Technology pulse: Opportunties with a twist

In the December 2012 issue of GEN, it was reported that by 2014 the global in vitro diagnostics (IVD) market is forecasted to surpass the $50 billion milestone. The two key drivers of demand are infectious disease testing and an aging population that is growing more susceptible to chronic disease such as arthritis, autoimmune diseases, asthma, diabetes, and cardiovascular diseases and cancer (which accounts for 12.5% of all deaths worldwide, more than HIV/AIDS, TB and malaria combined). Molecular diagnostics, which makes up more than 10% of the market, is one of the fastest growing segments with an 11% CAGR forecast. Together this means that molecular diagnostics will play an important role in these two market drivers.

Another major consideration is that clinical molecular testing remains a practice primarily in the developed world with greater than 80% of the molecular assays performed in North America and Western Europe. Nevertheless as reported in the 2013 Kalorma report on The World Market for Molecular Diagnostics: "IVD manufacturers and commercial laboratories have established partnerships in the top seven emerging markets: Brazil, Russia, India, China, South Korea, Mexico and Turkey." The Chinese market will be the largest in Asia within the next 10 years. While further opportunities for growth, as represented by the developing world are tantalizing, one must take into account that these countries often lack the widespread healthcare infrastructure of the US and Western Europe that utilize the more expensive platforms and tests because of their efficiency, and clinical performance. Because they are more expensive, particularly molecular tests, manufacturers face challenges in demonstrating the impact such tests could have on reduction of the disease burden and other appropriate health outcome measures such as detecting diseases early when they are more treatable and less costly.

As paradoxical as this might seem, there is a new perspective that rationalizes the higher cost of new technologies with better and lower healthcare costs. To explain this point, let’s focus on the infectious disease segment of growth. Worldwide, infectious or communicable disease, such as HIV/AIDS cause one in three deaths, and almost all these deaths occur in the non-industrialized world(1). In addition to effective treatments/vaccines, detection of diseases like HIV and TB early or in the chronically infected population would provide a means to target treatments more effectively. However, traditional methods like microbial culture are time-consuming and modern labs require special facilities and highly trained personnel that far and few between in many countries. In China, for example, only the top 50 hospitals out of 18,000 hospital-based labs have the resources to buy the type of clinical laboratory equipment used in developed countries. With molecular testing offering advantages of high throughput, rapid results with greater sensitivity, the critical question is, can the cost of such platforms be justified? They could if they were fully utilized to screen as much of the target population as possible, which in many cases in the developing world means accessing remote populations. Technologies that enable simple sample collection, sample stabilization and low-cost transport represent one such approach that would not add significant costs to the diagnosis and indeed could lower the cost of collection and transport. One of the best examples of this is the screening for HIV infections in Sub-Saharan Africa. The benefits and effectiveness of reaching the population in remote locations have been clearly validated in studies over the last several years (2-5).

The second major driver in diagnostic testing is the aging demographic in the industrialized world. Here again more cost-effective widespread screening programs would enable the detection of early disease such as cancer as well as monitoring for any changes in disease progression in chronic conditions. Perhaps more than in the case of infectious disease, this segment represents an even larger testing population because in many industrialized countries like the US, Europe, China and Japan, this population is the fastest growing cohort. With age comes the increased risk of many chronic diseases. Clearly widespread screening by traditional means is costly to already overburdened healthcare systems. As different as this need may seem from the infectious disease burden in the developing world, the maximum utilization of the same technology platforms utilizing simple cost-effective sample collection that can be conducted remotely or in the privacy of one’s home can provide similar benefits and maximum efficiency of stretched resources.

1. UC Atlas of Inequality-http://ucatlas.ucsc.edu/cause.php
2. Anitha et. al., Int J Biol Med Res. 2012; 3(1): 1369-1372, Comparative study of venous liquid blood and dried blood for HIV infection in infants
3. Ciaranello et al. BMC Medicine 2011, 9:59, Early infant HIV-1 diagnosis programs in resource limited settings: opportunities for improved outcomes and more cost-effective interventions.
4. HIV/AIDS in Ethiopia: The Clinton Health Access Initiative and UNITAID, August 2011
5. Fonjungo PN, Girma M, Melaku Z, et al. Field expansion of DNA polymerase chain reaction for early infant diagnosis of HIV-1: The Ethiopian experience. Afr J Lab Med. 2013;2(1), Art. #31, 7 pages