Commercial Opportunity or Addressing Unmet Needs-Loop-Mediated Isothermal Amplification (LAMP) as the Future of Rapid Diagnostic Testing?

Loop-Mediated Isothermal Amplification (LAMP) technology is emerging as a rapid pathogen testing method, potentially challenging the RT-PCR "gold standard". Despite recent advancements, LAMP's widespread adoption remains limited. This study provides a comprehensive market overview and assesses future growth prospects to aid stakeholders in strategic decision-making and policy formulation. Using a dataset of 1134 LAMP patent documents, we analyzed lifecycle and geographic distribution, applicant profiles, CPC code classifications, and patent claims. Additionally, we examined clinical developments from 21 curated clinical trials, focusing on trends, geographic engagement, sponsor types, and the conditions and pathogens investigated. Our analysis highlights LAMP's potential as a promising rapid pathogen testing alternative, especially in resource-limited areas. It also reveals a gap between clinical research, which targets bacterial and parasitic diseases like malaria, leishmaniasis, and tuberculosis, and basic research and commercial efforts that prioritize viral diseases such as SARS-CoV-2 and influenza. European stakeholders emphasize the societal impact of addressing unmet needs in resource-limited areas, while American and Asian organizations focus more on research, innovation, and commercialization.

Upscaling vaccine manufacturing capacity - key bottlenecks and lessons learned.

The COVID-19 pandemic put enormous pressure on the vaccine production chain as billions of vaccines had to be produced in the shortest timeframe possible. Vaccine production chains struggled to keep up with demand, resulting in disruptions and production delays. This study aimed to make an inventory of challenges and opportunities that occurred in the production chain of the COVID-19 vaccine. Insights derived through approximately 80 interviews and roundtable discussions were combined with findings from a scoping literature review. Data were analysed through an inductive process where barriers and opportunities were linked to specific facets of the production chain. Key bottlenecks identified include a lack of manufacturing facilities, a lack of tech-transfer personnel, inefficient arrangement of production stakeholders, critical shortages in raw materials, and restricting protectionist measures. A need for a central governing body to map out shortages and to coordinate allocation of available resource became evident. Other suggested solutions were to repurpose existing facilities and to build in more flexibility in the production process by making materials interchangeable. Also, simplification of the production chain could be achieved through geographical reengagement of processes. Three overarching themes were identified, impacting overall functioning of the vaccine production chain: regulatory and visibility, collaboration and communication, and funding and policy. The results in this study showed a multitude of interdependent processes underlying the vaccine production chain, executed by diverse stakeholders with differing objectives. It characterizes the global complexity of the pharmaceutical production chain and highlights its extreme vulnerability to disruptions. More resilience and robustness must be integrated into the vaccine production chain, and low-middle income countries should be empowered to manufacture vaccines themselves. In conclusion, there's a need to rethink the production system for vaccines and other essential medicines in order to become better prepared for future health crises.

Lower Respiratory Tract Infection Trends in East and South-East Asia: In the Light of Economic and Health Care Development.

This study explored to what degree economic development and improvement of healthcare are associated with lower respiratory tract infection (LRTI) mortality. A correlation analysis between LRTI mortality and Gross Domestic Product (GDP) per capita, and the Health Access and Quality Index (HAQI), respectively was conducted for 15 countries in East and South-East Asia. The results revealed a dramatic decrease in LRTI mortality in total populations for lower-middle income (LMI) countries but at the same time an increase in upper-middle income (UMI) and high-income (HI) countries. A highly significant (P < .001) growth-dependent relationship between LRTI mortality and economic growth was observed. Improvements in HAQI were significantly associated with a decrease in LRTI mortality in LMI countries, but an increase in UMI and HI countries. The decline of LRTI mortality amongst children in LMI countries is an encouraging trend and efforts against LRTI must be continued, though not at the expense of preparing health systems for the growing burden.