Postmenopausal Vaginal Atrophy Therapeutics Market is Forecast to Witness High Growth until 2019

Wednesday 18 April 2012, Amsterdam

The “Postmenopausal Vaginal Atrophy Therapeutics - Pipeline Assessment and Market Forecasts to 2019” report is an essential source of information on the global postmenopausal vaginal atrophy therapeutics market, and provides analysis of a number of key areas. The report identifies the key trends shaping and driving the global postmenopausal vaginal atrophy therapeutics market and provides insights into the current competitive landscape and emerging companies expected to significantly alter the market positioning of current market leaders. Most importantly, the report provides valuable insights into the pipeline products within the global postmenopausal vaginal atrophy sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.

Postmenopausal Vaginal Atrophy Therapeutics Market is Forecast to Witness High Growth until 2019

This analysis indicates that the global postmenopausal vaginal atrophy therapeutics market was worth $1,634.5m in 2011, after increasing at a Compound Annual Growth Rate (CAGR) of 8.0% during 2006-2011.The market is expected to grow at a CAGR of 8.5% during 2011-2019 to $3,144.3m in 2019. Estrogen Replacement Therapy (ERT) is the mainstay of treatment for postmenopausal vaginal atrophy patients. The currently used treatment options can be divided into four categories: vaginal cream, vaginal tablets, vaginal rings and oral estradiol, all of which are types of ERT. Estrace cream (estradiol) by Warner Chilcott and Premarin cream (conjugated estradiol) by Pfizer are examples of vaginal creams, while Vagifem (estradiol) is a vaginal tablet and is marketed by Novo Nordisk. Femring (estradiol, extended release) by Warner Chilcott and Estring (estradiol acetate, extended release) by Pfizer are types of vaginal ring. Oral estradiol is least preferred treatment option because its usage is associated with adverse events such as deep vein thrombosis, Coronary Heart Disease (CHD), stroke, and invasive breast cancer. Of these treatment options, vaginal cream and vaginal tablets are most widely used. The growth witnessed during 2006-2011 was due to increasing awareness of postmenopausal vaginal atrophy among patients and physicians, which resulted in increased diagnosis and treatment rates. The market is expected to show high growth during the forecast period (2011-2019) due to the expected launch of Phase III FIC pipeline molecules Vaginorm (dehydroepiandrosterone) and Ophena (ospemifene) in the US. They will further improve patient compliance through improved safety and efficacy profiles and therefore drive market growth during the forecast period.

Safety Concern, Low Diagnosis and Low Levels of Treatment-seeking Behavior are the Main Unmet Needs

This analysis suggests that postmenopausal vaginal atrophy therapeutics market has significant unmet need in terms of a low diagnosis rate, low levels of treatment-seeking behavior among menopausal women, and safety concerns associated with ERT. The vaginal ring drug class has already been issued a black box warning by the US Food and Drug Administration (FDA). With regards to diagnosis, women are often reluctant to discuss symptoms such as vaginal dryness, vaginal burning and discomfort during intercourse with healthcare professionals, leading to a low diagnosis rate and low treatment-seeking rate. ERT is associated with a number of adverse effects. Usage may lead to endometrial cancer, cardiovascular disorders, breast cancer and dementia. This significant unmet is likely to be fulfilled in the future by the launch of Vaginorm and Ophena, which have better safety and efficacy profiles and will further drive the postmenopausal vaginal atrophy therapeutics market.

Current Competition in the Postmenopausal Vaginal Atrophy Therapeutics Market is Weak

This analysis suggests that current competition in the postmenopausal vaginal atrophy therapeutics market is weak because it is dominated by products such as Premarin, Estrace, Vagifem, Femring and Estring, all of which are types of ERT.

These products are associated with a number of adverse events which cause poor patient compliance and present significant concerns to physicians treating postmenopausal vaginal atrophy. Premarin, Vagifem and Estrace are the most widely prescribed drugs. Vaginal cream and vaginal tablets are more convenient to use than vaginal rings, and they are associated with fewer adverse events than oral estrogen therapy (systemic). Thus, vaginal cream and vaginal tablets are the preferred modes of treatment.

The Pipeline of Postmenopausal Vaginal Atrophy Therapeutics Market is Strong with Predicted Launch of Two First-in-Class Molecules

This analysis shows that the postmenopausal vaginal atrophy therapeutics pipeline is strong with nine molecules in various Phases of development. There are three molecules in Phase III, one molecule in Phase II, one molecule in Phase I and three molecules in the Pre-clinical Phase. There is one molecule for which the Phase of development is unknown.

Two of the molecules in Phase III, Vaginorm and Ophena, are company-sponsored, First-in-Class (FIC) and have displayed good levels of safety and efficacy in clinical studies. Both are expected to enter the US market in 2014. Vaginorm is a type of Dehydroepiandrosterone Replacement (DHEAR) therapy, while Ophena is a Selective Estrogen Receptor Modulator (SERM). ERT is the only treatment option for postmenopausal vaginal atrophy patients, but the launch of Ophena and Vaginorm will have a significant impact on the treatment pattern.

Overall, these two late stage FIC pipeline molecules will fulfill some of the unmet need in the postmenopausal vaginal atrophy therapeutics market.