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.