The following is a guest blog post by Drs. Madhukar Pai and Nora Engel.
A recent conference at St. John´s Research Institute (SJRI) in Bangalore, India brought together for the first time more than 200 representatives from industry, government, donors, academia, civil society and the media to discuss what it takes to innovate in tuberculosis (TB) diagnostics in India and to move from importation and imitation to innovation. The goal was to stimulate industry interest and investments in TB innovations. Despite the enormous burden of TB in India, Indian industry and academics have not developed any new tools (diagnostics, drugs or vaccines) for TB. Why has India failed to innovate in TB R&D? The conference in Bangalore provided some clues.
To begin with, there is considerable confusion about the exact size and nature of the TB diagnostics market in India and elsewhere. A preliminary analysis by McKinsey and Company suggested that the annual TB diagnostics market in India might be in the ballpark of about $100 million, although there was uncertainty surrounding the estimates from the private sector which does not report TB. The Indian TB control program (RNTCP) screens more than 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. In addition, diagnostics will be needed to diagnose extrapulmonary TB, multidrug-resistand TB (MDR-TB), childhood TB, and latent TB infection. If a good, point-of-care test were to be developed, it might open the option of intensive and active case finding, increasing the overall number of patients identified. Furthermore, if a new test were to be developed on a platform that can be used for other diseases, then this opens new markets beyond TB. Lastly, there is a large potential market outside of India. Clearly, a more detailed TB market size analysis will be enormously helpful to engage both industry and funders.
Another big concern was lack of clearly defined target product profiles (TPP) from the RNTCP, users or donors. “What products should we develop, and if we did develop products will the RNTCP purchase them?” were questions on the minds of industry representatives. According to a presentation by a senior RNTCP official: What the RNTCP needs most is a new point-of-care test for active TB that is simple, easy, cheap and can be performed with minimal training at primary healthcare level; in addition, the program needs an indigenous, economical, simple, automated (battery operated) or manual molecular test to detect drug resistance that can be done in a peripheral lab with minimal training. This wish list will need to be converted into clearly defined TPPs that test developers and funders can aim for.
Other concerns raised by industry included: lack of access to Indian sample repositories for test development and validation, and limited R&D facilities for TB (e.g. BSL3 laboratories); poor regulatory mechanisms to evaluate new tests and assure quality; an unclear prequalification process for TB tests by the World Health Organization; general difficulties in accessing knowledge, infrastructure and qualified human resources required for innovation; a lack of venture capital funding for R&D and a lack of celebrity/philanthropic support from within India; and a lack of awareness about funding opportunities, weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia. In addition, there are the usual barriers to innovation in India.
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 issues specific to TB. When and how should companies engage with the RNTCP for advice, possible endorsement or evaluation? What is the exact procedure for companies to access the government market for TB tests? How will the RNTCP decide on which tests to scale-up, and how much is the RNTCP willing to spend? What is the target price that companies to should aim at?
As more TB products are developed, it is not clear which agency or organization can conduct head-to-head validation studies to identify the best products for scale-up. More importantly, which agency or organization should take on a convening role and serve as the “honest broker” to bring together key stakeholders that make up the complete value chain for TB innovations in India?
Increased industry involvement and investment in TB R&D is an important goal. While the Bangalore conference was clearly a first step to begin a dialogue among the various stakeholders, it became clear that a lot more work is needed to address the needs industry articulated.
Dr. Madhukar Pai is a professor and TB researcher based at McGill University, Montreal, Canada. He serves as co-chair of the Stop TB Partnership’s New Diagnostics Working Group (NDWG), and as a consultant to the Bill & Melinda Gates Foundation (BMGF). The views expressed in this article are the author’s own and do not necessarily reflect those of NDWG or BMGF.
Dr. Nora Engel is assistant professor in Global Health, Department of Health, Ethics and Society at Maastricht University, Netherlands. In her PhD thesis Tuberculosis in India: A case of innovation and control,she draws on innovation studies and science and technology studies to examine innovation dynamics in organizational, strategic, technological and service delivery aspects of TB control in India. It will be published as a book by Orient Blackswan in 2012.