novel and improved diagnostic tests for TB are urgently needed to control the epidemic that continues to affect

more than nine million people every year. Existing tests are slow, insensitive or expensive and require highly specialized facilities which are difficult to provide in resource-poor countries such as India, where TB is rampant. The current in-vitro diagnostics market, particularly molecular tests, in India is dominated by imported, expensive products. But India has the potential to solve its TB problem with "home-grown" solutions. Just as Indian pharma and biotech companies revolutionized access to high-quality, affordable AIDS drugs and hepatitis vaccines through generic production; Indian diagnostic companies could also become the world's hub for high-quality generic diagnostics. Two million new TB cases every year, India has the highest burden of TB in the world. Despite this large burden, Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. The conference featured several panel discussions comprised of a mix of different stakeholders that highlighted the challenge of R&D in TB diagnostics from its different angles and facets. The general challenges that industry representatives voiced can be summarised as: lack of clear definition of minimum and optimum target product profiles from either the Revised National TB Control Programme, users or donors; unclear definition of the size and nature of the TB diagnostics market in India; lack of clarity on what price points to aim for; limited access to sample repositories (for test development and validation) and R&D facilities for TB; poor regulatory mechanisms to evaluate new tests and assure quality; unclear prequalification process for TB tests by the World Health Organisation; general difficulties in accessing knowledge, infrastructure and qualified human resources required for innovation; lack of awareness about funding opportunities; weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia and general disconnect with the patient or end user; and a generally non-conducive culture for innovation that reduces creative confidence within companies. RNTCP should clearly articulate its diagnostic needs, and publish clearly defined target product profiles that test developers and industry partners and funders can aim for A preliminary analysis by McKinsey and Company suggests that the TB diagnostics market in India might be in the ballpark of about $100 million, although there is considerable uncertainty surrounding the estimates from the private sector. The RNTCP screens over 7.5 million people with suspected active TB every year, and a similar number is likely to seek care in the private sector. Thus, at least 15 million persons with suspected TB will need to be tested, and that should translate into a fairly sizeable market. Diagnostics will be needed to diagnose extrapulmonary TB, MDR-TB, childhood TB, and latent TB infection.

Companies, especially those not working in TB, seem to want mentorship or technical advice on TB, and it is not clear who they can approach for such issues. Indian TB Diagnostics Task Force must be formed, comprised of a small group of relevant stakeholders, with clear objectives and timelines. Such a Task Force would be able to support, fund and guide diagnostics test developers, academics and industry, liaise with governmental agencies such as RNTCP and Drug Controller General of India [DCGI], and to test and validate any new promising technologies, through the network of already existing research institutions. The Bangalore conference was clearly a first step to begin a dialogue among the stakeholders and to support networking among potential partners. A lot more needs to be done. A major challenge will likely be in continuing the engagement of various stakeholders. There is a general lack of collaboration and coordination, and lack of clarity on what various stakeholders want: Who is the consumer and what does she/he need? What does industry want and need to innovate in TB? What are the diagnostic needs of the RNTCP (target product profiles)? How can governmental agencies (e.g. Department of Biotechnology [DBT], Indian Council of Medical Research [ICMR], Translational Health Science and Technology Institute [THSTI] and Council of Scientific and Industrial Research [CSIR]) work together in supporting TB innovations? Given the overall lack of industry engagement in TB, even if a handful of companies and stakeholders make a serious effort at developing innovative products for TB, that would be a big success.

Diagnostic tests for TB in India slow, insensitive or expensive. Molecular tests, in India are dominated by imported, expensive products. Big opportunity for Indian diagnostic companies. Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. recent conference at St. Johns Research Institute (SJRI) in Bangalore o Unclear definition of the size and nature of the TB diagnostics market in India. o lack of clarity on what price points to aim for o poor regulatory mechanisms to evaluate new tests and assure quality; o lack of awareness about funding opportunities o weak or non-existent collaboration between RNTCP and industry, between industry and clinicians o a generally non-conducive culture for innovation that reduces creative confidence within companies. TB diagnostic market in India= $100 million (by McKinsey and Company) Landscaping the diagnostic market= RNTCP screens over 7.5 million people + 7 million screen in private sector. Hence, 15 million people needed to be treated, which could be the size of the diagnostic market.