Despite the massive need for new TB drugs, the commercial viability of the TB drug market has long been viewed as questionable at best. Reports suggest that there is a substantial market that will grow year-over-year, though there is no firm conclusion about its commercial viability. The first widely-circulated analysis was done by the Global Alliance for TB Drug Development (TB Alliance) in 2001, which concluded that “The potential market for a new anti-TB drug is estimated to range from $316 million to $432 million ($US).” Since then, further reports by the TB Alliance and others continue to support the idea of a viable market for new TB therapeutics.
Certainly, many in the TB R&D field realize that long duration of treatment, poor tolerability, and drug:drug interactions, have resulted in poor TB outcomes and fueled the development of multi- and extensively drug resistant TB strains. However, the over-burdened and under-resourced health care systems that are tasked with treating the vast majority of TB infected individuals don’t have the resources it takes to provide the financial incentives traditionally needed to fuel drug development.
Cost restraints limit the review of the full report and data, as the WGND is unable to purchase a full report to review at this time. However, based on information made available by the Global Industry Analysts, Inc., the report suggests that the global TB therapeutic market is estimated to increase ~US$100 million every three years (Figure 1).
However, there are many questions that surround this data, such as whether the world annual revenues provided includes both first- and second-line drugs (or first-line drugs alone), what was the criteria for determining which 35 companies are actively involved in TB R&D and how does the number of companies involved in TB R&D translate to the market?
In 2007, the TB Alliance issued an updated analysis of the TB drug market entitled “Pathways to Patients: Charting the Dynamics of the Global TB Drug Market” (study overview – .pdf – 997kb) that followed-up their earlier analysis from 2001 entitled “The Economics of TB Drug Development” (executive summary – .pdf – 1,300kb)
The 2007 report, which sought to evaluate the flow of TB drugs through the market by studying 10 countries, 6 of which are classified as WHO ‘high burden’ nations for TB, and 4 high income countries, and to provide a global estimate for the first-line TB drug market projected a high end estimate of US$310 million to US$418 million. These value estimates are similar to the values presented in figure 1, however as noted above it is unclear if the values in figure 1 are for first-line drugs alone.
Difficulties in estimating second-line TB drug costs exist for myriad reasons. To quote the 2007 TB Alliance report:
“There are a number of potential treatments included in second-line regimens, and there is variance in prescribing practices, length of regimen as well as adherence rates. Similarly, costs also vary dramatically across countries and there is no realistic ‘average cost’ for second-line regimens.”
Figure 2 depicts the estimated costs of first- and second-line TB drugs of studied countries from both the public and private sectors.
At the least, these publications present data and information that suggest a new TB drug will not translate into a blockbuster drug for one pharmaceutical company. These publications better suggest that while there is a small global market for new TB drugs, this market space must be viewed within the context of the standard cost of drug development, estimates of which range from $800M all the way up to $1B. Even if we were to accept, on faith, the premise that the market for new TB drugs will grow by $100M every few years (which is unfortunately an indication that the world’s TB problem is continuing to worsen), the available financial market is certainly not lucrative enough to support, on financial grounds, the R&D binge needed to address the profound flaws in the current treatment regimen.
Are TB drugs commercially viable despite reports that it costs ~US$1 billion to bring a drug to market? What cost cutting measures could be implemented to reduce the costs and increase the speed of delivering a safe, effective, and potent novel TB drug to market? Should commercial viability even be a factor considering the global rise in drug resistant TB strains? Please share your thoughts.