Molecular diagnostic tests for infectious diseases are proving to be one of the highest-growing segments of the in vitro diagnostics market. Accordingly, companies that participate in the clinical diagnostics industry understand that their market participation might be crucial to their future success. However, some segments of the infectious disease molecular diagnostics market are already well established and don’t offer much of an addressable opportunity for new market entrants. Therefore, it’s vital that companies understand where the true opportunities remain.
The technology is complex and labor-intensive, limited only to clinical laboratories with the resources and skilled staff that can meet CLIA requirements. Furthermore, the tests are expensive and run on different systems that end-users would have to install should they wish to perform them.
The molecular diagnostics market is fragmented, and there is no single vendor that can provide a comprehensive suite of products. Thus, only clinical laboratories with substantial resources for implementation can position themselves to provide molecular diagnostics to the medical community.
Given the small test menu on each system, it is primarily the size of the test volume that warrants adoption. Large national laboratories have the economies of scale to provide molecular diagnostics. Naturally, the largest segments in the molecular diagnostics market are human immunodeficiency virus (HIV) testing, hepatitis C virus (HCV) testing, and Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) testing.
The growth rates in these market segments have been stagnant, even declining. The markets are saturated, and the competition is intense. Two emerging molecular diagnostics markets, however, are enjoying rapid growth rates and even have the potential to surpass the market size of the more established infectious disease tests. The two emerging molecular diagnostics markets are human papillomavirus (HPV) testing and methicillin-resistant Staphylococcus aureus (MRSA) screening.
HPV Diagnostic Market
HPV, a sexually transmitted virus, has been clinically proven to be the primary cause of cervical cancer. This virus has been found in more than 99% of cervical cancers, and it continues to be one of the most astounding medical findings that an infectious disease can cause cancer.
In the U.S. and other developed countries, widespread screening programs have been in place for decades to reduce the incidence of cervical cancer. The introduction of the Pap test more than 50 years ago transformed the management of cervical cancer.
The Pap test, however, is subjective in nature and found to have a clinical sensitivity of roughly 80%. The stains used to identify deformed cells as a result of persistent HPV infection can be difficult to interpret. Direct testing for HPV with molecular diagnostics is entirely objective and when combined with the Pap test, clinical sensitivity is virtually 100%. There is tremendous value in HPV testing in the fight against cervical cancer and test volumes continue to soar.