There is a significant mismatch between the need for new antimicrobials and the traditional pharmaceutical business model.
Pictured: Illustration of Mycobacterium tuberculosis bacteria forming a biofilm/iStock, Dr_Microbe
The world is in desperate need of new antimicrobials to treat pathogens that have evolved to evade existing treatments. According to the Centers for Disease Control and Prevention (CDC), in 2019 antimicrobial resistance (AMR) killed at least 1.27 million people globally and was associated with nearly 5 million deaths. And the situation is expected to get worse.
But developers face commercial hurdles and research is dwindling. Clearly, there is a significant mismatch between the unmet medical need and the market forces at play. The traditional pharmaceutical business model is broken for AMR and change is imperative.
As CEO of Er-Kim, a company partnering with biopharma companies to introduce innovative treatments outside the U.S. and Western Europe, I have observed firsthand the urgent need to address antimicrobial resistance. And I believe that entering international markets first, as my company has done with some partners developing treatments for HBV or resistant fungal infections, could help meet this pressing challenge.
Antimicrobial Resistance: How We Got Here and What Needs to Change
For areas such as oncology and rare diseases, it may be appropriate for companies to follow traditional business models focusing on the U.S. and select Western countries, as these core markets can generate 40–70% of total revenue for many therapeutics. When it comes to AMR, approximately 93 percent of deaths occur outside of these regions, meaning that new antimicrobials are not always considered a revenue generator. However, an approach focusing on distribution to these emerging markets—for example, in countries such as Greece, Romania and Kazakhstan, to name a few—can be successful, both from a public health and a commercial standpoint.
For one, current demand for AMR products in these markets is extremely high, exceeding that in the U.S. by an order of magnitude. So even at reduced prices, companies could expect to see sizeable revenue gains from sales. Furthermore, our discussions with payors in these and other regions reveal a willingness to consider premiums over generic alternatives, meaning that a substantial discount may not be required.
However, for the biopharma industry to blaze a new path into these emerging markets and tackle the AMR crisis will require several shifts in traditional drug development strategy.
What Biopharma Companies Developing New Antimicrobials Need to Consider
One important consideration will be the distribution of novel antimicrobials that make it to market. Each individual market is relatively small, but the sum of the markets is great. Thus, it is important to look at the geographic breadth, and not depth, to ensure commercial viability of a product.
Once the drugs have gotten where they need to go, optimal pricing will be critical. Income levels, unmet needs and cost containment issues vary widely among the different emerging markets such that there is no one-size-fits-all pricing model. in some countries, confidential discounts of up to mid- to double-digit percentages might be required to enable widespread access. Concurrently, there is increasing receptiveness to the fixed monthly payment model introduced by the National Institute for Health and Care Excellence (NICE), particularly in regions where AMR is exacerbated by significant overuse. But where possible, price premiums should be the goal to reward innovation.
The biopharma industry also needs to encourage antimicrobial stewardship and responsible use by healthcare providers. Antimicrobial stewardship (AMS) refers to the optimal selection, dosing and duration of antimicrobial treatment resulting in the best clinical outcome with minimal subsequent resistance. By nature, infections will mutate and develop resistance, and our responsibility as an industry is to educate and promote responsible engagement of treatments.
Relatedly, I do not believe new antimicrobials should be heavily promoted. As such, a carefully thought-out, non-promotional model that enables access to medicines via Named Patient Programs or Emergency Use Authorizations can align very well with effectively delivering the treatment while minimizing the cost and overhead associated with obtaining a marketing authorization via a full commercialization strategy.
The rapid emergence of resistant bacteria is occurring worldwide and threatening the efficacy of existing antibiotics. While there is a high demand for AMR products, especially outside of the U.S., I believe that with industry collaboration and new product innovation and distribution, a larger number of patients will be able to have access to life-saving treatments.
Cem Zorlular is CEO of Er-Kim, a specialty pharmaceutical company that serves as a regional affiliate to small and large pharma and biotech companies to commercialize their medicines in markets that fall outside of the U.S. and Western Europe. Learn more at https://www.er-kim.com/.
