The Human Innovation Gap

Since the 1960s, there has been a significant decline in the number of new antimicrobials entering the . Alongside diminishing investments in these solutions, human behavioural patterns that do not promote good antimicrobial stewardship have resulted in humans losing our advantage with what used to be a full arsenal of tools at our disposal for tackling new pathogens. This exacerbates the negative impacts of increasing incidence of resistance and reflects a stagnation in efforts to develop new antimicrobials which are a key component of the strategy for addressing AMR and evolving pathogens.

Several interconnected factors contribute to this stagnation, including:

• High development costs and regulatory hurdles: The development of new antimicrobials is an expensive and time-consuming process. Pharmaceutical companies must invest heavily in research and clinical trials to demonstrate the safety and efficacy of new drugs, often taking decades to bring a product to market with a high financial risk for companies. In addition, regulatory approval processes are rigorous, further adding to costs and timeframes for bringing new antimicrobials to the market.

• Low profitability due to stewardship and conservation efforts: Unlike drugs for chronic conditions that patients take over long periods, antimicrobials are typically used for short treatments and are also subject to stewardship measures aimed at preventing their overuse and misuse. While these measures are critical for slowing AMR, they also reduce the potential for revenue generation for companies making new antibiotics less attractive for investment. As a result, pharmaceutical companies see limited returns on their investment, further disincentivizing the development of new antimicrobials.

• Complex manufacturing processes and supply chains: The nature of pharmaceutical supply chains introduces further challenges, including sourcing raw materials, ensuring regulatory compliance across different regions, and managing the logistics of distribution. These complexities add another layer of difficulty to bringing new antimicrobials to market.

• Market failures in incentivising long-term research: The current market system does not adequately reward long-term investments in antimicrobial R&D. Most pharmaceutical companies prioritise research in areas with higher commercial potential, such as chronic diseases. The long-term, global public health threat AMR poses needs to align with short-term market incentives, leading to a need for sustained investment in this critical area. There is also a limited number of funding mechanisms to de-risk investment in antimicrobial development, further exacerbating the issue.

• Educational gaps and diminishing expertise: There is a growing shortage of experts in antimicrobial research and development due to a perceived lack of job security in this field, leading to fewer scientists working on critical AMR issues in the field of R&D. The diminishing expertise hampers research and innovation efforts.

In addition to slowing down antimicrobial development, there is also a reduced availability of vaccines and rapid diagnostics for tackling AMR. The usage of vaccines to minimise the incidence of AMR (See Ref) and the presence of rapid diagnostic methods at the point of care (with a short turnaround time) to meaningfully inform clinicians before any antimicrobial is prescribed are impactful solutions which currently do not exist or exist in very few places, limiting the impact that these solutions can have on improving healthcare outcomes.