2009 TB Research Funding Trends, 2005 – 2008 – Second Edition

March 2010 – This is an update to Treatment Action Group’s 2009 report on funding trends for tuberculosis (TB) research and development (R&D) from the baseline year 2005 through 2008, the last year for which full data are reported. This edition includes updated information about the R&D investments of the Bill & Melinda Gates Foundation, the Research Institute of Tuberculosis, Japan Anti-TB Association (JATA) and the Japanese government.

Our purpose remains to document the world’s progress against the benchmark goals set forth by the Stop TB Partnership in the Global Plan to Stop TB: 2006–2015 and in TAG’s original report, which called for an increase in TB R&D spending to $2 billion per year, which will be required to eliminate TB by 2050.

For the 2009 report, TAG undertook this research tracking effort in conjunction with the Stop TB Partnership, and the George Institute’s G-FINDE R project to track Global Funding of Innovation for Neglected Diseases. In part, as a result of these partnerships, this years report tracks a larger number of donors than previously reported by TAG.

Here we report that in the year 2008, the top 71 reporting organizations invested a total of $491.5 million in TB R&D. This is a 4% increase over the 2007 total of $474 million—revised from the previously reported $483 million and a 38% increase in four years over the baseline year of 2005. While the absolute number continues to grow, the slow and steady pace of the increase is insufficient to achieve research investment levels needed to produce the new knowledge and tools that will be critical to eliminating TB.

Of the $491.5 million reported to TAG by the 71 investors in TB R&D in 2008, $265 million (54%) came from the public sector, $155 million (31%) from the philanthropic sector, and $72 million (15%) from the private sector.

Public-sector investment continued to decrease relative to total investment from nearly 65% in 2005 to 54% in 2008. Philanthropies—almost entirely represented by the Bill and Melinda Gates Foundation—made up the largest increase in proportion to total investment rising from 24% in 2005 to 30% in 2008. Private-sector investment rose slightly from 12% of total investment in 2005 to 15% in total investment in 2008.

In 2008, for the first time since TAG began reporting, the Gates Foundation outstripped the U.S. National Institute of Allergy and Infectious Diseases (NI AID ) at the National Institutes of Health (NI H) as the biggest funder of TB R&D at $148 million compared with NI AID ’s $105 million. The NI H as a whole spent $188 million on TB R&D in 2007 and just $142 million in 2008 according to recently revised estimates published by the NI H in “Estimates of Funding for Various Research, Condition, and Disease Categories” (http://report.nih.gov/rcdc/categories/; accessed on 26 October 2009). NI H investment in TB R&D may recover in 2009–2010 due to the American Relief and Recovery (economic stimulus package) Act of 2009, but will then fall back in 2011 unless the overall NI H budget increases substantially.

Investment in basic science decreased from 24% of TB R&D investment in 2007 to 20% at $99 million in 2008. Most publicly funded institutions that traditionally support basic research suffered from the economic crisis. The NI H supported 56% ($56 million) of global investment in basic science on TB in 2008, with 40% of it ($40 million) coming from NI AID alone.

Diagnostics research continues to be underfunded. The world only invested $50 million in this area of research in 2008, an embarrassingly slight increase from 2007’s $42 million. In 2008 TB diagnostics R&D received just 10% of TB R&D funding.

For the fourth year, TB drug development received the greatest investment, 35% of the total, and had the most funders (over 28) of any research category. This area is showing great promise, with two drugs from entirely new classes advancing into phase 2 studies to treat drug-resistant TB, and phase 3 studies ongoing with fluoroquinolones for treatment shortening of first-line therapy. However, current infrastructure remains grossly insufficient to carry out further phase 3 and postmarketing studies of new TB drugs.

Inadequate funding for TB vaccine R&D has been a concern in past reports, but this area received a significant increase in funding last year, rising from 15% to 22% of the total TB R&D investment in just one year. Most of the increase was attributable to a large grant from the Gates Foundation to the Aeras Global TB Vaccine Foundation.

Investment in operational research remained flat in 2008 at $34 million, nearly the same as in 2007. This category is crucial to support studies that integrate new and existing tools and knowledge into TB programs and to document their impact at the programmatic, national, and population levels. Insufficient funding for operational research will severely delay implementation of new and better tools.

In this report we are able to document significant or growing contributions to TB R&D from emerging economies with high TB-burden such as Brazil, China, India, South Africa, and South Korea. We are encouraged by their growing investment in TB, a disease that exacts such a high toll on their people and their economies.

Every year sponsors of TB research report a series of common concerns that the continued but anemic growth of R&D investment has failed to mitigate:

• There is need for increased basic science research as there are critical deficiencies in the understanding of pathogenesis of TB.
• Funding for TB R&D is grossly inadequate relative to its impact in terms of disease and death it causes.
• The lack of research capacity in areas of the world where the disease is common hinders rapid progress.
• Linked to the need for increased basic science research in particular is the lack of useful biomarkers that can be used to diagnose TB, provide a prognosis, and monitor the impact of vaccination or treatment.

In 2008, the TB research community was on the cusp of some major scientific breakthroughs. For the first time in nearly 40 years two new classes of TB drugs were close to entering phase 3 clinical trials. There was movement in the areas of genomics, biomarkers, and antigen research that, if coordinated, could yield a first generation point-of-care TB diagnostic test within a few years. However, current funding levels and research capacity and infrastructure are inadequate to conduct the studies needed. The trends that TAG documents in this report demonstrate the urgency of greater political leadership among policy makers, donors, researchers, and activists to increase the level of funding, address the bottlenecks in TB R&D, and fulfill the promise that the recent progress has made possible.