Biotechnology, key to curbing antimicrobial resistance and strengthening European health security

Antimicrobial resistance (AMR) has become a global health threat that jeopardizes the progress of modern medicine and the effectiveness of essential treatments. According to a recent study published in The Lancet, in 2021 AMR was associated with at least 4.7 million deaths worldwide, including 35,000 annual deaths in Europe and nearly 4,000 in Spain. The World Health Organization (WHO) warns of a sustained increase in resistant infections —one in six in 2023— particularly those caused by multidrug-resistant Gram-negative bacteria such as Escherichia coli and Klebsiella pneumoniae. Beyond its clinical impact, AMR places a significant economic and social burden, underscoring the urgent need for responsible antimicrobial use and equitable access to medicines, diagnostics and vaccines.

In the face of this challenge, biotechnology is emerging as a strategic ally for developing new antibiotics, therapies, vaccines and rapid diagnostic tools, as well as for applying artificial intelligence and large-scale data analytics to epidemiological surveillance. In this context, and within the framework of World Antimicrobial Awareness Week, AseBio —through its One Health Working Group— held the event “Biotechnology for a Safer Future” on 21 November at MSD’s headquarters in Madrid

Rapid and advanced diagnostics: key to curbing resistance

Rapid diagnosis of bacterial resistance is essential to ensuring more effective and safer treatment of infections. Early detection of resistant pathogens not only allows for more precise therapy adjustment but also contributes to responsible antibiotic use, reducing the spread of resistance.

Implementing these tools in hospitals requires close coordination between scientific research, the biotechnology industry and healthcare systems, as well as the integration of new technologies into daily clinical practice.

“Advances in diagnostic technologies are transforming microbiological diagnosis by enabling the identification of pathogens and the detection of resistance mechanisms with unprecedented speed and precision,” explained Teresa Coque, pharmacist and PhD in Microbiology from the Complutense University of Madrid, currently working in the Microbiology Department of the Ramón y Cajal Hospital.

She noted that advanced diagnostic techniques such as mass spectrometry (MALDI-TOF) and infrared spectroscopy (FTIR) allow for rapid identification of bacteria and epidemic clones, streamlining diagnostic workflows in hospitals. Multiplex PCR systems, including miniaturized PCR-on-chip devices, can simultaneously detect several pathogens and resistance genes in less than two hours, with syndromic panels proving especially valuable in complex infections such as sepsis, pneumonia or meningitis.

Rapid DNA sequencing combined with large-scale data analysis and machine learning offers significant potential for identifying resistance variants and developing diagnostic and prognostic biomarkers, advancing the field toward precision medicine. However, its routine use is still limited by costs and infrastructure needs. Its maximum effectiveness is achieved when integrated into antimicrobial stewardship programs (ASPs), combining rapid diagnostics with therapeutic strategies and continuous care to reduce resistance, enhance antibiotic selection and optimize clinical outcomes.

Immunization: prevention to reduce antibiotic pressure

Immunization has become a key strategy for preventing infections and reducing the emergence of antibiotic resistance, supported by biotechnological advances that enable the development of safer and more effective vaccines for humans and animals, following a One Health approach. However, challenges remain in the development, prioritization and implementation of new vaccines, which require coordination among research, industry and healthcare systems, as well as strategies that promote their acceptance and coverage across different populations.

“Thanks to the support of international organizations committed to combating antibiotic resistance, we are overcoming the technological and clinical challenges needed to build protective immunity in at-risk populations. But we need this message to reach healthcare professionals and the people who will benefit from these solutions,” said Juan José Infante, CEO of Vaxdyn.

“No one wants to be incapacitated by a recurrent urinary or respiratory tract infection that does not respond to antibiotics. No one wants to interrupt cancer treatment or cause suffering to their loved ones because of resistant infections. This is the reality for vulnerable populations: people with chronic kidney disease, or diabetics who must go to the hospital for any intervention. We can and must protect them,” Infante stressed, adding that “for these solutions to reach patients, we must communicate their value to healthcare professionals so that they themselves demand these innovations.” 

Big Data, bioinformatics, and AI: new tools for epidemiological surveillance

The combination of bioinformatics, large-scale data analysis, and artificial intelligence tools is transforming the surveillance of antimicrobial resistance. These technologies enable the identification of emerging patterns, anticipation of outbreaks, and guidance of more effective health policies, optimizing the response to resistant infections. “Artificial intelligence is allowing the integrated analysis of clinical, microbiological, and genomic data to identify emerging patterns of antimicrobial resistance and anticipate outbreaks preventively—before they manifest as clinical cases,” said Ane Goikolea, researcher at Vicomtech.

