Diagnostics are fundamental for successful outbreak containment. In this supplement, ‘Diagnostic preparedness for WHO Blueprint pathogens’, we describe specific diagnostic challenges presented by selected priority pathogens most likely to cause future epidemics.Some challenges to diagnostic preparedness are common to all outbreak situations, as highlighted by recent outbreaks of Ebola, Zika and yellow fever. In this article, we review these overarching challenges and explore potential solutions. Challenges include fragmented and unreliable funding pathways, limited access to specimens and reagents, inadequate diagnostic testing capacity at both national and community levels of healthcare and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods. Addressing these challenges in an efficient and effective way will require multiple stakeholders—public and private—coordinated in implementing a holistic approach to diagnostics preparedness. All require strengthening of healthcare system diagnostic capacity (including surveillance and education of healthcare workers), establishment of sustainable financing and market strategies and integration of diagnostics with existing mechanisms. Identifying overlaps in diagnostic development needs across different priority pathogens would allow more timely and cost-effective use of resources than a pathogen by pathogen approach; target product profiles for diagnostics should be refined accordingly. We recommend the establishment of a global forum to bring together representatives from all key stakeholders required for the response to develop a coordinated implementation plan. In addition, we should explore if and how existing mechanisms to address challenges to the vaccines sector, such as Coalition for Epidemic Preparedness Innovations and Gavi, could be expanded to cover diagnostics.

Gross inequities in disease burden between developed and developing countries are now the subject of intense global attention. Public and private donors have marshaled resources and created organizational structures to accelerate the development of new health products and to procure and distribute drugs and vaccines for the poor. Despite these encouraging efforts directed primarily from and funded by industrialized countries, sufficiency and sustainability remain enormous challenges because of the sheer magnitude of the problem. Here we highlight a complementary and increasingly important means to improve health equity: the growing ability of some developing countries to undertake health innovation.

Given what institutional scholars have described as an inhospitable institutional climate for entrepreneurial business, why has the German biotechnology industry suddenly taken off, while in the UK, where a ''correct'' institutional architecture exists, has the industry shown signs of stagnation? To explain these trends the article develops a firm-centered approach, recognizing that firms work with institutional frameworks - often with help from public policies - to create new business strategies. The argument is developed that such processes are associated with the ''hybridization'' of business strategies at the micro level, combined with the generation of new constellations of particular institutional frameworks within relatively stable national models.

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India and China have made major progress toward establishing research-and innovation-based health biotechnology sectors. Local health needs, including diseases that predominantly affect the poor, have driven much of this success. We argue that emerging domestic firms can play an important role as reliable and high-quality suppliers of existing products and as innovators for global health needs. Indeed, these firms' participation may make existing global health approaches more sustainable. However, global health stakeholders, including international donors and the Indian and Chinese governments, will need to fashion incentives for these companies to retain a strategic focus on the global poor.