How do countries procure TB diagnostics? How autonomous is their decision making? How much is it influenced/guided by WHO and/or donors?
- Who are the major buyers in developing countries (e.g. Ministries of Health (MoH), laboratories, National TB Programs (NTPs), international donors)? What is the reimbursement environment for diagnostics?
- What are the most important MOH concerns, and how does the MOH procure, direct procurement, and make decisions on vendors (e.g. tenders)?
- How important are ‘consumers’ in the various developing markets?
- What are the market access challenges and options for addressing them? Specifically, is procurement linked to regulatory approval? Will each country require an independent study of a TB diagnostic, or is a single study sufficient?
- What are the logistics and distribution challenges? How fragmented is the distribution pathway? What will be necessary to set up a distribution and supply chain? Who pays for distribution, the manufacturer or the purchaser? Are these issues separate for public and private sector purchasing and distribution, or is there a single national or centralized process in countries?
- Are there regulations such as taxes/import duties in country that affect business models?
- What will be required by developers/suppliers to provide sales and after-sales support, as well as service and maintenance in a reliable manner?
- Will countries use a mix of different products using the same technology (i.e. different NAAT tests from different manufacturers)?