These techniques are applied in decision-support systems that combine real-time diagnostic information with digitalized clinical guidelines, facilitating faster and more consistent decisions in infection management. Predictive models have also been developed based on electronic health records and large historical blood culture databases, “capable of anticipating the likelihood of resistant bacteremia and generating early alerts for clinical teams.” Real-world data trials have demonstrated improved sensitivity in identifying multidrug-resistant pathogens and the potential to reduce overtreatment, highlighting for specialists the key variables underlying each recommendation.

Despite their potential, integrating these tools faces significant challenges, particularly regarding interoperability between hospitals and countries, and the protection of health data privacy. Goikolea emphasized that “important challenges remain to integrate these tools into European health systems. We need true interoperability between hospitals, laboratories, and countries, based on common standards that allow data to flow seamlessly.” She also highlighted the need to ensure privacy using technologies such as federated learning or differential privacy. “Only with robust data infrastructures and clear governance frameworks will we be able to deploy artificial intelligence safely and effectively at a European scale,” she concluded.

Addressing AMR from a One Health perspective

The One Health approach recognises that human, animal and environmental health are interconnected, and that only through coordinated action across sectors is it possible to curb the spread of antibiotic resistance. To achieve this, it is essential to implement integrated policies and innovative biotechnological solutions that prevent the emergence of new resistances and foster collaboration among scientific research, industry, public authorities and society at large.

“For HIPRA, One Health shapes the very foundation of our purpose: we work in both animal and human health, with a strong commitment to prevention and to solutions that connect both fields, with sustainability as a transversal pillar. The company brings more than 50 years of experience working with over 300 pathogens and developing high-quality, innovative vaccines for animal health and, for the past five years, also for human health,” said Carlota Gómez, Executive Director of Corporate Affairs and Sustainability at HIPRA.

“Thanks to the synergies created between both divisions, HIPRA is uniquely positioned to understand and prevent zoonotic diseases, reducing the use of antibiotics and contributing to the fight against antimicrobial resistance. This integrated vision is essential to addressing potential health crises, and at this point the biotechnology industry has a key opportunity to drive innovative solutions that strengthen surveillance, prevention and response capacity.”

The Role of the European Regulatory Framework and Innovation Incentives

To effectively drive innovation against antimicrobial resistance (AMR) and strengthen Europe’s strategic autonomy, it is essential to have a regulatory framework that stops treating antibiotics as conventional commercial products and recognizes them as critical health infrastructure.
In this regard, Bruno González-Zorn, Professor and Head of the Antimicrobial Resistance Unit at the Complutense University of Madrid, emphasizes the need for incentive models that decouple economic returns from sales volume, promoting mechanisms such as subscription models or innovation prizes, which are currently being discussed at the European level.

He also highlights the priority of strengthening coordination among Member States, aligning policies on surveillance, prudent antimicrobial use, and R&D funding under a fully operational One Health approach. The creation of integrated European surveillance networks connecting human, veterinary, and environmental data, together with sustained investment in biotechnology, diagnostics, and new antimicrobials, will not only address the current crisis but also anticipate future threats.
González-Zorn stresses that “Spain has the knowledge, talent, and scientific capacity; what is now needed is political will and a long-term, coherent strategy to transform that capacity into real health security and innovation.”

At the closing of the event, Cristina Nadal, Second Vice President of AseBio and Executive Director of Government Affairs at MSD, highlighted the key role of biotechnology companies in developing innovative solutions —in prevention, diagnostics, and treatment— to tackle AMR. She also valued the initiatives already underway, some led by AseBio’s OneHealth-RAM Working Group, which help to raise awareness, generate understanding at multiple levels, and promote new incentives for research.

Nadal emphasized that a health challenge of this magnitude cannot be addressed solely by industry, and that a fully multidisciplinary and cross-sectoral approach is required. Understanding human, animal, and environmental health as one health is essential. She also stressed the critical role of the media in communicating this urgent message from the scientific community to society.

Finally, at the national level, she highlighted strategic instruments such as the National Plan against Antimicrobial Resistance (PRAN), the National Strategy for the Pharmaceutical Industry, and the forthcoming European Biotechnology Law, which represent opportunities to implement push & pull incentives, foster the development of new antimicrobials, and enhance recognition of the value that these drugs provide to patients, healthcare systems, and society as a whole.