The global marketplace for healthcare-associated infections (HAIs) caused by Gram-negative bacteria across the seven major pharmaceutical markets (7MM) is projected to exceed $3.6 billion in sales by 2026, at a compound annual growth rate (CAGR) of 10.8% from 2016–2026, according to GlobalData, a recognised leader in providing business information and analytics.

The company’s latest report, PharmaPoint: Healthcare-Associated Gram-Negative Infections – Global Drug Forecast and Market Analysis to 2026 reveals that market growth will be dominated by the launch of multiple pipeline products, which will contribute a combined 73% of the sales across the 7MM in 2026.

Owing to the lack of novel scaffolds being developed during the last few decades and limited investments into antibiotic R&D in recent years, the prevalence of resistant Gram-negative bacteria, especially in the hospital setting, has increased significantly; antibiotic resistance is now considered a major threat to the life expectancy of current and future generations.

The single most important driver of growth will be the launch of several new products during the forecast period. These novel drugs will not only provide additional treatment options, especially for HAIs with carbapenem-resistant Enterobacteriaceae (CRE), but will also drive overall market growth, as these products will have higher price points than the generic products currently dominating the market.

The increased prevalence of antibiotic resistance, particularly of strains with resistance against carbapenems, will also stimulate growth, as treatment options for those infections will include novel, branded antibiotics with improved clinical profiles over currently available “last-resort” antibiotics, such as polymyxins.

Christopher Pace, Director of the Infectious Diseases team at GlobalData, commented: “The continuous evolution of Gram-negative bacteria and increasing prevalence of resistance against second-line antibiotics provides a constantly changing and growing range of opportunities for companies to enter the market. However, companies must identify novel approaches, both scientifically and economically, to capitalize on these opportunities.”

Despite the access to a broad variety of antibiotic classes and individual products, which are often highly cost-effective because of the availability of generic options, the market landscape for HAIs caused by Gram-negative bacteria is characterised by a significant number of unmet needs, both clinical and environmental.

The main driver for the precipitous increase of clinical unmet needs, even after the launch of new products, is the adaptability of Gram-negative bacteria and their ability to evolve highly effective resistant mechanisms.

This requires the continuous replenishment of the antibiotic pipeline to combat novel defensive mechanisms. The ability of bacteria to develop and spread the genes for resistance also underscores the need for the development of novel products targeting specific bacteria, permitting targeted therapy.

Pace added: “The need for targeted therapies, which could partially be addressed by pipeline antibiotics, is further highlighted by the growing importance of antibiotic stewardship programs that provide guidance adapted to local circumstances.”

Increased awareness of the problems caused by multidrug-resistant (MDR) bacteria has resulted in national and international programs to reduce the overall usage of antibiotics, especially of novel products with activity against MDR strains. GlobalData expects this awareness to counteract some of the growth opportunities in the marketplace across the 7MM.

Pace continued: ‘‘To promote the utilisation of narrow-spectrum products, companies could work to increase the effectiveness of diagnostics to ensure improved diagnosis rates and physicians’ confidence that the diagnosis is not limited by possible false negatives.”

“Demonstrating superiority for specific pathogens, infection sites, and/or resistance mechanisms will provide products with a well-characterised market niche with limited competition, even at treatment costs far exceeding generic products.’’