In this report, the World Health Organization's Special Program for Tropical Diseases Research (TDR), in collaboration with the Foundation for Innovative New Diagnostics (FIND), has compiled existing epidemiological data and generated a wealth of new data on the availability of TB laboratory services, variations in physician diagnostic practices, workloads of national laboratory networks, and manufacturer's sales to authoritatively document the volume and market value of TB diagnostic testing in nearly 200 countries. Customer requirements and R& D opportunities are clarified and the major scientific, financial, and market entry challenges specific to TB diagnostic development are presented alongside short and long term strategies and solutions. Furthermore, the potential future TB diagnostic market is estimated for a range of hypothetical new diagnostic tests covering the three major testing indications. Fourteen countries are profiled in detail to complement the global perspective. This report drafted with extensive input from experts in tuberculosis and public health, as well as from private industry, provides essential data and knowledge to dispel common myths and inform investment decisions by industry foundations, government organizations, and world health and financial organizations. The report is comprised of seven chapters, fourteen country profiles, and an appendix addressing global in vitro diagnostic regulatory practices and classification schemes.