This opinion was written by Carmen Pérez Casas and Jessica Burry, with contributions from partners and collaborators[1]. It is based on the article “In critical condition: the urgent need to support mpox therapeutic and diagnostic pipelines,” published on 30 October 2025 in Clinical Infectious Diseases.
When mpox re-emerged as a global health emergency in 2024, the world was caught unprepared again. Despite years of warnings and two declarations as a public health emergency of international concern, people in the most affected regions are still without access to timely testing and treatment. Our recent article “In critical condition: the urgent need to support mpox therapeutic and diagnostic pipelines”, written together with partners and collaborators, highlights how much remains to be done. It is a reminder to us – as people dedicated to tackling access barriers – that access to lifesaving tools cannot be an afterthought.
At Unitaid, we are working to change that. Mpox has revealed the same weaknesses that slowed the COVID-19 response: fragmented systems, limited testing capacity, an empty therapeutic antiviral pipeline, and inequitable access to vaccines. Our pipeline analysis shows a clear gap between available tools and real-world needs, especially in low-resource settings. We believe that the global community must act now to fund mpox research and product development that put accessibility first, ensuring that innovation and equity move forward together.
Progress on diagnostics has been too slow. While a handful of molecular tests have been approved, rapid and affordable point-of-care tests that can be used in community clinics are still lacking. These are essential for early detection, especially in rural and remote areas. Without quick diagnosis, outbreaks continue to spread undetected. On the treatment side, the situation is even more concerning. Almost all mpox clinical trials to date have focused on one antiviral drug, tecovirimat, which has shown safety but not proven effectiveness in study populations and carries risks of developing resistance. Few studies include vulnerable groups such as children, pregnant women or people living with HIV even though these populations face the highest risk of severe disease.
We are working to help close these gaps Through our work at Unitaid, and building on our experience from HIV, tuberculosis and COVID-19, we are supporting efforts that strengthen innovation and access for mpox response, for today’s outbreak and future ones. Importantly, through our broader work on global health emergencies, Unitaid and 100 Day Mission partners are advancing the development of a Therapeutics Development Coalition. The goal is to remove fragmentation in research and development. It also aims to catalyze sustained funding for therapeutics that can be developed before the next pandemic hits. This effort covers all priority pathogens identified as having the highest potential to become dangerous and for which no effective or sufficient tools exist today, whether vaccines, diagnostics or therapeutics. It also ensures that equity is embedded from the earliest stages, rather than treated as an afterthought.
As a response to the current mpox outbreak, and given the scarcity of tools available, we are also supporting the introduction and evaluation of near point-of-care integrated diagnostic platforms that can bring testing to lower levels of the health system, closer to the most vulnerable; a key element of the mpox response.
Concretely, in partnership with the Aurum Institute, PATH, and the Clinton Health Access Initiative, we are supporting the Democratic Republic of Congo, Sierra Leone and other countries like Nigeria to ensure that rapid testing and effective care are integrated into the current response to protect the most vulnerable, including people with advanced HIV disease as well as pregnant women and their babies, and that affected communities are aware of the risks and can be at the forefront of the response.
In addition, through partnerships with the World Health Organization and the Africa Centres for Disease Control and Prevention (Africa CDC), and through our grants to organizations like PATH, we are helping to strengthen regional manufacturing and the evaluation of new diagnostics so that affordable, quality-assured tools are available closer to where they are needed.
Global preparedness must include mechanisms that guarantee timely access to diagnostics and therapeutics in every region, in addition to vaccines. Governments, donors and industry should commit to “access by design” as a standard for all future outbreak responses, in alignment with the recent WHO Pandemic Agreement.
The lesson from mpox is clear: the world cannot wait for the next outbreak to act. Investments made now will not only save lives today but will also build the foundation for faster, fairer responses to future threats. As Unitaid continues to strengthen pandemic preparedness from diagnostics and therapeutics to oxygen access and regional manufacturing, our goal remains the same: to ensure that no one is left behind when new health emergencies arise.
[1]Carmen Perez Casas, Jessica Burry, Nathalie Strub-Wourgaft, Emmanuel Agogo, Hanesh Chi, Sophie Crettaz, Devy Emperador, Kavi Ramjeet, Bastien Schyrr, Romain Wyss, Emily Bass, Mosoka Papa Fallah, In Critical Condition: The Urgent Need to Support Mpox Therapeutic and Diagnostic Pipelines, Clinical Infectious Diseases, ciaf529, https://doi.org/10.1093/cid/ciaf529