generating Antibiotic Incentives Now (GAIN) Act is a pull incentive designed to encourage antibiotic development by streamlining the regulatory approval process and extending the exclusivity period for a novel antibiotic. Push and pull incentives work on opposite ends of the drug development process. As the drug progresses past early-stage development, the impact of a push incentive begins to wane, but the enticement of a pull mechanism is not fully realized until the drug enters late-stage development. The resulting gap between push and pull incentives often hinders drug development. Hybrid incentives are designed to bridge this gap. Project Bioshield and the Orphan Drug Act are examples of programs that employ a hybrid mechanism.”
Posted: September 2013