Portfolios: Which companies produce important antibacterial and antifungal products?
By using antibiotics inappropriately, we drive drug resistance rates and make these medicines less effective. Yet, millions of people around the world cannot access antibiotics when they need them. For the pharmaceutical companies that produce and supply these medicines, the challenge is to work with governments and others to make these medicines more accessible, particularly in low- and middle-income countries, while supporting the stewardship efforts that will prevent their inappropriate use or overuse.
The 2020 Antimicrobial Resistance Benchmark has mapped the antibacterial and antifungal portfolios of the biggest players in the anti-infectives market. It also pinpoints the focus of company's portfolio and whether they have products listed on the 2017 WHO Model List of Essential Medicines (EML) — a list of products deemed to be essential for healthcare systems. The WHO EML categorises antibiotics into three groups: Access, Watch and Reserve. The three groups describe which antibiotics should be used more readily and which ones need to be carefully conserved.
- Access antibiotics: 1st- and 2nd-line treatments that should be widely available. For these, companies need broad strategies to improve access: e.g., registration filings, affordability measures, stronger supply chains.
- Watch antibiotics: To manage antibiotics in this group, companies need a nuanced approach, integrating suitable access plans with stewardship practices designed to limit misuse and overuse and to predict emerging resistance trends.
- Reserve antibiotics: Last-resort treatment options against the most severe, resistant infections, for when all other antibiotics fail. Companies must engage in stewardship activities that ensure their appropriate use and closely monitor resistance.
How many products are on the market?
In 2020, a total of 1,520 antibacterial on antifungal medicines and/or vaccines are already available by 22 companies, including all eight large R&D-based companies, all nine generic medicine manufacturers and five small and medium-sized enterprises. Over 80% of the total products are antibacterial medicines, while less than 4% are vaccines.
More than 40% of marketed products have been flagged as priorities
More than 600 antibacterial and antifungal products are on the WHO Model Lists of Essential Medicines. Collectively, companies have far more Access groups antibiotics than ones in the Reserve group. Access antibiotics should be widely available, affordable and quality assured. WHO advises that antibiotics in its Reserve category are used only to treat the most resistant pathogens, when all alternative treatments have failed. This is essential to minimise the chances of resistant strains from emerging. Such tight control will keep demand low. Nevertheless, it is critical that adequate supplies of quality-assured Reserve antibiotics are always available.
Since the publication of the first Benchmark in 2018, major changes in the market landscape for antibacterials have occurred. We have reached a tipping point where large drugmakers have retreated from the antibiotics field and smaller biotech companies (SMEs) have gone bankrupt due to the poor financial rewards on offer. As such, the companies in scope of this Benchmark are the remaining major actors that play a key role in shaping a market that is becoming more fragile.
Which large R&D-based companies produce the most products?
The eight companies in this group have over 590 antibacterial and/antifungal medicine or vaccine products on the market, including 39 on-patent products. These products are mostly Access group antibiotics. Pfizer has the largest portfolio with a total of 190 antibacterial and/or antifungal medicines and vaccines on the market.
Which generic medicine manufacturers produce the most products?
Generic medicine manufacturers have larger portfolios on average, and a greater proportion of Watch and Reserve antibiotics than other company groups. The generic medicine manufacturers evaluated in the Benchmark have just over 850 antibacterial and/or antifungal medicine and vaccine products on the market. The largest producer of these products is Teva, followed by Mylan.
Which pharmaceutical SMEs produce the most products?
Typically, pharmaceutical SMEs have smaller portfolios compared to larger R&D-based companies or generic medicine manufacturers, as much of their focus is on R&D and the development of new medicines that are novel. However, some pharmaceutical SMEs maintain a portfolio of marketed products as well as an R&D pipeline. There are five such companies in the scope of the 2020 AMR Benchmark. Together, they have 68 antibacterial and/or antifungal products on the market, with Wockhardt producing over 85% of these products.
* Includes anti-TB medicines with Reserve group properties
** Includes anti-TB medicines with Watch group properties
*** Includes anti-TB medicines without Watch or Reserve group properties