The $200M+ U.S. HPV molecular testing market will continue to grow despite increasing HPV vaccine usageBy David CavanaughThis article has been corrected to reflect a U.S. MDx HPV market size of $200M+, instead of $300M+ as originally cited. This adjustment has been made based on a more rigorous assessment of the HPV market. On Wednesday, the U.S. Centers for Disease Control and Prevention (CDC) announced the results of a study that “reveals that since the [HPV] vaccine was introduced in 2006, vaccine-type HPV prevalence decreased 56 percent among female teenagers 14-19 years of age.” This result was a pleasant surprise to scientists and public health officials, especially given the relatively limited use of the HPV vaccine (two currently available in the U.S.: Gardasil marketed by Merck & Co and Cervarix marketed by GlaxoSmithKline).On the surface, this news could be interpreted to mean that widespread adoption of the HPV vaccine could ultimately drive down future demand for HPV molecular (DNA / RNA based) tests. HPV molecular testing is a big business in the U.S., with over 10 million tests conducted per year. It is one of the top three most frequently conducted molecular tests, generating $200M+ in revenue for test manufacturers (including Qiagen, Hologic, BD and Roche). One would think that lower HPV incidence would drive a reduced need for HPV molecular testing. In the U.S., HPV molecular tests are typically conducted as a “reflex test” (secondary screening) when routine Pap smears (primary screening) identify abnormal cytology. So it seems logical that lower HPV incidence would translate to a reduced incidence of abnormal cytology and thus a reduced need for the reflex HPV molecular test. However, in reality there are a number of factors that will drive continued growth in the HPV molecular testing market:

• Treatment guidelines in the U.S. are moving towards a “co-testing” primary screening paradigm in which women receive both a Pap smear and an HPV molecular test simultaneously. In 2012, the American Congress of Obstetricians and Gynecologists (ACOG) announced new guidelines that recommend co-testing as the preferred screening method for women ages 30 and older. The benefit of including HPV molecular testing to Pap smears is that it is more sensitive, helping to identify more women that are at high risk for cervical cancer and it also allows for less frequent testing (co-testing recommended frequency is every 5 years vs. every 3 years for Pap alone)
• Treatment guidelines continue to recommend that HPV-vaccinated women follow the same cervical cancer screening guidelines as unvaccinated women. These recommendations will help drive continued HPV molecular testing even in vaccinated women
• HPV testing in men is expected to grow significantly. Today, very few men are tested for HPV, because it has not historically been perceived as a men’s health issue. This view is changing, as awareness of the health risks of HPV for men grows, especially for throat cancer. The actor Michael Douglas recently reported in The Guardian that his throat cancer was caused by HPV, helping to drive awareness of the issue and reducing its stigma. And there is growing scientific evidence that he is not alone. Recent studies have demonstrated that throat cancer is on the rise in the U.S. and that HPV may be the culprit in over 70% of cases. DeciBio expects that men will increasingly request HPV testing as part of their routine health exams
• ---
• Follow David Cavanaugh at https://plus.google.com/107070112832044351945/posts