Drawing on structured interviews with more than 30 global stakeholders, along with case studies of Ebola, dengue and H5N1 influenza, the report identifies six major and interconnected barriers across the diagnostics ecosystem: 

• Limited research and development (R&D), including underinvestment, delays in access to pathogen sequence data, and a lack of clearly defined target product profiles
• Severe challenges in accessing and validating samples, with weak infrastructure for reference standards and biobanking
• Fragmented and inconsistent regulatory systems, which lack harmonised processes and agile emergency pathways
• Highly concentrated manufacturing, with limited regional capacity and technology transfer, particularly in low and middle-income countries
• A suboptimal financing model, characterised by unpredictable demand, lack of financial incentives, fragmented procurement and inadequate mechanisms for surge investment.
• Structural and systemic weaknesses, including poor coordination, limited clinical adoption and weak integration with vaccines and therapeutics development pathways 

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